louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00645294: Open Label Study of Pharmacokinetics and Safety of Dose of Adefovir Dipivoxil in Children and Adolescents With HBV
Official title: A Phase 1-2 Open-Label Study of the Pharmacokinetics and Safety of a Single Dose of Adefovir Dipivoxil in Children and Adolescents (Aged 2-17) With Chronic Hepatitis B
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hepatitis B
Keywords: Hepatitis B
Adefovir dipivoxil
Children
Adolescents
Pharmacokinetics
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2008-03-27
Enrollment: 47
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Open-label study of the pharmacokinetics of adefovir dipivoxil in children and adolescents infected with chronic hepatitis B.

Detailed description: Children and adolescents with chronic hepatitis B and compensated liver, HBeAg-positive and serum HBV DNA positive (greater than or equal to 1 x 100,000 copies/mL by Roche Amplicor Monitor PCR) received doses of adefovir dipivoxil in a cross-over design. Subjects aged 2-11 received two single doses (0.14 mg/kg and 0.3 mg/kg liquid formulation) and subjects 2-17 received one dose (10 mg liquid formulation).

Eligibility criteria: Inclusion Criteria:

* Males and females between the ages of 2 and 17 (inclusive) with chronic hepatitis B as evidenced by the following:
* HBsAg positive for a minimum of 6 months
* HBeAg positive and HBV DNA greater than or equal to 1 x 100,000 copies/mL at screening
* Children and adolescents with compensated liver disease
* ALT levels greater than or equal to 1.2 upper limit of normal (applicable to 7- to 17-year-old children and adolescents only)

Primary outcomes:
measure: To characterize the PK profile of adefovir 0.14 mg/kg and 0.3 mg/kg in children 2-11 years, including dose proportionality of adefovir dipivoxil liquid formulation. To characterize the PK profile of adefovir dipivoxil 10 mg in adoloscents 12-17 years.
timeFrame: 8 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Cliniques Universitaries
city: Frankfurt
country: Germany
facility: J.W. Goethe-Universitat
city: Hannover
country: Germany
facility: Mid. Hochschule Hannover Kinderklinik
city: Mainz
country: Germany
facility: Kinderklinik der Gutenberg Universitat
city: Munchen
country: Germany
facility: Standort Lindwurmstrasse
city: Wuppertal
country: Germany
facility: Zentrum fur Kinder und Jugendmedizin der Klinikum
city: Krakow
country: Poland
facility: Oddzial Chorob Infekcyjnych Dzieci
city: Warszawa
country: Poland
facility: Klinika Gastroenterologii
city: London
country: United Kingdom
facility: King's College Hospital
state: England
city: Birmingham
country: United Kingdom
facility: University of Birmingham
Study officials:
References:
Clinical trial NCT00507494: Influence of Pioglitazone for Renal Transplant Function in Diabetics
Official title: Influence of Pioglitazone for Renal Transplant Function in Diabetics - a Double Blind Randomised Placebo Controlled Cross Over Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus
Kidney Transplantation
Proteinuria
Keywords: posttransplant diabetes mellitus
kidney transplantation
filtration fraction
proteinuria
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2007-07-26
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test whether pioglitazone is able to prevent the progression of diabetic nephropathy in kidney transplant recipients with diabetes mellitus.

Detailed description: About 30 % of kidney transplant recipients will develop diabetes mellitus. This condition is a risk factor for graft dysfunction, graft loss and increased mortality of patients. Inflammatory reactions within the graft and proteinuria are considered as pathogenetic mechanisms.

Recent studies indicated that pioglitazone might have beneficial effects on the urinary protein excretion of type 2 diabetic patients with diabetic nephropathy and was able to reduce systemic inflammation.

This lead to the hypothesis that pioglitazone could improve proteinuria of kidney transplant patients with diabetes.

Comparison: Effects of pioglitazone vs. placebo on proteinuria and renal function of kidney transplant recipients in a cross over study.

Eligibility criteria: Inclusion Criteria:

* kidney transplantation(\> 6 months ago) ; stable graft function
* diabetes mellitus type 2
* acceptable glycemia (HbA1c \< 8%)
* creatinin clearance (MDRD)\>30 ml/min 1,73m²)
* proteinuria \> 30 mg/24 hr

Exclusion Criteria:

* type 1 diabetes
* pregnant or breast feeding women
* congestive heart failure (\>stage 1 NYHA)
* creeping creatinin
* treatment for rejection within 3 months prior to inclusion
* ALT, AST \> 2.5 fold the upper limit of normal
* uncontrolled hypertension
* hypo- or hyperthyroidism

Primary outcomes:
measure: proteinuria
timeFrame: 12 weeks
Secondary outcomes:
measure: efficacy: filtration fraction, renal nitric oxide bioavailability, insulin resistance, platelet function safety: tolerability, plasma glucose, body weight, edema
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Nephrology, Department of Medicine, university hospital Dresden
Study officials:
affiliation: Nephrology, Department of Medicine, University hospital Dresden
name: Peter Gross, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lo C, Toyama T, Oshima M, Jun M, Chin KL, Hawley CM, Zoungas S. Glucose-lowering agents for treating pre-existing and new-onset diabetes in kidney transplant recipients. Cochrane Database Syst Rev. 2020 Jul 30;8(8):CD009966. doi: 10.1002/14651858.CD009966.pub3.
Clinical trial NCT06291194: Efficacy and Safety of AJU-S56 5% in Dry Eye Syndrome Patients
Official title: The Purpose of This Clinical Study is to Prove That the Test Drug (AJU-S56 5%) is Superior to the Control Drug After 24 Weeks of Administration to Patients Who Have Moderate or Severe Dry Eye Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Dry Eye Syndromes
Keywords: Dry eye
Lead sponsor: AJU Pharm Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: GL Pharm Tech Corporation
First posted: 2024-03-04
Enrollment: 396
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is planned to Evaluate the Efficacy and Safety of test drug (AJU-S56 5%) compared to control drug(vehicle) in Patients with Dry Eye Disease.


Eligibility criteria: Inclusion Criteria:

* Male and Female who over 19 years old
* Moderate to Severe Dry Eye Disease Patients
* Must meet all criteria listed below at least in one eye or both eyes.

  1. TCSS (National eye institute (NEI) scale)≥ 4
  2. Ocular discomfort score (ODS) ≥ 3
  3. Schirmer test(without anesthesia) ≤ 10mm in 5 mins
  4. Tear break-up time ≤ 6 secs
* Written informed consent to participate in the trial

Exclusion Criteria:

* Those who have clinically significant eye disease not related to dry eye syndrome
* Those who have worn contact lenses before 1week Screening visit or have to wear contact lenses or need to wear contact lenses during study period
* Those who have medical history with intraocular surgery 12months before screening visit
* Use of corticosteroid, beta blocker and anticholinergic agent within 4 weeks
* Participation in other studies within 4weeks of screening visit

Primary outcomes:
measure: Total corneal staining score (TCSS)
timeFrame: WEEK 4, 8, 12
Secondary outcomes:
measure: LGCSS
timeFrame: WEEK 4, 8, 12
measure: TFBUT
timeFrame: WEEK 4, 8, 12
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: AJU Pharm Co., Ltd.
Study officials:
References:
Clinical trial NCT06430294: Caracteristics of Pediatric Spinal Mobilizations
Official title: Force-time Characteristics of Spinal Mobilizations Delivered on Pediatric Manikins
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spinal Mobilization
Keywords: Chiropractic
Pediatric
Simulations
Lead sponsor: Université du Québec à Trois-Rivières
Sponsor class: OTHER
First posted: 2024-05-28
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Licensed chiropractors

Brief summary: This observational study aims to create simulations using pediatric manikins to teach pediatric spinal mobilizations. We'll measure the force and duration of spinal mobilizations applied by chiropractors on pediatric manikins. Another objective is to gather feedback from both students and teachers on the effectiveness of using manikins for teaching.

The main questions it aims to answer are:

1. How much force and for how long do chiropractors apply spinal mobilizations on pediatric manikins?

Detailed description: This project aims to initiate the development of low-fidelity simulations to enhance the learning of skills associated with performing pediatric spinal mobilizations. This will be achieved by gathering target values for the force and duration of spinal mobilizations performed by chiropractors on pediatric manikins.

Eligibility criteria: Inclusion Criteria:

* Being a chiropractor in private practice and a member of the Ordre des chiropraticiens du Québec

Exclusion Criteria:

* Not been able to perform pediatric spinal mobilizations

Primary outcomes:
measure: Peak force (N) reached during the spinal mobilization measured by a force sensor
timeFrame: During the spinal mobilization
measure: Duration (s) of spinal mobilization measured by a force sensor
timeFrame: During the spinal mobilization
Secondary outcomes:
Other outcomes:
Locations:
city: Trois-Rivières
country: Canada
facility: Université Québec à Trois-Rivières
state: Quebec
Study officials:
affiliation: Université du Québec à Trois-Rivières
name: Isabelle Pagé, DC, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02644694: PK Study of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution in Patients Undergoing Vitrectomy
Official title: A Prospective, Multi-Center, Single-Dose, Phase 1 Clinical Trial Designed to Evaluate the Pharmacokinetics of Dexamethasone Phosphate Ophthalmic Solution Delivered Via the EyeGate® II Drug Delivery System in Patients Undergoing Vitrectomy for Macular Hole Repair or Epiretinal Membrane Peeling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Vitrectomy
Lead sponsor: Eyegate Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2016-01-01
Enrollment: 10
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: The purpose of this study is to evaluate the pharmacokinetics (PK) of dexamethasone phosphate ophthalmic solution delivered via the EyeGate® II Drug Delivery System (EGDS) in patients undergoing vitrectomy for macular hole repair or epiretinal membrane peeling

Detailed description: This is an open-label, multi-center, single-dose, Phase 1 clinical trial designed to evaluate the pharmacokinetics (PK) of dexamethasone phosphate ophthalmic solution delivered via the EyeGate® II Drug Delivery System (EGDS) in the vitreous humor taken from patients undergoing vitrectomy for macular hole repair or epiretinal membrane peeling

Eligibility criteria: Inclusion Criteria:

1. Age 18 to 85 years
2. Receive, understand, and sign a copy of the written informed consent form

Exclusion Criteria:

-

Primary outcomes:
measure: Concentration of dexamethasone
timeFrame: Day 1
measure: Concentration of dexamethasone phosphate
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
Study officials:
affiliation: Study Principal Investigator
name: Jeffrey Heier, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04937894: Antibiotic Therapy for Infectious Diseases
Official title: The Efficacy and Safety of Tigecycline for the Treatment of Infectious Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infectious Disease
Lead sponsor: Shandong University
Sponsor class: OTHER
Collaborators: name: Shandong Provincial Hospital
First posted: 2021-06-24
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with severe infections

Brief summary: Tigecycline is a last-resort antibiotic that is used to treat severe infections caused by extensively drug-resistant bacteria. However, the efficacy and safety data for tigecycline in infectious patients are lacking. The aim of this study is to assess the efficacy and safety of tigecycline in infectious patients using pharmacokinetics and omics.


Eligibility criteria: Inclusion Criteria:

* critically ill hospitalized males or nonpregnant females aged 18 years with severe infections which the treating clinician was treating with tigecycline

Exclusion Criteria:

1. severe liver dis- eases (e.g., Child-Pugh score C);
2. patients allergic to tetracycline and tigecycline;
3. those who have participated in other clinical trials, or those who are considered unsuitable by researchers;
4. pregnant women and lactating women.

Primary outcomes:
measure: Adverse events
timeFrame: Through study completion, an average of 15 days
measure: Pharmacokinetics of tigecycline
timeFrame: Through study completion, an average of 3 days
measure: Rate constant for tigecycline distribution
timeFrame: Through study completion, an average of 3 days
measure: The ratio of area under the concentration-time curve (AUC) to minimum inhibitory concentration (MIC).
timeFrame: Through study completion, an average of 3 days
Secondary outcomes:
measure: fibrinogen levels in mg/dL
timeFrame: Through study completion, an average of 3 days
measure: prothrombin time
timeFrame: Through study completion, an average of 3 days
measure: activated partial thromboplastin time
timeFrame: Through study completion, an average of 3 days
measure: international normalized ratio
timeFrame: Through study completion, an average of 3 days
measure: blood platelet count
timeFrame: Through study completion, an average of 3 days
measure: thrombin time
timeFrame: Through study completion, an average of 3 days
Other outcomes:
Locations:
city: Jinan
country: China
facility: Wei Zhao
state: Shandong
Study officials:
References:
Clinical trial NCT02060994: Respiratory Morbidity Among Children Who Were Born by Elective Cesarean Section After 37-38 Weeks vs. 39 Weeks and More
Official title: Respiratory Morbidity Among Children Who Were Born by Elective Cesarean Section After 37-38 Weeks vs. 39 Weeks and More
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Complications
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-02-12
Enrollment: 123
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children born in 2007-2009 in "Hillel Yaffe" medical center by elective Cesarean section according to a list of IDs we have.

Brief summary: Background: It is known that after Cesarean section is correlated with respiratory complication more, if done after 37-38 week of gestation than if done after 39 weeks or more.

Goal: The aim of the current study is to find out if these respiratory complications extend to later life.

Methode: Reviewing the patients' medical file, and collecting data about respiratory complication.

Detailed description: Background: It is known that after Cesarean section is correlated with respiratory complication more, if done after 37-38 week of gestation than if done after 39 weeks or more. We have already conducted a study about this topic, and published our results.

Goal: The aim of the current study is to find out if these respiratory complications extend to later life.

Method: Reviewing the patients' medical file, and collecting data about respiratory complication. We will use the same patients we used at the first study. Respiratory complications are defined as diagnosis of asthma, treatment by inhalations or systemic steroids, or consultation by pulmonologist.

Eligibility criteria: Inclusion Criteria:

* Children born in 2007-2009 our medical center by elective Cesarean section according to a list of IDs we have.

Exclusion Criteria:

* Children with respiratory congenital defect that was not known at the first week of life.

Primary outcomes:
measure: There are respiratory complications.
timeFrame: Age 4-8 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe medical center
state: North
Study officials:
affiliation: Hillle Yaffe medical center, Hadera, Israel
name: Erez Nadir, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nir V, Nadir E, Feldman M. Late better than early elective term Cesarean section. Acta Paediatr. 2012 Oct;101(10):1054-7. doi: 10.1111/j.1651-2227.2012.02772.x. Epub 2012 Jul 16.
Clinical trial NCT03613194: Mechanistic and Molecular Study of the Process of Metastatic Dissemination in Colorectal Cancer
Official title: Mechanistic and Molecular Study of the Process of Metastatic Dissemination in Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2018-08-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: To confirm the role of the collective dissemination in the mechanisms of tumoral invasion of colorectal cancers


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Histological Diagnosis of stage IV colorectal cancer
* Hepatic metastasis and/or peritoneal potentially resecable
* Patient affiliated with a mode of the social security or recipient of such a mode
* Information of the patient or his legal representative and collection of his assent

Exclusion Criteria:

* None metastatic colorectal cancer
* Cancer of appendicular origin
* Patients deprived of liberty or unable to give his assent

Primary outcomes:
measure: Identification and characterization of the tumoral intermediaries on the overflowing peritoneal
timeFrame: Up to 24 months
measure: Identification and characterization of the tumoral intermediaries on the portal blood
timeFrame: Up to 24 months
measure: Identification and characterization of the tumoral intermediaries on the peripheral blood
timeFrame: Up to 24 months
measure: Identification and characterization of the tumoral intermediaries on the hepatic metastasis and/or peritoneal)
timeFrame: Up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Gustave Roussy
state: Val De Marne
Study officials:
References:
Clinical trial NCT05266794: A Novel Role of Alpha Lipoic Acid in Comparison With Selenium in Mitochondrial Resuscitation and miRNA-126 Expression in Hemodialysis Patients
Official title: A Novel Role of Alpha Lipoic Acid in Comparison With Selenium in Mitochondrial Resuscitation and miRNA-126 Expression in Hemodialysis Patients Randomized, Prospective, Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Antioxidative Stress
End Stage Renal Disease on Dialysis
Keywords: Oxidative stress
Antioxidants
mitochondrial function
CoQ10
miRNA-126
Hemodialysis
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-03-04
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: An Open labeled, Paralled, Randomized, Prospective, study was conducted on 60 patients who were randomized into 3 groups, 22, 20 and 18 patients in Control, Selenium and, Thiotacid groups respectively. Serum levels of ROS, CoQ10, and miRNA-126 were assessed at base line and after three months for all patients.


Eligibility criteria: Inclusion Criteria:

* prevalent hemodialysis patients

Exclusion Criteria:

* Patients with Inflammatory diseases, hepatic or respiratory diseases, smokers and alcoholics, were excluded from the study.

Primary outcomes:
measure: Change in miRNA-126 level
timeFrame: 3 months
measure: Change ROS level (ng/ml)
timeFrame: 3 months
measure: Change in Co Q10 level (ng/ml)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References:
Clinical trial NCT05290662: Registry of Patients Having Received oNKord®
Official title: A Prospective Multicenter Observational Study to Assess Long-term Outcome of Participants Who Have Received oNKord®
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: AML
Keywords: NK cells
Umbilical cord blood
oNKord
Registry
Off the shelf
Lead sponsor: Glycostem Therapeutics BV
Sponsor class: INDUSTRY
First posted: 2022-03-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who have received at least one dose of oNKord® in a clinical trial and are within 3 years of follow-up after the first infusion, and who have provided informed consent for participation in this Registry.

Brief summary: ReKORD is an observational study (Registry) enrolling participants who have received at least one dose of oNKord® (allogeneic ex vivo-generated Natural Killer \[NK\] cells from CD34+ umbilical cord blood progenitor cells) in a clinical trial. Participants from multiple previous clinical trials of oNKord® can be enrolled in this Registry.

Detailed description: To be eligible for this Registry, participants must have received at least one dose of oNKord® in a clinical trial. Eligible participants will be enrolled after signing the informed consent form (ICF). Participant characteristics, treatment history, and clinical trial outcome data at clinical trial discontinuation/completion will be collected. On a yearly basis after the last clinical trial visit, the investigator will collect the participants' medical status and enter them in the Registry database. Major clinical events, including concomitant medication or therapy, that occurred since the previous assessment will be recorded. No protocol-specific visits or interventions will be required. Participants will be followed up until 3 years after the first oNKord® infusion.

Eligibility criteria: Inclusion Criteria:

* Receipt of at least one dose of oNKord® in a clinical trial
* Participation must be within 3 years after the first infusion of oNKord®
* Signature of ICF

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Incidence of SAEs related to oNKord® over time
timeFrame: 3 years
measure: Incidence of SAEs related to Cyclophosphamide-Fludarabine over time
timeFrame: 3 years
measure: Long-term follow-up on survival
timeFrame: 3 years
measure: Long-term follow-up on disease status
timeFrame: 3 years
measure: Long-term follow-up on cancer-related treatments
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
References: