louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02299882: Surgical Infection Rates With Adjunct Vancomycin Compared to Standard Peri-Operative IV Antibiotics
Official title: Surgical Infection Rates With Adjunct Vancomycin Compared to Standard Peri-Operative IV Antibiotics
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lumbar Pain
Keywords: Posterior spine surgery
infection
vancomycin
surgical wound infection
Lead sponsor: Spectrum Health Hospitals
Sponsor class: OTHER
First posted: 2014-11-24
Enrollment: 700
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: Determine the effect of Vancomycin Powder added to the surgical wound at closure on surgical infection rates.

Detailed description: Study will be blinded and randomized 1:1 to either Vancomycin Powder at closure or no vancomycin powder at closure.

Eligibility criteria: Inclusion Criteria:

* All adult, 18 years or greater undergoing posterior approach spinal surgery

Exclusion Criteria:

* Prisoner, pregnant women, patient under the age of 18, those of diminished decision making capacity.
* patients with known reaction to Vancomycin.
* patients having surgery specifically for spine infection
* patients having ADCF or ALIF

Primary outcomes:
measure: Surgical wound infection rate, both deep and superficial infections
timeFrame: 12 weeks post surgery
Secondary outcomes:
measure: Post-operative rate of MRSA infections.
timeFrame: 12 weeks post surgery
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Spectrum Health Hospitals
state: Michigan
Study officials:
affiliation: Spectrum Health Hospitals
name: Jason Squires, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02150382: China Rural Hypertension Control Project 2014
Official title: Effectiveness of a Standardized Protocol-based Treatment Program on Hypertension Control in Rural China.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hypertension
Keywords: hypertension
rural
China
protocol-based treatment
Lead sponsor: First Hospital of China Medical University
Sponsor class: OTHER
First posted: 2014-05-29
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All study patients will be recruited from rural areas in Liaoyang County from blood pressure screening. Liaoyang County, Liaoning Province is located in Northeast China.

Brief summary: China Rural Hypertension Control (CRHC) Project is a cluster randomized trial aims to test the effectiveness of a standardized protocol-based treatment program on hypertension control in rural China.


Eligibility criteria: Inclusion Criteria:

* Man and women aged 40 years or older.
* Mean systolic blood pressure ≥140 mm Hg and/or diastolic blood pressure ≥90 mm Hg; and/or use of antihypertensive medications.Mean blood pressure is based on three measurements at two separate days at least two days apart and within one month.
* Permanent residents in the study villages.
* Do not plan to emigrate in the next 2 years.

Exclusion Criteria:

* Unable to provide consent.
* Treated for malignant tumor and life expectancy\<2 years judged by study physician.
* Pregnancy, currently trying to become pregnant, or of child-bearing potential and not using birth control.
* Diagnosted psychiatric patients.

Primary outcomes:
measure: a composite outcome of cardiovascular disease and all-cause mortality
timeFrame: up to 2-year
Secondary outcomes:
measure: Major cardiovascular diseases
timeFrame: up to 2-year
measure: Fatal and non-fatal stroke
timeFrame: up to 2-year
measure: Fatal and non-fatal myocardial infarction
timeFrame: up to 2-year
measure: Hospitalized or treated heart failure
timeFrame: up to 2-year
measure: Cardiovascular death
timeFrame: up to 2-year
measure: Change in mean systolic and diastolic blood pressure
timeFrame: up to 2-year
measure: Proportion of hypertension control
timeFrame: up to 2-year
Other outcomes:
Locations:
city: Shenyang
country: China
facility: First Hospital of China Medical University
state: Liaoning
Study officials:
References:
Clinical trial NCT03269682: Prevalence of Contrast Enhancement of the Oculomotor Nerve on 3D PD T1 MRI Sequence in Patients With Ophthalmoplegia
Official title: Prevalence of Contrast Enhancement of the Oculomotor Nerve on 3D PD T1 MRI Sequence in Patients With Ophthalmoplegia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ophthalmoplegia
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2017-09-01
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with ophtalmoplegia

Brief summary: Oculomotor nerve (third cranial nerve or "III") palsy is a relatively frequent cause of consultation in ophthalmology.

It may reveal a life-threatening pathology such as aneurysm rupture, pituitary apoplexy, and therefore need imaging in emergency. Apart from few extreme emergency situations, MRI of the oculomotor tract is the first-line examination required. In our usual clinical practice, we noticed in several patients unusual contrast enhancement within the oculomotor nerve on T1 sequence with gadolinium injection, observed in various locations along the nerve path (cavernous and/ or intra-orbital segment).

This contrast enhancement, could confirm the nerve impairment This study aims to analyse the efficiency of a new sequence 3D PD T1 which isotropic spatial resolution less than 1mm, not yet described in the literature, to depict this enhancement.

In patients with ophthalmoplegia involving probably the third cranial nerve, disclosing this MRI sign could help (i) to confirm the involvement of the oculomotor nerve and eliminate differential diagnoses such as myasthenia (ii) to orientate the etiological diagnosis (inflammatory or ischemic origin). This new sequence 3D PD T1 sequence focused on the III could thus be systematically included in the usual MRI protocol.


Eligibility criteria: Inclusion Criteria:

- Ophthalmoplegia whatever the clinical form (unilateral or not, isolated or not, sudden or progressive onset)

Exclusion Criteria:

-Absolute contraindication to MRI or injection of contrast agents.

Primary outcomes:
measure: Contrast enhancement of the oculomotor nerve on 3D PD T1 MRI sequence (presence or absence, determined by a radiologist)
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique A. de Rothschild
Study officials:
References:
Clinical trial NCT00782782: Vascular Sensitivity to Adrenergic Agonists in Patients With CHF and in Healthy Subjects
Official title: Effect of Medications on Vascular Response in Patients With CHF and in Healthy Subjects
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Congestive Heart Failure
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2008-10-31
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with congestive heart failure NYHA I-II and healthy subjects

Brief summary: Congestive Heart failure (CHF) is asociated with changes in cardiac function and vascular responses. The aim of this study is to characterize these differences. Our hypothesis is, that there are differences in vascular responses between healthy subjects and patients with CHF.


Eligibility criteria: Inclusion Criteria:

* Patients with congestive heart failure NYHA I-II
* Stable clinical condition

Exclusion Criteria:

* Resting systolic blood pressure \< 100
* Resting heart rate \< 50
* Hypersensitivity to dexmedetomidine, phenylephrine, isoproterenol, terbutaline

Primary outcomes:
measure: vascular sensitivity (ED50) and response (Emax) to dexmedetomidine, phenylephrine, isoproterenol and terbutaline
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah University Hospital
Study officials:
affiliation: Hadassah University Hospital
name: Mordechai Muszkat
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05757882: Reducing Fasting Time in Children for Sedation
Official title: Comparison of Gastric Ultrasound for Reduction of Fasting Time in Children for Sedation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric ALL
Lead sponsor: Kangbuk Samsung Hospital
Sponsor class: OTHER
Collaborators: name: Samsung Medical Center
First posted: 2023-03-07
Enrollment: 100
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patients are asked to be fasted for certain period of time before sedation to reduce the risk of pulmonary aspiration. However, fasting can be harmful, especially in children who has smaller reserves of energy and fluids compared to the adults. Prolonged fasting may increase nausea, vomiting, dehydration, and hypoglycemia. Therefore, it is important to minimize prolonged fasting time in pediatric patients.

This study is aimed to investigate the safety of minimal fasting time (2 hours) compared to the standard fasting time (4 hours) with gastric ultrasound.


Eligibility criteria: Inclusion Criteria:

* pediatric patients aged under 36 months
* scheduled for elective cardiac echocardiography

Exclusion Criteria:

* patients with disease that delay gastric emptying
* patients taking medication that delay gastric emptying
* structural deformities, or abnormalities that interrupt gastric ultrasound
* refuse to participate in the study
* sedation is failed or impossible

Primary outcomes:
measure: Risk of aspiration
timeFrame: 10 minutes before sedation
Secondary outcomes:
measure: The incidence of complications
timeFrame: 10 minutes after sedation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jinyoung Song
state: Gangnam
Study officials:
References:
Clinical trial NCT00004582: ABT-378/Ritonavir and Efavirenz in HIV-Infected Patients Who Have Taken More Than One Protease Inhibitor in the Past
Official title: A Phase II Study of ABT-378/Ritonavir and Efavirenz in Multiple Protease Inhibitor-Experienced Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: HIV Protease Inhibitors
Ritonavir
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load
ABT 378
efavirenz
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if ABT-378/ritonavir plus efavirenz is safe and effective in lowering the amount of HIV in the blood of patients who have been treated with more than 1 protease inhibitor (PI).

Detailed description: All patients take ABT-378/ritonavir and efavirenz; there are no placebos in this study. Patients take study medications for 48 weeks, during which time there will be 15 study visits. There is a possibility of a study extension after 48 weeks.

Eligibility criteria: Inclusion Criteria

Patients may be eligible for this study if they:

* Are HIV-positive.
* Have a viral load (level of HIV in the blood) of at least 1,000 copies/ml.
* Have been receiving stable (no changes) anti-HIV treatment that includes at least 1 PI for at least 8 weeks prior to study entry.
* Have received more than 1 PI for at least 12 weeks each at some time in the past.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Have had any active opportunistic (AIDS-related) infections within the past 30 days.
* Have ever received nonnucleoside reverse transcriptase inhibitors (NNRTIs), such as delavirdine, nevirapine, or efavirenz.
* Have received certain medications.
* Are pregnant or breast-feeding.
* Abuse alcohol or drugs.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: ViRx Inc
state: California
Study officials:
References:
Clinical trial NCT05179382: Integrated Analysis in Recovery After Exercise With and Without Hydration.
Official title: Integrated Analysis of Autonomic, Cardiovascular and Respiratory Parameters in Recovery After Physical Exercise With and Without Water Ingestion: Crossover Non-randomized Clinical Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho
Sponsor class: OTHER
First posted: 2022-01-05
Enrollment: 54
Sex: MALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This study aims to evaluate post-exercise recovery in healthy young men submitted to a prolonged exercise protocol of submaximal intensity with or without water intake, from the integrated analysis of autonomic (heart rate variability indices), cardiovascular outcomes (systolic blood pressure, diastolic blood pressure and heart rate) and respiratory (oxygen saturation and respiratory frequency). In addition, it will also be evaluated whether the proposed model is able to estimate the number of individuals undergoing hydration that have better recovery.


Eligibility criteria: Inclusion Criteria:

* Include healthy and male individuals, age between 18 and 25 years and physically active.

Exclusion Criteria:

* Volunteers with at least one of the following characteristics will be excluded: smoking, use of drugs that influence the autonomic activity of the heart, alcoholics, people with known metabolic and/or endocrine disorders, and sedentary individuals, insufficiently active and very active.

Primary outcomes:
measure: Blood Pressure
timeFrame: Acute evaluation during interventions
measure: Heart Rate
timeFrame: Acute evaluation during interventions
measure: Respiratory Rate
timeFrame: Acute evaluation during interventions
measure: Peripheral oxygen saturation
timeFrame: Acute evaluation during interventions
measure: Autonomic Modulation - rMSSD index
timeFrame: Acute evaluation during interventions
measure: Autonomic Modulation - SDNN index
timeFrame: Acute evaluation during interventions
measure: Autonomic Modulation - LF index
timeFrame: Acute evaluation during interventions
measure: Autonomic Modulation - HF index
timeFrame: Acute evaluation during interventions
measure: Autonomic Modulation - SD1 index
timeFrame: Acute evaluation during interventions
measure: Autonomic Modulation - SD2 index
timeFrame: Acute evaluation during interventions
Secondary outcomes:
Other outcomes:
Locations:
city: Presidente Prudente
country: Brazil
facility: Universidade Estadual Paulista Júlio de Mesquita Filho
state: São Paulo
Study officials:
affiliation: Professor
name: Luiz Carlos M Vanderlei, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00673582: Effectiveness of Rosuvastatin at Preventing the Progression of Atherosclerosis in HIV Positive Patients
Official title: Randomized, Multicentre, Double- Blind, Placebo Controlled Trial of Rosuvastatin 10 mg for Inhibition of Atherosclerosis Progression Assessed by Carotid Artery Ultrasound in HIV-positive Patients Treated With Antiretrovirals
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Atherosclerosis
HIV Infections
Keywords: Statins
Intima Media Thickness
Plaque Area
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: AstraZeneca
name: CIHR Canadian HIV Trials Network
First posted: 2008-05-07
Enrollment: 250
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Rosuvastatin is a drug used to lower cholesterol, which also has other cardiovascular benefits. The goal of this project is to determine if rosuvastatin is effective at slowing the development of heart disease in people with HIV. We expect that after 2 years of treatment people treated with rosuvastatin will show significantly better results than people treated with a placebo.

Detailed description: HIV+ patients with at least one cardiovascular risk factor will be randomized to either rosuvastatin 10mg/day or placebo for a period of 96 weeks. B-mode carotid ultrasound will assess the primary outcome measure of average total thickness (a composite measurement of intima media thickness and total plaque area) at baseline, 24, 48, 72 and 96 weeks. We hypothesize that rosuvastatin will be significantly more effective with respect to inhibition of change in average total thickness between baseline and 96 weeks compared to placebo.

Eligibility criteria: Inclusion Criteria:

* HIV positive, at least one cardiovascular disease risk factor

Exclusion Criteria:

* Diabetes
* Previous vascular disease
* Muscular disease
* Current use of other lipid lowering therapy

Primary outcomes:
measure: Average total thickness (a composite of carotid intima media thickness and total plaque area)
timeFrame: 96 weeks
Secondary outcomes:
measure: Carotid Intima Media Thickness, Total Plaque Area, Lipids
timeFrame: 96 weeks
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: The St. Paul's Hospital HIV Metabolic Clinic & The BC Centre for Excellence in HIV/AIDS
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Greg Bondy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: Marianne Harris, MD
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Marek Smeija, MD
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Joel Singer, MD
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: G.B. John Mancini, MD
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Sammy Chan, MD
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Julio Montaner, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01233882: Bosutinib In Subjects With Renal Impairment
Official title: An Open-Label, Single-Dose, Parallel-Group Study Of The Pharmacokinetics And Safety Of Bosutinib In Subjects With Renal Impairment And Matched Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Disease, End-Stage
Renal Insufficiency, Chronic
Renal Insufficiency, Acute
Keywords: Renal impairment
healthy volunteers
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-11-03
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a two-staged study of a single dose of 200 mg of bosutinib given to subjects with renal impairment and matching healthy volunteers. In Stage 1, only subjects with severe renal impairment and subjects with normal renal function will be enrolled. Subjects with mild and moderate renal impairment will be enrolled in Stage 2 if the results from Stage 1 suggest a substantial difference in PK profiles between subjects with severe renal impairment and subjects with normal renal function.


Eligibility criteria: Inclusion Criteria:

* Males and females, aged 18 to 65.
* Adequate hepatic function.
* Documented creatinine clearance by Cockroft-Gault formula indicative of the respective level of renal impairment: Severe renal impairment (CrCl \<30 mL/min/1.73m2), moderate renal impairment (30 ≤ CrCl ≤50 mL/min/1.73m2), mild renal impairment (50 \< CrCl≤80 mL/min/1.73m2) and normal renal function (CrCl \>80 mL/min/1.73m2).

Exclusion Criteria:

* Use of any investigational drug or biologic within 4 weeks prior to the screening visit of during the screening period.
* Ongoing treatment with Digoxin or strong CYP3A4 inhibitors or inducers.
* Uncontrolled hypertension (for renally impaired subjects only).

Primary outcomes:
measure: Serum concentrations of bosutinib and its active metabolites will be measured, PK parameters (AUCinf, Cmax, AUClast, Tmax, t1/2, Cl/F and Vz/F) of bosutinib and its active metabolites will be calculated.
timeFrame: 11 days
Secondary outcomes:
measure: Safety endpoints to include adverse events, physical examination findings, changes in clinical laboratory test results including ECGs, and changes in vital signs
timeFrame: 11 days
Other outcomes:
Locations:
city: DeLand
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Gainesville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Orlando
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Saint Paul
country: United States
facility: Pfizer Investigational Site
state: Minnesota
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: