louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05538780: Diagnosis of Transient Tachypnea of Newborn
Official title: Thoracic Fluid Content Using Electrical Cardiometry Versus Lung Ultrasound in the Diagnosis of Transient Tachypnea of Newborn
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Transient Tachypnea of the Newborn
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2022-09-14
Enrollment: 50
Sex: ALL
Minimum age (years): 0
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 50 neonates diagnosed with Transient Tachypnea of Newborn admitted at Neonatal Intensive Care Unit, Tanta University Hospitals

Brief summary: Transient tachypnea of the newborn (TTN) is the most common cause of respiratory distress in fullterm newborn. TTN is a diagnosis of exclusion, It is primarily diagnosed based on medical history and typical clinical presentation. Lung ultrasonography is an accurate, non invasive and reliable tool for diagnosing TTN. Cardiometry is presently the only tool to evaluate thoracic fluid content continuously and noninvasively at the bedside.


Eligibility criteria: Inclusion Criteria:

* fifty newborns with gestational age ≥ 34 weeks (calculated from the first day of last menstrual period and using New Ballard score) diagnosed with TTN

Exclusion Criteria:

1. Gestational age less than 34 weeks.
2. Major congenital abnormalities.
3. Congenital heart diseases.
4. Neonatal sepsis.
5. Neonatal pneumonia.
6. Other causes of respiratory distress (RD)

Primary outcomes:
measure: change of thoracic fluid content
timeFrame: at enrollment and after 72 hours of birth
measure: change of ultrasound data: double-lung point, interstitial lung syndrome, and fuzziness of the pleural lines (A-lines) and pleural effusion.
timeFrame: at enrollment and after 72 hours of birth
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University, faculty of medicine
Study officials:
affiliation: Tanta university faculty of medicine
name: ashraf abuhamama
role: STUDY_DIRECTOR
References:
citation: Hammad Y, Hasanin A, Elsakka A, Refaie A, Abdelfattah D, Rahman SA, Zayed M, Hassabelnaby Y, Mukhtar A, Omran A. Thoracic fluid content: a novel parameter for detection of pulmonary edema in parturients with preeclampsia. J Clin Monit Comput. 2019 Jun;33(3):413-418. doi: 10.1007/s10877-018-0176-6. Epub 2018 Jun 23.
citation: Paviotti G, De Cunto A, Moressa V, Bettiol C, Demarini S. Thoracic fluid content by electric bioimpedance correlates with respiratory distress in newborns. J Perinatol. 2017 Sep;37(9):1024-1027. doi: 10.1038/jp.2017.100. Epub 2017 Jul 27.
citation: Ibrahim M, Omran A, AbdAllah NB, Ibrahim M, El-Sharkawy S. Lung ultrasound in early diagnosis of neonatal transient tachypnea and its differentiation from other causes of neonatal respiratory distress. J Neonatal Perinatal Med. 2018;11(3):281-287. doi: 10.3233/NPM-181796.
Clinical trial NCT02041780: Non Invasive Assessment of Liver Fibrosis in Children: Comparison of ShearWave Elastography, Fibrotest and Liver Biopsy
Official title: Non Invasive Assessment of Liver Fibrosis in Children: Evaluation of Diagnostic Performances of ShearWave Elastography (SWE) and Fibrotest®/ Fibromax® by Comparison With Fibrosis Score on Liver Biopsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Fibrosis
Children
Keywords: Diagnostic
Liver fibrosis
Ishak score
Fibrotest
ShearWave elastography
Liver biopsies
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2014-01-22
Enrollment: 220
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine if SWE and Fibrotest®/ Fibromax®, alone or associated, are effective methods to assess liver fibrosis in children.

Detailed description: Liver biopsy will be the gold standard to assess fibrosis using Ishak score and morphometric evaluation of fibrosis. All children included will have a measure of liver stiffness using SWE with 5 measures performed in the area where the biopsy is performed and 5 measures in an other place in the liver. Fibrotest®/ Fibromax® will be performed on blood sample. All exams will be done within 1 month. diagnostic performance of SWE and Fibrotest®/ Fibromax® will be assessed respectively. algorithm using the results of both technics will be tested in order to test diagnostic performance and to obtain better performances.

Eligibility criteria: Inclusion Criteria:

* age \< 18 years;
* indication to liver biopsy;
* informed consent of both parents and child if applicable;
* social insurance

Exclusion Criteria:

-

Primary outcomes:
measure: liver fibrosis evaluated by the ISHAK score and morphometric evaluation
timeFrame: up to 1 month
Secondary outcomes:
measure: liver fibrosis evaluation : stiffness using SHEARWAVE elastography
timeFrame: up 1 month
measure: Liver fibrosis evaluation using Fibrotest (Fibromax)
timeFrame: up 1 month
Other outcomes:
Locations:
city: Le Kremlin-Bicêtre
country: France
facility: AP-HP, Bicêtre Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Stéphanie FRANCHI-ABELA, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04197180: Hybrid APC for Gastric Low Grade Intraepithelial Neoplasia
Official title: HybridAPC for the Treatment of Gastric Low Grade Intraepithelial Neoplasia (LGIN): a Prospective, Multi-center Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastric Low Grade Intraepithelial Neoplasia
Keywords: Gastric low grade intraepithelial neoplasia
Hybrid APC
Endoscopic Ablation
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Nanfang Hospital, Southern Medical University
name: Shenzhen Hospital of Southern Medical University
name: The Fifth Affiliated Hospital of Zunyi Medical College
First posted: 2019-12-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This cohort study aims to investigate the clinical efficacy and safety of Hybrid APC for treatment of gastric low grade intramucosal neoplasia.

Detailed description: This cohort study aims to investigate the clinical efficacy and safety of Hybrid APC for treatment of gastric low grade intramucosal neoplasia. Successful ablation is defined as no evidence of local recurrence at 12 months after HybridAPC upon follow up endoscopy. This is defined as absence of LGIN, HGIN and cancer in biopsies obtained at all locations during followup endoscopy.

Eligibility criteria: Inclusion Criteria:

1. Low grade intraepithelial neoplasia of stomach with size≤20 mm
2. Endoscopic diagnosis suspected gastric LGIN with biopsy confirmed gastric LGIN
3. Endoscopic appearance according to Paris classification of Type 0-IIa, IIb or IIc
4. Patients with informed consent

Exclusion Criteria:

1. Patients who had previous endoscopic treatment (including APC, EMR, ESD) for gastric LGIN, HGIN or gastric carcinoma.
2. Endoscopic evidence of ulcer
3. Biopsy confirmed HGIN
4. Endoscopic diagnosis suspected HGIN while biopsy confirmed LGIN
5. Pregnancy
6. informed consent not available

Primary outcomes:
measure: Complete ablation of gastric low grade intraepithelial neoplasia
timeFrame: 12 months
Secondary outcomes:
measure: Operative time
timeFrame: 1 day
measure: Intraoperative bleeding
timeFrame: 1 day
measure: Pain after procedure
timeFrame: 3 days
measure: Development of new neoplasia
timeFrame: 12, 24 and 36 months
measure: Progression of Low grade intraepithelial neoplasia
timeFrame: 12, 24 and 36 months
measure: Postoperative complications
timeFrame: 7 days
measure: Number of HybridAPC procedures required for treatment
timeFrame: 12 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Combined Endoscopy Center, Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Philip WY Chiu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04722380: Nigella Sativa Oil Extract and Xenograft Bone Graft in Treatment of Infra-bony Defects
Official title: Nigella Sativa Oil Extract and Xenograft Bone Graft in Treatment of Infra-bony Defects: a Combined Clinical and Histological Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Localized Aggressive Periodontitis
Keywords: Nigella Sativa oil extract
Localized Aggressive Periodontitis
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2021-01-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 10 patients, twenty sites with, localized aggressive periodontitis, with CAL ≥ 5 will be included in the present study. Sites will be allocated randomly to be surgically treated with, Nigella Sativa oil extract Mixed with xenograft or xenograft alone.
Primary purpose: TREATMENT

Brief summary: The aim of this study will be to evaluate, clinically, and radiographically the effect of Nigella Sativa oil extract Mixed with xenograft versus xenograft alone in the treatment of intra-bony defects in patients with aggressive periodontitis.

Detailed description: in 10 patients, twenty sites in subjects with, localized aggressive periodontitis, with CAL ≥ 5 will be included in the present study. Sites will be allocated randomly to be surgically treated with, Nigella Sativa oil extract Mixed with xenograft or xenograft alone. At baseline, 3, 6 after surgery, the following clinical parameters (PD, CAL, BOP) and CBCT at baseline and 6 months x-ray will be recorded.

Eligibility criteria: Inclusion Criteria:

* systemically healthy patients were selected

  * patients who had not received any medications for the previous six months that may interfere with periodontal tissue health or healing.
  * Patients should demonstrate their ability to maintain good oral hygiene

Exclusion Criteria:

* • Smokers and pregnant patients.

  * Medically compromised patients and systemic conditions precluding periodontal surgery.
  * Subjects who do not comply with oral hygiene measures as evidenced in recall visits.
  * Restoration or caries in the site to be treated or non-vital tooth
  * Restoration or caries in the site to be treated or non-vital tooth

Primary outcomes:
measure: probing pocket depth
timeFrame: 6 months
measure: clinical attachment level
timeFrame: 6 months
measure: bleeding on probing
timeFrame: 6 months
measure: cone beam x ray measuring bone fill
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Doaa Ahmed yousef bayoumi
state: Gharbiya
Study officials:
affiliation: Tanta University
name: doaa bayoumi, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00580580: Detection of Coronary Stenosis With Intravenous Microbubbles
Official title: The Detection of Coronary Stenosis With Intravenous Mircrobubbles and Contrast Pulse Sequence Low Mechanical Index Imaging
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Coronary Stenosis
Carotid Stenosis
Myocardial Reperfusion
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2007-12-24
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To detect coronary artery disease by both coronary and carotid artery imaging and myocardial perfusion imaging using a new low mechanical index real time system.

Detailed description: The objective of this clinical study will be to visualize both coronary and carotid arteries as well as detect myocardial perfusion following a routine intravenous injection of Definity (0.05-0.20 millimeters), Optison (0.1-0.4 millimeters) or PESDA (0.05-0.2 mL). Following these injections , we will attempt to Contrast Pulse Sequencing on the Siemens Acuson Sequoia system to image both the coronary and carotid arteries, as well as the Myocardial perfusion.

Eligibility criteria: Inclusion Criteria:

* subjects scheduled for routine echocardiogram to look for evidence of Coronary artery disease or a stress echocardiogram
* women of child-bearing potential must be taking a medically approved form of birth control with a negative urine pregnancy test
* be conscious and coherent, and be able to communicate effectively with study personnel
* last eight patients will be diabetics who smoke
* provide informed consent after receiving a verbal and written explanation of the purpose and nature of the study

Exclusion Criteria:

* severe valvular heart disease by Doppler Echocardiography
* females of child-bearing potential who are not taking a medically approved method of birth control will be excluded. If the patient is pregnant she will be excluded.
* patients who are allergic to blood or blood products will be excluded
* have contraindication to Optison, Definity, or PESDA (pulmonary HTN, cardiac shunt)
* non diabetics, non smokers

Primary outcomes:
measure: Detection of coronary and carotid artery stenoses and perfusion defects during standard echocardiographic examination
timeFrame: 2-4 months
Secondary outcomes:
measure: Visual analysis of coronary and carotid arteries and perfusion defects during standard echocardiogram examination
timeFrame: immediate
Other outcomes:
Locations:
Study officials:
affiliation: University of Nebraska
name: Thomas R Porter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03961880: Impact of Recurrence Score on Adjuvant Treatment Decisions in Breast Cancer Patients
Official title: Impact of Recurrence Score on Adjuvant Treatment Decisions and Tumor Cell Dissemination in Estrogen-receptor Positive and HER2 Negative Patients With Early Breast Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer Female
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2019-05-23
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with breast cancer

Brief summary: IRMA is a Prospective, monocenter, non-interventional investigator initiated (IIT) registry that aims to investigate the use of the CE-marked OncotypeDX and its impact on adjuvant therapy recommendations in the clinical routine. Additionally, the proportion of patients with low, intermediate and high RS in predefined clinical subgroups will be determined. To evaluate the impact of the RS on tumor cell dissemination, these subgroups also include DTC-negative versus DTC-positive patients.


Eligibility criteria: Inclusion Criteria:

* women ≥ 18 years of age
* histologically proven unilateral primary non-metastatic invasive breast cancer
* ER-/ or PR- positive and HER2-negative
* N0-N1 (0-3 involved lymph-nodes). The nodal status may be evaluated clinically.
* surgery or planed surgery at the Department of women's health, Tuebingen
* written informed consent into IRMA

Exclusion Criteria:

* ER-negative
* HER2-positive
* \> 3 involved lymph-nodes
* bilateral breast cancer
* preexisting cancer disease within the last 10 years
* preexisting invasive ipsi- or contralateral breast cancer (non-invasive ipsi- or contralateral breast cancer is not regarded as an exclusion criteria)
* primary systemic therapy
* locally advanced, inoperable or metastatic breast cancer
* pregnant or lactating patients
* inadequate general condition (not fit for chemotherapy)

Primary outcomes:
measure: Evaluation of the influence of the 21-gene Recurrence-Score (RS) on adjuvant therapy recommendation
timeFrame: 1 year
Secondary outcomes:
measure: Evaluation of the association of the RS with tumor cell dissemination into bone marrow
timeFrame: 1 year
measure: Correlation of the RS with age
timeFrame: 1 year
measure: Correlation of the RS with tumor nodal status
timeFrame: 1 year
measure: Correlation of the RS with tumor grading
timeFrame: 1 year
measure: Correlation of the RS with proliferation marker Ki-67
timeFrame: 1 year
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: Department for Women's Health
state: BW
Study officials:
References:
Clinical trial NCT04081480: Pharmacokinetics of Valacyclovir Oral Solution in Children
Official title: Pharmacokinetics of a New Paediatric Formulation of Valacyclovir Used for Prophylaxis and Treatment of Varicella Zoster Virus (VZV) and Herpes Simplex Virus (HSV) Infections in Children, Phase II (VALID II)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Herpes Simplex Virus Infection
Varicella Zoster Virus Infection
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2019-09-09
Enrollment: 7
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Intervention is pharmacokinetic (PK) curve collection in children, two age groups
Primary purpose: OTHER

Brief summary: Valacyclovir has replaced acyclovir in many clinical scenarios. Pharmacokinetic data support the use of oral valacyclovir in children, but practical problems exist in children having to take adult-dose tablets. A formulation with acceptable palatability, good pharmaceutical quality and possibility of flexible dosing is developed. Pharmacokinetic data of this formulation is missing.

The present study investigates the pharmacokinetics of valacyclovir oral solution in children by determine the area under the curve (AUC0-12), time above critical concentration (Ccrit), Cmax and Tmax of acyclovir.

Secondary, the safety profile of a single dose of valacyclovir oral solution will be determined.


Eligibility criteria: Inclusion Criteria:

* Subject is in the age of 2-12 years.
* Subject has an indication for (val)acyclovir prophylaxis and are planned to receive valacyclovir oral solution.
* Subject is managed with a central venous catheter (CVC/Port-a-Cath).
* Subject's parents have signed the Informed Consent Form prior to screening evaluations.
* Subject is willing to participate after study procedures are explained in comprehensible language for the child.

Exclusion Criteria:

* Severe anemia (\<6.0 mmol/L).
* Full dose has not been taken.

Primary outcomes:
measure: Area under the curve
timeFrame: 12 hours
measure: Cmax
timeFrame: 12 hours
measure: Tmax
timeFrame: 12 hours
Secondary outcomes:
measure: Number of adverse events
timeFrame: 1 day
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: Prinses Maxima Centrum voor kinderoncologie
Study officials:
References:
Clinical trial NCT04778280: Vitamin D Estimation With Giardia Lamblia Infections
Official title: Estimation of Vitamin D in Humans Infected With Giardia Lamblia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Giardia Lamblia Infection
Keywords: estimaion of vitamin D in humans infected with Giardia lamblia
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-03-03
Enrollment: 192
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: we take 192 samples then we will divide these samples into two groups :-

1. Group A (healty group with negative Giardia lamblia or control group)
2. Group B ( diseased group with positive Giardia lamblia or cases group)

Brief summary: investigators will take stool and blood samples from two groups of humans :-

1-group A (healthy group negative Giardia or control group),2-group B (positive Giardia or case group)then investigators make estimation for vitamin D in both groups then investigators try to find if there is relation between vitamin D level and Giardia lamblia infections

Detailed description: In this research a case- control study will be used) ,the percentage of case to control will be 1:1 the total number of samples 192 ,investigators will take stool and blood samples from two groups of humans :-

1-group A (healthy group negative Giardia or control group),2-group B (positive Giardia or case group)then investigators make estimation for vitamin D in both groups then investigators try to find if there is relation between vitamin D level and Giardia lamblia infections

Eligibility criteria: Inclusion Criteria:

* patient infected with Giardia lamblia.

Exclusion Criteria:

* patient takes vitamin D supplement - patient has kidney disease- patient has liver disease-patient has a debilitating disease disease such as cancer or diabetes.

Primary outcomes:
measure: fluctuation level of vitamin D level
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Faculty of Medicine Sohag University
city: Sohag
country: Egypt
facility: Faculty of Medicine
Study officials:
affiliation: faculty of medicine sohag university
name: Mohammed Sayed Farrag, Demonstrator
role: PRINCIPAL_INVESTIGATOR
affiliation: faculty of medicine sohag university
name: Mohammed Sayed Farrag, Demonstrator
role: STUDY_DIRECTOR
References: