louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01122355: Comparison of Fenofibrate and Niacin in Patients With Hypertriglyceridemia and Low High-Density Lipoprotein (HDL)-Cholesterol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertriglyceridemia With Low HDL-cholesterol
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2010-05-13
Enrollment: 240
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare the efficacy and tolerability of fenofibrate 160 mg and niacin 1500 mg in patients with hypertriglyceridemia and low HDL-cholesterol. The primary end point is the percent change of apoB/A1 and the secondary end points are other lipid parameters and biomarkers.


Eligibility criteria: Inclusion Criteria:

* Triglyceride 150-500 mg/dL and HDL-cholesterol \< 45 mg/dL after 8 week dietary run in period
* 20-79 years old

Exclusion Criteria:

* Low-density lipoprotein (LDL)-cholesterol ≥ 130 mg/dL without any lipid-modifying drug
* History of cerebrovascular or cardiovascular diseases
* Creatinine \> 2.0 mg/dL
* Transaminase \> 2x upper limit of normal
* Gall bladder disease
* Cancer
* Pregnant or breast feeding women
* History of adverse events associated with test drugs

Primary outcomes:
measure: percent change of apoB/A1
timeFrame: after 16 weeks of drug treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: professor of division of Cardiology
name: Sang Hak Lee
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01682655: Genetic Variant in Apolipoprotein C3 Gene and Fatty Liver in Obese Children
Official title: The Influence of Apolipoprotein C3 Variants on Liver Steatosis and Serum Liver Enzyme Values in Obese Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fatty Liver
Obesity
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2012-09-11
Enrollment: 500
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obese children and adolescents in Taiwan

Brief summary: In the past decades, obesity in children is much more prevalent in the world. Given the increasing prevalence of pediatric obesity worldwide, fatty liver incidence is on the rise.

Genetic variant in apolipoprotein C3 (APOC3) gene is associated with increased liver fat content in adults.

The aim of this study is to find out whether APOC3 single nucleotide polymorphism (SNP) influence fatty liver in obese children and adolescent.

Detailed description: The primary aim of this study is to assess the associations between to investigate the association of rs2854117 C \> T and rs2854116 T \> C SNPs of the APOC3 gene with liver steatosis, as measured by liver ultrasound.

As a secondary aim, the investigators will examine the associations between APOC3 rs2854117 C \> T and rs2854116 T \> C SNPs and serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels. In addition, the investigators will further analyze the association with other biomarkers, such as body mass index, adiponectin and insulin resistance.

Eligibility criteria: Inclusion Criteria:

* Age 6-18 years old
* Obesity definition: BMI \> 95% according to the age- and gender-specific standard suggested by National Health Institute in Taiwan
* Willing to give written informed consent by parents

Exclusion Criteria:

* Alcohol consumption
* Chronic liver diseases, including hepatitis B, hepatitis C, Wilson disease and autoimmune hepatitis
* Major systemic diseases, including cardiopulmonary disease, renal failure, cancer, and psychotic disorder

Primary outcomes:
measure: genotype distribution of APOC3 rs2854117 and rs2854116 polymorphisms in subjects with and without liver steatosis
timeFrame: Oct 2013 ~ Dec 2014
Secondary outcomes:
measure: genotype distribution of APOC3 rs2854117 and rs2854116 polymorphisms in subjects with and without insulin resistance
timeFrame: Oct 2013 ~ Dec 2014
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital
Study officials:
affiliation: Far Eastern Memorial Hospital
name: Yu-Cheng Lin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04783155: Effect of Inspiratory Muscle Training on Physiological Function and Clinical Outcomes After Lung Transplant
Official title: Effect of Inspiratory Muscle Training on Physiological Function and Clinical Outcomes After Lung Transplant: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post-Lung Transplantation Bronchiectasis
Keywords: Inspiratory muscle training
post lung transplant
exercise capacity
breathing
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-03-05
Enrollment: 30
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: The purpose of this research is to study the effect of training the inspiratory muscles (i.e. the muscle that allow you to breath-in) on exercise capacity, quality of life, and short-term clinical outcomes in patients post lung transplant.


Eligibility criteria: Inclusion Criteria:

- All patients who undergo single- or double-lung transplant at Mayo Clinic Florida.

Exclusion Criteria:

* Patients who do not survive the intra-operative period during the transplant surgery.
* Patients undergoing retransplantation.
* Patients undergoing multiorgan transplantation.
* Patients who are not willing to or who are unable to give written informed consent.

Primary outcomes:
measure: Maximal inspiratory mouth pressure (MIP) measured in cmH2O
timeFrame: 12 weeks
Secondary outcomes:
measure: Maximal oxygen uptake (V̇O2max) measured in mL/kg/min
timeFrame: 12 weeks
Other outcomes:
measure: Six-minute walk test distance (6MWTd) measured in meters (m)
timeFrame: 12 weeks
measure: Peak work rate (Wpeak) (watts)
timeFrame: 12 weeks
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Bryan Taylor, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01695655: Neovascularization Patterns in Corneal Graft Rejection
Official title: Neovascularization Patterns in Corneal Graft Rejection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Corneal Transplant
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2012-09-28
Enrollment: 44
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 with indications of corneal transplant

Brief summary: Corneal transplantation is the most commonly performed human tissue transplant worldwide. Over 40,000 corneal transplants occur in the US each year. .

This study will determine specific corneal neovascularization (CN) patterns in human corneal allograft recipients to determine the characteristics that worsen the prognosis for graft survival. We will test the hypothesis that specific characteristics of CN are prognostic for corneal allograft rejection.

Detailed description: The investigators hope to enroll 240 subjects into the study. These patients will be enrolled prior to penetrating keratoplasty. They will be examined by the full protocol preoperatively, and postoperatively at 1 week, 1, 3, 6, 12, 18, and 24 months. During these visits slit lamp biomicroscopy will be used to study CN patterns, and take slit lamp photographs if there is any neovascularization detected, permitting us to develop algorithms of CN characteristics that are predictive for corneal allograft rejection and failure. The corneal tissue removed during these patients' surgeries will be evaluated histopathologically to identify inflammation and neovascularization to confirm and compare to what is seen clinically. There will be two short questionnaires conducted at each visit to assess stress levels.

Eligibility criteria: Inclusion Criteria:

* scheduled for corneal transplant

Exclusion Criteria:

* previous corneal transplant

Primary outcomes:
measure: Corneal graft rejection
timeFrame: 0 to 2 years after transplant
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Kellogg Eye Center
state: Michigan
Study officials:
affiliation: University Of Michigam Kellogg Eye Center
name: Roni Shtein, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00273455: Lumigan Versus Cosopt
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Open-Angle Glaucoma
Lead sponsor: Pharmaceutical Research Network
Sponsor class: OTHER
First posted: 2006-01-09
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To compare the intraocular pressure effect and safety of the dorzolamide/timolol fixed combination given twice daily versus bimatoprost given once every evening in patients with open-angle glaucoma in patients insufficiently controlled on latanoprost monotherapy


Eligibility criteria: Inclusion Criteria:

* adults with a diagnosis of bilateral open-angle glaucoma including: primary, pigment dispersion or exfoliation in both eyes
* on no therapy the intraocular pressure should be 22-29 mm Hg inclusive at the 8:00 AM measurement
* visual acuity should be 20/200 or better in each eye

Exclusion Criteria:

* historical failure to respond to topical beta-blockers in a clinically meaningful manner
* any contraindication to study medications
* any anticipated change, or modification in the 6 weeks prior to Visit 1, in systemic hypertensive therapy during the trial

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Taustine Eye Center
state: Kentucky
city: Mt. Pleasant
country: United States
facility: Glaucoma Consultants & Center for Eye Research, PA
state: South Carolina
city: Houston
country: United States
facility: Houston Eye Associates
state: Texas
Study officials:
affiliation: Pharmaceutical Research Network, LLC
name: William C. Stewart, MD
role: STUDY_DIRECTOR
affiliation: Taustine Eye Center
name: Robert D. Williams, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Houston Eye Associates
name: Robert H. Stewart, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Glaucoma Consultants & Center for Eye Research, PA
name: Elizabeth D. Sharpe, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05456555: The Flapless Approach in Periodontal Regeneration
Official title: The Flapless Approach With and Without Enamel Matrix Derivatives in the Regenerative Treatment of Intrabony Defects: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis, Adult
Intrabony Periodontal Defect
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present investigation is designed in order to compare the radiographic and clinical effectiveness of flapless procedure performed alone or in combination with enamel matrix derivatives in the periodontal regenerative treatment of deep intrabony defects in patients with moderate or severe periodontitis. The study will have a follow-up of 12 months.


Eligibility criteria: Inclusion Criteria:

* diagnosis of periodontitis stage III or IV;
* presence of at least one tooth with ≥6 mm associated with a radiographic intrabony defect ≥3 mm at least 2 months after the completion of non-surgical therapy;
* a full-mouth plaque score and full-mouth bleeding score \<15% at the time of the experimental procedure;
* signed informed consent.

Exclusion Criteria:

* relevant medical disorders contraindicating periodontal surgery or detrimental to periodontal healing;
* consumption of drugs known to affect periodontal status;
* pregnancy and lactation;
* third molars, teeth with furcation involvement or inadequate endodontic treatment and/or prosthetic restoration;
* heavy smokers \>10 cigarettes per day.

Primary outcomes:
measure: Clinical attachment level change
timeFrame: 12 months
Secondary outcomes:
measure: Radiographic bone level change
timeFrame: 12 months
measure: Probing pocket depth change
timeFrame: 12 months
Other outcomes:
Locations:
city: Turin
country: Italy
facility: CIR Dental School
Study officials:
References:
Clinical trial NCT02872155: Comparative Study of the Efficacy of Oral Versus Intravenous Hydration as a Preventive Measure of Contrast-induced Nephropathy (CIN) in Patients With Renal Insufficiency (RI) Grade III Under Study Conducting Computed Tomography (CT)
Official title: Comparative Study of the Efficacy of Oral Versus Intravenous Hydration as a Preventive Measure of Contrast-induced Nephropathy (CIN) in Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Renal Insufficiency
Keywords: contrast-induced nephropathy
renal insufficiency
computed tomography
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Fundacion Clinic per a la Recerca Biomédica
First posted: 2016-08-19
Enrollment: 264
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: PREVENTION

Brief summary: This study evaluates if oral hydratation is as effective as endovenous hydratation in the prophylaxis of contrast-induced nephropathy in patients renal insufficiency grade III under study conducting contrasted computed tomography.


Eligibility criteria: Inclusion Criteria:

* Patients of both sexes over 18 years
* Candidates for a study with computed tomography and intravenous contrast
* A glomerular filtration rate between 30 and 45 mL / min including both determinations
* They have signed the written informed consent after being informed of the objectives and the nature of the case or be unable to have the authorization or agreement of its

Exclusion Criteria:

* refuse to participate in the study
* pregnancy or lactation
* Other risk factors for Contrast Induced Nephropathy: diabetes mellitus type I, have an age of 75 years or above, heart failure (defined by a scale New York Heart Association 3 or 4), hypotension (defined as systolic blood pressure \<100), being treated with nephrotoxic medications.
* Any disease or a history that, in the investigator's opinion, could confound the results of the study or pose an additional risk to patient treatment.

Primary outcomes:
measure: Proportion of contrast induced nephropathy
timeFrame: 48-72 hours after the completion of the computed tomography
Secondary outcomes:
measure: Need for hemodialysis
timeFrame: 15 days
measure: Reversibility of contrast induced nephropathy
timeFrame: 15 days
measure: Proportion of adverse events
timeFrame: 15 days
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic i Provincial de Barcelona
Study officials:
References:
Clinical trial NCT01833455: Premature Ventricular Contractions (PVCs) and Blood Pressure Control
Official title: The Effects of PVC Suppression on Blood Pressure Control in Patients With Frequent PVCs
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Ventricular Premature Complexes
Blood Pressure
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2013-04-16
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine if reduction in premature ventricular contraction (PVC) burden results in a decrease in blood pressure, sympathetic outflow, plasma catecholamines and an improvement in baroreflex gain. Flecainide will be used for PVC suppression in a randomized, double-blinded, crossover fashion.


Eligibility criteria: Inclusion Criteria:

* Frequent symptomatic premature ventricular contractions (PVCs) (\>10% of total QRSs on a 24-hour Holter)
* Willingness to participate in research

Exclusion Criteria:

* Age \> 65 years old
* Pacemaker implantation
* Implantable cardioverter defibrillator implantation requiring pacing
* Sick sinus syndrome
* Atrio-ventricular (AV) block
* Left ventricular dysfunction defined as left ventricular ejection fraction \< 50%
* History of myocardial infarction or coronary artery disease
* Severe left ventricular hypertrophy (wall thickness \> 1.5 cm by echocardiography performed within 3 months from enrollment)
* Severe liver dysfunction
* Creatinine clearance of 35 mL/min/1.73 square meters or less
* Pregnancy
* Known hypersensitivity to the drug
* QRS duration \> 120 ms
* Recent change in blood pressure medication within 30 days of enrollment

Primary outcomes:
measure: Change in Mean Arterial Pressure
timeFrame: Baseline and 28 days
Secondary outcomes:
measure: Change in Muscle Sympathetic Nerve Activity
timeFrame: Baseline and 28 days
Other outcomes:
measure: Change in Baroreflex Gain
timeFrame: Baseline and 28 days
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Mohamed H Hamdan, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02756455: Procalcitonin Reveals Early Dehiscence in Gastric Surgery: the PREDIGS Study
Official title: Procalcitonin Reveals Early Dehiscence In Gastric Surgery: the PREDIGS Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Cancer
Keywords: gastric cancer
procalcitonin
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2016-04-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing gastric cancer surgery in our institution

Brief summary: Background. Gastric cancer surgery is associated with high risk for postoperative morbidity and mortality. Anastomotic leak (AL) is one of the worst complications associated with relevant short and long-term sequelae. Procalcitonin (PCT) is a biomarker used to monitor bacterial infections and guide antibiotic therapy and has been shown to have better predictive value of AL after colorectal surgery than C-reactive protein (CRP) and white blood cell count (WBC).

Purpose. Investigators designed a monocentric pilot study to test if PCT might be a sensitive and reliable marker of AL after gastric surgery


Eligibility criteria: Inclusion Criteria:

* patients undergoing all different kinds of gastric surgery (from partial to total gastrectomy) for cancer, WITH an anastomosis performed
* elective setting

Exclusion Criteria:

* age \< 18 years
* pregnant women
* patients undergoing gastric surgery for benign disease or other kinds of gastric surgery without an anastomosis being performed

Primary outcomes:
measure: % of patients with leaks after gastric surgery correctly identified by the biomarkers (PCT and CRP)
timeFrame: 2 years
measure: % of patients without leaks after gastric surgery correctly identified by PCT and CRP
timeFrame: 2 years
Secondary outcomes:
measure: PCT cut-off that gives good negative predictive (NPV) value for leak after gastric surgery in 3rd POD
timeFrame: 2 years
measure: PCT cut-off that gives good negative predictive value for leak after gastric surgery in 5th POD
timeFrame: 2 years
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Sant'Andrea University Hospital
Study officials:
References:
Clinical trial NCT04198155: Renal Denervation Using Stereotactic Radiotherapy System for the Treatment of Refractory Hypertension
Official title: Renal Denervation Using Stereotactic Radiotherapy System for the Treatment of Refractory Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2019-12-13
Enrollment: 18
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is conducted to investigate the short-term safety and preliminary efficacy of stereotactic radiotherapy for renal denervation to treat refractory hypertension.

Detailed description: This will be a single centre, single arm, prospective cohort study. Patients with refractory hypertension will receive single fraction stereotactic radiotherapy for renal denervation. The study has been designed in a careful and stepwise dose escalation fashion in order to minimize the potential risks associated with this innovative technique. The dose escalation is guided by 3+3 algorithm to ensure more patients will be spared dose limiting toxicities and more patients will be entered on the dose level that will be chosen as optimal dose of maximal effect. Low dosing levels with established safety profile will first be applied before administering higher dosing levels based on preclinical studies.

Safety is the primary endpoint of this study. Safety will be assessed by incidence and evaluation of any serious adverse events using CTCAE v5.0 criteria associated with the procedure through 90 days. Efficacy will be evaluated by assessing mean reduction in average 24-hour ambulatory blood pressure at 90 days post-treatment.

Eligibility criteria: Inclusion Criteria:

Age ≥ 55 and ≤ 75 years. Systolic blood pressure of 160 mmHg or greater despite being treated with at least three hypertensive drugs for more than 3 months.

Exclusion Criteria:

GFR \< 45 ml/min/1.73 m2. Known causes of secondary hypertension. Hospitalized for hypertensive crisis within 1 year. History of acute coronary syndrome or cerebrovascular accident within the last 6 months.

Pregnancy or have a pregnancy plan. Contrast media or iodine allergy. History of abdominal radiotherapy or adhesive intestinal obstruction. Severe valvular heart disease. Stenosis \>50% or renal artery aneurysm in either renal artery. Others.

Primary outcomes:
measure: Safety Endpoint
timeFrame: 90 days
measure: Ambulatory Blood Pressure Reduction
timeFrame: 90 days
Secondary outcomes:
measure: Office Blood Pressure Reduction
timeFrame: 90 days
measure: Number of Drug Adjustments
timeFrame: 90 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University
state: Shanghai
Study officials:
affiliation: Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University
name: Yi-Gang Li, MD
role: PRINCIPAL_INVESTIGATOR
References: