louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02883478: Clinical and Structural Outcome of Conventional Versus Accelerated Corneal Collagen Cross-linking (CXL).
Official title: A Randomized Study of Clinical and Structural Outcome of Corneal Collagen Crosslinking (CXL) With Conventional Versus Accelerated Ultraviolet-A Irradiation Using Riboflavin With Hydroxypropyl Methylcellulose (HPMC).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Keratoconus
Corneal Ectasia
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2016-08-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Compare different corneal parameters and visual outcome of corneal collagen cross-linking (CXL) with conventional versus accelerated ultraviolet-A irradiation using riboflavin with hydroxypropyl methylcellulose.

Detailed description: 40 patients with signs of progressive keratoconus are randomized to either corneal collagen cross-linking (CXL) with conventional ultraviolet-A (UVA) irradiation at 3 milliwatt/cm² (mW/ cm²) or accelerated ultraviolet-A (UVA) irradiation at 9 mW/ cm². In both groups riboflavin with hydroxypropyl methylcellulose was used. The objectives of this study are to evaluate and compare different corneal parameters (maximum corneal curvature, depth of collagen cross-linking, endothelial cell density) and clinical outcomes of uncorrected visual acuity (UCVA) and best spectacle corrected visual acuity (BSCVA)) after CXL with conventional and accelerated UVA irradiation.

Eligibility criteria: Inclusion Criteria:

* Patients with increase of minimum of 1,0 diopter in maximum keratometry.
* Patients with increase in corneal astigmatism of minimum 1,0 diopter.
* Patients with in spherical equivalent of min 0,5 diopter.
* Patients living in Eastern Norway.

Exclusion Criteria:

* Minimum pachymetric corneal thickness (Pentacam)\<360 µm.
* Central corneal scar.
* Chemical burn, serious corneal infections and ocular surface diseases.
* Pregnancy.
* Lactation.

Primary outcomes:
measure: Compare change in maximum corneal curvature, visual acuity, endothelial cell density and depth of cross-linking in CXL with conventional versus accelerated UVA irradiation.
timeFrame: 2 years
Secondary outcomes:
measure: Compare depth of corneal collagen cross-linking on anterior segment optical coherence tomography and confocal microscopy with change in endothelial cell density in CXL with conventional versus accelerated ultraviolet-A irradiation.
timeFrame: 2 years
measure: Compare depth of corneal collagen cross-linking on anterior segment optical coherence tomography and confocal microscopy with change in maximal corneal curvature (Kmax) and visual acuity in CXL with conventional versus accelerated UVA irradiation.
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06087978: Study of RPT193 in Healthy Adult Male Subjects
Official title: A Phase 1, Open-Label Study to Characterize the Absorption, Metabolism, Excretion (ADME), and Mass Balance of a Single Oral Dose of [14C]-RPT193 in Healthy Adult Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Male Subjects
Lead sponsor: RAPT Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2023-10-18
Enrollment: 7
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Phase 1, open-label, absorption, metabolism, excretion, and mass balance study.

Detailed description: A study of RPT193 in healthy volunteers to evaluate the route(s) of elimination and overall mass balance of RPT193 in urine and feces

Eligibility criteria: Inclusion Criteria:

* Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to dosing
* Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at the screening

Exclusion Criteria:

* Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit
* History or presence of clinically significant medical or psychiatric condition or disease
* History or presence of alcohol or drug abuse within the past 2 years prior to dosing
* History or presence of:

  * Gastrointestinal ulcers, or history of other significant GI diseases
  * Malignancy within the last 5 years, with the exception of successfully treated basal cell carcinoma.
  * Clinically significant history of angina, myocardial infarction, syncope, clinically significant cardiac arrhythmias, left ventricular hypertrophy, cardiomyopathy, or any other cardiovascular abnormality
  * Ongoing or recent (within 30 days prior to RPT193 administration) bacterial, fungal, or viral infection requiring therapy
  * Known family history of sudden death.
* Positive for human immunodeficiency virus, hepatitis B, hepatitis C
* Unwilling to abstain from alcohol, xanthane-containing beverages or food or foods containing grapefruit/Seville orange prior to admission
* Received radiolabeled substances or exposed to radiation sources over past 12 months

Primary outcomes:
measure: Route(s) of elimination 1
timeFrame: 14 days
measure: Route(s) of elimination 2
timeFrame: 14 days
measure: Quantitate total radioactivity (TRA)
timeFrame: 14 days
measure: Characterize pharmacokinetics (PK) profile of RPT193
timeFrame: 14 days
measure: Characterize pharmacokinetics (PK) profile of RPT193
timeFrame: 14 days
measure: Characterize pharmacokinetics (PK) profile of RPT193
timeFrame: 14 days
measure: Characterize pharmacokinetics (PK) profile of RPT193
timeFrame: 14 days
measure: Characterize pharmacokinetics (PK) profile of RPT193
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Celerion
state: Nebraska
Study officials:
References:
Clinical trial NCT05505578: A Digital Intervention to Improve Physical Activity and Sleep Behaviors in Youth With Psychiatric Diagnoses
Official title: GamerFit: A Digital Intervention to Improve Physical Activity and Sleep Behaviors in Youth With Psychiatric Diagnoses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychiatric Diagnosis
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Merrimack College
First posted: 2022-08-17
Enrollment: 62
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of "GamerFit" is to test the delivery of a theory-based mHealth app that utilizes social support, exergaming, and telehealth coaching to improve PA levels, sleep, and psychiatric symptoms among youth participants (ages 13-17 y) with PD. In order to aid future intervention optimization, up to 65 participants with at least one PD will be randomized, with 30-35 using the GamerFit app with weekly telehealth coaching sessions and 30-35 using a commercial healthy habits app as a comparator group


Eligibility criteria: Inclusion Criteria:

* 13-17 years of age (child/participant)
* At least one PD diagnosis (excluding eating disorders) confirmed by parent report of physician diagnosis (child/participant)
* IQ≥85/no intellectual disability that precludes participation confirmed by parent report (child/participant)
* Can understand verbal English-language exergaming instructions (child/participant)
* Physically capable of exercise confirmed by parent report (child/participant)
* Has access to a smart phone or compatible tablet (child/participant)
* Willing to download and use the app (child/participant)
* Willing and able to be present during telehealth coaching sessions (parent)
* Can have a competent translator present during coaching sessions if not fluent in English (parent)

Exclusion Criteria:

- Families for whom the mPIs think the study and/or intervention is clinically/medically inappropriate (e.g. developmental delay, or emotional or cognitive difficulties, if the PI believes these factors will interfere with study/intervention participation)

Primary outcomes:
measure: Feasibility of the App
timeFrame: 12 weeks
Secondary outcomes:
measure: Physical Activity
timeFrame: 12 weeks
measure: Sleep
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
city: North Andover
country: United States
facility: Merrimack College
state: Massachusetts
Study officials:
affiliation: Pennington Biomedical Research Center
name: Amanda E Staiano, PhD, MPP
role: PRINCIPAL_INVESTIGATOR
affiliation: Merrimack College
name: April Bowling, MA, ScD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05349578: Gastric Swab for Helicobacter Pylori Detection
Official title: A Prospective Comparison of Cotton Swab Method and Conventional Biopsy Sampling in Rapid Urease Test for Helicobacter Pylori Detection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter Pylori
rapid urease test
swab
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-04-27
Enrollment: 69
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: A randomized controlled trial for comparing the Helicobacter pylori test using the swap method and the method using the conventional biopsy.

Detailed description: The aim of this study is to conduct a prospective study under the hypothesis that a cotton swab method in the rapid urease test is not inferior to the conventional biopsy.

Eligibility criteria: Inclusion Criteria:

* Adults aged 20-80
* Patients who undergo esophagogastroduodenoscopy and need for investigation of Helicobacter pylori infection.

Exclusion Criteria:

* Surgical history of any kind of gastrectomy
* Patients with contraindication of esophagogastroduodenoscopy

Primary outcomes:
measure: Accuracy
timeFrame: the same day wtih EGD
Secondary outcomes:
measure: sensitivity, false positive, false negative rate, etc.
timeFrame: the same day wtih EGD
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University
Study officials:
References:
Clinical trial NCT02354378: A Pilot Study to Assess the Amnesic Properties of Dexmedetomidine in Pediatric Patients
Official title: A Pilot Study to Assess the Amnesic Properties of Dexmedetomidine in Pediatric Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Memory
Dexmedetomidine
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Memorial Sloan Kettering Cancer Center
First posted: 2015-02-03
Enrollment: 84
Sex: ALL
Minimum age (years): 4
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children between the ages of 4 and 14 years old either requiring sedation or attempting without sedation for MRI imaging will be offered inclusion in the study. Sedation will be administered per established and approved BCH sedation guidelines: over 10 minutes, a bolus of 2 mcg/kg of dexmedetomidine will be administered intravenously. The sedation process will not change for this study. During the bolus, pictures will be shown to the child who will be encouraged to name the item in the picture.

Brief summary: The goal of this study is to determine the effects of dexmedetomidine on memory and recall of children who are receiving dexmedetomidine sedation administered for magnetic resonance imaging (MRI) studies. Dexmedetomidine is currently the standard drug for sedation for diagnostic (MRI, computerized tomography (CT) and Nuclear Medicine) radiological studies at Boston Children's Hospital (BCH). The effect of dexmedetomidine on memory and recall in children has not been studied.


Eligibility criteria: Inclusion Criteria:

* The patient must be between 4 and 14 yrs of age and be undergoing a therapeutic or diagnostic procedure with or without sedation
* The patient must be able to comprehend and perform the task (naming pictures)
* The patient must have a minimum weight of 8 kg

Exclusion Criteria:

* Allergy to Dexmedetomidine (for those patients requiring sedation)
* Procedure of short duration (\< 15 min)
* Pregnancy
* Recent use (within 5 half-lives) of centrally acting medications that could affect concentration (e.g. diphenhydramine)

Primary outcomes:
measure: Sedation Threshold
timeFrame: Until the child has reviewed cards and is under sedation or for the control group has reviewed 100 cards
Secondary outcomes:
measure: Memory Threshold
timeFrame: Until 100 cards have been presented to the child. Approx. 10 minutes.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Keira Mason, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mason KP, Kelhoffer ER, Prescilla R, Mehta M, Root JC, Young VJ, Robinson F, Veselis RA. Feasibility of measuring memory response to increasing dexmedetomidine sedation in children. Br J Anaesth. 2017 Feb;118(2):254-263. doi: 10.1093/bja/aew421.
Clinical trial NCT03555578: Specified Drug-Use Survey of Leuprorelin Acetate Injection Kit 11.25 mg "All-Case Investigation: Spinal and Bulbar Muscular Atrophy (SBMA)"
Official title: Specified Drug-Use Survey of Leuprorelin Acetate Injection Kit 11.25 mg "All-Case Investigation: Spinal and Bulbar Muscular Atrophy (SBMA)"
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spinal and Bulbar Muscular Atrophy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2018-06-13
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: SBMA patients treated with Leuprorelin Acetate Injection Kit 11.25 mg as part of routine medical care

Brief summary: The purpose of this survey is to evaluate the long-term safety and efficacy of leuprorelin acetate injection kit 11.25 mg in patients with spinal and bulbar muscular atrophy (SBMA) in the routine clinical setting.

Detailed description: The drug being tested in this survey is called leuprorelin acetate injection kit 11.25 mg. This injection kit is being tested to treat people who have SBMA.

This survey is an observational (non-interventional) study and will look at the long-term safety and efficacy of the leuprorelin acetate injection kit 11.25 mg in the routine clinical setting. The planned number of observed patients will be approximately 300.

This multi-center observational trial will be conducted in Japan.

Eligibility criteria: Inclusion Criteria:

* All SBMA patients who have been confirmed as receiving the drug

Exclusion Criteria:

* None

Primary outcomes:
measure: Percentage of Participants who had One or More Adverse Drug Reactions
timeFrame: Up to 1 Year
measure: Percentage of Participants who had One or More Serious Adverse Events
timeFrame: Up to 1 Year
Secondary outcomes:
measure: Percentage of Participants without Death Event
timeFrame: At final assessment point (up to 8 years)
measure: Percentage of Participants without Pneumonia Requiring Hospitalization Event
timeFrame: At final assessment point (up to 8 years)
measure: Percentage of Participants without Composite Events of Death and Pneumonia Requiring Hospitalization
timeFrame: At final assessment point (up to 8 years)
measure: Percentage of Participants without Dysphagia Events
timeFrame: At final assessment point (up to 8 years)
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Takeda Selected Site
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04654078: Study to Evaluate the Pharmacokinetic Characteristics and Safety of IN-C004 in Healthy Volunteers
Official title: An Open-label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics and Safety of IN-C004 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: HK inno.N Corporation
Sponsor class: INDUSTRY
First posted: 2020-12-04
Enrollment: 48
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To evaluate the pharmacokinetic characteristics and safety of IN-C004 in healthy volunteers

Detailed description: An Open-label, Randomized, Single-dose, Crossover Study

Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) ≥19.0 kg/m2 and ≤27.0 kg/m2 with a body weight ≥ 45 kg at screening.

Exclusion Criteria:

* History or evidence of clinically significant disease
* History of drug/alcohol abuse
* Participated in other studies and received investigational products within 6 months prior to the first study dose.
* AST(GOT) or ALT(GPT) \> 2 X upper limit of normal at screening
* Not able to use a medically acceptable contraceptive method throughout the study.

Primary outcomes:
measure: AUCt of tegoprazan
timeFrame: pre-dose(0 hour), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours
measure: Cmax of tegoprazan
timeFrame: pre-dose(0 hour), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours
measure: AUCt of tegoprazan metabolite M1
timeFrame: pre-dose(0 hour), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hour
measure: Cmax of tegoprazan metabolite M1
timeFrame: pre-dose(0 hour), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
Study officials:
affiliation: Chonbuk National University Hospital
name: Min-Gul Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04677478: Impact of the Respiratory Isolation on the Quality of Life in Patients Hospitalized for Tuberculosis or COVID-19
Official title: Impact of the Respiratory Isolation on the Quality of Life in Patients Hospitalized for Tuberculosis or COVID-19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tuberculosis
Covid19
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-12-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated for tuberculosis or COVID-19 and placed in respiratory isolation.

Brief summary: The respiratory isolation could have a harmful impact on the well-being of patients, especially in a psychological point of view such as anxiety and depression disorders or through the relationship with medical team and/or relatives but also in terms of informations.

The evaluation of the impact of respiratory isolation in patients hospitalized for tuberculosis or COVID-19 could allow to identify the different kinds of problems encountered by these patients (physical, psychological, sociological, informations, ...) in order to adapt the environment for efficient care and to improve patient's well-being.

The purpose of this research is to evaluate the psychological impact of the respiratory isolation on the quality of life in patients hospitalized for tuberculosis or COVID-19.


Eligibility criteria: Inclusion Criteria:

1. Patient who are more than 18 years old hospitalized in respiratory isolation for tuberculosis or COVID-19.
2. Patient able to understand questions and to communicate verbally with investigators.
3. Patient who has given his consent.

Exclusion Criteria:

1. Patient deprived of their rights
2. Patient under tutorship or guardianship or under the protection of a conservator
3. Tuberculosis without respiratory isolation

Primary outcomes:
measure: Quality of life using semi-structured interview.
timeFrame: at 28 days respiratory isolation
measure: Quality of life using 36-Item Short Form Health Survey (SF-36)
timeFrame: at 28 days respiratory isolation
measure: Quality of life using State-Trait Anxiety Inventory (STAY) A+B scale
timeFrame: at 28 days respiratory isolation
measure: Quality of life using Beck Depressive Inventory (BDI) -13
timeFrame: at 28 days respiratory isolation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05187078: Allis Clamp Versus Single-tooth Tenaculum
Official title: Cervical Bleeding With Cervical Stabilization During IUD Placement: Allis Clamp Versus Single-tooth Tenaculum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: IUD
Keywords: Cervical stabilization
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 95
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to determine whether an Allis clamp is an effective clamp for cervical stabilization compared to a single-tooth tenaculum.


Eligibility criteria: Inclusion Criteria:

* Obtaining IUD

Exclusion Criteria:

-

Primary outcomes:
measure: Number of patients who experienced bleeding after IUD placement
timeFrame: At the time of IUD insertion
Secondary outcomes:
measure: IUD insertion success rate
timeFrame: At the time of IUD insertion
measure: Number of interventions required for cervical clamp site bleeding hemostasis
timeFrame: At the time of IUD insertion
measure: Time to hemostasis
timeFrame: At the time of IUD insertion
measure: Participant reported pain
timeFrame: At the time of IUD insertion
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Bryan Rone, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04547478: L1 M1 of LDCT for Low Muscle Mass Measurement
Official title: Evaluation of Low Muscle Mass by Muscle Surface Index of First Lumbar Vertebrae Using Low Dose Computed Tomography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcopenia
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2020-09-14
Enrollment: 3304
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: subjects in routine health assessments

Brief summary: The first lumbar spine muscle index (L1 MI) on computed tomography (CT) obtained by measuring muscle surface at the first lumbar vertebrae (L1) level is an indicator of total skeletal mass in specific populations. Nevertheless, the utility of L1 MI derived from low dose chest CT (LDCT) in health assessments and relevant cutoff points are unclear.


Eligibility criteria: Inclusion Criteria:

* Adults older than 20 years who received LDCT in routine health assessments from January to December 2017 were enrolled at a tertiary care hospital (Far Eastern Memorial Hospital, New Taipei City, Taiwan).

Exclusion Criteria:

* nil

Primary outcomes:
measure: Cross sectional muscle area of the 1st vertebrae level
timeFrame: 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New Taipei
country: Taiwan
facility: Far Eastern Memorial Hospital
Study officials:
References: