louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03914560: Nutritional Intakes in Burn Patients Treated as Outpatients
Official title: Evaluation of Macronutrients and Micronutrients Intakes in Burn Patients Treated as Outpatients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Burns
Nutritional Deficiency
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 51
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All burn patients admitted in the outpatient clinic of the investigator's burn center for minor burns

Brief summary: Nutrition is a key component of burn care. The primary goal of nutrition is to provide adequate supply in macro and micronutrients that are necessary to maintain organ function but also to wound healing, infection control and muscle preservation.

Studies about nutrition and burn care are mainly focused on severe burn patients. There is a few or no data regarding nutrition in minor burns. Those patients rarely receive a multidisciplinary approach, at least in Belgium.

The present study aimed to describe the nutritional condition of less severe burn patients treated as outpatients in a Belgian burn center. The ultimate goal was to determine whether this population needs specific dietetics follow-up or not.


Eligibility criteria: Inclusion Criteria:

* Burn treated exclusively in an outpatient clinic

Exclusion Criteria:

* Not french speaking
* Psychiatric disorders
* Patient refusal

Primary outcomes:
measure: nutritional intakes
timeFrame: During the first week following injury
Secondary outcomes:
measure: Body composition
timeFrame: During the first week following injury
measure: Handgrip strength
timeFrame: During the first week following injury
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: University Hospital of Li§ge
Study officials:
References:
Clinical trial NCT02030860: A Randomized Pilot/Pharmacodynamic/Genomic Study of Neoadjuvant Paricalcitol to Target the Microenvironment in Resectable Pancreatic Cancer
Official title: A Randomized Pilot/Pharmacodynamic/Genomic Study of Neoadjuvant Paricalcitol to Target the Microenvironment in Resectable Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Adenocarcinoma of the Pancreas
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2014-01-09
Enrollment: 15
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: This study is a randomized pilot/pharmacodynamic/genomic study of neoadjuvant paricalcitol to target the microenvironment in resectable pancreatic cancer to determine the effect of targeting the vitamin D metabolic program in the tumors of patients treated with one cycle of gemcitabine/abraxane with or without paricalcitol prior to surgery for resectable pancreatic cancer through an assessment of cellular and imaging markers.

Detailed description: This study is a randomized pilot/pharmacodynamic/genomic study of neoadjuvant paricalcitol to target the microenvironment in resectable pancreatic cancer to determine the effect of targeting the vitamin D metabolic program in the tumors of patients treated with one cycle of gemcitabine/abraxane with or without paricalcitol prior to surgery for resectable pancreatic cancer through an assessment of cellular and imaging markers.

Eligibility criteria: Inclusion Criteria

* Previously untreated, apparently resectable, adenocarcinoma of the pancreas at registration.
* Age greater than or equal to 18 years
* Eastern Cooperative Oncology Group performance status of 0-2.
* Standard laboratory criteria for hematologic, biochemical, and urinary indices within a range that, in the opinion of the physician, clinically supports enrollment of the patient on the trial. Note: subjects must have: Creatinine \< 2x Upper Normal Limit , Transaminases \< 3x Upper Normal Limit, Neutrophils \>1.5x109/L, and Platelets \>100,000/mm3
* Ability to provide written informed consent

Exclusion Criteria

* Patients with hypercalcemia (blood levels greater than 11.5 mg/dL; in patients with kidney disease, blood calcium levels must be 9.5 mg/dL or lower before starting paricalcitol).
* Patients who are currently pregnant, planning to become pregnant, or breast-feeding.
* Patients who, in the opinion of the physician, would not be clinically appropriate for receipt of the therapy regimen associated with participation

Primary outcomes:
measure: Number of Adverse Events
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Peter O'Dwyer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06410560: Culture is Care: Training Workshop for Care Workers (VerbaCurant)
Official title: "Culture is Care: Training Workshop for Care Workers" Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Empathy
Well-Being, Psychological
Lead sponsor: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Sponsor class: OTHER
Collaborators: name: Compagnia di San Paolo
name: Scuola Holden Contemporary Humanities
First posted: 2024-05-13
Enrollment: 175
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The study aims to measure the empathic capacity of healthcare professionals belonging to the Alessandria Hospital, by applying validated measuring instruments, before and after a specific training intervention. The secondary objective is to assess how the training initiative impacts on subjects with a different attitude towards cultural participation.

Detailed description: The aim of this project is to identify how a medical humanities intervention can act on the empathic capacity of carers through culture. One of the aims is to introduce an additional element to overcome the problems about language, prejudices, legitimisation by stakeholders who do not yet recognise the value and importance of projects promoting the relationship between culture, wellbeing and health. "Verba Curant" is aimed at generating cultural value, with the hope that it can unite the different professional fields involved and become the heritage of the community.

The project of the Alessandria Hospital Centre in collaboration with the Holden School intends to launch a series of actions aimed at promoting the beneficial impact of culture, in particular storytelling, on the caregivers and patients of the Alessandria Hospital in order to measure how much cultural enjoyment can impact on health literacy. It is planned to define a methodological tool useful for making care workers aware of the importance of culture and dialogue with patients, as well as being able to measure their degree of literacy. The tool will be the object of a widespread training action on care workers, which will also involve all the stakeholders involved in the transmission of health information to patients.

Eligibility criteria: Inclusion Criteria:

* Health professionals related to the Alessandria Hospital

Exclusion Criteria:

* none

Primary outcomes:
measure: Empatic capacity
timeFrame: Before the intervention (Baseline/T0) and immediately after the intervention (Final/T1)
measure: Wellbeing
timeFrame: Before the intervention (Baseline/T0) and immediately after the intervention (Final/T1)
Secondary outcomes:
Other outcomes:
Locations:
city: Alessandria
country: Italy
facility: Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo
state: Piedmont
Study officials:
affiliation: Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo
name: Marinella Bertolotti, Biologist
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02413060: The Impact of Resistance Training on Type 2 Diabetes Patients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2015-04-09
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
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 whether the long-term effects of high-intensity progressive resistance training could improve glucose and lipid metabolism in chinese type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* established type 2 diabetes

Exclusion Criteria:

* severe joint cardiovascular and respiratory system disease, uncontrolled hypertension (160/90 mmHg), severe diabetic nephropathy and neuropathy
* with severe liver and kidney dysfunction
* with mental system disease
* pregnant women or nursing mothers

Primary outcomes:
measure: HbA1c
timeFrame: up to six months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Cao jia du community health service centre
state: Shanghai
Study officials:
References:
Clinical trial NCT06803160: Comparative Study of Laparoscopic Combined Trans-vesical and Extravesical Versus Laparoscopic Extravesical Fistula Excision in Uterovesical Fistula Repair: A Retrospective Observational Study
Official title: Comparative Study of Laparoscopic Combined Trans-vesical and Extravesical Versus Laparoscopic Extravesical Fistula Excision in Uterovesical Fistula Repair: A Retrospective Observational Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Success of Operation
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-01-31
Enrollment: 20
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * This is a retrospective study involving the retrieval and analysis of medical records of uterovesical patients who were managed at the Urology and Gynecology departments at Ain Shams University Hospitals.
* Patient's records that were included in the study satisfied the following criteria:

  * The patient was diagnosed with uterovesical fistula.
  * The patient had laparoscopic surgery with either approach at the Urology and Gynecology departments at Ain Shams University Hospitals.
  * The fistulous track was confirmed and had been repaired.

Brief summary: • The aim of this study is to compare between laparoscopic combined trans-vesical and extravesical versus laparoscopic extravesical fistula excision in uterovesical fistula repair.


Eligibility criteria: Inclusion Criteria:

Patients diagnosed with uterovesical fistula with history of uterine cesarean section or any urogenital surgery complaining of amenorrhea, cyclic hematuria, with or without urinary incontinence.

Exclusion Criteria:

* • Pregnant females.

  * Patients who refuse to participate in the study.
  * Patients with concomitant pathology that could affect symptoms e.g., polycystic ovary disease, stress incontinence, bladder cancer or overactive bladder.
  * Patients with malignant fistula.

Primary outcomes:
measure: success of operation
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References:
Clinical trial NCT01804660: Longitudinal Therapeutically Non-interventional Study of MSRV-Env Burden in Normal Population
Official title: A One Year Longitudinal Therapeutically Non-Interventional Study of MSRV-Env Burden in Normal Population as Assessed by PCR and ELISA in Blood
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis (MS)
Multiple Sclerosis associated RetroVirus (MSRV)
MSRV envelop protein (MSRV-Env)
Temelimab
Lead sponsor: GeNeuro SA
Sponsor class: INDUSTRY
First posted: 2013-03-05
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Blood donors coming for regular blood draw in the center of transfusion.

Brief summary: This study intends to explore the levels of MSRV expression by analyzing the levels of MSRV transcripts in blood, as well as the levels of the MSRV-Env protein in serum in the normal population. This study is important for establishing a baseline to analyze results obtained in MS patients (another dedicated study is performed in parallel in MS patients). The study will be conducted over one year in a cohort of healthy subjects. The MSRV RNA level, MSRV-Env protein levels, reverse transcriptase activity, inflammatory markers assessed by cytokines levels will be analysed to define control levels in the normal population and their variation during one year. The data obtained in this study in healthy controls will be compared to those obtained in a parallel similar study, GN-E-002, conducted in different types of MS patients.


Eligibility criteria: Inclusion Criteria:

* Signature of an informed consent;
* Male or female between 18 and 60 years of age.

Exclusion Criteria:

* Positive serology for hepatitis B or C or HIV;
* Acute infection at inclusion;
* Severe psychiatric disorder, neurological, inflammatory, or autoimmune disease;
* Pregnancy or breastfeeding;
* Heavy smokers i.e. more than 10 cigarettes per day;
* History of alcohol or drug abuse in the last 3 years;
* Participation in a clinical trial (within the last 3 months).

Primary outcomes:
measure: Establish a control value for the levels of MSRV expression in the normal population over time
timeFrame: 1 year
Secondary outcomes:
measure: Inflammatory markers and reverse transcriptase activity in blood.
timeFrame: 1 year
Other outcomes:
Locations:
city: Annemasse
country: France
facility: Etablissement Français du Sang Rhône Alpes - 1 route de Taninges
Study officials:
References:
Clinical trial NCT00606060: BAY14-2222 Continuous Infusion in Surgeries
Official title: Safety and Efficacy of Continuous Infusion of Recombinant Factor VIII - Sucrose-formulated (BAY 14 2222) Concentrate in Patients With Hemophilia A Undergoing Major Elective Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hemophilia
Keywords: Hemophilia,
Continuous Infusion
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-02-01
Enrollment: 15
Sex: MALE
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Phase III study, to evaluate the efficacy and safety of continuous infusion of rFVIII-FS in the treatment of patients with hemophilia A undergoing major elective surgery by achieving the required therapeutic concentrations.


Eligibility criteria: Inclusion Criteria:

* Severe hemophilia A (FVIII:C \</=1%)
* No history of FVIII inhibitor formation and no current evidence of inhibitor antibody (Bethesda Assay \< 0.6 BU)
* Elective major surgery requiring at least 6 days of rFVIII-FS therapy
* Subjects should have been previously treated with FVIII concentrates for at least 150 exposure days. Previous treatment could have been with any type of rFVIII or with plasma-derived FVIII concentrate or cryoprecipitate

Exclusion Criteria:

* Abnormal renal function (serum creatinine \>1.3 mg/dL)
* Any treatments, which may change the clearance of FVIII (dialysis, plasma exchange)
* Anemia (hemoglobin \<11 g/dL)
* Known AIDS (HIV seropositive patients may be enrolled)
* Active liver disease (transaminases \> 5 times the upper limit of normal)
* History of severe reaction to FVIII concentrates
* Interferon treatment within the last 3 months
* Thrombocytopenia (\< 100,000 platelets/mm3) or other known hematological/bleeding problems other than hemophilia A
* Intake of other investigational drugs within 1 month prior to study entry
* Need for pre-medication for FVIII infusions (e.g. antihistamines)
* Diastolic blood pressure \>100 mm/Hg, which could not be controlled with antihypertensive medications

Primary outcomes:
measure: efficacy of continuous infusion of recombinant Factor VIII - sucrose-formulated (rFVIII-FS) in the treatment of patients with hemophilia A
timeFrame: 28 days
Secondary outcomes:
measure: Evaluate the safety of rFVIII-FS.
timeFrame: 28 days
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03720860: Inflammatory Mediators of Acute Kidney Injury in Intensive Care
Official title: Prospective Studie of Inflammatory Markers in Urine, Plasma and Sputum Associated With Acute Kidney Injury
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sepsis
Surgery
Acute Kidney Injury
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Maastricht University
First posted: 2018-10-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients subjected to major surgery or intensive care

Brief summary: Acute kidney injury (AKI) affects more than 50% of patients admitted to the intensive care unit. The most common underlying cause is sepsis. Severe AKI in combination with sepsis is associated with high mortality. The mechanisms for sepsis-induced AKI are largely unknown. Our hypothesis is that the inflammatory response to an infection cause collateral damage to host tissue and contributes to the development of AKI. In this study we want to investigate the presence of novel inflammatory mediators in patients with sepsis, patients subjected to major surgery (sterile inflammation) and non-inflamed patients and correlate their levels with the risk for AKI.


Eligibility criteria: Inclusion Criteria:

Patients admitted to the intensive/post operative care unit

* with septic shock or
* post major surgery or
* after intoxication with a chemical compund

Exclusion Criteria:

* Pregnancy or
* Breast feeding or
* Chronic kidney disease or
* intoxication with nephrotoxic compund or
* lack of informed consent

Primary outcomes:
measure: Histones
timeFrame: Within 1 month
Secondary outcomes:
measure: Other inflammtory mediators
timeFrame: Within 1 month
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Akademiska sjukhuset, Centraloperation
Study officials:
References:
Clinical trial NCT05830760: Expression of Sodium-glucose Co-transporter 2 in Human Heart
Official title: Expression of Sodium Glucose Co-transporter2 in Myocardium From Patients With Aortic Valve Stenosis and With/Without Diastolic Heart Failure
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Aortic Valve Stenosis
Keywords: human heart
myocardium
aortic valve stenosis
heart failure
sodium glucose cotransporter 2
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2023-04-26
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the study is to evaluate the expression of Sodium Glucose Co-transporter 2 (SGLT2) in myocardium from patients with aortic stenosis. 2 groups of patients will be defined: Group A with diastolic heart failure and Group B without heart failure. The expression of SGLT2 will be measured on small myocardium specimens harvested during aortic valve replacement operation. This study should allow us to better understand the effect of glifozines in human heart failure.


Eligibility criteria: Inclusion Criteria:

* adults over 18 years-old
* Patient with surgical aortic valve stenosis, with or without heart failure, in two equal-sized groups (40 subjects in each group)
* Subjects affiliated with a social security health insurance plan
* Subject able to understand the objectives and risks of the research and to give dated and signed informed consent

Exclusion Criteria:

* Infective endocarditis in aortic stenosis
* Severe coronary pathology associated with aortic stenosis
* Impossible to give the subject informed information (subject in emergency situation, difficulties in understanding the subject, ...)
* Subject under legal protection
* Subject under guardianship or curatorship
* Pregnancy and/or breastfeeding

Primary outcomes:
measure: To study the expression levels of SGLT2 in the myocardium of patients with surgical aortic stenosis
timeFrame: Day 0
measure: To study the SGLT2 tissue localization in the myocardium of patients with surgical aortic stenosis
timeFrame: Day 0
Secondary outcomes:
measure: Comparison of SGLT2 expression levels between heart failure and non-heart failure patients.
timeFrame: Day 0
measure: Assess oxidative stress
timeFrame: Day 0
measure: Evaluate the pro-inflammatory response by analysing the expression level of tissue activation molecules VCAM-1, ICAM-1, MCP-1
timeFrame: Day 0
measure: Evaluate the pro-fibrotic response
timeFrame: Day 0
measure: Evaluate the pro-senescent response
timeFrame: Day 0
measure: Evaluate the pro-thrombotic response
timeFrame: Day 0
measure: Evaluate endothelial dysfunction
timeFrame: Day 0
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg
Study officials:
References: