louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05134220: Electrolytes in Chronic Kidney Disease Patients With Acute Coronary Syndrome
Official title: Study of Serum Calcium and Phosphorus Level in Chronic Kidney Disease Patients With Acute Coronary Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Coronary Syndrome
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-11-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: two groups :

1. CKD patients with and without dialysis who admitted to Sohag university hospital with acute coronary syndrome
2. CKD patients with and without dialysis who admitted to Sohag university hospital with no previous or current history of acute coronary syndrome

Brief summary: Study of serum calcium and phosphorus level in chronic kidney disease patients and its relation to occurrence of acute coronary syndrome in them.

Detailed description: Prospective study to :

1. find the relation between electrolytes disturbance and renal diseases
2. the effect of electrolyte abnormalities on atherosclerosis
3. prevalence of acute coronary syndrome in patients with chronic kidney disease

Eligibility criteria: Inclusion Criteria:

* 1-The CKD patients with or without dialysis who admitted to coronary care unit with chest pain consistent with ACS with any of following features :

  a- Electrocardiogram (ECG) changes:
* ST elevation.
* ST depression.
* T wave inversion.
* recent left bundle branch block.

  b- Troponin T elevation.

  2-The CKD patient with or without dialysis with no previous history of ACS.

Exclusion Criteria:

1. Patients who were diagnosed with primary hyperparathyroidism.
2. Acute Kidney injury (AKI) which is defined as any of the following:(KDIGO2012)

   * Increase in S.Cr by ≥ 0.3 mg/dl (≥ 26.5 μmol/l) within 48hours; or
   * Increase in S.Cr to ≥ 1.5 times baseline, which is known or presumed to have occurred within the prior 7 days;or
   * Urine volume \<0.5 ml/kg/h for 6 hours

Primary outcomes:
measure: Chronic kidney disease hospitalization
timeFrame: from the day of admission to the day of discharge through study completion, an average of 28 weeks, in sohag university hospital
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university
Study officials:
References:
citation: Block GA, Hulbert-Shearon TE, Levin NW, Port FK. Association of serum phosphorus and calcium x phosphate product with mortality risk in chronic hemodialysis patients: a national study. Am J Kidney Dis. 1998 Apr;31(4):607-17. doi: 10.1053/ajkd.1998.v31.pm9531176.
Clinical trial NCT03205020: Maternal Serum Amyloid A Levels in Pregnancies Complicated With Preterm Labour.
Official title: Maternal Serum Amyloid A Levels in Pregnancies Complicated With Preterm Labour.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Preterm Labor
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 58
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 58 pregnant women will be recruited

Brief summary: The aim of the current study is to assess the accuracy of maternal serum amyloid A for prediction of preterm labor in women with threatened preterm labor.


Eligibility criteria: Inclusion Criteria:

* Pregnant women, age 18 - 35.
* Gestational age: 28 - 36+6 weeks.
* Singleton pregnancy.
* No past history of any medical disorder and with no other medical complications during pregnancy
* Nonsmoker.
* Diagnosis of preterm labor is based on the American College of Obstetricians and Gynecologists Guidelines

Criteria of preterm delivery:

1. Gestational age: 28 - 36+6 weeks
2. Presence of uterine contractions (at least 4 in 20 minutes or 8 in 60 minutes)
3. cervical dilation ≥ 4 cm
4. Cervical effacement ≥ 80%.

Exclusion Criteria:

* Of any patient with the following risk factors for preterm labor:

  * Over distended uterus .
  * hemorrhage
  * Uterine anomalies

Primary outcomes:
measure: prevalence of Amyloid A level in women with preterm labour
timeFrame: 6 months
Secondary outcomes:
measure: neonatal complications
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: Ain Shams University
name: mona mohamed, MS
role: STUDY_CHAIR
References:
Clinical trial NCT01275820: A Study to Evaluate Glucose and Insulin Response to Nutralin
Official title: A Study to Evaluate Glucose and Insulin Response to Nutralin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Keywords: diabetes, insulin, blood sugar
Lead sponsor: Avera McKennan Hospital & University Health Center
Sponsor class: OTHER
Collaborators: name: Vintek, LLC
First posted: 2011-01-12
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals in and around the area of Sioux Falls, SD

Brief summary: The purpose of this study is to evaluate how an investigational food product affects a healthy person's blood sugar and insulin levels.

Detailed description: The investigational food product has helped decrease the amount of insulin needed in treating diabetic dogs and has improved the dogs' longevity and quality of life. Observational analysis by trained veterinarians has indicated that the natural fluctuations in blood glucose levels do not exist in dogs using the product. The hypothesis for this study is that healthy human subjects will have an increase in insulin levels after consuming the investigational food product.

Eligibility criteria: Inclusion Criteria:

* Men and women who are at least 18 years of age
* Non-diabetic

Exclusion Criteria:

* Diabetes
* Women who are pregnant, breastfeeding or planning to become pregnant
* Current and active liver or kidney disease
* Any food allergies
* Celiac disease

Primary outcomes:
measure: Glucose blood level
timeFrame: 4 weeks
Secondary outcomes:
measure: Dosage of Insulin
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Sioux Falls
country: United States
facility: Avera Research Institute
state: South Dakota
Study officials:
affiliation: Avera McKennan Hospital & University Health Center
name: Edward Zawada, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04040920: Ozone Application Before Fissure Sealants
Official title: The Effect of Ozone Application Before Fissure Sealants: a Split Mouth Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Caries,Dental
Keywords: Ozone
Pits and fissures sealants
Prevention
Lead sponsor: IRCCS Burlo Garofolo
Sponsor class: OTHER
First posted: 2019-08-01
Enrollment: 67
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Splith mouth design
Primary purpose: TREATMENT

Brief summary: Decay is a multifactorial infective degenerative disease of hard dental tissues, caused by Streptococcus mutans and Lactobacillus forming the bacterial biofilm of teeth surfaces. Decays generally evolve in fissures and pits of secondary molars. Pits and fissure sealants prevent decays if performed in two years from eruption. Ozone has bactericidal effect and remineralizing capacity on enamel.

The aim of this study is to assess the effectiveness of ozone application before sealants in increasing their duration in time.


Eligibility criteria: Inclusion Criteria:

* first or second secondary molars to be sealed
* possibility to isolate with rubber dam both the teeth involved
* no clear signs of pigmentations
* good general health

Exclusion Criteria:

* latex allergy
* epilepsy or other severe neurological pathologies
* psychiatric disease
* excessive sensibility to electrical current
* severe asthma
* enamel disorders, such as amelogenesis imperfect, white spots, fluorosis or Molar Incisors Hypomineralization

Primary outcomes:
measure: Sealants failure
timeFrame: 12 months after sealant
Secondary outcomes:
measure: Sealants failure
timeFrame: 6 months after sealant
measure: Sealants failure
timeFrame: 24 months after sealant
measure: Secondary decay in failed sealants
timeFrame: 6 months after sealant
measure: Secondary decay in failed sealants
timeFrame: 12 months after sealant
measure: Secondary decay in failed sealants
timeFrame: 24 months after sealant
Other outcomes:
Locations:
city: Trieste
country: Italy
facility: Institute for Maternal and Child Health - IRCCS Burlo Garofolo-
Study officials:
affiliation: IRCCS Burlo Garofolo
name: Milena Cadenaro, DDS,MSc,PhD
role: STUDY_CHAIR
affiliation: IRCCS Burlo Garofolo
name: Maddalena Chermetz, DDS,MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05551520: ImPACT Version 4-Touchscreen: Normative and Reliability Study
Official title: ImPACT Version 4-Touchscreen: Normative and Reliability Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Concussion
Keywords: Brain
Lead sponsor: ImPACT Applications, Inc.
Sponsor class: INDUSTRY
First posted: 2022-09-22
Enrollment: 1437
Sex: ALL
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This research study is designed to establish normative database and reliability of ImPACT for adolescents and adults ages 12 through 80 to expand the use of devices to include touchscreen.

Detailed description: This research study is designed to establish normative database and reliability of ImPACT for adolescents and adults ages 12 through 80 to expand the use of devices to include touchscreen. Enrollment will be 900 participants.

Eligibility criteria: Inclusion Criteria:

1. Age 12-80
2. Primary English speaking or fluent in English

Exclusion Criteria:

1. Documentation of a known special education diagnosis other than a 504 designation.
2. History of concussion less than 6 months to the study participation
3. Known physical (e.g., visual impairment not fixable by usual means, such as glasses) or psychological impairment (ADHD, LDD, etc.) that would affect their ability to perform the test.

Primary outcomes:
measure: Validity
timeFrame: 12 months
Secondary outcomes:
measure: Reliability
timeFrame: Baseline test will be administered at enrollment and re-test will be administered within 60 days of baseline test.
Other outcomes:
Locations:
city: Coralville
country: United States
facility: ImPACT Applications, Inc.
state: Iowa
Study officials:
References:
Clinical trial NCT03220620: Influence of Perioperative Fluid Therapy on Hemoglobin and Methemoglobin Levels
Official title: Influence of Perioperative Fluid Therapy on Hemoglobin and Methemoglobin Levels in Major Abdominal Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Perioperative/Postoperative Complications
Fluid Overload
Hemoglobin H
Keywords: fluid therapy
perioperative
hemodilution
Lead sponsor: University of Rostock
Sponsor class: OTHER
First posted: 2017-07-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing major abdominal surgery

Brief summary: The objective of the study is to evaluate influence of perioperative fluid therapy on Methemoglobin levels, and to changes in hemoglobin. Further, changes in Methemoglobin will be related to metabolic signs of oxidative stress (changes in blood lactate). Patients undergoing major abdominal surgery will be included into the study.

Detailed description: Increasing plasma volume by intravenous administration of crystalloid and/or colloid solutions may cause a relative reduction in hemoglobin (Hb) concentration, a situation that is termed 'dilutional anemia'. Such hemodilution may lead to an iatrogenic reduction in oxygen-carrying capacity and the development of organ dysfunction. Paradoxically, large amounts of fluids that are administered with the aim of increasing oxygen delivery (DO2), as is frequently done as part of perioperative goal-directed therapy; this may lead to an actual decrease in the DO2 due to a decrease in Hb concentration.

Another potential parameter that may reflect the development of dilutional anemia is methemoglobin (MetHb), a form of Hb with reduced ability for oxygen binding. Experimental studies showed that dilutional anemia may lead to up-regulation of perivascular nitric oxide synthase (NOS) and increase NOS-derived nitric oxide (NO) leading to local vasodilation and oxidization of Hb to MetHb. MetHb may potentially serve as a biomarker of 'anemic stress' associated with reduced tissue perfusion during acute hemodilution.

Eligibility criteria: Inclusion Criteria:

* major abdominal surgery
* informed consent

Exclusion Criteria:

* violation of study protocol

Primary outcomes:
measure: Influence of perioperative fluid therapy on hemoglobin levels
timeFrame: during surgery
measure: Influence of perioperative fluid therapy on Methemoglobin levels
timeFrame: during surgery
Secondary outcomes:
measure: Influence of perioperative fluid therapy on changes in lactate
timeFrame: during surgery
measure: Influence of perioperative fluid therapy on SvO2
timeFrame: during surgery
Other outcomes:
Locations:
city: Rostock
country: Germany
facility: University of Rostock
state: Mecklenburg/Vorpommern
Study officials:
affiliation: University of Rostock
name: Thomas Mencke, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00345020: Deep Lamellar Endothelial Keratoplasty: Small Incision Technique
Official title: Deep Lamellar Endothelial Keratoplasty: Small Incision Technique
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Corneal Transplantation
Keywords: Deep Lamellar Endotheliam Keratoplasty
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2006-06-27
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: The research objectives of this study are to determine if small incision Deep Lamellar Endothelial Keratoplasty (DLEK) is able to further reduce the degree of corneal astigmatism and shorten the time course of corneal topography stabilization compared to standard full thickness corneal transplant (PKP) surgery.

Detailed description: Split thickness lamellar corneal transplants have been performed for many years to replace the front part of the cornea and have been highly successful. What is different about this study is that the surgical procedure involves replacement of the back layers of the cornea rather than the front layers of the cornea. This replacement is done through a small pocket incision to avoid changes in the front surface of the cornea. By leaving the front surface in the cornea without sutures or incisions there is felt to be an advantage in healing and recovery time for the patient. In addition, this particular study will use a pocket incision that is even shorter and smaller in length than the one used in previous DLEK surgeries to try to make healing time even faster and more predictable. This procedure has been successfully performed on patients in the Netherlands for over five years. The procedure has also been successfully performed by doctors in the United States. Subjects participating in this study will be among the first patients to undergo this procedure in the The University of Texas Southwestern Medical Center at Dallas.

Eligibility criteria: Inclusion Criteria: Subjects enrolled in this study will have endothelial dysfunction to a level generally accepted as requiring standard PKP for treatment. Subjects will be offered the alternative surgery of this protocol. All subjects will be between the ages of 21 and 95. Males and females are eligible.

-

Exclusion Criteria: Central corneal scars, presence of a filtering bleb and uncontrolled glaucoma.

-

Primary outcomes:
measure: to determine if small incision Deep Lamellar Endothelial Keratoplasty (DLEK) is able to further reduce the degree of corneal astigmatism and shorten the time course of corneal topography stabilization
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center at Dallas
state: Texas
Study officials:
affiliation: University of Texas, Southwestern Medical Center at Dallas
name: Vinod Mootha, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03257020: The Diagnostic Performance of BMO-MRW and RNFL Thickness and Their Combinational Index Using Artificial Neural Network
Official title: The Comparison of Bruch's Membrane Opening-minimum Rim Width and Retinal Nerve Fiber Layer Thickness and Their Combinational Index Using Artificial Neural Network
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Tomography, Optical Coherence
Keywords: OCT
RNFL
BMO-MRW
Glaucoma
Lead sponsor: Pusan National University Hospital
Sponsor class: OTHER
First posted: 2017-08-22
Enrollment: 402
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients who visited Pusan National University Hospital glaucoma clinic.

Brief summary: This study evaluates the relationship between BMO-MRW and RNFL thickness measured by OCT. SD-OCT exam will be performed to all patients in this study.

Detailed description: spectral domain optical coherence tomography, SD-OCT, (Heidelberg Engineering, Heidelberg, Germany) is a widely used commercial device in ophthalmology field. For a long time, retinal nerve fiber layer (RNFL) thickness was measured with OCT to detect and follow up glaucoma patients. Bruch's membrane opening - minimum rim width (BMO-MRW) is relatively new parameter which measures the minimum distance between Bruch's membrane opening to internal limiting membrane (ILM). BMO-MRW,a new parameter, is known to have better diagnostic performance than RNFL thickness and recently, many researches has been performed on this new parameter. SD-OCT can measure RNFL thickness and BMO-MRW at the same time. The test procedure is not different from RNFL thickness measurement but only software implemented in OCT device calculates BMO-MRW as well as RNFL thickness. The investigators are going to compare these two parameters and find out the relationship between two parameters.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years with a clear cornea and clear ocular media
* BCVA ≥ 20/40
* Refractive error within ± 6.0 diopters (D) of 0 and astigmatism ± 3.0 D of 0

Exclusion Criteria:

* uveitis
* secondary glaucoma
* corneal abnormalities
* non-glaucomatous optic neuropathies
* previous trauma
* ocular surgery or laser treatment
* any other eye disease except glaucoma.

Primary outcomes:
measure: Bruch's membrane opening - minimum rim width (BMO-MRW)
timeFrame: 5~10 minutes
Secondary outcomes:
measure: Retinal nerve fiber layer (RNFL) thickness
timeFrame: 5~10 minutes
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
Study officials:
affiliation: Medical Research Institute, Pusan National University Hospital, Busan, Korea
name: Jiwoong Lee, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01387620: Comparison of DisCoVisc and Hydroxypropylmethylcellulose 2%
Official title: Intraindividual Randomized Clinical Comparison of DisCoVisc and Hydroxypropylmethylcellulose 2% in Phacoemulsification
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Corneal Edema
Intraocular Pressure
Keywords: Phacoemulsification
Corneal Edema
Corneal Endothelium
Viscoelastic Substances
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2011-07-04
Enrollment: 39
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This prospective study was performed to compare two ophthalmic viscosurgical devices, DisCoVisc (hyaluronic acid 1.6% - chondroitin sulfate 4.0%) and hydroxypropylmethylcellulose 2% in terms of their overall clinical performance during phacoemulsification.


Eligibility criteria: Inclusion Criteria:

* Bilateral age-related cataract
* Grade 1-3 lens opacities classification system (LOCS III)
* Pupil dilatation greater than 7.0 mm

Exclusion Criteria:

* Black, brunescent, traumatic or subluxated cataract
* Corneal endothelial disease (endothelial cell count less than 2.000 cells/mm3)
* Glaucoma, uveitis
* Previous ocular surgery

Primary outcomes:
measure: Corneal endothelial cell count
timeFrame: 6 months
Secondary outcomes:
measure: Central Corneal Thickness
timeFrame: 7 days
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of São Paulo
Study officials:
References:
citation: Espindola RF, Castro EF, Santhiago MR, Kara-Junior N. A clinical comparison between DisCoVisc and 2% hydroxypropylmethylcellulose in phacoemulsification: a fellow eye study. Clinics (Sao Paulo). 2012 Sep;67(9):1059-62. doi: 10.6061/clinics/2012(09)13.
Clinical trial NCT04203420: Prevalence of Primary Aldosteronism in Young Adults With Acute Stroke
Official title: Prevalence of Primary Aldosteronism in Young Adults With Acute Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Aldosteronism
Lead sponsor: Chongqing Medical University
Sponsor class: OTHER
First posted: 2019-12-18
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who were once admitted in the First affiliated hospital of CQMU during Jan.2006 to Feb.2019 with stroke onset less than two weeks. Age between 18 to 45y.

Brief summary: The guideline requires clinical works to screen for primary aldosteronism(PA) in young adults with family history of stroke at early onset. But the prevalence of PA in young adults with stroke onset before 45 years old had never been investigated. The study aimed to discover the prevalence as well as the clinical characteristics between patients with PA and those without PA during stroke attack. In order to fulfill this objective, investigators intended to conduct a cross-sectional study by taking screening and confirmatory tests among young adults who once admitted due to early onset of acute stroke.


Eligibility criteria: Inclusion Criteria:

- patients who were once admitted in the First affiliated hospital of Chongqing Medical university(CQMU), with stroke onset less than two weeks

Exclusion Criteria:

death, serious sequela with motor, comprehensive or linguistic dysfunction, patients unwilling to join in, etiology of trauma, infective or tumor disease, patients with impaired cardiac, renal or liver function during admission-

Primary outcomes:
measure: prevalence of PA
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affilated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
References: