louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01109108: Streptococcus Pneumonia: Effects of PCV13 on Pneumococcal Carriage
Official title: Streptococcus Pneumonia: Herd Effects and Emergence of Potentially Virulent Serotypes PCV13_Impact of NP Colonization, Herd Effects and Emergence of Potentially Virulent Serotypes of Pneumococci
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nasopharyngeal Carriage of S. Pneumoniae
Keywords: pneumococcal vaccine
nasopharyngeal carriage
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2010-04-22
Enrollment: 9000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children \< 5 years of age receiving care at Primary Care center at BMC and as many parent(s) as willing to particpate

Brief summary: The specific aim is to evaluate the impact of PCV13 as administered in the pediatric primary care clinic at Boston medical center on the serotype specific carriage of Streptococcus pneumoniae in children \< 5.

Specifically the investigators will measure the decline in vaccine serotypes, the proportion of children receiving vaccine required to achieve 50% reduction in serotype specific carriage and the correlation between immunogenicity of the specific serotypes and decline in carriage. The study has been extended to complete 5 years of surveillance to determine the new SP serotype distribution at the time presumably a new equilibrium has been achieved.


Eligibility criteria: Inclusion Criteria:

* children \< 5 years of age receiving care at Primary Care center at BMC and as many parent(s) as willing to participate

Exclusion Criteria:

* children with facial malformations making NP sampling unacceptable
* children in foster care

Primary outcomes:
measure: Nasopharngeal Colonization With PCV13 S. Pneumoniae
timeFrame: Study years 1-5
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Pediatric Primary Care, Boston Medical Center
state: Massachusetts
Study officials:
References:
Clinical trial NCT03948308: Alteration of the Immune Response in Bacterial Infection
Official title: Alteration of the Immune Response in Bacterial Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infection
Lead sponsor: Versailles Hospital
Sponsor class: OTHER
First posted: 2019-05-13
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The pilot study "ARIIBO" was conducted to analyze changes in immune parameters reported in obese subjects, which had never been the subject of a global study outside of an infectious context, and studied in period septic only sporadically. This study was intended to contribute to a better understanding of the probably adverse impact of obesity on the immune response to bacterial infections, and to describe a specific immunological profile of an infectious excess risk in obese subjects.

In terms of infection, obesity is a risk factor due to "mechanical" and pharmacodynamic variations, but also to the immune system. One of the best studied immunological parameters in obese patients, leptin resistance, is associated with a decrease in innate and adaptive immunity through a modification of the lymphocyte and cytokine profile.

It is important to compare the data collected in obese patients infected (first study called "ARIIBO"), with those of non-obese subjects presenting the same type of infection, which will be included in the study "ARIIBACT"


Eligibility criteria: Inclusion Criteria:

* age between 18 and 80 years
* BMI 18 to 25
* presence of a bacterial infection
* pneumopathy (documented or probable)
* acute pyelonephritis / prostatitis
* skin and soft tissue infection (erysipelas, fasciitis, excluding pressure ulcers)
* cholecystitis / cholangitis,
* surgical site infection
* signed informed consent

Exclusion Criteria:

* patients with documented viral, parasitic or mycotic infections
* patients with bacterial infection\> 4 weeks (eg endocarditis, osteoarticular infections)
* patients followed in intensive unit care
* patients with progressive cancerous pathology or malignant hemopathy diagnosed in the previous five years
* patients with systemic diseases (connective tissue diseases, vasculitis)
* known immunodepression syndrome (CVID, HIV ...)
* immunosuppressive therapy in progress until less than one month before inclusion (corticosteroids, DMARDs, biotherapies, hydroxychloroquine)

Primary outcomes:
measure: cytokin analysis (IL-6, IL-10, IL-17, TNFα, IFNγ)
timeFrame: 1 month
measure: adipokin analysis (leptine, adiponectine)
timeFrame: 1 month
measure: leptin polymorphism analysis
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Le Chesnay
country: France
facility: CH Versailles
Study officials:
References:
Clinical trial NCT02104908: Study of Nerve Block Anesthesia for Surgery of Hip Fracture in the Elderly
Official title: Target-controlled Propofol Infusion as a Technique of Anesthesia for Surgery of Hip Fracture Under Ultrasound Guidance Lumbar and Sacral Plexus Block or Lumbar, Sacral and Paravertebral Nerve Block in the Elderly
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Anesthesia; Reaction
Lead sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Sponsor class: OTHER
First posted: 2014-04-07
Enrollment: 80
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators aim to examine target-controlled propofol infusion as a technique of anesthesia for surgery of hip fracture under ultrasound guidance lumbar and sacral plexus block or lumbar, sacral and paravertebral nerve block in the elderly; and to evaluate which regional anesthesia was more sufficient for the old.

Detailed description: Eighty patients with American Society of Anesthesiologists（ASA） Ⅰ-Ⅲ older than 80 years are randomly assigned to 2 groups: a lumbar and sacral plexus block(LS) group with 20ml 0.5% ropivacaine at lumbar plexus(level L3-4) and 10ml 0.5%ropivacaine at sacral plexus; a lumbar, sacral plexus and paravertebral nerve block(LSP) group with 20ml 0.5% ropivacaine at lumbar plexus(level L3-4) , 10ml 0.5%ropivacaine at sacral plexus and 10ml 0.5%ropivacaine at paravertebral nerve(level L1). The target-controlled propofol infusion is started immediately after positioning the patient on the operating table. The initial target concentration was 0.5μg/mL. The infusion rate is adjusted every 5min by increasing or decreasing the target concentration by 0.2μg/mL steps based on the patients' respiratory rate(RR), blood pressure(BP), heart rate(HR), and level of sedation(score of 5 on Ramsay Sedation Scale ). The minimal, maximal, optimal target concentration, cumulative propofol dose, frequency of spontaneous movement and incidences of associated complications are recorded. Patients were phoned for followup and questioned for activity status in one year. If the patients were dead, date of death; if they survived, daily living activity questioned.

Eligibility criteria: Inclusion Criteria:

* ASA Ⅰ-Ⅲ
* hip fracture need surgery

Exclusion Criteria:

* patient refusal
* chronic use of opioids
* coagulation disorders
* preexisting neurological disorders

Primary outcomes:
measure: cumulative propofol dose
timeFrame: 24 weeks
Secondary outcomes:
measure: The optimal target concentration propofol
timeFrame: 24 weeks
Other outcomes:
measure: Mortality
timeFrame: 1 year
Locations:
Study officials:
affiliation: Shanghai Jiaotong University Affiliated Sixth People's Hospital Shanghai,China
name: Daqiang Zhao, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00518908: Organ Protection With Sevoflurane Postconditioning
Official title: Role of Volatile Anesthetics for Hepatic Protection in Ischemia-reperfusion: Postconditioning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatectomy
Keywords: Ischemia reperfusion injury
Organ protection
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2007-08-21
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Organ protection, volatile anesthetics, postconditioning, hepatic surgery

Detailed description: This study aims at the evaluation of a potential attenuation of ischemic-reperfusion injury in the liver with sevoflurane postconditioning upon reperfusion.

Eligibility criteria: Inclusion criteria:

* older than 18 years
* patients undergoing liver resection (benign or malignant tumors)

Exclusion criteria:

* non-german speakers
* laparoscopic liver resection
* coagulopathy (platelets \< 50'000/ml, Quick \< 50%)
* liver cirrhosis

Primary outcomes:
measure: Liver transaminase AST
timeFrame: Postoperative phase until discharge
Secondary outcomes:
measure: ALT peak value
timeFrame: Postoperative phase until discharge
measure: Course of transaminases
timeFrame: From the day before surgery, to 6 hours after surgery, up to postoperative day 7
measure: Postoperative complications
timeFrame: Postoperative phase until discharge
measure: Length of hospital stay
timeFrame: Postoperative phase until discharge
measure: Need for prolonged intensive care unit stay (>24 hours)
timeFrame: Postoperative phase until discharge
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital of Zurich
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: 01 Studienregister MasterAdmins
role: STUDY_DIRECTOR
References:
Clinical trial NCT03354208: Asphyxia Associated Metabolite Biomarker Investigation (AAMBI)
Official title: Verification of Biomarkers to Examine Neonatal Asphyxia Induced Hypoxic-ischemic Encephalopathy. A Prospective Multicenter Observational Study for Development of a Diagnostic Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asphyxia Neonatorum
Keywords: biomarkers
Lead sponsor: Life Science Inkubator
Sponsor class: OTHER
Collaborators: name: Cukurova University
name: University Children's Hospital Tuebingen
First posted: 2017-11-27
Enrollment: 155
Sex: ALL
Minimum age (years): 0
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infants at risk for perinatal hypoxic-ischemic brain injury

Brief summary: Verification of biomarkers in a human population for their ability to diagnose the severity of neonatal asphyxia. These biomarkers linked to asphyxia have been identified in animal studies.

Detailed description: The aim of the study is to verify the application of combinations of several laboratory parameters in early postnatal blood samples, for identification of infants, who will suffer from early abnormal neonatal neurological outcome, in a population at risk.

The population at risk is defined as term and late preterm (\>36 weeks of gestation) human infants following perinatal hypoxia-ischemia with or without postnatal resuscitation.

Eligibility criteria: Inclusion Criteria:

Group 1: inclusion criteria fulfilled for hypothermia treatment Group 2: Infants with suspected perinatal brain injury due to one of the followings

* Perinatal hypoxia-ischemia (defined as a perinatal acidosis indicated by a pH≤7.10 or a base excess ≤-12mmol/l in umbilical cord blood or early postnatal blood collected at \<90min of age (outborn patients)
* 5min APGAR-score ≤ 5
* Need for resuscitation after birth for \>1 min. after birth, positive pressure respiratory support with face mask or endotracheal tube, or cardiac compressions Group 3: UApH \>7,25, and adaptation disorder of the newborn and need of postnatal clinical surveillance

Exclusion Criteria:

gestational age \< 36 weeks

* age at time of screening \>2,5h
* congenital malformation
* missing or invalid informed parental consent
* unsuccessful resuscitation
* infant considered not-viable
* decision for palliative care only

Primary outcomes:
measure: abnormal short-term outcome (NE)
timeFrame: 14 days for clinical diagnosis
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University
city: Elazığ
country: Turkey
facility: University of Firat
city: İstanbul
country: Turkey
facility: Özel Güngören Hastanesi
city: Mersin
country: Turkey
facility: Mersin University School of Medicine
Study officials:
affiliation: Life Science Inkubator Betriebs GmbH & Co. KG
name: Ron Meyer
role: STUDY_DIRECTOR
References:
Clinical trial NCT04326608: Psycho-social Aspects After a Physiotherapy Intervention in Chronic TMD Pain
Official title: Psycho-social Aspects After a Physiotherapy Intervention in Chronic TMD Pain
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: TMD
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2020-03-30
Enrollment: 70
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: Chronic TMD pain

Brief summary: How patients psycho-social factors change after a physical intervention in patients with chronic TMD pain


Eligibility criteria: Inclusion Criteria:

* Chronic myofascial TMD pain

Exclusion Criteria:

* Neurologic pain

Primary outcomes:
measure: TSK-11
timeFrame: immediately after treatment
measure: TSK-11
timeFrame: at 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00178308: Measuring Alterations of DNA in Human Blood
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplasms
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Litron Laboratories
First posted: 2005-09-15
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: The purpose of this research is to evaluate an automated, laser-based technique for measuring DNA damge resulting from radiation. We want to use controlled exposure on cancer patients to help develop a measurement to test people who may have been accidentally exposed to radiation.


Eligibility criteria: Inclusion Criteria:

* Male or female, age 21 to 70 years old.
* Patient undergoing with anti-neoplastic agent(s) known to have genotoxic activity (e.g., cyclophosphamide, 5-FU, cisplatin, Ara-C.
* X-irradiation may be considered, so long as a substantial fraction of red marrow is exposed (e.g., femur or chest/trunk region);
* treatment could be ongoing therapy or initial therapy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: Universtiy of Rochester, Dept of Radiation Oncology
name: Yuhchyau Chen, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05887908: Efficacy and Safety of Cefepime/Nacubactam or Aztreonam/Nacubactam Compared to Imipenem/Cilastatin in Subjects With Complicated Urinary Tract Infections or Acute Uncomplicated Pyelonephritis
Official title: A Phase 3, Multi-Center, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Cefepime/Nacubactam or Aztreonam/Nacubactam Compared to Imipenem/Cilastatin in the Treatment of Complicated Urinary Tract Infections or Acute Uncomplicated Pyelonephritis, in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Complicated Urinary Tract Infection
Acute Pyelonephritis
cUTI
AP
Keywords: OP0595
nacubactam
Integral
Lead sponsor: Meiji Seika Pharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-06-05
Enrollment: 614
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Phase 3 study to evaluate the efficacy and safety of cefepime/nacubactam or aztreonam/nacubactam compared to imipenem/cilastatin in the treatment of complicated urinary tract infections (cUTI) or acute uncomplicated pyelonephritis (AP).


Eligibility criteria: Inclusion Criteria:

1. Male or female patients at least18 years of age (or age of legal consent, whichever is older) at the time of obtaining informed consent and who can be hospitalized throughout the Treatment Period;
2. Weight at most 140 kg;
3. Expectation, in the opinion of the Investigator, that the patient's cUTI or AP will require treatment with at least 5 days of IV antibiotics;

Exclusion Criteria:

1. Has a known imipenem- and/or meropenem-resistant Gram-negative uropathogen (at least 10\^5 CFU/mL), isolated from study-qualifying urine culture; Note: If after randomization the susceptibility testing indicates resistance to imipenem and/or meropenem, the patient may remain on the study drug at the Investigator's discretion.
2. Has known or suspected single or concurrent infection with Acinetobacter spp. or other organisms that are not adequately covered by the study drug (eg, concurrent viral, mycobacterial, or fungal infection) and needs to be managed with other anti-infectives; Note: Patients with qualifying pathogen coinfected with a Gram-positive pathogen may be administered narrow spectrum, open-label glycopeptide (eg, vancomycin), oxazolidinone (eg, linezolid), or daptomycin concomitantly with the study drug at the Investigator's discretion.
3. Has only a known Gram-positive primary uropathogen (at least 10\^5 CFU/mL), isolated from study qualifying urine culture;

Primary outcomes:
measure: The primary efficacy endpoint is the proportion of patients who achieve composite clinical and microbiological success at TOC in the Microbiological Modified Intent-to-Treat (m-MITT) Population.
timeFrame: 7 [±2] days after EOT [Day 10 to 23]
Secondary outcomes:
Other outcomes:
Locations:
city: Meegomäe
country: Estonia
facility: Meiji Research Site
state: Voru
Study officials:
References:
Clinical trial NCT03541408: Preventative Delirium Protocol in Elderly Patients
Official title: A Randomized, Controlled Trial Reviewing the Effectiveness of a Preventative Delirium Protocol in Elderly Patients While Analyzing Its Consequential Effects on Awareness, PONV, and/or Pain Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delirium
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2018-05-30
Enrollment: 263
Sex: ALL
Minimum age (years): 65
Maximum age (years): 89
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The current study aims to elucidate the effectiveness of a preventative delirium protocol in patients older than 65 years of age undergoing elective surgery.

Detailed description: A comprehensive analysis of patient specific risk factors and predisposing perioperative risk factors will be completed. The objective is to see if delirium incidences are significantly lower in the group that receives a preventative delirium protocol compared to a control group, while not increasing other adverse undesirable side effects. We hypothesize that a preventative delirium protocol will reduce the incidence of delirium compared to the control group (primary outcome), but this protocol may lead to increased side effects such as PONV, poor pain control, and increased awareness (secondary outcomes).

Eligibility criteria: Inclusion Criteria:

* Age \> 65 years
* Scheduled for Elective Surgery (outpatient/same-day admit)

Exclusion Criteria:

* Need emergency surgery
* Need intracranial surgery
* Dependent on opiate narcotics
* Surgeon-specified perioperative procedures that precludes the current study's protocol

Primary outcomes:
measure: Presence or absence of Delirium (CAM_ICU)
timeFrame: Within one post-operative day
Secondary outcomes:
measure: PONV
timeFrame: Within one post-operative day
measure: NRS Pain
timeFrame: Within one post-operative day
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Asokumar Buvanendran, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00538408: Whole Body Magnetic Resonance Angiography in Ischemic Patients
Official title: Whole Body Magnetic Resonance Angiography in Patients With Symptomatic Peripheral Ischemia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atherosclerosis
Intermittent Claudication
Keywords: Magnetic resonance
whole body
angiography
vasovist
gadofosveset
dotarem
blood pool agent
Lead sponsor: Copenhagen University Hospital at Herlev
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
First posted: 2007-10-02
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: To investigate the diagnostic performance of whole body magnetic resonance angiography (WB-MRA) using two different magnetic resonance contrast agents.

Detailed description: Atherosclerosis of the lower leg arteries is a common disease. Patients with this condition has symptoms of ischemia, for instance intermittent claudication (pain during exercise). Diagnosis of atherosclerosis in the legs is normally done with an interventional x-ray-based angiography (DSA- digital subtraction angiography). This is uncomfortable for the patient, and associated with risks of complications (bleeding, vascular damage, embolism).A novel approach to diagnosing atherosclerosis is the use of magnetic resonance angiography. A variant of this is the whole body magnetic resonance angiography(WB-MRA), that produce a picture of the arteries in almost the whole body (excluding the coronary arteries). WB-MRA has a number of advantages compared to DSA. It does not use ionizing radiation, is not invasive, uses a contrast medium with fewer side affects and finally gives a covers a great deal of the arteries in the body.

This study will compare WB-MRA with DSA in patients with symptoms of peripheral atherosclerosis in the lower legs. We will investigate 2 different contrast agents used for WB-MRA. The patients will be randomized to receive either the contrast medium Dotarem or the contrast medium Vasovist. In both groups we will compare the results of WB-MRA with DSA.

Eligibility criteria: Inclusion Criteria:

* Symptomatic lower extremity ischemia (claudication, ischemic wounds)
* Referred to digital subtraction angiography (DSA)

Exclusion Criteria:

* Renal insufficiency (GFR \< 30 ml/min)
* Contra-indications for MRI-examination (claustrophobia, metal-implants, pacemaker)
* Dementia
* Pregnancy/lactation
* Allergy to gadolinium based MRI contrast agents
* Acute disease

Primary outcomes:
measure: Vascular diagnostic quality on the WB-MRA. Degree of arterial stenosis on the WB-MRA.
Secondary outcomes:
Other outcomes:
Locations:
city: Herlev, Copenhagen
country: Denmark
facility: Department of Radiology, Herlev University Hospital
Study officials:
affiliation: University Hospital at Herlev Copenhagen Denmark
name: Henrik S Thomsen, Prof.
role: STUDY_CHAIR
References: