louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06366230: Adding Urea to the Final Dialysis Fluid
Official title: Adding Urea to the Final Dialysis Fluid in Order to Prevent Dialysis Disequilibrium in Patients Who Need Aggressive Dialysis for Electrolyte Abnormalities
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Dysequilibrium Syndrome
ESRD
Hyperkalemia
Metabolic Acidosis
Keywords: ESRD
Urea
Disequilibrium
Potassium
Acid/base
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2024-04-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: At times patients with advanced renal failure present with severe hyperkalemia or acidosis and very high serum blood urea nitrogen (BUN) concentrations. These patients cannot be dialyzed aggressively as the lowering of serum BUN may results in disequilibrium syndrome but on the other hand they need aggressive dialysis in order to lower their serum potassium or fix their severe acidosis. If one is able to add urea to the dialysis fluid, one can prevent the rapid lowering of serum BUN and osmolality at the same time as doing aggressive dialysis to lower serum potassium and/or fix the metabolic acidosis.

Detailed description: Ure-Na 15 gram tablets would be used to add to the dialysis fluid How much urea to add would be a simple calculation based on the 45X dialysis system and the patients serum urea concentration. The dialysate fluid urea concentration would be made to be about 15-40 mg/dL lower than the serum concentration. The patients labs/vitals and symptoms would be closely monitored throughout the dialysis treatment.

Eligibility criteria: Inclusion Criteria:

* Serum Urea \> 120
* Serum Potassium \> 5.5 or serum CO2 \< 15 or need for aggressive dialysis due to toxic ingestion
* need for dialysis

Exclusion Criteria:

* Pediatric
* need for CRRT

Primary outcomes:
measure: Disequilibrium
timeFrame: within 24 hours after starting dialysis
measure: Serum potassium concentration
timeFrame: Potassium levels every 6 hours for 24 hours after end of dialysis
measure: Serum CO2 concentration
timeFrame: Serum CO2 levels every 6 hours for 24 hours after end of dialysis
Secondary outcomes:
measure: Serum BUN concentration
timeFrame: Serum BUN concentration twice a day for 3 days
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Zuckerberg San Francisco General Hospital
state: California
Study officials:
affiliation: Zuckerberg San Francisco General- UCSF
name: Ramin Sam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00834730: Comparison of N2O Inhalation and Ketamine in Pediatric PSA
Official title: Comparison of N2O Inhalation and Ketamine IV Injection for Sedation in the Treatment of Laceration of Pediatric Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Moderate Sedation
Laceration
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2009-02-03
Enrollment: 32
Sex: ALL
Minimum age (years): 36
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: * Ketamine provides effective and relatively safe sedation analgesia for primary closure of lacerated pediatric patients
* However, deep sedation and adverse effects suggest the opportunity to develop alternative strategies
* We compared the efficacy and adverse effects of ketamine to those of N2O gas for analgesia and anxiolysis during primary repair of lacerated pediatric patients

Detailed description: * There were 32 children who were randomly assigned
* Recovery times were markedly shorter in the N2O group compared with those in the ketamine group (median, 0.0 min (interquartile range \[IQR\], 0.0-4.0 min) vs. median, 21.5 min (IQR, 12.5-37.5 min), N2O vs. ketamine, respectively, p \< 0.05)
* Sedation levels were deeper in the ketamine group than in the N2O group, but pain scales were comparable between groups
* No difference was observed in the satisfaction scores by physicians, parents, or nurses.
* N2O inhalation was preferable to injectable ketamine for pediatric patients because it is safe, allows for a faster recovery, maintains sufficient sedation time, and does not induce unnecessarily deep sedation

Eligibility criteria: Inclusion Criteria:

* Pediatric patients with lacerated wound

Exclusion Criteria:

* Contraindication of ketamine or N2O gas
* A wound around eye and mouth

Primary outcomes:
measure: The recovery time (from completion of laceration repair to recovery of mental state)
timeFrame: before discharge
Secondary outcomes:
measure: Sedation scale
timeFrame: before discharge
measure: pain scale
timeFrame: before discharge
measure: Side effects
timeFrame: during procedure and bedore discharge and 1day after discharge
measure: Satisfaction of parents and clinicians
timeFrame: before discharge
Other outcomes:
Locations:
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Jin Hee Lee, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee JH, Kim K, Kim TY, Jo YH, Kim SH, Rhee JE, Heo CY, Eun SC. A randomized comparison of nitrous oxide versus intravenous ketamine for laceration repair in children. Pediatr Emerg Care. 2012 Dec;28(12):1297-301. doi: 10.1097/PEC.0b013e3182768a86.
Clinical trial NCT02007330: The Effect of Systemic Lidocaine Infusion to Postoperative Pain and Quality of Recovery After Laparoscopic Hernia Repair in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inguinal Hernia
Keywords: systemic lidocaine
postoperative pain
recovery, pediatric
inguinal hernia
laparoscopy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-12-10
Enrollment: 66
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Systemic lidocaine administration may improve postoperative pain and recovery after laparoscopic inguinal hernia repair in pediatric patients


Eligibility criteria: Inclusion Criteria:

* Age between 1 and 6 year-old
* ASA class 1 and 2
* Pediatric Inguinal hernia patients who are scheduled for elective laparoscopic inguinal hernia repair

Exclusion Criteria:

* Allergy to local anesthetics or contraindication to use of lidocaine
* Current active upper respiratory infection or history of upper respiratory infection within 2 weeks
* Severe cardiovascular disease
* Renal failure
* Liver failure
* Neurologic and psychologic disease
* Chronic treatment with analgesics
* Previous history of laparoscopic operation
* Parents' refusal

Primary outcomes:
measure: Assessing postoperative pain
timeFrame: 24 hours after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
Study officials:
References:
Clinical trial NCT05375630: Vitamin K2 and Muscle Weakness in Type 2 Diabetes
Official title: Effects Vitamin K2 on Muscle Mass and Function in People With Muscle Weakness and Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabete Type 2
Lead sponsor: Dasman Diabetes Institute
Sponsor class: OTHER
Collaborators: name: Kappa Bioscience
First posted: 2022-05-16
Enrollment: 150
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Group Randomised Controlled Trial
Primary purpose: TREATMENT

Brief summary: The aim of the current study is to determine the effects of vitamin K2 supplementation on muscle size and function in adults with muscle weakness and type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Physician confirmed type 2 diabetes.
* Age \>/= 40 years
* No changes in anti-diabetic medication in the last 3 months.
* Muscle weakness (grip strength \<27kg and females \<16kg)

Exclusion Criteria:

* BMI of 45 or higher
* BP of 160/100mmHg or higher
* Cancer or cancer that has been in remission \<5 years
* Any medical condition that prevents participants from exercising safely
* On anticoagulant therapy
* Currently consuming vitamin K2 supplements
* Current smoker

Primary outcomes:
measure: Grip Strength
timeFrame: Baseline to one year
Secondary outcomes:
measure: SPPB
timeFrame: Baseline to one year
measure: HbA1c
timeFrame: Baseline to one year
measure: Blood Pressure
timeFrame: Baseline to one year
measure: Body Mass
timeFrame: Baseline to one year
measure: Lean Mass
timeFrame: Baseline to one year
measure: Body Fat
timeFrame: Baseline to one year
measure: BMC
timeFrame: Baseline to one year
measure: BMD
timeFrame: Baseline to one year
measure: Vitamin K status
timeFrame: Baseline to one year
Other outcomes:
Locations:
city: Kuwait City
country: Kuwait
facility: Dasman Diabetes Institute
Study officials:
affiliation: Dasman Diabetes Institute
name: Ebaa AlOzairi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02563730: Open Label Trial of Utility of Cryobiopsy in the Multidisciplinary Diagnosis of Idiopathic Interstitial Lung Disease
Official title: Open Label Trial of Utility of Cryobiopsy in the Multidisciplinary Diagnosis of Idiopathic Interstitial Lung Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Interstitial Lung Disease
Keywords: Cryobiopsy
lung biopsy
interstitial lung disease
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2015-09-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A multicenter, multinational, prospective study to clarify, whether the addition of cryobiopsy can avoid surgical lung biopsy in a clinically relevant proportion of patients with suspected Idiopathic Interstitial Pneumonia


Eligibility criteria: Inclusion Criteria:

* IIP suspected on clinical and radiologic grounds

Exclusion Criteria:

* Age \>80y and \<18y
* FVC\< 55%, DCO\<35%
* Platelet count \<100000/µl
* acetylsalicylic acid, clopidogrel or equivalent during the last 5 days
* INR \> l,3,
* elevated PTT (\> 40 s)
* documented pulmonary hypertension PAPS \>50mmHg
* HR-CT highly suspicious for sarcoidosis

Primary outcomes:
measure: Percentage of conclusive diagnosis after bronchoscopy with transbronchial cryobiopsy
timeFrame: two weeks
Secondary outcomes:
measure: numer of bleeding events
timeFrame: 1 day
measure: Rate of pneumothoraxes
timeFrame: 1 day
measure: numer of exacerbations after biopsy
timeFrame: 6 weeks
measure: Contribution of BAL and cryobiopsy to diagnosis
timeFrame: 2 weeks
measure: Size of specimen
timeFrame: 2 weeks
measure: Quality of specimen
timeFrame: 2 weeks
measure: Distribution of histological changes in the specimen
timeFrame: 2 weeks
measure: Influence of the size of the cryoprobe in the primary endpoint
timeFrame: 2 weeks
measure: Comparative group (out of trial) - who are referred for VATS directly ['positive control group']
timeFrame: 6 weeks
measure: Rate of exacerbations after cryobiopsy and after surgical biopsy
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Ruhrlandklinik
city: Heidelberg
country: Germany
facility: Thoraxklinik
city: Tuebingen
country: Germany
facility: University Hospital Tuebingen
city: Forlì
country: Italy
facility: Ospedale G.B. Morgagni
city: Barcelona
country: Spain
facility: Respiratory Department Hospital of Santa Creu i Sant Pau
city: London
country: United Kingdom
facility: Royal Brompton Hospital
Study officials:
References:
Clinical trial NCT01935830: LAAM-HAART PET Imaging
Official title: Efavirenz and Ritonavir Influence on Human Brain Levo-acetylmethadol (LAAM) Disposition Assessed Using PET Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy Volunteers
Keywords: PET Imaging
Efavirenz
Ritonavior [11C] LAAM
Healthy volunteers
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2013-09-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine the effects of the antiretroviral drugs efavirenz and ritonavir on human brain LAAM disposition in vivo.


Eligibility criteria: Inclusion

Each subject must meet all of the following criteria:

1. Male or non-pregnant female volunteer, 18-50 yr old
2. Good general health with no known major medical conditions
3. BMI \< 33
4. Provide informed consent

Exclusion Criteria

Subjects will not be enrolled if any of the following criteria exist:

1. Known history of liver or kidney disease
2. History of major medical conditions
3. HIV seropositive
4. Fasting blood glucose \> 110 mg/dl (because HAART can cause glucose intolerance)
5. Family history of type 2 diabetes
6. Use of prescription or non prescription medications, herbals or foods known to be metabolized by or altering P-glycoprotein or CYP3A (hormonal birth control medications are acceptable if alternative means of contraception are used)
7. Females who are pregnant or nursing
8. Females taking hormonal contraceptives who are unwilling to use alternative means of contraception
9. Contraindications to MRI (e.g., metal implants or splinters in the body; a worn or implanted medical device, such as a pacemaker or drug pump; inability to lie flat for up to one hour; claustrophobia) or contraindications to PET scanning (e.g., inability to lie flat for up to one hour, claustrophobia, current
10. Current or recent (within 12 months prior to screening) participation in research studies involving radiation exposure such that the total research-related radiation dose to the subject in any given year would exceed the limits set forth in the US Code of Federal Regulations (CFR) Title 21 Section 361.1 (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=361.1))

Primary outcomes:
measure: cerebral [11C]LAAM distribution volume
timeFrame: approximately 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Evan D Kharasch, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03876730: International Classification of Functioning, Disability and Health and Lower Extremity Orthoses in Cerebral Palsy
Official title: Assessment of the Use of Lower Extremity Orthosis in Children With Cerebral Palsy Within The Scope of International Classification of Functioning, Disability and Health
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Keywords: Cerebral Palsy
Lower Extremity Orthosis
ICF Core Set
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2019-03-15
Enrollment: 75
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The children who will come to the investigator's unit, Cerebral Palsy and Pediatric Rehabilitation

Brief summary: International Classification of Functioning, Disability and Health (ICF) is a coding system developed to describe the health status of individuals in a universal way. The increasingly common core sets are short forms of ICF categories that are specifically selected for diseases. The aim of this study is to investigate the relationship among the lower extremity orthoses commonly used in children with cerebral palsy (CP), body structure and functions, activity and participation level, and is to determine the relationship between clinical tests and ICF CP core set. For this purpose, a total of 75 children with ages between 3 and 18 will be divided into 3 groups, including using a walking orthosis, using a resting orthosis, and using both walking and resting orthoses. Children's muscle tone, joint limitation, gross motor functions, balance skills, activity and participation levels and quality of life will be assessed with the tests frequently used in the clinic separately and with the core set in a holistic framework.


Eligibility criteria: Inclusion Criteria:

* Being 3-18 age years old
* Having the diagnosis with cerebral palsy
* Being no Botulinum Toxin Application or no surgery for the last 6 months

Exclusion Criteria:

* If there is any other neurological or orthopedic problem other than cerebral palsy

Primary outcomes:
measure: Pediatric Berg Balance Scale (PBS)
timeFrame: 3 minutes
measure: Gross Motor Function Measurement (GMFM)-88
timeFrame: 5 minutes
measure: Measurements of range of motions
timeFrame: 5 minutes
measure: Modified Ashworth Scale (MAS)
timeFrame: 5 minutes
measure: Pediatric Quality of Life (PedsQL)
timeFrame: 5 minutes
measure: Pediatric Functional Independence Measurement (WeeFIM)
timeFrame: 5 minutes
Secondary outcomes:
measure: ICF CP Core Set
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
state: Sıhhiye
Study officials:
References:
Clinical trial NCT07009730: Clinical Outcomes Between Pulsatile and Non-Pulsatile Flow During Cardiopulmonary Bypass
Official title: Clinical Outcomes Between Pulsatile and Non-Pulsatile Flow During Cardiopulmonary Bypass
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Surgery
Cardiac Surgery Requiring Cardiopulmonary Bypass
Lead sponsor: Tribhuvan University Teaching Hospital, Institute Of Medicine.
Sponsor class: OTHER
First posted: 2025-06-08
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All Patients undergoing Atrial Septal Defect closure and mitral Valve replacement

Brief summary: The aim of this prospective, randomized study was to compare clinical outcomes of Pulsatile and non-pulsatile flow during Cardiopulmonary Bypass.


Eligibility criteria: Inclusion Criteria:

* patients undergoing Atrial Septal Defect closure and Mitral Valve replacement

Exclusion Criteria:

* • Moderate and severe LVEF
* • Patient with bleeding dysfunction;AKI ;deranged liver dysfunction\\
* • Patient/Surrogate decision maker not giving written informed consent

Primary outcomes:
measure: ICU Length of Stay
timeFrame: 12 months
Secondary outcomes:
measure: Duration of Cardiopulmonary Bypass (CPB)
timeFrame: 12 months
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: Tribhuvan University Teaching Hospital, Institute of Medicine (IOM), Kathmandu, Nepal
Study officials:
References:
Clinical trial NCT04872530: Bioavailability of Plant Protein Amino Acids
Official title: Bioavailability of Amino Acids and Metabolic Products Following Oral Ingestion of Plant-Based Proteins in Young, Healthy Men and Women Aged 18-35y
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bioavailability of Amino Acids Following Oral Ingestion of Plant-Based Proteins in Young, Healthy Men
Keywords: Bioavailability of Amino Acids Following Oral Ingestion of Plant-Based Proteins in Young, Healthy Men
Lead sponsor: University of Limerick
Sponsor class: OTHER
Collaborators: name: Marigot Ltd.
name: Enterprise Ireland
First posted: 2021-05-04
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Subjects who volunteer for this study will undertake SIX controlled feeding trials, each trial separated by 7 days.Subjects will be assigned to a randomised sequence of six protein isolates including: (1) pea-protein concentrate; (2) fava-bean protein concentrate; (3) chickpea protein concentrate; (4) red lentil protein concentrate; (5) non-essential amino acid blend (negative control);( 6) whey protein concentrate. Protein is dosed at 0.33 g/kg body mass in 500 ml of water.
Primary purpose: OTHER

Brief summary: This study aims to inform of the mechanism of action of plant-based protein by measuring the bioavailability (i.e. rate of appearance and magnitude of concentration in the circulation following oral ingestion) of key amino acid and metabolic products that regulate skeletal muscle protein synthesis (MPS) in humans.

Detailed description: Plant-based proteins contain several amino acids that are essential to signal muscle growth/repair and act as a substrate during muscle protein synthesis. However, compared to animal protein or free-amino acids, the bioavailability of certain essential amino acids may be compromised. Following selective processing (e.g. removal of carbohydrate and/or other anti-nutritive factors) food grade plant-based protein concentrates possibly confer greater bioavailability and bioactivity in vivo. This project explores the bioavailability and bioactivity of selected plant-based protein concentrates following oral ingestion in young, healthy men and women.

Eligibility criteria: Inclusion Criteria:

* No known intolerance to any item contained in the protein products.
* No blood borne disease risk, current illness or medication that would adversely affect participation
* No known adverse reaction to venepuncture

Exclusion Criteria:

* n/a

Primary outcomes:
measure: Plasma amino acids
timeFrame: 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Limerick
country: Ireland
facility: Education and Health Sciences
Study officials:
affiliation: University of Limerick
name: Phil Jakeman, PhD
role: PRINCIPAL_INVESTIGATOR
References: