louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03182387: Key to Improve DiagNosis in Aspiration Pneumonia
Official title: Evaluation du Dosage de l'Amylase Dans le Liquide Broncho Alveolaire Dans le Diagnostic précoce de la Pneumopathie d'Inhalation Infectieuse du Sujet Comateux intubé-ventilé.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infectious Pneumonia
Coma
Keywords: Bronchoalveolar lavage
amylase assay
aspiration pneumonia
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2017-06-09
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient admitted to ICU with mechanical ventilation need.

Brief summary: To evaluate the diagnostic performance of amylase assay performed from bronchial alveolar fluid to differentiate aseptic chemical inhalation pneumonitis from an infectious inhalation pneumonitis in comatose patients with intubated ventilation for less than 24 hours.

Detailed description: Validation of the potential diagnostic performance of amylase assay compared to gold standard in diagnosis of infectious inhalation pneumonia of the comatose patient enabling the realization of a multicentric study using this innovative method in a diagnostic strategy with the objective of reducing the consumption of antibiotics.

Eligibility criteria: Inclusion Criteria:

* Patient intubated ≤ 24 hours for unconsciousness (stroke, meningitis, drug intoxication, metabolic disorders, epilepticus, cardiac arrest).
* Inhalation table with hypoxemic acute respiratory insufficiency post-consciousness + chest x-ray revealing one or more compatible infiltrates + t °\> 38 ° C).
* Age ≥18 years
* Patient affiliated to the social security system.
* No opposition obtained

Exclusion Criteria:

* Immunocompromised patient.
* Cardiorespiratory arrest requiring therapeutic hypothermia.
* Pneumopathy nosocomiale (pneumopathy beginning\> 48h after hospital admission).
* Infectious Pneumonia in the previous 30 days.
* Previous hospitalization in the previous 30 days.
* Patient under antibiotic at baseline.
* Bacteremia.
* Mechanical ventilation begun before unconsciousness.
* Report Pa02 / FI02 \<80.
* Patient under curatorship and / or guardianship.

Primary outcomes:
measure: Sensitivity and specificityof amylase test.
timeFrame: 5 days after inclusion day
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Hôpital Pellegrin
Study officials:
affiliation: USMR
name: Linda Wittkop, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02069587: Pomegranate to Reduce Maternal and Fetal Oxidative Stress and to Improve Outcome in Pregnancies Complicated With Preterm Premature Rupture of Membranes
Official title: Pomegranate to Reduce Maternal and Fetal Oxidative Stress and to Improve Outcome in Pregnancies Complicated With Preterm Premature Rupture of Membranes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: PPROM
Keywords: PPROM
PREGNANCY
POMEGRANATE
OXIDATIVE STRESS
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-02-24
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Preterm premature rupture of membrane is associated with increased oxidative stress and inflammatory process, enhancing the activity or the availability of antioxidants may modulate the inflammatory response associated with PPROM, thereby reducing oxidative stress and the risk to the fetus. In this study the investigators sought to determine the effects of Pomegranate 1. On the patients (maternal and fetal) oxidative stress and inflammation associated with PPROM. 2. On the time interval from PPROM to delivery and on the patients (fetal )Ph and apger scores

Detailed description: In this study the investigators sought to determine the effects of Pomegranate 1. On the patients (maternal and fetal )oxidative stress and inflammation associated with PPROM. 2. On the time interval from PPROM to delivery and on the patients (fetal )Ph and apger scores

Eligibility criteria: Inclusion Criteria:

* Pregnant patients
* admitted with PPROM
* between 24-32 weeks of gestation

Exclusion Criteria:

* Women with contractions
* abruption
* monochorionic multiple pregnancy
* abnormal (non-reassuring) cardiotocogram
* meconium-stained amniotic fluid
* signs of intrauterine infection
* major fetal anomalies
* hemolysis
* elevated liver enzymes
* low platelets (HELLP syndrome); or severe preeclampsia.

Primary outcomes:
measure: Maternal and fetal oxidative stress
timeFrame: 10 weeks
measure: Maternal and fetal oxidative stress
timeFrame: 10 weeks
Secondary outcomes:
measure: Time interval from PPROM to delivery
timeFrame: 10 weeks
measure: time interval from PPROM to delivery
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical center technion
name: ron beloosesky
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04850287: Improving Health Awareness Using Social Network Interventions
Official title: Improving Health Awareness Using Social Network Interventions
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Health Knowledge, Attitudes, Practice
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2021-04-20
Enrollment: 2000000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The overarching hypothesis of our study is that social network interventions using artificial intelligence and social media can be used to increase population awareness about health issues. The overarching objective is to improve population awareness on multiple relevant health issues using social network interventions (SNI) and estimate the effect by conducting randomized control trials. Increase population awareness about organ donation in California, especially among minorities

Detailed description: The population of California will be stratified into demographic environments which are groups of ZIP Codes of similar cultural, socioeconomic, and ethnic/racial factors. Digital markers of population awareness about organ donation will be estimated from publicly available online conversations of users in social media. A clustered randomized control trial will be conducted and ZIP Codes from each demographic environment will be randomly assigned to control and intervention arms. Digital educational materials about organ donation will be exposed to online users in social media belonging to ZIP Codes assigned to the intervention arm.

Eligibility criteria: Inclusion Criteria:

* Have a California zip code.
* Be a Facebook user

Primary outcomes:
measure: Change the number of organ donor registration
timeFrame: 3 years
Secondary outcomes:
measure: Change population awareness about health issues
timeFrame: 3 years
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
Study officials:
References:
Clinical trial NCT00460187: EPIC US Pivotal Study
Official title: Evaluating the Use of the FiberNet Embolic Protection System in Carotid Artery Stenting: The EPIC US Pivotal Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Percutaneous Intervention of the Carotid Arteries.
Keywords: carotid artery, distal protection device, carotid stenting
Lead sponsor: Lumen Biomedical
Sponsor class: INDUSTRY
First posted: 2007-04-13
Enrollment: 237
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Multicenter, prospective, pivotal study designed to demonstrate the safety and efficacy of the Lumen Biomedical, Inc. FiberNet® Embolic Protection System as an adjunctive device during carotid artery percutaneous intervention in high surgical risk patients.


Eligibility criteria: Inclusion Criteria:

* One or more of the high surgical risk criteria.
* Symptomatic with atherosclerotic stenosis ≥ 50% or asymptomatic with atherosclerotic stenosis ≥ 70% of the carotid artery by NASCET Criteria.

Exclusion Criteria:

* Prior stenting of ipsilateral carotid.
* Planned treatment of contralateral carotid within 30 days.
* Experienced a myocardial infarction within the last 14 days.
* Undergone an angioplasty or PTCA/PTA procedure within the past 48 hours.
* Undergone cardiac surgery within the past 60 days.
* Suffered a stroke within the past 14 days.
* Suffered a transient ischemic neurological attack (TIA) or amaurosis fugax within the past 48 hours.
* Abnormal baseline blood counts; platelets \<50,000 or \>700,000/mm3 or WBC count \< 3 x103/uL.
* Intracranial stenosis that exceeded the severity of an extracranial stenosis.
* Total occlusion of the target vessel.
* Lesion within 2cm of the ostium of the common carotid artery.
* A stenosis that is known to be unsuitable for stenting
* Serial lesions that requires more than one stent to cover entire lesion.

Primary outcomes:
measure: The rate of all death, all stroke and myocardial infarction within 30 days of the procedure.
Secondary outcomes:
measure: Secondary Endpoints are: all death and all stroke rates, non-stroke neurological event rates, technical success rates, procedural success rates, and access site complication rates.
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Hoag Hospital
state: California
city: Sioux Falls
country: United States
facility: Heart Hospital of South Dakota
state: South Dakota
Study officials:
affiliation: Heart Hospital of South Dakota
name: J. Michael Bacharach, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hoag Hospital
name: Subbarao Mylavarapu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01186887: A Trial Assessing the Outcome of Celecoxib Administration Versus Placebo Following Anterior Cruciate Ligament (ACL) Reconstruction
Official title: A Trial Assessing the Outcome of Celecoxib Administration Versus Placebo Following Anterior Cruciate Ligament Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: primary ACL reconstruction with a hamstring graft
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2010-08-23
Enrollment: 40
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: The aim of this study is to directly compare the clinical outcomes of both the celecoxib and placebo groups following anterior cruciate ligament (ACL) reconstruction. The study will have short and long term goals. Validated outcome measures will aim to quantify pain control at 2 weeks after surgery, as well as knee function at 2 year follow-up. Groups will be compared using pain control scales, and functional knee outcome scores. The first null hypothesis tested by this study is that the celecoxib group experiences equal pain control compared with the placebo group. The second null hypothesis is that no knee function difference will be found between the celecoxib and placebo groups.


Eligibility criteria: Inclusion Criteria:

* Any patient 18 years and over undergoing primary anterior cruciate ligament reconstruction with hamstring grafts will be considered for this study.

Exclusion Criteria:

* Patients will be excluded if they have bilateral ACL injuries, require revision ACL reconstruction, require meniscus repair, have multiple ligament injuries, gross osteoarthritis, significant clinical malalignment or if they cannot attend appropriate follow-up. Other exclusion criteria will include use of a regional block during the surgery, a diagnosis of esophageal, gastric, or duodenal ulceration, hepatic disease, renal disease, hypertension, hypersensitivity to Celecoxib, known allergic-type reactions to sulfonamides, known allergies to ASA or other NSAIDS, inflammatory bowel disease or hyperkalemia

Primary outcomes:
measure: The primary outcome measure is to test the null hypothesis that Celecoxib perioperatively does not negatively influence the static testing of ACL reconstruction as measured by KT arthrometer at 2 years post op.
timeFrame: 2 years
Secondary outcomes:
measure: The 2nd outcome tested by this study is that the celecoxib group experiences equal pain control compared with the placebo group.
timeFrame: 2 years
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: The Ottawa Hospital
name: Geoff Dervin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01505387: Litramine in Weight Maintenance
Official title: Double-blind, Randomized, Placebo-controlled Clinical Investigation to Evaluate the Safety and Efficacy of Litramine in Maintaining Body Weight Loss in Overweight and Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Weight Maintenance
Overweight
Obese
Keywords: Weight maintenance
Overweight
Obese
Weight management
Lead sponsor: InQpharm Group
Sponsor class: INDUSTRY
First posted: 2012-01-06
Enrollment: 50
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: The effect of Litramine on weight loss has previously been studied during a 12-week intervention period with promising results. The present study looks into the effect of weight maintenance using Litramine following initial weight loss, for a longer period of 24 weeks.


Eligibility criteria: Inclusion Criteria:

* Documented weight loss, achieved over the last 3 to 6 months either from participation in weight loss clinical trials or weight loss regimens, of at least 3% at the point of screening
* BMI 25-35 before initial weight loss
* Documented compliance (according to the investigator's judgement) to previous weight loss clinical trials/ regimens

Exclusion Criteria:

* Known sensitivity to the ingredients of the device (citric acid, acacia or Fabaceae family)
* BMI \< 18.5
* Presence of other factor(s) that, in the investigator's judgement, should preclude subject participation

Primary outcomes:
measure: Mean Change in Body Weight From Baseline to End of 24 Weeks
timeFrame: 24 weeks
Secondary outcomes:
measure: Waist and Hip Circumference (cm)
timeFrame: 24 weeks
measure: Body Mass Index (kg/m^2)
timeFrame: 24 weeks
measure: Full Blood Count
timeFrame: 24 weeks
measure: Blood Pressure
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Barbara Grube
Study officials:
References:
citation: Grube B, Chong PW, Alt F, Uebelhack R. Weight Maintenance with Litramine (IQP-G-002AS): A 24-Week Double-Blind, Randomized, Placebo-Controlled Study. J Obes. 2015;2015:953138. doi: 10.1155/2015/953138. Epub 2015 Sep 7.
Clinical trial NCT03372187: Pilot and Feasibility Trial of a Telehealth Dietary Intervention for MS
Official title: Pilot and Feasibility Trial of a Telehealth Dietary Intervention for MS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: diet
MS
Telehealth
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Multiple Sclerosis Society
First posted: 2017-12-13
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All 20 participants will be placed into the intervention group.
Primary purpose: OTHER

Brief summary: This project aims to determine the feasibility of delivering a comprehensive behavioral lifestyle intervention including dietary and exercise components via an evidence based, internet-delivered telehealth coaching platform. Further, investigators will gather preliminary data on the change in multiple sclerosis clinical outcomes and cardiometabolic risk factors after participation in the intervention. The outcomes will inform the design of a larger randomized controlled trial.


Eligibility criteria: Inclusion criteria:

1. Relapsing-Remitting Multiple Sclerosis
2. On disease modifying treatment for 6 months
3. No relapse within the previous 30 days
4. Self-identify as not currently meeting recommendations for healthy diet and physical activity
5. Ambulatory with or without assistance
6. Reliable access to the internet via computer or smartphone
7. Be responsible for their personal food preparation or have input into the food prepared for them

Exclusion criteria

1. Unstable cardiovascular disease
2. Unstable renal disease
3. Unstable pulmonary disease
4. Physician does not approve participation

Primary outcomes:
measure: Dietary adherence
timeFrame: 1 year
measure: Physical activity adherence
timeFrame: 1 year
Secondary outcomes:
measure: Feasibility of intervention implementation
timeFrame: 1 year
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
References:
Clinical trial NCT04590287: ICF in Secondary Prevention of Cardiovascular Disease
Official title: The Use of ICF Classification System in Secondary Prevention of Cardiovascular Disease Among Others Ischemic and Hemorrhagic Stroke.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Secondary Prevention
Risk Factor, Cardiovascular
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 120
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 60 patients after ischemic stroke 60 patients after hemorrhagic stroke

Brief summary: The aim of this study was to develop a practical protocol based on the ICF(The International Classification of Functioning, Disability, and Health) the risk factors of cardiovascular disease (CVD) in secondary prevention.

Detailed description: The original ICF assessment sheet contains CVD risk factor categories, such as comorbidities (depressive disorders, insomnia, heart rhythm and heart rate disorders, carotid artery disease, and hypertension), measures of liver and renal impairment, disorders of carbohydrate and lipid metabolism). The evaluation criteria for each category were determined based on recommendations defined in the ESC, AHA, EFSD, and KIDIGO guidelines.

Eligibility criteria: Inclusion Criteria:

* the first episode of ischemic stroke or hemorrhagic stroke,
* full medical documentation with a description of the above-mentioned risk factors

Exclusion Criteria:

* another neurological disease: brain tumor, trauma craniocerebral
* incomplete medical history - no data on assessed risk factors CVD

Primary outcomes:
measure: emotional functions
timeFrame: first examination on admission
measure: sleep functions
timeFrame: first examination on admission
measure: heart rate
timeFrame: first examination on admission
measure: heart rhythm
timeFrame: first examination on admission
measure: functions of arteries
timeFrame: first examination on admission
measure: increased blood pressure
timeFrame: first examination on admission
measure: functions related to the coagulation of blood.
timeFrame: first examination on admission
measure: Glycosylated hemoglobin
timeFrame: first examination on admission
measure: lipid metabolism.
timeFrame: first examination on admission
Secondary outcomes:
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: Department of Rehabilitation and Physiotherapy Rehabilitation,
Study officials:
affiliation: Clinic Rehabilitation, University of Medical Sciences in Poznań
name: Ewa Chlebuś, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lucki M, Chlebus E, Warenczak A, Lisinski P. Risk Factors for the Recurrence of CVD Incidents in Post-Stroke Patients over a 5-Year Follow-Up Period Based on the ICF Classification. Int J Environ Res Public Health. 2021 Jun 3;18(11):6021. doi: 10.3390/ijerph18116021.
Clinical trial NCT00525187: Onychomycosis: Diagnosis and Prevalence in Diabetic Neuropathic Patients
Official title: Onychomycosis: Diagnosis and Prevalence in Diabetic Neuropathic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prevalence of Onychomycosis
Diabetic Neuropathic Patients
Diagnostic of Onychomycosis
Patients Clinically Suspected of Onychomycosis
Reliability of the Diagnosis of Onychomycosis
Keywords: onychomycosis
diabetic neuropathic patients
reliability of the diagnostic of onychomycosis
Lead sponsor: Vésale Hospital
Sponsor class: OTHER
Collaborators: name: Janssen-Cilag Ltd.
First posted: 2007-09-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: The prevalence of onychomycosis among diabetic patients is still a debated question as well as the best way to diagnose the disease. We conducted a prospective study to assess the prevalence of onychomycosis in diabetic neuropathic (DN) patients clinically suspected of this disease and to assess the reliability of the diagnosis of onychomycosis.

Detailed description: From December 2000 to January 2005, we followed 100 successive diabetic patients, type 1 and type 2, suffering from (DN). At baseline we assessed age, gender, medical history and medications, foot insensitivity defined by a vibration perception threshold (VPT) \>25 volts and onychomycosis by clinical diagnosis.

Multiple samples of the most affected nail, often the big toe, were taken. A potassium hydroxide (KOH) test was done by 2 independent and blinded investigators and a culture in a laboratory (lab) specialized in mycology.

Pictures of the nails and particularly of the sampled nail were taken. Apart from the laboratory results, two independent and blinded dermatologists gave their diagnosis looking at the pictures.

Eligibility criteria: Inclusion Criteria:

* Inclusion criteria were: presence of diabetes mellitus, type 1 or type 2, age between 18 and 80 years, neuropathy demonstrated by a VPT (Vibration Perception Threshold) \>25 volts tested with a neurothesiometer (Horwell Scientific, London, UK) and a clinical diagnosis of onychomycosis.

Exclusion Criteria:

* Exclusion criteria were a history of psoriasis, systemic antifungal therapy during the year preceding the enrolment, immunosuppression either by disease or treatment induced.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Montigny-le-Tilleul
country: Belgium
facility: CHU A Vésale
state: Hainaut
Study officials:
name: Isabelle J DUMONT, MD
role: PRINCIPAL_INVESTIGATOR
References: