louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00177788: Voriconazole as Prophylaxis for Liver Transplant Recipients
Official title: Voriconazole as Prophylaxis for Liver Transplant Recipients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fungemia
Mycoses
Keywords: liver transplant
voriconazole prophylaxis
liver transplantation
voriconazole
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2005-09-15
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: liver transplant patients receiving voriconazole

Brief summary: The study aims to determine if voriconazole prevents invasive fungal infections in liver transplant recipients. Endpoints would be: occurrence of invasive fungal infection and fungal colonization. Two groups will be compared: patients who received voriconazole as prophylaxis and historical controls who did not receive this prophylaxis.

Detailed description: The following variables will be followed: time and location of positive cultures, underlying diseases and severity of illness, voriconazole usage prophylactically, physical exam findings, laboratory and radiographical data, antimicrobial usage, microbiological data and resistance patterns, choice of antifungal drugs once organism identified, suspected source of infection, microbiological outcomes, laboratory results, demographic information, medications, clinical outcome, gender, weight, ethnicity, and past medical history.

Eligibility criteria: Inclusion Criteria:

* Patients receiving a liver transplant at University of Pittsburgh Medical Center (UPMC) between January 1, 2001 and June 30, 2005.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh Medical Center
name: David Paterson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01893788: Eplerenone and Aliskiren Research Targeting Hypertensive Patients With Left Ventricular Hypertrophy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hypertensive Left Ventricular Hypertrophy
Keywords: hypertension
left ventricular hypertrophy
renin angiotensin system
aldosterone
aliskiren
eplerenone
P3NP
Lead sponsor: Nagoya University
Sponsor class: OTHER
First posted: 2013-07-09
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to determine which treatment will be more effective to reduce left ventricular mass in hypertensive patients with left ventricular hypertrophy comparing aliskiren and eplerenone.


Eligibility criteria: Inclusion Criteria:

Male or female ≧ 20 years of age Clinical diagnosis of hypertension Patients who are able to provide written informed consent

Exclusion Criteria:

1. History of congestive heart failure, myocardial infarction, or coronary revascularization in the recent 6 months.
2. Planned to taking percutaneous coronary intervention and coronary artery bypass graft
3. Severe hypertension (≧ 180/110 mmHg) or secondary hypertension or malignant hypertension.
4. History of stroke, cerebral hemorrhage, subarachnoid hemorrhage, transient ischemic attack in the recent 6 months
5. Severe valvular heart disease or atrial fibrillation
6. Congenital heart disease
7. Severe heart failure (NYHA functional class Ⅳ)
8. Current treatment with aliskiren or eplerenone or diuretics
9. Taking potassium preparation or potassium-sparing diuretic
10. Estimated GFR ≦ 30ml/min/1.73m２ at screening or current treatment with hemodialysis
11. Potassium \> 5.0mEq/L at screening
12. Diabetes mellitus with microalbuminuria or albuminuria
13. Impairment of liver function (liver failure, liver cirrhosis)
14. Pregnant woman or possibly pregnant woman
15. History of malignant tumor include hematological neoplasm
16. Current treatment with itraconazole, cyclosporin, ritonavir or nelfinavir
17. Prior treatment with, hypersensitivity to, intolerance of or contra-indication to aliskiren and/or eplerenone
18. Current participation in another clinical trial
19. Serious non-cardiovascular disease severely limiting life expectancy
20. Contra-indication to MRI

Primary outcomes:
measure: reduction of left ventricular hypertrophy measured by magnetic resonance imaging
timeFrame: 12 month
Secondary outcomes:
measure: Cardiovascular events
timeFrame: 12 month
Other outcomes:
measure: Biochemical parameters
timeFrame: 12 month
Locations:
city: Nagoya
country: Japan
facility: Department of Cardiology, Nagoya University Graduate School of Medicine
state: Aichi
Study officials:
affiliation: Department of Cardiology, Nagoya University Graduate School of Medicine
name: Toyoaki Murohara, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04966988: Multimodal Imaging Evaluation and Prognostic Analysis of Cardiac Allograft Vasculopathy in Heart Transplantation
Official title: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Heart Transplant
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
Collaborators: name: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Shanghai Zhongshan Hospital
name: Henan Provincial People's Hospital
name: Wuhan Asia Heart Hospital
name: Guangdong Provincial People's Hospital
First posted: 2021-07-19
Enrollment: 1000
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: All adult HT recipients were consecutive prospectively enrolled who underwent transthoracic echocardiography for surveillance at their routine follow-up

Brief summary: The aim is to (1) establish a system of multimodal imaging technology; (2) jointly apply multimodal imaging technology to diagnose of cardiac allograft vasculopathy of heart transplantation; (3) construct a multimodal imaging technology prediction model of adverse events, screening the best non-invasive imaging prediction indicators.

Detailed description: This study will enrolled 1000 HT patients, and the cardiac allograft vasculopathy will be evaluated by multimodal imaging technology. The aim is to (1) establish a system of multimodal imaging technology; (2) jointly apply multimodal imaging technology to diagnose of cardiac allograft vasculopathy of heart transplantation; (3) construct a multimodal imaging technology prediction model of adverse events, screening the best non-invasive imaging prediction indicators.

Eligibility criteria: Inclusion Criteria:

• Heart transplantation after January 1st, 2015.

Exclusion Criteria:

•Age \< 18 years at the time of transplantation; Died within 48 h; Heart-lung transplantation; Heart/kidney transplantation; Re-transplanted within 7 days after transplantation.

Primary outcomes:
measure: All cause death
timeFrame: up to 10 year
Secondary outcomes:
measure: Major adverse cardiac events
timeFrame: 5 year and 10 year
Other outcomes:
Locations:
Study officials:
affiliation: Department of Ultrasound, Union Hospital, Wuhan, China
name: Li Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04176588: A Phase 3 Study of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis
Official title: A Phase 3, Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Etrasimod for Induction and Maintenance Treatment in Subjects With Moderately to Severely Active Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Moderately to Severely Active Ulcerative Colitis
Lead sponsor: Everstar Therapeutics Limited
Sponsor class: INDUSTRY
First posted: 2019-11-25
Enrollment: 341
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 etrasimod is a safe and effective treatment for moderately to severely active ulcerative colitis.

Condition or disease: Ulcerative Colitis Intervention/treatment: Drug: Etrasimod Drug: Placebo Phase: Phase 3


Eligibility criteria: Inclusion Criteria:

1. A documented of diagnosis with UC at least 3 months prior to screening.
2. Have active UC confirmed by endoscopy with ≥ 10 cm rectal involved.

Exclusion Criteria:

1. Have severe extensive colitis
2. Diagnosis of Crohn's disease or indeterminate colitis or the presence or history of a fistula consistent with Crohn's disease
3. Diagnosis of microscopic colitis, ischemic colitis, infection colitis or colonic mucosal dysplasia

Primary outcomes:
measure: Proportion of Subjects With Clinical Remission Assessed by modified Mayo score(mMS)
timeFrame: induction period week 12
measure: Proportion of Subjects With Clinical Remission Assessed by modified Mayo score(mMS)
timeFrame: Maintenance period week 40
Secondary outcomes:
measure: Proportion of Subjects Achieving Endoscopic Improvement Assessed by endoscopic subscore
timeFrame: induction period week 12
measure: Proportion of Subjects with Clinical Response Assessed by modified Mayo score(mMS)
timeFrame: induction period Week 12
measure: Proportion of Subjects Achieving Endoscopic Improvement Assessed by endoscopic subscore
timeFrame: Maintenance period Week 40
measure: Proportion of Subjects with Clinical Response Assessed by modified Mayo score(mMS)
timeFrame: Maintenance period Week 40
measure: Proportion of Subjects who achieve symptomatic response over time
timeFrame: Open label treatment period up to 40 Weeks
measure: Proportion of Subjects who achieve Symptomatic Remission over time
timeFrame: Open label treatment period up to 40 Weeks
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The First Affiliated Hospital of Fourth Military Medical University, PLA
state: Shanxi
Study officials:
affiliation: The First Affiliated Hospital of Fourth Military Medical University, PLA
name: Kaichun Wu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01547988: Training Improves Balance Control
Official title: Improving Balance Control and Self-Reported Lower Extremity Function in Community Dwelling Older Adults - A Randomized Control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Accidental Falls
Keywords: Aging
Falls
Balance Control
Voluntary Step Execution Test
Dual-Task
Self-reported function
Lead sponsor: Boston University
Sponsor class: OTHER
First posted: 2012-03-08
Enrollment: 66
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate the effect of a group-based functional and specific balance training program on balance function in healthy older adults. It is commonly considered difficult to improve balance function in healthy older adults. The program included dual-task exercises; physical training exercises and a cognitive task (e.g. reading or reciting a story) performed simultaneously, as well as perturbation exercises, where balance is challenged in unexpected ways.

The investigators hypothesized that following the proposed training, older adults would improve their speed of taking a step in both single and dual task conditions, refine their ability to control balance when standing still and improve their self-reported physical function.


Eligibility criteria: Inclusion Criteria:

* 65 years or older
* Independently ambulatory (cane acceptable; not walker)
* Score better than 45 on the Berg Balance Scale
* Higher than 24 Mini-Mental Score

Exclusion Criteria:

* Severe focal muscle weakness or visual impairment
* Known neurological disorders (including stroke, Parkinson disease)
* Metastatic cancer
* Use of medication that impairs balance or strength

Primary outcomes:
measure: Reaction time of dual task step execution
timeFrame: 12 weeks
Secondary outcomes:
measure: Late Life Functional Disability Index - LLFDI
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: NeuroMuscular Research Center, Boston University
state: Massachusetts
Study officials:
affiliation: NeuroMuscular Research Center, Boston University
name: Lars IE Oddsson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lars I. E. Oddsson, Patrick Boissy and Itshak Melzer. How to improve gait and balance function in elderly individuals-compliance with principles of training. European Review of Aging and Physical Activity Volume 4, Number 1, 15-23, DOI: 10.1007/s11556-007-0019-9
citation: Melzer I, Oddsson LI. The effect of a cognitive task on voluntary step execution in healthy elderly and young individuals. J Am Geriatr Soc. 2004 Aug;52(8):1255-62. doi: 10.1111/j.1532-5415.2004.52353.x.
citation: Melzer I, Shtilman I, Rosenblatt N, Oddsson LI. Reliability of voluntary step execution behavior under single and dual task conditions. J Neuroeng Rehabil. 2007 May 29;4:16. doi: 10.1186/1743-0003-4-16.
Clinical trial NCT02682888: Trait Anxiety and Defensive Networks
Official title: Trait Anxiety Modulates Resting State Functional Connectivity of Defensive Networks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: brain functional connectivity changes
Lead sponsor: University of Electronic Science and Technology of China
Sponsor class: OTHER
First posted: 2016-02-17
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: to examine the association between trait and defensive network connectivity and the modulatory effect of oxytocin on it

Detailed description: Individuals with high trait anxiety show stable anxiety proneness even in the absence of real threat, which could be a result of intrinsic hyper-connectivity in the defensive systems. In the present study, healthy subjects' trait anxiety levels will be assessed by the sub-trait inventory of the State-Trait Anxiety Inventory. Then two experiments using resting-state fMRI technique will be conducted to first map how hubs in the defensive systems organized in high anxious individuals in a stimuli-free situation (Experiment 1) and then we will examine the modulatory effect of the intranasal administration of oxytocin on functional connectivity in these independently defined defensive networks (Experiment 2).

Eligibility criteria: Inclusion Criteria:

* Healthy subjects without past or current psychiatric or neurological disorders

Exclusion Criteria:

* females should not be pregnant or during menstruation.

Primary outcomes:
measure: the resting state functional connectivity changes in the defensive network
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: school of life science and technology, University of Electronic Science and Technology of China
state: Sichuan
Study officials:
affiliation: University of Electronic Science and Technology of China
name: Keith Kendrick, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02499588: User Evaluation of the Peristomal Skin Condition in Ostomates Using ConvaTec Moldable Technology™
Official title: Observational User Evaluation of the Peristomal Skin Condition in Ostomates Using ConvaTec Moldable Technology™
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colostomy
Ileostomy
Urostomy
Lead sponsor: ConvaTec Inc.
Sponsor class: INDUSTRY
First posted: 2015-07-16
Enrollment: 600
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: Subjects with colostomy, ileostomy or urostomy

Brief summary: The primary aim of this study is to demonstrate the maintenance of healthy peri-stomal skin over a two month period in subjects who use ConvaTec Moldable Technology™ Skin Barriers as part of their standard protocol of care following surgery.


Eligibility criteria: Inclusion Criteria:

* Subjects who are 18 years old and older.
* Subjects who agree to participate in the evaluation and who have signed the informed consent form.
* Subjects presenting with a stoma (ileostomy, colostomy or urostomy).
* Subjects for whom ConvaTec Moldable Technology™ per package insert, within the context of routine clinical care is used as the first long-term (within 7 days of ostomy surgery) system following surgery and who have intact peristomal skin (healthy or SACs L1).

Exclusion Criteria:

* Subjects who, according to the investigator, have cognitive problems that prevent them from answering a questionnaire or for whom the evaluation could be a problem.
* Subjects who are in a simultaneous clinical evaluation.

Primary outcomes:
measure: Peri-stomal skin condition at 8-15 days following the application of the barrier.
timeFrame: 8-15 days
Secondary outcomes:
measure: Peristomal skin condition in ostomates at 1 month (± 15 days) following the application of the barrier.
timeFrame: 1 month (± 15 days)
measure: Peristomal skin condition in ostomates at 2 months (± 15 days) following the application of the barrier.
timeFrame: 2 months (± 15 days)
Other outcomes:
Locations:
city: Gorzow Wielkopolski
country: Poland
facility: Voivodeship Specialistic Hospital in Gorzow Wlkp.
state: Lubuskie
Study officials:
affiliation: Sponsor GmbH
name: Kim Peters, BSc (Hons)
role: STUDY_DIRECTOR
References:
Clinical trial NCT05213988: Effects on Glucose Homeostasis of Changes in Plasma Lipoproteins Induced by Nutritional and Pharmacologic Strategies
Official title: Effects on GLUcose Homeostasis of Changes in Plasma Lipoproteins Induced by Nutritional and Pharmacologic STrategies Against Diabetes-Related Metabolic Diseases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glucose Metabolism Disorders
Lead sponsor: Azienda Ospedaliero, Universitaria Pisana
Sponsor class: OTHER
First posted: 2022-01-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators aim to examine the impact of changes in plasma lipoproteins induced by nutritional and pharmacological interventions on glucose homeostasis


Eligibility criteria: Inclusion Criteria:

* age 18-65 years
* both males and females

Exclusion Criteria:

* acute or chronic conditions influencing glucose and lipid metabolism
* pregnancy

Primary outcomes:
measure: Glucose tolerance
timeFrame: 180 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: Azienda Ospedaliero-Universitaria Pisana
state: PI
Study officials:
affiliation: University of Pisa
name: Andrea Natali, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02617888: Effects of Heart Imaging Radiation on DNA Double-Stranded Breaks in Blood Lymphocytes and Hair Follicle Cells
Official title: The HEART BREAK Study: Effects of Heart Imaging Radiation on DNA Double-Stranded Breaks in Blood Lymphocytes and Hair Follicle Cells
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Chest Pain
Keywords: radiation
cardiac computed tomography
CCTA
breast shielding
Myocardial perfusion scintigraphy
MPS
Invasive coronary angiography
ICA
Lead sponsor: Walter Reed National Military Medical Center
Sponsor class: FED
First posted: 2015-12-01
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Purpose

1. To investigate the effects of cardiac imaging radiation on the induction of DNA double-strand breaks by enumerating gamma-H2AX foci in blood lymphocytes and plucked hair follicle cells.
2. To estimate whether the use of breast shields in cardiac computed tomographic angiography (CCTA) limits the effective radiation exposure of breast tissue.

Detailed description: The primary objective of the study is to analyze blood and hair samples from patients undergoing cardiac imaging to estimate radiation exposure levels as well as their biological effects (i.e. to determine the degree of genotoxicity by measuring the amounts of DNA double-strand breaks).

The secondary objective is to investigate whether the use of in-plane breast shielding in female patients undergoing CT angiography (CCTA) limits the radiation exposure of breast tissue and subsequent DNA damage in blood lymphocytes and hair follicle cells.

Eligibility criteria: Inclusion Criteria:

* Adult male and female adult subjects (age greater than 18 years)
* Referred for cardiac computed tomography angiography (CCTA), myocardial perfusion scintigraphy (MPS), or diagnostic invasive coronary angiography (ICA).

Exclusion Criteria:

* Female patients that identify themselves as pregnant or have a positive pregnancy test prior to cardiac imaging.
* History (present or past) of leukemia or lymphoma.
* History of radiation therapy
* X-ray examination or scintigraphy within the last 72 hours.
* History of coronary revascularization (coronary artery bypass grafting or percutaneous coronary intervention)
* Patients undergoing percutaneous coronary intervention at completion of diagnostic left heart catheterization

Primary outcomes:
measure: Number of Excess Double-strand DNA Break Foci Per Cell in Peripheral Blood Samples Post-imaging
timeFrame: Change from baseline double strand DNA breaks at 30 minutes post-imaging
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: WRNMMC
name: Todd C Villines, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00262288: Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema
Official title: A Phase II/III Study of the Efficacy and Safety of Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Genetic Disorders
Lead sponsor: Pharming Technologies B.V.
Sponsor class: INDUSTRY
First posted: 2005-12-06
Enrollment: 14
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this multi-center study is to explore the efficacy, safety, tolerability and pharmacokinetics/pharmacodynamics of recombinant human C1 inhibitor in the treatment of acute attacks in patients with hereditary angioedema.


Eligibility criteria: Main inclusion Criteria:

* Clinical and laboratory diagnosis of HAE
* Plasma level of functional C1INH of less than 50% of normal
* Severe attack of abdominal, facial-oro-pharyngeal, genito-urinary and/or peripheral HAE.

Main exclusion Criteria:

* Acquired angioedema
* Pregnancy or breastfeeding
* Participation in another clinical study within prior 3 months

Primary outcomes:
measure: Primary outcomes: Relief of angioedema symptoms
timeFrame: 24 hours
Secondary outcomes:
measure: Secondary outcomes: Safety and tolerability; pharmacokinetics/pharmacodynamics
timeFrame: 90 days
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: For information on sites in Europe, please contact Pharming Technologies.
Study officials:
affiliation: Pharming Technologies B.V.
name: Jan Nuijens, MD, PhD
role: STUDY_CHAIR
References: