louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00001107: Comparison of Two Treatments to Prevent Invasive Fungal Infections in Patients Who Have Received Liver Transplants
Official title: Invasive Fungal Infection in Liver Transplant Recipients: A Randomized Double-Blind Trial Comparing AmBisome and Fluconazole in the High Risk Group and an Observational Cohort Study in the Low Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Candidiasis
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2001-08-31
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to compare the safety and effectiveness of 2 treatments to prevent invasive fungal infections (IFI), which are infections caused by yeasts and molds that are common in patients with weak immune systems or transplant patients. AmBisome, a new treatment, will be compared to fluconazole, the traditional treatment for fungal infections caused by the yeast Candida. Treatment will only be given to liver transplant patients who are found to be at high risk for IFI. Liver transplant patients who are at low risk for IFI will be monitored but will receive no study medication.

IFIs are found mainly in a high risk group of liver transplant patients, and are not common in those with low risk. If IFI preventive therapy is focused on the high risk group, there may be a lesser chance of Candida becoming resistant (able to grow despite the presence of drugs used to kill it). Treating only the high risk group will also save money.

Detailed description: If you are in the high risk group you will be assigned randomly (like tossing a coin) to receive either AmBisome or fluconazole. If you are in the low risk group, you will not receive any treatment. Both groups will be monitored for IFIs. The study will last for 100 days following your liver transplant.

Eligibility criteria: Inclusion Criteria:

You may be eligible for this study if you:

* Have had a liver transplant within 5 days of enrollment and agree to receive tacrolimus.

Exclusion Criteria:

You will not be eligible for this study if you:

* Are HIV-positive.
* Have a history of invasive fungal infection.
* Have received antifungal agents within 14 days prior to your liver transplant.
* Are allergic to azoles, amphotericin B, or tacrolimus.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Mary Ellen Bradley
state: Alabama
Study officials:
References:
citation: Hadley S, Huckabee C, Pappas PG, Daly J, Rabkin J, Kauffman CA, Merion RM, Karchmer AW. Outcomes of antifungal prophylaxis in high-risk liver transplant recipients. Transpl Infect Dis. 2009 Feb;11(1):40-8. doi: 10.1111/j.1399-3062.2008.00361.x. Epub 2008 Dec 19.
Clinical trial NCT02306707: Outcomes of Endoscopic Resection of Mucosal and Submucosal Lesions in the Stomach
Official title: Outcomes of Endoscopic Resection of Mucosal and Submucosal Lesions in the Stomach.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adenoma, Villous
Lead sponsor: Western Sydney Local Health District
Sponsor class: OTHER
First posted: 2014-12-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have stomach adenomas which are amendable to Endoscopic Mucosal Resection

Brief summary: A patient referred to have a lesion in the stomach removed. The aims of this study are to collect information on the technique of endoscopic removal of such lesions. By collecting information on a large number of patients undergoing this procedure the investigators can determine the best ways of diagnosing and removing these lesions safely and effectively.


Eligibility criteria: Inclusion Criteria:

* Stomach lesion \> 10mm
* Lesion limited to the mucosal and/or submucosal layer (T1 lesion)
* Aged 18 years or older

Exclusion Criteria:

* Lesion less than 10mm
* Stomach lesion involves the muscularis propria (T2 lesion) on other staging modalities such as endoscopic ultrasonography (EUS)
* Aged younger than 18 years

Primary outcomes:
measure: Observed procedural data: Number of Participants with Adverse Events as a Measure of Safety and Tolerability Outcomes
timeFrame: 14 days
Secondary outcomes:
measure: Analysis of the costs of this procedure compared to previous treatments
timeFrame: 14 days
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Westmead Hospital Endoscopy Unit
state: New South Wales
Study officials:
affiliation: Western Sydney Local Health District
name: Michael J Bourke, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tate DJ, Klein A, Sidhu M, Desomer L, Awadie H, Lee EYT, Mahajan H, McLeod D, Bourke MJ. Endoscopic submucosal dissection for suspected early gastric cancer: absolute versus expanded criteria in a large Western cohort (with video). Gastrointest Endosc. 2019 Sep;90(3):467-479.e4. doi: 10.1016/j.gie.2019.04.242. Epub 2019 May 8.
Clinical trial NCT05743907: Clinical Trial to Evaluate the Efficacy and Safety of DA-2811 When Added to Ongoing Metformin Monotherapy in Patients with Type 2 Diabetes Who Have Inadequate Glycemic Control
Official title: A Multicenter, Double-blind, Active-controlled, Randomized, Parallel, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of DA-2811 When Added to Ongoing Metformin Monotherapy in Patients with Type 2 Diabetes Who Have Inadequate Glycemic Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-02-24
Enrollment: 231
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a multicenter, double-blind, active-controlled, randomized, parallel, phase IV clinical trial to evaluate the efficacy and safety of DA-2811 when added to ongoing metformin monotherapy in patients with type 2 diabetes who have inadequate glycemic control


Eligibility criteria: Inclusion Criteria:

* Subjects with 7.0%≤HbA1c≤10.0% at screening
* Subjects treated with 1,000mg/day or higher dose of metformin for at least 8 weeks prior to screening
* Subjects with 18.5kg/m2≤BMI≤40kg/m2 at screening
* Subject who is willing and able to provide informed consent indicating that they understand the purpose and procedures required for the study

Exclusion Criteria:

* Subjects with fasting plasma glucose≥240mg/dL at screening
* Patients with type 1 diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus
* Subject with ALT and AST 3 times or higher than upper normal range
* Subject with history of myocardial infarction, cerebral infarction within 3 months prior to screening

Primary outcomes:
measure: HbA1c(%)
timeFrame: Change from baseline at 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: The Catholic University of Korea Bucheon St. Mary's Hospital
Study officials:
References:
Clinical trial NCT03839407: The Impact of the MUSE Meditation Device on Student Registered Nurse Anesthetists
Official title: The Impact of the MUSE Meditation Device on Perceived Stress, Anxiety, Affect, and Burnout Among Student Registered Nurse Anesthetists
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Anxiety
Affect
Burnout, Professional
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 34
Sex: ALL
Minimum age (years): 24
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The question this study is designed to answer is whether or not the use of a MUSE Meditation Device lowers student registered nurse anesthetist's perception of stress, anxiety, and burnout within the Mayo Clinic Doctorate of Nurse Anesthesia Practice Program.


Eligibility criteria: Inclusion Criteria:

* Student Registered Nurse Anesthetists at Mayo Clinic in the class of 2021 and 2022.

Exclusion Criteria:

* Student Registered Nurse Anesthetists at Mayo Clinic who are not in the class of 2021 and 2022.

Primary outcomes:
measure: Change in Stress, as measured by the Perceived Stress Scale-10
timeFrame: baseline and 3, 6, and 12 months
Secondary outcomes:
measure: Change in Anxiety, as measured by the Generalized Anxiety Disorder Scale-7
timeFrame: baseline and 3, 6, and 12 months
measure: Change in Affect, as measured by the Positive and Negative Affect Scale
timeFrame: baseline and 3, 6, and 12 months
measure: Change in Burnout, as measured by the Maslach Burnout Inventory-2
timeFrame: baseline and 3, 6, and 12 months
measure: Change in Self-Perceived Medical Error, as measured by a single question.
timeFrame: 3 & 6 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Diana Kelm, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05658588: Hemodynamic Impact of Cytosorb and CKRT in Children With Septic Shock
Official title: Impact of Cytosorb and CKRT on Hemodynamics in Pediatric Patients With Septic Shock: the PedCyto Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Septic Shock
Keywords: Pediatric Septic Shock
Blood Purification
AKI
Pediatric Critical Care
Hemoperfusion
CKRT
Lead sponsor: Ospedale Pediatrico Bambin Gesù
Sponsor class: OTHER
First posted: 2022-12-21
Enrollment: 17
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: a two-stage plan by Simon
Primary purpose: TREATMENT

Brief summary: Impact of the hemoadsorption with Cytosorb on hemodynamic in pediatric patients with septic shock: a prospectic pediatric pilot study

Detailed description: Prospective interventional pilot study included children with septic shock, weight ≥ 10 Kgs and requiring continuous kidney replacement therapy. Cytosorb (CytoSorbents Inc, New Jersey, USA) cartridge was added to CKRT every 24 hours for a maximum of 96 hours. A control group of matched patients was also identified from an external database. The primary outcome of the study was the proportion of patients who achieved an equal or more than 50% relative reduction in vasopressors or inotropes dose from baseline to the end of treatment. Secondary outcomes included doses of vasopressors and inotropes, hemodynamic and biological changes, changes in severity scores and 28-day mortality.

Eligibility criteria: Inclusion Criteria:

1. Children weighing ≥ 10 kg
2. Septic shock as defined by the International Pediatric Consensus Conference
3. Need for Continuous Renal Replacement Therapy (CRRT) = acute kidney injury defined by the KDIGO criteria (16) AND/OR fluid overload ≥ 10%

Exclusion Criteria:

* Refused consensus by parents
* Concomitant use of other extracorporeal blood purification techniques.

Primary outcomes:
measure: Vasopressors and inotropes reduction
timeFrame: 96 hours
Secondary outcomes:
measure: Changes in hemodynamic parameters
timeFrame: 96 hours
Other outcomes:
measure: Organ dysfunction change
timeFrame: 96 hours
measure: Biomarkers of infection change
timeFrame: 96 hours
measure: Perfusion indexes change
timeFrame: 96 hours
measure: Mortality
timeFrame: 90 days
Locations:
city: Rome
country: Italy
facility: Gabriella Bottari
Study officials:
References:
Clinical trial NCT06208007: Arterial Stiffening as a Predictor for Diastolic Cardiac Dysfunction and HFpEF
Official title: Arterial Stiffening as a Predictor for Diastolic Cardiac Dysfunction and HFpEF
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure With Preserved Ejection Fraction
Cardiovascular Morbidity
Lead sponsor: University Medical Center Goettingen
Sponsor class: OTHER
First posted: 2024-01-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients at risk for HFpEF

Brief summary: Patients at risk for developing heart failure with preserved ejection fraction (HFpEF) will undergo a structured clinical assessment, transthoracic echocardiography and pulse-wave analysis to investigate the association of arterial stiffening and the development of cardiac diastolic dysfuntion and HFpEF.


Eligibility criteria: Inclusion Criteria:

One or more of the following criteria:

* Age \> 60 years
* Arterial hypertension (RR systolic ≥ 140 mmHg or diastolic ≥ 90 mmHg or ≥ 2 antihypertensive drugs)
* Diabetes mellitus Type I or II
* Atrial fibrillation
* Chronic kidney disease (GFR \< 60 ml/min/1,73 m2 or urine albumin ≥ 30mg/24h or ACR ≥ 30 mg/g)
* BMI ≥ 30 kg/m2
* NYHA ≥ II
* E/e' \> 8

Exclusion Criteria:

* Left ventricular ejection fraction \< 50 %
* Significant valve disease (Grade III or higher)
* History of interventional or surgical valve repair
* Regional wall motion abnormalities
* Respiratory diseases as a known cause for dyspnea
* Atrial flutter or fibrillation during examination
* Hypertrophic/restrictive/arrhythmogenic/dilatative cardiomyopathies including cardiac amyloidosis or sarcoidosis and toxic cardiomyopathy
* History of heart transplantation

Primary outcomes:
measure: Change in HFA-PEFF-Score
timeFrame: 24 months
measure: Development of HFpEF
timeFrame: 24 months
measure: Composite endpoint cardiovascular events
timeFrame: 24 months
Secondary outcomes:
measure: Change of individual parameters included in the HFA-PEFF-Score
timeFrame: 24 months
measure: Change of NT-proBNP
timeFrame: 24 months
measure: Change of NYHA-class
timeFrame: 24 months
measure: Development or aggravation of albuminuria
timeFrame: 24 months
measure: Change of blood-creatinine
timeFrame: 24 months
Other outcomes:
Locations:
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen
state: Niedersachsen
Study officials:
References:
Clinical trial NCT05818007: Is Hyaluronic Acid Gel Effective on Oral Mucositis in Children Who Receiving Chemotherapy
Official title: The Effects of Hyaluronic Acid Gel on Oral Mucositis in Children Receiving Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Oral Mucositis
Keywords: mucositis
hyaluronic acid
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Oral mucositis (OM) is a common side effect of systemic chemotherapy (CT) in cancer patients. The aim of this study was to investigate the effect of hyaluronic acid (HA) gel on OM in children receiving CT.


Eligibility criteria: Inclusion Criteria:

* children who receive chemotherapy
* hospitalized patient

Exclusion Criteria:

- Allergy about using drugs

Primary outcomes:
measure: World Health Organization Common Toxicity Criteria Scale
timeFrame: day 1st
measure: World Health Organization Common Toxicity Criteria Scale
timeFrame: day 2nd
measure: World Health Organization Common Toxicity Criteria Scale
timeFrame: day 3rd
measure: World Health Organization Common Toxicity Criteria Scale
timeFrame: day 4th
measure: World Health Organization Common Toxicity Criteria Scale
timeFrame: day 5th
measure: World Health Organization Common Toxicity Criteria Scale
timeFrame: day 6th
measure: World Health Organization Common Toxicity Criteria Scale
timeFrame: day 7th
measure: World Health Organization Common Toxicity Criteria Scale
timeFrame: day 11th
measure: VAS pain score
timeFrame: Day 1st
measure: VAS pain score
timeFrame: Day 2nd
measure: VAS pain score
timeFrame: Day 3rd
measure: VAS pain score
timeFrame: Day 4th
measure: VAS pain score
timeFrame: Day 5th
measure: VAS pain score
timeFrame: Day 6th
measure: VAS pain score
timeFrame: Day 7th
measure: VAS pain score
timeFrame: Day 11th
Secondary outcomes:
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Yuzuncu Yil University
Study officials:
References:
Clinical trial NCT01857388: School-Based Mental Health Program Implementation in Uganda
Official title: Implementing a School-based Mental Health Prevention Program in Ugandan Schools
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Teacher Mental Health Knowledge
Teacher Skills in Addressing Child Mental Health Problem
Keywords: school-based program, mental health, implementation
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Makerere University
First posted: 2013-05-20
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Implementation of an adapted ParentCorps program in Ugandan schools will improve school mental health service resources, teachers' knowledge about child mental health, and teachers' classroom behavioral management and parent involvement skills.

Detailed description: Participating schools are randomly assigned to a 6-month long school-based intervention or to a wait-list control group. The intervention focuses on improving teacher's classroom behavioral management practices, parent engagement, and child mental health knowledge.

Teachers are assessed at the beginning and the end of the study, and again after 6 months of intervention. Teachers' parent engagement, mental health knowledge, and behavioral practices in the classroom are assessed through observations and teacher ratings.

Eligibility criteria: Inclusion Criteria:

* Early childhood teachers

Exclusion Criteria:

* Not early childhood teachers

Primary outcomes:
measure: Change of School Teacher Behaviors
timeFrame: Outcome will be measured 3 times--before interveniton, after intervention (about 6 month after the baseline assessment), and 6-month post intervention (about 6 months after the 2nd evaluation)
Secondary outcomes:
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Makerere University
Study officials:
affiliation: NYU School of Medicine
name: Keng-Yen Huang, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Makerere University
name: Janet Nakigudde, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01074788: Mind Body Therapy During Geriatric Rehabilitation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patients Who Are in Need of Short or Long Term Rehabilitation Due to Neurological Event (Mainly Stroke) or Post Orthopedic Surgery
Keywords: rehabilitation
mind body therapy
integrative medicine
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-02-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The main goal of geriatric rehabilitation following an acute illness is rapid restoration of normal activity. The key elements are pain control, restoration of bowel functions, good sleep quality, appetite and general well-being, as well as return to pre illness physical capabilities. Emphasis has recently been placed on finding innovative multi-disciplinary methods that can improve the care of elderly people who had suffered an acute illness. The aim of this prospective study is to assess the effect of mind-body therapy(including guided imagery, relaxation techniques, mediation and touch therapy) as as an adjunct to medical and physical rehabilitation in geriatric patients.


Eligibility criteria: Inclusion Criteria:

1. Inpatients,age 18 and above.
2. Getting standard rehabilitation therapy
3. Can fill an informed consent.

Exclusion Criteria:

1. Medically unstable patients (uncontrolled heart failure,rapid AF, severe infection, constant need of oxygen therapy).
2. Demented patients who are unable to fill an informed consent

Primary outcomes:
measure: effect on quality of life
timeFrame: 1 year
Secondary outcomes:
measure: effect of treatment on rehabilitation
timeFrame: 1 year
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Medical Center; ,
Study officials:
References:
Clinical trial NCT00584688: A Double Blind, Placebo Controlled Trial of Quetiapine in Anorexia Nervosa, a Dual Site Study
Official title: A Double Blind, Placebo Controlled Trial of Quetiapine in Anorexia Nervosa, a Dual Site Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Anorexia Nervosa
Keywords: anorexia
nervosa
eating
disorder
study
research
clinical
trial
psychiatry
psychiatric
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: University of California, San Diego
First posted: 2008-01-02
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Research studies raise the possibility that medications such as quetiapine may improve mood or reduce obsessions in people with anorexia nervosa and may even help to normalize appetite. The medication quetiapine also known as seroquel works by activating certain systems in the brain, such as ones known as dopamine and serotonin chemical systems in the brain.


Eligibility criteria: Inclusion Criteria:

* Must be aged 18-65
* Must be at least 15% below ideal body weight

Exclusion Criteria:

* Allergy to quetiapine
* Diagnosis of schizophrenia

Primary outcomes:
measure: To determine efficacy of seroquel in anorexia nervosa
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Floirda
state: Florida
Study officials:
References: