louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00747604: IGFD Registry: A Patient Registry for Monitoring Long-term Safety and Efficacy of Increlex
Official title: Increlex® (Mecasermin [rDNA Origin] Injection) Growth Forum Database - IGFD Registry: A Patient Registry for Monitoring Long-term Safety and Efficacy of Increlex
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Primary Insulin-like Growth Factor-1 Deficiency
Keywords: Growth Hormone (GH) Insensitivity Syndrome
Insulin-like Growth Factor Deficiency (IGFD)
Short Stature
Insulin-like Growth Factor (IGF-1)
Growth
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2008-09-05
Enrollment: 1378
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible patients will be patients beginning therapy with Increlex® or those previously treated with Increlex.

Brief summary: This project is a retrospective (beginning January 2006) and prospective patient registry program sponsored by Ipsen (formerly Tercica, Inc.). In collaboration with participating health care practitioners, the patient registry program is an observational study monitoring the long-term safety of patients treated with Increlex® (mecasermin \[rDNA origin\] injection). The IGFD (Increlex® Growth Forum Database) Registry is intended primarily to monitor the safety and efficacy of Increlex replacement therapy in children with growth failure.

Detailed description: The data collected for a patient will be those that exist in the patient's medical record as part of standard medical care. No additional patient procedures or activities are mandated by this study. The specific data to be collected at each visit and the schedule of data collection are listed in a schedule of assessments.

The collection of safety events is considered essential to the Registry. The website will provide the opportunity to report the occurrence of targeted adverse events (AEs), other important events considered to be related to Increlex administration and serious adverse events (SAEs).

Eligibility criteria: Inclusion Criteria:

* Parents or legally authorized representatives must give signed informed consent before any Registry-related activities are conducted. Assent from the subject should also be obtained where appropriate.
* Patients receiving Increlex® by a qualified practitioner may be enrolled

Exclusion Criteria:

Primary outcomes:
measure: To obtain long-term safety and efficacy data for Increlex® replacement therapy in children with growth failure
timeFrame: periodically assessed over the course of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Ipsen Central Contact
state: New Jersey
Study officials:
affiliation: Ipsen (formerly Tercica)
name: Medical Director, Endocrinology
role: STUDY_DIRECTOR
References:
Clinical trial NCT07003204: Neutrophil-to Lymphocyte and Monocyte-to-Lymphocyte Ratios in Exudative Pleural Effusion
Official title: Diagnostic and Prognostic Role of Pleural Fluid Neutrophil-to Lymphocyte and Monocyte-to-Lymphocyte Ratios in Exudative Pleural Effusion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Effusion
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2025-06-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 60 person with pleural effusion

Brief summary: Exudative pleural effusion (EPE) presents a diagnostic challenge, requiring accurate biomarkers to predict outcomes and guide treatment. The neutrophil-to-lymphocyte ratio (NLR) and monocyte-to-lymphocyte ratio (MLR) in pleural fluid are emerging as potential prognostic markers. We aimed to assess the diagnostic and prognostic utility of pleural fluid NLR and MLR in EPE.

Detailed description: Pleural fluid NLR and MLR are reliable biomarkers for diagnosing malignant pleural effusion and predicting poorer survival outcomes. These ratios may be useful in clinical practice, especially in resource-limited settings, to guide decision-making in the management of pleural effusions.

Eligibility criteria: Inclusion Criteria:

* adult patients aged 18-80 years with an EPE diagnosis confirmed by thoracentesis.

Exclusion Criteria:

* Exclusion criteria included patients with a history of recent surgery, corticosteroid use, or those with mixed effusion types.

Primary outcomes:
measure: MLR and NLR measuring in pleural fluid
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
measure: MLR and NLR measuring in pleural fluid
timeFrame: one month
Locations:
city: Alexandria
country: Egypt
facility: Chest Department -Faculty of Medicine
Study officials:
affiliation: Alexandria University
name: mohamed Sabry eltarhony, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06540404: Effect of Knee Mobilisation on Joint Position Sense and Tissues
Official title: Effects of Traction Mobilization Techniques on Knee Joint Position Sense and Biomechanical Properties of Knee Joint Tissues
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Manual Therapy
Knee
Keywords: knee
manual therapy
healthy people
MyotonPRO
Lead sponsor: The Jerzy Kukuczka Academy of Physical Education in Katowice
Sponsor class: OTHER
First posted: 2024-08-06
Enrollment: 126
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to evaluate the effects of traction mobilizations on position sense in the knee joint and on the biomechanical properties of the knee joint tissues.


Eligibility criteria: Inclusion Criteria:

* no lower extremity injuries within the past year,
* no pain within the past seven days and on the day of the study,
* feeling well on the day of the study,
* no intense physical exertion on the day of the study,
* no occurrence of delayed muscle pain on the day of the study and up to three days back.

Exclusion Criteria:

* chronic diseases affecting motor skills,
* lower extremity injuries occurring within a year and treated with a physiotherapist or physician,
* complaints of pain or malaise on the day of the study,
* knee pain within the last 7 days,
* the occurrence of delayed muscle pain up to three days back,
* participation in intense physical exertion on the day of the study.

Primary outcomes:
measure: Joint position sense
timeFrame: Before intervention and immediately after intervention
Secondary outcomes:
measure: Biomechanical properties of knee joint tissues: Frequency
timeFrame: Before intervention and immediately after intervention
measure: Biomechanical properties of knee joint tissues: Stiffness
timeFrame: Before intervention and immediately after intervention
measure: Biomechanical properties of knee joint tissues: Relaxation
timeFrame: Before intervention and immediately after intervention
measure: Biomechanical properties of knee joint tissues: Decrement
timeFrame: Before intervention and immediately after intervention
measure: Biomechanical properties of knee joint tissues: Creep
timeFrame: Before intervention and immediately after intervention
Other outcomes:
Locations:
city: Katowice
country: Poland
facility: Motion Analysis Laboratory, The Jerzy Kukuczka Academy of Physical Education
Study officials:
affiliation: The Jerzy Kukuczka Academy of Physical Education, Katowice, Poland
name: Agnieszka Polaczek, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03964701: Peritoneal Membrane Dysfunction in Peritoneal Dialysis Using Metabolomics
Official title: Identification of Early Biomarkers of Peritoneal Membrane Dysfunction in Children on Peritoneal Dialysis Using Metabolomics Analysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: End Stage Renal Disease
Dialysis
Keywords: children
renal failure
dialysis
Lead sponsor: Baxter (Hellas) Ltd
Sponsor class: INDUSTRY
First posted: 2019-05-28
Enrollment: 18
Sex: ALL
Minimum age (years): 30
Maximum age (years): 20
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants, children and adolescent patients on chronic peritoneal dialysis

Brief summary: Ability and sensitivity of metabolomics analysis to highlight biomarkers or a score of biomarkers that will be able to identify those pediatric patients on peritoneal dialysis at high risk for possible peritoneal dialysis complications and mainly encapsulating peritoneal sclerosis

Detailed description: Ability and sensitivity of metabolomics analysis to highlight biomarkers or a score of biomarkers that will be able to identify those pediatric patients on peritoneal dialysis at high risk for possible peritoneal dialysis complications and mainly encapsulating peritoneal sclerosis. Identification of peritoneal membrane functional status changes over time, at the same patient (cohort study), by metabolomics, aiming in personalized medicine best practice.

Identification of peritoneal membrane functional status changes over time in immature infants' peritoneal membrane.

Identification of early and accurate markers of peritoneal membrane dysfunction when membrane status is possibly reversible that could predict peritoneal patients at risk for future loss of ultrafiltration and dialysis adequacy of small molecules examined today be PET, KT/V and Cr/Cl (when membrane status is not reversible).

Improve PD survival in infants and children.

Eligibility criteria: Inclusion Criteria:

* Pediatric and adolescent patients on peritoneal dialysis
* Aged:1month -20 years

Exclusion Criteria:

-Abdominal surgery

Primary outcomes:
measure: Change of Peritoneal Equilibration test profile
timeFrame: 1 year
Secondary outcomes:
measure: Loss of dialysis adequency
timeFrame: 1 year
measure: Elevated creatinine
timeFrame: 1 year
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: 1st ACADEMIC PEDIATRIC DEPARTMENT
Study officials:
affiliation: Aristotle University
name: Nikoleta Printza
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01139801: Cervical Ripening for Induction of Labor: Misoprostol Versus Oxytocin in Conjunction With Foley Balloon
Official title: Cervical Ripening for Induction of Labor: Misoprostol Versus Oxytocin in Conjunction With Foley Balloon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Induction of Labor
Keywords: Cervical Ripening
Rate of Cesearean Section
Lead sponsor: Aultman Health Foundation
Sponsor class: OTHER
First posted: 2010-06-09
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to specifically investigate the efficacy of an alternative pharmacologic cervical ripening agent, misoprostol, versus the standard oxytocin, as an adjunct to Foley balloon for induction of the unfavorable cervix.

Detailed description: The design of this study is a randomized, controlled study with two arms. Both groups will undergo placement of a Foley catheter, through the external and internal os of the cervix, according to standard practice. In group A, receiving intravenous infusion of oxytocin, will serve as the control group as it is standard protocol at Aultman Hospital. Group B, intravaginal placement of misoprostol, will serve as the experimental group. The expected duration of participation begins at induction of labor and concludes at time of delivery.

Eligibility criteria: Inclusion Criteria:

* Participant or surrogate is capable of giving informed consent
* Anticipated number - 50 patients with 25 in each study arm Female with singleton gestation, live intrauterine pregnancy
* Participant is undergoing an indicated induction of labor
* Participant is found to have cervical Bishop score ≤5 on initial cervical exam
* Participant has no medical or obstetrical contraindications to induction of labor

Exclusion Criteria:

* Participant has ≥2 painful contractions in 10 min in 2 subsequent 10 min periods
* Manufacturer's contraindications to misoprostol or oxytocin

Primary outcomes:
measure: Rate of Induction To Delivery
timeFrame: 24 hrs
Secondary outcomes:
measure: Delivery Route
timeFrame: 24 hrs
Other outcomes:
Locations:
city: Canton
country: United States
facility: Aultman Health Foundation
state: Ohio
Study officials:
affiliation: Aultman Health Foundation
name: Erica Downey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02915601: Bicarbonate Administration in CKD
Official title: Bicarbonate Administration in CKD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Metabolic Acidosis
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2016-09-27
Enrollment: 109
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Low serum bicarbonate levels, even within the normal laboratory range, are strongly associated with increased risks of hypertension, endothelial dysfunction, cardiovascular disease and death. The current proposal will investigate whether bicarbonate administration in patients with chronic kidney disease (CKD) will improve the health and function of arteries and reduce the size of the left ventricle of the heart. Overall, the proposed research will provide important new scientific evidence upon which physicians can base recommendations to patients with CKD to decrease the risk of developing cardiovascular diseases.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 21 years
* Serum bicarbonate 22-25 mEq/L on 2 separate measurements (at least 1 day apart)
* CKD stage 3B or 4 at time of screening (eGFR 15-44 ml/min/1.73m2)
* Blood pressure \<130/80 mm Hg prior to randomization
* BMI \< 40 kg/m2 (FMD measurements can be inaccurate in severely obese patients).
* Able to provide consent
* Stable anti-hypertensive regimen for at least one month prior to randomization
* Not taking medications that interact with agents administered during experimental sessions (e.g. sildenafil interacts with nitroglycerin).

Exclusion Criteria:

* Use of chronic daily oral alkali within the last 3 months (including sodium bicarbonate, calcium carbonate or baking soda)
* Uncontrolled hypertension
* Serum potassium \< 3.3 or ≥ 5.5 mEq/L at screening
* New York Heart Association Class 3 or 4 heart failure symptoms, known EF ≤30%, or hospital admission for heart failure within the past 3 months
* Factors judged to limit adherence to interventions
* Anticipated initiation of dialysis or kidney transplantation within 12 months
* Current participation in another research study
* Pregnancy or planning to become pregnant or currently breastfeeding
* Chronic use of supplemental oxygen
* Use of immunosuppression in past 3 months
* Metal implant or implanted electrical device (patient will be unable to get MRI)

Primary outcomes:
measure: Change in Brachial Artery Flow Mediated Dilation
timeFrame: Measured at baseline and 12 months
measure: Change in Aortic Pulse Wave Velocity
timeFrame: Measured at baseline,12 months
Secondary outcomes:
measure: Change in Left Ventricular Mass Index
timeFrame: Measured at baseline and 12 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Jessica Kendrick, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01802801: Intra- and Interobserver Agreement in the Assessment of Human Embryos
Official title: Intra-and Inter-observer Agreement in the Morphological Assessment of Human Embryos
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: the Focus of This Study is to Measure the Intra- and Interobserver Agreement for the Evaluation of Early Stage Embryos
Lead sponsor: University Hospital, Gasthuisberg
Sponsor class: OTHER
First posted: 2013-03-01
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Sampling method: PROBABILITY_SAMPLE
Study population: embryos of IVF/ICSI patients

Brief summary: The purpose of this study is to determine the intra- and interobserver agreement.


Eligibility criteria: Inclusion Criteria:

* fertilized embryos

Exclusion Criteria:

* unfertilized embryos

Primary outcomes:
measure: Evaluation of the intra- and inter-observer variability in the assessement of human embryos
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospital Leuven, Catholic University Leuven
Study officials:
References:
Clinical trial NCT00198601: Determination of Gentamicin Dosing in Neonatal Patients
Official title: Determination of Gentamicin Dosing in Neonatal Patients for Use in the Uniject Pre-filled Syringe [A Three-site Study at: 1) Dhaka Shishu Hospital, Dhaka Bangladesh; 2) Christain Medical Center, Vellore, India; and 3) Aga Khan University Medical Center, Karachi, Pakistan]
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infection
Keywords: meningitis
neonatal deaths
gentamicin
Uniject
aminoglycoside
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
First posted: 2005-09-20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine what dosage of gentamicin for use in one-time administration device (Uniject) is appropriate.

Detailed description: This study aims to verify dosages of gentamicin for use in Uniject, chosen based on a consideration of gentamicin pharmacokinetics, safety, efficacy, target population body weight, cost, feasibility and acceptability.

Eligibility criteria: Inclusion Criteria:

* infants with culture proven sepsis
* infants 2000-2499 at birth
* infants \> 2500 gm at birth
* infants \< 2000 gm at birth
* in study site areas: Pakistan, Bangladesh and India

Exclusion Criteria:

* infants w/o culture proven sepsis

Primary outcomes:
measure: Patients 2.0-2.24 kg high peak>12.0: 2/6 patients
measure: Low peak<4.0: none
measure: High trough > 2.0: 1/6 patients
Secondary outcomes:
measure: Patients 2.5-3.0 kg
measure: High peak>12.0: 2/14 patients
measure: Low peak <4.0: none
measure: High trough>2.0:2/14 patients
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Dhaka Shishu Hospital
city: Vellore
country: India
facility: Neonatal Intensive Care Unit - Christian Vellore Medical
city: Karachi
country: Pakistan
facility: Aga Khan
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Gary Darmstadt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05615701: Image Quality of EOSedge for Radiographic Evaluation of Hip Implant
Official title: Image Quality of the EOSedge Radiographic System Versus a Standard Digital Radiographic (DR) System for Preoperative Assessment for Hip Replacement or Revision Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hip Osteoarthritis
Hip Prosthesis Infection
Keywords: EOS
Radiography
Hip
Hip replacement
Image quality
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: EOSedge is a precise, low dose imaging system that delivers full body, high-quality images covering the full set of musculoskeletal and orthopedic exams.

The objective of the study is to evaluate the quality of the focused pelvis/hip X-ray images on EOSedge compared to those performed on DR (current practice) to perform a preoperative radiographic evaluation of hip implant, A sufficient image quality on focused X-ray images performed on EOSedge would allow (1) to avoid the passage on two different radiographic systems (saving time) (2) to reduce the patient's x-ray radiation dose


Eligibility criteria: Inclusion Criteria:

* Patient 18 years of age or older
* Came to the imaging department to perform a preoperative assessment for hip replacement or revision

Exclusion Criteria:

* Patient under guardianship or curatorship
* Patient participating in an interventional study
* Patient unable to read and/or write

Primary outcomes:
measure: Score of Image quality
timeFrame: Day 0
Secondary outcomes:
measure: Dosimetry
timeFrame: Day 0
measure: Dosimetry
timeFrame: Day 0
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Departement of Medical Imaging
state: Occitanie
Study officials:
affiliation: Departement of Medical Imaging - Montpellier University hospital LAPEYRONIE Hospital
name: Catherine c-cyteval@chu-montpellier.fr, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01810601: Effect of Ultrasound Guided Embryo Transfer on Pregnancy Rates
Official title: Effect of Ultrasound Guided Embryo Transfer on Pregnancy Rates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: Embryo transfer, transabdominal ultrasound, IVF, ICSI
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2013-03-13
Enrollment: 90
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the effect of transabdominal ultrasound guided embryo transfer on the pregnancy rates versus clinical touch technique

Detailed description: A total of 90 patients undergoing treatment with ICSI were divided into 2 groups: group 1 (45 patients), had ultrasound guided embryo transfer and group 2 (45 patients), underwent embryo transfer using the clinical touch technique

Eligibility criteria: Inclusion Criteria:

* Age (20-39)
* Male factor infertility
* Ovarian factor infertility
* Unexplained infertility

Exclusion Criteria:

* Tubal factor infertility
* Endometriosis
* FSH \> 16 iu/l on cycle day 3
* Less than 2 embryos grade A
* Difficult embryo transfer

Primary outcomes:
measure: To assess clinical pregnancy rates after using ultrasound guided embryo transfer
timeFrame: After December, 2012
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: IVF Unit, Ain Shams Maternity Hospital, Ain Shams University
Study officials:
affiliation: Ain Shams University
name: Ahmed R Ammar, MD
role: STUDY_DIRECTOR
References:
citation: Coroleu B, Barri PN, Carreras O, Belil I, Buxaderas R, Veiga A, Balasch J. Effect of using an echogenic catheter for ultrasound-guided embryo transfer in an IVF programme: a prospective, randomized, controlled study. Hum Reprod. 2006 Jul;21(7):1809-15. doi: 10.1093/humrep/del045. Epub 2006 Mar 23.