louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06893536: Impact of Perioperative Nutritional Status and Management in the Context of Resectable Pancreatic Adenocarcinoma
Official title: Impact of Perioperative Nutritional Status and Management in the Context of Resectable Pancreatic Adenocarcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatic Adenocarcinoma
Keywords: Pancreatic Adenocarcinoma
Digestive tract
Hypercatabolism
Malnutrition,
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2025-03-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Major subject (≥18 years old) with pancreatic adenocarcinoma authenticated by pathology and operated on in the visceral and digestive surgery department, NHC Strasbourg, during the period from January 1, 2018 to December 31, 2022

Brief summary: Patients with pancreatic adenocarcinoma are frequently in a situation of malnutrition, in a context of functional alteration of the digestive tract, and hypercatabolism.

As a result, nutritional support is frequently necessary perioperatively, but currently does not follow a specific protocol, and without coordination.

It then appears the need to evaluate the prevalence of malnutrition, its impact on perioperative morbidity and mortality, and current management methods.

Depending on the findings, subsequent interventional studies will be carried out on the subject, exploring the different modalities of artificial nutrition.


Eligibility criteria: Inclusion Criteria:

* Major subject (≥18 years old)
* Subject with pancreatic adenocarcinoma authenticated by pathology
* Subject candidate for curative surgical treatment
* Subject operated on in the visceral and digestive surgery department, NHC Strasbourg, during the period from January 1, 2018 to December 31, 2022
* Absence of written opposition in the subject's medical file to the reuse of their data for scientific research purposes.

Exclusion criteria:

* Subject having expressed opposition to participating in the study
* Subject presenting a metastatic form or one not accessible to surgical treatment considered curative of pancreatic adenocarcinoma
* Subject under guardianship or curatorship
* Subje

Primary outcomes:
measure: Study of the Severity of Perioperative Malnutrition in Pancreatic Adenocarcinoma
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Chirurgie Viscérale et Digestive - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT01290536: Yttrium-90 Radioembolization Using Glass Microspheres (TheraSphere) for Patients With Liver Metastases
Official title: Safety Profile Assessment of TheraSphere® Yttrium-90 Glass Microspheres Used for Treatment of Metastatic Liver Disease From Primary Colorectal, Neuroendocrine, Cholangiocarcinoma, Melanoma, and Breast Cancers Refractory to Chemotherapy: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Neoplasms
Neuroendocrine Tumors
Cholangiocarcinoma
Melanoma
Breast Cancer
Keywords: Liver metastases
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2011-02-07
Enrollment: 42
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: This is a prospective pilot study designed to document safety and efficacy of liver-directed therapy for colorectal, neuroendocrine, cholangiocarcinoma, melanoma, and breast cancer metastases to the liver using Yttrium-90 glass microspheres (TheraSphere).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of metastatic colorectal, neuroendocrine, cholangiocarcinoma, melanoma, or breast malignancy with liver dominant disease. Diagnosis may be made by histo- or cyto-pathology, or by clinical and imaging criteria.
* The cancer is unresectable.
* All patients must be off all chemotherapeutic regimens for 30 days prior to and 30 days after TheraSphere treatment. Concurrent therapy with octreotide is permitted, when appropriate.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
* Age 18 years or older.
* Able to understand informed consent.

Exclusion Criteria:

* Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs on either:

  * single TheraSphere administration; or
  * cumulative delivery of radiation to the lungs greater than 50 Gy over multiple treatments.
* Evidence of any detectable Tc-99m macroaggregated albumin deposition in the stomach or duodenum, after application of established angiographic techniques to stop such deposition.
* Previous radiation therapy to the lungs and/or to the upper abdomen
* Pregnancy
* Symptomatic lung disease.
* Significant extrahepatic disease representing an imminent life-threatening outcome.
* Active uncontrolled infection
* Any pre-treatment laboratory findings within 30 days of treatment demonstrating:

  * Aspartate or alanine aminotransferase level greater than 5 times upper normal limit.
  * Serum bilirubin greater than 2 mg/dl
  * Infiltrative tumor on imaging
  * Tumor volume greater than 70% of liver volume
  * Tumor volume greater than 50% of liver volume and serum albumin level less than 3 mg/dL

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: 6 months
Secondary outcomes:
measure: Radiographic Response
timeFrame: 6 months after treatment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01498536: Effect of Diet and Exercise in Breast Cancer Survivors
Official title: Fit for the Fight: Effect of a Multidisciplinary Diet and Exercise Program on Body Weight, Quality of Life and Inflammation in Survivors of Triple-negative Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Obesity
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2011-12-23
Enrollment: 28
Sex: FEMALE
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: SUPPORTIVE_CARE

Brief summary: This study seeks to see if a 12-week diet and exercise program improves exercise ability, energy level, and quality of life.


Eligibility criteria: Inclusion Criteria:

* ER/PR/HER2neu negative breast cancer
* at least 3 months after end of treatment
* BMI at least 25

Exclusion Criteria:

* stage IV cancer

Primary outcomes:
measure: weight loss
timeFrame: 12 weeks
measure: quality of life
timeFrame: 12 weeks
Secondary outcomes:
measure: markers of inflammation
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
References:
Clinical trial NCT00580736: Optical Clearing of the Skin in Conjunction With Laser Treatments
Official title: Optical Clearing of the Skin in Conjunction With Laser Treatments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Port Wine Stain
Nevus of Ota
Tattoos
Scars
Acne
Hypertrichosis
Sebaceous Gland Diseases
Keywords: sebaceous hyperplasia
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Beckman Laser Institute University of California Irvine
First posted: 2007-12-27
Enrollment: 35
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: The research hypothesis is that topical application of a mixture of pre-polymers of polypropylene glycol and polyethylene glycol (an optical clearing agent) will reduce skin light scattering, increasing the amount of light reaching the target for diagnostic as well as therapeutic purposes.

Detailed description: The researchers expect that application of the optical clearing agent for treatment of benign vascular lesions, tattoos, nevus of Ota, hypertrichosis, scars, acne and sebaceous hyperplasia will result in

1. decreased reflectance of the predominant color from the surface of skin (decreased red light scattering in case of benign vascular lesions, etc) as compared to the control group.
2. greater Optical Coherence Tomography a non-invasive light based imaging method imaging depth as compared to the control group.
3. greater improvement in the treatment outcome (decrease in the erythema index following laser treatment of vascular lesions as compared to the laser alone group; improved lightening of the tattoo or nevus of Ota as compared to the laser treatment alone group; significant decrease in hair re-growth as compared to laser treatment alone in patients seeking hair removal; greater improvement of scars, acne and sebaceous hyperplasia).

Eligibility criteria: Inclusion Criteria:

* Adult 18 years and older
* Lesion diagnoses in an area measuring 3 cm2 or more on any body site
* Apparent good health

Exclusion Criteria:

* Pregnant women
* History of cutaneous photosensitivity
* History of photodermatoses

Primary outcomes:
measure: Outcome measure is to evaluate the optical clearing effects of the combination mixture of pre-polymers of polypropylene glycol and polyethylene glycol.
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Beckman Laser Institute Medical and Surgical Clinic
state: California
Study officials:
affiliation: Beckman Laser Institute
name: Kristen M Kelly, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01190709: Study of Tibial Shaft Fracture Fixation: Intramedullary Nailing Comparing With Dynamic Compression Plate
Official title: Study of Surgical Methods for Treatment of Tibial Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tibial Shaft Fracture
Keywords: Close Fracture
Tibia
Unreamed Intramedullary Nailing
Dynamic Compression Plate
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2010-08-30
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine which surgical approach is better for treatment of tibial shaft fracture

Detailed description: Tibial fracture is more common fracture. We aimed to compare unreamed intramedullary nailing (UTN) and dynamic compression plate (DCP) with regard to fracture healing and complications in patients with closed tibial shaft fractures.

Eligibility criteria: Inclusion Criteria:

* patient with tibial shaft fracture

Exclusion Criteria:

* nothing

Primary outcomes:
measure: time of fracture healing
timeFrame: at 16 months post-operatively
Secondary outcomes:
measure: malunion
timeFrame: at 16 months post-operatively
measure: nonunion
timeFrame: at 16 months post-operatively
measure: infection
timeFrame: at 16 months post-operatively
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Al-zahra university hospital
Study officials:
affiliation: MD,research comittee
name: hamidreza shemshaki, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00474409: A Study To Evaluate The Efficacy And Safety Of Betahistine Mesilate In The Treatment Of Patients With Vertigo Caused By Cerebral Infarction In Posterior Circulation
Official title: A Multicenter, Placebo-Controlled, Double-Blind Study To Evaluate The Efficacy And Safety Of Betahistine Mesilate In The Treatment Of Patients With Vertigo Caused By Cerebral Infarction In Posterior Circulation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Vertigo
Keywords: Vertigo
Posterior circulation infarction
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2007-05-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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 determine the efficacy and safety of Betahistine Mesilate in the treatment of patients with vertigo caused by Cerebral Infarction in posterior circulation.


Eligibility criteria: Inclusion Criteria:

1. Patients that have a clinical diagnosis of posterior circulation infarction and vertigo occurring within 1 month after the infarction.

Primary outcomes:
measure: Changes in the European Evaluation of Vertigo (EEV) scale in 4 weeks.
timeFrame: 4 weeks
Secondary outcomes:
measure: The duration of the vertigo symptom.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Shanghai
country: China
facility: Shanghai Renji Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Huashan Hospital
state: Shanghai
Study officials:
affiliation: Beijing Tiantan Hospital
name: Wang Yong Jun
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01654809: Safety and Immunogenicity Study of Split Influenza Virus Vaccine in Different Age Groups
Official title: Evaluation of Safety and Immunogenicity Among Different Age-groups Receiving Different Split Influenza Vaccines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Lead sponsor: Beijing Center for Disease Control and Prevention
Sponsor class: OTHER_GOV
First posted: 2012-08-01
Enrollment: 900
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to observe the adverse reaction ratio and hemagglutination inhibition (HI) antibody positive rate, Geometric mean titer (GMT) of three brands split influenza virus vaccine in different population.

Detailed description: Observational Objectives:

To describe the safety of evaluated vaccine, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to ≤ 36 months,6th to 12th birthday and ≥ 60th birthday.

To describe the immunogenicity of evaluated vaccine, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to ≤ 36 months, 6th to 12th birthday and ≥ 60rd birthday.

Eligibility criteria: Inclusion Criteria:

* participants were enrolled (toddlers: 6 months to 3 years; school-aged children: 6 to 12 years and older adults: ≥60 years）
* Eligible participants were generally healthy or had stable chronic medical conditions (for older adults only)

Exclusion Criteria:

* History of allergic reaction to any component of the study vaccines or previous influenza vaccine
* History of systemic hypersensitivity to hens' eggs
* History of Guillain Barré syndrome following administration of any influenza vaccine
* Any immunodeficient or immunocompromised conditions
* Receipt of cytotoxic or immunosuppressive drugs within the past 6 months
* Receipt of blood-derived product within the past 3 months
* Receipt of any vaccine within one month prior to study entry with exception of paediatric routine vaccination
* Receipt of non-study 2010-2011 seasonal TIV
* Participation in any other study with a non-approved drug during the study
* Acute febrile disease and other self-limiting illness were the temporary exclusion criteria

Primary outcomes:
measure: To evaluate the immunogenicity of evaluated vaccine
timeFrame: 6 months
measure: To evaluate the safety
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Langfang
country: China
facility: Sanhe Centre for Disease Control and Prevention
state: Hebei
city: Baotou
country: China
facility: Jiuyuan Center for Disease Control and Prevention
state: Inner Mongolia
Study officials:
affiliation: Beijing Chaoyang District Center for Disease Control and Prevention
name: Nianmin Shi, Master
role: STUDY_CHAIR
References:
Clinical trial NCT00961909: A Study of RO5095932 in Patients With Type 2 Diabetes Mellitus
Official title: A Multi-Center, Randomized, Double-Blind, Multiple Ascending Dose, Placebo-Controlled, Parallel Group, 2-Part Study to Investigate the Safety, Tolerability, PK, and PD of Once Weekly RO5095932 in Patients With Type 2 Diabetes Mellitus on a Stable Dose of Metformin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus Type 2
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2009-08-19
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized, double-blind, placebo-controlled study will assess the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of RO5095932 in patients with type 2 diabetes mellitus. Patients will be randomized to receive either RO5095932 subcutaneously once weekly or placebo for 4 weeks (part 1) or 6 weeks (part 2), in addition to their current stable doses of metformin.


Eligibility criteria: Inclusion Criteria:

* adult patients, 18-65 years of age
* females who are either surgically sterile or post-menopausal
* type 2 diabetes treated with a stable dose of metformin
* BMI between 25-39kg/m2
* HbA1c between 7 and 10%
* fasting plasma glucose between 7 and 13.3mmol/L

Exclusion Criteria:

* history of clinically significant cardiovascular disease
* history of clinically significant hepatic or renal disease or impairment
* recent therapy with insulin, thiazolidinedione, glucagon-like peptide-1 analogues, amylin analogues and/or DPP-IV inhibitors

Primary outcomes:
measure: Safety and tolerability: AEs, laboratory parameters, ECG, body weight, vital signs
timeFrame: monitored throughout study, with weekly ECG and 2x weekly to 2-weekly laboratory assessments on study treatment and at intervals during follow-up
measure: Change in hemoglobin A1c (HbA1c)
timeFrame: from baseline to week 6
Secondary outcomes:
measure: Pharmacokinetics: blood concentration of RO5095932 after multiple dosing
timeFrame: multiple sampling weeks 1-4 or 1-6 respectively, and weekly during follow-up
measure: Change in metabolic parameters: glucose, insulin, C-peptide
timeFrame: assessed after 4 or 6 weeks on study treatment
Other outcomes:
Locations:
city: Anaheim
country: United States
state: California
city: Chula Vista
country: United States
state: California
city: Ft. Myers
country: United States
state: Florida
city: Miramar
country: United States
state: Florida
city: San Antonio
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01627509: Comparison of Two Insulin Regimens in Optimally-controlled Patients With DM2.
Official title: Comparison of Modern Premixed Insulin and Basal-Bolus Regimens on Blood Glucose Control Using CGMS Device in Optimally-controlled Subjects With DM2.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus 2 Type
Keywords: continuous glucose monitoring system
hypoglycemia
insulin regimen
basal bolus therapy
modern premixed insulin
diabetes control
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2012-06-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 40 Subjects with 1 year and more of T2DM history , with two consistent HbA1C values of 7% or less - according to the blood tests within last six months.

Brief summary: Intensive Insulin Therapy (IIT) may be given in Type 2 Diabetes (T2DM) in two different ways :

* as Basal/bolus therapy (B/B) in four-five injections per day .
* as Modern Premixed Insulins( MPI's) three times per day . The better diabetes control is achieved, the more likely patient would suffer from hypoglycemic episodes. We propose that the probability of hypoglycemia and its severity has no difference in two main insulin therapy schemes mentioned above.

The objective of the study is to compare the incidence of hypoglycemia and its severity in well-controlled ( HBA1C less than 7%) diabetic individuals treated by two different regimens, through analysis of data received by Continuous Glucose Monitoring (CGM, Free Style Navigator).


Eligibility criteria: Major Inclusion Criteria:

* Diabetes Mellitus Type 2 diagnosis confirmed by endocrinologist.
* Diabetes Mellitus Type 2 history of one year at least.
* HAb1C \< 7% and less
* Age 18-80 yrs
* Normal Liver function tests

Major Exclusion Criteria:

* History of substance use
* Pregnancy or breastfeeding mothers
* Abnormal liver or kidney functional tests
* Type 1 Diabetes or LADA
* any active disease ( like viral) at the period of investigation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: The Institute of Endocrinology, Sheba Medical Center
state: Gush Dan
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
Study officials:
References:
Clinical trial NCT03248609: Glycemic Index of Table Grape Varietals
Official title: Investigation of the Glycemic Index of Table Grape Varietals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2017-08-14
Enrollment: 14
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Investigate the postprandial glycemic responses of healthy individuals when consuming commercially available table grape varietals or grape juice, compared to a standard amount of glucose.

Detailed description: The study aims to investigate the postprandial glycemic responses of healthy individuals when consuming commercially available table grape varietals, compared to a standard amount of glucose. The study also aims to evaluate a new grape varietal, compared to other common table grapes, with regard to glycemic index and metabolic response related to inflammation.

Eligibility criteria: Inclusion Criteria:

* Healthy men and women
* 21-75 years of age
* BMI range 20-35

Exclusion Criteria:

* adults unable to consent, individuals who are not yet adults (children), pregnant women, and prisoners.
* BMI of \>35 or morbid obesity.
* Diagnosed type 1 or 2 diabetes, fasting blood glucose of \>125 mg/dl, or reported use of medications or supplements known to affect glucose metabolism (insulin, sulfonylureas, metformin, glucosidase inhibitors, thiazolidinedione, insulin sensitizers, GLP-1 mimetics).
* Medications known to affect gastrointestinal motility (prokinetic agents such as reglan).
* Renal, liver, pancreatic or cardiovascular disease, uncontrolled hypertension of \> 160/90, inflammatory bowel disease, disorders of esophageal and gastrointestinal motility, previous gastric resection or restriction procedures, autoimmune or immunologic disorders, anemia, breastfeeding women
* Food allergy to grapes, or inability to tolerate gluten (celiac disease).
* Poor venous access.
* Smoking, illicit drug use, consuming \>7 alcoholic drinks per week.
* Weight gain or loss of \> 5 kg within the prior 6 months.
* Unwillingness to adhere to study protocol.

Primary outcomes:
measure: Glycemic Index
timeFrame: 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Davis
country: United States
facility: University of California Davis (Academic Surge, Ragle Human Nutrition Research Facility)
state: California
Study officials:
References: