louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06717945: The Efficacy and Safety of Remimazolam Besylate for Cardiac Anesthesia
Official title: The Efficacy and Safety of Remimazolam Besylate for Cardiac Anesthesia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Anesthesia
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2024-12-05
Enrollment: 320
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: The evidence on the practice of remimazolam besylate during cardiac anesthesia is scarce. This study investigates the efficacy and safety of remimazolam besylate general induction and maintenance during cardiac surgery.

Detailed description: Remimazolam besylate (RB), as a new benzodiazepine sedative agent, has been approved in clinical anesthesia with prominent characteristics of short onset/offset, less depression for cardiovascular or respiratory function and specific antagonist. Some studies have confirmed the comparable anesthesia efficacy of remimazolam for outpatient digestive endoscopy, fiberoptic bronchoscopy, facial plastic and orthopedic surgery as propofol. Currently, the evidence on its application in cardiac anesthesia is insufficient. Our study aims to evaluate the efficacy of remimazolam besylate and propofol and provide an ideal anesthetic agent to achieve the goal of early recovery after cardiac surgery.

Eligibility criteria: Inclusion Criteria:

1. Elective cardiac surgery via cardiopulmonary bypass;
2. Aged 18-65 years;
3. American Society of Anesthesiologists (ASA) grade I-III;
4. Body mass index (BMI) 18-28 kg/m2.

Exclusion Criteria:

1. A history of sternotomy for heart disease;
2. Angina or arrhythmia with severe dynamics flutters pre-operation;
3. Respiratory, hepatic or renal dysfunction (oxygenation index\<300, alanine transaminase\> 2 upper limits of normal value, creatinine \> 200 μmol/L);
4. Diagnosed with advanced tumors;
5. Psychiatric or mental disorders;
6. Myasthenia gravis or seizures;
7. Pregnant or lactating females;
8. A history of benzodiazepines administration within 3 months before surgery;
9. Known allergic to benzodiazepines, opioids, propofol and flumazenil;
10. Involved in another interventional clinical trial.

Primary outcomes:
measure: ratio of successful sedation during the whole surgery
timeFrame: Intraoperative period
Secondary outcomes:
measure: time interval for BIS from baseline before induction to 60
timeFrame: Intraoperative period
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00429845: Effect of Nutritional Intervention on the Lipid Profile of HIV-Positive Patients Who Start HAART: a Randomized Trial
Official title: Effect of Nutritional Intervention on the Lipid Profile of HIV-Positive Patients Who Start on Highly Active Antiretroviral Therapy: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: HIV
HAART
Nutrition
Dyslipidemia
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2007-02-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Highly active antiretroviral therapy (HAART) in HIV-positive patients is associated with the development of dyslipidemia, a risk factor for cardiovascular events. The objective of this study was to evaluate the effect of dietary intervention in individuals who start HAART.

Detailed description: Adult patients prescribed to HAART that met the exclusion criteria were consecutively enrolled in a randomized trial:

* control (receiving general guidelines on dietary education)
* intervention (receiving general guidelines on dietary education and nutritional follow-up every 3 months)

Eligibility criteria: Inclusion Criteria:

* HIV-positive individuals naive to HAART, with clinical indication to start therapy

Exclusion Criteria:

* Diabetes Mellitus
* Pregnancy
* Active opportunistic disease
* Any mental deficiency
* Use of lipid profile influencing drugs
* Use of illicit drugs

Primary outcomes:
measure: Total cholesterol and of triglycerides levels
Secondary outcomes:
measure: HDL-cholesterol, LDL-cholesterol, weight, waist to hip ratio
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande do Sul
Study officials:
affiliation: Associate Professor and Chief of Non-invasive Cardiology
name: Jorge P Ribeiro, MD, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lazzaretti RK, Kuhmmer R, Sprinz E, Polanczyk CA, Ribeiro JP. Dietary intervention prevents dyslipidemia associated with highly active antiretroviral therapy in human immunodeficiency virus type 1-infected individuals: a randomized trial. J Am Coll Cardiol. 2012 Mar 13;59(11):979-88. doi: 10.1016/j.jacc.2011.11.038.
Clinical trial NCT00492245: Phototherapeutic Keratectomy (PTK) With Mitomycin in Adenoviral Opacities
Official title: Phototherapeutic Keratectomy With Mitomycin C in Adenoviral Infiltrates
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Keratitis
Corneal Opacity
Keywords: PTK
corneal opacity
mitomycin
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2007-06-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study was designed to evaluate the treatment of adenoviral corneal opacities with PTK and mitomycin C.

Detailed description: Epidemic keratoconjunctivitis is a very common disease, some patients developed a complication after the infection wich is corneal infiltration. Topical treatment sometimes helps to avoid loss of visual acuity. Therefore recurrence of the opacities after topical drops is observed. When corneal fibrosis occur is difficult to achieve visual rehabilitation with topical approach. This study evaluate pre and postoperative data of patients with subepithelial fibrosis caused by adenoviral infiltrates submitted to phototherapeutic keratectomy (PTK) using mitomycin C.

Eligibility criteria: Inclusion Criteria:

* visual acuity worse than 20/40, caused by central subepithelial fibrosis

Exclusion Criteria:

* pregnancy, age less than 18 years-old or more than 80 years-old.
* diabetes, autoimmune diseases, corneal thickness less tha 400 micron.

Primary outcomes:
measure: Refractive data, visual acuity, slit lamp findings, subjective evaluation, topography patterns, pachymetry measurements.
timeFrame: one year
Secondary outcomes:
measure: wavefront analysis, anterior segment tomography data, corneal biomechanics data.
timeFrame: one year
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Federal University of Sao Paulo
Study officials:
affiliation: Federal University of Sao Paulo - Brazil
name: Ester S Yamazaki, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Sao Paulo - Brazil
name: Mauro S Campos, MD
role: STUDY_CHAIR
References:
citation: Fagerholm P. Phototherapeutic keratectomy: 12 years of experience. Acta Ophthalmol Scand. 2003 Feb;81(1):19-32. doi: 10.1034/j.1600-0420.2003.00015.x.
citation: Porges Y, Ben-Haim O, Hirsh A, Levinger S. Phototherapeutic keratectomy with mitomycin C for corneal haze following photorefractive keratectomy for myopia. J Refract Surg. 2003 Jan-Feb;19(1):40-3. doi: 10.3928/1081-597X-20030101-08.
citation: Khurana RN, Li Y, Tang M, Lai MM, Huang D. High-speed optical coherence tomography of corneal opacities. Ophthalmology. 2007 Jul;114(7):1278-85. doi: 10.1016/j.ophtha.2006.10.033. Epub 2007 Feb 20.
citation: Yamazaki ES, Ferraz CA, Hazarbassanov RM, Allemann N, Campos M. Phototherapeutic keratectomy for the treatment of corneal opacities after epidemic keratoconjunctivitis. Am J Ophthalmol. 2011 Jan;151(1):35-43.e1. doi: 10.1016/j.ajo.2010.07.028. Epub 2010 Nov 24.
Clinical trial NCT03977545: Actigraphy and Neonatal Abstinence Syndrome
Official title: Assessment of Actigraphy in the Management of Neonatal Opioid Abstinence Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neonatal Abstinence Syndrome
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2019-06-06
Enrollment: 50
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of our study is to analyse the correlation between actigraphy and Lipsitz scoring system in neonatal opioid abstinence syndrome.

Detailed description: Neonatal opioid abstinence syndrome occurs after birth when opioids were used by the mother during pregnancy.

Many scoring systems, like Lipsitz scoring system, are used to diagnose and manage neonatal abstinence syndrome but they are subjective. The majority of items in these scores are motor skills items.

Actigraphy allows to measure objectively the newborn motricity. We will analyse the correlation between actigraphy and Lipsitz scoring system in four groups of newborns.

Eligibility criteria: Inclusion Criteria:

* Newborn \> 32 weeks of gestation + 0 day

Exclusion Criteria:

* perinatal asphyxia
* 5- minute Apgar score \< 7
* ante or post-natal brain injury diagnosis
* upper arm motor deficit
* hospitalization in intensive care unit
* neonatal respiratory distress

Primary outcomes:
measure: Correlation between actigraphy and Lipsitz scoring system
timeFrame: ninety minutes after feeding
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen Univerity Hospital
Study officials:
References:
Clinical trial NCT03908645: Development and Validation of a Deep Learning Algorithm for Bowel Preparation Quality Scoring
Official title: Development and Validation of a Deep Learning Algorithm for Bowel Preparation Quality Scoring
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bowel Preparation
Keywords: Bowel Preparation, Deep Learning, Central Neural Networks
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2019-04-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to develop and validate the performance of an artificial intelligence(AI) assisted Boston Bowel preparation Scoring(BBPS) system for evaluation of bowel cleanness, then testify whether this new scoring system can help physicians to improve the quality control parameters of colonoscopy in clinic practice.

Detailed description: Colonoscopy is recommended as a routine examination for colorectal cancer screening. Adequate bowel preparation is indispensable to ensure a clear vision of colonic mucosa，complete inspection of all colon segments, and furthermore improves the detection rates of small adenomas. Thus, the adequacy of bowel preparation should be accurately evaluated and documented. However, the accuracy of current bowel preparation quality scales greatly relies on intra-observer and inter-observer consistency for lack of objective measurements. Recently, deep learning based on central neural networks (CNN) has shown multiple potential in computer-aided detection and computer-aided diagnose of gastrointestinal lesions. While, no studies have been conducted to evaluate the performance of deep learning algorithm in bowel preparation quality scoring. This study aims to train an algorithm to assess bowel preparation quality using the BBPS, and testify whether the engagement of AI can improve the quality control parameters of colonoscopy.

Eligibility criteria: Inclusion Criteria:

• Patients aged 18-70 years undergoing afternoon colonoscopy

Exclusion Criteria:

* Known or suspected bowel obstruction, stricture or perforation
* Compromised swallowing reflex or mental status
* Severe chronic renal failure(creatinine clearance \< 30 ml/min)
* Severe congestive heart failure (New York Heart Association class III or IV)
* Uncontrolled hypertension (systolic blood pressure \> 170 mm Hg, diastolic blood pressure \> 100 mm Hg)
* Dehydration
* Disturbance of electrolytes
* Pregnancy or lactation
* Hemodynamically unstable
* Unable to give informed consent

Primary outcomes:
measure: The rate of patients achieving adequate bowel preparation in each group.
timeFrame: 6 months
Secondary outcomes:
measure: Adenoma Detection Rate
timeFrame: 6 months
measure: Polyp Detection Rate
timeFrame: 6 months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu hosipital
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Xiuli Zuo, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00394745: Effect of Valsartan on Lipid Subfractions in Hypertensive Patients With Metabolic Syndrome
Official title: A 12 Week Treatment, Open-label, Multicenter Study to Investigate the Efficacy and Safety of Valsartan 160-320 mg With Regard to Effects on Lipid Subfractions in Hypertensive Patients With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Metabolic Syndrome
Keywords: Hypertension, Metabolic Syndrome, lipid subfractions
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-11-01
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate potential effects of valsartan on lipid subfractions and other parameters in lipid metabolism in patients with essential hypertension and metabolic syndrome.


Eligibility criteria: Inclusion Criteria:

* Male or female outpatients \>= 18 years of age at Visit 1
* Hypertension (systolic blood pressure \>= 140 mmHg and \< 170 mmHg and/or diastolic blood pressure \>= 90 mmHg and \< 105 mmHg
* Elevated triglycerides
* Metabolic syndrome as defined by Adult Treatment Panel III criteria

Exclusion Criteria:

* MSSBP \>= 170 mmHg and/or MSDBP \>= 105 mmHg at any time between Visit 1 and Visit 2
* Diabetes mellitus
* Patients treated with lipid lowering drugs in the last 6 weeks prior to Visit 1
* A history of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, and peripheral artery disease, heart failure NYHA II - IV Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: To evaluate the effect of valsartan 320 mg on small, dense low density lipoprotein (LDL) subfractions in hypertensive patients with metabolic syndrome.
Secondary outcomes:
measure: To evaluate the effect of valsartan 320 mg on further lipid subfractions and enzymes related to the lipoprotein metabolism.
measure: To evaluate the effect of valsartan 160-320 mg on blood pressure and pulse rate.
measure: To assess the safety and tolerability of valsartan 160-320mg.
Other outcomes:
Locations:
city: Investigative Centers
country: Germany
city: Basel
country: Switzerland
facility: Novartis
Study officials:
affiliation: Novartis Basel+ 41 61 324 1111
name: Novartis + 41 61 324 1111 Basel
role: STUDY_DIRECTOR
References:
Clinical trial NCT00438945: The Effect of Eprosartan on Hormones and Kidney Function in Patients With Essential Hypertension
Official title: The Effect of Eprosartan in Patients With Essential Hypertension on Renal Tubular Function and Vasoactive Hormones During Baseline Conditions and After Activation of the Sympathetic Nervous System.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Essential Hypertension
Lead sponsor: Regional Hospital Holstebro
Sponsor class: OTHER
First posted: 2007-02-22
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: We, the investigators at Holstebro Hospital, want to test the hypothesis that eprosartan reduces the activity of the sympathetic nervous system in patients with essential hypertension - during baseline conditions and after activation of the sympathetic nervous system.


Eligibility criteria: Inclusion Criteria:

* Age 18 - 65 years.
* Body mass index less or equal to 30 kg/m2.
* Women must use oral hormonal anticonceptive drugs, use intrauterine anticonceptive device, be sterilized / hysterectomized or be postmenopausal.
* Arterial hypertension, defined by 24 hour ambulatory blood pressure above 125 mmHg systolic or above 80 mmHg diastolic.

Exclusion Criteria:

* History of myocardial infarction.
* History of stroke.
* Heart failure.
* Endocrine organ disease.
* Lung disease.
* Clinically significant abnormal biochemical screening of the blood regarding: B-hemoglobin, P-sodium, P-potassium, P-creatinine (under 200 µmol/L will be accepted), P-albumin, p-bilirubin, p-alaninaminotransferase, P-alkaline phosphatase, p-cholesterol and B-glucose.
* Clinically significant abnormal screening of the urine regarding: albumin and glucose (protein excretion below 0.5 g/L will be accepted).
* Renovascular hypertension.
* Malignant disease.
* Alcohol abuse.
* Usage of medical drugs besides antihypertensives or statins.
* Drug abuse.
* Pregnancy or breast feeding.
* Known intolerance or allergic to eprosartan or sodium nitroprusside.
* Blood donation within 1 month of the start of the study.

Primary outcomes:
measure: Heart rate
measure: Fractional sodium excretion
measure: Plasma levels of noradrenaline
Secondary outcomes:
measure: Fractional lithium excretion
measure: Glomerular filtration rate
measure: plasma levels of renin, angiotensin II, aldosterone, vasopressin, atrial natriuretic peptide and brain natriuretic peptide
measure: free water clearance
measure: urinary excretion of aquaporin 2
Other outcomes:
Locations:
city: Holstebro
country: Denmark
facility: Department of Medical Research, Holstebro Hospital
Study officials:
affiliation: Department of Medical Research, Holstebro Hospital
name: Erling B Pedersen, MD, professor
role: STUDY_CHAIR
References:
citation: Vase H, Lauridsen TG, Graffe CC, Pedersen EB. The effect of eprosartan on reflex sympathetic activation in sodium restricted patients with essential hypertension. J Am Soc Hypertens. 2011 Sep-Oct;5(5):385-94. doi: 10.1016/j.jash.2011.03.007. Epub 2011 Jun 2.
Clinical trial NCT01477645: Health Effects Following Use of Lead Free Ammunition Used With HK416
Official title: In Norwegian: Helseffekter av Stoff Som Avgis Ved Skyting Med HK416
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Function Tests
Markers of Inflammation
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian Defence Research Establishment
First posted: 2011-11-22
Enrollment: 55
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Voluntary army soldiers

Brief summary: The purpose of this study is to determine whether use of lead free ammunitions cause more respiratory problems than use of lead containing ammunitions.


Eligibility criteria: Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* active respiratory disease

Primary outcomes:
measure: Forced Expiratory Volume (FEV1)
timeFrame: Before, Immediately after, and 24 hrs after exposure
Secondary outcomes:
measure: Inflammation markers
timeFrame: Before and 24 hrs after esposure
Other outcomes:
measure: Subjective Symptoms
timeFrame: During exposure, and during the 24 hrs after exposure
Locations:
city: Kjeller
country: Norway
facility: Norwegian Defence Research Establishment
state: Akershus
Study officials:
affiliation: Norwegian Defence Reasearch Establishment
name: Kjetil Longva, PhD
role: STUDY_DIRECTOR
affiliation: Oslo University Hospital
name: Anne-Katrine Borander, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Norwegian Research Defence Establishment
name: Øyvind Albert Voie, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oslo University Hospital
name: Johny S Kongerud, MD PhD
role: STUDY_DIRECTOR
affiliation: Oslo University Hospital
name: Liv Ingunn Bjoner Sikkeland, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Borander AK, Voie OA, Longva K, Danielsen TE, Grahnstedt S, Sandvik L, Kongerud J, Sikkeland LIB. Military small arms fire in association with acute decrements in lung function. Occup Environ Med. 2017 Sep;74(9):639-644. doi: 10.1136/oemed-2016-104207. Epub 2017 Apr 13.
Clinical trial NCT00034645: Prophylaxis Trial in High Risk Allogenic Stem Cell Transplant Recipients With Graft vs. Host Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Mycoses
Keywords: Allogenic Stem cell transplantation
Fungal infections
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2002-05-02
Enrollment: 600
Sex: ALL
Minimum age (years): 13
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This trial is in high risk patients to determine the safety, tolerance and efficacy of posaconazole (POZ) vs. fluconazole in the prophylaxis against development of invasive fungal infections (IFI).

Detailed description: This study is designed to determine the safety, tolerance and efficacy of POZ used as prophylaxis of IFI in high-risk subjects with Grade II-IV acute graft vs. host disease (GVHD) or extensive chronic GVHD. The primary objective is to assess the efficacy of SCH56592 vs fluconazole in preventing proven or probable IFI within the time period from randomization to 16 weeks after the start of treatment with study drug.

Eligibility criteria: Inclusion Criteria:

* Hematopoietic progenitor cell transplant subjects with chronic or Grade II-IV acute GVHD being treated with high dose immunosuppressive therapy.
* One of the following to the subject's prior immunosuppressive regimen:

  1. at least 1mg per kg per day of methylprednisolone or equivalent,
  2. Antithymocyte globulin (ATG) for the therapy of acute GVHD,
  3. Tacrolimus, mycophenolate mofetil, or other steroid-sparing immunosuppressive regimen.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Ullmann AJ, Lipton JH, Vesole DH, Chandrasekar P, Langston A, Tarantolo SR, Greinix H, Morais de Azevedo W, Reddy V, Boparai N, Pedicone L, Patino H, Durrant S. Posaconazole or fluconazole for prophylaxis in severe graft-versus-host disease. N Engl J Med. 2007 Jan 25;356(4):335-47. doi: 10.1056/NEJMoa061098.