louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01908309: Contrast-inDuced nephRotoxicity as Assessed by the KIdney Load-to-DAmage RElationship
Official title: Contrast-inDuced nephRotoxicity as Assessed by the Cystatin-modified KIdney Load-to-DAmage RElationship
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Contrast Induced Acute Kidney Injury
Keywords: acute kidney injury
contrast media
cystatin-C
Lead sponsor: Azienda Sanitaria Locale 9, Grosseto
Sponsor class: OTHER_GOV
First posted: 2013-07-25
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: We previously demonstrated that the slope of the relationship plotting individual iodine loads against contrast-induced serum creatinine changes ( the load-to-damage relationship, LDR) characterizes the intrinsic nephrotoxicity of the contrast. Aim of the present study is to compare, through the assessment of the LDR slope, the intrinsic nephrotoxicity of two different contrast media using serum cystatin-C changes as the LDR dependent variable.

Detailed description: We previously demonstrated that the slope of the relationship plotting individual iodine loads against contrast-induced serum creatinine changes ( the load-to-damage relationship, LDR) characterizes the intrinsic nephrotoxicity of the contrast and it may allow for reliable comparative evaluations among small sized study groups randomized to different contrast media. The aim of the present study is to compare, through the assessment of the LDR slope, the intrinsic nephrotoxicity of two different contrast media using serum cystatin-C changes as the LDR dependent variable.

Eligibility criteria: Inclusion Criteria:

* Patients candidate to coronary angiography and/or angioplasty and
* Baseline creatinine clearance \< 60 ml/min

Exclusion Criteria:

* Patients with STEMI
* Patients with shock
* Known allergy to contrast media
* Prior contrast administration within 1 month
* Current use of nonsteroidal anti-inflammatory drugs

Primary outcomes:
measure: Slope of LDR (as assessed by serum cystatin-C changes)
timeFrame: 48 hours
Secondary outcomes:
measure: Slope of LDR (as assessed by serum creatinine changes)
timeFrame: 72 hours
Other outcomes:
Locations:
city: Grosseto
country: Italy
facility: Misericordia Hospital, ASL 9
Study officials:
References:
citation: Limbruno U, Picchi A, Micheli A, Calabria P, Cortese B, Brizi G, Severi S, De Caterina R. Refining the assessment of contrast-induced acute kidney injury: the load-to-damage relationship. J Cardiovasc Med (Hagerstown). 2014 Jul;15(7):587-94. doi: 10.2459/JCM.0b013e3283638e56.
Clinical trial NCT03793309: Different Doses of Vitamin D and T Regulatory Cells in Preterm Infants
Official title: A Randomized Controlled Trial on the Effect of 400 vs. 800 IU of Vitamin D on T Regulatory Cells in Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prematurity
Immune Defect
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-01-04
Enrollment: 40
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluate the effect of two different doses of vitamin D on T-regulatory cells in preterm infants. Half of the subjects receives 400 IU vitamin D and the other half receives 800 IU vitamin D.

Detailed description: Vitamin D, in addition to its bone mineralization effect, is an immune- modulatory agent. Fetal and premature cellular immunity are generally delayed. Whether vitamin D can enhance cellular immunity by increasing T regulatory cells is unknown. The effect of two different doses of vitamin D; 400 IU and 800 IU will be studied.

Eligibility criteria: Inclusion Criteria:

* Preterm infants with gestational age 28-33 weeks

Exclusion Criteria:

* Necrotizing enterocolitis
* Bowel perforation
* Chromosomal anomalies
* Inborn errors of metabolism
* Major congenital anomalies

Primary outcomes:
measure: Percent Change in The Number of T Regulatory Cells
timeFrame: At 1 week (compared to baseline)
measure: Percent Change in The Number of T Regulatory Cells
timeFrame: At 4 weeks (compared to baseline)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University Children's Hospital
name: Lamiaa Mohsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bozkurt O, Uras N, Sari FN, Atay FY, Sahin S, Alkan AD, Canpolat FE, Oguz SS. Multi-dose vitamin d supplementation in stable very preterm infants: Prospective randomized trial response to three different vitamin D supplementation doses. Early Hum Dev. 2017 Sep;112:54-59. doi: 10.1016/j.earlhumdev.2017.07.016. Epub 2017 Aug 2.
citation: Zittermann A, Dembinski J, Stehle P. Low vitamin D status is associated with low cord blood levels of the immunosuppressive cytokine interleukin-10. Pediatr Allergy Immunol. 2004 Jun;15(3):242-6. doi: 10.1111/j.1399-3038.2004.00140.x.
citation: Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2.
citation: Aly H, Mohsen L, Bhattacharjee I, Malash A, Atyia A, Elanwary S, El Hawary R. Vitamin D Supplementation and T Cell Regulation in Preterm Infants: A Randomized Controlled Trial. J Pediatr Gastroenterol Nutr. 2019 Nov;69(5):607-610. doi: 10.1097/MPG.0000000000002448.
Clinical trial NCT02438709: Effect Observation Study of COX-2 Inhibitor to Treat Primary Hypertrophic Osteoarthropathy
Official title: Application of COX-2 Inhibitor for Treatment of Primary Hypertrophic Osteoarthropathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Primary Hypertrophic Osteoarthropathy
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2015-05-08
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether COX-2 inhibitor is effective in the treatment of primary hypertrophic osteoarthropathy

Detailed description: Patients with primary hypertrophic osteoarthropathy(PHO) were diagnosed based on clinical manifestations and symptoms. PHO patients were treated with COX-2 inhibitor after signing informed consent. The extend of alleviation, the change of the markers on prostaglandin E metabolic pathway and the adverse event on different time points were recorded to identify the efficacy and safety.

Eligibility criteria: Inclusion Criteria:

* diagnosed with primary hypertrophic osteoarthropathy clinically
* over 16 years old
* no other medication intake
* informed consent signed

Exclusion Criteria:

* below 16 years old
* active gastric ulcer
* inflammatory bowel disease
* New York Heart Association classification（NYHA） II to IV
* liver or renal failure
* allergic to nonsteroid anti-inflammatory drugs
* not willing to participate

Primary outcomes:
measure: Prostaglandin E2（PGE2） level change after COX-2 inhibitor treatment in PHO patients
timeFrame: 3 months
measure: Prostaglandin E2（PGE2） level change after COX-2 inhibitor treatment in PHO
timeFrame: 6 months
Secondary outcomes:
measure: change in pain on VAS scale after COX-2 inhibitor treatment
timeFrame: 3 months
measure: change in pain on VAS scale after COX-2 inhibitor treatment
timeFrame: 6 months
measure: change in pain on VAS scale after COX-2 inhibitor treatment
timeFrame: 12 months
measure: The volume of distal part of middle finger change after COX-2 inhibitor treatment
timeFrame: 3 months
measure: The volume of distal part of middle finger change after COX-2 inhibitor treatment
timeFrame: 6 months
measure: The volume of distal part of middle finger change after COX-2 inhibitor treatment
timeFrame: 12 months
measure: Circumference of knee joint change after COX-2 inhibitor treatment
timeFrame: 3 months
measure: Circumference of knee joint change after COX-2 inhibitor treatment
timeFrame: 6 months
measure: Circumference of knee joint change after COX-2 inhibitor treatment
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Department of Endocrinology, Key Laboratory of Endocrinology, Ministry of Health, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences
name: Weibo Xia, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05726409: Mobile Application to Create Healthy Food Preparation Habits for Patients With Diabetes and Prediabetes
Official title: Mobile Application to Create Healthy Food Preparation Habits for Patients With Diabetes and Prediabetes: A Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Pre Diabetes
Keywords: Mobile application
Meal preparations
Recipes
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Boston Medical Center Food Kitchen
First posted: 2023-02-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Boston Medical Center (BMC) serves many underserved, low-income patients and has developed an innovative strategy to combat food insecurity including a preventative food pantry, a teaching kitchen, and a rooftop farm that provides fresh produce directly to the patients. The presence of this well-established, three-pronged approach places BMC in an ideal position to develop a nutritional education intervention that supports experiential learning in this high-risk population.

For this first exploratory study, 75 enrolled participants will be given a free mobile application with recipes designed to build habits. Participants will cook at least three meals weekly for two months using the app. Self-reported survey data and activity on the app will be collected and used to assess the feasibility of teaching cooking skills through a mobile application.


Eligibility criteria: Inclusion Criteria:

* Access to an oven OR microwave, stovetop OR hot plate, and food storage.
* Access to the internet on a smartphone
* Owns a smartphone with iOS Apple Store or Google Play
* Reading proficiency in English
* Has a diagnosis of diabetes or prediabetes(Hb A1C\> 5.6)

Exclusion Criteria:

* Inability to provide informed consent
* Taking any medications or has a condition that limits the ability to increase intake of fruits and vegetables (including warfarin and end-stage renal disease)
* Attended a Diabetes Self-Management Education (DSME) at BMC within the past year or plans to attend during the study.

Primary outcomes:
measure: Frequency of mobile app use
timeFrame: 12 weeks
measure: Recipe completion rate
timeFrame: 12 weeks
measure: Satisfaction with the mobile application
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in dietary patterns
timeFrame: baseline, 12 weeks
measure: Change in nutrition knowledge
timeFrame: baseline, 12 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center, Department of Family Medicine
name: Lauren Ciszak, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00913809: To Demonstrate the Relative Bioequivalency of Cord's 100 mg Desipramine HCL Tablets To Merrell Dow's 100 mg Norpramin Tablets
Official title: A Two-Way Single Dose Crossover Bioequivalency of Cord's 100 mg Desipramine HCL Tablets To Merrell Dow's 100 mg Norpramin Tablets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depression
Keywords: Antidepressant
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-06-04
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To demonstrate the relative bioequivalency of Cord's 100 mg Desipramine HCl tablets to Merrell Dow's 100 mg Norpramin tablets.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.

Primary outcomes:
measure: Bioequivalence based on AUC and Cmax
timeFrame: 24 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Biodecision Laboratories
name: Jules Kann, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00631709: REmote MOnitoring Transmission Evaluation of IPGs
Official title: REmote MOnitoring Transmission Evaluation of IPGs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pacemaker
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2008-03-10
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate the potential clinical and economic benefits of using CareLink remote management for pacemaker follow-up.

Study Objectives include:

1. To determine clinician perceived quality of care for CareLink remote follow-up.
2. To determine patient satisfaction with CareLink follow-up.
3. To estimate the time required to perform patient follow-up via CareLink remote transmissions.
4. To determine the percentage of regular CareLink follow-ups that do not require further in-clinic review of the patient.
5. To estimate potential patient cost avoidance for one year of follow up incorporating CareLink.
6. To evaluate compliance to scheduled CareLink transmissions with the remote management system

This is a non-randomized, multi-center, prospective study in which 120 patients who have a pacemaker are enrolled into the study and receive a CareLink monitor. Patients will replace their regularly scheduled pacemaker clinic follow-up visits with a CareLink remote transmission for 12months.

Patients will require a test transmission within 1 month after they receive their CareLink monitor. Afterwards, patients are followed via CareLink transmissions as per their usual clinic schedule for 12 months.


Eligibility criteria: Inclusion Criteria:

* Patients who have received a market released Medtronic pacemaker with automatic threshold management features for all active leads.
* Patients who have been implanted with their current pacemaker for at least 3 months.
* Patients who are willing, or who have caregivers willing, to use the Medtronic CareLink Monitor.
* Patients who are willing and able to sign an IRB/MEC approved patient informed consent.

Exclusion Criteria:

* Patients participating in another study that would affect the objectives of this study
* Patients who have already previously used a Medtronic CareLink Monitor.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kelowna
country: Canada
facility: Kelowna General Hospital
state: British Columbia
city: Newmarket
country: Canada
facility: Southlake Regional Hospital
state: Ontario
city: Quebec City
country: Canada
facility: CHUQ, L'Hotel Dieu de Quebec
state: Quebec
Study officials:
References:
Clinical trial NCT01563809: Basal Androgens and LH Needing for Ovarian Stimulation for in Vitro Fertilization
Official title: The Relationship Between Basal Androgen Levels and the Needing of LH for Controlled Ovarian Stimulation for in Vitro Fertilization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infertility
Lead sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA
Sponsor class: OTHER
First posted: 2012-03-27
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Basing the investigators study on the evidence that basal serum androgens decrease with age, the investigators hypothesize that women with serum androgens below a certain level could be the population obtaining a benefit of Luteinizing Hormone (LH) supplementation. The objective of the present study is to explore the relationship between basal serum androgen levels and the need of LH for Controlled Ovarian Stimulation (COS) in IVF.

Detailed description: Design: Single centre, open label, randomized controlled trial.

* Population: Patients with indication of In Vitro Fertilization (IVF) with the following criteria:
* Protocol: All patients are tested on day 3-5 of cycle for total Testosterone (Te), Dehydroepiandrosetnodione sulphate (DHEAS) and Androstenodione (Δ4). Samples are frozen and stored at -20ºC for later analysis. FSH, LH, E2, PRL and TSH are also determined. All patients follow Controlled Ovarian Stimulation for IVF with a GnRH agonist long protocol. They are randomized to receive recombinant (r) FSH alone (225 IU/day) or r-FSH + r-LH (225+75 IU/day).
* Sample size calculation: To detect a difference from 40 to 60% (Relative risk: 1.50) on pregnancy rate (PR) between patients with low and high androgen levels with respect to the mean of each COS protocol, with a confidence level of 95% (error α=0.05) and 80% of power (error β=0.2), 97 patients per arm were needed. (n=388 patients). Rounding up, 400 patients are to be recruited.

Eligibility criteria: Inclusion Criteria:

* 1st-2nd IVF cycle
* Regular cycle (25-35 days)
* Age 18 - 42
* BMI: 18-29.9

Exclusion Criteria:

* LH:FSH \> 2
* Low response background (\< 5 oocytes)
* Recurrent pregnancy loss
* Preimplantational genetic diagnosis indication
* Any systemic, metabolic or endocrinological disorder.

Primary outcomes:
measure: Clinical Pregnancy Rate
timeFrame: 45 days
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: IVI Valencia
Study officials:
References:
Clinical trial NCT01543009: Use of Local Warming in Children Venipuncture
Official title: Use of Local Warming in Children to Facilitate Venipuncture. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: EARLY_PHASE1
Conditions: Phobia Phlebotomy
Keywords: child
venipuncture
pain
Lead sponsor: University of Florence
Sponsor class: OTHER
First posted: 2012-03-02
Enrollment: 72
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to determine if local application of heat increases the probability of insertion of peripheral venous catheter at the first attempt, reduces the time needed to obtain cannulation and maintains the analgesic effect of Emla in children undergoing peripheral venous cannulation and previously treated with local analgesia with Emla.


Eligibility criteria: Inclusion Criteria:

* age between 8 and 13 years
* Intravenous drug therapy prescribed by a physician
* no allergy to lidocaine
* no local skin disease
* absence of burns scars
* child and his/her family are native speaker of Italian
* BMI not lower than 10° centile for sex and age according to the CDC standards

Exclusion Criteria:

* age of child not included in the age range established for the study
* Intravenous drug therapy not needed
* Presence of an allergy to lidocaine products
* Skin disease
* Presence of burns scars
* The child or his/her family are not native speaker Italian
* BMI lower than 10° centile according to the CDC standards

Primary outcomes:
measure: rate of success of peripheral venous cannulation at the first attempt
timeFrame: The outcome is observed and recorded immediatly after the venous cannulation. No follow up is required
Secondary outcomes:
measure: pain perceived by the child undergone to the cannulation
timeFrame: The outcome is observed and recorded immediatly after the venous cannulation. No follow up is required
measure: Difficulty in performing cannulation perceived by Nurse
timeFrame: The outcome is observed and recorded immediatly after the venous cannulation. No follow up is required
measure: Time needed to obtain cannulation
timeFrame: From positioning tourniquet to completion of cannulation. No follow up is required
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Meyer Children Hospital
Study officials:
affiliation: University of Florence
name: Filippo Festini, RN, BA, BSN, MSN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03498209: Prevalence of Molar Incisor Hypominerlization (MIH) Among a Group of Egyptian Children
Official title: Prevalence of Molar Incisor Hypominerlization (MIH) Among a Group of Egyptian Children: A Cross Sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Molar Incisor Hypomineralization
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-04-13
Enrollment: 100
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Data for this study will be conducted in Department of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University, Egypt.

Participants will be selected from the outpatient's clinic of Pediatric Dentistry and Dental Public Health department, Faculty of Dentistry, Cairo University.

Brief summary: To determine the Prevalence of MIH in a group of Egyptian children attending the Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University.

Detailed description: One single operator, Master degree student in the department of Pediatric Dentistry and Dental public health, Faculty of Dentistry, Cairo University will assess incidence of molar incisor hypomineralization for all the patients who will be included in the study sample. The survey will involve a structured questionnaire which will be followed by clinical examination to assess the presence / absence of molar incisor hypomineralization and its severity based on EAPD criteria

Eligibility criteria: Inclusion Criteria:

1. Children age from eight to twelve years.
2. Medically free.
3. Singed informed consent.
4. Both sexes are included
5. Parent and children cooperation.

Exclusion Criteria:

1. Children with (amelogenesis imperfecta, tetracycline tooth stains, extensive destruction due to caries, or have restoration or crown and fluorosis).
2. Children with orthodontic bands on the first permanent molars preventing adequate clinical examination.

Primary outcomes:
measure: prevalence of molar incisor hypomineralization among a group of Egyptian Children
timeFrame: baseline
Secondary outcomes:
measure: Relationship of MIH with dental caries
timeFrame: baseline
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: eman S ELMASRY, PHD
role: STUDY_DIRECTOR
References:
citation: Biondi AM, Lopez Jordi Mdel C, Cortese SG, Alvarez L, Salveraglio I, Ortolani AM. Prevalence of molar-incisor hypomineralization (MIH) in children seeking dental care at the Schools of Dentistry of the University of Buenos Aires (Argentina) and University of la Republica (Uruguay). Acta Odontol Latinoam. 2012;25(2):224-30.