louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06693063: Impact of General Practice Follow-up on Emergency Hospitalization of Patients Admitted for Chest Pain
Official title: Impact of General Practice Follow-up on Emergency Hospitalization of Patients Admitted for Chest Pain
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chest Pain
Keywords: emergency admission
general practitioner
Lead sponsor: Centre Hospitalier Emile Roux
Sponsor class: OTHER
First posted: 2024-11-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient admitted to Emile Roux hospital emergency department with chest pain

Brief summary: This is a prospective observational study carried out in the emergency department of Emile Roux Hospital. Its aim is to compare the medical, psychological and social characteristics of patients followed up by a general practitioner and those without regular follow-up, using an anonymous questionnaire completed by the general practitioner in the emergency department, for patients consulting for the reason "chest pain".


Eligibility criteria: Inclusion Criteria:

* Patient admitted to Emile Roux hospital emergency department with chest pain
* Patient affiliated to the Social security system
* Patient able to give informed non-opposition to participating in research

Exclusion Criteria:

* Patient under guardianship, curatorship, safeguard of justice or prisoners
* Patient with cognitive disorders
* Pregnant or breast-feeding women
* Refusal to participate

Primary outcomes:
measure: Compare the hospitalization rate of patients admitted for chest pain, according to their medical follow-up by a general practitioner.
timeFrame: Only once, within 24 hours of admission to the emergency department
Secondary outcomes:
measure: Describe the population of patients admitted to the Emile Roux hospital emergency department with chest pain and followed by a general practitioner versus those without medical follow-up.
timeFrame: Only once, within 24 hours of admission to the emergency department
Other outcomes:
Locations:
city: Le Puy-en-Velay
country: France
facility: Centre Hospitalier Emile Roux
Study officials:
affiliation: Hospital Center Emile Roux, Le Puy-en-Velay (France)
name: Luc PIGEON
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01308463: Discovery Elbow Long-Term Survivorship
Official title: Discovery Elbow Long-Term Survivorship Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Survivorship
Pain
Keywords: elbow long-term Survivorship
Study participant Discovery Elbow Multi-center Study who
consent for the Discovery Elbow Long-term SurvivorshipStudy
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2011-03-04
Enrollment: 29
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The Study population shall be participanting in the Discovery Elbow Multi-center Study who provide consent for the Discovey Elbow Long-term Survivoship Study

Brief summary: The Discovery™ Elbow Multi-Center Prospective Study (5-year Study) patients will be consented at the two year or next scheduled follow-up period for the early-enrolled patients.

Detailed description: Eligibility: Patient(s) must be enrolled in the Discovery Multi-Center Prospective Study. The patient must consent to participation in the Discovery Long-term Survivorship Study.

In order to continue to follow the multi-center subjects long-term Biomet would like to extend the follow-up to include annual follow-ups from 10 to 15 years to document long-term survivorship. The annual follow-up will be obtained by sending annual questionnaire directly to the patients by mail. The Patient ASES questionnaire and survivorship data questions will be collected.

Eligibility criteria: Inclusion Criteria:

1. Participant in the Discovery Elbow Multi-center Study
2. Consent to participate in the Discovery Elbow Long-Term Survivorship Study

Exclusion Criteria:

1. Patient is not a Discovery Elbow Multi-center Participant
2. Patient does not provide consent for the Discovery Elbow Long-term Survivorship Study

Primary outcomes:
measure: Patient Derived American Shoulder and Elbow Society (ASES) Pain Score
timeFrame: 10 Years Post-op
measure: Patient Derived American Shoulder and Elbow Society (ASES) Function
timeFrame: 10 Years Post-op
measure: Patient Derived American Shoulder and Elbow Society (ASES) Satisfaction
timeFrame: 10 Years Post-op
Secondary outcomes:
measure: Survivorship Will be Measured by the Incidence of Revision or Removals
timeFrame: 10 years Post-op
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Florida Orthopedic Institute
state: Florida
city: Indianapolis
country: United States
facility: The Indiana Hand to Shoulder Center
state: Indiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Nashville
country: United States
facility: Vanderbilt Hand Center
state: Tennessee
Study officials:
affiliation: Director Clinical Research, Biomet Orthopedics, LLC
name: Russell Schenck, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05234463: Study of the Link Between Complement Activation and IgA Nephropathy Severity
Official title: Study of the Link Between Complement Activation and IgA Nephropathy Severity
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: IgA Nephropathy Severity in Kidney Transplantation
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-02-10
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with a histologically proven diagnosis of IgA nephropathy, with or without kidney transplantation history followed in the Nephrology Department of Strasbourg University Hospital.

Brief summary: ICONE study (IgA Complement and NEphropathy is a prospective monocentric observational study.

The main objective is to evaluate the relevance of complement activation as a biomarker of disease severity and progression in patients with a biopsy proven IgAN.

Detailed description: IgA nephropathy (IgAN) is a common cause of glomerulonephritis and a major cause of end stage renal disease in up to 20-40% of patients. However, its prognosis still cannot be accurately predicted due to the high heterogenicity of clinical presentations and courses. Complement dysregulation is a main driver of glomerular damages in many glomerulonephritis. Given the growing body of evidence of complement lectin/alternative pathways activation in IgAN pathogenesis, the investigators propose the evaluation of a combination of biomarkers of infra-clinical complement activation to stratify the risk of disease's progression. This study aims to identify subsets of patients in whom complement activation plays a critical role in disease progression. This is of particular interest in the aera of emergence of complement-targeting therapies in IgAN

Eligibility criteria: Inclusion Criteria:

* Adult patients, male or female, with a biopsy proven IgA nephropathy.
* Primitive and secondary forms can be included
* Regardless of the date of diagnosis and the level of kidney function
* With or without past of kidney transplantation
* Followed in the Nephrology Department, Strasbourg University Hospital
* Signed informed consent

Exclusion Criteria:

* Active or recent infectious or inflammatory syndrome (\<2 months), recent vaccination (\<2 months), ongoing acute humoral rejection treatment, treatment with plasma exchanges (\<2 months), current treatment with complement inhibitors
* Impossibility of giving informed information (emergency situation, difficulties in understanding, etc.)
* Subject under safeguard of justice, guardianship or curatorship

Primary outcomes:
measure: Incidence of a severe form of IgA nephropathy
timeFrame: At inclusion
measure: Incidence of a severe form of IgA nephropathy
timeFrame: 1 year after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de néphrologie
Study officials:
References:
Clinical trial NCT05922163: Blood Transfusion Education Using Blended Virtual Reality and Simulation for Nursing Undergraduate Students
Official title: Blood Transfusion Education Using Blended Virtual Reality and Simulation for Nursing Undergraduate Students: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Transfusion Complication
Keywords: Blood transfusion
Nursing education
Nursing practice
Simulation
Virtual reality
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2023-06-28
Enrollment: 151
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Nurse-administered blood transfusion (BT) is a common form of medical treatment, but nursing students are often excluded from participating in and observing BTs during clinical placements. To address clinical placement limitations, nursing educators have increasingly adopted technology-guided simulation pedagogies, including virtual reality (VR) simulation, for nursing students' clinical skills education.


Eligibility criteria: Inclusion Criteria:

* All undergraduate nursing students enrolled in the 'Nursing of Adults' course in a pre-licensure program at a Hong Kong university.

Exclusion Criteria:

* Students who had vision impairment to watch VR videos;
* Students who had neck pain/ injury to move their head, or open wound to wear the VR headset;
* Students who experienced nausea and dizziness when watching VR videos;
* Students who had epileptic symptoms

Primary outcomes:
measure: Blood transfusion knowledge scale (optimised version of the routine blood transfusion knowledge questionnaire [RBTKQ-O])
timeFrame: 12-week
Secondary outcomes:
measure: Student satisfaction and self-confidence scale [SSSC]
timeFrame: 12-week
measure: General self-efficacy scale [GSES]
timeFrame: 12-week
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: University of Hong Kong
Study officials:
References:
Clinical trial NCT05983263: Analgesic Efficacy of Capsaicin 8% Patch (QUTENZA®) in Coccygodygnia
Official title: Neuropathic Determining Factors and Analgesic Efficacy of Capsaicin 8% (QUTENZA®) Patches in Refractory Coccygodygnia
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Coccyx Disorder
Keywords: Chronic Coccygodynia
Neuropathic pain
Capsaicine 8%
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2023-08-09
Enrollment: 106
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Medical files of 106 patients hospitalized between 2016 and 2022 for persisting coccygodynia (\>3months) and at least one neuropathic symptom in pain expression, and who received capsaicin 8% patch (QUTENZA®) topical treatment.

Brief summary: A retrospective study over a period of 6 years to explore analgesic efficacy of 8% Capsaicin patch (QUTENZA®) in coccygodynic patients, as well as neuropathic predictive factors of therapeutic response.

Detailed description: Coccygodynia corresponds to a localized pain in the coccyx region, aggravated or triggered by sitting and/or by getting up from a seat. Even if there is no epidemiology of this pain in France, coccygodynia represents a frequent recourse to specialized consultations (Rheumatology or Algology). Currently in France, there is no recommendation on the management of chronic disabling coccygodynia. Treatments are proposed in accordance with known/presumed underlying pathophysiology. Anti-inflammatory drugs and manual therapy (pressure relief cushions) are thus always offered as first-line treatments. But despite their common use/prescription, their efficacy is variable, with low level of evidence. More over, upstream of invasive coccygectomy, therapeutic arsenal is largely deficient, inviting to explore new approaches. Considering frequent neuropathic expression in coccygodynic pain pattern (tingling, itching, pain cold sensation...), capsaïcine 8% patch (QUTENZA®) are often performed. And in the same way, no/few researches tried to measure real-life analgesic pain efficacy of QUTENZA® strategy. Observational retrospective study (non-interventional anonymized data) CAPSACOXp aims to assess analgesic efficacy of Capsaicin 8% patch (QUTENZA®) and explore possible neuropathic determinants of therapeutic response in coccygodynia.

Eligibility criteria: Inclusion Criteria:

* Patients who received topical Capsaicin 8% patch therapy for the treatment of their coccygodygnia between August 2016 and August 2022

Exclusion Criteria:

* Patients who have already received 8% Capsaicin patch topical treatment in coccyx area.

Primary outcomes:
measure: Responder rate
timeFrame: 3 months after the inclusion visit.
Secondary outcomes:
measure: Therapeutic response neuropathic predictive factors
timeFrame: 3 months after the inclusion visit
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00525863: Oxygen Therapy in Schizophrenia
Official title: Oxygen Therapy in Schizophrenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Chronic Schizophrenia
Keywords: schizophrenia
oxygen therapy
Lead sponsor: Beersheva Mental Health Center
Sponsor class: OTHER_GOV
Collaborators: name: National Alliance for Research on Schizophrenia and Depression
First posted: 2007-09-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Due to intense ATP-consuming processes in the brain, a high level of brain energy supply is required. A popular hypothesis regarding the pathogenesis and pathophysiology of schizophrenia postulates hypofunction of neuronal circuits in the prefrontal and limbic-temporal areas. An emerging body of data suggests that impaired energy metabolism due to mitochondrial dysfunction plays a role in the pathophysiology of schizophrenia.

Under normal conditions cellular metabolic rate, i.e. oxygen and glucose consumption, increases proportionally with any increase in neuronal activity. The impaired energy metabolism due to mitochondrial dysfunction and frontal lobe hypofunction might be improved by increasing O2 supply to the brain. Oxygen-enriched air inhalation has been shown to increase brain oxygen supply. Hyperoxia therapy is a useful tool in the treatment of neurological and neurotrauma deficits.

We therefore suggest a randomized double blind cross-over study of enriched inspired O2 partial pressure in schizophrenia.

It is surprising given the numerous findings on reduced energy metabolism in schizophrenia that simple treatment with inspired enriched oxygen has not been studied.


Eligibility criteria: Inclusion Criteria:

* 18-45 years old
* 2 years of illness
* PANSS more than 60

Exclusion Criteria:

* unstable or serious physical illness
* suicidality
* drug abuse
* BMI above 30
* taking anti-hypertension medication

Primary outcomes:
measure: PANSS
timeFrame: every two weeks
Secondary outcomes:
measure: Clinical Global Impressions
timeFrame: every two weeks
Other outcomes:
Locations:
city: Beersheva
country: Israel
facility: Beersheva Mental Health Center
Study officials:
affiliation: Ben-Gurion University of the Negev
name: Yuly Bersudsky, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04243863: VNRX-7145 SAD/MAD Safety and PK in Healthy Adult Volunteers
Official title: A Randomized, Double Blind, Placebo-Controlled, Sequential Group, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of Single and Repeat Doses of VNRX-7145 in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: VNRX-7145
Safety
Pharmacokinetics
Lead sponsor: Venatorx Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2020-01-28
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This is a 2-part, first-in-human dose-ranging study to evaluate the safety and pharmacokinetics of escalating doses of VNRX-7145. In part 1, subjects will receive a single dose of VNRX-7145; in part 2 subjects will receive multiple doses of VNRX-7145 for 10 days.


Eligibility criteria: Inclusion Criteria:

* Healthy adults 18-45 years
* Males or non-pregnant, non-lactating females
* Body mass index (BMI): ≥18.5 kg/m² and ≤32.0 kg/m²
* Normal blood pressure
* Normal laboratory tests

Exclusion Criteria:

* Current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorder
* History of drug allergy
* Abnormal ECG or history of clinically significant abnormal rhythm disorder
* Positive alcohol, drug, or tobacco use/test

Primary outcomes:
measure: Part 1: Number of subjects with adverse events
timeFrame: Day 8
measure: Part 2: Number of subjects with adverse events
timeFrame: Day 17
Secondary outcomes:
measure: Part 1: AUC0-tau
timeFrame: Days 1-3
measure: Part 1: Cmax
timeFrame: Days 1-3
measure: Part 1: tmax
timeFrame: Days 1-3
measure: Part 1: CLr
timeFrame: Days 1-3
measure: Part 2: AUC0-tau
timeFrame: Days 1-10
measure: Part 2: Cmax
timeFrame: Days 1-10
measure: Part 2: tmax
timeFrame: Days 1-10
measure: Part 2: CLr
timeFrame: Days 1-10
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Worldwide Clinical Trials Early Phase Services, LLC
state: Texas
Study officials:
References:
Clinical trial NCT00721435: Combined Digital X-ray and Ultrasound Technique for Improved Detection and Characterization of Breast Lesions
Official title: Combined Digital X-ray and Ultrasound Technique for Improved Detection and Characterization of Breast Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Mass Cystic
Benign Mass
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2008-07-24
Enrollment: 183
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The study will evaluate and refine a breast screening and diagnosis device.

Detailed description: The device produces 3-D mammograms and ultrasound pictures of the breast at the same time and in the same position. This should help make sure that any area on a mammogram can be easily found in the ultrasound when using the new device. The 3-D mammograms should provide better visualization of the suspected lesion and improve diagnostic accuracy.

Eligibility criteria: Inclusion Criteria:

* To participate in this research study you must be a female over the age of 25
* Have had a normal mammogram or are scheduled for a breast biopsy
* Have cysts or have been recommended to have a 6 month follow up mammogram after your biopsy.

Exclusion Criteria:

* Male
* Under the age of 25
* Documented breast cancer

Primary outcomes:
measure: To have a device that produces 3D/ultrasound imaging of the breast at the same time and in the same position.
timeFrame: To be determined later.
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Paul L Carson, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02323035: Investigative Headgear With CPAP Mask
Official title: Investigative Headgear With CPAP Mask
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Fisher and Paykel Healthcare
Sponsor class: INDUSTRY
First posted: 2014-12-23
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This investigation is designed to evaluate the at-home usability, performance, user acceptance and reliability of the Headgear with a CPAP Mask for a duration of 2-4 weeks.

Detailed description: Up to 300 participants will be recruited for the trial, consisting of male and female participants diagnosed with OSA and receiving CPAP or Bi-level PAP for the treatment of their OSA. These include current CPAP mask users.

Eligibility criteria: Inclusion Criteria:

* AHI≥5 from the diagnostic night
* ≥18 years of age
* Prescribed CPAP or Bilevel therapy for OSA
* Existing CPAP mask users

Exclusion Criteria:

* Inability to give informed consent
* Patient intolerant to PAP
* Anatomical or physiological conditions making PAP therapy inappropriate
* History of respiratory disease or CO2 retention.
* Pregnant or think they may be pregnant
* Investigated by Land Transport Safety Authority

Primary outcomes:
measure: Participants perception of the headgear on mask performance
timeFrame: 2-4 weeks
Secondary outcomes:
measure: Number of participants that choose this Headgear over their usual.
timeFrame: 2-4 weeks
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: Fisher & Paykel Healthcare
Study officials:
affiliation: Clinical Research Scientist
name: Bhavi Ogra, BSc
role: PRINCIPAL_INVESTIGATOR
References: