louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04051840: Safely and Efficacy of ClinOleic-based Lipid Parenteral Nutrition
Official title: Safely and Efficacy of ClinOleic-based Lipid Parenteral Nutrition After Pancreatectomy:a Prospective Study of Real World Clinical Research in China
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Nutritional Supplement Toxicity
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2019-08-09
Enrollment: 200
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: TREATMENT

Brief summary: Small studies suggest differences in efficacy and safety exist between olive oil-based and soybean oil-based parenteral nutrition regimens in hospitalized adult patients. A study in China suggested that olive oil-based parenteral nutrition provided effective nutrition, was well tolerated, was associated with fewer infections and conferred greater ease-of-use than soybean oil-based parenteral nutrition. The objectives of this study were to assess safety and efficacy of an ClinOleic-based lipid parenteral nutrition regimen compared with Structolipid-based lipid parenteral nutrition regimen in Chinese adults after pancreatectomy for whom oral or enteral nutrition was not possible, insufficient or contraindicated.


Eligibility criteria: Inclusion Criteria:

* hospitalized ≤14 days before enrolment
* required parenteral nutrition
* had the capability to complete at least five days of study treatment;
* useable peripheral vein for parenteral nutrition;
* written informed consent.

Exclusion Criteria:

* A life expectancy of \<6 days;
* hypersensitivity to the study treatments;
* use of prohibited medications within 30 days before enrolment;
* serious clinically significant condition such as congestive heart failure or severe renal insufficiency;
* impaired hepatic function；
* history of human immunodeficiency virus infection;
* congenital abnormalities of amino acid metabolism;
* severe dyslipidemia;
* clinically significant abnormalities of plasma electrolytes;
* currently pregnant or lactating; prior enrolment in this clinical trial;
* participation in a clinical trial of any investigational drug or device concomitantly or within 30 days before enrolment in this clinical trial;
* unsuitable in the opinion of the Investigator.

Primary outcomes:
measure: biomarkers of liver functions
timeFrame: 48 hours after operation.
Secondary outcomes:
measure: markers of infection and inflammation
timeFrame: 48 hours after operation.
measure: Trenal function
timeFrame: 48 hours after operation.
measure: lipids and lipid upper derivatives
timeFrame: 48 hours after operation.
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
Study officials:
References:
Clinical trial NCT02903940: The Application of Negative Atrioventricular Hysteresis in Cardiac Resynchronization Therapy
Official title: The Application of Negative Atrioventricular Hysteresis in Cardiac Resynchronization Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2016-09-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients already implanted with SJM Quadripolar CRT Pacing Systems will be enrolled in the study

Brief summary: The purpose of this study is to evaluate the application of Negative Atrioventricular Hysteresis (NAVH) to improve electrical synchrony in Cardiac Resynchronization Therapy (CRT) patients.


Eligibility criteria: Inclusion Criteria:

* Implanted with a functioning SJM Quadripolar CRT Pacing System
* QRS duration \> 140 ms
* Left bundle branch block documented
* Ability to provide informed consent for study participation
* Willing to comply with the study evaluation requirements
* At least 18 years of age

Exclusion Criteria:

* CRT Pacing System implanted less than 1 week at time of enrollment
* CRT Pacing System implanted more than 24 months at time of enrollment
* CRT Pacing System implanted more than 90 days at time of enrollment AND intrinsic QRS duration is shorter than pre-implant intrinsic QRS duration by more than 10 ms
* Resting ventricular rate \>100 bpm
* Intrinsic PR interval \> 300 ms
* Paroxysmal or persistent atrial tachycardia or atrial fibrillation documented
* A recent myocardial infarction, ablation, drug intoxication, electrolyte imbalance, or any condition within the last 90 days that would be contraindicated for CRT programming changes in the opinion of the investigator
* Women who are pregnant or who plan to become pregnant during the study

Primary outcomes:
measure: Acute changes in surface ECG QRS duration resulting from Cardiac Resynchronization Therapy with Negative Atrioventricular Hysteresis over a range of programmable values
timeFrame: 1 day
Secondary outcomes:
measure: Ambulatory changes in surface ECG QRS duration resulting from Cardiac Resynchronization Therapy with Negative Atrioventricular Hysteresis
timeFrame: 1 day
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
References:
Clinical trial NCT00722540: Dose Study in Healthy Japanese Males Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083
Official title: Dose Study Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NCC126-0083 in Healthy Male Japanese Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Growth Hormone Disorder
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-07-25
Enrollment: 40
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 Europe. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of a NNC126-0083 in healthy male Japanese subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects with Japanese passport and Japanese born parents
* Body Mass Index (BMI, kg/m2) between 18.0 and 27.0, both inclusive
* Subjects must be in good health according to age

Exclusion Criteria:

* A history or presence of cancer, diabetes, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major diseases
* History of any illnesses or disease that, in the opinion of the Investigator might confound the results of the trial or pose additional risk in administering the trial product to the subject
* Any clinically significant abnormal haematology, biochemistry or urinalysis screening tests, as judged by the Investigator

Primary outcomes:
measure: Safety and tolerability (adverse events, local tolerability, physical examination)
timeFrame: 0 to 10 days after third dosing, (day 15-25 after first dose)
Secondary outcomes:
measure: Cmax, maximum concentration of IGF-I
timeFrame: 7 days after first dosing and 10 days after the third dosing (day 1-25 after first dose)
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Rasmussen MH, Jensen L, Anderson TW, Klitgaard T, Madsen J. Multiple doses of pegylated long-acting growth hormone are well tolerated in healthy male volunteers and possess a potential once-weekly treatment profile. Clin Endocrinol (Oxf). 2010 Dec;73(6):769-76. doi: 10.1111/j.1365-2265.2010.03863.x.
Clinical trial NCT03765840: Study of Postoperative Cognitive Decline in Aged Patients
Official title: Relationship Between Postoperative Cognitive Decline and Cytokines in Elderly Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cognitive Decline
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2018-12-05
Enrollment: 300
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: aged patients who recieve surgery for orthopedic surgery under spinal or general anesthesia

Brief summary: postoperative cognitive decline is a common and deleterious complication in aged patients.The link between inflammation and postoperative cognitive decline has also been reported.However,the link between SOD1，SOD2，Osteopontin， Kallikrein-6，and Contactin-1 and postoperative cognitive decline is unknown. In this project ,investigators examine the relationship between 5 cytokines measured at there timepoints (preoperative \[PREOP\], postoperative day 1 \[POD1\] , and postoperative day 3\[POD2\]) and postoperative cognitive decline among older adults undergoing orthopedic surgery.


Eligibility criteria: Inclusion Criteria:

* patients who are more than 65 years old
* patients who undergo orthopedic surgery(trauma ,especially fracture of lower limb)
* patients with ASA physical status I-III
* patients who have a consent

Exclusion Criteria:

* patients who are more than 85 years old
* patients with ASA physical status \>III
* patients who have neurological disorders, stroke or other affective central nervous system diseases
* patients who have a history of serious psychiatric illness
* patients with long-term use of psychoactive substances
* patients who undergo multiple trauma and the presence of head injury

Primary outcomes:
measure: Differences in cytokines levels between the two groups
timeFrame: preoperation
measure: Differences in cytokines levels between the two groups
timeFrame: 24h after operation
measure: Differences in cytokines levels between the two groups
timeFrame: 72h after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Deartment of anesthesiology,changhai hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT02300740: Pharmacokinetic Analysis of Nicotinamide Riboside
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy Participants
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2014-11-25
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Nicotinamide riboside is a newly discovered vitamin B3. The pharmacokinetics in humans is so far not analyzed.


Eligibility criteria: Inclusion Criteria:

* BMI 18-25, healthy, male,

Exclusion Criteria:

* liver or kidney diseases, other diseases

Primary outcomes:
measure: Serum nicotinamide riboside
timeFrame: 8 hours, blood samples every 15 min
Secondary outcomes:
measure: serum concentrations of metabolites of nicotinamide riboside
timeFrame: 8 hour, blood samples every 15 min
measure: area under the curve for serum nicotinamide riboside
timeFrame: 8 hours, blood samples every 15 min
measure: calculation of halftime of serum nicotinamide riboside
timeFrame: 8 hours, blood samples every 15 min
measure: calculation of C-max of serum nicotinamide riboside
timeFrame: 8 hours, blood samples every 15 min
measure: calculation of t-max of serum nicotinamide riboside
timeFrame: 8 hours, blood samples every 15 min
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Medical Research Laboratories, Aarhus University Hospital
Study officials:
References:
Clinical trial NCT03270540: Abdominal Ultrasonography in Urinary Tract Infection - When and Why?
Official title: Abdominal Ultrasonography in Urinary Tract Infection - When and Why?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Tract Infections
UTI
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2017-09-01
Enrollment: 65
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children with UTI treated in Medical University of Warsaw Children's Hospital

Brief summary: Urinary tract infection (UTI) in a child may be the first symptom of congenital anomaly of the kidneys and the urinary tract (CAKUT). Thus, imaging diagnostics are warranted in children with first episode of UTI.

Abdominal ultrasonography (USG) is the first line imaging modality in evaluating children with UTI. Abnormalities suggesting CAKUT found on USG are an indication for further, more invasive tests. The timing of USG in UTI depends on the clinical situation. It always should be performed urgently when serious acute complications of UTI are suspected. However, appropriate timing of USG in children responding well to therapy, is a matter of debate. According to animal studies, E. coli produces toxin which dilates the urinary tract. This may result in misleading picture on USG in acute phase of infection. Guidelines on UTI management in children differ in respect to recommended USG timing.

The purpose of the study is to investigate how UTI does affect USG results in children and when its effect subsides.

Methods 150 children up to 3 years of age, with the first episode of UTI, will be included in our study. Three USG examinations will be performed by single radiologist in every child:

1. in the first day of treatment,
2. two weeks after treatment initiation,
3. four weeks after treatment initiation. Age, gender, etiologic factor, C-reactive protein concentration and white blood cells count will be included in statistical analysis.

The study is aimed to help clinicians interpret USG findings during UTI and make reasonable plans for further imaging diagnostics in children with UTI.


Eligibility criteria: Inclusion Criteria:

- laboratory diagnosis of UTI in a child (positive leucocyturia and significant bacteriuria)

Exclusion Criteria:

* known previous UTIs
* known congenital abnormality of the kidney and the urinary tract (CAKUT)

Primary outcomes:
measure: USG abnormality persistence
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Medical University of Warsaw Children's Hospital
Study officials:
References:
Clinical trial NCT05136040: Low-Doses Of Isobaric Bupivacaine On Intraoperative Hemodynamics In Spinal Anesthesia During Cesarean Section
Official title: Comparison Of The Effects Of Two Different Low-Doses Of Isobaric Bupivacaine On Intraoperative Hemodynamics In Spinal Anesthesia During Cesarean Section: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section
Hemodynamic Instability
Keywords: Ceseaean section
Spinal anesthesia
Hemodynamics
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2021-11-26
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary aim of this study was to compare the effects of two different low-dose bupivacaine used in spinal anesthesia on intraoperative hemodynamics in cesarean section operations.Investigators think that low-dose bupivacaine and fentanyl mixture applied in cesarean section cause fewer hemodynamic changes,provide adequate anesthesia and analgesia quality,cause fewer side effects,and postoperatively,patients may return to their daily activities more quickly.This study was conducted on 80 pregnant women undergo an elective cesarean section.Patients were randomly allocated in GrupA and GroupB. Combined spinal-epidural anesthesia was performed in the sitting position using the needle-inside-needle technique.After cerebrospinal fluid flow was observed, GroupA patients were given a solution containing 5 mg isobaric bupivacaine+15 µg fentanyl (1.3 ml),and Group B was administered a solution containing 7 mg isobaric bupivacaine+15 µg fentanyl (1.7ml).Hypotension,bradycardia,duration of analgesia,postoperative nausea and vomiting were recorded.


Eligibility criteria: Inclusion Criteria

* ASA I-II
* Pregnant women
* 18-50 years of age
* BMI\<40kg/m2
* 150-180 cm in height

Exclusion Criteria:

* Patients with hypertension induced by emergency obstetric surgery
* Significant systemic disease,
* Multiple pregnancies,
* Fetal or placental abnormality,
* Hypersensitivity or allergy history to the drugs to be used in the study
* Contraindicated neuraxial anesthesia,
* Infection at or around the region to be anesthetized,
* Coagulation abnormalities
* Patients unable to decide or unwilling to participate in the study

Primary outcomes:
measure: The primary aim of study was to compare the effects of two different low-dose bupivacaine used in spinal anesthesia on intraoperative systolic and diastolic blood pressure (mmHg) in cesarean section operations.
timeFrame: during cesarean procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Yakutiye
country: Turkey
facility: Aysenur Dostbil
state: Erzurum
Study officials:
affiliation: Ataturk University, Department of Anesthesiology and Reanimation
name: Mehmet Aksoy, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04833140: Estrogen Administration for the Treatment of NASH in Postmenopausal Women
Official title: Estrogen Administration for the Treatment of NASH in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: NASH - Nonalcoholic Steatohepatitis
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2021-04-06
Enrollment: 60
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Non-alcoholic fatty liver disease (NAFLD) is a growing epidemic in the United States. Despite this, the treatment options remain limited. Preclinical and preliminary clinical data suggest that estrogen deficiency plays an important role in the pathology of steatosis, inflammation and fibrosis in non-alcoholic steatohepatitis (NASH), the progressive form of NAFLD. Post-menopausal women are a growing population with particularly high risk of NASH due to their lack of estrogen. This study will examine the effect of estradiol on hepatic fibrosis and fat in post-menopausal women with NASH.


Eligibility criteria: Inclusion criteria:

* Postmenopausal women 45-70 years old
* NASH by biopsy or NAFLD by imaging within 6 months of screen
* Hepatitis C antibody and hepatitis B surface antigen negative
* Negative mammogram within 1 year

Exclusion criteria:

* Heavy alcohol use
* Use of NASH pharmacotherapies within 12 months of study entry
* Known cirrhosis, stage 4 fibrosis on biopsy, or clinical evidence of cirrhosis or portal hypertension on imaging or exam
* Participation in NASH clinical trial within 6 months of study entry
* Chronic use of corticosteroids, methotrexate, amiodarone, or tamoxifen within 6 months of entry
* Known diagnosis of chronic liver disease other than NAFLD or found on biopsy
* Contraindication to liver biopsy including INR \> 1.5, platelets \< 50,000/mL, ascites, chronic anticoagulation (other than aspirin), biliary obstruction, peritonitis, inability to lie supine for 30 minutes
* Hgb \< 10.0 g/dL or glomerular filtration rate \< 60 mL/min
* Contraindications to estrogen therapy
* Any vaginal bleeding, including spotting, within the last year
* Active malignancy
* Severe chronic illness
* Use of estrogen or progesterone within a year of baseline visit
* Routine MRI exclusion criteria such as the presence of a pacemaker or cerebral aneurysm clip

Primary outcomes:
measure: Liver fibrosis
timeFrame: 12 months
measure: Liver fat
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachsuetts General Hospital
name: Karen K. Miller, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06672640: Effects of Remote Exercise on Physical Function in Pre-Frail Older Adults
Official title: Effects of Remote Exercise on Physical Function in Pre-Frail Older Adults: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frail Elderly
Keywords: Telerehabilitation
Postural balance
Gait
Frail Elderly
Lead sponsor: Kyungdong University
Sponsor class: OTHER
First posted: 2024-11-04
Enrollment: 90
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to compare the effects of remote versus in-person exercise interventions on physical function, balance, gait stability, and fall efficacy in pre-frail older adults aged 65 years and above. Participants are randomly assigned to either a remote exercise group, an in-person exercise group, or a control group. The exercise intervention includes balance, strength, and gait training conducted twice weekly for eight weeks. The control group receives educational materials on physical activity. The primary outcome measures include assessments of balance, lower limb strength, gait ability, and fall efficacy. This study seeks to determine if remote exercise is as effective as in-person exercise in enhancing physical function in pre-frail older adults, potentially providing a feasible alternative to traditional in-person programs and addressing barriers such as limited mobility and access to exercise facilities.


Eligibility criteria: Inclusion Criteria:

* Aged 65 years or older
* Classified as pre-frail based on Fried's frailty criteria (meeting at least two out of five specified indicators)
* Experienced a fall in the preceding six months or have impaired gait and balance (TUG ≥ 13.5 seconds, BBS ≤ 45)
* Mini-Mental State Examination (MMSE) score of 24 or higher
* Demonstrate the physical capacity to engage in the remote exercise (e.g., ability to stand from a seated position and walk short distances)

Exclusion Criteria:

* Neurological or musculoskeletal conditions that impede physical activity
* Recent history of severe cardiovascular disease (within the past three months)
* Inability to commit to continuous participation throughout the study period
* Any other medical condition that might interfere with the intervention or pose a risk to the participant

Primary outcomes:
measure: Balance ability
timeFrame: Baseline and post-intervention at 8 weeks
measure: Lower Limb Strength
timeFrame: Baseline and post-intervention at 8 weeks
measure: Gait Ability
timeFrame: Baseline and post-intervention at 8 weeks
measure: Fall Efficacy
timeFrame: Baseline and post-intervention at 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Wonju
country: Korea, Republic of
facility: Department of Physical Therapy, Kyungdong University
state: Gangwon-do
Study officials:
References: