louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05077007: Evaluation of Renal Damage After PCNL and ESWL Using Novel RNA Based Biomarkers
Official title: Evaluation of Renal Damage After PCNL and ESWL Using Novel RNA Based Biomarkers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Kidney Injury
Renal Calculi
Percutaneous Nephrolithotomy
Extracorporeal Shockwave Lithotripsy
Keywords: lncRNA, mRNA, ESWL,PCNL,SBF2-AS1, FENDRR-19, NLRP3.
Lead sponsor: Ain Shams University
Sponsor class: OTHER
Collaborators: name: Science,Technology & Innovation Funding Authority
First posted: 2021-10-13
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The study evaluate the damage effect of ESWL and PCNL on kidney tissue by measuring non-coding lnc-RNA profile in urine before and after ESWL and PCNL procedures

Detailed description: The study evaluate the damage effect of ESWL and PCNL on kidney tissue by measuring non-coding lnc-RNA profile in urine before and after ESWL and PCNL procedures and assess their usefulness as diagnostic biomarkers for AKI and the relationship between the selected RNA based biomarker panel and clinicopathological changes of patients.

Eligibility criteria: Inclusion Criteria:

* Inclusion criteria for patients :

  1. Patients undergoing treatment for a stone(s) located in the kidney less than 2 cm
  2. Radiopaque stone
  3. Able and willing to give informed consent

Inclusion criteria for Healthy volunteers

1. No history of kidney or stone disease
2. Asymptomatic
3. No indwelling ureteral stent
4. Willing to provide medical history information
5. Able and willing to give informed consent

Exclusion Criteria:

* Exclusion criteria for patients

  1. Active urinary tract infection
  2. Bleeding disorder
  3. Chronic renal failure (eGFR\<30)
  4. Ureteral stone

Primary outcomes:
measure: Evaluation of renal damage after PCNL and ESWL using novel RNA based Biomarkers
timeFrame: Before the procedure by 2hours and after the procedure by 2 and 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Urology Department, Faculty of Medicine, Ain Shams University
Study officials:
affiliation: Urology Department, Ain Shams University, Abassia, Cairo
name: waleed Mousa
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05026307: Corneal Topographic Changes After Pterygium Surgery
Official title: Corneal Topographic Changes After Pterygium Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pterygium
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-08-30
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess the corneal topographic changes after primary pterygium surgery

Detailed description: Prospective interventional comparative study . This study will be conducted on eyes with primary pterygium before and after successful excision in department of ophthalmology, Sohag university hospital to assess the corneal topographic changes using pentacam .

Postoperative evaluation will be scheduled for one month ,three and six months postoperative.

Eligibility criteria: Inclusion Criteria:

* patients with primary pterygium

Exclusion Criteria:

* patients with recurrent pterygium
* patients with primary pterygium with other ocular pathologies.

Primary outcomes:
measure: Changes in corneal topography
timeFrame: One month, three and six months postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag
Study officials:
References:
citation: Nangia V, Jonas JB, Nair D, Saini N, Nangia P, Panda-Jonas S. Prevalence and associated factors for pterygium in rural agrarian central India. The central India eye and medical study. PLoS One. 2013 Dec 4;8(12):e82439. doi: 10.1371/journal.pone.0082439. eCollection 2013.
citation: Moran DJ, Hollows FC. Pterygium and ultraviolet radiation: a positive correlation. Br J Ophthalmol. 1984 May;68(5):343-6. doi: 10.1136/bjo.68.5.343.
citation: Di Girolamo N, Chui J, Coroneo MT, Wakefield D. Pathogenesis of pterygia: role of cytokines, growth factors, and matrix metalloproteinases. Prog Retin Eye Res. 2004 Mar;23(2):195-228. doi: 10.1016/j.preteyeres.2004.02.002.
citation: Xu Z, Li W, Jiang J, Zhuang X, Chen W, Peng M, Wang J, Lu F, Shen M, Wang Y. Characteristic of entire corneal topography and tomography for the detection of sub-clinical keratoconus with Zernike polynomials using Pentacam. Sci Rep. 2017 Nov 28;7(1):16486. doi: 10.1038/s41598-017-16568-y.
Clinical trial NCT03695107: Clinical Study on the Effect of PTH on CYP3A4 Activity
Official title: Clinical Study on the Effect of PTH on CYP3A4 Activity
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Kidney Diseases
Lead sponsor: The Third Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2018-10-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Chronic renal function associated with hypertension

Brief summary: Parathyroid hormone (PTH) may play an important role in the down-regulation of CYP3A4 expression induced by Chronic kidney diseases (CKD). In the study of molecular mechanism, the research group found that the expression of CYP3A2 metabolic enzyme in rat liver decreased in the state of CKD.And PTH may down-regulate the expression of CYP3A4 metabolic enzyme by inhibiting the expression of Nuclear factor- Kilobuse (NF-kB) p65 subunit


Eligibility criteria: Inclusion Criteria:

* Chinese male or female subjects with an age of 18 or older were included;
* The clinical physician diagnosed CKD with hypertension;
* The physician decided that nifedipine controlled release tablets should be given.
* Subjects agree to the study protocol, clinical and follow-up time, and sign the informed consent after the approval of the ethics committee;
* Subjects will be able to communicate well with the investigator and will be able to complete the study as required.

Exclusion Criteria:

* Patients with CKD requiring dialysis treatment;
* Other clinical reasons that may be considered inappropriate for inclusion by clinicians.

Primary outcomes:
measure: the concentration of nifedipine
timeFrame: at 5-7days
Secondary outcomes:
measure: 24-hour ambulatory blood pressure
timeFrame: at 1 day and 7day
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University , , China,
state: Hunan
Study officials:
affiliation: The Third Xiangya Hospital of Central South University
name: Yang GuoPing, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02062307: Bone Mineral Markers in Hypogonadism
Official title: Osteoprotegerin, Fibroblast Growth Factor 23 and Vitamin D3 Levels in Male Patients With Hypogonadism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypogonadotropic Hypogonadism
Endothelial Dysfunction
Insulin Resistance
Keywords: Hypogonadism
Asymmetric Dimethyl Arginine
Osteoprotegerin
Fibroblast Growth Factor
Vitamin D
Lead sponsor: Gulhane School of Medicine
Sponsor class: OTHER
First posted: 2014-02-13
Enrollment: 92
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study group was selected from the male subjects with hypogonadotropic hypogonadism who were not previously given testosterone or human chorionic gonadotropin therapy. The patients did not have any chronic metabolic disorders or organ dysfunction. Forty three age and BMI matched male volunteers were enrolled as control subjects.

Brief summary: The aim of this study is to investigate the markers of bone mineral metabolism in an unconfounded group of patients with hypogonadism and to search for a relationship between endothelial dysfunction and insulin resistance.

Detailed description: Cardiometabolic disorders are prevalent in patients with hypogonadism. Endothelial dysfunction and insulin resistance are used in determining cardiovascular risk. The role of markers of bone mineral metabolism in hypogonadism is not clearly presented.

49 male patients with hypogonadotropic hypogonadism (HH) and 43 BMI and age matched healthy male subjects were enrolled. Osteoprotegerin (OPG), fibroblast growth factor-23 (FGF-23), vitamin D and asymmetric dimethylarginine (ADMA) levels were measured. The insulin sensitivity was estimated by homeostatic model assessment-insulin resistance (HOMA-IR) formula.

Eligibility criteria: Inclusion Criteria:

* male patients with hypogonadotropic hypogonadism
* being under the age of 45 and over the age of 18
* not previously given testosterone or human chorionic gonadotropin therapy
* not have any chronic metabolic disorders or organ dysfunction

Exclusion Criteria:

* female patients
* Other reasons hipogondism
* receive any treatment of hypogonadism
* presence of comorbid diseases

Primary outcomes:
measure: Osteoprotegerin, Fibroblast Growth Factor 23 and Vitamin D3 levels
timeFrame: one year
Secondary outcomes:
measure: relationship between bone mineral metabolism and endothelial dysfunction, insulin resistance
timeFrame: one year
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gulhane School of Medicine
Study officials:
affiliation: Gulhane School of Medicine Department of Endocrinology
name: Coskun Meric
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03060707: Continuous Infusion Versus Intermittent Bolus Injection of Rocuronium
Official title: Comparison of Hourly Rocuronium Consumption Using Continuous Infusion Versus Intermittent Bolus Injection: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Muscle Relaxation
Anesthesia
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 70
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The research is to find out whether continuous infusion of rocuronium requires more or less amount of rocuronium, per kilogram and per hour, than bolus administered rocuronium during noncardiac surgery.

Detailed description: comparing the total dose of rocuronium between continuous infusion and intermittent injection

Eligibility criteria: Inclusion Criteria:

* Pediatric patients aged between 2 and 12, undergoing elective noncardiac surgery which requires general anesthesia but does not require intense block, and estimated time of surgery is between 2 and 5 hours

Exclusion Criteria:

* ASA class 3-6
* BMI \>= 30
* Previous history of hepatic failure, renal failure or neuromuscular disease
* Patients taking medicine which interacts with rocuronium bromide, before or during surgery: aminoglycosides, lincosamides, acylamino-penicillin antibiotics, tetracyclines, metronidazole (high dose), diuretics, MAO inhibitors, calcium channel blockers, corticosteroids, phenytoin, carbamazepine, or norepinephrine
* Previous history of allergic reaction (including anaphylactic reaction) and/or malignant hyperthermia during general anesthesia
* Patients taking medicines which contains magnesium

Primary outcomes:
measure: Rocuronium dose per kilogram per hour
timeFrame: end of the surgery
Secondary outcomes:
measure: Desaturation event
timeFrame: Right after the patient is transferred to the ward, from PACU (1 day)
measure: Surgical rating scale
timeFrame: end of the surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: SNUH
state: Jongro Gu
Study officials:
References:
citation: Choi SN, Jang YE, Lee JH, Kim EH, Kim JT, Kim HS. Comparison of rocuronium requirement in children with continuous infusion versus intermittent bolus: A randomised controlled trial. Eur J Anaesthesiol. 2019 Mar;36(3):194-199. doi: 10.1097/EJA.0000000000000934.
Clinical trial NCT05112107: Evaluation Of Strategies For Improving Ketogenic Diet Compliance
Official title: Evaluation Of Strategies For Improving Ketogenic Diet Compliance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Epilepsy
Ketogenic Dieting
Compliance, Treatment
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2021-11-08
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: In order to increase adherence to ketogenic diet treatment, palatability of meals and diversify the foods offered to patients a ketogenic kitchen will be created. Intervention: Incorporation of culinary workshops and supply of recipes for patients undergoing ketogenic diet treatment at Instituto da Criança - HCFMUSP.

Detailed description: Introduction: The ketogenic diet is a therapeutic option for the control of drug-resistant epileptic seizures. It is based on high fat consumption, protein control and carbohydrate restriction. As a result, the body uses fat as an energy substrate instead of glucose. Changing the patient's daily menu and eating routine is hard and requires dedication from the caregiver for the best therapeutic result. In clinical practice, the diet becomes monotonous and poorly accepted by the patient over time. Besides, there is a difficulty in understanding nutritional guidelines. It is necessary to develop strategies to increase adherence to treatment, palatability of meals and diversify the foods offered to patients. Objective: To evaluate the effectiveness of creating a ketogenic kitchen in improving compliance of patients with CD in the outpatient clinic of Instituto da Criança - HCFMUSP. Methods: this work will be carried out in 4 steps: (1st) Creation and validation of a questionnaire of ketogenic diet compliance, (2nd) Creation of ketogenic recipes of easy preparation and low cost, (3rd) Incorporation of culinary workshops and supply of recipes for patients undergoing treatment at Instituto da Criança - HCFMUSP and (4th) Application of the questionnaire of ketogenic diet compliance.

Eligibility criteria: Inclusion Criteria:

* Patients 0 to 18 years old;
* Clinical indication of a classic ketogenic diet;
* Predominantly oral feeding.

Exclusion Criteria:

* Patients using exclusive gastrostomy;
* Patients with other types of KD than Classical KD.

Primary outcomes:
measure: Ketogenic diet compliance score
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto da Criança Hospital das Clinicas da Universidade de São Paulo
Study officials:
affiliation: University of Sao Paulo General Hospital
name: Erasmo Casella, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04014907: Open Repair Versus Branched Endograft Repair for Treatment of Residual Chronic Aortic Arch Dissection During Follow-up After Open Type A Acute Ascending Aorta Replacement: Results From an International Multicenter Study.
Official title: Open Repair Versus Branched Endograft Repair for Treatment of Residual Chronic Aortic Arch Dissection During Follow-up After Open Type A Acute Ascending Aorta Replacement: Results From an International Multicenter Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peri-operative Mortality
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2019-07-10
Enrollment: 170
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing endovascular TAA repair with Frozen Elephant Trunk Technique

Brief summary: This study aims to evaluate peri-operative mortality and main post-operative complications (for example cardiovascular, respiratory and renal) in patients treated with frozen elephant trunk techinque.


Eligibility criteria: Inclusion Criteria:

* patients with post-dissection arch aneurysm with a maximal aortic diameter \>55mm or rapid growth (\>10mm/year)

Exclusion Criteria:

* Emergency setting

Primary outcomes:
measure: Peri-operatory mortality
timeFrame: 36 months
Secondary outcomes:
measure: Post-operatory complications
timeFrame: 36 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
state: RM
Study officials:
References:
Clinical trial NCT04021407: Laryngeal Mask Airway Versus Air Q Laryngeal Airway
Official title: Laryngeal Mask Airway Versus Air Q Laryngeal Airway in Dacryocystorhinostomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Airway Devices
Keywords: AirQ
LMA
dacrocystorhinostomy surgery
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2019-07-16
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment
Primary purpose: SUPPORTIVE_CARE

Brief summary: Nowadays, supraglottic airway devices are simple and effective alternatives to endotracheal intubation. Both laryngeal mask airway LMA and air-Q airway are supraglottic airway devices that can be used to maintain and protect airways from aspiration of secretions and blood during DCR surgery. The present study was designed to compare standard LMA versus air Q as regards the sealing effect and aspiration of blood in DCR surgery.

Detailed description: 72 patients were divided into two groups, 36 patients each, named LMA group, and air Q group according to supraglottic devices used. The following parameters were recorded in both studied groups, continuous Electrocardiography (ECG), heart rate (HR), means arterial pressure (MAP), arterial oxygen saturation (SpO2), end tidal carbon di-oxide (PCO2)..Oro pharyngeal leak pressure in (cmH2O), exhaled tidal volume in (ml), leak volume in (ml), leak fraction in (%) number of shifting from LMA to air Q or ETT and shifting from air Q to LMA or ETT was recorded with absence or presence of surgical blood on The undersurface of the device used.

Eligibility criteria: Inclusion Criteria:

* Both sex
* Age: 18-60 years
* ASA I-II
* Patients scheduled for dacryocystorhinostomy surgery

Exclusion Criteria:

* Any pathology of the neck, upper respiratory tract, upper alimentary tract
* Patients with a history of gastric regurgitation, heartburn
* Morbid obese,
* Patients with esophageal reflux (hiatus hernia)
* Anticipating difficult airway management
* Patients with coagulation disorders

Primary outcomes:
measure: Oro pharyngeal leak pressure in (cmH2O)
timeFrame: Just after insertion of supraglottic airway devices
Secondary outcomes:
measure: Leak fraction in (%)
timeFrame: Just after insertion of supraglottic airway devices
Other outcomes:
Locations:
city: Shibīn Al Kawm
country: Egypt
facility: Ashraf Eskandr
state: Menoufiya
Study officials:
References:
Clinical trial NCT04073407: Study of the Safety and Tolerability of AXA1957 in Adolescent Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD)
Official title: A Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Physiological Effects on Liver Structure and Function of an Amino Acid Food Product, AXA1957, in Adolescent Subjects With Fatty Liver
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: NAFLD
Lead sponsor: Axcella Health, Inc
Sponsor class: INDUSTRY
First posted: 2019-08-29
Enrollment: 9
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This is a randomized, single blind study to determine whether AXA1957, a novel composition of amino acids, is safe and well tolerated. Subjects will be adolescents with non-alcoholic fatty liver disease (NAFLD), and it will also examine liver biology using blood tests and magnetic resonance imaging (MRI).


Eligibility criteria: Key Inclusion Criteria:

* Willing to participate in the study and provide written informed consent.
* Male and female adolescent subjects aged 12 to 17 years
* Subjects must not have participated in any diet/lifestyle intervention or observational studies, or engaged in any body weight altering regimens that resulted in body weight fluctuations (i.e. body weight loss or gain by 5%) in the preceding 30 days prior to Screening.
* Non alcoholic fatty liver disease
* Diabetes or prediabetes
* A screening MRI consistent with liver inflammation and fibrosis

Key Exclusion Criteria:

* Current or history of significant alcohol consumption
* History or presence of liver disease (other than NAFLD/NASH)
* History or presence of cirrhosis and/or history or presence of hepatic decompensation
* Any diabetes other than Type 2
* Other poorly controlled medical condition (for example, uncontrolled hypertension with a systolic blood pressure \> 100 mmHg)
* Known sensitivity and/or history of clinically significant food intolerance/allergies to proteins (including whey, soy, casein, amino acids, etc.),
* Unable or unwilling to adhere to contraception requirements
* Any contraindications to a MRI scan
* Any other condition that, in the opinion of the Investigator, renders the subject at risk for compliance, compromises the well-being of the subject, or hinders study completion

Primary outcomes:
measure: Number of Subjects With Adverse Events (AEs).
timeFrame: AEs Baseline to week 13 - Part 1
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal London Children's Hospital
city: London
country: United Kingdom
facility: King's College Hospital
city: Manchester
country: United Kingdom
facility: Royal Manchester Children's Hospital
city: Southampton
country: United Kingdom
facility: Univeristy of Southhampton
Study officials:
affiliation: University of Southampton
name: Saul Faust, MBBS MRCPCH PhD
role: PRINCIPAL_INVESTIGATOR
References: