louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04326452: Treating COVID-19 With a Bidirectional Oxygenation Valve
Official title: The Use of a Bidirectional Oxygenation Valve in the Management of Respiratory Failure Due to COVID-19 Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronavirus Infection
Lead sponsor: TMC HealthCare
Sponsor class: OTHER
Collaborators: name: PEEP Medical, LLC
First posted: 2020-03-30
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will utilize a single center internal control study design. The objective of this study is to determine the feasibility and safety of a bidirectional oxygenation PEEP generating mouthpiece when combined with oxygen by non-rebreather face mask, compared to support by oxygen non-rebreather face mask alone.

Detailed description: We have developed a simple and straightforward silicone rubber-made oral appliance that promotes positive expiratory airway pressures with the potential to enhance respiratory function while preventing and reversing atelectasis and hypoxia. The purpose of this study is to compare the use of our bidirectional oxygenation mouthpiece with conventional oxygen support versus conventional oxygen support of any Person Under Investigation for infection by the COVID-19 virus.

Eligibility criteria: Inclusion Criteria:

* Oxygen saturation \<93%
* Able to provide informed consent
* Not currently requiring intubation
* Receiving oxygen by face mask

Exclusion Criteria:

* Unable or unwilling to provide informed consent, cognitive impairment
* Rapidly decompensating status requiring urgent or emergent higher level of care

Primary outcomes:
measure: Pulse oximetry level
timeFrame: Change from Baseline pulse oximetry level at 15 minutes post treatment
Secondary outcomes:
measure: Respiratory rate
timeFrame: Change from Baseline clinical measurements at 15 minutes post treatment
measure: Heart rate
timeFrame: Change from Baseline clinical measurements at 15 minutes post treatment
measure: Blood pressure
timeFrame: Change from Baseline clinical measurements at 15 minutes post treatment
measure: Systemic carbon dioxide
timeFrame: Change from Baseline clinical measurements at 15 minutes post treatment
Other outcomes:
Locations:
city: Tucson
country: United States
facility: TMC HealthCare
state: Arizona
city: Stanford
country: United States
facility: Stanford University
state: California
city: Atlanta
country: United States
facility: Emory Saint Joseph's Hospital
state: Georgia
Study officials:
References:
Clinical trial NCT02233452: Methadone and Ketamine for Neuropathic Pain Treatment
Official title: Management of Neuropathic Chronic Pain With Methadone Combined With Ketamine: Randomized, Double Blind, Active-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neuropathic Pain
Keywords: Neuropathic pain
Methadone
Ketamine
Multimodal analgesia
Lead sponsor: Universidade Federal de Santa Maria
Sponsor class: OTHER
Collaborators: name: Santa Casa de Misericórdia de Belo Horizonte
name: Hospital de Clinicas de Porto Alegre
First posted: 2014-09-08
Enrollment: 37
Sex: ALL
Minimum age (years): 22
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Methadone and ketamine are effective for neuropathic pain management. However, the benefits of the association of both drugs are uncertain. Here, the investigators conducted a randomized, double-blind, in parallel, active controlled clinical trial to test the hypothesis that methadone combined ketamine (methadone/ketamine) is more effective than methadone or ketamine alone in reducing neuropathic pain.

Detailed description: Either oral methadone or ketamine have been used in neuropathic pain management, however, the benefits of the association of both drugs are uncertain. Here, we conducted a randomized, double-blind, in parallel, active controlled clinical trial to test the hypothesis that methadone combined ketamine (methadone/ketamine) is more effective than methadone or ketamine alone in reducing neuropathic pain.

Methods: Fourthly two patients with neuropathic pain refractory to conventional therapy were randomly assigned to receive during three months oral methadone (n= 13), ketamine (n=13) or methadone combined with ketamine (n=13). The primary outcome was pain score on visual analogical scale (VAS) assessed on baseline, 8, 15, 30, 60 and 90 days throughout the treatment, and the secondary outcomes were symptoms of neuropathic pain such as allodynia, burning or shooting pain as well the side effects.

Eligibility criteria: Inclusion Criteria:

* patients complaining of pain for more than 6 months with neuropathic pain poorly responsive to drugs used to treat neuropathic pain (i.e. opioid, non-opioid, anticonvulsants, antidepressants), who were 22 to 77 years old

Exclusion Criteria:

* patients with a history of severe psychiatric disorder,
* misuse of illegal drugs or
* hepatic disease

Primary outcomes:
measure: The primary outcome was pain intensity as assessed by visual analogical scale (VAS) scores
timeFrame: 90 days
Secondary outcomes:
measure: The secondary outcomes were the presence of burning and/or shooting pain, allodynia and side effects.
timeFrame: 90 days
Other outcomes:
Locations:
city: Santa Maria
country: Brazil
facility: University Hospital in Santa Maria
state: Rio Grande do Sul
Study officials:
affiliation: Federal University of Santa Catarina
name: Juliano Ferreira, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04564352: Hypolipidemic Effect of Adansonia Digitata
Official title: Hypolipidemic, Antioxidant Activity of Adansonia Digitata Juice Consumption
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperlipidemias
Lead sponsor: Taibah University
Sponsor class: OTHER
First posted: 2020-09-25
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study is association case-control in design and involved Sudanese adult subjects (\>18 years old - 60 years) living in Saudi Arabia. The cases were subjects who use AD fruit juice as tradition juice.

Brief summary: Adansonia digitata L. (AD) also known as Baobab is a huge tree that grows in many countries in sub-Saharan Africa. Many studies talking about AD biological activity including hypolipidemic, antioxidant and antimicrobials in animal's but not in human, This study will be undertaken to examine the effect of AD juice consumption against lipid profiles in traditional users and blood samples will be collected form participant's for investigated of lipid profiles pre and post AD juice drinking and the results will be compared.


Eligibility criteria: Inclusion Criteria:

* Tradition users (drink AD juice)

Exclusion Criteria:

* Diabetes, hypertension, or chronic illness

Primary outcomes:
measure: Decrease cholesterol level
timeFrame: 6 month's
Secondary outcomes:
Other outcomes:
Locations:
city: Medina
country: Saudi Arabia
facility: Taibah University
Study officials:
References:
Clinical trial NCT00874952: Regional Observation of the Metabolic Syndrome
Official title: Regional Observation of the Metabolic Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolic Syndrome
Keywords: Metabolic syndrome
Lipids
Waist Circumference
HDL
hypertension
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-04-03
Enrollment: 1600
Sex: ALL
Minimum age (years): 40
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: The aim of the study, is to assess the prevalence of metabolic syndrome in Italy on a regional basis, defined according to National Cholesterol Education Program/Adult Treatment Panel III (NCEP/ATPIII) guidelines criteria.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Laboratory analysis (lipidic profile and glycemia) performed in the last year

Exclusion Criteria:

* Subjects with serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's successful participation in the study
* Pregnancy or breast feeding
* Patients enrolled in clinical studies which the aim is to evaluate the efficacy and/or tolerability of anti-hypertensive and/or lipid lowering drugs

Primary outcomes:
measure: Prevalence of metabolic syndrome in primary care population
timeFrame: At visit
measure: Concomitant presence of other cardiovascular (CV) risk factors.
timeFrame: At visit
Secondary outcomes:
Other outcomes:
Locations:
city: Torino
country: Italy
facility: Research Site
Study officials:
affiliation: AstraZeneca S.p.A.
name: Mario Mangrella
role: STUDY_CHAIR
affiliation: AstraZeneca S.p.A.
name: Raffaele Sabia
role: STUDY_DIRECTOR
References:
Clinical trial NCT03577652: The Optimal Strategy of Switching From Clopidogrel to Ticagrelor in Patients With Complexity of Coronary Artery Disease
Official title: The Optimal Strategy of Switching From Clopidogrel to Ticagrelor in Patients With Complexity of Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Ticagrelor
Keywords: Ticagrelor
Clopidogrel
Switching strategy
Lead sponsor: Shenyang Northern Hospital
Sponsor class: OTHER
First posted: 2018-07-05
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is to further exploring the optimal switching strategy by evaluating the pharmacodynamic responses as well as adverse events in patients with complexity of coronary artery disease managed by percutaneous coronary intervention (PCI). All participants will be divided into three groups and recieving ticagrelor 90mg plus aspirin 100mg at 12 hours after the last dose of clopidogrel; recieving ticagrelor 90mg plus aspirin 100mg at 24 hours after the last dose of clopidogrel; recieving ticagrelor 180mg plus aspirin 100mg at 24 hours after the last dose of clopidogrel.


Eligibility criteria: Inclusion Criteria:

1. Age between 18-75
2. Patients with complexity of CAD determined by coronary angiography and implanted stent successfully
3. Taking clopidogrel 75mg daily over 5 days or paients never took clopidogrel previously should receive 300-600mg drugs at least 12 hours before coronary angiography
4. Agreeing to participate in this trial and signed the written informed consent.

Exclusion Criteria:

1. They contraindicated with ticagrelor (including: allergying to ticagrelor or its active metabolite
2. Concomitanting therapy with a strong cytochrome P-450 3A inhibitor or inducer
3. Previous intracranial haemorrhage or ongoing bleeds
4. Moderate or severe hepatic impairment)
5. Having a previous medication with ticagrelor or long term anticoagulation
6. Having a history of asthma or chronic obstructive pulmonary disease (COPD) and recurrent attacked
7. Having an uncontrolled hypertension\>180/110mmHg
8. Having a hemoglobin\<100g/L 9.Having a platelet counts\<100×10\^9/L
9. Having severe renal impairment (clearance\<30mL/min)
10. Having a history of hepaein-induced thrombocytopenia (HIT)
11. Having a pregnancy or were during lactation.

Primary outcomes:
measure: Platelet function assessments
timeFrame: 7 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Shenyang
country: China
facility: General Hospital of Shenyang Military Region
state: Liaoning
Study officials:
References:
citation: Yao Y, Wang P, Wang XZ, Zhao X, Zhao W, Zhou TN, Zhang L. Optimal strategy of switching from clopidogrel to ticagrelor in Chinese acute coronary syndrome patients with complicated coronary artery disease: the switching from clopidogrel to ticagrelor (SHIFT-CACS) study. Chin Med J (Engl). 2019 Oct 5;132(19):2292-2299. doi: 10.1097/CM9.0000000000000444.
Clinical trial NCT03231852: Patient Perceptions and Willingness to Enroll in Clinical Trials
Official title: Patient Perceptions and Willingness to Enroll in Clinical Trials
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer, Clinical Trials
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2017-07-27
Enrollment: 166
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All women presenting to the gynecologic oncology clinic meeting the inclusion/exclusion criteria will be approached to participate in this study.

Brief summary: The objective of our study is to determine which factors affect willingness to participate in gynecologic oncology clinical trials. Women with a diagnosis of gynecologic malignancy will be approached to complete a survey assessing willingness to participate in clinical trials. The validated Attitudes and Randomized Trials Questionnaire (ARTQ) will be used to assess willingness to participate.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of gynecologic malignancy
* English or Spanish literate

Exclusion Criteria:

* Prior enrollment in a clinical trial
* Currently pregnant
* Currently incarcerated

Primary outcomes:
measure: Willingness to Participate in Clinical Trials
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Linda Duska, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06964152: Computational Cardiac Imaging Analysis to Guide Ventricular Tachycardia Ablation Procedures (AI-VT)
Official title: Prospective Use of Computational Cardiac Imaging Analysis to Guide Ventricular Tachycardia Ablation Procedures (AI-VT)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Ventricular Tachycardia (VT)
Premature Ventricular Contraction (PVC)
Ventricular Fibrillation
Keywords: electrocardiography, arrhythmia mapping, 3D mapping, electroanatomic mapping, cardiac computed tomography, artificial intelligence, computational modeling
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2025-05-09
Enrollment: 250
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate the clinical outcomes (clinical efficacy and safety) of using supplemental non-invasive computational ECG and cardiac imaging analysis tools to help guide ablation of ventricular tachycardia.


Eligibility criteria: Inclusion Criteria:

1. Age between 21 and 100
2. Evidence of ventricular tachycardia on ECG, telemetry or by CIED interrogation.

Exclusion Criteria:

Primary outcomes:
measure: Recurrent ventricular tachycardia
timeFrame: 1 year
measure: All-cause death
timeFrame: 1 year
Secondary outcomes:
measure: Acute hemodynamic decompensation
timeFrame: 24 hours post-op
measure: Unplanned prolonged ICU upgrade
timeFrame: 48 hours
measure: acute cerebrovascular accident (embolic)
timeFrame: 24 hours post-op
measure: acute pericardial tamponade requiring intervention
timeFrame: 24 hours post-op
measure: vascular complication requiring intervention
timeFrame: 24 hours post-op
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UC San Diego Health
state: California
Study officials:
References:
citation: Krummen DE, Villongco CT, Ho G, Schricker AA, Field ME, Sung K, Kacena KA, Martinson MS, Hoffmayer KS, Hsu JC, Raissi F, Feld GK, McCulloch AD, Han FT. Forward-Solution Noninvasive Computational Arrhythmia Mapping: The VMAP Study. Circ Arrhythm Electrophysiol. 2022 Sep;15(9):e010857. doi: 10.1161/CIRCEP.122.010857. Epub 2022 Sep 7.
Clinical trial NCT02061852: Evaluation of the Safety of the Medical Device Simeox®
Official title: Prospective Trial for the Evaluation of Safety, Tolerability and Efficacy of the Medical Device Simeox ® Compared to Traditional Respiratory Physiotherapy Techniques for Airway Secretion Clearance
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Broncho-degenerative Disease
Chronic Obstructive Airway Disease
Cystic Fibrosis
Idiopathic Bronchiectasis
Ciliary Dyskinesia
Chronic Bronchitis
Lead sponsor: Physio-Assist
Sponsor class: INDUSTRY
Collaborators: name: CEISO
name: University Hospital, Marseille
First posted: 2014-02-13
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the medical device "simeox" is safe in the treatment of respiratory diseases, in comparison with traditional physiotherapy.


Eligibility criteria: Inclusion Criteria:

* Patient over 18, male or female.
* Patient affected by broncho-degenerative disease, chronic obstructive airway disease, cystic fibrosis, idiopathic bronchiectasis, ciliary dyskinesia and/or chronic bronchitis.
* Hospitalization for a minimum of five days or a maximum of 8 days.
* Bronchial clearance is usually productive.
* FVC and / or FEV \<85% predicted, with stable lung function.
* Agreement to participate to the study and signature of the informed consent form
* Social security coverage.

Exclusion Criteria:

* Patient infected with bacteria resistant to antibiotics.
* Bronchial clearance is not usually productive.
* Patient with contra-indication for physiotherapy bronchial clearance.
* Patient who received a lung transplant.
* Care requires more than 2 sessions of chest physiotherapy daily.
* Duration of mechanical ventilation \> 8h/day.
* Patient with an episode of hemoptysis during the month before inclusion.
* Patient with an episode of pneumothorax during the last month.
* Pregnant or lactating women.
* Patient with a disability and/or unwillingness to follow protocol requirements.
* Patient participating in another clinical study or having tested an experimental drug within 30 days prior to his inclusion in the study.
* Patient ( s) with another condition which, according to the investigator , may interfere with the result or conduct of the trial and thus justify their non- inclusion in the study.

Primary outcomes:
measure: Safety of the simeox®
timeFrame: Day 8
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: CHU Nord
Study officials:
affiliation: Hospital Marseille
name: Martine Reynaud-Gaubert, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06662552: Pulsed Electromagnetic Therapy Versus Whole Body Vibration on Quadriceps Strength Post Burn
Official title: Pulsed Electromagnetic Therapy Versus Whole Body Vibration on Quadriceps Strength Post Burn
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pulsed Electromagnetic Field
Whole Body Vibration
Burns
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate which is more effective pulsed electromagnetic field therapy or whole-body vibration on quadriceps strength after chronic burn

Detailed description: Severe burn is associated with excessive muscle wasting and atrophy. Muscle wasting is defined as unintentional weight loss of 5%- 10% of muscle mass, and severely burned patients are reported to lose up to 25% of total body mass acutely. (Dirks et al., 2016). These are worsened by deconditioning (eg, prolonged bed rest, immobilization, and inactivity). (Baker et al., 2007).

Furthermore, the need of this study is developed from the lack in the quantitative knowledge and information in the published studies about the effect of pulsed electromagnetic field therapy and whole-body vibration on quadriceps strength after chronic burn.

This study will be designed to provide a guideline about the effect of pulsed electromagnetic field therapy and whole-body vibration on quadriceps strength after chronic burn

Eligibility criteria: Inclusion Criteria:

1. Both sex.
2. Their ages will be ranged from 25 to 40 years.
3. Have second degree burn of 10 % to 25 %.
4. Their body mass index (BMI) will not exceed 34.9 Kg/m2.
5. All patients will be clinically and medically stable when attending the study.

Exclusion Criteria:

1. Unstable cardiovascular problems like arrhythmia and heart failure.
2. Diabetes mellitus.
3. Chronic chest disease.
4. Patients on medications affecting muscle power as steroids.
5. Auditory and visual problems.
6. Pregnancy \& lactation.
7. Patients with history of epilepsy.
8. Clinically significant peripheral vascular disease.
9. Musculoskeletal or neurological limitation to physical exercise.
10. Any cognitive impairment that interferes with prescribed exercise procedures.
11. Amputation of lower limb.

Primary outcomes:
measure: Assessment of change on quadriceps muscle strength using hand-held dynamometer
timeFrame: at baseline and after 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: out-patient clinic, faculty of physical therapy, Cairo university
Study officials:
References:
Clinical trial NCT04265352: Postnatal Managemant of Prenetal Cardiac Echogenic Foci in Hillel Yaffe Medical Center
Official title: Postnatal Managemant of Prenetal Cardiac Echogenic Foci in Hillel Yaffe
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prenatal Diagnosis
Keywords: cardiac echogenic focus
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2020-02-11
Enrollment: 120
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newborn infants at hillle Yaffe medical center during 10 years: 2010-2019

Brief summary: Cardiac echogenic foci are common finding on prenatal follow-up. At hillel Yaffe medical center a post natal echography is performed to all newborns with prenatal cardiac echogenic foci. Reviewing the data collected until now may reduce the need for poist natal echography.

Detailed description: Cardiac echogenic foci are common finding on prenatal follow-up. At hillel Yaffe medical center a post natal echography is performed to all newborns with prenatal cardiac echogenic foci. The investigator will review all echographies performed in the last ten years. Reviewing the data collected until now may reduce the need for poist natal echography.

Eligibility criteria: Inclusion Criteria:

* Newborns who had a cardiac echogenic focus during prenatal pollow-up.

Exclusion Criteria:

* Newborns who did not had postnatal echocardiography due to technical reasons.

Primary outcomes:
measure: Any sonographic cardiac pathologic finding exists
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: H̱adera
country: Israel
facility: Hillel Yaffe medical center
state: Hadera
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Erez Nadir, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shakoor S, Ismail H, Munim S. Intracardiac echogenic focus and fetal outcome - review of cases from a tertiary care centre in Karachi, Pakistan. J Matern Fetal Neonatal Med. 2013 Jan;26(1):2-4. doi: 10.3109/14767058.2012.703724. Epub 2012 Jul 13.