louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06354296: Comparison of the Accuracy of Different Intraocular Lens Power Calculation Formulas in Cataract Patients With Prior Radial Keratotomy
Official title: Comparison of the Accuracy of Different Intraocular Lens Power Calculation Formulas in Cataract Patients With Prior Radial Keratotomy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cataract
Keywords: cataract
RK surgery
formula
Lead sponsor: He Eye Hospital
Sponsor class: OTHER
First posted: 2024-04-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with cataract after RK

Brief summary: The Web-based Barret True K formula with no history formula has been proven to be a good choice for cataract patients after RK in several studies. The American society of cataract and refractive surgeons provides several IOL formulas for cataract patients who have undergone previous corneal refractive surgery. In cases where only IOL-Master data are available, Holladay 1 (Double-K) \[Holladay 1 (D-K)\] can be used for IOL power calculation in cataract patients with a history of RK. The traditional Haigis formula has also been shown to be effective for cataract patients after RK. To compare the accuracy of four intraocular lens (IOL) power calculation formulas in cataract patients after RK. They are Barrett True-K formula, Holladay 1(D-K) formula, Haigis formula, and MM formula.

Detailed description: Myopia is the most common cause of distance vision impairment. The prevalence of myopia has increased dramatically in the past few decades, especially in China. Corneal refractive surgery is an effective method to correct adult myopia. Radial keratotomy (RK) is one of the corneal refractive surgeries developed in the 1980s. Thirty years ago, many myopic patients underwent RK. As patients age, more and more patients have cataracts requiring cataract extraction and intraocular lens (IOL) implantation. The selection of appropriate and accurate IOL is an important factor to improve patient satisfaction. Recent studies have compared the accuracy of the newly developed IOL formula in patients with previous RK cataract. However, as a country with myopia and myopia surgery, there is no similar study in China. In addition, most patients with cataract after RK had lost ocular data before RK surgery. For RK patients without previous ocular data, how to accurately calculate the IOL power is still a clinical challenge.

Eligibility criteria: Inclusion Criteria:

* Had a previous history of RK surgery
* IOL-Master is available
* There were no intraoperative and postoperative complications
* Obvious refraction was performed 1 to 6 months after cataract surgery

Exclusion Criteria:

* The investigator decided that it was not suitable for this study

Primary outcomes:
measure: Accuracy of the IOL formula
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00541996: Study Comparing Bioavailability of Oral Formulations of Vabicaserin
Official title: A Randomized, Open-Label, Single-Dose, 4-Period Crossover, Comparative Bioavailability Study of 3 Sustained- Release Formulations and an Immediate- Release Formulation of Vabicaserin (SCA-136) in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-10-10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to determine the absorption rate of four oral formulations of vabicaserin.


Eligibility criteria: Inclusion Criteria:

* Healthy men aged 18-50 years.

Exclusion Criteria:

* Any significant disease state.
* History of drug or alcohol abuse within 1 year.
* Abnormal liver function tests.

Primary outcomes:
measure: Assess the bioavailability of four oral formulations of vabicaserin.
Secondary outcomes:
measure: Obtain additional safety and tolerability data for vabicaserin in healthy male subjects.
Other outcomes:
Locations:
city: Philadelphia
country: United States
state: Pennsylvania
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04896996: The Effect of Continuous Egg Supplement on Personalized Nutri-omics in Primary School Children (SI-EGG STUDY)
Official title: The Effect of Continuous Egg Supplement on Personalized Nutri-omics in Primary School Children (SI-EGG STUDY)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition, Child
Keywords: malnutrition
whole egg consumption
primary school student
growth
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2021-05-21
Enrollment: 635
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled cluster trial
Primary purpose: BASIC_SCIENCE

Brief summary: This research compares the effects of one-year continuous whole egg supplement vs. egg yolk substitutes and control on anthropometry, biochemical blood parameters, metabolic enzymes and microbiome data in primary school children.

Detailed description: This research study determine the long-term effects of egg supplementation on growth, blood lipoproteins, blood proteins, nutritional status, metabolic enzymes and microbiomes in children, enrolling in the school lunch program.

Eligibility criteria: Inclusion Criteria:

1. Aged between 8-14 years

Exclusion Criteria:

1. Allergic of eggs
2. People who cannot continue to follow up the protocol

4. Having contra-indication i.e. problems with blood clotting

Primary outcomes:
measure: changes in body weight following the dietary intervention
timeFrame: week 0 (baseline), week 13 - 14, week 34 - 35
measure: changes in height following the dietary intervention
timeFrame: week 0 (baseline), week 13 - 14, week 34 - 35
measure: change in blood protein levels following dietary intervention
timeFrame: week 0 (baseline), week 13 - 14, week 34 - 35
measure: changes in blood biochemistries following dietary intervention
timeFrame: week 0 (baseline), week 13 - 14, week 34 - 35
Secondary outcomes:
measure: changes in microbioma and stool metabolites following dietary intervention
timeFrame: week 0 (baseline), week 13 - 14, week 34 - 35
measure: changes in blood biochemistries following dietary intervention metabolite enzyme
timeFrame: week 0 (baseline), week 13 - 14, week 34 - 35
Other outcomes:
Locations:
city: Bangkok Noi
country: Thailand
facility: Faculty of Medicine Siriraj Hospital, Mahidol University
state: Bangkok
Study officials:
affiliation: Population Health and Nutrition Research Group, Siriraj Hospital, Mahidol University, Thailand
name: Sophida Suta, MS.
role: STUDY_DIRECTOR
References:
citation: Mayurasakorn K, Sitphahul P, Hongto PO. Supplement of three eggs a week improves protein malnutrition in Thai children from rural areas. J Med Assoc Thai. 2010 Mar;93(3):301-9.
Clinical trial NCT01877096: Motivational Interviewing for Colonoscopy
Official title: Motivational Interviewing for Colonoscopy: A Feasibility and Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: Motivational Interviewing
Screening Colonoscopy
Cancer Prevention
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2013-06-13
Enrollment: 57
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to begin to examine the efficacy of a motivational interviewing intervention to increase African Americans' screening colonoscopy rates. The results from this pilot study will allow us to estimate the magnitude of the intervention and mediation effect sizes.

Detailed description: Compared to other racial groups, African Americans have the highest colorectal cancer (CRC) morbidity and mortality rates. Screening colonoscopy can aid in the early detection and prevention of CRC. A motivational interviewing (MI) intervention holds strong promise to increase African Americans' screening colonoscopy adherence and, by doing so, decrease CRC disparities. There is a great need to conduct a randomized clinical trial (RCT) that tests the efficacy of an MI intervention to increase screening colonoscopy adherence in African Americans. The first critical and necessary step in this line of research is to pilot test such an RCT.

Objective/hypotheses: The primary objective of the proposed study is to conduct pilot testing for a future RCT which will formally test the effects of MI on screening colonoscopy adherence in African Americans. The results from this pilot study will directly inform the development of a future RCT.

Specific aims: 1) To estimate the magnitude of the MI intervention effect size; and 2) To estimate the magnitude of the mediation effect sizes (drawn from Self Determination Theory).

Eligibility criteria: Inclusion Criteria:

* self-identified as African American
* aged 50 years or older
* attended a non-acute visit with a primary care physician
* received a primary care physician referral for a screening colonoscopy
* deemed eligible for an open access screening colonoscopy
* agreed to have a screening colonoscopy conducted at Mount Sinai
* English speaking

Exclusion Criteria:

* Personal history of CRC or chronic GI disorder

Primary outcomes:
measure: Screening colonoscopy completion
timeFrame: 6 months
Secondary outcomes:
measure: Psychological mediators
timeFrame: 5 minutes before intervention
measure: Psychological mediators
timeFrame: 5 minutes after intervention
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Sarah J Miller, PsyD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05068596: Effect of Loaded Functional Training on Hemiplegic Cerebral Palsy
Official title: Influence of Loaded Functional Strength Training From a Plantigrade Foot Position Using Shoe Holder on Hip and Knee Extensors Strength and Function Walking Capacity in Children With Spastic Hemiplegic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiplegic Cerebral Palsy
Lead sponsor: Badr University
Sponsor class: OTHER
First posted: 2021-10-06
Enrollment: 72
Sex: ALL
Minimum age (years): 10
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: weakness of lower limb is common in cp children


Eligibility criteria: Inclusion Criteria:

* age 10-12
* level I,II according to GMFCM
* Able to follow and understand instructions

Exclusion Criteria:

* visual and respiratory disorder

Primary outcomes:
measure: Muscle strength dynamometry
timeFrame: pre and post three month of intervention high score indicate improvement
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Hanaa Mohsen Abd-Elfattah
Study officials:
affiliation: lecturer
name: Hanaa M Abd-Elfattah, ph.d
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03386396: Brain Fuel - Morning Nutrition and Cognitive Function
Official title: Morning Nutrition and Cognitive Function in Preadolescents
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obese
Healthy
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
First posted: 2017-12-29
Enrollment: 151
Sex: ALL
Minimum age (years): 9
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group will be given a high protein/low carbohydrate shake and one group will be given a high carbohydrate/low protein shake
Primary purpose: OTHER

Brief summary: This study will help us learn more about how what a child eats can affect how their brain works.

Detailed description: Following a high protein/low carbohydrate meal brain activation and performance measurements will differ from those following a high carbohydrate/low protein meal and executive functioning will be affected.

Eligibility criteria: Inclusion Criteria:

* 9-10 yr, 3rd to 5th grade
* Obese
* Right hand dominance
* Report eating breakfast at least 4 days/week
* Able to hear at least 20dB stimulus
* Visual acuity must be at least 20/40
* Biological mother available to attend visit

Exclusion Criteria:

* Full scale IQ \<80
* Children taking medications or having chronic illness/disorders

Primary outcomes:
measure: Psychological assessments
timeFrame: 9-10 years
Secondary outcomes:
measure: Neurocognitive measures
timeFrame: 9-10 years
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Nutrition Center
state: Arkansas
Study officials:
affiliation: Arkansas Children's Nutrition Center
name: Linda Larson-Prior, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04270396: Early and Late Implant Failure
Official title: Implant Failure and Risk Indicators
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Implant Failed
Peri-Implantitis
Keywords: dental implant survival
implant failure
early implant failure
late implant failure
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A sample of men and women over 18 years old, which they had received an implant-supportive restorative therapy in a university setting throughout a period of at least 7 years.

Brief summary: The aim of this study was to evaluate the early and late implant loss rate in a sample of patients who had received implant-supportive restorative therapy in a university setting. Moreover, the study aimed to identify patient- and implant-related variables for implant failure


Eligibility criteria: Inclusion Criteria:

* Men and women over 18 years old
* Partially or totally edentulous patients with at least one implant placed at the university and at least 7 years before.
* Cemented, screwed, or mechanically retained prosthesis.
* Single and partial prostheses, as well as complete arch prosthesis (fixed and removable).

Exclusion Criteria:

-

Primary outcomes:
measure: Implant survival
timeFrame: October 2017 to March 2019
Secondary outcomes:
measure: Implant failure
timeFrame: October 2017 to March 2019
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Joan
Study officials:
affiliation: Universitat Internacional de Catalunya
name: Joan Takamoli
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06761196: Quality of Life After Breast Cancer Surgery
Official title: Assessing Quality of Life After Breast Cancer Surgery: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer Surgery
Quality of Life
Keywords: breast cancer
oncoplastic surgery
quality of life
quality of recovery
Lead sponsor: Centre Hospitalier de Colmar
Sponsor class: OTHER
First posted: 2025-01-07
Enrollment: 1500
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: Primary care clinic

Brief summary: The goal of this observational study is to prospectively collect data on quality of life after oncoplastic breast surgery.

Participants will be followed-up and answer quality of life questionnaire for a duration of 5 years after surgery.


Eligibility criteria: Inclusion Criteria:

* Patient aged 18 or over
* Patient with breast cancer of any stage (including in situ) or healthy individual at high personal risk.
* Patient requiring breast surgery under general anesthesia, whether for therapeutic or prophylactic purposes.
* Patient capable, in the opinion of the investigator, of complying with the requirements and restrictions of the study.
* Patient with a computer, tablet or smartphone connected to the Internet.
* Patient followed in the center on a regular basis according to standard recommendations.

Exclusion Criteria:

* Patient requiring surgical intervention under local anesthesia only.
* Patient requiring surgery for the installation or removal of an chemotherapy implantable port only.
* Patients with a history of cancer other than breast cancer. Patients with a history of cancer more than three years old are eligible if they are treated and considered cured. Patients with a history of cervical carcinoma in situ or non-melanoma skin carcinoma are eligible.
* Impossibility of being subject to regular monitoring for geographical, social or psychological reasons.
* Patient under protective measure

Primary outcomes:
measure: Quality of life measured with BREAST-Q
timeFrame: From enrollment to the end of 5 years follow-up
Secondary outcomes:
measure: Quality of life measured with EORTC QLQ C30
timeFrame: From enrollment to the end of 5 years follow-up
measure: Quality of life measured with EORTC QLQ-BR42
timeFrame: From enrollment to the end of 5 years follow-up
measure: Safety of postoperative period
timeFrame: Form enrollment to the end of 5 years follow-up
measure: Quality of postoperative period
timeFrame: At enrollment aund day 1 and 7 after surgery
Other outcomes:
Locations:
city: Colmar
country: France
facility: Hôpitaux Civils de Colmar
Study officials:
References:
Clinical trial NCT04631796: Clinical Characterization of an Investigational Soft Silicone Hydrogel Contact Lens
Official title: Clinical Characterization of an Investigational Soft Silicone Hydrogel Contact Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Errors
Keywords: Vision
Contact lenses
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2020-11-17
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the overall clinical performance of an investigational silicone hydrogel contact lens over 2 weeks of daily wear.

Detailed description: Participants will attend a Screening visit, a Dispense visit (0 to 4 days later), and a follow-up visit approximately 2 weeks after the Dispense visit.

Eligibility criteria: Inclusion Criteria:

* Understand and sign an Informed Consent that has been approved by an Institutional Review Board.
* Successful wear of spherical weekly/monthly soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months.
* Willing to stop wearing habitual contact lenses for the duration of study participation.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Any condition that contraindicates contact lens wear, as determined by the Investigator.
* Any use of systemic or ocular medications that contraindicates contact lens wear, as determined by the Investigator.
* History of refractive surgery or plan to have refractive surgery during the study.
* Current or history of dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear.
* Habitual contact lenses worn in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.
* Any use of topical ocular medications or artificial tear or rewetting drops that would require instillation during contact lens wear.
* Monovision or multifocal contact lens wear.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Front Surface Wettability, by Category
timeFrame: Dispense; Week 2 Follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Alcon Investigative Site
state: Florida
city: Bloomington
country: United States
facility: Alcon Investigative Site
state: Illinois
city: Powell
country: United States
facility: Alcon Investigative Site
state: Ohio
Study officials:
affiliation: Alcon Research
name: Sr. Clinical Trial Lead, CDMA Vision Care
role: STUDY_DIRECTOR
References:
Clinical trial NCT05534516: A Study of Physiologic Changes in a Telemetry Unit
Official title: Physiologic Changes Associated With Health Deterioration, Medications and Fluids Used in the Telemetry Unit
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Acute Illness Requiring to Hospital Telemetry Admission
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-09-09
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients (18-65 years) admitted to the telemetry unit at Mayo Clinic Florida's Hospital with acute illness followed from admission to discharge.

Brief summary: The purpose of this study is to determine the physiological changes associated with health deterioration, as well as different types, doses, and routes of administration of medications and fluids in acutely ill patients.


Eligibility criteria: Inclusion Criteria: Mayo Clinic patients who:

* Admitted to telemetry unit
* With acute illness
* Received any type of medication via any route of administration (oral, sublingual, intranasal, inhalational, intramuscular, intravenous, subcutaneous, transdermal)
* Received any amount of any type of intravenous fluids
* Cognitively and/or physically be able to sign consent

Exclusion Criteria:

- None

Primary outcomes:
measure: Change in Heart Rate
timeFrame: Baseline, through telemetry unit stay (approximately 1-3 days)
measure: Change in Blood Pressure
timeFrame: Baseline, through telemetry unit stay (approximately 1-3 days)
measure: Change in Respiratory Rate
timeFrame: Baseline, through telemetry unit stay (approximately 1-3 days)
measure: Change in Oxygen Saturation Levels
timeFrame: Baseline, through telemetry unit stay (approximately 1-3 days)
measure: Change in ECG morphology
timeFrame: Baseline, through telemetry unit stay (approximately 1-3 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Antonio Forte, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: