louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05388955: Risk Assessment Tool for Graft Survival in Pediatric Kidney Transplantation
Official title: A Pre-transplantation Risk Assessment Tool for Graft Survival After Pediatric Kidney Transplantation Based on 1425 Dutch Transplantations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Transplant Failure and Rejection
Pediatric Kidney Disease
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2022-05-24
Enrollment: 1425
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All pediatric kidney recipients that received their kidney \<18 years in the Netherlands

Brief summary: Registry study in which data of all pediatric kidney recipients in the Netherlands (registered in the Nederlandse Orgaan Transplantatie Registry) are studied to develop a risk calculator for graft loss.

Detailed description: The pre-transplantation parameters of all recipients are used to do a multivariable regression analysis.

The B-coefficients of this analysis will be used to develop a risk calculator that predicts graft survival after transplantation per year of transplantation.

Eligibility criteria: Inclusion Criteria:

Pediatric kidney recipients

* transplantation in the Netherlands
* signed informed consent

Exclusion Criteria:

* combined transplantation (pancreas-kidney of liver-kidney transplantation)
* No informed consent

Primary outcomes:
measure: Graft survival
timeFrame: Up to 50 years after transplantation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Radboud University Medical Center
name: Liesbeth De Wall
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03258255: Analgesic Efficiency of Pudendal Nerve Block Versus Penil Block for Circumsion in Children
Official title: Comparison of Analgesic Efficiency of Pudendal Nerve Block and Penil Block for Circumsion in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Analgesia
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2017-08-23
Enrollment: 80
Sex: MALE
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this prospective randomized study is to assess the analgesic efficacy of Pudendal block compared with penil block for pediatric patients undergoing circumsion concerning postoperative analgesic consumption within 24 hours.

Detailed description: In this prospective study, patients will be randomized into 2 groups, either receiving penil Block( PNL) or nerve stimulator-guided Pudendal Nerve Block(PNB). Analgesic consumption will be assessed during the first 24 hours postoperatively. The "CHEOPS pain scale" will use to assess postoperative pain.

Eligibility criteria: Inclusion Criteria:

ASA I-II patients, aged 1-12 years old patient undergoing circumcision,

Exclusion Criteria:

history of local anesthetics's allergy, infection at the injection side, anatomical abnormalities, coagulopaty, bleeding disease, liver disease

Primary outcomes:
measure: Postoperative pain evaluatiom
timeFrame: 24 hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Cyna AM, Middleton P. Caudal epidural block versus other methods of postoperative pain relief for circumcision in boys. Cochrane Database Syst Rev. 2008 Oct 8;2008(4):CD003005. doi: 10.1002/14651858.CD003005.pub2.
Clinical trial NCT01690455: An Observational Study of Mircera in Renal Anemia Correction In Dialysed Patients During Daily Clinical Practice
Official title: Non-interventional Study to Assess the Efficacy of Mircera for Renal Anemia Correction in Dialysis Patients in Everyday Clinical Practice in Poland.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-09-21
Enrollment: 247
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with renal anemia and on dialysis therapy

Brief summary: This observational, multi-center study will evaluate the efficacy and safety of Mircera (methoxy polyethylene glycol-epoetin beta) in renal anemia correction in dialysed patients in daily clinical practice. Patient will receive Mircera according to local summary of product characteristics. Data will be collected for 12 months.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/=18 years of age
* Adequate iron status
* Signed informed consent form

Exclusion Criteria:

* Anemia due to non-renal causes
* Where investigator considers the patient unsuitable for inclusing for other reasons (e.g. severe co-morbidities as active bleeding, infections or cancer)
* Pregnant or lactating female patients
* Any contraindications against treatment with Mircera (according to local Summary of Product Characteristics)

Primary outcomes:
measure: Proportion of patients who achieve a hemoglobin level of >/=10 g/dl
timeFrame: 12 months
Secondary outcomes:
measure: Safety: incidence of adverse events
timeFrame: 12 months
Other outcomes:
Locations:
city: Bartoszyce
country: Poland
city: Bydgoszcz
country: Poland
city: Ciechanow
country: Poland
city: Czestochowa
country: Poland
city: Debica
country: Poland
city: Gliwice
country: Poland
city: Gorzow Wielkopolski
country: Poland
city: Grudziadz
country: Poland
city: Hajnowka
country: Poland
city: Jastrzębie Zdrój
country: Poland
city: Jaworzno
country: Poland
city: Kepno
country: Poland
city: Konin
country: Poland
city: Koscierzyna
country: Poland
city: Lapy
country: Poland
city: Lodz
country: Poland
city: Milicz
country: Poland
city: Pila
country: Poland
city: Polanica Zdroj
country: Poland
city: Radom
country: Poland
city: Rybnik
country: Poland
city: Rzeszow
country: Poland
city: Rzeszow
country: Poland
city: Sandomierz
country: Poland
city: Siedlce
country: Poland
city: Slupsk
country: Poland
city: Starachowice
country: Poland
city: Suwalki
country: Poland
city: Swiecie
country: Poland
city: Warszawa
country: Poland
city: Wolomin
country: Poland
city: Wroclaw
country: Poland
city: Zgorzelec
country: Poland
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04683055: Phaco-Trabeculotomy Vs Phaco-Trabeculectomy
Official title: Phacoemulsification Combined With Trabeculectomy Versus Phacoemulsification Combined With Trabeculotomy for Treatment of Chronic Angle Closure Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ophthalmopathy
Glaucoma
Glaucoma, Angle-Closure
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-12-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A prospective, randomized comparative study on adult patients with synechial angle closure glaucoma.

Detailed description: Patients were randomized into two groups: group A : patients will undergo two site phacoemulfication combined with trabeculectomy Group B with Phacoemulsification combined with ab-externo trabeculotomy. Preoperative assessments including full ophthalmic examination, anterior segment Optical Coherence Tomography (OCT) of the angle , endothelial cell count , visual fiend Perimetry and Biometry. Patients were followed up: first day, first week and every two months for 6 month. We will compare adverse effects and outcomes in both groups.

Eligibility criteria: Inclusion Criteria:

Patients with chronic angle closure glaucoma, with or without peripheral anterior synechiae, age more than 18

Exclusion Criteria:

* Patient unable for follow up
* Patients with corneal or retinal disease that affects visual outcome of surgery
* Patients with previous glaucoma procedure in the eye of study

Primary outcomes:
measure: Absolute Success
timeFrame: 1,3,6 months
measure: Visual outcome
timeFrame: 1,3,6 month
Secondary outcomes:
measure: Adverse events
timeFrame: 1 week, 1 month, 3 months, 6 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospital
Study officials:
References:
citation: Lichter PR, Musch DC, Gillespie BW, Guire KE, Janz NK, Wren PA, Mills RP; CIGTS Study Group. Interim clinical outcomes in the Collaborative Initial Glaucoma Treatment Study comparing initial treatment randomized to medications or surgery. Ophthalmology. 2001 Nov;108(11):1943-53. doi: 10.1016/s0161-6420(01)00873-9.
citation: Rebolleda G, Munoz-Negrete FJ. Phacoemulsification in eyes with functioning filtering blebs: a prospective study. Ophthalmology. 2002 Dec;109(12):2248-55. doi: 10.1016/s0161-6420(02)01246-0.
citation: Hansapinyo L, Choy BNK, Lai JSM, Tham CC. Phacoemulsification Versus Phacotrabeculectomy in Primary Angle-closure Glaucoma With Cataract: Long-Term Clinical Outcomes. J Glaucoma. 2020 Jan;29(1):15-23. doi: 10.1097/IJG.0000000000001397.
citation: Toteberg-Harms M, Wachtl J, Schweier C, Funk J, Kniestedt C. Long-term efficacy of combined phacoemulsification plus trabeculectomy versus phacoemulsification plus excimer laser trabeculotomy. Klin Monbl Augenheilkd. 2017 Apr;234(4):457-463. doi: 10.1055/s-0043-100291. Epub 2017 Mar 6.
Clinical trial NCT04871555: Structural Cartography of the Insula in Temporal Epilepsy Patients
Official title: Structural Cartography of the Insula in Temporal Epilepsy Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epilepsy, Temporal Lobe
MRI Scans
Keywords: structural connectivity
insula
temporal lobe epilepsy
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
Collaborators: name: Centre de Recherche du Centre Hospitalier de l'Université de Montréal
name: University Hospital, Lille
name: Hospices Civils de Lyon
First posted: 2021-05-04
Enrollment: 115
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: temporal epilepsy patients and healthy subjects

healthy subjects will be selected in the healthy cohort of Nguyen G-Dang (Ghaziri et al., 2017)

Brief summary: The purpose of this study is to investigate insula structural connectivity in temporal epilepsy patients. Insula being at the interface of frontal, parietal, occipital and temporal lobes, its structural organization reflects the brain function. We hypothetize that insular structural organization will be different according to the different subtypes of temporal epilepsy.

Detailed description: The purpose of this study is to investigate insula structural connectivity in temporal epilepsy patients. Insula being at the interface of frontal, parietal, occipital and temporal lobes, its structural organization reflects the brain function. We hypothetize that insular structural organization will be different according to the different subtypes of temporal epilepsy.

Eligibility criteria: Inclusion Criteria:

* epileptic patients: temporal epilepsy or temporal plus epilepsy (temporomesial epilepsy, basal temporal epilepsy, mesio lateral or lateral epilepsy, temporo insular epilepsy, operculo insular epilepsy)
* patients who underwent video EEG monitoring with recorded seizures (at least one)
* patients who underwent a brain MRI with DTI sequence before epilepsy surgery
* patients who did not refuse the use of their clinical and MRI data for this study

Exclusion Criteria:

* patients younger than 15 years old
* patients with previous brain surgery (before MRI)
* uncompleted MRI sequences (DTI, T1 anatomical)

Primary outcomes:
measure: cartography of insula in temporal epilepsy patients
timeFrame: 1 year after the last inclusion
Secondary outcomes:
measure: Correlation structural cartography and electroclinical data
timeFrame: 1 year after the last inclusion
Other outcomes:
Locations:
city: Nancy
country: France
facility: Central Hospital nancy
Study officials:
affiliation: CHRU Nancy, CRAN UMR 7039 Université de Lorraine
name: Louise Tyvaert, MD PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00874055: The Presence of Friends Increases Food Intake in Youth
Official title: The Presence of Friends Increases Food Intake in Youth
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Total Caloric Intake
Nutrient Dense Caloric Intake
Energy Dense Caloric Intake
Keywords: social influence
friends
eating behavior
childhood overweight
Lead sponsor: University at Buffalo
Sponsor class: OTHER
First posted: 2009-04-02
Enrollment: 72
Sex: ALL
Minimum age (years): 9
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Sampling method: PROBABILITY_SAMPLE
Study population: Boys and girls between the ages of 9-15.

Brief summary: Participants will be matched with either their friend or an unfamiliar peer who is the same gender and about the same age. Participants will have 45 minutes of free-play in an experimental room where they will have free access to energy-dense and nutrient-dense foods and an assortment of games and puzzles.

The investigators predict that participants eating with a friend will eat significantly more than participants eating with an unfamiliar peer. The investigators also predict that overweight participants eating with an overweight partner will eat significantly more than participants eating with a non overweight participant.


Eligibility criteria: Inclusion Criteria:

* Boys and girls ages 9-15
* Between 15th and 95th BMI percentile for their age

Exclusion Criteria:

* Sickness, psychopathology or developmental disabilities
* Participant has a cold or upper respiratory distress
* Food allergies to the study food
* Participant is on medication or has a medical condition that could influence taste, appetite or olfactory sensory responsiveness.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: University at Buffalo, Division of Behavioral Medicine
state: New York
Study officials:
affiliation: University at Buffalo
name: Sarah J Salvy, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Salvy SJ, Howard M, Read M, Mele E. The presence of friends increases food intake in youth. Am J Clin Nutr. 2009 Aug;90(2):282-7. doi: 10.3945/ajcn.2009.27658. Epub 2009 Jun 17.
Clinical trial NCT01865955: Comparison Between Palpatory and Preprocedural Ultrasound Guided Techniques on Performance of Spinal Anesthesia
Official title: Comparison Between Palpatory and Preprocedural Ultrasound Guided Techniques on Performance of Spinal Anesthesia in Term Parturients Undergoing Elective Caesarian Section- A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: Ultrasound
Spinal anesthesia
Cesarean section
Lead sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Sponsor class: OTHER
First posted: 2013-05-31
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pre-procedural ultrasound for Spinal \& Epidural anesthesia is now being increasingly performed worldwide. Pre-procedural ultrasound assessment of the spine has been shown to facilitate the placement of epidural anesthesia in pregnant women, diagnostic lumbar punctures, performance of spinal anesthesia in non-obstetric patients and accurate identification of the interspace at which the puncture is being performed. This is especially important during spinal anesthesia, where puncture below the ending of the spinal cord is recommended for safety.

The purpose of this study is to compare the performance of spinal anesthesia between the pre-procedural ultrasound assessment of the spine and the traditional palpatory technique, in term pregnant women undergoing elective cesarean delivery. Furthermore, we aim to describe sonoanatomic features of the spine that could predict the ease of insertion of spinal anesthesia in that patient population.

We hypothesize that in term pregnant women undergoing elective cesarean delivery, pre-procedural ultrasound assessment of the spine will improve the success rate of spinal anesthesia at first attempt, compared to the traditional palpatory technique.


Eligibility criteria: Inclusion Criteria:

* Pregnant patients scheduled to receive spinal anesthesia for elective cesarean sections
* ASA physical status 1 - 3
* Written informed consent
* Gestational age ≥ 37 weeks.

Exclusion Criteria:

* Patient's refusal.
* Body mass index ≥ 45
* Patient with marked spinal bony deformity (Severe scoliosis on visual inspection and previous spinal instrumentation).

Primary outcomes:
measure: Spinal needle redirections
timeFrame: 15 minutes
Secondary outcomes:
measure: Needle reinsertions
timeFrame: 15 minutes
measure: Need to change to another interspace.
timeFrame: 15 minutes
measure: Procedure time
timeFrame: 15 minutes
measure: Pain score
timeFrame: 15 minutes
measure: Intervertebral level agreement
timeFrame: 3 hours
measure: Ultrasound Grading
timeFrame: 3 hours
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Cristian Arzola, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03627455: Troponin I and T and Adverse Outcomes in Patients With and Without Diabetes Mellitus After Coronary Intervention
Official title: A Sex-specific Analysis of the Predictive Value of Troponin I and T in Patients With and Without Diabetes Mellitus After Successful Coronary Intervention
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Diabetes Mellitus
Lead sponsor: Wilhelminenspital Vienna
Sponsor class: OTHER
Collaborators: name: Association for the Promotion of Research in Atherosclerosis, Thrombosis and Vascular Biology
First posted: 2018-08-13
Enrollment: 818
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients undergoing percutaneous coronary intervention at the department of cardiology at the Wihelminenspital

Brief summary: Elevated levels of troponin are associated with future MACE. Data on the prognostic value of high sensitive troponin T (hs-TnT) as compared to high sensitive troponin I (hs-TnI) in diabetic and non-diabetic patients are sparse.

We aimed to assess the risk for MACE according to gender and diabetes status and to compare the prognostic value of hs-TnT and hs-TnI with regards to clinical outcomes in diabetic and non-diabetic patients undergoing percutaneous coronary intervention (PCI).


Eligibility criteria: Inclusion Criteria:

* Percutaneous coronary intervention

Exclusion Criteria:

* unsuccessful percutaneous coronary intervention

Primary outcomes:
measure: MACE
timeFrame: 8 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01868555: Safety, Pharmacokinetics and Pharmacodynamics of Two IDegAsp (One Explorative) Preparations and Two Insulin Degludec (One Explorative) Preparations in Japanese Subjects
Official title: A Randomised, Double-blind, Single Centre, Placebocontrolled, Parallel Group, Multiple s.c. Dose Trial to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Two SIAC Preparations and Two Insulin 454 (SIBA) Preparations in Healthy Japanese Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2013-06-04
Enrollment: 32
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Asia. The aim of this trial is to assess the safety, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of two insulin degludec/insulin aspart (IDegAsp) preparations and two insulin degludec (insulin 454) preparations in healthy Japanese male subjects. IDegAsp 45 (B) and insulin degludec (B) are explorative formulations, not similar to the proposed commercial formulations.


Eligibility criteria: Inclusion Criteria:

* Healthy Japanese male subjects
* Body mass index (BMI) between 18.0 and 27.0 kg/m\^2 (both inclusive)
* Body weight above or equal to 50 kg

Exclusion Criteria:

* The receipt of any investigational drug within 16 weeks prior to this trial (the planned first dosing)
* Any clinical laboratory values deviated from the reference range at the laboratory (except for cases within physiological change) or any abnormal electrocardiogram (ECG) findings at the screening, as judged by the investigator or sub-investigator
* Known or suspected allergy to trial product(s) or related products

Primary outcomes:
measure: Adverse events (AEs)
timeFrame: Day 1-6 and 7-28 days after day 6
Secondary outcomes:
measure: Area under the serum insulin 454 concentration curve
timeFrame: 0-96 hours after last dosing
measure: Area under the serum insulin aspart concentration curve
timeFrame: 0-6 hours after dosing
Other outcomes:
Locations:
city: Tokyo
country: Japan
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: