louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04715854: Effect on paO2 of Adding an Aerosol Mask Above the Nasal Canulas
Official title: Comparison of the Addition of an Aerosol Mask Above Nasal Canula on Oxygenation in Hypoxemic Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypoxemic Respiratory Failure
Emergencies
Covid19
Keywords: mask, oxygen
Lead sponsor: Laboratory of Movement, Condorcet, Tournai, Belgium
Sponsor class: OTHER
First posted: 2021-01-20
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: One group will receive oxygen by classical nasal cannula. The second group will receive oxygen by aerosol mask associated with the nasal cannula. Afterward, the sequence will be inverted.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will compare the impact of a classical aerosol mask above low-flow nasal cannula on the arterial oxygen tension in patients with COVID-19.

Detailed description: Hospitalized patients with COVID-19 typically present with hypoxemia. In some patients, hypoxemia can be corrected with low flow nasal cannula. When placed above nasal cannula, some systems have demonstrated their interest in improving the performance of the patient's oxygen delivery. For example, two recent studies have shown that adding a Double-Trunk Mask (DTM) or Surgical Mask (SM) above nasal cannula has the potential to improve the PaO2 despite no change in oxygen output (1, 2) . However, no study has compared the effect on PaO2, of the addition of a classical aerosol mask above nasal canula.

Eligibility criteria: Inclusion Criteria:

Hypoxemia

Exclusion Criteria:

Hypercapnia

Confusion

Primary outcomes:
measure: Change in PaO2 and PaCO2
timeFrame: 30 minutes
Secondary outcomes:
measure: Respiratory frequency
timeFrame: 1 minute
Other outcomes:
Locations:
city: Hornu
country: Belgium
facility: Epicura
state: Hainaut
Study officials:
References:
Clinical trial NCT00213954: Ultrasound Guidance in Nerve Block Anaesthesia
Official title: Ultrasound Guidance in Nerve Block Anaesthesia: Classic Nerve Stimulation Technique Versus Ultrasound-Neurostimulation Combination in Four Blocks: Interscalene, Humeral, Parasacral and Lumbar Blocks
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia
Keywords: Nerve block anaesthesia
ultrasound-guidance
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 1002
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: Nerve block anaesthesia is wildly practised in France, avoiding general anaesthesia in a number of cases and producing excellent post-operative analgesia in trauma and orthopaedic surgeries. Even realised by experimented anaesthetists, 5-15% of failures and rare complications (such as vascular puncture, paresthesia, systemic local anaesthetic toxicity, epidural and spinal anaesthesia, neuropathy) are noticed. The aim of the study is the evaluation of an ultrasound-guidance technique in the four predetermined blocks and the incidence of their complications.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years and greater, scheduled for one of these blocks: interscalene, humeral, parasacral or lumbar blocks, for trauma or orthopaedic surgeries, who have consented to the study and are with social insurance registration

Exclusion Criteria:

* Block's contraindications, treatment by verapamil or flecainide

Primary outcomes:
measure: Sensory and motor block quality
timeFrame: 15, 30 and 60 min after the block is performed
Secondary outcomes:
measure: Complications
timeFrame: during the hospitalisation and by phone 1, 3, 6 and 9 months after the surgery
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Unité d'Anesthésiologie et de Réanimation Chirurgicale, Hôpital de Hautepierre
Study officials:
affiliation: Unité d'Anesthésiologie et de Réanimation Chirurgicale, Hôpital de Hautepierre
name: Laurence LE GOURRIER, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03285854: Calcium Balance Studies in Children With CKD and on Dialysis
Official title: Assessing Calcium Balance in Children With Chronic Kidney Disease to Optimise Treatment Strategies
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Kidney Disease Mineral and Bone Disorder
Keywords: CKD
Dialysis
calcium
mineral and bone disorder (MBD)
calcification
DXA
peripheral quantitative CT scan (pqCT)
Lead sponsor: Great Ormond Street Hospital for Children NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Kiel
name: Athens General Children's Hospital "Pan. & Aglaia Kyriakou"
name: Cukurova University
First posted: 2017-09-18
Enrollment: 120
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All children with chronic kidney disease stage 3-5 and on dialysis and age matched controls

Brief summary: This is a novel, non-invasive method of assessing Ca balance by natural Ca isotope fractionation.

Detailed description: Detailed description and study protocol will be available to individuals on request.

Eligibility criteria: I - For healthy children

Inclusion criteria

* All children \<18 years
* Normal renal function (eGFR 90-120ml/min/1.73m2 \[calculated by Schwartz formula\] in children \>1 year and serum creatinine \<35μMol/L in children \<1 year)
* Weight, height and BMI within 2 SD of normal using WHO growth charts In order to make this study as 'real-life' as possible, free-living UK children on their usual diet and dietary supplementation (including Ca and Vit D), if any, will be included, but analysis will account for medication doses and blood levels.

Exclusion criteria

* Pre-existing bone disease - inherited or acquired
* Fractures in the preceding 6 months
* Glucocorticoid therapy in the preceding year, or a lifetime cumulative steroid exposure ≥6 months
* Bisphosphonate therapy at any time in the past
* Any acute illness in the preceding 2 weeks (when the child is unable to maintain their usual diet or has bed rest)

II - For CKD and dialysis children

Inclusion criteria

* Children of all ages with an eGFR \<60ml/min/1.73m2, including those on dialysis.

Exclusion criteria

* As listed above for healthy children.

Primary outcomes:
measure: Calcium isotope fractionation in blood, urine and stool in healthy children and those with CKD
timeFrame: 24 months
measure: number of children with fractures, and clinical and biochemical correlates of fractures
timeFrame: 12 months
measure: Bone scans - whole body & lumbar spine DEXA, bone mineral density on tibial peripheral quantitative CT scan
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Great Ormond Street Hospital for Children NHS Foundation Trust
Study officials:
affiliation: Great Ormond Street Hospital for Children NHS Foundation Trust
name: Rukshana C Shroff, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04429633: Strain vs. Left Ventricular Ejection Fraction-based Cardiotoxicity Prevention in Breast Cancer
Official title: Strain-based vs. Left Ventricular Ejection Fraction-based Cardiotoxicity Prevention Strategy in Patients With Breast Cancer Who Treated With Adjuvant Trastuzumab
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiotoxicity
Breast Cancer
Prevention
Adjuvant
Trastuzumab
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2020-06-12
Enrollment: 136
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Comparing preventive effect of myocardial global longitudinal strain-based cardioprotective stragety (angiotensin receptor blocker prophylaxis) with left ventricular ejection fraction-based strategy in breast cancer patients treated with adjuvant trastuzumab.

Detailed description: Despite the left ventricular global longitudinal strain (GLS) enables early prediction of trastuzumab-related cardiomyopathy, its clinical application has been hampered due to the lack of appropriate evaluation and treatment strategies. Therefore, we aimed to evaluate the effect of early intervention strategy (GLS-based cardiotoxicity monitoring and administration of candesartan) by comparing with conventional intervention strategy (left ventricular ejection fraction-based cardiotoxicity monitoring and administration of candesartan) in breast cancer patients who treated with adjuvant trastuzumab.

Eligibility criteria: Inclusion Criteria:

* Female aged ≥ 18 years
* Pathologically confirmed HER2-positive breast cancer
* Adjuvant treatment plan comprises at least 12 cycles of Trastuzumab
* Baseline echocardiogram should be performed before starting trastuzumab
* Cumulative anthracycline dose ≤ 300mg/m2
* Written informed consent to participate in the study

Exclusion Criteria:

* History of hypersensitivity or alllergic reaction to the study medication
* Metastatic breast cancer
* Treatment with angiotensin converting enzyme(ACE) inhibitor , Angiotensin receptor blocker (ARB), beta-blocking agents, or diuretics
* Patients with NCI/CTCAE grade ≥ 2 congestive heart failure, myocardial infarction, symptomatic left ventricular systolic dysfunction, heart's valve disease (≥ moderate), arrhythmias (Grade ≥ 3) \< 12 months before enrollment
* Pregnancy or breast feeding
* Baseline systolic pressure \< 90mmHg
* Cumulative anthracycline dose \> 300mg/m2
* Serious concurrent illness

Primary outcomes:
measure: Left ventricular ejection fraction (LVEF)
timeFrame: at months 3,6,9,12,18
Secondary outcomes:
measure: Overt chemotherapy induced cardiotoxicity
timeFrame: any time
measure: Changes in cardiac biomarker
timeFrame: at months 3,6,9,12,18
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT06110533: Epidemiological Study of Hospitalized Children for Pulmonary Tuberculosis at Strasbourg University Hospitals
Official title: Descriptive Epidemiological Study of Hospitalized Children for Pulmonary Tuberculosis at Strasbourg University Hospitals
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Tuberculosis
Keywords: Pulmonary tuberculosis
Tuberculosis in children
Childhood tuberculosis
Mycobacterium tuberculosis
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2023-10-31
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Child (1 to 17 years old) hospitalized for pulmonary tuberculosis at Strasbourg University Hospital between January 1, 2012 and December 31, 2022.

Brief summary: Pulmonary tuberculosis is the most common form of tuberculosis in children; According to the WHO, tuberculosis pulmonary tuberculosis in children represents approximately 80% of all cases of tuberculosis in children. In 2020, there were approximately 1.0 million new cases of pulmonary tuberculosis among children worldwide.

In France, childhood tuberculosis remains a rare disease; the most recent data show a rate of 3.3 cases per 100,000 inhabitants among children under 15 years old in 2019.

Pulmonary tuberculosis in children can lead to complications such as bronchiectasis and pneumothorax. Children living in homes where an adult has a active tuberculosis, or children with diseases chronic, malnourished or suffering from HIV are more likely to contract tuberculosis.

The aim of this research is to determine the incidence, identify the risk factors as well as the clinical forms of pulmonary tuberculosis in children hospitalized at Strasbourg University Hospitals between 2012 and 2022.


Eligibility criteria: Inclusion Criteria:

* Child (1 to 17 years old)
* Child hospitalized for pulmonary tuberculosis at Strasbourg University Hospital between January 1, 2012 and December 31, 2022.
* Child and/or his/her parental authority who have not expressed their opposition to the reuse of data for scientific research purposes.

Exclusion Criteria:

- Subject and/or their parental authority having expressed their opposition to the re-use of the child's data for scientific research purposes.

Primary outcomes:
measure: Incidence and risk factors for pulmonary tuberculosis in children hospitalized at Strasbourg University Hospital between 2012 and 2022
timeFrame: 1 month after hospitalization for pulmonary tuberculosis
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Centre de Ressources et de Compétences de la Mucoviscidose (CRCM) - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT01057433: Drug-Drug Interaction of Lopinavir/Ritonavir on Pitavastatin
Official title: Drug-Drug Interaction Study to Assess the Effects of Steady-State Lopinavir/Ritonavir on Pitavastatin in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy Volunteers
Keywords: Healthy Volunteers
Lead sponsor: Kowa Research Institute, Inc.
Sponsor class: INDUSTRY
First posted: 2010-01-27
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a Phase 4, single center, open label, fixed-sequence, 2-way drug-drug interaction study.

Detailed description: This is a Phase 4, single center, open label, fixed-sequence, 2-way drug-drug interaction study.

Each subject will qualify for entry into the study not more than 30 days prior to admission into the clinical unit. Subjects will check into the clinical unit on Day -1 for baseline assessments. There will be one treatment period, with each subject receiving a once daily dose of pitavastatin 4 mg on Days 1 through 5 and Days 20 through 24 and a twice daily dose of lopinavir/ritonavir 400 mg/100 mg (two 200 mg/50 mg tablets per dose) on Days 9 through 24. Pitavastatin will be administered under fasting conditions in the morning and lopinavir/ritonavir will be administered under fasting conditions in the morning and evening.

Eligibility criteria: Inclusion Criteria:

* Healthy adult male or female volunteer aged 18 to 45 years, inclusive.
* Subject has a body mass index of 18 to 30 kg/m2, inclusive.
* Subject has normal hematology, serum chemistry, and urinalysis test results
* Subject is able and willing to abstain from alcohol, grapefruit, caffeine, or caffeine containing products for 4 days before Day 1 until after completion of this study.
* Subject is a nonsmoker or has quit smoking at least 6 months before the first dose of study drug.

Exclusion Criteria:

* Subject has had any surgery of the gastrointestinal tract likely to affect drug absorption, distribution, metabolism, or excretion.
* Subject has had a previous allergy or intolerance to treatment with pitavastatin or lopinavir/ritonavir.
* Subject has a history of drug or alcohol abuse.
* Subject has had a clinically significant illness within 4 weeks before the first dose of study drug.

Primary outcomes:
measure: Area Under the Curve From Time 0 to Tau (AUC 0-τ)
timeFrame: 0, 1, 2, 3, 4, 5, 6, 8, and 12 hours after dosing on days 19 and 24
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
state: Texas
Study officials:
affiliation: Kowa Research Institute, Inc.
name: Roger Morgan, MD, FACS
role: STUDY_DIRECTOR
References:
citation: Morgan RE, Campbell SE, Suehira K, Sponseller CA, Yu CY, Medlock MM. Effects of steady-state lopinavir/ritonavir on the pharmacokinetics of pitavastatin in healthy adult volunteers. J Acquir Immune Defic Syndr. 2012 Jun 1;60(2):158-64. doi: 10.1097/QAI.0b013e318251addb.
Clinical trial NCT00878033: Autonomic Dysfunction and Inflammation in Chronic Hemodialysis Patients
Official title: Autonomic Dysfunction and Inflammation in Chronic Hemodialysis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autonomic Dysfunction
Chronic Renal Failure
Lead sponsor: Martin-Luther-Universität Halle-Wittenberg
Sponsor class: OTHER
First posted: 2009-04-08
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diabetic and Non-diabetic Dialysis Patients. Healthy Controls.

Brief summary: This study investigates the relationship between autonomic dysfunction and chronic inflammation in hemodialysis patients.


Eligibility criteria: Inclusion Criteria:

* Chronic Kidney Disease Stadium KDIGO 5D for at leat 3 months on Dialysis
* Age \>18 years
* Sinus action in EKG
* Patient capable for informed consent
* Written and signed informed consent

Exclusion Criteria:

* Clinical overt signs of infections of any kind
* Active malign disease
* CRP levels above 50 mg/L
* Cardiac Pace Maker
* Atrial Fibrillation
* Refusal of informed consent
* Cardiac Transplantation
* Immunosuppressive medication

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Halle (Saale)
country: Germany
facility: Martin-Luther-Universität Halle-Wittenberg, Dept. of Internal Medicine II
state: Saxony-Anhalt
Study officials:
affiliation: University Hospital Halle, Dept. of Internal Medicine II
name: Matthias Girndt, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Seibert E, Zohles K, Ulrich C, Kluttig A, Nuding S, Kors JA, Swenne CA, Werdan K, Fiedler R, Girndt M. Association between autonomic nervous dysfunction and cellular inflammation in end-stage renal disease. BMC Cardiovasc Disord. 2016 Nov 3;16(1):210. doi: 10.1186/s12872-016-0385-1.
Clinical trial NCT04542733: The Efficacy of Everolimus with Reduced-dose Tacrolimus Versus Reduced-dose Tacrolimus in Treatment of BK Virus Infection in Kidney Transplantation Recipient
Official title: The Efficacy of Everolimus with Reduced-dose Tacrolimus Versus Reduced-dose Tacrolimus in Treatment of BK Virus Infection in Kidney Transplantation Recipient
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Kidney Transplant Infection
BK Virus Infection
Keywords: Kidney Transplantation
mTOR inhibitor
Leflunomide
BK virus
Lead sponsor: King Chulalongkorn Memorial Hospital
Sponsor class: OTHER
First posted: 2020-09-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: BK virus infection is one of the causes of renal allograft loss in the current era. Reduction of immunsuppression is the only intervention that prooved to be effective in treating of BK virus in kidney transplant recipient. However, there are evidences from retrospective and prospective studies showed that leflunomide and mTOR inhibitor such as everolimus or sirolimus have positive outcomes in treatment of BK virus in kidney tranplant recipient. The investigators conduct the RCT to compare the efficacy of leflunomide and mTOR inhibitor everolimus, in treatment of BK virus infected patients who do not respond to immunosuppression reduction.


Eligibility criteria: Inclusion Criteria:

* Kidney transplant recipients at King Chulalongkorn Memorial Hospital
* age \>= 18 years
* persistent BK viremia \>1000 copies/mL at least 2 times in 3 weeks or single time \> 10000 copies/mL

Exclusion Criteria:

* BK VL \>10\^5 log
* Previous BKVAN treatment
* Drug hypersensitivity to mTORi or leflunomide

Primary outcomes:
measure: Plasma BK viral load change
timeFrame: 3 months
Secondary outcomes:
measure: Plasma BK viral load clearance rate
timeFrame: 1, 3, 6 months
measure: Acute rejection rate
timeFrame: 6 months
measure: Glomerular filtration rate (GFR) change
timeFrame: 3, 6 months
measure: Chronicity score in kidney allograft
timeFrame: 6 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
Study officials:
affiliation: Chulalongkorn University
name: Suwasin Udomkarnjananun, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02191033: Text Messaging for Smoking Cessation in College Health Clinics
Official title: Text Messaging to Augment Physician Brief Advice for Smoking Cessation in College Health Clinics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cigarette Smoking
Keywords: cigarette smoking
tobacco use cessation products
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Southern Connecticut State University
name: University of New Haven
First posted: 2014-07-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a randomized-controlled clinical trial which evaluates the efficacy of physician brief advice, nicotine replacement therapy and a 6-week course of text messaging in promoting cigarette smoking in smokers enrolled in college.

The primary hypothesis is that smokers receiving physician brief advice, nicotine replacement therapy, and text messaging will have higher quit rates that smokers receiving physician brief advice and nicotine replacement therapy alone.


Eligibility criteria: Inclusion Criteria:

* Aged 18 through 24 years
* Enrolled as a full/part time college student
* A current smoker (Have smoked more than 100 cigarettes in their lifetime and now smoke every day or some days)
* English-speaking
* Interested in quitting
* Have a cell phone for personal use with an unlimited text messaging plan.

Exclusion Criteria:

* History of hypersensitivity/allergy to nicotine patch;
* Serious arrhythmias - History of heart disease (myocardial infarction, severe chest pain, or coronary artery disease)
* Current pregnancy/breastfeeding/plan for pregnancy

Primary outcomes:
measure: Study Enrollment- Number of Participants Who Join the Study
timeFrame: baseline
measure: Study Retention- Number of Participants Who Attend the 6- and 12-week Follow up Visits.
timeFrame: 6- and 12- weeks
Secondary outcomes:
measure: Smoking Abstinence
timeFrame: 6- and 12- weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Southern Connecticut State University
state: Connecticut
Study officials:
affiliation: Yale University
name: Deepa R Camenga, MD
role: PRINCIPAL_INVESTIGATOR
References: