louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00591097: Normal Reference Ranges for Urinary Metabolites and Supersaturation Indices in Pediatric Populations
Official title: Determining Normal Reference Ranges for Urinary Metabolites and Supersaturation Indices in the Pediatric Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: urine
pediatric
Normal urine from healthy pediatric population
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Medical College of Wisconsin
First posted: 2008-01-11
Enrollment: 300
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All normal, healthy volunteer children between the ages of 3 and 18, inclusive, with no personal or first relative family history of urolithiasis. Both boys and girls will be enrolled with an effort to enroll an equal number of children of all ages after toilet training.

Brief summary: The reported normal values used in diagnosing and treating pediatric kidney stone formers are based on adult values or historic data from small studies. Urinary supersaturation indices which are now described in the adult stone literature as more sensitive predictors of stone composition, and precise predictors of response to therapy, are not established in children. The goals of this prospective study are to redefine normal values for pediatric urinary metabolites and supersaturation indices based on samples from a large number of healthy children and to identify if a difference in urinary supersaturations in children is protective.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female children between the ages of 3 and 18, inclusive, of all races who are toilet trained and who can submit a 24-hour urine sample

Exclusion Criteria:

* Active urinary tract infection
* Known urologic anatomic abnormality
* Personal or first-degree relative family history of urolithiasis or metabolic abnormality known to lead to urinary stone development
* Renal insufficiency
* Inability to collect a 24-hour urine specimen
* Intake of medications known to alter the risk of stone development such as steroids or diuretics or vitamins or calcium supplementation exceeding recommended daily allowances
* Adherence to restrictive diet for medical reasons
* Inflammatory or absorptive bowel disease

Primary outcomes:
measure: Define normal reference ranges for urinary metabolites in the pediatric population
timeFrame: Assessed one time with normal urine
Secondary outcomes:
measure: Determine supersaturation indices in normal urine of the pediatric population
timeFrame: Assessed one time in normal urine
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
city: Milwaukee
country: United States
facility: Charles Durkee, MD
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Bruce L. Slaughenhoupt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05193097: Vasopressor Preload Modulation During General Anaesthesia
Official title: Vasopressor Preload Modulation During General Anaesthesia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anesthesia
Keywords: monitoring
cardiac output
perfusion index
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2022-01-14
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: PROBABILITY_SAMPLE
Study population: Cohort of patient with planned surgery under general anesthesia

Brief summary: Is is debated whether administration of pure vasopressor may augment cardiac output (CO) by means of preload modulation. We wish to test this in 20 patients under general anesthesia, with preload dependency induced by head-up-tilt and preload modulation with infusion of phenylephrine. To document any changes in CO the patients will be monitored by Lithium dilution method. Furthermore we will monitor changes in peripheral perfusion index and test the ability of this non-invasive modality to track changes in CO.


Eligibility criteria: Inclusion Criteria:

* Planned surgery under general anesthesia

Exclusion Criteria:

* atrial fibrillation
* refusal to participate

Primary outcomes:
measure: Changes in cardiac output
timeFrame: 30 minutes
measure: Changes in peripheral perfusion index
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hvidovre University Hospital
name: Jakob Højlund, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00890097: Geographic Atrophy Treatment Evaluation
Official title: The Safety and Efficacy of AL-8309B Ophthalmic Solution for the Treatment of Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Geographic Atrophy
Age-Related Macular Degeneration
Keywords: Geographic Atrophy
GA
Age-Related Macular Degeneration
AMD
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2009-04-29
Enrollment: 772
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate the safety and efficacy of AL-8309B Ophthalmic Solution versus Vehicle administered as a topical ocular drop for the treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD).


Eligibility criteria: Inclusion Criteria:

* Willing to give written informed consent, make required study visits, and follow instructions.
* Able to administer eye drops or have a caretaker to administer the eye drops.
* Study eye: Atrophy secondary to age-related macular degeneration, best corrected visual acuity (BCVA) of 35 letters (20/200 Snellen equivalent) or better, clear ocular media, and adequate pupillary dilation.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Pregnant, nursing, or not using adequate contraception.
* Ocular disease in the study eye, other than non-exudative AMD.
* History of cataract surgery in either eye within the past 3 months of screening.
* History or evidence of serious ocular trauma or intraocular surgery in either eye within the past 6 months of screening.
* Any medical condition that would make participation in the trial or adherence to the study schedule difficult or unlikely.
* Participation in an investigational drug or device study within 30 days of screening.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Mean Annualized Lesion Enlargement Rate From Baseline as Assessed With Fundus Autofluorescence Imaging
timeFrame: Baseline, up to Month 30
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Sally Scheib, Sr. Clinical Lead
role: STUDY_DIRECTOR
References:
Clinical trial NCT02153697: Comparative Study of the Therapy of Solar Lentigines With a Q-switched Rubin Laser Versus a Bleaching Cream
Official title: Comparative Study Investigating the Therapy of of Solar Lentigines With the Q-switched SINON Rubin 694nm Laser Versus Pigmanorm® Cream
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Solar Lentigines
Keywords: solar lentigines
Q-switches Laser
bleaching cream
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2014-06-03
Enrollment: 15
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Benign pigmented lesions as solar lentigines are a common finding in Caucasian individuals. Their removal may be requested for aesthetic reasons.

The goal of the study is comparing the efficacy and tolerance of two different therapy modalities established for treating solar lentigines.

The right back of the hand side will be treated with the Q-switched SINON Rubin 694nm Laser, the left back of the hand side with a hydrochinon containing bleaching cream (Pigmanorm® cream).

The investigators estimate that a physical therapy with a Q-switched Rubin laser system is more effective in the removal of solar lentigines than a topical chemical therapy with a hydrochinon containing bleaching cream.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 50
* female patient must be in post-menopause (\> 2 years)
* Clinically and dermoscopic confirmed solar lentigines on both sides back of the hands

Exclusion Criteria:

* non melanocytic pigmentation, vitiligo, melanoma and suspicion of melanoma
* intolerance against an ingredience of pigmanorm® cream
* acute inflammation or eczema on back of the hands
* patients with renal disease
* intake of photosensibilisating medication in the past 3 months
* treatment of solar lentigines on back of the hands in the past 6 months
* solarium or sun exposure about 6 weeks before and after treatment
* immunsuppressed patients

Primary outcomes:
measure: Evaluation of clearing of pigmentation
timeFrame: 140 days (Baseline, Day 28, Day 56, Day 140)
Secondary outcomes:
measure: Evaluation of safety profile
timeFrame: 140 days (Baseline, Day 28, Day 56, Day 140)
measure: Change from Baseline in Pigmentation at day 140
timeFrame: Long term outcome is assessed 3 months after finishing treatment.
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Division of Dermatology
Study officials:
References:
Clinical trial NCT06257797: Fenugreek: an Emergent Allergen
Official title: Fenugreek: New Therapeutic Resource or Emerging Allergen
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fenugreek Hypersensitivity - Cross-reactivity - Food Allergy
Lead sponsor: Azienda Ospedaliera Universitaria Policlinico "G. Martino"
Sponsor class: OTHER
First posted: 2024-02-14
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients referred to outpatients visit to the Operative Unit of Allergy and Clinical Immunology of Messina University Hospital with a suggestive history of allergy after ingestion of spices and tested for fenugreek.

Brief summary: Fenugreek or Trigonella foenum greacum is an ancient medicinal plant native to the eastern Mediterranean, later spread to Asia (especially in India); it belongs to Rosaceae order, Leguminosae family, subfamily of Papilonaceae and it is used as a medicinal herb, spice or food. It is a component of spice mix, such as curry, and it is also used as a supplement in wheat and corn flour for bread-making. Fenugreek appears to have many health benefits and potential medicinal properties (antioxidant, antidiabetic, hepatoprotective, hypocholesterolemic, antimicrobial, anti-inflammatory, neuroprotective, anticarcinogenic, antiulcer, and antilithigenic) both in vitro and in vivo studies; for this reason it may be increasingly being used as nutraceutical formulations (powder, herbal teas, tablets and various combinations).This study aims to describe patients who came to our operating unit for suspected adverse reaction after ingestion of fenugreek and to highlight possible cross-reactivity between fenugreek and other legumes or other foods. Given the increasing use of novel spices in Mediterranean cuisine and the possible spread of fenugreek-based nutraceuticals, it is relevant to draw attention to possible allergic reactions.


Eligibility criteria: Inclusion Criteria:

* age \> 18 yo
* history of allergic reactions to spices
* history of allergic reactions to phytotherapics containing fenugreek

Exclusion Criteria:

* age \< 18 yo
* non suggestive history of allergic reactions to spices

Primary outcomes:
measure: Cutaneous sensitization to fenugreek
timeFrame: 1 hour
Secondary outcomes:
measure: Cross-reactivity between fenugreek and other legumes and other foods
timeFrame: 1 hour
Other outcomes:
Locations:
city: Messina
country: Italy
facility: AOU Policlinico Universitario G. Martino
state: Sicily/Messina
Study officials:
References:
Clinical trial NCT05865197: Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF
Official title: Feasibility of Home-based, Ambient Passive Sensor Technology to Provide Early Warning of Health Decompensation by Detecting Deviations in Activities of Daily Living (ADLs) of Elderly Subjects With Diagnosed Chronic Heart Failure
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: CHF
Congestive Heart Failure
Lead sponsor: Sensorum Health Inc.
Sponsor class: INDUSTRY
First posted: 2023-05-18
Enrollment: 20
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Current Patient of PI's clinic at Weill Cornell Medicine

Brief summary: Sensorum Health (Sensorum) is conducting a pilot study to determine if Sensorum's proprietary passive sensor network can be used to identify signals of early health decompensation in subjects prior to a hospitalization for chronic disease exacerbation or other ambulatory care sensitive conditions. Successful early detection would provide a window of opportunity to intervene outside of the acute setting in future interventional studies.


Eligibility criteria: Inclusion Criteria:

* Current Patient at Weill Cornell Medicine
* Aged 55 years or older
* Able to consent
* Documented diagnosis of congestive heart failure (CHF)
* At least 1 of the following prior hospital utilization events in the past 12 months
* Inpatient admission for any reason
* Facility observation stay for any reason
* Emergency Department visit for any reason

Exclusion Criteria:

* Significant cardiac valvular disease
* End-Stage Renal Disease (ESRD)
* End-Stage CHF
* End-Stage COPD

Primary outcomes:
measure: Recall of AI in passive sensor system
timeFrame: 6 months
measure: Precision of AI in passive sensor system
timeFrame: 6 months
Secondary outcomes:
measure: Recall of sensor data review by trained nurses
timeFrame: 6 months
measure: Precision of sensor data review by trained nurses
timeFrame: 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Parag Goyal, M.D., MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05876897: US vs MRI for Stress Injuries
Official title: Correlation Between MRI and Ultrasound for Diagnosis of Lower Limb Bone Stress Injuries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress Fracture
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2023-05-26
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 25 patients ages 18-50 with a suspected diagnosis of a lower limb stress injury (specifically of the tibia or metatarsal) will be recruited. Patients will excluded if they have a prior history of stress fracture or fracture in the affected limb at the region on concern.

Brief summary: The primary purpose of this study is to determine whether or not there is a correlation between MRI and ultrasound for the diagnosis of lower limb stress injuries. Patients that are seen at the University of Iowa Sports Medicine Center with a suspected diagnosis of a lower limb stress injury will be recruited. These patients will undergo a diagnostic ultrasound of the affected region prior to undergoing an MRI of that region. Then, the ultrasound findings will be compared to the MRI findings to determine if a correlation exists.


Eligibility criteria: Inclusion criteria:

* Age 18-50
* MRI confirmed tibial or metatarsal stress injury

Exclusion criteria:

-Prior history of stress fracture or fracture in the affected limb at the region of concern.

Primary outcomes:
measure: US correlation to MRI
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Sports Medicine
state: Iowa
Study officials:
References:
Clinical trial NCT06000397: Reminder Emails to Improve Pneumococcal Vaccine Completion at 12 Months of Age
Official title: Parents' Enhanced Reminder Intervention to Improve Children's Timely Completion of Immunization Series of Pneumococcal Vaccine at the 12-month's Visit
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pneumococcal Vaccines
Immunization Coverage
Keywords: Vaccine coverage
Vaccine uptake
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 700
Sex: ALL
Minimum age (years): 10
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to assess the effectiveness of enhanced email reminders in improving vaccine coverage at the 12-month visit in CANImmunize app users. The main questions it aims to answer are:

* Do enhanced email reminders improve coverage of the 12- month dose of the pneumococcal vaccine and the timely completion of its immunization series at the 12-month's visit in CANImmunize app users?
* What are the predictors of predictors of timely completion of the 12-month's series of pneumococcal vaccines in the CANImmunize app users?

Participants will be randomized to either receive enhanced reminder/recall materials via email or the standard CANImmunize notifications. Researchers will compare the enhanced reminder group to the standard notification group to see if there is a difference in vaccine coverage at the 12-month visit.


Eligibility criteria: Inclusion Criteria

To be included in the study, CANImmunize account holders must have:

* Enabled the reception to receive emails from CANImmunize, and
* Record(s) for an infant aged between 10- and 11-months, who have already received the earlier doses of the pneumococcal vaccine in accordance with their provincial/territorial routine immunization schedule.

Exclusion Criteria

* The account holder (parent, or guardian of the child) has an inactive or undelivered email address, or
* No record(s) for an infant aged 10- and 11-months, or
* The record for the 10- or 11-month-old indicates that he/she has not received the prior pneumococcal vaccine doses.

Primary outcomes:
measure: Receipt of 12-month pneumococcal vaccine
timeFrame: 12 months of age
Secondary outcomes:
measure: Timeliness of 12-month pneumococcal vaccine
timeFrame: 12-13 months of age will be considered as timely, after 13 months considered late
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: CANImmunize
Study officials:
References:
Clinical trial NCT06942897: Evaluation of a Dietary Supplement Containing Melissa Officinalis Formulated in Phospholipids on Mood Well-being and Cortisol Modulation
Official title: Pilot Study for the Evaluation of a Dietary Supplement Containing Melissa Officinalis Formulated in Phospholipids on Mood Well-being and Cortisol Modulation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stress
Mood Disorders
Emotional Well-being
Lead sponsor: Azienda di Servizi alla Persona di Pavia
Sponsor class: OTHER
First posted: 2025-04-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, placebo-controlled pilot study designed to evaluate the effect of an oral nutritional supplement containing Melissa officinalis formulated in phospholipids on mood and cortisol levels in healthy adults. Participants will be randomly assigned to receive either the active supplement or a placebo daily for 3 weeks. The primary outcome measures include changes in mood well-being, perceived stress, and salivary cortisol levels. The study aims to assess both efficacy and safety of the supplement in modulating stress response and emotional balance.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 65 years
* Healthy volunteers as assessed by medical history and physical examination
* Willingness to comply with the study procedures

Exclusion Criteria:

* Current use of medications or supplements that may affect mood or cortisol levels
* Known allergy or sensitivity to Melissa officinalis or phospholipids
* History of psychiatric disorders (e.g., major depression, anxiety disorders)
* Significant comorbidities (e.g., cardiovascular, hepatic, renal diseases)
* Pregnant or breastfeeding women
* Participation in another clinical trial in the past 30 days

Primary outcomes:
measure: Change in perceived stress levels measured by the Perceived Stress Scale (PSS)
timeFrame: week 4 (after 3 weeks of intervention)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06572397: Open-Label Study of Safety of H1337 in Healthy Volunteers
Official title: An Open-Label Study Assessing the Ocular and Systemic Safety and Systemic Absorption of H1337 Ophthalmic Solution, 1% in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Glaucoma Open-Angle Primary
Ocular Hypertension
Lead sponsor: D. Western Therapeutics Institute, Inc.
Sponsor class: INDUSTRY
First posted: 2024-08-27
Enrollment: 17
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 trial will evaluate the safety of one dose regimen of H-1337 \[1% twice daily (b.i.d.)\] in both eyes in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy adult male or female subjects
* Subjects in good ocular and systemic health with clinically insignificant medical and ophthalmic history

Exclusion Criteria:

* Chronic or acute ophthalmic disease in each eye including but not limited to any form of glaucoma, retinal diseases, clinically significant cataract (primary or secondary)
* Recent intraocular surgery in either eye (within 6 months)

Note: Other inclusion/exclusion criteria apply.

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events Reporting [Safety and Tolerability]
timeFrame: Screening through Day 9
Secondary outcomes:
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Eye Research Foundation Inc.
state: California
Study officials:
References: