louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05498675: Effect of Sacubitril/Valsartan on Cardiac Function in Hypertensive Patients Stratified by BMI: A Real World Study
Official title: Effect of Sacubitril/Valsartan on Cardiac Function Assessed by Cardiac Magnetic Resonance (CMR) in Hypertensive Patients Stratified by Body Mass Index (BMI): A Real World Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sacubitril/Valsartan
Hypertension
Obesity
Keywords: Cardiac function
Cardiac magnetic resonance
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2022-08-12
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hypertensive patients stratified by BMI.

Brief summary: The purpose of this study is to investigate the effect of sacubitril/valsartan on cardiac function assessed by cardiac magnetic resonance (CMR) in hypertensive patients stratified by BMI.

Detailed description: Obesity is one of the risk factors of hypertension, and affects cardiac structure and function in the long term for hypertensive patients. Sacubitril/valsartan is regarded as a better antihypertensive drug for the improvement of cardiac function for patients with heart failure, but it remains unclear whether there are differences among different BMI groups. Therefore, the aim of this study was to evaluate the benefit of sacubitril/valsartan versus other antihypertensive drugs on cardiac structure and function assessed by CMR in hypertensive patients stratified by BMI in the real world.

Eligibility criteria: Inclusion Criteria:

* Patients with essential hypertension
* 18-70 years old
* No major barriers to provide written consent

Exclusion Criteria:

* Secondary hypertension, except because of sleep apnea
* cardiovascular disease (myocardial infarction, heart failure, stroke or coronary revascularization) within 6 months
* Severe concomitant diseases (autoimmune disease, malignancy, late stage of liver diseases, respiratory diseases and digestive diseases)
* Unable to understand or comply with the study procedures

Primary outcomes:
measure: Changes on left ventricular ejection fraction (LVEF)
timeFrame: 6 months
Secondary outcomes:
measure: Changes on left ventricular end-systolic diameter (LVESD)
timeFrame: 6 months
measure: Changes on left ventricular end-diastolic diameter (LVEDD)
timeFrame: 6 months
measure: Changes on cardiac systolic function
timeFrame: 6 months
measure: Major adverse cardiac events
timeFrame: 6 months
measure: Major adverse cardiac events
timeFrame: 12 months
measure: Changes on hypertension-mediated target organ damage
timeFrame: 12 months
measure: Changes on blood pressure
timeFrame: 6 months
measure: Changes on blood pressure
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Friendship Hospital
name: Rongchong Huang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06146075: Insights Into Participating in Clinical Studies for Anorexia
Official title: Assessing Engagement Patterns and Participation Trends in Individuals Joining Anorexia Clinical Trials
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Anorexia
Keywords: anorexia
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-11-24
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Anorexia patients who are actively considering enrolling in a clinical trial for the said condition, but have not yet completed enrollment and randomization phases.

Brief summary: Clinical trials centered on anorexia serve a pivotal function in assessing the safety and effectiveness of emerging treatments for this condition.

The primary aim revolves around meticulously scrutinizing both trial completion rates and instances of voluntary withdrawal within specific patient cohort.


Eligibility criteria: Inclusion Criteria:

* Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
* Diagnosis of anorexia
* No prior treatment for anorexia

Exclusion Criteria:

* Pregnant or lactating women
* Any serious and/or unstable pre-existing medical disorders
* Patients receiving any other investigational agents

Primary outcomes:
measure: Number of patients who decide to enroll in an anorexia clinical research
timeFrame: 3 months
measure: Rate of patients who remain in an anorexia clinical trial to trial completion
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Power Life Sciences
state: California
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Michael
role: STUDY_DIRECTOR
References:
citation: Peters K, Meule A, Voderholzer U, Rauh E. Effects of interval-based inpatient treatment for anorexia nervosa: An observational study. Brain Behav. 2021 Nov;11(11):e2362. doi: 10.1002/brb3.2362. Epub 2021 Sep 20.
citation: Matsuo N, Morita T, Matsuda Y, Okamoto K, Matsumoto Y, Kaneishi K, Odagiri T, Sakurai H, Katayama H, Mori I, Yamada H, Watanabe H, Yokoyama T, Yamaguchi T, Nishi T, Shirado A, Hiramoto S, Watanabe T, Kohara H, Shimoyama S, Aruga E, Baba M, Sumita K, Iwase S. Predictors of responses to corticosteroids for anorexia in advanced cancer patients: a multicenter prospective observational study. Support Care Cancer. 2017 Jan;25(1):41-50. doi: 10.1007/s00520-016-3383-z. Epub 2016 Aug 18.
citation: Tanahashi T, Kawai K, Tatsushima K, Saeki C, Wakabayashi K, Tamura N, Ando T, Ishikawa T. Purging behaviors relate to impaired subjective sleep quality in female patients with anorexia nervosa: a prospective observational study. Biopsychosoc Med. 2017 Aug 16;11:22. doi: 10.1186/s13030-017-0107-7. eCollection 2017.
Clinical trial NCT01858675: Biomarkers Correlation With Volemia
Official title: Predictive Value of Biomarkers on Volemia, Extra and Intra Vascular Varation and Hydroelectrolytic Disorders in Different ICU Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Hemorrhage
Head Injury
Non Traumatic Post Surgery
Poly Trauma Patients Without Heart Failure
Renal Insufficiency
Keywords: ProADM
ProANP
proendothelin
proAVP
Cr 51
Volemia
fluid management
ICU patients
poly trauma patients
Lead sponsor: ThermoFisher Scientific Brahms Biomarkers France
Sponsor class: INDUSTRY
First posted: 2013-05-21
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine whether the Biomarkers (pro adrenomedullin (MR proADM), pro arginin vasopressin (CT proAVP), pro atrial natriuretic peptid (MR proANP), Pro Endothelin) changes at Day 2, Day 5 and Day 7 of ICU admission are correlated with Intravascular volume assessed by Cr 51 on red blood cells (Day 2 and Day 7) and by I 125 on albumine Day 7. The correlation of these Biomarkers are also evaluted with other markers such as erythropoietin and catecholamines. 80 ICU patients are included.


Eligibility criteria: Inclusion Criteria:

* 20 Cerebral Hemorrhage
* 20 Head Injury
* 20 post surgery non traumatic non neuro
* 20 Polytrauma patients

Exclusion Criteria:

* Heart failure NYHA III or IV
* Renal insufficiency creatinin clearance \< 30 ml/mn
* age \< 18 Y
* Pregnancy

Primary outcomes:
measure: Predictive value of biomarkers changes in Volemia variation
timeFrame: at Day 2, Day 5 and Day 7 of ICU admission
Secondary outcomes:
measure: Predictive value of biomarkers changes with efficient volemia, fluid managements and other Markers such erythropoietin
timeFrame: at Day 2, Day 5 and Day 7 of ICU admission
measure: Predictive value of Biomarkers with APACHE II and SOFA score and Prognosis at ICU discharge
timeFrame: at Day 2 , Day 5 and Day 7 of ICU admission and at discharge
Other outcomes:
Locations:
city: Le Krémilin Bicêtre
country: France
facility: Hôpital Bicêtre
state: Ile de France
Study officials:
References:
citation: Vigue B, Leblanc PE, Moati F, Pussard E, Foufa H, Rodrigues A, Figueiredo S, Harrois A, Mazoit JX, Rafi H, Duranteau J. Mid-regional pro-adrenomedullin (MR-proADM), a marker of positive fluid balance in critically ill patients: results of the ENVOL study. Crit Care. 2016 Nov 9;20(1):363. doi: 10.1186/s13054-016-1540-x.
Clinical trial NCT03742375: Quantitative HPV Genotyping in Screening of Anal Intraepithelial Neoplasia in HIV-positive Patients
Official title: Quantitative HPV Genotyping in Screening of Anal Intraepithelial Neoplasia in HIV-positive Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Human Immunodeficiency Virus
Keywords: Human Papilloma Virus
Anal Intraepithelial Neoplasia
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Sciensano
First posted: 2018-11-15
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The pathophysiology from anal HPV infection to Anal Intraepithelial Neoplasia is less well understood than cervical HPV infection. In cervical screening programs it is well accepted that the sole presence of a high-risk HPV strain (irrespective of number of viral particles) is sufficient to justify further investigation and treatment. The investigators hypothesize that in anal HPV infection not only the presence but the extent of HPV infection (single genotype viral load) or combination of different HPV genotypes (cumulative viral load) is of importance in determining the risk of anal dysplasia.


Eligibility criteria: Inclusion criteria

* Stable HIV disease (i.e. receiving ART for at least 1 year, no adverse drug reactions requiring regular monitoring, no current illnesses or pregnancy, good understanding of lifelong adherence and evidence of treatment success: two consecutive undetectable viral load measures)
* Referred for high-resolution anoscopy

Exclusion criteria

* Documented AIN (treated or untreated)
* Local anal inflammation (proctitis) and/or acute fissure

Primary outcomes:
measure: Incidence of HPV subtypes in HIV-positive patients
timeFrame: 1 minute
Secondary outcomes:
measure: Correlation between high-resolution anoscopy findings and quantitative HPV genotyping
timeFrame: 30 minutes up to 10 days
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Philip Roelandt, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00622375: PK Study of Encapsulated Mesalamine Granules in Healthy Volunteers
Official title: A Phase I, Single- And Multiple-Dose, Relative Bioavailability and Pharmacokinetic Study of Encapsulated Mesalamine Granules Administered Orally to Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Pharmacokinetic study
Healthy subjects
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2008-02-25
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The current study is being conducted to evaluate the relative bioavailability and single- and multiple-dose pharmacokinetics of encapsulated mesalamine granules(eMG) in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* The subject is Male, or female of Non-childbearing potentia.l
* The subject is female of childbearing potential, who has a negative serum pregnancy test at screen and agrees to using appropriate birth control.
* The subject is between the ages of 18 and 45 years.
* The subject has a body mass index (BMI) between 18 and 32 kg/m2 (weight/\[height\]).

Exclusion Criteria:

* The subject is seropositive for human immunodeficiency virus (HIV),hepatitis B surface antigen, and/or hepatitis C virus.
* The subject has any clinically significant medical, social, or emotional problem.
* The subject is pregnant or lactating
* The subject has a history of clinically significant renal, hepatic,endocrine, oncological,gastrointestinal, or cardiovascular disease or a history of epilepsy, asthma, diabetes mellitus, psychosis, glaucoma, or severe head injury.
* The subject is currently receiving mesalamine or aspirin containing products
* The subject has a history of viral, bacterial, or fungal infection within 4 weeks of screening.
* The subject has an acute illness within 1 week of study-drug administration.
* The subject has an abnormal nutritional status, including unconventional, alternative,and abnormal diets; excessive or unusual vitamin intake; malabsorption; psychological eating disorders; difficulty swallowing medication; significant recent weight change; etc.
* The subject has clinically significant allergies.
* The subject has a hypersensitivity or allergy to mesalamine or other salicylate.
* The subject has known or suspected alcohol abuse or illicit drug use within the past year
* The subject has used tobacco (or nicotine products) during the 6 months prior to screening
* The subject has participated in an investigational drug study within the 30 days before receiving study drug

Primary outcomes:
measure: Individual pharmacokinetic parameters for mesalamine and its metabolites will be summarized with descriptive statistics
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
state: Texas
Study officials:
affiliation: Bausch Health Americas, Inc.
name: Audrey Shaw, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06170775: Sodiumhexametaphosphate as Pulp Capping Material for Primary Teeth
Official title: Sodiumhexametaphosphate Versus MTA as Pulp Capping Material for Primary Teeth ( Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pulp Disease, Dental
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2023-12-14
Enrollment: 100
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sodiumhexametaphosphate will be tested as pulp capping material in comparison to MTA for primary teeth pulp therapy


Eligibility criteria: Inclusion Criteria:

* physical healthy children
* cooperative children
* primary molar with deep carious lesion
* absence of pain or transient momentary pain

Exclusion Criteria:

* Uncooperative children
* children with systemic disorders
* periapical lesions
* sever pain

Primary outcomes:
measure: Clinical success
timeFrame: One year
measure: Radiographic success
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01586975: Aspirin Resistance and Stroke Risk: Platelet Function Analysis in Patients With Ischemic Events
Official title: Multiphase Study to Determine if Platelet Function Analysis Results Correlate With Ischemic Events and Bleeding Complications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Stroke
Myocardial Infarctions
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2012-04-27
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if PFA results correlate with ischemic event outcomes as well as bleeding complications. Hypothesis is antiplatelet agents will be more efficacious if they are administered in a dose-adjusted manner using PFA results as a guide.

Detailed description: Atherothrombotic disease is a leading killer of adults throughout the world. The current mainstay for the prevention of ischemic vascular events is the use of aspirin Antiplatelet agents are used routinely for the primary and secondary prevention of vascular events in patients with a prior history of stroke, TIA, or at high risk for the development of cerebrovascular disease. Numberous individual studies and meta-analyses have shown that essentially all of the oral antiplatelet agents have limited efficacy, with relative risk reductions in the range of 20-35%. The purpose of this study is to perform serial platelet function assays (PFAs) on patients with cerebrovascular disease who are taking antiplatelet agents and perform a pilot study to determine the feasibility of administering ASA as a dose adjusted medication using PFA. The long term goal of this study is to determine whether antiplatelet therapy will be more efficacious and/or safer if it is administered in a dose-adjusted manner.

Eligibility criteria: Inclusion Criteria:

* Patient must be taking Aspirin or Plavix
* Patient must have had a stroke, TIA or cerebrovascular disease

Exclusion Criteria:

-None

Primary outcomes:
measure: PFA1
timeFrame: 3-6 months (Collected once between regulalary scheduled follow-up visit between 3-6 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Mark J Alberts, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Taylor TN, Davis PH, Torner JC, Holmes J, Meyer JW, Jacobson MF. Lifetime cost of stroke in the United States. Stroke. 1996 Sep;27(9):1459-66. doi: 10.1161/01.str.27.9.1459.
Clinical trial NCT02390375: Phase 3 Study to Evaluate the Efficacy and Safety of the DW0929 in Patients With Primary Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Lead sponsor: Daewon Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-03-17
Enrollment: 348
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of the DW0929 in patients with primary hypercholesterolemia


Eligibility criteria: Inclusion Criteria:

* Adult over 19years
* Patients with primary hypercholesterolemia whose LDL-C level is below 250mg/dL and TG level is below 350mg/dL
* Patients whose LDL-C level is under 'Anti- dyslipidemia drug administration considered standard' of NCEP ATP III(2004)
* Those who voluntarily written consent to participate in this clinical trial

Exclusion Criteria:

* Uncontrolled hypertension
* Severe renal impairment(CrCl\<30mL/min)
* Those who have active liver disease and whose ALT, AST levels greater than twice the upper limit of normal
* Serum creatinine \> 2.0mg/dL
* Those who have been geunyukbyeong or rhabdomyolysis caused by using statin or have hypersensitivity to ezetimibe
* Combined cyclosporine -treated patients
* HbA1c ≥ 9%
* TSH ≥ 1.5 X ULN
* HIV-positive person
* Congestive heart failure patients classified as NYHA Class III or IV
* Patients with uncontrolled arrhythmias
* Patients who have malignant tumors needed chemotherapy, radiation therapy, etc.
* Blood clotting disorders
* Patients who had a myocardial infarction within 6 months or cardiovascular bypass surgery, patients who have underwent angioplasty
* Patients who had a history of anxiety or severe typical peripheral arterial disease within three months
* Women of childbearing age who don't agree with contraception during this clinical trials
* Pregnant women or nursing mothers
* Those who take the drug in combination taboo
* Who have been treated for another investigational drug within 30 days
* Unsuitable characters in a clinical trial to test self- determination

Primary outcomes:
measure: LDL-C level
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Boramae Hospital
state: Dongjak-gu
Study officials:
References:
Clinical trial NCT00531375: The Effect of Silicone Hydrogel Contact Lenses on Conjunctival Flora
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: University of Melbourne
Sponsor class: OTHER
Collaborators: name: Clinical Vision Research Australia
name: Johnson & Johnson Vision Care, Inc.
First posted: 2007-09-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to investigate the effect of silicone hydrogel contact lenses on conjunctival flora over a period of 6 months of daily wear. A secondary aim is to compare the levels of microbial contamination of silicone hydrogel lenses after daily wear.


Eligibility criteria: Inclusion Criteria:

* Is correctable to at least 6/9 distance visual acuity in each eye with spherical contact lenses.
* Is a current full time soft contact lens wearer.
* Has no clinically significant anterior eye findings.
* Has no other active ocular disease

Exclusion Criteria:

* Has any systemic disease that might interfere with contact lens wear
* Is using any systemic or topical medications that will affect ocular health.
* Has any pre-existing ocular irritation that would preclude contact lens fitting.
* Has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that would affect the wearing of contact lenses.
* Has undergone corneal refractive surgery.
* Is pregnant, lactating or planning a pregnancy.
* Is participating in a concurrent clinical trial.
* Has a latex sensitivity.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Clinical Vision Research Australia
state: Victoria
Study officials:
affiliation: Clinical Vision Research Australia, Victorian College of Optometry
name: Carol Lakkis, BScOptom, PhD, PGCertOcTher
role: PRINCIPAL_INVESTIGATOR
References: