louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00486057: Daclizumab Experience in Pediatric Heart Transplant
Official title: A Retrospective Review of Daclizumab Experience in Pediatric Heart Transplant
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Congenital Disorders
Keywords: Daclizumab
Immuno-suppression protocol
Heart Transplant
Rejection
Lead sponsor: Children's Healthcare of Atlanta
Sponsor class: OTHER
First posted: 2007-06-13
Enrollment: 30
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Status post heart transplant Age 0-21 years Received Daclizumab as induction therapy

Brief summary: The purpose of this study is to examine the outcomes of those who have received Daclizumab as part of their immuno-suppression protocol following heart transplantation. Literature suggests that the time to first rejection episode can be avoided or delayed by using induction therapy.

Detailed description: In August 2005 the heart transplant team at Children's Healthcare of Atlanta began a protocol of Daclizumab 1mg/kg IV every two weeks for 5 doses; 1st dose to be received in the operating room following discontinuation of cardiopulmonary bypass.

Since one year has passed following initiation of this practice, it is necessary to review this immuno-suppression strategy and determine if, in fact, there was clinical benefit of reducing rejection without increasing the vulnerabilities of the immuno-compromised host.

We wish to review all heart transplant recipient records between August 1, 2004 and October 15, 2006. Historically, Children's has done approximately 10 transplants per year; therefore, we will review approximately 15 charts at Children's Healthcare of Atlanta and Sibley Heart Center Cardiology.

Eligibility criteria: Inclusion Criteria:

* Status post heart transplant
* Age 0-21 years
* Received Daclizumab as induction therapy

Exclusion Criteria:

* Those who do not meet inclusion criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
Study officials:
affiliation: Children's Healthcare of Atlanta, Pediatric Surgery
name: Kirk R Kanter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06018857: Registry 17-009: Multi-Institutional Study Examining Patients With HCC Undergoing Liver Transplantation
Official title: Registry 17-009: Multi-Institutional Study Examining Patients With HCC Undergoing Liver Transplantation
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hepatocellular Carcinoma
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Ohio State University
First posted: 2023-08-31
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients (age\>18 years) undergoing Liver transplant for hepatocellular carcinoma

Brief summary: This is a registry study examining patients with HCC undergoing liver transplantation including outcomes and predictors of recurrence


Eligibility criteria: Inclusion Criteria:

* Adult patients (age\>18 years) undergoing Liver transplant for hepatocellular carcinoma

Exclusion Criteria:

* Patients under 18 years old
* Patients who do not have hepatocellular carcinoma
* patients who have hepatocellular carcinoma but do not undergo liver transplantation

Primary outcomes:
measure: Recurrence Free Survival
timeFrame: From date of surgery to date of identified cancer recurrence through either clinical judgement or scans. This is assessed up to 10 years after the surgery.
measure: Overall Survival
timeFrame: From date of surgery to date of death, up to 10 years after the surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Federico Aucejo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01162057: The Effect of Hemodialysis on Hearing
Official title: The Effect of Hemodialysis on Hearing in Hemodialysis Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hearing
Keywords: Hemodialysis
Hearing
Hemodialysis patients
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-07-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing regular thrice-weekly hemodyalysis

Brief summary: The inner ear contains transporters that are responsible for maintaining a strict homeostatic environment, necessary for transmission and transduction of sound waves. Hemodialysis affects the body's composition including the aspects regulated by these transporters (pH, osmolarity, Na, K). We wish to observe if hemodialysis affects hearing, and if so, by which parameters.


Eligibility criteria: Inclusion Criteria:

* patients on hemodialysis

Exclusion Criteria:

* known hearing defect

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01562457: Intra-subject Variability Following Administrations of Activated Recombinant Human Factor VII in Haemophilia Patients in a Non-bleeding State
Official title: A Randomised, Open-label, Multi-centre Trial Investigating the Intra-subject Variability of ROTEM® and TEG® Parameters Following Two Intravenous Administrations of the Same Dose of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in Haemophilia Patients in a Non-bleeding State
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Congenital Bleeding Disorder
Haemophilia A
Haemophilia B
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-03-23
Enrollment: 30
Sex: MALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Asia and Europe. The aim of this trial is to evaluate the intra-subject variability of thromboelastographic parameters (TEG® and ROTEM®) following two administrations of activated recombinant human factor VII in haemophilia patients in a non bleeding state.

The TEG® parameters are: R time (Reaction Time), K time (K Time (arbitrary measurement)), a (a angle), MA (Maximum Amplitude) and LY30 (Lysis 30 min after MA) while the ROTEM® parameters are: CT (Clotting Time), CFT (Clot Formation Time), a (a angle), MCF (Maximum Clot Firmness) and LI60 (Lysis index 60 min after CT).


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of congenital haemophilia A or B with a FVIII:C (Activated Coagulation Factor VIIa Clotting activity) or FIX:C (Coagulation Factor IX Clotting activity) one stage activity, respectively, at less than 5% of normal (based on medical records) plus/minus inhibitors (a positive inhibitor status defined as 0.6 Bethesda units)
* Non-bleeding state (i.e. no clinical manifestation of active bleed) at the time of administration of trial product

Exclusion Criteria:

* Known or suspected allergy to trial product or any of its components or to related products
* Known clinically relevant coagulation disorders or insufficiencies other than congenital haemophilia A or B
* Platelet count below 50,000 platelets/mcL
* Received any haemostatic treatment (e.g. Feiba) within the last 7 days prior to administration of trial product, except for activated recombinant human factor VII

Primary outcomes:
measure: TEG® (Thromboelastography) parameters after dosing of trial product
measure: ROTEM® (Thromboelastometry) parameters after dosing of trial product
Secondary outcomes:
measure: TEG® parameters obtained from blood samples spiked ex vivo with activated recombinant human factor VII
measure: ROTEM® parameters obtained from blood samples spiked ex vivo with activated recombinant human factor VII
measure: Serious adverse events and non-serious adverse events
Other outcomes:
Locations:
city: Lille
country: France
city: München
country: Germany
city: Tel Hashomer
country: Israel
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT02553057: Low Tidal Volume for Lung Protection During Anesthesia of Laparoscopic Surgery in Trendlenburg Position
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intraoperative Mechanical Ventilation
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2015-09-17
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Mechanical ventilation of patients undergoing laparoscopic surgery may induce lung injury. Since lung protective ventilation has been recommended during anesthesia to prevent ongoing lung injury, so in our study the investigators will compare three different lung protective strategies regarding their lung protective effect measured by the incidence of postoperative pulmonary complications, perioperative oxygenation and postoperative inflammatory mediator release.


Eligibility criteria: Inclusion Criteria:

* all patients undergoing laparoscopic colorectal or gynaecologic surgery with expected time more than two hours

Exclusion Criteria:

* refusal, preoperative pulmonary disease

Primary outcomes:
measure: postoperative pulmonary complications
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura university
state: Dkahleya
Study officials:
References:
Clinical trial NCT03100357: Changes in Esophageal Motility and Swallowing Symptoms After Thyroid Surgery
Official title: Changes in Esophageal Motility and Swallowing Symptoms After Thyroid Surgery - a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Esophageal Motility Disorders
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2017-04-04
Enrollment: 39
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with benign nodular goiter

Brief summary: The pronounced effect of goiter on the esophagus needs further exploration, as the mechanisms by which goiter leads to swallowing difficulties are unknown. By investigating esophageal motility using high resolution esophageal manometry before and after thyroidectomy we seek to examine the impact of the goiter mass on the esophagus and swallowing with six months follow-up.


Eligibility criteria: Inclusion Criteria:

* Patients with symptomatic benign nodular goiter referred for thyroidectomy

Exclusion Criteria:

* Previous surgery to the neck;
* Suspicion of thyroid cancer
* Age below 20 years or above 80 years
* Neuromuscular disease.

Primary outcomes:
measure: Motility disturbances
timeFrame: Before and six months following thyroidectomy
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Sorensen JR, Markoew S, Dossing H, Hegedus L, Bonnema SJ, Godballe C. Changes in Swallowing Symptoms and Esophageal Motility After Thyroid Surgery: A Prospective Cohort Study. World J Surg. 2018 Apr;42(4):998-1004. doi: 10.1007/s00268-017-4247-5.
Clinical trial NCT02092857: Assessment of Arachidonic Acid Supplementation in Infant Formula on the Immune Response of Infants
Official title: Assessment of Arachidonic Acid Supplementation in Infant Formula on the Immune Response of Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Focus: Nutritional Requirements for Infants
Keywords: nutrient
nutrition
arachidonic acid
essential fatty acids
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Mead Johnson Nutrition
First posted: 2014-03-20
Enrollment: 89
Sex: ALL
Minimum age (years): 14
Maximum age (years): 21
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The immune system of newborn infants is immature with low activity of both innate and acquired immune reactions. Early nutrition has an impact on early immune responses. Dietary fatty acids are one nutritional factor noted to play a role in immune function. The omega-6 long-chain polyunsaturated fatty acid, ARA (Arachidonic acid) and the omega-3 fatty acid, DHA (docosahexaenoic acid) are found naturally in breastmilk and some infant formulas. The balance or relative amounts of ARA and DHA have been associated with immune response. Some commercial infant formula contains both ARA and DHA. However, the optimal balance of ARA and DHA has not been determined with respect to immune function. This study will assess two levels of ARA and the impact on immune response in healthy, term infants and whether genes that influence essential fatty acid metabolism alter the nutritional requirement of infants.


Eligibility criteria: Inclusion criteria:

* healthy term infants
* birth weight, length and head circumference between the 5th and 95th percentile for gestational age (according to the National Center for Health Statistics growth charts)
* receiving \>80% for their intake by mouth from commercial infant formula
* low-risk for allergy based on a negative family history.

Exclusion criteria:

* corticosteroid use
* red cell or plasma transfusions
* IV lipid emulsions prior to study entry
* major congenital malformations
* systemic or congenital infection
* significant neonatal morbidity
* maternal autoimmune disorders
* acute illness precluding oral feedings or conditions requiring feedings other than standard formula

Primary outcomes:
measure: Number of Antigen-presenting B Cells
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
Study officials:
affiliation: University of Alberta
name: Michael T Clandinin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01897857: Influence of DM on Artery Blood Flow and Complications After Radial Artery Cannulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
Keywords: diabetes mellitus(DM)
radial artery cannulation
artery blood flow
complication
End stage renal disease undergoing kidney transplantation
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-07-12
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In atherosclerotic patients undergoing kidney transplantation, arterial cannulation is commonly performed for continuous monitoring of systemic blood pressure and intermittent assessment of arterial blood gases. The radial artery is the preferred artery, because of its well-documented low complication rate and easy access, but, radial artery cannulation is may associated with complications. Atherosclerosis is a systemic phenomenon, and structural changes attributable to atherosclerosis, such as luminal narrowing, intimal hyperplasia, and reduction in distensibility occur frequently throughout the arterial tree. Especially in patients with diabetes mellitus (DM), the radial artery is prone to atherosclerosis and perhaps calcification. In a recent study, it was found that the radial artery flow was decreased immediately after cannulation, but recovered to its pre-cannulation value after 5min, whereas a compensatory increase of blood flow in the ulnar artery occured immediately after cannulation, persisting until 5 min. This study enrolled the patients of ASA physical status 1-2. In the patients scheduled for elective kidney transplantation, this compensatory increase of blood flow in the ulnar artery may not be occurred, because of atherosclerosis, particularly in patients with DM. In our study, we found whether there is appropriate compensatory increase of blood flow in the ulnar artery after the radial artery cannulation in two groups, patients with DM (group DM) or without DM (group nonDM), both undergoing elective kidney transplantation.


Eligibility criteria: Inclusion Criteria:

* age \> 20yrs undergoing kidney transplantation
* ASA physical status ≥ 3
* patients with DM (DM group), patients without DM (nonDM group)

Exclusion Criteria:

* coagulopathy
* inflammation or infection at the puncture site for cannulation
* a positive result on the modified Allen's test
* the cannulation failed twice
* Acute renal allograft rejection

Primary outcomes:
measure: the compensatory changes in ulnar artery blood flow after radial artery cannulation
timeFrame: Change from Baseline in ulnar artery blood before anesthesia, before cannulation, 5 min after cannultion, 20 min after removal of the arterial catheter, 24 hous after cannulation
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine
Study officials:
References:
Clinical trial NCT05484557: Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury
Official title: Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Spinal Diseases
Lead sponsor: Loewenstein Hospital
Sponsor class: OTHER
First posted: 2022-08-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Currently, Enoxaparin is the usual prophylactic anticoagulant treatment at the acute and sub-acute phases of spinal cord injury (SCI). Patients at the sub-acute phase of SCI (rehabilitation) will be given either Enoxaparin 40 mg/day (control) or Apixaban 2.5-5 mg twice a day. Apixaban dose will be determined by the treating physician. Treatment will be continued for either 6 or 12 weeks following injury (for AIS grades C-D and A-B respectively).

Endpoints: Venous thromboembolism will be evaluated by D-Dimer test every 2 weeks and an ultrasound doppler at the beginning and the end of the treatment. Bleeding events will be recorded and hematocrit will be monitored every two weeks.


Eligibility criteria: Inclusion Criteria:

* spinal cord injury (traumatic of not traumatic), Hebrew speaker.

Exclusion Criteria:

* contra-indication for anticoagulant treatment
* concomitant treatment with any other anticoagulant
* anticoagulant treatment needed for indications other than VTE prevention following spinal cord injury
* active clinically significant bleeding
* any lesion or condition considered a significant risk factor for major bleeding.
* hepatic disease associated with coagulopathy and clinically relevant bleeding risk
* pregnancy or breast-feeding
* heart valve related issues
* galactose intolerance
* active cancer
* patients who require thrombolysis or pulmonary embolectomy
* patients with renal impairment
* sensitivity to excipients of the medication
* anti phospholipid syndrome
* prosthetic heart valve
* acute ischemic stroke

Primary outcomes:
measure: Number of participants with venous thromboembolism (VTE)
timeFrame: 2 years
Secondary outcomes:
measure: Number of participants with bleeding events.
timeFrame: 6 to 12 weeks
Other outcomes:
Locations:
city: Ra'anana
country: Israel
facility: Loewenstein Rehabilitation Hospital
Study officials:
References:
Clinical trial NCT01533857: Pharmacokinetic Behavior of Phenolic Acids Derived From Black Tea
Official title: Pharmacokinetic Behavior of Phenolic Acids Derived From Black Tea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Black tea
phenolic acids
Lead sponsor: Unilever R&D
Sponsor class: INDUSTRY
First posted: 2012-02-15
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is set up to determine pharmacokinetics of phenolic acids after a single oral dose to healthy males.


Eligibility criteria: Inclusion Criteria:

* healthy males
* not smoking

Exclusion Criteria:

* use of NSAIDS and/or antibiotics
* no blood donation 1 months prior to screening

Primary outcomes:
measure: Plasma concentrations of selected phenolic acids
timeFrame: up to 30 hrs
Secondary outcomes:
measure: plasma concentration of selected flavonoid metabolites
timeFrame: up to 30 hrs
measure: Identification of unknown phenolic acids (metabolites of black tea) in plasma
timeFrame: up to 30 hrs
Other outcomes:
Locations:
city: Gieres
country: France
facility: Optimed Eurofins
Study officials:
affiliation: Eurofins Optimed
name: Yves Donazzolo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van Duynhoven J, van der Hooft JJ, van Dorsten FA, Peters S, Foltz M, Gomez-Roldan V, Vervoort J, de Vos RC, Jacobs DM. Rapid and sustained systemic circulation of conjugated gut microbial catabolites after single-dose black tea extract consumption. J Proteome Res. 2014 May 2;13(5):2668-78. doi: 10.1021/pr5001253. Epub 2014 Apr 10.
Clinical trial NCT02382757: Changing Diabetes in Children
Official title: Changing Diabetes in Children (CDiC): Type 1 Diabetes in Economically Underprivileged Children in India
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2015-03-09
Enrollment: 3089
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children with type 1 diabetes aged below 18 years will be included.

Brief summary: This study is conducted in Asia. The primary objective of the CDiC programme is to improve access to comprehensive diabetes care among the children with diabetes from the economically underprivileged section of the population and to establish a registry for this group of children with type 1 diabetes in India.


Eligibility criteria: Inclusion Criteria:

* Children diagnosed with type 1 diabetes
* Parents/caretakers agree to participate in the study
* Child belongs to the below poverty line economic strata (Centre Director certifies economic status for inclusion in to the study)

Exclusion Criteria:

* Children with type 2 diabetes
* Children from higher economic status
* Those getting coverage under other government / private schemes

Primary outcomes:
measure: Patient assessments: Number of days on insulin
timeFrame: After 40 months
measure: Number of days with home blood glucose monitoring
timeFrame: After 40 months
measure: HbA1c (glycosylated haemoglobin)
timeFrame: After 40 months
measure: Number of episodes of ketoacidosis
timeFrame: After 40 months
measure: Number of episodes of severe hypoglycaemia
timeFrame: After 40 months
measure: Long-term complications
timeFrame: After 40 months
Secondary outcomes:
measure: Percentage of children with HbA1c equal to or below 8.0
timeFrame: After 40 months
measure: Percentage of children who died during the study
timeFrame: After 40 months
measure: Percentage of children lost to follow-up
timeFrame: After 40 months
Other outcomes:
Locations:
city: Bangalore
country: India
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: