louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01178957: Very-Low-Density-Lipoprotein-Triglyceride(VLDL-TG) Metabolism During Acute Hyperglycemia
Official title: Very-Low-Density-Lipoprotein-Triglyceride(VLDL-TG) Metabolism During Acute Hyperglycemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Keywords: Type 1 diabetes
Very-Low-Density-Lipoprotein(VLDL)
Hyperglycemia
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2010-08-10
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 1 diabetics

Brief summary: The purpose of this study is to estimate the acute effect of hyperglycemia on Very-Low-Density-Lipoprotein-triglyceride(VLDL-TG) secretion.


Eligibility criteria: Inclusion Criteria:

1. Type 1 diabetes
2. Age 18-50 years

Exclusion Criteria:

1. Smoking
2. Alcohol abuse
3. Use of medications (except insulin in diabetics)

Primary outcomes:
measure: Very-Low-Density-Lipoprotein-Triglyceride(VLDL-TG) secretion
timeFrame: 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Department of Endocrinology MEA, Aarhus Hospital
Study officials:
References:
citation: Johansen RF, Sondergaard E, Sorensen LP, Nellemann B, Christiansen JS, Nielsen S. Isolated hyperglycaemia does not increase VLDL-triacylglycerol secretion in type 1 diabetic men. Diabetologia. 2015 Feb;58(2):355-62. doi: 10.1007/s00125-014-3422-6. Epub 2014 Nov 11.
Clinical trial NCT04740957: Characterising the Natural History of Mucosal Metabolism During Colorectal Anastomotic Healing
Official title: Characterising the Natural History of Mucosal Metabolism During Colorectal Anastomotic Healing
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healing of Colorectal Anastomoses
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2021-02-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This pilot study aims to investigate anastomotic healing and its underlying mechanisms at a mucosal level. It is a first-in-human study which will demonstrate the safety of post-operative endoscopic assessment of a colorectal anastomosis and provide preliminary data in order to power future interventional studies.

100 patients undergoing elective left colonic or rectal resection with a primary anastomosis will be recruited pre-operatively throughout the study period. This study will not affect or delay the intended treatment for study participants.

Patients will undergo serial endoscopic examination of the anastomosis post-operatively. Blood, urine, stool, and mucosal biopsies will be serially collected.

A subgroup of 20 patients with a defunctioning ileostomy will be recruited to an interventional arm. This interventional arm will demonstrate the safety of re-introducing ileostomy effluent into the downstream (distal) limb of an ileostomy. The preliminary data will enable exploration of the association between microbiome and post-operative function and enable adequate powering of future interventional studies.


Eligibility criteria: Inclusion Criteria:

Patients undergoing elective left sided colonic or rectal resections with primary anastomosis with or without diverting ileostomy.

Exclusion Criteria:

* Inability to communicate in English
* People who lack capacity to consent
* Emergency colorectal resection whilst awaiting elective surgery
* Age \<18
* Permanent stoma formation
* People on long term immunosuppressive medication
* People on long term renal replacement therapy.

Primary outcomes:
measure: Anastomotic healing
timeFrame: 1 year
Secondary outcomes:
measure: Failure of anastomotic healing
timeFrame: 1 year
Other outcomes:
measure: Changes in microbial diversity
timeFrame: 1 year
Locations:
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
Study officials:
References:
Clinical trial NCT06215157: A Comparison of Stroke Volume Variation for Prediction of Fluid Responsiveness
Official title: A Comparison of Stroke Volume Variation for Prediction of Fluid Responsiveness Measured by Thoracic Electrical Bioimpedance and FloTrac/Vigileo
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke Volume Variation
SVV-FloTrac
Thoracic Electrical Bioimpedance
Fluid Responsiveness
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Stroke volume variation (SVV) is an indicator used to assess the patient's volume status. The FloTrac system (Edwards Lifesciences, Irvine, CA) continuously monitors cardiac output (CO) and SVV (SVV-FloTrac) by analyzing the systemic arterial pressure wave. Numerous studies have demonstrated that SVV-FloTrac serves as a reliable indicator of fluid responsiveness. However, its peripheral invasiveness raises concerns about susceptibility to reflecting waves, damping, and vascular tone influences.In contrast, Transthoracic electrical bioimpedance (BioZ.com™) offers a non-invasive approach for continuously monitoring various hemodynamic variables. In this study, the primary aim was to assess the agreement between simultaneously measured SVV-FloTrac and SVV-BioZ.


Eligibility criteria: Inclusion Criteria:

* Age 18≤ Age ≤65
* patients undergoinglaparoscopic elective surgery for gastrointestinal tumors under general anesthesia
* 18 kg/m2≤BMI≤30 kg/m2
* ASA classification I-III
* Patients signed informed consent form

Exclusion Criteria:

* Arrhythmias
* The patient is diagnosed with severe cardiovascular disease（pulmonary arterial hypertension、left ventricular ejection fraction\< 50%、aortic aneurysm、extensive peripheral arterial occlusive disease,、significant valvulopathy）
* Severe heart failure (METS\<4)
* The patient is diagnosed with severe hepatic dysfunction (ChildePugh class C)
* The patient is diagnosed with severe renal dysfunction (undergoing dialysis before surgery)
* There is an infectious lesion on the skin or subcutaneous tissue where the non-invasive electrode piece is placed
* History of allergy to anesthetic drugs
* Weight\<40kg
* Allergies to 6% hydroxyethyl starch, Fresenius Kabi, Deutschland

Primary outcomes:
measure: The capacity to predict fluid responsiveness.
timeFrame: From anesthesia induction to the nonresponsive VLS about one hour.
Secondary outcomes:
measure: The agreement between simultaneously measured SVV-FloTrac and SVV-BioZ
timeFrame: From anesthesia induction to the nonresponsive VLS about one hour.
Other outcomes:
Locations:
city: Pudong
country: China
facility: Renji Hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
References:
Clinical trial NCT04191057: Determining Normal Range for Free Light Chains in Serum Among Twins
Official title: Normal Range Study for Free Light Chains in Blood Among Identical or Fraternal Twins
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Myeloma
Keywords: free light chains
healthy twins
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2019-12-09
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The objective of this study is to recruit healthy adult identical and fraternal twins for the collection of one teaspoon of blood to be sent to the Clinical Lab at San Francisco General Hospital. The serum will be tested to determine the reference range for free light chains.

Detailed description: Serum free light chains are used to assist in the diagnosis of multiple myeloma. The test measures kappa (K) and lambda (L) chains, and the calculation of the ratio of kappa to lambda (K/L). Previous studies have shown that the K/L ratio does not change over time (1 year). The hypothesis of this study is that healthy twins will have a K/L ratio that are close to each other in value, suggesting that this ratio is genetically linked.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects 18-80 years.
* Must be an identical or fraternal twin (both must be recruited)

Exclusion Criteria:

* Symptoms suggestive of multiple myeloma (e.g., renal insufficiency, anemia, bone pain) -

Primary outcomes:
measure: Free light chain reference range
timeFrame: One month after the completion of the enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco General Hospital
state: California
Study officials:
affiliation: University of California, San Francisco
name: Alan Wu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Braga F, Infusino I, Dolci A, Panteghini M. Biological variation of free light chains in serum. Clin Chim Acta. 2013 Jan 16;415:10-1. doi: 10.1016/j.cca.2012.09.008. Epub 2012 Sep 11. No abstract available.
citation: Katzmann JA, Clark RJ, Abraham RS, Bryant S, Lymp JF, Bradwell AR, Kyle RA. Serum reference intervals and diagnostic ranges for free kappa and free lambda immunoglobulin light chains: relative sensitivity for detection of monoclonal light chains. Clin Chem. 2002 Sep;48(9):1437-44.
Clinical trial NCT04737057: Clinical Efficiency and Child's Behavior of Hall Versus SDF Techniques in the Management of Carious Primary Molar:
Official title: Clinical Efficiency and Child's Behavior of Hall Versus SDF Techniques in the Management of Carious Primary Molar:
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Early Childhood Caries
Keywords: hall technique
Silver diamide fluoride
non invasive technique
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-02-03
Enrollment: 72
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare two non- invasive treatment options: Hall technique and 38% Silver diamine fluoride. Both are methods used to create a more favorable environment without removal of caries leading to the arrest of the progression of demineralization process and restoring the function of the diseased molars.

Detailed description: Dental caries, also known as tooth decay, it can occur in primary teeth in early childhood, is formed through interaction between acid-producing bacteria and carbohydrate. The caries develops in both the crowns and roots of teeth. Progress of caries depended on the lifestyle of the child (as high numbers of cariogenic bacteria, inadequate salivary flow, insufficient fluoride exposure and poor oral hygiene). To avoid this disease should follow the proper oral hygiene and improve lifestyle . A lot of methods found to treatment the decayed tooth - like; Hall technique and Silver diamine fluoride The first report on the Hall Technique published in 2007 by a general dental practitioner from Aberdeen/Scotland, Dr. Norna Hall. Dr. Hall used PMCs to restore carious primary molars rather than using the standard technique, placed them using a simplified method2

Previous studies have recommended that Silver diamine fluoride (SDF) solution would exert a preventive result in managing early childhood caries ECC. However, no well-designed clinical trials have yet been performed to study the effect of SDF on caries prevention. the objective is useful in arresting early childhood caries (ECC)

Eligibility criteria: Inclusion Criteria:

1. Age: From 4 to 6 years
2. Caries in primary molars within enamel / dentin without pulp disease

Exclusion Criteria:

1. Presence of signs and symptoms of necrosis
2. Root caries
3. Spontaneous pain

Primary outcomes:
measure: Child's behavior
timeFrame: immediately after the procedure
Secondary outcomes:
measure: Canine overbite
timeFrame: one year
measure: Arresting caries in SDF
timeFrame: one year
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: gihan abo el neil, professor
role: STUDY_CHAIR
affiliation: Cairo univeristy
name: ahmed alkhadem, assistant professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06242457: Poorly Differentiated Adenocarcinoma of the Jejunum in a Patient With Peutz-Jeghers Syndrome: A Case Report
Official title: Poorly Differentiated Adenocarcinoma of the Jejunum in a Patient With Peutz-Jeghers Syndrome: A Case Report
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peutz-Jeghers Syndrome
Lead sponsor: Haramaya Unversity
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 1
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: New patient came to emergency department as routine activity.

Brief summary: Our study is a case report of one of the rarest risk factor, Peutz-Jeghers syndrome, of small bowel malignancy detected in a patient with poorly differentiated adenocarcinoma of small bowel(jejunum)

Detailed description: Case presentation: A 25-year-old male patient presented to the emergency department with generalized peritonitis caused by a perforated jejunal mass. The patient underwent an emergency exploratory laparotomy. There was 800 ml of thin pus in the peritoneal cavity and 5 cm by 6 cm perforated mass over the jejunum, 30cm from the ligament of the treitz, which extends to the mesentery. Palpable jejunal mesenteric lymphadenopathies were found. There were palpable intraluminal polyps with an inverted serosal surface for some of them, which were identified as 10cm proximal and 20cm distal to the mass. The pus was sucked out, and the mass was resected with its mesenteric lymph nodes and segments containing polyps, a total of 40cm of jejunum. Subsequently, end-to-end hand-sewn anastomosis was performed, and the abdomen was closed. The histopathology report showed poorly differentiated adenocarcinoma, stage IIIC (PT3, PN2), and Peutz-Jeghers polyps, suggesting Peutz-Jeghers syndrome. Lympho-vascular invasion was also noted. The tumor has affected seven of the 12 lymph nodes that have been identified. After 6weeks of uneventful follow-up at the surgical referral clinic, the patient was referred to the oncology department for adjuvant chemotherapy.

Eligibility criteria: Inclusion Criteria:

* not necessary

Exclusion Criteria:

* not necessary

Primary outcomes:
measure: Complete resection of adenocarcinomas located in the jejunum or ileum is associated with 5-year survival rates of 20% to 30%.
timeFrame: 5months
Secondary outcomes:
Other outcomes:
Locations:
city: Harar
country: Ethiopia
facility: Haramaya University
Study officials:
References:
Clinical trial NCT05114057: Use of NGAL for Fluid Dosing and CRRT Initiation in Pediatric and Neonatal AKI
Official title: Use of NGAL to Optimize Fluid Dosing, CRRT Initiation and Discontinuation in Critically Ill Children and Neonates with Acute Kidney Injury
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acute Kidney Injury
Acute Kidney Injury Due to Sepsis
Neonatal Sepsis
Keywords: Renal Angina Index
NGAL
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2021-11-09
Enrollment: 1380
Sex: ALL
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: This study will follow patients admitted to the PICU with sepsis, NICU with sepsis or after abdominal surgery, or CICU who are identified as being at risk for developing acute kidney injury. The investigators will use risk-stratification, biomarker testing, and a functional assessment to predict children and neonates who will become fluid overloaded and develop severe acute kidney injury.

Detailed description: In the pediatric population, acute kidney injury (AKI) is commonly observed in critically ill patients. At this time, there are no standardized care pathways that begin at identifying patients at risk for developing AKI and progress through to early recognition and treatment. Through previous work, the investigators have integrated a risk-stratification tool (renal angina index or RAI) and a urine biomarker (NGAL) to try to identify PICU patients at risk versus not at-risk for developing AKI. Through this study, the investigators will tailor the RAI to the septic population in the PICU, create a new NICU RAI, and investigate the utility of the CICU specific RAI in a prospective population. Biomarker testing will be used to further risk-stratify those patients deemed at highest risk through the RAI.

Eligibility criteria: Inclusion Criteria:

* Admitted to the Pediatric Intensive Care Unit (PICU), Cardiac Intensive Care Unit (CICU), or Neonatal Intensive Care Unit (NICU) at participating institution

Exclusion Criteria:

* Baseline Chronic Kidney Disease (CKD) Stage IV or V (estimated GFR \<60 mL/min/1.736m2)
* History of kidney transplant within the previous 90 days
* Ongoing AKI or Acute Kidney Disease (AKD) at ICU admission requiring renal replacement therapy initiated prior to ICU admission
* Acute DNR order or clinical team is not committed to escalating medical care
* Anticipated to require intensive care for less than 48 hours

Primary outcomes:
measure: Clinical Decision Support Performance
timeFrame: Days 2-4 after ICU admission
Secondary outcomes:
measure: Rate of Clinical Decision Support Completion
timeFrame: 48 hours
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Stuart L Goldstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00688857: Open-label Pharmacokinetic Study of Diazoxide Choline Coated vs. Uncoated Formulations
Official title: A Randomized, Open-label, Multi-dose Crossover Study Assessing the Pharmacokinetic Profiles of Diazoxide Choline Coated Versus Uncoated Formulations in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertriglyceridemia
Lead sponsor: Essentialis, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Cetero Research, San Antonio
First posted: 2008-06-03
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a single-center, randomized, open-label, multi-dose crossover study assessing the pharmacokinetic profiles of diazoxide choline coated versus uncoated formulations in healthy volunteers. The primary objective is to compare the pharmacokinetic (PK) profiles of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers under fed conditions. Secondary objectives are to assess diazoxide choline pharmacokinetic (PK) parameters under fasted conditions, and to assess the safety and tolerability of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Healthy male and female subjects 18 to 75 years of age
* Body mass index (BMI) between 22-35 kg/m2
* Fasting glucose ≤ 125 mg/dL and HbA1C ≤ 6.5.
* Fasting triglyceride ≥100 mg/dL and ≤ 500 mg/dL
* Not pregnant

Exclusion Criteria:

* Significant underlying medical conditions
* Clinical laboratory test values outside the accepted range
* Smokers, tobacco users, or subjects currently using nicotine products
* Substance abuse
* History of allergic response(s) to diazoxide or related drugs
* Recent significant weight loss
* Use of medication affecting body weight, lipid or glucose metabolism
* Unable to comply with study procedures

Primary outcomes:
measure: Compare the pharmacokinetic (PK) profiles of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers under fed conditions.
timeFrame: 16 days
Secondary outcomes:
measure: Assess diazoxide choline pharmacokinetic (PK) parameters under fasted conditions
timeFrame: Study days 8 and 16
measure: Assess the safety and tolerability of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers.
timeFrame: Entire study
Other outcomes:
Locations:
city: Fargo
country: United States
facility: PRACS Institute, Ltd. - Cetero Research
state: North Dakota
Study officials:
affiliation: PRACS Institute, Ltd. - Cetero Research
name: Alan K. Copa, Pharm. D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05962957: Role of Pentoxifylline and Celecoxib in Parkinsonism
Official title: Clinical Study to Compare the Possible Safety and Efficacy of Pentoxifylline and Celecoxib in Patients With Parkinson's Disease Treated With Conventional Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Parkinson Disease
Lead sponsor: Tanta University
Sponsor class: OTHER
Collaborators: name: Tanta University
name: Mohanad Omar Khrieba Clinical Pharmacy Department, Faculty of Pharmacy - Horus University
First posted: 2023-07-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Parkinson's disease (PD) is a chronic neurodegenerative disease clinically characterized by bradykinesia, hypokinesia, rigidity, resting tremor, and postural instability. These motor manifestations are attributed to the degeneration and selective loss of dopaminergic neurons in the substantia nigra pars compacta (SNpc), leading to a dopamine (DA) deficiency in the striatum.

The environmental factors are the most common risk factor for Parkinson's disease, while hereditary determinants have minor role for disease. Furthermore, the clinical diagnosis of PD rests on the identification of characteristics related to dopamine deficiency. However, nondopaminergic and nonmotor symptoms, including cognitive dysfunction and depression, which is one of the most common and persistent symptoms, are sometimes present at an earlier disease stage and, almost inevitably, emerge with the disease progression.

Neuroinflammation is considered one of the most important factors contributing critically to pathophysiology of PD . Recently, high mobility group box-1 (HMGB1) protein has been encoded as a potential inflammatory biomarker in PD. HMGB1 mediates immune response mostly through endothelial cells and macrophage activation via targeting two vital cell receptors; Toll-like receptor 4 (TLR4) and advanced glycation end products (RAGE). HMGB1 leads to a sequential cascade of inflammatory response through enhanced release of tumor necrosis factor-alpha (TNF-α) and interleukins (ILs), prominently IL-1β and IL-6. HMGB1 mediated also up-regulation of nuclear factor kappa-β (NF-κB) with subsequent flared pro-inflammatory storm.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years.
* Both male and female will be included.
* Patients diagnosed with PD according to Unified Parkinson's Disease Rating Scale.

Exclusion Criteria:

* Breast feeding
* Patients with significant liver and kidney function abnormalities.
* Alcohol and / or drug abusers.
* Patients with known allergy to the study medications

Primary outcomes:
measure: - Change From Baseline for Unified Parkinson's Disease Rating Scale (UPDRS) Total Score
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Faculty of Medicine, Mansoura University
Study officials:
References: