louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06759831: Clinical and Immunological Outcomes of Living and Deceased Donor Transplantation
Official title: Clinical and Immunological Outcomes of Living and Deceased Donor Transplantation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Transplant Recipient (Kidney)
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-01-06
Enrollment: 1293
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: The medical records of all patients undergoing kidney transplantation performed at the O.U. Nephrology, Dialysis and Transplantation of IRCCS AOUBO from January 2017 until the start of the study will be retrospectively reviewed. After that, all kidney transplant recipients over the next 9 years, performed c/o the U.O. Nephrology, Dialysis and Transplantation of IRCCS AOUBO, will be prospectively enrolled.

Brief summary: This is a retrospective, prospective, single-centre, non-pharmacological observational study.

The primary objective is to investigate the long-term prognosis of the kidney transplant function of different types of donors.

Detailed description: It provides for the systematic collection of clinical information of patients undergoing kidney transplantation from 01/01/2017 until the Ethics Committee approves the study and the Director General of the IRCCS issues the authorisation. Data collection will continue for 9 years after the start of the study.

Patients participating in the prospective part will be treated according to clinical practice, in accordance with the judgement of the physician and the information reported in the Technical Data Sheet of each individual product of any concomitant therapies administered according to clinical practice. There are no additional study-specific visits/examinations for enrolled patients and any data recorded for the purposes of the study is collected for care purposes during the patient's normal course of treatment.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years.
* Kidney transplant recipient from any donor.
* Acquisition of Informed Consent to study participation and data processing.

Exclusion Criteria:

-

Primary outcomes:
measure: the functionality of kidney transplantation
timeFrame: 1 month, 6 months, 1 year, 5 years, 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Sant'Orsola University Hospital - Nephrology, Dialysis and Transplant Unit
state: BO
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Giorgia Comai, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02304731: Physical Exercise and Pollution: Cardiorrespiratory, Cerebral and Molecular Aspects
Official title: Physical Exercise and Pollution: Cardiorrespiratory, Cerebral and Molecular Aspects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cognitive Function 1, Social
Keywords: Physical Exercise, Atmospheric Pollution, Cognition.
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: University of Sao Paulo
First posted: 2014-12-02
Enrollment: 45
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Modern society increasingly seeks healthy life style, and regular physical activity is considered one of the main factors that improve the quality of life. The evidence shows that the aerobic physical training in controlled environments benefit various aspects of human health, including cognition in the elderly population. However, when exercise is performed in a polluted environment, the individual is subjected to grater exposure to pollutants due to increased ventilation (breathing).

Detailed description: Modern society increasingly seeks healthy life style, and regular physical activity is considered one of the main factors that improve the quality of life. The evidence shows that the aerobic physical training in controlled environments benefit various aspects of human health, including cognition in the elderly population. However, when exercise is performed in a polluted environment, the individual is subjected to grater exposure to pollutants due to increased ventilation (breathing). It is well known that inhaled pollutants can cause oxidative modification in biomolecules and oxidative stress is a cause of diverse diseases. This scenario raises important questions: the deleterious effects of pollution can abolish the beneficial effects of exercise? This issue is currently relevant given the increasing level of air pollution in large urban centers such as Sao Paulo city and at the same time, outdoor physical activity in public places is largely stimulated by public organizations, particularly for elderly. Thus this multidisciplinary project aims to investigate the deleterious effects of urban air pollution in elderly people who practice aerobic physical exercise outdoors in Sao Paulo and compare with those who practice in Laboratory. This study can provide important knowledge for public health and welfare of the population.

Eligibility criteria: Inclusion Criteria: Health Subjects that lives in São Paulo city for at least 10 years.

-

Exclusion Criteria: Neuropsychological issues.

-

Primary outcomes:
measure: Cognitive Benefits
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of São Paulo
name: Luciana Caxá, Master
role: STUDY_CHAIR
References:
Clinical trial NCT02859831: Sautour PHRC IR 2008
Official title: Fungal Contamination of a Hospital Water System With Fusarium App.: Prospective Environmental and Medical Surveillance During a Construction Period
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mycosis
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2016-08-09
Enrollment: 551
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: water samples from the rooms of hospitalized patients in 4 departments of Dijon and Nancy CHU

Brief summary: Fusarium are microscopic filamentous fungi that live as saprobiontics in outside environments. They are found in the soil, the air, in water and on numerous plants. The frequency of fusariosis is currently increasing and Fusarium-related mycoses are the 3rd most frequent invasive mycoses. Most cases have been reported in the United States, in France, in Italy and in Brazil. A few epidemiological studies have shown the role of water in the appearance of mycoses in highly immunodepressed patients. Few studies have focused on the role of water in the transmission of mycoses in hospitals. The aim of this prospective study is to describe, in time and pace, the contamination by Fusarium sp. in the water of two different hospitals (Dijon, Nancy), by taking into account factors such as seasons and major works (reconstruction of a hospital). In each hospital, one reconstruction site will be compared with a site not under reconstruction (control).

Water samples will be taken from the rooms of hospitalized patients.


Eligibility criteria: Inclusion Criteria:

all patients with new-onset fusariosis in the Adult Haematology, Internal Medicinie, Digestive Surgery and Rheumatology Departments

Exclusion Criteria:

none

Primary outcomes:
measure: Presence of Fusarium sp
timeFrame: every week throughout the study, thus over 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References:
Clinical trial NCT04357431: COVID-19 Among Egyptian Health Care Providers
Official title: Knowledge, Attitude, Perceived Worry and Stigma About COVID-19 Among Egyptian Health Care Providers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-04-22
Enrollment: 565
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Health care providers include physicians, nurses, and health officers both medical and nursing subjects.

Brief summary: The study aims to identify COVID 19 knowledge, working conditions, perception of anxiety and stigma among Egyptian health care providers as well as their predictors.


Eligibility criteria: Inclusion Criteria:

* Health care providers include physicians, nurses, and health officers both medical and nursing subjects.

Exclusion Criteria:

* Medical students

Primary outcomes:
measure: The percentage of knowledge regarding COVID-19 information
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Abbas
state: Cairo
Study officials:
References:
Clinical trial NCT04733131: Long-term Outcomes After Conversion to Belatacept
Official title: Long-term Outcomes After Conversion to a Belatacept-based Immunosuppression in Kidney Transplant
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Kidney Transplant Failure and Rejection
Immunosuppression
Graft Loss
Drug Effect Prolonged
Keywords: belatacept
multicenter study
Long term outcomes
Lead sponsor: Paris Translational Research Center for Organ Transplantation
Sponsor class: OTHER
First posted: 2021-02-01
Enrollment: 324
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients converted to a belatacept regimen after kidney transplant

Brief summary: belatacept is a selective T-cell co-stimulation blocker that was approved by Food and Drug Administration (FDA) in 2011 for the prophylaxis of graft rejection in adult kidney transplant recipients. This treatment is indicated as an alternative to Calcineurin Inhibitors (CNIs) for prophylaxis of graft rejection in de novo renal transplant recipients. Long term efficacy and safety outcomes of a kidney transplant population converted to a belatacept regimen after transplant have not been yet reported.

Detailed description: belatacept is a selective T-cell co-stimulation blocker that was approved by Food and Drug Administration (FDA) in 2011 for the prophylaxis of graft rejection in adult kidney transplant recipients. This treatment is indicated as an alternative to Calcineurin Inhibitors (CNIs) for prophylaxis of graft rejection in de novo renal transplant recipients. Major studies evaluating belatacept showed that de novo kidney transplant patients treated with belatacept presented an improved renal function with a higher average estimated glomerular filtration rate (eGFR) compared to ciclosporin (CsA) regimen in patients. Conversion to belatacept after transplant seems to be safe even in highly sensitized patients. However, long term efficacy and safety outcomes of a kidney transplant population converted to a belatacept regimen after transplant and compared to a matched control group under a CNIs regimen have not been yet reported.

A multicenter cohort of kidney transplant patients, will be use to match patients converted to a belatacept immunosuppressive regimen to a control group under CNIs immunosuppressive regimen.

Eligibility criteria: Inclusion Criteria:

* Male or Female, over 18 years of age
* Recipient of kidney allograft from a living donor or a deceased donor

Exclusion Criteria:

* Graft loss during the first three months post-transplant
* Epstein-Barr virus Seronegative in the belatacept group

Primary outcomes:
measure: Allograft survival after conversion to belatacept
timeFrame: 5 years
measure: Patient survival after conversion to belatacept
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Paris Translational Research Center for Organ Transplantation
name: Alexandre Loupy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04597931: Evaluation of Romosozumab vs. Zoledronic Acid Effect in Patients With Spinal Cord Injury and Low Bone Mineral Density
Official title: Evaluation of Romosozumab vs. Zoledronic Acid Effect in Patients With Spinal Cord Injury and Low Bone Mineral Density
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Osteoporosis Fracture
Spinal Cord Injuries
Keywords: bone mineral density
fracture
romosozumab
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2020-10-22
Enrollment: 30
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: open label
Primary purpose: TREATMENT

Brief summary: This is a randomized study to determine the effects of monthly romosozumab for one year or one-time zoledronic acid on bone mineral density (BMD) and biochemical markers of bone formation and resorption, in patients with spinal cord injury (SCI) and low BMD.

Detailed description: This is a randomized open-label study to determine the effects of monthly romosozumab for 12 month or one-time zoledronic acid infusion on bone mineral density (BMD) and biochemical markers of bone formation and resorption, in patients with spinal cord injury (SCI) and low BMD.

Patients: Thirty women between 20-70 years of age with spinal cord injury and low bone mass (BMD T-score lower than -2.0 in at least one location: Lumbar Spine, Femoral Neck or Total Hip sites) will receive study medication.

Primary outcome:

Total hip BMD change during a one-year treatment period.

Secondary outcome:

Change in Femoral neck BMD at 12 months, Bone turnover markers change over time (3, 9 and 12 month): C-terminal telopeptide of type I collagen (CTX), N-terminal propeptide of type I procollagen (P1NP).

Study population:

Thirty women between 20-70 years of age with spinal cord injury that occurred more than 24 month ago and low bone mass (BMD T-score lower than -2.0 in at least one location: Lumbar Spine, Femoral Neck or Total Hip sites)

Eligibility criteria: Inclusion Criteria:

* BMD T-score ≤ -2.0 at the lumbar spine, total hip or femoral neck
* SCI of at least 24-month but less than 7 years duration,
* American Spinal Injury Association (ASIA) Impairment Scale A-C

Exclusion Criteria:

* myocardial infarction (MI) or stroke within the preceding year
* high cardiovascular risk, 10 years Framingham score over 20 %.

Primary outcomes:
measure: Total hip BMD change during a one-year treatment period
timeFrame: one year
Secondary outcomes:
measure: Change in Femoral neck BMD at 12 months
timeFrame: one year
measure: Bone turnover markers change
timeFrame: one year
Other outcomes:
Locations:
Study officials:
affiliation: Sheba Medical Center, Tel Hashomer
name: Liana Tripto-Shkolnik, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01926431: Effects of Intense Exercise on Neural Responses to Food.
Official title: The Effects of High Intensity Exercise on Neural Responses to Images of Food
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neural Responses
Appetite Hormones
Subjective Appetite Sensations
Lead sponsor: University of Birmingham
Sponsor class: OTHER
First posted: 2013-08-21
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The primary aim of this study was to determine the effects of an acute bout of high intensity exercise on the brains response to viewing pictures of food using functional magnetic resonance imaging (fMRI).

Detailed description: It is clear that intense exercise impacts on peripheral appetite regulation, however very little is known about the impact of high-intensity exercise on central appetite regulation. This study aimed to investigate the effects of high-intensity exercise on both central and peripheral responses to images of food. Functional magnetic resonance techniques were used to assess the brains response to images of high and low calorie foods, following a short bout of high-intensity exercise. Appetite hormone concentrations were also measured. It was hypothesized that, due to the known effects of high-intensity exercise on appetite regulatory hormones and subjective appetite ratings, the activation of reward-related brain regions to visual food cues would be modulated following intense physical activity.

Eligibility criteria: Inclusion Criteria:

* Healthy, non-smokers, free from cardiovascular disease and metabolic disease, no medication, participated in moderate/vigorous physical activity (\>2 hours per week)

Exclusion Criteria:

* Smokers, history of cardiovascular/metabolic disease, low physical activity levels, inability to participate in fMRI scanning sessions including contraindications to MRI

Primary outcomes:
measure: Neural responses following exercise and rest
timeFrame: Ten minutes post-exercise/rest
Secondary outcomes:
measure: Appetite hormones
timeFrame: Blood samples taken at baseline, following exercise/rest, prior to the fMRI assessment and immediately following the fMRI assessment
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Birmingham University Imaging Centre
state: Midlands
Study officials:
affiliation: University of Birmingham
name: Andrew Blannin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Crabtree DR, Chambers ES, Hardwick RM, Blannin AK. The effects of high-intensity exercise on neural responses to images of food. Am J Clin Nutr. 2014 Feb;99(2):258-67. doi: 10.3945/ajcn.113.071381. Epub 2013 Dec 4.
Clinical trial NCT00781131: Trial of Pregabalin for Post-operative Pain in Women Undergoing Abdominal Hysterectomy
Official title: A Randomized, Placebo Controlled Trial of Pregabalin for Post-operative Pain in Women Undergoing Abdominal Hysterectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Opioid Use
Lead sponsor: IWK Health Centre
Sponsor class: OTHER
First posted: 2008-10-28
Enrollment: 101
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We hypothesize that pregabalin will decrease post-operative pain scores and opioid use following abdominal hysterectomy compared to placebo. This study has been designed to determine if after an abdominal hysterectomy, the addition of pregabalin to their peri-operative analgesia regimen will demonstrate superior analgesia compared to placebo in terms of lower pain scores and reduced usage of opioids. The primary outcome will be post-operative pain, measured by total opioid consumption.

Do women undergoing an abdominal hysterectomy with general anesthesia and receiving pregabalin prior to their surgery and 12 hours later have lower opioid consumption in the first 24 hours after their surgery than those women who received placebo?


Eligibility criteria: Inclusion Criteria:

1. American Society of Anesthesia physical status class I \& II
2. Age \> 18 years
3. English-speaking
4. Capability to operate a patient-controlled analgesia (PCA) device

Exclusion Criteria:

1. Known or suspected allergy, sensitivity, or contraindication to pregabalin or any of the standardized medications (i.e. morphine, anesthetic agents)
2. Morbid Obesity (Body Mass Index ≥ 45 kg/m2)
3. History of a seizure disorder
4. Current therapy with pregabalin, gabapentin, or any opioid
5. Any other physical or psychiatric condition which may impair their ability to cooperate with post-operative study data collection
6. CrCl \< 60 ml/min \[CrCl = 0.85 x ((140 - age) x weight(kg)) / (72 x Cr(mg/dL)))\]

Primary outcomes:
measure: Do women undergoing an abdominal hysterectomy with general anesthesia and receiving pregabalin prior to their surgery and 12 hours later have lower opioid consumption in the first 24 hours after their surgery than those women who received placebo?
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
Study officials:
affiliation: IWK Health Centre
name: Ronald B George, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: George RB, McKeen DM, Andreou P, Habib AS. A randomized placebo-controlled trial of two doses of pregabalin for postoperative analgesia in patients undergoing abdominal hysterectomy. Can J Anaesth. 2014 Jun;61(6):551-7. doi: 10.1007/s12630-014-0147-4. Epub 2014 Mar 26.
Clinical trial NCT01827631: Single and Repeat Dose Pharmacokinetic Study of GSK1605786 in Healthy Chinese Subjects
Official title: Single and Repeat Dose Pharmacokinetic Study of GSK1605786 in Healthy Chinese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Crohn's Disease
Keywords: healthy
GSK1605786
CCR9 receptor antagonist
Chinese subjects
pharmacokinetics
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2013-04-09
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an open-label, parallel group, single and repeat dose pharmacokinetic (PK) study in healthy male and female subjects. This study will confirm the PK and safety profile in Chinese subjects. GSK1605786 is currently in clinical development for the treatment of Crohn's disease. Subjects will receive one of two GSK1605786 doses (500 mg once daily or 500mg twice daily) within 30 minutes after a meal. The study will consist of single and repeat dose sessions, with pre-dose and serial PK samples taken up to 72-h post-dose.


Eligibility criteria: Inclusion Criteria:

* Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and ECG
* Male or female between 18 and 45 years of age
* Body weight 50 kg (110lbs) for men and women, and body mass index (BMI) within the range 19 24 kg/m2

Exclusion Criteria:

* A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
* Current or chronic history of liver disease, or known hepatic or biliary
* A positive test for HIV antibody at screening
* Known coeliac disease and positive serologic testing for anti-tTG antibodies
* A positive pre-study drug/alcohol screen
* Lactating females

Primary outcomes:
measure: Cmax
timeFrame: up to 72 hour post dose
measure: AUC(0-τ)
timeFrame: up to 24 hour post last dose
Secondary outcomes:
measure: adverse events (AEs)
timeFrame: up to 21 days, from the first dose until the follow-up visit
measure: vital signs
timeFrame: before each morning dose on Day 1 and 8-14, and on Day 17 prior to leaving the clinic
measure: lab assessment
timeFrame: Day 17 prior to leaving the clinic
Other outcomes:
Locations:
city: Shanghai
country: China
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: