louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01031004: Vistakon Investigational Lens Worn as a Single Use Daily Wear
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2009-12-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is intended to show that the investigational contact lens is clinically equivalent to a currently approved contact lens, when worn as single-use on a daily basis.


Eligibility criteria: Inclusion Criteria:

* eyes must be best-corrected to a visual acuity of 20/30 or better in each eye
* must be able and willing to wear soft contact lenses on a single use, daily wear basis for the duration of the study
* distance spherical contact lens prescription must be within the range available for the study

Exclusion Criteria:

* systemic diseases which may interfere with contact lens wear
* ocular infection or clinically significant ocular disease
* any previous intraocular surgery
* grade 2 or greater slit lamp findings
* currently pregnant or lactating
* more than 1.00D of refractive astigmatism in either eye

Primary outcomes:
measure: Slit Lamp Findings - Corneal Edema
timeFrame: after 1 week of lens wear
measure: Corneal Edema at Month 1
timeFrame: after 1 month of lens wear
measure: Slit Lamp Findings - Corneal Neovascularization
timeFrame: after 1 week of lens wear
measure: Slit Lamp Findings - Corneal Neovascularization
timeFrame: after 1 month of lens wear
measure: Slit Lamp Findings - Corneal Staining
timeFrame: after 1 week of lens wear
measure: Slit Lamp Findings - Corneal Staining
timeFrame: after 1 month of lens wear
measure: Slit Lamp Findings - Injection
timeFrame: after 1 week of lens wear
measure: Slit Lamp Findings - Injection
timeFrame: after 1 month of lens wear
measure: Slit Lamp Findings - Tarsal Abnormalities
timeFrame: after 1 week of lens wear
measure: Slit Lamp Findings - Tarsal Abnormalities
timeFrame: after 1 month of lens wear
measure: Slit Lamp Findings - Infiltrates
timeFrame: after 1 week of lens wear
measure: Slit Lamp Findings - Infiltrates
timeFrame: after 1 month of lens wear
measure: Subject Reported Symptoms
timeFrame: after 1 week of lens wear
measure: Subject Reported Symptoms
timeFrame: after 1 month of lens wear
measure: Visual Acuity (VA)
timeFrame: after 1 week
measure: Visual Acuity (VA)
timeFrame: after 1 month
measure: Average Wear Time
timeFrame: after 1 week of lens wear
measure: Average Wear Time
timeFrame: after 1 month of lens wear
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
state: Utah
city: Virginia Beach
country: United States
state: Virginia
city: Laramie
country: United States
state: Wyoming
Study officials:
References:
Clinical trial NCT01016704: Reinforcing Therapist Performance
Official title: Reinforcing Therapist Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use
Lead sponsor: Chestnut Health Systems
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2009-11-19
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The specific aims of the proposed study are to evaluate the effectiveness and cost-effectiveness of providing monetary incentives to therapists as a method to improve implementation of evidence-based treatments.


Eligibility criteria: Inclusion Criteria:

* Must work at one of the participating demonstration sites funded by the Center for Substance Abuse Treatment to deliver the Adolescent Community Reinforcement Approach and/or Assertive Continuing Care.

Primary outcomes:
measure: Target A-CRA
timeFrame: 14 weeks post intake
measure: A-CRA Competence
timeFrame: Monthly
Secondary outcomes:
measure: Percent of days abstinent
timeFrame: 6 months post-intake
measure: Pay-for-performance Cost-Effectiveness
timeFrame: First six months of study
Other outcomes:
Locations:
city: Normal
country: United States
facility: Lighthouse Institute, Chestnut Health Systems
state: Illinois
Study officials:
affiliation: Chestnut Health Systems
name: Bryan R Garner, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Garner BR, Godley SH, Bair CM. The impact of pay-for-performance on therapists' intentions to deliver high-quality treatment. J Subst Abuse Treat. 2011 Jul;41(1):97-103. doi: 10.1016/j.jsat.2011.01.012. Epub 2011 Feb 11.
citation: Garner BR, Lwin AK, Strickler GK, Hunter BD, Shepard DS. Pay-for-performance as a cost-effective implementation strategy: results from a cluster randomized trial. Implement Sci. 2018 Jul 4;13(1):92. doi: 10.1186/s13012-018-0774-1.
citation: Garner BR, Godley SH, Dennis ML, Hunter BD, Bair CM, Godley MD. Using pay for performance to improve treatment implementation for adolescent substance use disorders: results from a cluster randomized trial. Arch Pediatr Adolesc Med. 2012 Oct;166(10):938-44. doi: 10.1001/archpediatrics.2012.802.
Clinical trial NCT01640704: Impact of Computerized Reminders on Blood Pressure Documentation and Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Lead sponsor: Agency for Healthcare Research and Quality (AHRQ)
Sponsor class: FED
First posted: 2012-07-16
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: FACTORIAL

Brief summary: Numerous studies have examined potential causes for the racial differences in HTN prevalence and severity including baseline insulin levels, sympathetic nervous activity, intracellular calcium levels and intracellular sodium levels.\[21-23\] However, to our knowledge, there have been no studies examining the relationship of physician adherence to JNC guidelines to racial disparities in outcomes from HTN; nor have there been published studies examining the use of interventions such as computerized decision support tools or case-management to improve JNC adherence with the goal of reducing racial differences in blood pressure control. The aims of this study are: 1) To determine if physician's prescribing practices for HTN medications adhere to JNC guidelines for drug therapy.

2) To determine if there are variations in adherence to JNC guidelines based on patient race.

3) To determine if adherence to JNC guidelines improves blood pressure control. 4) To determine if the use of computerized medical reminders improves adherence to JNC guidelines.


Eligibility criteria: Inclusion Criteria:

We examined data obtained from the electronic medical record review of patients older than 20 years with a diagnosis of hypertension, with at least one hypertension-related outpatient visit to one of fourteen general medicine clinics in community health centers, community-based practices, and hospital-based practices affiliated with a large urban academic medical center during the one-year period prior to the beginning of the intervention trial.

Exclusion Criteria:

Patients without documented hypertension-related primary care visits or less than 20 years of age

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: LeRoi S. Hicks, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gandhi TK, Seger AC, Overhage JM, Murray MD, Hope C, Fiskio J, Teal E, Bates DW. Outpatient adverse drug events identified by screening electronic health records. J Patient Saf. 2010 Jun;6(2):91-6. doi: 10.1097/PTS.0b013e3181dcae06.
Clinical trial NCT06501404: PREMAPROB. Probiotics to Prevent Necrotizing Enterocolitis
Official title: Effects of Probiotic Supplementation During the Neonatal Period on the Preterm Infant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Infants
Necrotizing Enterocolitis
Lead sponsor: Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
Sponsor class: OTHER
Collaborators: name: University Hospital Virgen de las Nieves
name: Hospital Regional de Malaga
name: Hospital of Jaen
name: Hospital Costa del Sol
name: Hospital Universitario Torrecárdenas
name: Hospital Universitario Virgen Macarena
name: Complejo Hospitalario de Especialidades Juan Ramón Jimenez
name: Hospital Universitario de Valme
name: Hospitales Universitarios Virgen del Rocío
name: Hospital Universitario Puerta del Mar
name: Hospital General Universitario Santa Lucia
name: Hospital del SAS de Jerez
First posted: 2024-07-15
Enrollment: 583
Sex: ALL
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The main objective of this study is to assess the impact of two different doses of a mixture of probiotics from two strains isolated in human milk on the incidence of severe necrotizing enterocolitis (NEC) and death among preterm infants of gestational age less than or equal to 32 weeks of gestation and weighing between 750 and 1500 g.


Eligibility criteria: Inclusion Criteria:

* Preterm infants of gestational age less than 33 weeks of gestation with birth weight below 1500 g, admitted to the Neonatology Unit.
* Premature newborns who meet the above criteria and receive enteral feeding (mother breast milk, donors milk and/or premature formula) from the amount of 5 ml/kg/day.

Exclusion Criteria:

* Any clinical circumstance that prevents the initiation of enteral nutrition in the first 72 hours of life.
* Chromosomopathies and complex fetal malformations, incompatible with enteral nutrition in the first 72 hours of life.
* Non-acceptance of informed consent to participate in the study by the parents or legal guardians of the newborn.

Primary outcomes:
measure: Incidence of necrotizing enterocolitis and all-cause mortality
timeFrame: From birth until three months
Secondary outcomes:
measure: Intestinal colonization by administered strains
timeFrame: From birth until three months
measure: Incidence of Late Onset Sepsis
timeFrame: From birth until three months
measure: Time to complete enteral nutrition
timeFrame: From birth until three months
measure: Days of Central Vascular Catheter
timeFrame: From birth until three months
measure: Length of hospital stay
timeFrame: From birth until three months
measure: Weight change
timeFrame: From birth until three months
measure: Incidence of Bronchopulmonary Dysplasia
timeFrame: From birth until three months
measure: Incidence of patent ductus arteriosus
timeFrame: From birth until three months
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Hospital Virgen de las Nieves
Study officials:
References:
Clinical trial NCT04906304: Comparison of Safety and Efficacy of de Novo Everolimus
Official title: Comparison of Safety and Efficacy of de Novo Everolimus Plus Low Dose of Cyclosporine With Standard Dose of Cyclosporine Plus Cellcept on CMV and BK Virus Infections Prevention in Renal Transplant Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cytomegalovirus Infections
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2021-05-28
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Nowadays, de novo everolimus regimen in renal transplant patients is considered for reduction of cyclosporine dose and it is mentioned that this regimen not only has similar safety and efficacy, but also could prevent Cytomegalovirus (CMV )infections. So, the aim of this study was comparison of safety and efficacy of de novo everolimus plus low dose of cyclosporine with standard dose of cyclosporine plus cellcept on CMV virus infections prevention in renal transplant patients.

Detailed description: This randomized clinical trial was conducted in Shahid Labbafi nejad hospital. 35 renal transplanted patients enter the study and randomized to one of two groups: everolimus or control (Sandimmun or tacrolimus). However, 34 patients completed study (17 patients in each group). The treatment regimen in everolimus group was 0.75 mg/bid everolimus with everolimus C0 3-8 ng/mL plus Sandimmun (Neoral) low dose and in control group was standard dose of Sandimmun or tacrolimus plus cellcept. All patients gave Antithymocyte Glubolin and prednisolone. In addition, they gave CMV prophylaxis until 3 months. Kidney biopsies were done for raise of creatinine or protocol biopsy at 6 month after transplantation. Demographic, renal disease and transplantation characteristics, CMV and BK virus status, rejection, and routine laboratory tests recorded during study period and compared between two groups.

Eligibility criteria: Inclusion Criteria:

* Adult Transplanted patients \> 18 years

Exclusion Criteria:

* Simultanous Kidney -Pancreas Transplantation

Primary outcomes:
measure: CMV Infection
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Nooshin Dalili
Study officials:
affiliation: Shahid Beheshti University of Medical Sciences
name: SBMU University of Medical Sciences
role: STUDY_DIRECTOR
References:
Clinical trial NCT01825304: The Study of Using Esophageal Pressure to Guide the PEEP Setting in Abdominal Hypertension Patients Who Undergoing Mechanical Ventilation
Official title: the Study of Using Esophageal Pressure to Guide the PEEP Setting in Abdominal Hypertension Patients Who Undergoing Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: ARDS
Intra-abdominal Hypertension
Keywords: mechanical ventilation
Intra-abdominal hypertension
positive end-expiratory pressure
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: Jinling Hospital, China
First posted: 2013-04-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Intra-abdominal hypertension can increase the pleural pressure, and then end-expiratory transpulmonary pressures will be turn to negative, Pulmonary atelectasis/acute lung injury/acute respiratory distress syndrome will appear. In the group of people who suffering intra-abdominal hypertension, the investigators use the pressure of esophagus to speculate the Intrathoracic pressure, and to setting PEEP in order to decrease the happening of ALI/ARDS, which may decrease morbidity in this population.


Eligibility criteria: Inclusion Criteria:

* intra-abdominal hypertension
* mechanical ventilation
* sedation

Exclusion Criteria:

* underlying pulmonary disease
* age older than 60 years and younger than 18 years
* vital signs were not stable
* non voluntary

Primary outcomes:
measure: ventilator-free days
timeFrame: 28d
Secondary outcomes:
measure: mortality
timeFrame: 28d
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Ventilator
Study officials:
References:
Clinical trial NCT04834804: Effects of a 12-week Suspension Versus Free Weight Training Program on Body Composition and Handgrip Strength in Older Men
Official title: Effects of a 12-week Suspension Versus Free Weight Training Program on Body Composition and Handgrip Strength in Older Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effect of Different Exercise Programs on Body Composition
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 36
Sex: MALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The present investigation lasted a total of 16 weeks, of which 4 were employed for assessment and measurements and 12 weeks were used for the exercise treatment. The participants underwent two different training programs carried out in three weekly 75-min sessions, on alternate days (Mondays, Wednesdays and Fridays, in the morning). Each session of both training programs consisted of a warm-up at the beginning and general stretching at the end. The exercises used in the suspension training program were: squat, rear deltoid row, biceps curl, chest press, low row, rotational ward, split squat whit Y deltoid fly, triceps pushdown. The exercises used in the free weight training program were: squat with support, unilateral squat, hip adduction and abduction, calves, hip flexor, alternating curl, French triceps press, and high row. Eleven participants were included in the control group.


Eligibility criteria: Inclusion Criteria:

* not having chronic disabling diseases
* not being bedridden institutionalized or hospitalized
* have their own mobility, without assistance from people, even if they have the aid of devices -without amputations.

Exclusion Criteria:

* the use of pacemakers and the presence of chronic and uncontrolled metabolic diseases

Primary outcomes:
measure: Body composition
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Francesco Campa
Study officials:
References:
Clinical trial NCT03602404: Estimating Usual Iodine Intake From Spot Urinary Iodine Concentrations
Official title: Estimating the Usual Iodine Intake From Spot Urinary Iodine Concentrations to Obtain the Prevalence of Inadequate or Excess Iodine Intake in School-aged Children and Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Iodine Deficiency
Keywords: Iodine
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
Collaborators: name: Almazov National Medical Research Centre
name: University of Papua New Guinea
First posted: 2018-07-26
Enrollment: 1592
Sex: ALL
Minimum age (years): 9
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Apparently healthy school-age children and women of reproductive age

Brief summary: The overall objective of this study is to develop a reliable method to obtain habitual iodine intakes from spot urinary iodine concentration (UIC) and to assess the prevalence of inadequate iodine intake in school-age children and women of reproductive age. We will evaluate different methods to estimate iodine intake from UIC and estimate the prevalence of inadequate and excess iodine intake in UIC studies conducted in populations with low, adequate and high iodine intakes using the the established estimated average requirement (EAR)/Tolerable Upper Intake Level (UL) cut-point method.


Eligibility criteria: Inclusion Criteria:

* lived in study area \>= 12 months
* no reported intake of Amiodarone
* no history of thyroid dysfunction / goiter (past \& present)
* no exposure to iodine containing contrast agents within the last 12 months

Second arm: Women aged 18 - 49, exclusion / inclusion criteria apply, plus non-pregnant, non-lactating.

Primary outcomes:
measure: Estimated iodine intake
timeFrame: 17 months
Secondary outcomes:
measure: Urinary iodine concentration
timeFrame: 17 months
measure: Urinary creatinine concentration
timeFrame: 17 months
Other outcomes:
Locations:
city: Sia
country: Papua New Guinea
facility: University of Papua New Guinea
state: Morobe
city: Saint Petersburg
country: Russian Federation
facility: Almazov Medical Research Center
Study officials:
References:
Clinical trial NCT02680704: Mechanical Ventilation in Severe Brain Injury: The Effect of Positive End Expiratory Pressure on Intracranial Pressure
Official title: Mechanical Ventilation in Severe Brain Injury: The Effect of Positive End Expiratory Pressure on Intracranial Pressure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Intracranial Hypertension
Critical Illness
Brain Injuries
Lung Injury
Respiratory Failure
Positive-Pressure Respiration, Intrinsic
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2016-02-11
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to collect physiologic data from patients with severe brain injury who require mechanical ventilation in order to describe the impact of ventilation, specifically positive end expiratory pressure (PEEP), on intracranial pressure (ICP).


Eligibility criteria: Inclusion Criteria:

* Patients with severe brain injury (GCS 8 or less)
* Receiving mechanical ventilation
* Receiving intracranial pressure monitoring

Exclusion Criteria:

* Esophageal varices
* Esophageal trauma
* Recent esophageal surgery
* Coagulopathy (Platelets \< 80k or INR\> 2 )
* Other contraindication for esophageal manometry
* Already receiving PEEP \> 15 cmH2O at enrollment
* Intracranial hypertension (defined as ICP \> 20 mmHg)
* Decompressive hemi-craniectomy

Primary outcomes:
measure: Association between PEEP and ICP
timeFrame: Change from baseline to 20 minutes
Secondary outcomes:
measure: Association between transpulmonary pressure and ICP
timeFrame: Change from baseline to 20 minutes
measure: Association between PEEP and cerebral hemodynamics
timeFrame: Change from baseline to 20 minutes
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Principal Investigator
name: M. Dustin Boone, MD
role: PRINCIPAL_INVESTIGATOR
References: