louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06689904: The Effect of Eyedrop Size on Pupillary Dilation Using the Nanodropper Bottle Adapter
Official title: The Effect of Eyedrop Size on Pupillary Dilation Using the Nanodropper Bottle Adapter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Delivery
Eye Drop Delivery
Keywords: eye drops
pupil dilation
eye drop bottle device
eye drop size
Lead sponsor: Sutter Health
Sponsor class: OTHER
First posted: 2024-11-15
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The average drop size produced by standard eyedrop bottle exceeds the maximal capacity that the human eye are absorb topically. This excess leads to medication waste, increased costs, and greater risk of side effects.

The Nanodropper is a commercially available, FDA listed eyedrop bottle adapter that delivers a smaller drop size. The investigators hypothesize the Nanodropper is noninferior to the standard eye drop bottle for pupil dilation.

In this study, participants have one eye randomly chosen to be dilated with the Nanodropper and the fellow eye dilated with the standard bottle with a 50/50 mixture of tropicamide 1% and phenylephrine 2.5%. Pupil size before and after 30 minutes of dilation are measured with a pupillometer and compared between fellow eyes to see if there is a difference.

Detailed description: Ophthalmic medications are available in eyedrop bottles that produce on average a drop size of about 40 uL, while the human eye can only hold about 7-10uL. This excess leads to medication waste, increased costs, and greater risk of side effects.

The Nanodropper is a commercially available, FDA listed (class 1 medical device, 510(k) exempt) eyedrop bottle adapter that delivers a smaller drop size of 10 uL. The investigators hypothesize the Nanodropper is noninferior to the standard eye drop bottle for pupil dilation.

This is a prospective comparative matched pairs study of adults scheduled for routine bilateral eye dilation. Exclusion criteria includes anisocoria and medications affecting pupil size. One eye is randomly dilated with the Nanodropper and the fellow eye dilated with the standard bottle with a 50/50 mixture of tropicamide 1% and phenylephrine 2.5%. Pupil size before and after 30 minutes of dilation are measured with a pupillometer and compared between fellow eyes within the same subject with a noninferiority margin of 0.5mm.

Eligibility criteria: Inclusion Criteria:

* age \>18 years old
* scheduled for routine bilateral eye dilation

Exclusion Criteria:

* narrow angles
* allergies to phenylephrine or tropicamide
* concurrent use of any mydriatic agents (e.g., atropine, cyclopentolate, brimonidine)
* baseline anisocoria (\>1 mm)
* traumatic pupil,
* surgical pupil
* unilateral pseudoexfoliation.

Primary outcomes:
measure: Pupil size (diameter)
timeFrame: 30 minutes after dilation
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Lions Eye Clinic
state: California
Study officials:
References:
Clinical trial NCT02770404: A Phase 1 Pharmacokinetic Study of Single-Ascending Doses of Intravenous Nafithromycin in Healthy Adult Subjects
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability, and Pharmacokinetic Study of Single-Ascending Doses of Intravenous Nafithromycin in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Wockhardt
Sponsor class: INDUSTRY
First posted: 2016-05-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a Phase 1, randomized, double-blind, single-center, placebo-controlled, sequential-cohort study in at least 60 healthy adult male and female subjects. Subjects in Cohorts 1 through 5 will be randomly assigned in an 8:2 allocation to receive active or placebo treatments. Subjects in Cohort 6 will be randomly assigned in a 1:1 allocation to receive an IV dose of nafithromycin and a single oral dose of nafithromycin in each crossover period. Subjects in each of Cohorts 1, 2, and 3 will receive a single dose of 100, 200, or 400 mg, respectively, of nafithromycin or matching placebo on Day 1.


Eligibility criteria: Inclusion Criteria:

* Male or female subject between 18 and 55 years of age, both inclusive,
* creatinine clearance ≥80 mL/minute (Cockcroft-Gault method).

Exclusion Criteria:

1. Clinically relevant pathology or any other systemic disorder/major surgeries that in the opinion of the investigator would confound the subject's participation and follow-up in the clinical study.
2. Drug or food allergy.

Primary outcomes:
measure: Area under the plasma concentration-time curve
timeFrame: 72 hours from dosing
measure: Maximum observed plasma concentration (Cmax)
timeFrame: 72 hours from dosing
measure: Time to Cmax (Tmax)
timeFrame: 72 hours from dosing
Secondary outcomes:
measure: clinical laboratory- Number of subjects with deranged heamatology parameters test results
timeFrame: 14 days
measure: 12-lead safety ECG results
timeFrame: 14 days
measure: Number of subjects reported with any local tolerability at the injection site assessments
timeFrame: 14 days
measure: Number of subjects with any abonormal physical examination findings
timeFrame: 14 days
measure: Total number of reported AEs
timeFrame: 14 days
Other outcomes:
Locations:
city: West Bend
country: United States
facility: Phase 1 unit : Spaulding Clinical Research, LLC
state: Wisconsin
Study officials:
References:
Clinical trial NCT05066204: Evaluation of Different Teaching- and Learningmethods
Official title: Evaluation of Different Teaching- and Learningmethods Concerning the Humeral Intraosseal Access in Inexperienced Providers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complication of Infusion
Education, Medical
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2021-10-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two unbound samples running through a different sequence of teching-/learningmethods
Primary purpose: OTHER

Brief summary: Due to the corona pandemia and the consecutive reduction of teaching students face to face the imparting of medical skills is limited. Video sequences may be an adequate alternative to educate selected practical skills. The investigators explored this aspect in spring 2021 concerning the humeral intraosseous access. This study was registered under ClinicalTrials: NCT04842357. Data is still under statistical analysis and not published yet. As a secondary endpoint we found participant having done self-study first and watched a teaching-video one week later performed better than participant in the vice versa sequence. This may have important curricular implications. So, we launch the present study to investigate, if the sequence: Self-Study, then Teaching-Video is more efficient than vice versa.

Detailed description: The investigators will recruit last year medical students and randomise them into two groups: Group A and Group B. Group A will watch a standardised video about the skill, then directly do self-study. Group B will do self-study and then directly watch a standardised video. Right after this, both groups will be video recorded during the performance of the skill: humeral intraosseous access on a simulator. The performance will be quantified by a scale by two investigators

Eligibility criteria: Inclusion Criteria:

* voluteer medical students in their last year of medical school (i.e. after 2nd state board in Germany)
* writen informed consert

Exclusion Criteria:

* denial of participation

Primary outcomes:
measure: sum of score
timeFrame: 1 Day
Secondary outcomes:
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: University Hospital Centre Mainz
state: RLP
Study officials:
References:
Clinical trial NCT01751204: Comparison of Absorbability Between Calcium Tablet and Calcium Ion Water
Official title: A Randomized, Double-blind, Crossover Study to Compare the Absorbability Between Calcium Tablet and Calcium Ion Water
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Hiroshima University
Sponsor class: OTHER
Collaborators: name: CHUGOKU KAYAKU CO., LTD.
First posted: 2012-12-17
Enrollment: 10
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the absorbability of calcium tablet and calcium ion water.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal females

Exclusion Criteria:

* Taking medicines or functional food that affect serum calcium levels
* Diseases that affect bone
* Renal or hepatic dysfunction
* Heart disease
* Participation in any clinical trial within 90 days of the commencement of the trial

Primary outcomes:
measure: Serum calcium profile (including AUC, Cmax, and Tmax)
timeFrame: Overall 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Hiroshima,
country: Japan
facility: Hiroshima University
Study officials:
affiliation: Hiroshima University
name: Fumiko Higashikawa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06085404: Patients Derived Organoids in Ovarian Cancer
Official title: Patients Derived Organoids (PDOs) Immune Cells Co-culture in Ovarian Cancer: the Role of TUmoR microEnvironment.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ovarian Cancer
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-10-17
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants are prospectively assigned to an intervention consisting of a blood draw and tumor biopsy.
Primary purpose: OTHER

Brief summary: Among cancer models, patients derived organoids (PDOs) best reproduce tumor's tissue architecture, intratumor heterogeneity and are able to mimic in vivo patients' drugs response.

For these reasons, it has been designed a study to assess the feasibility of PDOs immune cells co-culture in OC patients and the concordance between ex vivo sensitivity and in vivo treatment response. If proven effective and reliable, PDOs could be introduced into clinical practice as empirical predictor of patients' response to antineoplastic drugs.


Eligibility criteria: Inclusion Criteria:

1. Preoperative clinical, serological and radiologic suspicion of International Federation of Gynecology and Obstetrics (FIGO) stage IIIC or greater ovarian, fallopian tube, or primary peritoneal cancer;
2. Histologic diagnoses of epithelial ovarian cancer at frozen section
3. Age \>18 and years;
4. Estimated life expectancy of at least 4 weeks;
5. Performance status (PS) according to Eastern Cooperative Oncology Group (ECOG) \< 2

Exclusion Criteria:

1. Non-serous histology at frozen section;
2. Patients with a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (\> 10 mg equivalent prednisone/daily) or any other form of immunosuppressive therapy within 7 days prior to the enrollment.

Primary outcomes:
measure: To improve the knowledge of advanced ovarian cancer by developing an experimental laboratory model.
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Policlinico Universitario Agostino Gemelli
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Camilla Nero
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02376504: Modifying the Workplace to Decrease Sedentary Behavior and Improve Health
Official title: Modifying the Workplace to Decrease Sedentary Behavior and Improve Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Workplace Inactivity
Total Worker Health
Lead sponsor: Northeastern University
Sponsor class: OTHER
First posted: 2015-03-03
Enrollment: 66
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: PREVENTION

Brief summary: The primary objective of this project is to determine the effects of decreasing sedentary behavior at work by at least 3hrs/day using treadmill (walking and standing) and sit-to-stand (standing only) workstations on the health of overweight office workers.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index greater than 25 kg.m-2
* Does not engage in any structured physical activity lasting at least 30 mins for more than 2 days/week
* Employed in a full-time sedentary desk job.
* No major orthopedic limitations or medical conditions that prevents walking or standing at a treadmill work sit-stand workstation.

Exclusion Criteria:

-

Primary outcomes:
measure: Change in Weight
timeFrame: Baseline, 3, 6, 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Northeastern University
name: Dinesh John, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arguello D, Thorndike AN, Cloutier G, Morton A, Castaneda-Sceppa C, John D. Effects of an "Active-Workstation" Cluster RCT on Daily Waking Physical Behaviors. Med Sci Sports Exerc. 2021 Jul 1;53(7):1434-1445. doi: 10.1249/MSS.0000000000002594.
Clinical trial NCT03363204: Interest of the BRUXENSE Occlusal Splints for Bruxism Diagnosis: a Feasibility Study
Official title: Interest of the BRUXENSE Occlusal Splints for Bruxism Diagnosis: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bruxism, Sleep-Related
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-12-06
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: There is no accurate diagnosis method for bruxism for now. Consequences of bruxism over teeth, muscles and articulation of the jaw are important.

This study aims to develop a innovative tool in order to accurately rapidly diagnose bruxism in ambulatory evaluation.


Eligibility criteria: Inclusion Criteria:

* adult from 18-70
* patients diagnosed with bruxism according to the following criteria:
* positive question at one of the following question:

  * are you aware of your grinding?
  * does your partner hear you grinding?
  * are you aware that you are frequently tighten your jaws during the day and/or the night?
  * are you tired and/or do experience jaws 'muscular pain in the morning.
* presence of at least one criteria:

  * abnormal tooth wear or tooth prosthesis damages
  * Hypertrophy of the masseter muscles
* patients agreeing to participate
* patient able to understand and follow the protocol
* patient with health insurance

Exclusion Criteria:

* patients with more than 2 missing tooth
* Severe troubles to correctly close the mouth.
* neurological disorder (Parkinson, Alzheimer) or psychiatric disorder
* Sleep disorder (insomnia, narcolepsy, sleep apnea, restless leg disorder)
* use of drugs that potentially impair sleep (benzodiazepines, neuroleptics, tricyclic antidepressants) alcohol or narcotics.
* complete or partial removal dental prosthesis or orthodontic device
* Patient under legal protection
* pregnant women
* Patients deprived of their freedom by a judicial or administrative decision

Primary outcomes:
measure: Patient rate with successful use of BRUXENSE occlusal splint
timeFrame: At day 10
Secondary outcomes:
measure: Number of usable measurements
timeFrame: At day 10
measure: Satisfaction scale score
timeFrame: At day 10
measure: Proportion of patients diagnosed with bruxism
timeFrame: At day 10
Other outcomes:
Locations:
city: Lyon
country: France
facility: Service de Consultations et de Traitements Dentaires, Hospices Civils de Lyon
Study officials:
References:
citation: Robin O, Claude A, Gehin C, Massot B, McAdams E. Recording of bruxism events in sleeping humans at home with a smart instrumented splint. Cranio. 2022 Jan;40(1):14-22. doi: 10.1080/08869634.2019.1708608. Epub 2020 Jan 8.
Clinical trial NCT02570204: Self-Assessment of Medical Abortion Outcome Using Serial Multi-level Pregnancy Tests
Official title: Self-Assessment of Medical Abortion Outcome Using Serial Multi-level Pregnancy Tests
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medical Abortion
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
First posted: 2015-10-07
Enrollment: 343
Sex: FEMALE
Minimum age (years): 11
Maximum age (years): 56
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study aims to investigate the effectiveness and acceptability of the multi-level pregnancy test for self-assessment of abortion outcomes, without a routine provider contact.


Eligibility criteria: Inclusion Criteria:

* Gestational age of less than or equal to 63 days
* Determined by the site investigator or designee to be fully eligible for medical abortion with mifepristone followed by misoprostol according to the site's standard criteria
* Willing to use the MLPT at home
* 11-56 years old
* Willing and able to comply with study procedures
* In the judgement of the site investigator, she is capable of giving informed consent and she has signed the study informed consent or assent form

Exclusion Criteria:

-

Primary outcomes:
measure: Proportion of subjects who fail to contact the clinic when indicated within two weeks after taking the mifepristone
timeFrame: One month
Secondary outcomes:
Other outcomes:
Locations:
city: West Palm Beach
country: United States
facility: Presidential Women's Center
state: Florida
city: Chevy Chase
country: United States
facility: Carafem
state: Maryland
city: Philadelphia
country: United States
facility: Philadelphia Women's Center
state: Pennsylvania
Study officials:
affiliation: Gynuity Health Projects
name: Elizabeth Raymond, MD, MPH
role: STUDY_DIRECTOR
References:
citation: Raymond EG, Tan YL, Grant M, Benavides E, Reis M, Sacks DN, Hannum C, Frapp S, Weaver MA. Self-assessment of medical abortion outcome using symptoms and home pregnancy testing. Contraception. 2018 Apr;97(4):324-328. doi: 10.1016/j.contraception.2017.12.004. Epub 2017 Dec 11.
Clinical trial NCT01796704: Comparison of the Prediction Derived by the Cardiovascular Performance Reserve Index With the Clinical Evaluation
Official title: Comparison of the Prediction Derived by the Cardiovascular Performance Reserve Index (Calculated From Physiological Parameters) With the Clinical Evaluation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Heart Failure
Keywords: functional capacity
NYHA class
Lead sponsor: Clalit Health Services
Sponsor class: OTHER
First posted: 2013-02-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is composed of adults both genders:

healthy subjects visiting for administrative cause healthy subject during acute illness patients with chronic conditions

Brief summary: The study hypothesizes that an assumed cardiovascular performance reserve is physiologically detectable.

High reserve at rest characterizes a healthy person while low reserve at rest characterizes low functional capacity e.g. heart failure. The lower the reserve the severer the morbidity.

The reserve may be estimated through CVRI (cardiovascular reserve index) which is computed by an algorithm composed of physiological measurements taken during the patient visit.

In this study the investigators evaluate CVRI capability in prediction of functional capacity in comparison with the clinical evaluation during the same visit.

Detailed description: The study hypothesizes that an assumed cardiovascular performance reserve is physiologically detectable and continuously monitored by a physiological control (reserve control)not yet discovered.

High reserve at rest characterizes a healthy person while low reserve at rest characterizes low functional capacity e.g. heart failure. The lower the reserve the severer the morbidity.

The reserve is decreased reversibly with aerobic activity and may reach an exhaustion threshold in which the assumed reserve control induces a reversible fatigue and dyspnea which dissolve once the activity decreased.

The reserve may be estimated through CVRI (cardiovascular reserve index) which is computed by an algorithm composed of physiological measurements taken during the patient visit (composed of blood pressure, heart rate, respiratory rate, central venous pressure or its estimation, weight, height and gender.

In this study the investigators evaluate CVRI capability in prediction of functional capacity in comparison with the clinical evaluation during the same visit (cross sectional comparison).

Eligibility criteria: Inclusion Criteria:

* adult informed consent

Exclusion Criteria:

* an emergency case

Primary outcomes:
measure: cardiovascular reserve index
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Independent physician Clinic Clalit Health Services
Study officials:
affiliation: Tel Aviv University
name: Uri Gabbay, M.D, M.P.H.
role: PRINCIPAL_INVESTIGATOR
References: