louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01509027: Study of the Compliance With Phosphorus Restricted Diet and Phosphate Binder Therapy in Hemodialysis Patients
Official title: A Randomized Controlled Trial to Evaluate the Impact of Education on the Knowledge About and Compliance With a Phosphorus Restricted Diet and Phosphate Binder Therapy in Maintenance Dialysis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Kidney Disease
Keywords: hemodialysis
hyperphoshatemia
compliance
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2012-01-12
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Hyperphosphatemia is a common and severe complication in chronic kidney disease patients treated with hemodialysis. A phosphate restricted diet and oral phosphate binders are the cornerstones in the prevention and treatment of this complication. However, noncompliance is an prevalent problem resulting in poorly controled hyperphosphatemia in a substantial proportion of hemodialysis patients. The present study aims at identifying risk factors for non compliance and also test the hypothesis that compliance can be improved by education patients on the consequences of hyperphosphatemia and the importance of diet and phosphate binder therapy.


Eligibility criteria: Inclusion Criteria:

* prevalent (\>3months) hemodialysis patients
* aged \> 18 years
* informed consent

Exclusion Criteria:

* decreased consciousness
* unstable
* medical contraindication for phosphorus restricted diet or phsophate binder therapy

Primary outcomes:
measure: compliance
timeFrame: baseline and after intervention
measure: serum phosphate levels
timeFrame: baseline and after intervention
Secondary outcomes:
measure: risk factors of noncompliance
timeFrame: baseline
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
Study officials:
References:
Clinical trial NCT06412627: The Effect of Intervention About Dry Mouth and Thirst in Patients With Endotracheal Tube
Official title: The Effect of Intervention About Dry Mouth and Thirst in Patients With Endotracheal Tube
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Endotracheal Tube
Thirst
Dry Mouth
Keywords: dry mouth
thirst
endotracheal tube
Lead sponsor: Changhua Christian Hospital
Sponsor class: OTHER
First posted: 2024-05-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is an experimental study aimed at exploring the effectiveness of using 4°C frozen gauze with normal saline for relieving dry mouth and thirst in patients with endotracheal tubes.

Detailed description: Long-term placement of endotracheal tubes often causes discomfort, including lip ulcers, laryngeal pain, and dry oral mucosa, leading to frequent complaints of dry mouth and thirst among conscious patients. However, these symptoms are commonly overlooked in the nursing process, resulting in emotional distress and irritability in patients. Although healthcare providers recognize the issue of dry mouth and thirst in patients with endotracheal tubes, effective management is challenging due to concerns about treatment limitations, aspiration pneumonia, and the risk of coughing or vomiting. This experimental study aims to explore the effectiveness of using 4°C frozen gauze soaked in normal saline to relieve dry mouth and thirst in patients with endotracheal tubes.

Eligibility criteria: Inclusion Criteria:

* Endotracheal intubation.
* Aged 18 years or older.
* Patient or family members are willing to sign the consent form.

Exclusion Criteria:

* History of head and neck cancer.
* Oral mucosal damage, swelling, or bleeding that precludes placement of a moist gauze pad.

Primary outcomes:
measure: Oral moisture checking device
timeFrame: Change from baseline dry mouth at Day 3, and Day 7
Secondary outcomes:
measure: Oral health assessment Tool
timeFrame: Change from baseline oral health status at Day 3, and Day 7
measure: Bedside oral examination scale
timeFrame: Change from baseline oral health function at Day 3, and Day 7
Other outcomes:
Locations:
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
Study officials:
References:
Clinical trial NCT02365727: Exparel vs Exparel Plus ACB in TKAs
Official title: Two-arm, Double-blind Randomized Study Comparing Exparel and Exparel Plus an Adductor Canal Block in Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Knee Osteoarthritis
Lead sponsor: The Hawkins Foundation
Sponsor class: OTHER
First posted: 2015-02-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients will be randomized (like the flip of a coin) to receive Exparel and a nerve block, standard of care for this procedure, or Exparel alone for pain management after surgery. They will also be asked to complete questionnaires before surgery, during their stay at the hospital after surgery, then at 3 months, 6 months and 12 months after surgery to assess pain and/or function levels, as well as the amount of pain medicine patients have used after surgery. Patients' leg strength will be measured immediately after surgery and again at 3, 6 and 12 months after surgery.


Eligibility criteria: Inclusion Criteria:

* Male or female, aged 18 to 80 years at the time of surgery.
* Willing and able to give voluntary informed consent to participate in this investigation.
* Candidate for total knee arthroplasty.
* BMI \< 35.

Exclusion Criteria:

* Subject has had previous arthroplasty or fracture procedure(s) on the operative knee.
* Creatine level ≥ 1.5
* Pre-existing gait disturbance or neuropathy.
* Allergy to local anesthetics.
* Inflammatory arthropathies.
* Female patient who is pregnant or nursing.
* Chronic use of narcotics
* Any other reason (in the judgment of the investigator).

Primary outcomes:
measure: Pain as assessed by Visual Analog Scale (VAS)
timeFrame: 12 Months
Secondary outcomes:
measure: Function as assessed by Knee Society Score (KSS) and EQ-5D
timeFrame: 12 Months
measure: Opioid consumption as assessed by dosage and frequency of narcotic usage
timeFrame: 30 hours
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Steadman Hawkins Clinic of the Carolinas - Greenville Health System
state: South Carolina
Study officials:
affiliation: Steadman Hawkins Clinic of the Carolinas - Greenville Health System
name: Brayton Shirley
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01559727: Dose-comparison Study of Prednisone in Heart Failure
Official title: Randomized Dose-comparison Study of Prednisone in Patients With Symptomatic Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heart Failure
Keywords: heart failure
diuresis
prednisone
Lead sponsor: Hebei Medical University
Sponsor class: OTHER
First posted: 2012-03-21
Enrollment: 40
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 examine the efficacy of three doses of prednisone, a glucocorticoid, in treatment of patients with symptomatic heart failure.

Detailed description: Heart failure is a leading cause of cardiovascular morbidity and mortality in the world. Most patients with acute symptomatic heart failure are admitted with fluid overload. Intravenous loop diuretics are an essential component of current treatment in such patients. Newly emerging evidence showed that glucocorticoids could potentiate natriuretic peptides' action by upregulating the expression natriuretic peptide receptor A (NPR-A) in the kidney, and produce a potent diuresis. Therefore, the investigators designed this nonblinded, randomized dose comparison study to compare the efficacy of prednisone at 15, 30 and 60 mg/day in patients with in symptomatic heart failure.

Eligibility criteria: Inclusion Criteria:

* hospitalized for symptomatic heart failure
* dyspnea at rest or with minimal activity
* NT-proBNP \> 1000pg/ml
* LVEF ≤ 40%

Exclusion Criteria:

* any condition (other than CHF) that could limit the use of prednisone;
* acute decompensated heart failure
* active myocarditis
* obstructive or restrictive cardiomyopathy
* cardiac surgery within previous 3 months
* acute coronary syndrome

Primary outcomes:
measure: Daily urinary volumes
timeFrame: 10 days
measure: Urinary sodium excretion
timeFrame: 10 days
Secondary outcomes:
measure: The effect of prednisone on renin angiotensin aldosterone system.
timeFrame: 10 days
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: The First Hospital of Hebei Medical University
state: Hebei
city: Shijiazhuang
country: China
facility: The First Hospital of Hebei Medical University
Study officials:
affiliation: The First Hospital of Hebei Medical University
name: Kunshen Liu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liu C, Zhao Q, Zhen Y, Zhai J, Liu G, Zheng M, Ma G, Wang L, Tian L, Ji L, Li L, Duan L, Liu K. Effect of Corticosteroid on Renal Water and Sodium Excretion in Symptomatic Heart Failure: Prednisone for Renal Function Improvement Evaluation Study. J Cardiovasc Pharmacol. 2015 Sep;66(3):316-22. doi: 10.1097/FJC.0000000000000282.
Clinical trial NCT06840327: Impact of VARIation of OXYdo-reduction Potential in Cardiac Surgery on Post-operative Outcome
Official title: Impact of VARIation of OXYdo-reduction Potential in Cardiac Surgery on Post-operative Outcome
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cardiac Surgery
Extracorporeal Circulation
Keywords: extracorporeal circulation
cardiac surgery
biological markers
Redox balance
post-operative outcome
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2025-02-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing scheduled cardiac surgery under CEC for coronary bypass surgery with saphenous vein harvesting at Toulouse University Hospital

Brief summary: Observational, prospective, monocentric study conducted in the cardiac surgery department about biological markers to predict the short-term outcome of heart surgery patients.

Detailed description: At present, there are no biological markers to predict the short-term outcome of heart surgery patients. Redox balance, determined by the interaction between oxidants and reducers in tissues, is an essential parameter in the regulation of cellular functions. Cardiac surgery with extracorporeal circulation (CEC) induces major disturbances in this balance. In preliminary work, it was observed that the redox potential (Eg) varied with the introduction of CEC, and a persistent imbalance appeared to correlate with post-operative complications. It is believed that Eg potential could be a new biomarker of the post-operative outcome of major surgery.

Eligibility criteria: Inclusion Criteria:

Patients over 18 years of age Scheduled cardiac surgery patients undergoing bypass surgery with saphenous vein harvesting.

Patients able to understand the protocol; Patients able to express non-opposition to participating in the study Patients affiliated to a social security system or equivalent.

Exclusion Criteria:

Emergency surgery patients. Pregnant or breast-feeding women. Patients deprived of their freedom or under legal protective measures.

Primary outcomes:
measure: Simplified Gravity Index
timeFrame: Day 7
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01450527: Etiology and Outcomes of Tropical Acute Respiratory Distress Syndrome
Official title: Etiology and Outcomes of Acute Respiratory Distress Syndrome in Medical ICU in AIIMS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Respiratory Distress Syndrome
Keywords: Etiology and outcomes of ARDS
Lead sponsor: All India Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2011-10-12
Enrollment: 64
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient admitted in medical ICU

Brief summary: This is a prospective observational study done to know the etiology and outcomes of Acute Respiratory Distress Syndrome.

Detailed description: The study will be a prospective observational study and 64 patients with ARDS will be recruited . Written informed consent will be taken prior to inclusion of study. Study will be conducted in Medical ICU (C2 ICU) of AIIMS. Based on medical history and physical examination, radiology, biochemical and microbiological investigations etiology of ARDS will be decided.Sample will be taken at te eime of admission for estimation of inflammatory markers hsCRP,IL-1.IL-6,TNF ,Procalcitonin.From the available variables APACHE II, Sequential organ failure assessment score (SOFA), Simplified acute physiological score (SAPS)II and 3 will be calculated to assess the severity of ARDS.All patients will be given mechanical ventilation using the protocol followed by the ARDS Network low-tidal volume ventilation strategy.The data will be registered on ICU admission and there after every 24 hr. Day 0 will be defined as the interval from the time of ICU admission to 8:00 am the next day .Every day data will be recorded at a fixed time at 9 am. It will include Tidal volume Vt (ml/kg),respiratory rate/min, Minute ventilation(l/min),FiO2,PaO2/FiO2,Inspiratory flow(I:E), Ppeak (cm of H2O),Static respiratory compliance(ml/cm of water).Plateau pressure (Pplat), Peak end expiratory pressure (PEEP).Patient will be monitored throughout the course of illness and the outcome of ARDS will be assessed.

Eligibility criteria: Inclusion Criteria:

1. Subjects fulfilling the criteria of ARDS according to American-European consensus definition
2. Admitted in medical ICU(CII/CU)
3. No known previous lung pathology e.g. bronchiectasis, Interstitial lung disease

Exclusion Criteria:

1. HIV positive serology.
2. Chronic obstructive airway disease
3. Not giving consent for study
4. Known lung pathology

Primary outcomes:
measure: 28-day mortality
timeFrame: with in 28 days after ICU admission
Secondary outcomes:
measure: Duration of hospital stay
timeFrame: with in the discharge from the hopsital
measure: Duration of ICU stay
timeFrame: Duration for which patient stays in ICU after ICU admission
Other outcomes:
Locations:
city: New Delhi
country: India
facility: All India Institute Of Medical Sciences
state: Delhi
Study officials:
affiliation: All India Institute of Medical Sciences
name: Surendra K. Sharma, MD,Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03109327: Investigating the Clinical Utility of the MDS
Official title: Investigating the Clinical Utility of the MDS Test for the Oncogenic Activity in Nevi Suspected of Being Melanoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Skin Lesion
Melanoma
Moles
Lead sponsor: Orlucent, Inc
Sponsor class: INDUSTRY
Collaborators: name: NHS Lanarkshire
name: NHS Tayside
name: NHS Greater Glasgow and Clyde
name: University Hospitals, Leicester
name: University of Dundee
First posted: 2017-04-12
Enrollment: 250
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: PROBABILITY_SAMPLE
Study population: Subjects referred to a specialist for possible presence of melanoma in skin lesions.

Brief summary: The purpose of this study is to establish the clinical utility of the Melanoma Detection System (MDS).

Detailed description: The purpose of this study is to establish the clinical utility of the MDS while continuing to evaluate the safety and performance of the MDS in patients with skin lesions who are referred to secondary care clinics for evaluation, whose lesions (moles) are suspicious for melanoma.

Eligibility criteria: Inclusion Criteria:

1. Lesion has one or more of the ABCDE features and is recommended for excision.
2. Lesion has at least 1 cm of skin around it that is accessible to the MDS.
3. Patient is at least 18 years old.
4. Patient is capable of giving written informed consent.
5. Lesion is scheduled for primary excision.

Exclusion Criteria:

1. Lesion is less than one centimetre from the eyes.
2. Lesion is on the palms of the hands or soles of the feet.
3. Lesion is mucosal.
4. Lesion is ulcerated.
5. Patient is pregnant.
6. Low patient study procedure compliance.
7. Patient who is mentally or physically unable to comply with all aspects of the study.
8. Patient is undergoing chemotherapy.
9. Patient has known sensitivity to fluorescent dyes.
10. Ink marking on or adjacent to lesion.
11. Lesions larger than 20mm or too large to allow imaging.

Primary outcomes:
measure: Utility of the MDS in determining urgent or non-urgent excision of moles.
timeFrame: 1 day
Secondary outcomes:
measure: Does the MDS have an additive value to clinical evaluation of moles.
timeFrame: 1 day
Other outcomes:
measure: User feedback for clinical use of the MDS in the clinical management of moles.
timeFrame: 1 day
Locations:
city: Airdrie
country: United Kingdom
facility: NHS Lanarkshire, Monklands Hospital
Study officials:
References:
Clinical trial NCT03937427: Unified Airway Model
Official title: Unified Airway Model: Comparison of the Microbiome of the Upper and Lower Airways in Chronic Rhinosinusitis and Asthma Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Rhinosinusitis (Diagnosis)
Asthma
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2019-05-03
Enrollment: 24
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will analyze and compare the upper and lower airways from 12 CRS with asthma patients and 12 CRS without asthma patients matched for age, sex and degree of sinus disease based on CT grading using Lund-Mackay staging system.14

Brief summary: Chronic rhinosinusitis (CRS) impacts approximately 5% of Canadians. CRS patients suffer from a combination of symptoms that include facial pain, nasal obstruction, hyposmia and mucopurulence discharge. Asthma may additionally worsen quality of life and many patients suffer from both conditions. The unified airway model illustrates a link between both conditions as tissue from the middle ear to the sinus cavity to the lungs function as one unit. Despite evidence for the unified airway model in the setting of CRS and asthma, there are no studies to our knowledge that have evaluated the microbiome (the resident microbes and their genetic expressions that affect disease) of the upper and lower airways in this patient population. Determining the microbiome of the upper and lower airways in patients suffering from CRS and asthma will further support the unified airway model but more importantly, will help contribute to understanding the pathophysiology of this inflammatory process and may help guide future management.


Eligibility criteria: Inclusion Criteria:

* 19 years or older
* Able to speak and understand English
* Diagnosed with chronic rhinosinusitis with or without asthma and COPD or with a sinonasal tumor
* Undergoing sinus surgery in St Paul's Hospital

Exclusion Criteria:

* Oral antibiotics in the past month prior to surgery;
* Immunocompromised;
* Prior lung transplants;
* Known sinonasal or bronchial tumors, current or previous;
* Smoking;
* Known bleeding disorders:
* Deemed unfit by the rhinologists/respirologist for bronchoscopy.

Primary outcomes:
measure: Pathology (histological assessment)
timeFrame: 1 day
measure: Gene Expression Patterns
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: B.C.
Study officials:
affiliation: University of British Columbia
name: Andrew Thamboo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00267527: A Study to Evaluate CJC 1295 in HIV Patients With Visceral Obesity
Official title: A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Phase 2 Study to Evaluate the Efficacy and Safety of CJC 1295 Administered for 12 Weeks in HIV Infected Patients With HIV Associated Visceral Obesity
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Obesity
HIV Infections
Keywords: Treatment Experienced
HIV Visceral Obesity
Lead sponsor: ConjuChem
Sponsor class: INDUSTRY
First posted: 2005-12-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multicenter, randomized, placebo-controlled, double-blind, Phase 2 study. Patients will be treated for a total of 12 weeks. There will be a 6 week follow-up period after the treatment period ends. Patients will be randomly assigned to low dose CJC 1295, high dose CJC 1295 or placebo.

The objective is to assess and compare the efficacy, pharmacokinetics, safety, and tolerability of CJC 1295 in patients with human immunodeficiency virus (HIV) associated visceral obesity.


Eligibility criteria: Inclusion Criteria:

* Age 18-65 on stable antiviral regimen
* Documented HIV infection
* HIV associated visceral obesity
* Body mass index (BMI) \> 24 and \< 30 kg/m2

Exclusion Criteria:

* Diabetes
* Use of growth hormone (GH) or other GH secretagogues
* Use of systemic glucocorticoids,
* Use of megestrol acetate or other appetite stimulants,
* Use of general anorexigenic or weight-reducing agents, or
* Use of androgens, other than testosterone replacement therapy for male hypogonadism at physiological doses and on a stable regimen for at least 6 months prior to randomization.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: