louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05787405: Early Diagnosis of Clinical Evolution From SARS-CoV-2
Official title: CORONABED.BOT: an Automation Project Using Artificial Intelligence for Early Diagnosis of Clinical Evolution From SARS-CoV-2"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV-1 Infection
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-03-28
Enrollment: 8000
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: adult patients

Brief summary: The aim of the CORONA.BOT project is to exploit the Artificial Intelligence methods of Generator Real World Data Facility to automatically extract structured and unstructured data from hospital databases and to implement an early risk assessment (warning system) regarding the negative outcome for patients infected with SARS-CoV-2.

The objective of CORONABED.BOT is to analyze the care pathways of patients from the same cohort as CORONA.BOT, in order to identify the total length of stay, intensive care occupations and flows between departments, based on variables demographics and first entry clinics Early identification of patients with symptoms compatible with SARS-CoV-2 infection will enable more rapid activation of isolation procedures, contact monitoring/contact history and decisions on the most appropriate clinical pathway in terms of type of treatment and unit. Similarly, the identification of factors correlated with worse outcomes will allow more effective planning for the use of critical resources (such as intensive care and others).


Eligibility criteria: Inclusion Criteria:

* adult patients (18 years of age or older)
* admitted to the Gemelli and Columbus Polyclinic
* diagnosis of SARS-CoV-2 infection (suspected cases will also be included).

Exclusion Criteria:

* aaaa

Primary outcomes:
measure: the implementation of prediction models
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Gemelli
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Rita Murri
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01617005: A Study of Tocilizumab in Participants With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Non-Biological Disease-modifying Anti-rheumatic Drugs (DMARDs)
Official title: Non-interventional Local Study to Describe the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-biologic DMARD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-06-12
Enrollment: 50
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: Participants with RA and an inadequate response to non-biologic DMARDs.

Brief summary: This observational study will evaluate the safety and efficacy of tocilizumab in participants with active moderate to severe RA and an inadequate response to non-biologic DMARDs. Data will be collected from each eligible participant initiating tocilizumab treatment over 6 months.


Eligibility criteria: Inclusion Criteria:

* Moderate to severe active RA (European League Against Rheumatism \[EULAR\] criteria)
* Inadequate response to DMARDs or tumor necrosis factor (TNF) antagonists
* Initiating treatment with tocilizumab according to SPC

Exclusion Criteria:

* Rheumatic autoimmune disease other than RA
* Prior history or current inflammatory joint disease other than RA
* Previous treatment with any biological drug used in the treatment of RA
* Previous treatment with tocilizumab
* Any contraindication to treatment with tocilizumab
* Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment
* Pregnant women or nursing (breastfeeding) mothers

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
timeFrame: Baseline up to Week 24
Secondary outcomes:
measure: Number of Participants With Good or Moderate Response According to European League Against Rheumatism (EULAR) Criteria
timeFrame: Baseline, Week 24
measure: Number of Participants Who Discontinued Treatment Due to Lack of Efficacy
timeFrame: Baseline up to Week 24
measure: Time to Discontinuation Due to Lack of Efficacy
timeFrame: Baseline up to Week 24
Other outcomes:
Locations:
city: Podgorica
country: Montenegro
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03608605: Advanced MRI Sequences in Multiple Sclerosis and Its Mimics
Official title: Role of Advanced MRI Sequences in Differentiating MS and Its Mimics
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Sclerosis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-08-01
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients among those attend to Assiut university hospital with clinical symptoms suspicious of MS according to McDonald criteria 2017 with age range from (18-50 years old).

Brief summary: We aim to evaluate the role of conventional and advanced MRI sequences in:

1. Establishing the diagnosis of multiple sclerosis and differentiate it from its mimics.
2. Predict the prognosis and evaluate the treatment response in the first year of patients with multiple sclerosis.

Detailed description: All patients in the study will be referred among those attend to Assuit university hospital with clinical symptoms suspicious of MS according to McDonald criteria 2017 with age range from (18-50 years old).

MRI study will be done for each patient. MRI study will be repeated for those already diagnosed as MS after starting the suitable treatment as decided by attending physician after one year to assess the efficacy of treatment and the patient prognosis.

MR imaging will be performed on a 1.5-T MR imaging unit (Siemens, Sembra medical system,German).

Prospectively completed data forms will be analyzed and compared. Statistical tests appropriate to the nature of the data will be used.

All patients will not be subjected to risk of any kind during this study. All patients' data will be confidentially kept. Approval of the ethical committee of Faculty of Medicine, Assiut University.

An informed consent will be taken from all patients included in this study.

* The research will be conducted only by scientifically qualified and trained personnel.
* The procedures included in this study have been already used in hospital and centers in and outside Egypt.

Eligibility criteria: Inclusion Criteria:

* All patients in the study will be referred among those attend to Assuit university hospital with clinical symptoms suspicious of MS according to McDonald criteria 2017 with age range from (18-50 years old).

Exclusion Criteria:

* o Any general contraindication of MRI in some cases as presence of paramagnetic substance as pacemakers or in patients with claustrophobia.

  * Patient above 50 years old.

Primary outcomes:
measure: role of advanced MRI sequences in establishing the diagnosis of multiple sclerosis(MS)
timeFrame: baseline
Secondary outcomes:
measure: follow up of MS patients after one year of treatment
timeFrame: one year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00935805: Glycemic And Blood Pressure Control In Type 2 Diabetes, In A Primary Care Unit: A Staged Management Strategy
Official title: ANALYSIS OF THE EFFECTIVENESS OF A STAGED MANAGEMENT PROGRAM AIMED AT CONTROLLING BLOOD PRESSURE AND BLOOD GLUCOSE OF TYPE 2 DIABETIC PATIENTS USING EXCLUSIVELY THE RESOURCES AVAILABLE IN A PRIMARY CARE SETTING IN BRAZIL
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus
Arterial Hypertension
Keywords: Diabetes Mellitus
Arterial Hypertension
Treatment
Primary Care
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
First posted: 2009-07-09
Enrollment: 124
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Type 2 diabetic patients attending a primary care outpatient facility

Brief summary: The aim of this study is to to analyze if it is possible to reach the goals of HbA1c \<7.0% and blood pressure \<= 130/80 mm Hg in a cohort of patients with type 2 diabetes attending a primary care unit, using ony those resources available at the unit, and provided by the Brazilian National Health System. It is an open label, observational study, with a duration of 4-6 years. Patients attending a primary care outpatient facility will be sequentially included in the study provided they give consent. They will be followed on a monthly basis by a team of physicians and nurses. Glucose, A1c, Blood PRessure will be the outcomes.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus (WHO)

Exclusion Criteria:

* Terminal disease (renal, cancer, heart failure)

Primary outcomes:
measure: Glycated hemoglobin A1c
timeFrame: 3 months
measure: Blood pressure
timeFrame: 1 month
Secondary outcomes:
measure: 24 hr blood glucose profile
timeFrame: once
measure: Fasting blood glucose
timeFrame: 3 months
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: RS
Study officials:
affiliation: Hospital de Clinicas de Porto Alegre
name: Rogerio Friedman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Clinicas de Porto Alegre
name: Jorge L Gross, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00441805: The Treatment of Acne Vulgaris With Radiofrequency Device
Official title: The Treatment of Acne Vulgaris With Radiofrequency Device
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Acne Vulgaris
Keywords: Acne
RadioFrequency
Lead sponsor: Alma Lasers
Sponsor class: INDUSTRY
First posted: 2007-03-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Radiofrequency emmitting device, normaly used for thermage treatments will be used on 22 mild to moderate acne patients faces.

The aim of the study is to check whether RF heating of subcutaneous and dermis will improve acne in needed patients.


Eligibility criteria: Inclusion Criteria:

* mild-moderate Acne
* age over 18
* otherwise healthy

Exclusion Criteria:

* age under 18
* pregnancy
* systemic acne treatment in the last month
* local acne treatment in the last month

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Lase Ohr clinic
Study officials:
affiliation: Alma Lasers LTD
name: Yussi Levcelter, Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03834805: Monitoring of Fetal Lung Elasticity by Elastography Between 24 and 39 Weeks
Official title: Monitoring of Fetal Lung Elasticity by Elastography Between 24 and 39 Weeks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnant Woman
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2019-02-08
Enrollment: 74
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The objective of the study is to evaluated the evolution of the LLE ratio (Lung to Liver Elastography ratio) during normal pregnancy


Eligibility criteria: Inclusion Criteria:

* major pregnant women
* singleton pregnancy

Exclusion Criteria:

foetus:

* fetal pulmonary disease
* fetal liver disease
* chromosome fetal abnormalities
* fetal growth restriction

mother:

* BMI\>30 in beginning of pregnancy
* premature ruptured membranes
* high blood pressure
* pre-eclampsia
* gestational diabetes

Primary outcomes:
measure: Change of Lung to liver Elastography ratio (LLE ratio) between 24 and 39 weeks of amenorrhea
timeFrame: measurements at: 24, 28, 32, 36, 39 weeks of amenorrhea (WA)
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU Jean Minjoz
state: Doubs
Study officials:
References:
citation: Nallet C, Pazart L, Cochet C, Vidal C, Metz JP, Jacquet E, Gorincour G, Mottet N. Prenatal quantification of human foetal lung and liver elasticities between 24 and 39 weeks of gestation using 2D shear wave elastography. Eur Radiol. 2022 Aug;32(8):5559-5567. doi: 10.1007/s00330-022-08654-1. Epub 2022 Mar 10.
Clinical trial NCT02813005: High Frequency Jet Ventilation for Percutaneous Interventional Radiology
Official title: High Frequency Jet Ventilation for Percutaneous Interventional Radiology
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Percutaneous Tumor Ablation
Keywords: High frequency jet ventilation
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2016-06-24
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Evaluate benefits of High Frequency Jet Ventilation compare to standard ventilation during general anesthesia in patient undergoing peri diaphragmatic percutaneous tumor ablation.

The investigators hypothesis that procedure is shorter and more accurate in High Frequency Jet Ventilation group reducing target movement induced by ventilation.


Eligibility criteria: Inclusion Criteria:

* use of percutaneous ablation tumor techniques (\<3cm) for inferior lung, superior kidney, superior liver or adrenal gland lesion

Exclusion Criteria:

* Severe chronic obstructive pulmonary disease
* Recent pneumothorax (one month)
* Recent thoracic surgery (one month)
* Body Mass Index \> 40

Primary outcomes:
measure: Time to hit the target
timeFrame: during the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Starsbourg
Study officials:
affiliation: Les Hôpitaux Universitaires de Strasbourg
name: Sandra PETIOT, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05410405: Osseodensification Drills Versus Piezoelectric Surgery
Official title: Changes in Implant Stability Using Different Site Preparation Techniques: Osseodensification Drills Versus Piezoelectric Surgery. A Multicenter Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Edentulous; Alveolar Process, Atrophy
Lead sponsor: International Piezosurgery Academy
Sponsor class: OTHER
Collaborators: name: University of Foggia
name: University of Trieste
First posted: 2022-06-08
Enrollment: 27
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: split mouth
Primary purpose: TREATMENT

Brief summary: implant stability is the first requirement for implant success. the aim is to assess whether different implant site preparation technique may impact the value of the primary stability.

Detailed description: Impianti stability represents one of the most fundamental issue for implant success. Different techniques of implant site preparation are available such as twist drill, osteotome, piezosurgery and lastly, osseodensification. Due to their different approach an biological rationale, piezosurgery and osseodensification might show diverse impact on implant first and secondary stability, therefore the aim of the present study was the assessment of primary and secondary stability changes of values between implant sites prepared with piezoelectric bone surgery and with specific osseodensification drills.

Patients with bilateral single maxillary edentulism will randomly receive implant site preparation with piezoelectric approach or with osseodensification drills. standardized implants will be therefore inserted and primary stability will be assessed at the time of implant insertion and during the subsequent timepoints.

Eligibility criteria: Inclusion Criteria:

* bilateral single maxillary edentulism

Exclusion Criteria:

* smoking habit
* history of periodontal disease
* uncontrolled diabetes
* pregnancy or breastfeeding
* head and neck radiotherapy or chemotherapy
* bone antiresorptive therapy
* coagulopaties

Primary outcomes:
measure: implant insertion torque
timeFrame: at implant insertion
measure: implant stability quotient
timeFrame: at implant insertion
Secondary outcomes:
measure: implant secondary stability
timeFrame: 7 days after implant insertion
measure: implant secondary stability
timeFrame: 14 days after implant insertion
measure: implant secondary stability
timeFrame: 21 days after implant insertion
measure: implant secondary stability
timeFrame: 28 days after implant insertion
measure: implant secondary stability
timeFrame: 2 months after implant insertion
measure: implant secondary stability
timeFrame: 3 months after implant insertion
Other outcomes:
Locations:
city: Cassano allo Ionio
country: Italy
facility: Hesire
state: CS
city: Parma
country: Italy
facility: Piezosurgery Academy
Study officials:
affiliation: International Piezoelectric Surgery Academy
name: Claudio Stacchi, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT05332405: SPY Angiography To Assist With Ulnar Nerve Transposition at the Elbow
Official title: SPY Angiography To Determine the Extent of Nerve Release After Nerve Decompression
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Cubital Tunnel Syndrome
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2022-04-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with vascular disease, thyroid disease or an allergy to indocyanine green (ICG) will be excluded. Patients with either median or ulnar nerve compression will be treated with nerve decompression. SPY angiography will be used to assess the vascularity of the nerve both pre and post release as the primary outcome measure.

Detailed description: The purpose of this study is to use laser imaging to determine the extent of nerve decompression (release) while patients are still in surgery. Commonly, this is determined by electrodiagnostic tests or physical examination. The researchers will use the SPY elite device along with an injection of a drug called SPY Agent green (indocyanine green) in an imaging procedure called fluorescence angiography to visualize the change in blood supply to the nerve, following the nerve decompression surgery and assess if SPY is a useful tool for evaluating the success of nerve decompression surgery. The use of fluorescence angiography with the SPY elite device and SPY agent green is Food and Drug Administration (FDA) approved.

Eligibility criteria: Inclusion Criteria:

* 18 years old or older; male and female patients
* Ulnar Nerve Compression at the Elbow
* Failed conservative treatment (i.e. hand therapy, pain medications, splinting)
* Able to provide informed consent

Exclusion Criteria:

* Pregnancy/breastfeeding
* Thyroid Disease
* Vascular Disease
* Known allergy to any study drug

Primary outcomes:
measure: Change in level of Fluorescence before and after nerve release.
timeFrame: 2 weeks, 6 weeks, 3 months, 6 months, and 12 months visits
Secondary outcomes:
measure: nerve function determined by grip strength
timeFrame: 2 weeks, 6 weeks, 3 months, 6 months, and 12 months visits
measure: Change in Monofilament sensory testing
timeFrame: 2 weeks, 6 weeks, 3 months, 6 months, and 12 months visits
measure: Change in DASH Score
timeFrame: 2 weeks, 6 weeks, 3 months, 6 months, and 12 months visits
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Jacques Hacquebord, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04555005: Mindfulness-based Crisis Intervention for COVID-19 Frontline Healthcare Workers During COVID-19
Official title: Implementation of a Mindfulness-based Crisis Intervention for Frontline Healthcare Workers During the COVID-19 Outbreak in a Public General Hospital in Madrid, Spain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mindfulness
COVID-19
Healthcare Worker
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
Collaborators: name: Hospital Universitario La Paz
First posted: 2020-09-18
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The COVID-19 outbreak is having an impact on the well-being of healthcare workers. Previous reports on pandemics show that such an impact may last beyond the time of the outbreak. Mindfulness-based interventions help healthcare professionals to reduce stress and may foster resilience and recovery, although they have never been tested in a context such as the current one. This single-arm trial explores the acceptability, safety and usefulness of an on-site, brief Mindfulness-based intervention to reduce stress for front line health workers during a crisis.


Eligibility criteria: Inclusion Criteria:

* All frontline healthcare workers present in the ward at the time of intervention

Exclusion Criteria:

* Extreme adverse events

Primary outcomes:
measure: Perceived helpfulness to reduce current stress
timeFrame: through study completion, up to three days
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: La Paz University Hospital
Study officials:
References:
citation: Rodriguez-Vega B, Palao A, Munoz-Sanjose A, Torrijos M, Aguirre P, Fernandez A, Amador B, Rocamora C, Blanco L, Marti-Esquitino J, Ortiz-Villalobos A, Alonso-Sanudo M, Cebolla S, Curto J, Villanueva R, de-la-Iglesia MJ, Carracedo D, Casado C, Vidal E, Trigo D, Iglesias N, Cabanas D, Mellado L, Garcia D, Fernandez-Encinas C, Navarro R, Mediavilla R, Vidal-Villegas MP, Bravo-Ortiz MF, Bayon C. Implementation of a Mindfulness-Based Crisis Intervention for Frontline Healthcare Workers During the COVID-19 Outbreak in a Public General Hospital in Madrid, Spain. Front Psychiatry. 2020 Oct 30;11:562578. doi: 10.3389/fpsyt.2020.562578. eCollection 2020.