louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00704535: Evaluation of the Safety, Tolerability and Efficacy of Ezetimibe on a Select Population of Filipinos With Hypercholesterolemia (Study P04748)(COMPLETED)
Official title: Post-marketing Surveillance of the Safety, Tolerability and Efficacy of Ezetimibe Among Filipino Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Hypercholesterolemia
Homozygous Familial Hypercholesterolemia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-06-25
Enrollment: 4105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Filipino subjects with hypercholesterolemia

Brief summary: The purpose of this study is to evaluate the overall safety, tolerability, and efficacy of Ezetimibe when used alone or in combination with a statin in patients with hypercholesterolemia


Eligibility criteria: Inclusion Criteria:

* Outpatient men or women, age 18 years and above.
* Patients with primary (heterozygous familial and non-familial) hypercholesterolemia or homozygous familial hypercholesterolemia.

Exclusion Criteria:

* Known hypersensitivity to Ezetimibe.
* Moderate to severe hepatic insufficiency.
* Persistent elevation of serum transaminase levels of more than 1.5 times the upper limit of normal.
* Pregnancy or lactation.
* Concomitant intake of bile acid sequestrants (resins), nicotinic acid (niacin), fibric acid (fibrates), or cyclosporine

Primary outcomes:
measure: Safety as Measured by Number of Subjects With at Least One Adverse Event
timeFrame: 28 days after Visit 1
measure: Safety as Measured by Number and Type of Adverse Events.
timeFrame: 28 days after Visit 1
measure: Safety as Measured by Severity of Adverse Events as Determined by the Investigator
timeFrame: 28 days after Visit 1
measure: Safety as Measured by Adverse Event Relatedness to Study Drug as Reported by the Investigator.
timeFrame: 28 days after Visit 1
measure: Safety as Measured by Dose Adjustment Upon Incidence of an Adverse Event
timeFrame: 28 days after Visit 1
measure: Safety as Measured by Outcome of Adverse Events
timeFrame: 28 days after Visit 1
measure: Tolerability as Measured by Subject Self-assessment
timeFrame: 28 days after Visit 1
Secondary outcomes:
measure: To Evaluate the Efficacy of Ezetimibe in Lowering Serum Cholesterol Levels 28 Days After Visit 1 (Baseline)
timeFrame: 28 days after Visit 1
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00018135: Parathyroid Hormone Levels in Relation to the Phosphorus Content of Meals
Official title: Parathyroid Hormone Levels in Relation to the Phosphorus Content of Meals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Failure
Keywords: high iPTH levels
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
First posted: 2001-07-05
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: Patients on hemodialysis tend to have chronic elevations in the level of phosphorus in the blood and a secondary increase in the iPTH level. This chronic elevation in iPTH can have adverse consequences, thus a variety of phosphate binders are given in an attempt to decrease the absorption of phosphorus present in the normal diet. Some preliminary studies have indicated that the iPTH level may change based on the amount of phosphorus present in a meal prior to any significant absorption of phosphorus. If this is true in hemodialysis patients, then the timing of the administration of phosphate binders in relation to the ingestion of meals needs to be considered

Detailed description: Drugs used will include three phosphate binders already approved and commonly used. Calcium acetate, aluminum hydroxide, and sevelamer (Renagel) will be given on separate occasions in conjunction with a high phosphorus meal. They will be given in standard doses used in the treatment of high phosphorus levels in hemodialysis patients.

The population targeted will included hemodialysis patients with elevated iPTH and phosphorus levels.

The patients will receive up to five separate meals. Four of these will be high phosphorus content meals and one will be a low phosphorus content meal. On up to three occasions with the high phosphorus content meals the patients will ingest one of the three phosphate binders. The meals will be ingested after a twelve-hour overnight fast. Labs will be drawn prior to meal ingestion and then at 15, 30, 60, 120 and 240-minute intervals. The labs will consist of iPTH, phosphorus, calcium, and glucose. A serum albumin level will be obtained with the initial specimen only. The patients will have an iPTH level of at least 200pg/ml and a serum phosphorus level of at least 4.0 mg/dl.

The primary outcome will be the change in the iPTH level in relation to the phosphorus content of the meals. Secondary outcomes will include the change in iPTH level in relation to the various phosphate binders being used.

Eligibility criteria: Inclusion criteria:

* Patients 18 years of age or older
* Receiving treatment with hemodialysis for at least 90 days
* Serum iPTH levels greater than 200pg/ml
* Serum phosphorus levels greater than 4.0mg/dl

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
References:
Clinical trial NCT03633435: Home Hemodialysis Assisted by a Nurse for Arterio-venous Fistula Cannulation
Official title: Feasibility of a Home HD Program Assisted by a Nurse Coming at Home for Arterio-venous Fistula (AVF) Cannulation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemolysis
Cannulation
Arteriovenous Fistula
Nurse's Role
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
Collaborators: name: NxStage Medical
First posted: 2018-08-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All incident and prevalent dialysis patients of our unit will get information on that assisted HHD program and will be able to choose this technique
Primary purpose: TREATMENT

Brief summary: Home HD (HHD) is associated with better outcome in end-stage renal disease patients compared to in-center HD, in particular in terms of quality of life. However fear of AVF cannulation is a known barrier for patient's choice and adoption of a HHD program. Providing nurse assistance for the cannulation can help developing HHD programs. The aim of this study is to evaluate the feasibility of assisted home hemodialysis, with the intervention of a nurse at home for arterio-venous fistula cannulation.

Detailed description: * Monocentric prospective interventional study.
* Intervention is assisted HHD, defined as: rope-ladder cannulation at the patient's home provided by a trained private nurse at each dialysis session, and connection to the Nxstage System One
* pilot study, with main objective defined as feasibility of the investigator's assisted HHD program. Pilot study usually concerns a small population, allowing us to develop thereafter a bigger study if the results are encouraging.
* primary end-point criteria defined as definitive cessation of HHD with transfer to an other dialysis modality.

Eligibility criteria: Inclusion Criteria:

* The patient must be aged more than 18, able to read and write, and have a person with him at home during HD session, according to the french law.

Exclusion criteria:

* medical contra-indication for HHD

Primary outcomes:
measure: failure of assisted- HDD
timeFrame: 12months
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: caen University hospital
Study officials:
References:
Clinical trial NCT06295835: Method Comparison Study for Measuring Potassium (K) and Ionized Calcium (iCa) in Blood
Official title: Clinical Evaluation of the Potassium (K) and Ionized Calcium (iCa) Tests in Capillary Specimens Using the i-STAT CG8+ Cartridge With the i-STAT 1 Analyzer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Potassium (K) & Ionized Calcium (iCa) in Capillary Whole Blood
Lead sponsor: Abbott Point of Care
Sponsor class: INDUSTRY
First posted: 2024-03-06
Enrollment: 232
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Capillary whole blood specimens will be tested in duplicate on the i-STAT 1 Analyzer with the CG8+ cartridge and a blood analyte testing comparator device.
Primary purpose: DIAGNOSTIC

Brief summary: Method comparison study for Potassium (K) and ionized calcium (iCa).

Detailed description: The objective of this study is to compare the performance of the K and iCa Tests using the IUO i-STAT CG8+ Cartridge on the i-STAT 1 Analyzer to the performance of the K and iCa Tests on the comparator device using capillary whole blood specimens. This objective will be assessed as part of a Method Comparison evaluation.

Eligibility criteria: Inclusion Criteria:

* Signed and dated consent form (if required by the IRB)
* ≥ 18 years of age

Exclusion Criteria:

• Prior enrollment in the study

Primary outcomes:
measure: Performance comparison
timeFrame: Up to 5 minutes
measure: Performance comparison
timeFrame: Up to 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland (UMD)
state: Maryland
city: Hershey
country: United States
facility: Penn State University Hershey Medical Center (Hershey)
state: Pennsylvania
city: Redmond
country: United States
facility: Eastside Research Associates (ERA)
state: Washington
city: Ottawa
country: Canada
facility: Abbott Point of Care (APOC)
state: Ontario
Study officials:
affiliation: Abbott Point of Care
name: Manish Gupta, BS, MBA
role: STUDY_DIRECTOR
References:
Clinical trial NCT05016258: Performance and Safety Use of the Mono Block Implant "KONTACT MB"
Official title: Multicenter Observational Study on Performance and Safety Use of "KONTACT MB" Dental Implant in Daily Practice
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dentistry
Dental Implant
Dental Restoration
Implant-supported Fixed Prosthesis
Keywords: Mono Block design
KONTACT MB
Biotech Dental
Lead sponsor: Biotech Dental
Sponsor class: INDUSTRY
First posted: 2021-08-23
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient who is eligible and planned for an implant-supported prosthetic restoration following the instructions for use of the KONTACT MB implant and who meets the inclusion / exclusion criteria.

Brief summary: A multicenter prospective observational study aims to illustrate the clinical outcome of dental implants "Kontact MB" and the effects of its Mono Block design on the peri implant bone tissue recession and soft tissue conservation.

All the enrolled patients will be eligible for one or multiple implant-supported fixed restoration(s) according to the routine clinical practice and the manufacturer's instruction for use.


Eligibility criteria: Inclusion Criteria:

* Edentulous patient (partially or completely AND formerly, recently or just before implantation) requiring the placement of one (or more) dental implant (s) in maxillary or mandibular
* Age ≥ 18 years
* Good general health (ASA score between \[1-2\])
* Sufficient bone volume and quality (with or without bone graft) to support the implant
* Given a writing consent for the collection of his medical data as part of the study (delivery of a patient's sheet)

Exclusion Criteria:

* Poor oral hygiene
* Bruxism, parafunctional habits, occlusion disorders and / or temporomandibular joints
* Infections and oral inflammation such as periodontitis, gingivitis
* Patient with metabolic disorders (eg diabetes mellitus) or bone disease that may compromise peri-implant tissue healing
* Heavy smoker (\> 10 cigarettes / day)
* Patient with a pathology or immunosuppressive therapy such as chemotherapy, radiotherapy
* Patient on prolonged steroid therapy
* Titanium / titanium alloy allergy
* Alcohol or drug abuse
* Pregnant woman (or likely to be pregnant); or breastfeeding
* Difficulty of medical follow-up patients with geographical, social or psychological constraints
* Persons deprived of liberty or guardianship
* Involuntary / patient refusal to participate in the study

Primary outcomes:
measure: Implant survival rate
timeFrame: up to 36 months
measure: Peri implant bone level
timeFrame: up to 36 months
measure: Keratinized tissues level
timeFrame: up to 36 months
measure: Gingival index
timeFrame: up to 36 months
measure: Bleeding index
timeFrame: up to 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hadi Antoun Office
Study officials:
affiliation: Hadi Antoun office
name: Hadi Antoun
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01264458: Microvesicle Production After Acute Trauma and Its Clinical Impact on Venothromboembolism
Official title: Microvesicle Production After Acute Trauma and Its Clinical Impact on Venothromboembolism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venothromboembolism
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2010-12-21
Enrollment: 1234
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Trauma patients arriving to Saint Mary's Emergency Department and control patients.

Brief summary: The purpose of this research study is to look at how trauma affects the ability of blood to clot. The blood of people who suffer a traumatic injury can under-clot or over-clot, and this research study will look at blood drawn from people after they suffer a traumatic injury to see how well their blood clots.


Eligibility criteria: Inclusion Criteria:

* Male and female patients 18 years of age or older
* Blunt trauma patients including those with closed head injury
* Penetrating trauma patients

Exclusion Criteria:

* Are on therapeutic anticoagulation
* Have preexisting coagulopathy
* Patients greater than 12 hours from time of injury
* Have history of malignancy or preexisting diagnosis of sepsis or renal failure
* Patients with burn injuries
* Male and female patients younger than 18 years of age
* Pregnant patients

Primary outcomes:
measure: Estimate the distribution over time of procoagulant Microvesicles (MVs) concentration by cell of origin and endogenous thrombin potential (ETP).
timeFrame: 6 months
measure: Determine the cumulative incidence of Venothromboembolism (VTE) within three months after major trauma and test the distribution of procoagulant MV concentration and endogenous thrombin generation potential over time as potential predictors of VTE.
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Myung Park, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03924258: Study of the Prevalence of Iron Deficiency in Patients With Heart Failure
Official title: Study of the Prevalence of Iron Deficiency in Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Lead sponsor: VIFORFRANCE
Sponsor class: INDUSTRY
First posted: 2019-04-23
Enrollment: 1300
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: Despite its known prevalence in Heart Failure, a recent study conducted by Prof. Cacoub (unpublished) on the French national health insurance database showed that iron deficiency was a poorly diagnosed and poorly treated comorbidity. In chronic diseases including Heart Failure, Transferrin Saturation Factor is only performed in about 10% of cases while it is recommended for patients with Heart Failure (French Health High Authority 2011). The purpose of this study is to obtain current data on the prevalence of iron deficiency in France in patients with Heart Failure, applying the recommendations of European Society of Cardiology and French Health High Authority (determination of ferritinemia and Transferrin Saturation Factor).


Eligibility criteria: Inclusion Criteria:

* Patient, male or female, over 18 years of age
* Patient present at the hospital on the day of the study
* Diagnosis of Heart Failure (acute or chronic) regardless of left ventricular ejection fraction (LVEF)
* Patient with signed consent

Exclusion Criteria:

* Protected patient: major under guardianship, tutorship or other legal protection, deprived of liberty by judicial or administrative decision
* Pregnant or breastfeeding woman

Primary outcomes:
measure: Complete blood iron status
timeFrame: One day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06304558: "Effectiveness of Non-invasive Neuromodulation Treatment for Improving Sexual Satisfaction in Healthy Subjects.
Official title: "Effectiveness of Non-invasive Neuromodulation Treatment (NESA) for Improving Sexual Satisfaction in Healthy Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Satisfaction
Lead sponsor: Universidad Europea de Madrid
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objectives of the programming with the XSignal device will be to influence the sexual satisfaction of the participants.

As secondary objectives, the effectiveness of the XSignal device during a defined treatment period will be analyzed in terms of quality of life, pain, stress, anxiety, sexual function, sleep quality, cortisol, heart rate, blood pressure, respiratory rate, and body temperature of the same subjects, compared with a placebo group, observing the long-term influence of the results.

Detailed description: Considering the objectives set: In the first phase, the directing electrode will be located at C6-C7 to generate a systemic and general effect on the organism, with program 1, program 2, program 7, and program 8. In the second phase, the directing electrode will be placed at the abdominal level in the area of the mesenteric plexus to influence the sympathetic innervation of the viscera. In the third phase, the directing electrode is located at S2-S3 to concentrate the action of the therapy on the sacral parasympathetic plexus,. In this way, both the sympathetic and parasympathetic innervation of the main sexual organs are covered through the sympathetic paravertebral ganglia and the sacral plexus.

Eligibility criteria: Inclusion Criteria:

* Subjects from 18 to 65 years
* Sexually active
* Signed consent form

Exclusion Criteria:

* Diagnosed diseases.
* Severe previous psychiatric conditions.
* Medical contraindications that prevent the use of non-invasive neuromodulation therapy.
* Having exercised in the hours prior to the NESA treatment.
* Having consumed coffee or tobacco in the hours prior to the treatment.
* Minors.
* Individuals who have previously received any type of neuromodulation treatment.
* Cancer.

Primary outcomes:
measure: Sexual satisfaction
timeFrame: 10 minutes
Secondary outcomes:
measure: Stress levels
timeFrame: 10 minutes
measure: Blood Pressure (Sistolic and diastolic)
timeFrame: 5 minutes
measure: Heartbeats per minute
timeFrame: 5 minutes
measure: Sleep Quality
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Villaviciosa de Odón
country: Spain
facility: Universidad Europea de Madrod
Study officials:
References:
Clinical trial NCT00585858: Cytokine Kinetics Test to Assess the Presence or Absence of Tolerance in Organ Transplant
Official title: Cytokine Kinetics Assay to Assess the Presence or Absence of Tolerance in Organ Transplant Recipients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Kidney Transplantation
Liver Transplantation
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2008-01-03
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Kidney or liver transplant recipients

Brief summary: The purpose of this pilot study is to determine if there is clinical correlation between the CKT and transplant recipients who are known to be on minimal or no immunosuppression (presumed tolerant) and those who are on conventional amounts of immunosuppression and have either experienced rejection (presumed hyper-responsive to donor) or have not experienced rejection (unknown responsive state).


Eligibility criteria: Inclusion Criteria:

* Kidney or liver transplant recipients for whom donor cells are available

Exclusion Criteria:

* HcT \<32%

Primary outcomes:
measure: Correlation between cytokine kinetics test and clinical status of subject
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
References:
Clinical trial NCT02916563: Dario Blood Glucose Monitoring System - Android Devices Altitude Evaluation Study
Official title: Dario Blood Glucose Monitoring System - Android Devices Altitude Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: LabStyle Innovations Ltd.
Sponsor class: INDUSTRY
First posted: 2016-09-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study evaluates the performance of a blood glucose monitoring system at high altitudes (approximately 10,000 feet). The performance is assessed via a reference method for glucose analysis (Yellow Springs Instrument 2300 STAT Plus Glucose Analyzer).

Detailed description: This study will be a non-randomized study conducted to assess the accuracy and performance of the Dario Blood Glucose Monitoring System at an elevated altitude. 50 subjects will be enrolled in this study. Participation includes a 15-20 minute visit to the clinical site where they will be consented. The participant will then receive a fingerstick to obtain capillary blood used to test the performance of the BGMS and to obtain a comparative glucose measurement on the reference method, the Yellow Springs Instrument 2300 STAT Plus Glucose Analyzer.

Eligibility criteria: Inclusion Criteria:

* Able to speak and read English

Exclusion Criteria:

* Pregnant
* Has any condition that the principle investigator believes may interfere in the subject's participation in the trial.

Primary outcomes:
measure: Number of Successful Glucose Readings
timeFrame: One day
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Barbara Davis Center
state: Colorado
Study officials:
References: