louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01461603: Local Effects of Amino Acids and 3-hydroxybutyrate in the Bilaterally Perfused Human Leg
Official title: Local Effects of Amino Acids and 3-hydroxybutyrate in the Bilaterally Perfused Human Leg
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Critical Illness
Protein Metabolism
Pharmaconutrients
Keywords: critical illness
protein metabolism
pharmaconutrients
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2011-10-28
Enrollment: 10
Sex: MALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Introduction: Protein loss during critical illness is an important problem and is shown to predict overall survival. In animal studies, infusion of leucine is shown to increase the synthesis of muscle protein by 30-40% and decrease protein degradation by 30%.

Objectives: Compared to saline, an amino acid or 3hydroxybutyrate infusion in the femoral artery will promote protein synthesis and inhibit breakdown assessed with local a/v phenylalanine and tyrosine tracer kinetics in healthy volunteers. These effects will include distinct alterations in muscle signal events, in particular mTOR.

Methods: n = 10 healthy male subjects are equipped with catheters in aa. femorals and vv. femorals bilaterally under local anaesthetics. Each study comprises a 3-hour basal period and a 3-hour period with hyperinsulinaemic-euglycaemic clamp. During the test, samples of arterial and venous blood and 4 muscle biopsies are obtained. The intervention contain continues saline infusion compared to either amino acids (Vamin) or 3hydroxybutyrate solution FFa-3OHB.

Perspectives: This study elucidates the direct effect of aminoacids and ketone bodies on muscle protein metabolism in humans and contribute to further development of nutritional therapy in human catabolic states.


Eligibility criteria: Inclusion Criteria:

* BMI between 19 and 28
* Written consent before study start

Exclusion Criteria:

* Diabetes
* Inclusion in other studies using ionizing radiation.
* Allergic to egg or soy

Primary outcomes:
measure: Changes in muscle metabolism after administration of amino acids.
timeFrame: Basal period and a glucose clamp (6 hours pr.day)
Secondary outcomes:
measure: Intracellular mTOR and pAkt signal activation after infusion of amino acids.
timeFrame: Basal period and a glucose clamp (6 hours pr. day)
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: M-researchlab. MEA, Aarhus University Hospital, NBG
Study officials:
affiliation: University of Aarhus
name: Niels Møller, Professor, Dr.Med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00555503: Registry of Mastectomy for Breast Cancer Risk Reduction
Official title: Registry of Mastectomy for Breast Cancer Risk Reduction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Life
Mastectomy
Breast Neoplasms
Genetic Predisposition to Disease
Adjustment Disorder
Keywords: prospective study
registry
quality of life
mastectomy
reconstructive surgical procedures
BrCa1
BrCa2
breast cancer prevention
Lead sponsor: Georgetown University
Sponsor class: OTHER
First posted: 2007-11-08
Enrollment: 261
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients are enrolled from the plastic surgery, breast surgery, or oncology clinics at Georgetown University Hospital who are at elevated risk for breast cancer. Please note that the Registry can only enroll Georgetown University Hospital patients.

Brief summary: This is a registry for patients who have a risk-reduction mastectomy ("prophylactic mastectomy") due to being at high risk for developing breast cancer, followed by breast reconstruction. Eligible patients include those who have a breast cancer-related gene, a strong family history of breast cancer, or a personal history of high-risk conditions such as cancer in the other breast or ductal carcinoma in situ (DCIS). Patients are enrolled in the registry before surgery, and are followed for up to ten years afterwards. In addition to studying medical outcomes, we will periodically survey patients for quality-of-life issues and psychological well-being. There is no compensation for being enrolled in this registry. This registry is conducted through the Department of Plastic Surgery at Georgetown University Hospital, and is a sub-registry to the Fisher Familial Cancer Registry at the Lombardi Comprehensive Cancer Center at Georgetown University.


Eligibility criteria: Inclusion Criteria:

* Patients at an elevated risk for breast cancer.

Exclusion Criteria:

* None.

Primary outcomes:
measure: The primary study endpoint is the quality of life of the individual patient at the end of one year. Quality of life is measured using standardized self-report instruments administered preoperatively and in annual follow-up.
timeFrame: 10 years
Secondary outcomes:
measure: Cancer occurrence, adverse effects, imaging findings, and survival are all secondary outcomes that we will be following.
timeFrame: 10 years
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University Hospital
state: District of Columbia
Study officials:
affiliation: Georgetown University Hospital
name: Scott L. Spear, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01527903: A Comparison Between Propofol-Remifentanil and Midazolam-Remifentanil Sedation in the Intensive Care Unit
Official title: Sedation of Surgical Patients in the Intensive Care Unit: A Randomized Comparison Between Propofol-Remifentanil and Midazolam-Remifentanil Sedation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sedation
Keywords: propofol
midazolam
sedation
ICU
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2012-02-07
Enrollment: 77
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: The purpose of this study is to compare propofol-remifentanil sedation with midazolam-remifentanil sedation in regards to extubation and weaning time, length of stay in the ICU, as well as the incidence of delirium. Primary end-points were weaning time and extubation time, and secondary end-points were the incidence of delirium and length of stay in the ICU.

Detailed description: With on-going emphasis on early extubation, as well as further recognition of morbidity and mortality associated with delirium, the specific sedatives and analgesics used in the ICU is an issue of interest. Recent studies have focused on comparing sedatives, but interpretations are often confounded by the fact that in most studies, different analgesics were used when comparing two sedative medications. The role of remifentanil as the main analgesic in the ICU is being recognized. Pharmacodynamic and pharmacokinetic profiles of remifentanil makes it an ideal analgesic in the ICU setting. The investigators therefore designed this randomized study to compare sedation with propofol and midazolam in a remifentanil-based sedation and analgesia.

The purpose of this study is to compare propofol-remifentanil sedation with midazolam-remifentanil sedation in regards to extubation and weaning time, length of stay in the ICU, as well as the incidence of delirium. Primary end-points were weaning time and extubation time, and secondary end-points were the incidence of delirium and length of stay in the ICU.

Eligibility criteria: Inclusion Criteria:

* surgical patients over 18 years old who were admitted to the ICU for postoperative ventilator care after sevoflurane-remifentanil based general anesthesia

Exclusion Criteria:

* pre-existing neurologic dysfunction (dementia)
* head trauma patients
* previous history of alcohol abuse or substance abuse
* patients who had baseline serum creatinin levels of over 2.5mg/100ml
* uncompensated liver cirrhosis
* hemorrhagic, cardiogenic, or septic shock
* pregnancy or breast feeding
* tracheostomy or extubation before ICU admission.

Primary outcomes:
measure: Extubation time
timeFrame: monitored from dicontinuation of sedatives to extubation, during an expected average of 3 hours
Secondary outcomes:
measure: delirium
timeFrame: monitored during the entire ICU stay (an expected average of 6 days)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
Clinical trial NCT04108403: Mechanisms of Massage
Official title: Mechanisms of Massage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Pain
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2019-09-30
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators have previously found moderately painful massage produces comparable changes in pain sensitivity as a conditioned pain modulation paradigm in healthy participants suggesting shared underlying mechanisms. The researchers aim to extend these findings by understanding the influence of expectation on these findings.

Detailed description: Massage is a muscle biased intervention individuals seek for pain alleviation; however, the mechanisms of massage are not well established. In this study, the investigators aim to determine the effect of expectations on massage related hypoalgesia. Individuals meeting eligibility criteria and agreeing to participate will attend one session that lasts approximately one hour. A myofascial trigger point (taut band of muscle tissue) will be assessed on the neck of the participant. Next, a baseline assessment of pressure pain threshold will be performed followed by random assignment to one of four study arms.

Eligibility criteria: Inclusion Criteria:

* Pain Free

Exclusion Criteria:

* non-English speaking
* systemic medical condition known to affect sensation (i.e. diabetes)
* regular use of prescription pain medication to manage pain
* current or history of chronic pain condition
* currently using blood thinning medication
* any blood clotting disorder such as hemophilia

Primary outcomes:
measure: Pressure Pain Threshold
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health
state: Florida
Study officials:
affiliation: University of Florida
name: Joel Bialosky, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00842803: Post-Operative Use of Salt Poor Albumin Solution in Resuscitation of Orthotopic Liver Transplant
Official title: Post-Operative Use of Salt Poor Albumin Solution in Resuscitation of Orthotopic Liver Transplant Recipients Status 1-2. A Prospective Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Transplantation
Keywords: Liver
transplant
albumin
outcome
Liver transplant recipients canadian transplant status 1 or 2
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2009-02-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to examine if outcome after liver transplantation is improved by using albumin infusion post-transplantation.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Canadian Transplant status 1 or 2
* Patients at the Royal Victoria Hospital, Montreal, Canada

Exclusion Criteria:

* Emergency liver transplant (canadian transplant status 3 or 4)
* patients who have received more than 300cc of albumin within 48 hours prior to transplant
* patients who underwent previous solid organ transplant
* multi-organs transplant recipients
* patients who had previous adverse reaction to human albumin solution
* patients who have religious restriction to receiving human blood products.
* patients or surrogate unable to give consent to the study

Primary outcomes:
measure: Post Transplant Liver Function Test (PTLFT)
timeFrame: Post-operative Day1 through 7 and Day 15,30, 45
Secondary outcomes:
measure: Functional 6 minutes walking test
timeFrame: Post-operative
measure: Calculated creatinine clearance
timeFrame: Post-operative day 1, 7, 15, 30, 45
measure: Length of hospital stay
timeFrame: post-operative
measure: ICU length of stay
timeFrame: post-operative
measure: duration of mechanical ventilation
timeFrame: post-operative
measure: duration of renal replacement therapy
timeFrame: postoperative
measure: ICU readmission rate
timeFrame: post-operative
measure: reintubation rate
timeFrame: post-operative
measure: Post-operative infection rate
timeFrame: Post-operative
measure: Need to re-operation unrelated to technical complication
timeFrame: post-operative
measure: Functional hand grip Jamar Dynamometer hand grip test
timeFrame: Post-op day 7, 15, 30
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Royal Victoria Hospital
state: Quebec
Study officials:
References:
Clinical trial NCT01865890: Prevalence of Clopidogrel (Plavix) Resistance in Hemodialysis Patients
Official title: Prevalence of Clopidogrel (Plavix) Resistance in Hemodialysis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Disease
Keywords: Plavix or clopidogrel resistance
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: Staten Island University Hospital
First posted: 2013-05-31
Enrollment: 100
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: Hemodialysis patients who are taking plavix daily

Brief summary: The investigators are trying to find out if Clopidogrel (Plavix) is as effective in hemodialysis patients as in patients not hemodialysed.

Detailed description: Cardiovascular disease is very frequent in hemodialysis patients. Lot of hemodialysis patients are on Clopidogrel (plavix). Their is some evidence that clopidogrel is not effective in hemodialysis as it is effective in patient without kidney problem.

VerifyNow plavix is a machine that measure the ability of the blood to clot after giving plavix.

We will collect blood from hemodialysis patients on plavix and check the ability of their blood to clot and thus indirectly measuring the efficacy of Plavix.

Eligibility criteria: Inclusion Criteria:

* All patients on hemodialysis taking Plavix

Exclusion Criteria:

* known to have bleeding disorder
* Severely anemic with hemoglobin level (Hb) \< 10g/dl
* Low Platelets \< 10000

Primary outcomes:
measure: Prevalence Of Plavix resistance
timeFrame: 1 day ( one study visit)
Secondary outcomes:
measure: assess the risk factors for plavix resistance in the hemodialysis population
timeFrame: 1 day (one study visit)
Other outcomes:
Locations:
city: Staten Island
country: United States
facility: Staten Island University Hospital
state: New York
Study officials:
affiliation: Staten Island University Hospital
name: Suzanne El-Sayegh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04716790: Comparison Between the Effect of Ultrasound Debridement and Conventional Treatment in Diabetic Foot Ulcers (DFU).
Official title: Randomized Clinical Trial to Elucidate the Effects of Low Frequency Ultrasound Debridement (LFU), in Patients With Diabetic Foot Ulcers, Compared to Its Conventional Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Foot Ulcer
Keywords: Diabetic Foot
Diabetic Foot Ulcer
Ultrasound Debridement
Ultrasonic Debridement
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
Collaborators: name: Yolanda García Álvarez
name: Francisco Javier Álvaro Afonso
First posted: 2021-01-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized and controlled parallel clinical trial
Primary purpose: TREATMENT

Brief summary: The investigators aimed to elucidate the effects of ultrasound debridement on the area and healing of diabetic foot ulcers compared to their conventional treatment.


Eligibility criteria: Inclusion Criteria:

* Male and female patients ≥18 years old.
* Type 1 or type 2 diabetes mellitus with HbA1c ≤ 10%.
* DFU grades IA, IIA, IB, IIB, IC, IIC, ID, IID, according to the University of Texas Classification.
* DFU grades PEDIS 1-Absence of Infection, PEDIS 2-Mild infection and PEDIS 3-Moderate infection, according to the PEDIS-IDSA Classification.
* Wound size between 1 cm² and 30 cm².
* Evolution time DFU between 1 and 24 months.
* Ankle-brachial index (ABI) ≤0.9 and ankle systolic blood pressure (ASBP) ≥70mmHg, or toe systolic blood pressure (TSBP) ≥50mmHg, ABI\>0.9, TSBP ≥50mmHg and toe-brachial index (TBI) ≤0.7

Exclusion Criteria:

* Critical limb ischemia patients with ABI≤0.5 and ASBP\<70mmHg or TSBP\<50mmHg.
* Clinical suspicion of osteomyelitis.
* Pregnant or lactating women or women of childbearing potential who are not using effective contraception.
* Patients diagnosed with hepatitis or human immunodeficiency virus (HIV)

Primary outcomes:
measure: Healing Rate
timeFrame: 12 weeks
measure: Healing Time
timeFrame: 12 weeks
measure: Wound Size
timeFrame: 12 weeks
Secondary outcomes:
measure: Wound Conditions
timeFrame: 12 weeks
measure: Transcutaneous oxygen pressure (TcPO2)
timeFrame: baseline and week 7
measure: Pain intensity
timeFrame: 12 weeks
measure: Health-related quality of life
timeFrame: baseline and 12 week
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Complutense University
Study officials:
affiliation: Universidad Complutense de Madrid
name: Yolanda García Álvarez
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06554990: Sensory Perceptual Training on Activities of Daily Living and Hand Functions
Official title: Effect of Sensory-Perceptual Motor Training on Activities of Daily Living and Hand Functions in Unilateral Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy, Spastic
Lead sponsor: Badr University
Sponsor class: OTHER
First posted: 2024-08-15
Enrollment: 52
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Many risk factors can come to the fore in CP. With the new studies on CP, new risk factors are defined and existing risks are better understood. In the light of current information, general risk factors for CP are defined as premature birth, fetal growth restriction, multiple pregnancies, infections in the fetal or neonatal period, birth asphyxia, perinatal stroke, and congenital developmental disorders In addition, related risk factors are classified as prenatal, perinatal and postnatal

Detailed description: Children and youth with cerebral palsy face unique challenges when learning, practicing, and mastering activities of daily living (ADLs). Active participation in dressing, feeding, toileting, clothing management, and small space mobility is influenced by body structures and function and environmental and personal factors

Eligibility criteria: Inclusion Criteria:

* Modified Ashworth 1 and 1 +
* GMFCS level I and II
* Able to understand and follow instructions

Exclusion Criteria:

* fixed contracture or deformities in the spine or extremities
* visual or respiratory Problems,
* orthopedic surgery

Primary outcomes:
measure: Katz Index
timeFrame: pre and post treatment for 12 weeks
Secondary outcomes:
measure: Jebsen Taylor Hand Function Test
timeFrame: pre and post treatment for 12 weeks
measure: box and block test
timeFrame: pre and post treatment for 12 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Badr UNIVERSITY and Cairo University
city: Cairo
country: Egypt
facility: BADR
Study officials:
affiliation: Associate professor
name: Hanaa mohsen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06900790: Management of Pediatric Pancreatic Calculi At a Single Center: a Retrospective Cohort Study
Official title: A Single-Center Retrospective Cohort Study Evaluating the Management and Outcomes of Pediatric Pancreatic Duct Stones Using Endoscopic and Surgical Techniques
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pancreatic Duct Stenting
ERCP
Surgery in Early Childhood
Pediatric Surgery
Keywords: pancreatic duct stones
ERCP
Frey surgery
Lead sponsor: West China Second University Hospital
Sponsor class: OTHER
First posted: 2025-03-28
Enrollment: 60
Sex: ALL
Minimum age (years): 2
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: Children and adolescents (≤18 years old) diagnosed with pancreatic duct stones between 2015 and 2025 at a single tertiary care center. Data includes patients who underwent ERCP or surgery when the first treatment.

Brief summary: The goal of this observational study is to evaluate the long-term effects of ERCP and surgery in pediatric patients with pancreatic duct stones. The main objective is to determine the optimal treatment choice(ERCP or surgery) for children with pancreatic duct stones and identify the appropriate timing for surgery in patients who have undergone multiple ERCP procedures, in order to avoid adverse outcomes caused by repeated trauma to the duodenal papilla.

Last updated on January 24, 2025.


Eligibility criteria: Inclusion Criteria:

* Patients aged 0 to 18 years
* Diagnosed with pancreatic duct stones by imaging (e.g., ultrasound, CT, MRCP)
* Treated and followed at pediatric surgery, west china hospital, between 2014 and 2025
* Complete clinical data available for review

Exclusion Criteria:

* Pancreatic duct stones secondary to previous pancreatic or biliary surgery
* Concurrent severe systemic diseases (e.g., advanced cardiac, renal, or hepatic disease)
* Incomplete or missing key clinical records

Primary outcomes:
measure: stone clearance
timeFrame: From intervention to the end of treatment at 1 week
measure: complication rate
timeFrame: From enrollment to the end of treatment at 2 weeks
measure: reintervention rate
timeFrame: From enrollment to the end of treatment at 1 year.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: