louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02776358: HFS in the Assessement and Management of Severe Asthma Attack Among Fifth Year Medical School Students
Official title: High Fidelity Simulation (HFS) Versus Video-case(VC) Trainings in the Assessement and Management of Severe Asthma Attack Among Medical School Students: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2016-05-18
Enrollment: 33
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: Bedside clinical case learning, such for respiratory distress, represent a challenge for medical teachers, especially in critical conditions. In fact, this kind of learning implicate the presence of an appropriate case (the patient itself), framework and may be time consuming which could compromise the patient's safety and wellbeing.

New pedagogic tools have emerged to strengthen the medical reasoning and the acquisition of knowledge. in recent years, the development of medical simulation has found a growing interest in the medical teaching field. Contextualization, reproducibility and reliability are the characteristics of high-fidelity simulation (HFS) which guarantee a lifetime experience of clinical conditions without putting at risk patient's safety and comfort.

The aim of this study is to assess the impact of HFS on fifth year medical students learning skills in the assessement and management of an acute asthma attack in the emergency room, and to compares it to other modern teaching tools such as "video-case"


Eligibility criteria: Inclusion Criteria:

* all fifth year medical students allocated to the one month internship period in the emergency departement.

Exclusion Criteria:

* students refusing to participate in the protocol.

Primary outcomes:
measure: Difference between the pre and the post-test scores in each group (delta Score)
timeFrame: Just before the teaching course (baseline) and one hour later
Secondary outcomes:
measure: Late performance score
timeFrame: 7 days after the teaching course
measure: Level of satisfaction
timeFrame: one hour after the teaching course
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: university of Monastir
Study officials:
affiliation: Emergency Department , university hospital of Monastir, TUNISIA
name: Mohamed habib Grissa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emergency Department , university hospital of Monastir, TUNISIA
name: Nouira Semir, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04221958: Surface ECG Mapping
Official title: Surface ECG Mapping in Healthy Adult Volunteers
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Electrocardiogram
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-01-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population of participants include healthy volunteers from the research/administrative/health care staff from the institution.

Brief summary: This study aims to confirm a scientific concept that superficially placed electrocardiogram (ECG) leads may be compared to one another to help determine positioning. If proven to be effective, this could offer a more non-invasive means of positioning using superficial ECG tracings.


Eligibility criteria: Inclusion Criteria:

* Adult volunteers from institution's staff
* Age \>18 years

Exclusion Criteria:

- Existing heart conditions

Primary outcomes:
measure: ECG Tracing
timeFrame: Approximately 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Health Care
state: California
Study officials:
References:
Clinical trial NCT00575458: Splinting for Dupuytren's Contracture Release
Official title: Prospective Randomized Comparison of Dynamic Versus Static Splinting After Dupuytren's Contracture Release
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dupuytren's Disease
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2007-12-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Orthopaedic Hand Clinic

Brief summary: This study is comparing two different kinds of splints for patients who have had a surgical contracture release of dupuytren's disease. It compares a static splint and a dynamic splint.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* males and females with Dupuytren's contracture
* patients with contracture of less than 30 degrees of MCP contractions and no contractions of the IP joints

Exclusion Criteria:

* previous surgical treatment for Dupuytren's
* contracture of MCP greater than 30 degrees
* contraindications for dynamic splinting (upper limb amputees, paresis, ect.)

Primary outcomes:
measure: DASH questionnaire, PCS questionnaire, Wahler Physical Symptom Inventory, CESD questionnaire
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: David C. Ring, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03668158: Multi-center Study on Therapy-oriented Molecular Subtyping of Hepatocellular Carcinoma
Official title: Multi-center Study on Therapy-oriented Molecular Subtyping of Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatocellular Carcinoma
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2018-09-12
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalization patient

Brief summary: The purpose of this study is to establish molecular subtyping of HCC.

Detailed description: Hepatocellular carcinoma is one of the most common malignant tumors in the world with high incidence and mortality. Liver transplantation is the most effective treatment for HCC and is in high demand in China. However, recurrence of HCC among liver transplantation recipients is still a great challenge and threat to the survival of recipients. So it is of great significance to establish molecular subtyping of HCC and achieve precise selection of recipients. Based on large scales of samples, the investigator's study aims to establish multi-omics characteristic profiles of liver transplantation for HCC in integration of apparent biological characteristics, clinical management and prognostic information by utilizing genomics, transcriptomics and proteomics, etc. This study will contribute to the therapy-oriented molecular subtyping of HCC.

Eligibility criteria: Inclusion Criteria:

Liver transplantation due to HCC within Hangzhou criteria

Exclusion Criteria:

Liver transplantation due to HCC beyond Hangzhou criteria Liver transplantation due to other disease except HCC Multiple organ transplantation

Primary outcomes:
measure: recurrence rate
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04600258: Chocolate for Patients With Chronic Kidney Disease
Official title: Chocolate for the Patient With Chronic Kidney Disease: a New Strategy to Modulate Inflammation?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Lead sponsor: Universidade Federal Fluminense
Sponsor class: OTHER
First posted: 2020-10-23
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Chocolate group Control Group
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Chocolate is a widely appreciated foodstuff with historical appreciation as food from the gods. It is a rich source of (poly)phenolics, which have several proposed salutogenic effects, including neuroprotective anti-inflammatory, antioxidant, and cardioprotective properties.

This study will evaluate the potential salutogenic contribution of chocolate intake, to mitigate inflammatory and oxidative burden in chronic kidney disease patients.

Detailed description: This study is evaluating patients with CKD on a regular HD program randomized in the chocolate group and control group. The chocolate group is receiving 40g of dark chocolate per day for 2 months and the control group is not receiving any intervention. Peripheral blood mononuclear cells (PBMC) are being isolated for expression of Nrf2, NF-kB, and NADPH quinone oxidoreductase 1 (NQO1) by a quantitative real-time polymerase chain reaction. Antioxidant enzymes activity (catalase-CAT and glutathione peroxidase-GPx), high-sensitivity C-reactive protein (hs-CRP) will be assessed using an enzyme-linked immunosorbent assay (ELISA).

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Chronic Kidney Disease
* Hemodialysis patients for more than 6 months
* Aged 18 years or older

Exclusion Criteria:

* Patients pregnant
* Smokers
* Using antibiotics in the last 3 months
* Autoimmune diseases
* Clinical diagnosis of infectious diseases
* Clinical diagnosis of Cancer
* Clinical diagnosis of AIDS

Primary outcomes:
measure: Antioxidants and anti-inflammatory biomarkers
timeFrame: 2 months
measure: Inflammatory biomarkers
timeFrame: 2 months
Secondary outcomes:
measure: Uremic toxins
timeFrame: 2 months
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Denise Mafra
state: RJ
city: Rio de Janeiro
country: Brazil
facility: Denise Mafra
state: RJ
Study officials:
References:
citation: Fanton S, Cardozo LFMF, Combet E, Shiels PG, Stenvinkel P, Vieira IO, Narciso HR, Schmitz J, Mafra D. The sweet side of dark chocolate for chronic kidney disease patients. Clin Nutr. 2021 Jan;40(1):15-26. doi: 10.1016/j.clnu.2020.06.039. Epub 2020 Jul 14.
Clinical trial NCT06828458: Determining Elements of Anti-Fungal Immunity in BURN Patients
Official title: Determining Elements of Anti-Fungal Immunity in BURN Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Burn
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 327
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 burn injury

Brief summary: Scientific justification Invasive fungal diseases (IFDs) pose a substantial threat, especially in immunocompromised patients, necessitating urgent research focus and therapeutic advancements. The IFI-BURN study, involving a cohort of patients with severe burn injury (n=276), revealed a significant IFD incidence of 31.6% and underscored their critical impact on morbidity and mortality. While fungi are present everywhere, for moulds within the environment and for yeasts within our microbiota, why certain patients develop IFDs and others do not, remains poorly understood. The answer most likely resides in the impact of the burn injury on the immune response, loss of skin barrier and particular predisposing immune phenotype of patients. The immune system is composed of both cellular and humoral components, but the latter is far less studied in antifungal immunity although they exert multiple antimicrobial mechanisms.


Eligibility criteria: Inclusion Criteria:

Burn patients

* Adult patients ≥ 18 years old
* Admission \< 4 days following burn injury
* Total burn surface Area ≥ 15%
* Non opposition of the patient or his/her relatives to the research
* Affiliation to social security or any health insurance

Exclusion Criteria:

* Pregnancy
* Opposition of the patient or his/her relatives
* Decision not to resuscitate or to limit or stop active therapies

Primary outcomes:
measure: Invasive fungal disease (IFD) onset during hospitalisation time
timeFrame: Up to 18 months
Secondary outcomes:
measure: Overall survival
timeFrame: At day 30
measure: Overall survival
timeFrame: At day 90
measure: Hospital mortality
timeFrame: Up to 18 months
measure: Incidence of organ failure during hospitalisation
timeFrame: Up to 18 months
measure: Severity score at admission
timeFrame: At inclusion
measure: Severity score at admission
timeFrame: At inclusion
measure: Severity score at admission
timeFrame: At inclusion
measure: Number of days without renal replacement therapy
timeFrame: At day 30
measure: Number of days without mechanical ventilation
timeFrame: At day 30
measure: Length of stay in Intensive Care Unit
timeFrame: Up to 18 months
measure: Length of stay in hospital
timeFrame: Up to 18 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03499158: Terminal Latency Index, Residual Latency and Median Ulnar F Latency Difference in Carpal Tunnel Syndrome
Official title: Role of Terminal Latency Index, Residual Latency and Median Ulnar F Latency Difference in Carpal Tunnel Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carpal Tunnel Syndrome
Lead sponsor: Ufuk University
Sponsor class: OTHER
Collaborators: name: Baskent University
First posted: 2018-04-17
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who had gone to electrodiagnostic study and diagnosed as carpal tunnel syndrome

Brief summary: Terminal latency index, residual latency and median ulnar F latency difference in carpal tunnel syndrome are specific parameters for the diagnosis

Detailed description: Carpal tunnel syndrome is the most common compression neuropathy. This study was performed to determine the value of terminal latency index, residual latency and median ulnar F latency difference to investigate their sensitivity and specificity in the diagnosis of this syndrome.

We retrospectively determined the 160 patients. We evaluated the nerve conduction studies of patient and healthy arms. We recorded all nerve conduction study values.

Eligibility criteria: Inclusion Criteria:

* Patients who had gone to electrodiagnostic study and diagnosed as carpal tunnel syndrome

Exclusion Criteria:

* any history of hereditary polyneuropathies
* acquired polyneuropathies
* surgery or local steroid injections for upper limbs or effect the study
* any history of fracture at the sites of stimulation or recording

Primary outcomes:
measure: nerve conduction studies
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03092258: Do we Prepare Patients for Their Digital Legacy? A Survey of Palliative Care Professionals in the West Midlands
Official title: Do we Prepare Patients for Their Digital Legacy? A Survey of Palliative Care Professionals in the West Midlands
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Death
Lead sponsor: The Royal Wolverhampton Hospitals NHS Trust
Sponsor class: OTHER_GOV
First posted: 2017-03-27
Enrollment: 210
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Palliative care professionals (medical, nursing and social worker) affiliated to a hospice in the West Midlands.

Brief summary: Conduct a questionnaire survey of palliative care professionals including doctors, nurses and social workers currently working within the West Midlands to establish how much the palliative care community in the West Midlands engage in preparing patients for their digital legacy and find out if there is a further education need in this community about digital legacy.


Eligibility criteria: Inclusion Criteria:

* Palliative care professionals (medical, nursing and social worker) affiliated to a hospice in the West Midlands.

Exclusion Criteria:

* Medical, nursing or social worker not working in a hospice in the West Midlands.

Primary outcomes:
measure: Professionals' behaviour.
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Wolverhampton
country: United Kingdom
facility: Compton Hospice
Study officials:
affiliation: The Royal Wolverhampton NHS Trust
name: Hazel Coop
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00219258: Efficacy and Safety of Zoledronic Acid in Patients With Bone Metastases of Any Solid Tumors or Multiple Myeloma
Official title: A Randomized, Double-blind, Multi-centre Study to Evaluate the Fficacy and Safety of Zometa as a Treatment in Patients With Bone Metastases of Any Solid Tumors or Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Treatment of Bone Metastases
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 240
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: Zoledronic acid is a medication that slows the breakdown of bone. This study will assess the efficacy and safety of zoledronic acid in Chinese patients with multiple myeloma or other solid tumors with bone metastases.


Eligibility criteria: Inclusion Criteria

* Cancer patients (multiple myeloma or other solid tumors) and confirmed evidence of bone lesions
* Significant bone pain

Exclusion Criteria

* Poor renal function
* Use of other investigational drugs within 30 days of visit 2
* Dental or other surgery to the jaw within 6 weeks of screening, or planned during the 4 week study

Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: To compare in a randomized fashion the effect of zoledronate and pamidronate 90 mg on pain relief as assessed by pain score after 1-dose treatment in patients with bone pain induced by any solid tumors with bone metastases or Multiple Myeloma
Secondary outcomes:
measure: Changes in bone markers (urinary N-telopeptide/creatinine ratio, urinary C-telopeptide/creatinine ratio).
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_CHAIR
References:
Clinical trial NCT05944458: The Effect of NAC in Decreasing the Incidence of Linezolid-induced Thrombocytopenia in Critically Ill Patients
Official title: The Effect of N-acetylcysteine in Decreasing the Incidence of Linezolid-induced Thrombocytopenia in Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Linezolid Associated Thrombocytopenia
Lead sponsor: Helwan University
Sponsor class: OTHER
First posted: 2023-07-13
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: * Study the effect of acetylcysteine on decreasing the incidence of LIT in critically ill patients.
* Study the impact of acetylcysteine on the time to onset of LIT and the time to recovery of platelets.

Detailed description: Primary outcome: difference in incidence of LIT between patients who received NAC and patients who didn't.

* Primary outcome definition: Defined as platelets \< 150000 OR decrease \> 50% of baseline platelets.
* Secondary outcome: difference in Time to onset of LIT and time to recovery between the 2 groups. Blood products transfusion, bleeding, length of stay, and in-hospital mortality incidence between 2 groups.
* Secondary outcome definitions: after having thrombocytopenia, regardless of discontinuation of linezolid, recovery is defined as the restoration and maintenance of platelet counts \> 70% of baseline values.

Eligibility criteria: Inclusion Criteria:

* All adult patients, age \> or = 18 years old, admitted to the ICU with different indications.
* Candidates for intravenous linezolid therapy for \> or =1 day.

Exclusion Criteria:

* Taking any myelosuppressive drug.
* Baseline platelets \< 50000.
* Patients with hematological malignancy.
* COVID-19 patients.
* Patients with immune thrombocytopenia.
* Patients who refused to sign the informed consent

Primary outcomes:
measure: difference in incidence of LIT between patients who received NAC and patients who didn't.
timeFrame: From starting linezolid untill 14 days after linezolid discontinuation or ICU discharge whichever comes first.
Secondary outcomes:
measure: difference in Time to onset of LIT and time to recovery between the 2 groups
timeFrame: After starting linezolid untill 14 days after linezolid discontinuation or ICU discharge whichever comes first
measure: Blood products transfusion, bleeding, length of stay, and in-hospital mortality incidence between 2 groups.
timeFrame: From start linezolid until ICU discharge
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: 15 May hospital
Study officials:
affiliation: Clinical pharmacy, 15 May hospital
name: Mohamed Abdeltawab, Pharm D
role: PRINCIPAL_INVESTIGATOR
References: