louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03333044: Diabetes Management Intervention For South Asians
Official title: Diabetes Management Intervention For South Asians
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HbA1c
Diabetes
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2017-11-06
Enrollment: 859
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this study is to evaluate the effectiveness and implementation process of a multi-level, integrated intervention to decrease HbA1c among South Asians with uncontrolled diabetes, including four components: 1) an EHR-based registry function to increase identification of South Asian patients with uncontrolled diabetes; 2) CHW-led health coaching of registered patients to promote health behavior change; 3) HIT-enabled and CHW-facilitated identification and referral to culturally relevant community resources for patients; and 4) HIT-enabled care coordination between the CHW and other members of the healthcare team.


Eligibility criteria: Inclusion Criteria:

* South Asian ethnicity (identified through a race and language code available in the EHR);
* an appointment with a physician for routine non-emergent primary care in the last 12 months
* diagnosis of diabetes
* an HbA1c reading of \>7 in the last 12 months

Exclusion Criteria:

* Pregnant women and visits to obstetrician/gynecologist are excluded from the study

Primary outcomes:
measure: Percentage of Participants who had a 0.5% reduction in HbA1c
timeFrame: Baseline, Month 6
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: One Park Avenue
state: New York
Study officials:
affiliation: NYU Langone Health
name: Nadia Islam, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lim S, Wyatt LC, Mammen S, Zanowiak JM, Mohaimin S, Troxel AB, Lindau ST, Gold HT, Shelley D, Trinh-Shevrin C, Islam NS. Implementation of a multi-level community-clinical linkage intervention to improve glycemic control among south Asian patients with uncontrolled diabetes: study protocol of the DREAM initiative. BMC Endocr Disord. 2021 Nov 23;21(1):233. doi: 10.1186/s12902-021-00885-5.
Clinical trial NCT00697944: Ambisome® Preemptive Treatment of Multiple Candida Colonization in Sepsis Patients
Official title: Ambisome® Preemptive Treatment of Multiple Colonizations by Candida in Intensive Care Patients With a Sepsis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Sepsis
Candida
Keywords: FUNGAL INFECTION
SEPSIS
INTENSIVE CARE
AMBISOME
PREEMPTIVE TREATMENT
Sepsis with candida colonisation
Lead sponsor: Fovea
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2008-06-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To assess the safety of Ambisome 10 mg/kg/week in patients as a preemptive treatment in intensive care patients with a sepsis and rising candida colonisation.

Preemptive treatment (i.e., prophylactic treatment with two high doses of Ambisome® administered with an interval of one week, in patiens with a high risk of developing a fungal infection) should decrease the incidence of actual systemic infections.

The incidence of such actual fungal infections will be assessed directly and its impact on patients' survival and intensive care resourches assessed


Eligibility criteria: Inclusion Criteria:

* Supportive mechanical ventilation for more than 48 h
* LOD \> 5 with with ailing body systems
* Candida colonisation of at least one site in addition to the digestive tract
* Suspected nosocomial infection with antibiotic treatment
* Informed consent

Exclusion Criteria:

* Patients treated with oral or systemic antifungal agents within 15 days prior to inclusion
* Patients requiring treatment with an antifungal agent or with a documented (proven or probable) fungal infection according to the EORTC criteria
* Patients with a SAPS score \> 65
* Patients with neutropenia of that underwent a bone marrow tar organ transplant or with cancer chemotherapy
* Blood creatinine \> 220 µmol/L
* Hemodyalysis
* Pregnant women

Primary outcomes:
measure: Global assessment of severity of adverse events; incidence, severity and consequences of treatment emergent effects
timeFrame: 28-day observation period
Secondary outcomes:
measure: Duration of stay in the intensive care unit; occurrence of a systemic fungal infection
timeFrame: 28 days after first treatment administration
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Chu Michallon
city: Paris
country: France
facility: Hopital Saint Louis
Study officials:
affiliation: University Teaching Hospital Saint Louis, Paris
name: Elie AZOULAY, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Azoulay E, Timsit JF, Lautrette A, Legriel S, Max A, Ruckly S, Misset B, Cohen Y, Wolff M. Weekly high-dose liposomal amphotericin B (L-AmB) in critically ill septic patients with multiple Candida colonization: The AmBiDex study. PLoS One. 2017 May 22;12(5):e0177093. doi: 10.1371/journal.pone.0177093. eCollection 2017.
Clinical trial NCT03698344: Sympathetic Nerve Response Incited by Biodiesel Exhaust Exposure
Official title: Sympathetic Nerve Response Incited by Biodiesel Exhaust Exposure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Exposure to Pollution
Keywords: air pollution
microneurography
MNSA
Biodiesel
RME
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2018-10-09
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The adverse effects of current ambient air pollution on cardiovascular and respiratory health have been demonstrated in an extensive series of epidemiological, observational and experimental studies. Similar cardiovascular responses seen post diesel exposure have been shown to occur following biodiesel exhaust exposure as well. In the current project the investigators aim to determine whether an acute exposure to biodiesel exhaust (rapeseed methyl ester) causes impacts on sympathetic nervous system activation in healthy volunteers.

Detailed description: Brief as well as chronic exposures to ambient air pollution have been linked with increases in cardiovascular morbidity and mortality. Evidence suggests that the strongest associations between air pollution exposure and adverse cardiovascular effects are found for combustion-derived particulate matter, especially in the fine and ultrafine ranges such as is found in diesel engine emissions as well as biodiesel exhaust (RME, rapeseed methyl ester). Despite a greater understanding of the cardiovascular effects of air pollution, the underlying mechanism through which exposure to fine and ultrafine particulate air pollution alters vascular function has yet to be determined. Microneurography is a method that records nerve impulse traffic in human peripheral nerves, allowing for the assessment of sympathetic nervous activity. The current study will employed microneurography techniques to evaluate autonomic function in association with inhaled biodiesel exhaust exposure in healthy human volunteers.

Eligibility criteria: Criteria:

Inclusion Criteria:

Healthy (normal ECG, lung function, blood sample, clinical examination)

Exclusion Criteria:

Metabolic disease Cardiovascular disease Respiratory disease BMI ≥ 30 Use of psychoactive medication Infection within 2 weeks of the study Smokers or regular snus usage

Primary outcomes:
measure: Microneurography
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Dept of Medicine, Lung and Allergy section, University Hospital
Study officials:
affiliation: Umeå University
name: Jenny A Bosson, MD;PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04722744: Marginal Bone Changes of CAD/CAM Implant Supported Screw-retained and Screw-mented Metal Frameworks
Official title: Marginal Bone Changes of CAD/CAM Implant Supported Screw-retained Metal Frameworks Based on Actual Versus Screwmented Ones Based on Virtual Implant Position: A Randomized Clinical Stud
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patient Satisfaction
Bone Loss
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-01-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: compare CAD/CAM implant supported screw-retained metal frameworks based on actual versus screw-mented ones based on virtual implant position regarding marginal bone changes.

Detailed description: patients with at least three missing teeth will be recruited and randomly assigned into two parallel groups. both groups will receive three implants based on planned implant positions and then one group will receive screw retained CAD CAM restoration with conventional impression technique while the second group will receive screw-mented CAD CAM restoration based on planned implant positions.

Eligibility criteria: Inclusion Criteria:

* Kennedy class I, II Or IV cases.
* Opposing completely dentulous, fully or partially restored dentition.
* Good oral hygiene.
* The patient should have bone for implants, minimum bone height 10 mm and minimum bone diameter should be 6 mm.
* Adequate inter arch space for restoration 15mm or more.
* Adult patients age ≥18 years

Exclusion Criteria:

* any medical disorder that could complicate surgical phase or affect osteointegration. Radiation chemotherapy.
* smokers more than 10/daily.
* Uncooperative patients.
* Patients with Para-functional habits
* Patients with severe periodontal diseases.
* Patients with limited mouth opening.
* Presence of intraoral pathological lesions.
* Diabetic (HbA1c \>7.5%).

Primary outcomes:
measure: marginal bone changes.
timeFrame: 6 months
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry
state: Manial
Study officials:
affiliation: Professor of Prosthodontics
name: Azza Hussein, PhD
role: STUDY_CHAIR
affiliation: Lecturer of prosthodontics
name: Mohamed ElKhashab, PhD
role: STUDY_DIRECTOR
affiliation: Professor of Prosthodontics
name: Iman Radi, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01093144: Assessment of Pelvis Diameters as a Predictor for the Mode of Delivery ,Using Non-invasive, Ultrasound Based Measurements
Official title: Assessment of Pelvis Diameters as a Predictor for the Mode of Delivery ,Using Non-invasive, Ultrasound Based Measurements.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy
Women
Keywords: Delivery mode
pelvic measurement
Lead sponsor: Trig Medical Inc
Sponsor class: INDUSTRY
First posted: 2010-03-25
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Assessing the relation between the Pelvis diameters measured by the LaborPro, and the mode of delivery(normal vaginal delivery/instrumental delivery/Caesarean section.

Detailed description: Assessing the relation between the Pelvis diameters measured by the LaborPro, and the mode of delivery(normal vaginal delivery/instrumental delivery/Caesarean section.

Eligibility criteria: Inclusion Criteria:

* A subject is eligible to participate in the study if she meets all of the following inclusion criteria:
* Singleton pregnancy

  * Pregnant adult woman in labor
  * Willing to participate in the study and understands the study procedures

Exclusion Criteria:

* A subject is not eligible for participation in this study if he/she meets any of the following exclusion criteria scheduled for c/s active infection

Primary outcomes:
measure: pelvis measurements influence on the Delivery mode
timeFrame: labor and delivery process
Secondary outcomes:
measure: the influence of maternal parameters on delivery mode.
timeFrame: 1 year
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Shiba Medical Center
Study officials:
affiliation: Tel Hashomer Medical Center
name: Yinon Gilboa, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00809744: Vitamin D AND Glucose Handling Evaluated by Glucose Clamp
Official title: Vitamin D AND Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Insulin Sensitivity
Intraocular Pressure
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
Collaborators: name: Norwegian Council on Cardiovascular diseases
First posted: 2008-12-17
Enrollment: 160
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: In this study the investigators want to compare glucose handling (insulin secretion and insulin sensitivity) in 100 persons with low and 50 persons with normal-high levels of vitamin D, using a hyperglycemic clamp technique, were sugar is given intravenously for 3 hours in order to keep the blood sugar level at 10 mmol/L. Those with low vitamin D levels will be randomized to treatment with vitamin D3 (cholecalciferol) 40 000 IU/week or placebo for 6 months before a new clamp is performed.

The study hypothesis is that persons with low vitamin D levels have impaired glucose handling which might be improved by vitamin D supplementation.


Eligibility criteria: Inclusion Criteria:

* generally: Subjects are recruited from the 6th Tromsø Study
* cases: serum 25-hydroxyvitamin D-levels below the 10 percentile; low levels confirmed with new serum analyses.
* controls: serum 25-hydroxyvitamin D levels 80-95 percentile, normal-high levels confirmed with new serum analyses.

Exclusion Criteria:

* diabetes
* myocardial infarction or apoplexia
* active cancer during last 5 years
* history of kidney stone
* pregnancy or premenopausal without safe anticonception
* primary hyperparathyroidism
* systolic blood pressure \>175 or diastolic blood pressure \>105

Primary outcomes:
measure: insulin secretion and sensitivity as assessed by an hyperglycemic clamp
timeFrame: 6 months
measure: intraocular pressure
timeFrame: 6 months
Secondary outcomes:
measure: telomer length
timeFrame: 6 months
measure: 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D-levels
timeFrame: 6 months
measure: serum calcium, PTH, phosphate
timeFrame: 6 months
measure: inflammatory markers and lipids
timeFrame: 6 months
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: University Hospital of North Norway
Study officials:
affiliation: Medical Dpt, University Hospital of Northern Norway
name: Rolf Jorde, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grimnes G, Figenschau Y, Almas B, Jorde R. Vitamin D, insulin secretion, sensitivity, and lipids: results from a case-control study and a randomized controlled trial using hyperglycemic clamp technique. Diabetes. 2011 Nov;60(11):2748-57. doi: 10.2337/db11-0650. Epub 2011 Sep 12.
Clinical trial NCT05868044: REsponse to Combined SONS and ONS in Chronic Cluster HeadachE
Official title: REsponse to Combined SuPra-orbital and Occipital Nerve Stimulation in Chronic Cluster HeadachE with the PRIMUS System, a First in Human Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Cluster Headache
Lead sponsor: Salvia BioElectronics
Sponsor class: INDUSTRY
First posted: 2023-05-22
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of this study is to demonstrate the safe use of the PRIMUS System in subjects with chronic cluster headache. This is a single-centre, open label, prospective, first in human study to collect initial clinical data on the PRIMUS system for the treatment of chronic cluster headache.


Eligibility criteria: Main Inclusion Criteria:

* Able and willing to provide informed consent
* Documented chronic cluster headache for at least 1 year as per ICHD-3 criteria
* Attack frequency of ≥ 4 attacks per week for ≥ 4 weeks before enrolment
* Documented failure of verapamil (failure meaning ineffective, provoked unacceptable side-effects or contra-indicated)
* Stable on preventive treatment for at least two weeks prior to enrolment.
* Agree to refrain from starting new prophylactic cluster headache medication or other preventive treatments, from 4 weeks before entering the baseline period throughout the duration of the study
* MRI available (not older than 4 years prior to study enrolment) or willing to undergo an MRI to exclude structural lesions potentially causing headache
* Able and willing to complete a headache Diary

Main Exclusion Criteria:

* Any other chronic primary or secondary headache disorder, unless they can clearly differentiate them from cluster headache attacks based on the quality and associated symptoms
* Concomitant neuromodulation, except tVNS
* Previous failure to any implantable neuromodulation device for neurovascular headache
* Have an existing Active Implantable Medical Device nearby the implant location (e.g. DBS, cochlear implant, ...)
* Metal implants in the skull (e.g. skull plates, seeds) nearby the implant
* Have a pacemaker or implantable cardioverter defibrillator (ICD)
* Suboccipital infiltrations with steroids and/or local anaesthetics or use of oral steroids in the past 3 months
* Use of botulinum toxin injections in the past 12 weeks
* Calcitonin gene-related peptide inhibitors started less than 12 weeks prior to enrolment
* Women of childbearing age who are pregnant, nursing or not using contraception

Primary outcomes:
measure: Safety Evaluation
timeFrame: 4 weeks
measure: Safety Evaluation
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Buderim
country: Australia
facility: Resolve Pain
state: Queensland
Study officials:
affiliation: Resolve Pain
name: Paul Frank, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01600144: Data Collection for CAD Evaluation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Data Collection
Keywords: data mammography
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2012-05-16
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women

Brief summary: Mammographical data collection (raw data) for CAD evaluation by VUCOMp software.


Eligibility criteria: Inclusion Criteria:

* women who underwent a digital mammography imaging

Exclusion Criteria:

* men

Primary outcomes:
measure: Datacollection
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZLeuven
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Chantal Van Ongeval, MR,Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06177444: Post-operative Antibiotics; Effects on Risk of Infection After Cochlear Implant Surgery
Official title: Post-operative Antibiotics; Effects on Risk of Infection After Cochlear Implant Surgery: A Retrospective Comparison
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Postoperative Infection
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Odense Patient Data Explorative Network
First posted: 2023-12-20
Enrollment: 920
Sex: ALL
Minimum age (years): 0
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who underwent a CI-procedure from January 2010 to December 2022, in the department of ORL at OUH, which is estimated to approximately 900 patients in total. There seems to be no study made with such a great sample-size, which therefore will have a major contribution to the knowledge on this subject.

Brief summary: Currently there is little consensus regarding postoperative antibiotic prophylactic treatment and its effect on the postoperative infection rate after Cochlear implantation. The literature on this subject is contradictory, and very limited. The aim is to assess the impact of postoperative antibiotic treatment on post-operative infection rate, and thereby discuss if postoperative antibiotic treatment has any benefits in the preventing treatment against infectious complication.


Eligibility criteria: Inclusion Criteria:

* All patients undergoing cochlear implantation at this facility from 2010 to 2022

Exclusion Criteria:

* none

Primary outcomes:
measure: Infection rate
timeFrame: 1 year
Secondary outcomes:
measure: Infection type
timeFrame: 1 year
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
References:
Clinical trial NCT01657344: PECARN Emergency Care Registry
Official title: Improving the Quality of Pediatric Emergency Care Using an Electronic Medical Record Registry and Clinician Feedback
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Emergency Care
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
name: Pediatric Emergency Care Applied Registry Network (PECARN)
First posted: 2012-08-06
Enrollment: 2019461
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study subjects are all patients (0-18 regardless of race, ethnicity, or gender and of diagnosis or chronic health condition) who are registered to the ED.

Brief summary: The objectives of this study are to: develop an emergency care visit registry for pediatric patients for Quality Improvement purposes and to support future research; to use the emergency care visit registry to collect stakeholder-prioritized emergency care performance improvement measures for important pediatric medical and trauma conditions; and report emergency care performance improvement measures.


Eligibility criteria: Inclusion Criteria:

* All patients (0-18) who registered in the ED

Exclusion Criteria:

* Greater than 18 years of age for ED patients

Primary outcomes:
measure: The Number of Visits Obtained From Electronic Health Record Data From the Sites
timeFrame: January 2012 - June 2016
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: The Children's Hospital of Colorado
state: Colorado
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
city: Salt Lake City
country: United States
facility: Data Coordinating Center
state: Utah
Study officials:
affiliation: Lurie Children's Hospital of Chicago
name: Elizabeth R Alpern, MD
role: PRINCIPAL_INVESTIGATOR
References: