louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04389645: Interferon Gamma Induced Protein 10 (IP-10) in a Clinical Decision Support Protocol in COVID-19 Patients
Official title: Interferon Gamma Induced Protein 10 (IP-10) in a Clinical Decision Support Protocol in COVID-19 Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Lead sponsor: MeMed Diagnostics Ltd.
Sponsor class: INDUSTRY
First posted: 2020-05-15
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: PCR-positive COVID-19 all comers

Brief summary: The proposed project will pilot incorporation of rapid serial measurements of IP-10 into a CDS tool for moderate and severe COVID-19 patients.

The tool was applied to all comers with confirmed COVID-19 diagnosis at a secondary medical center in Israel.


Eligibility criteria: Inclusion Criteria:

* PCR- positive for COVID-19

Exclusion Criteria:

* \<18 years of age

Primary outcomes:
measure: IP-10 levels
timeFrame: up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Rabin Medical Center
Study officials:
affiliation: Rabin Medical Center
name: Shaul Lev, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lev S, Gottesman T, Sahaf Levin G, Lederfein D, Berkov E, Diker D, Zaidman A, Nutman A, Ilan Ber T, Angel A, Kellerman L, Barash E, Navon R, Boico O, Israeli Y, Rosenberg M, Gelman A, Kalfon R, Simon E, Avni N, Hainrichson M, Zarchin O, Gottlieb TM, Oved K, Eden E, Tadmor B. Observational cohort study of IP-10's potential as a biomarker to aid in inflammation regulation within a clinical decision support protocol for patients with severe COVID-19. PLoS One. 2021 Jan 12;16(1):e0245296. doi: 10.1371/journal.pone.0245296. eCollection 2021.
Clinical trial NCT05074745: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Buccal Screening Evaluation Using an RT-PCR Assay and a Rapid ELISA Test Among Symptomatic and Asymptomatic Patients
Official title: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Buccal Screening Evaluation Using an RT-PCR Assay and a Rapid ELISA Test Among Symptomatic and Asymptomatic Patients: the CORDAGES Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: SARS-CoV-2
COVID-19
Keywords: SARS-CoV-2
POCT
RT-PCR
Contact case
ELISA
Buccal
Lead sponsor: Centre Scientifique de Monaco
Sponsor class: OTHER
Collaborators: name: Department of Health Affairs, Monaco
First posted: 2021-10-12
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Monocentric, Prospective, 3 components Nasopharyngeal swab by PCR Buccal swab by PCR Buccal by ELISA POCT
Primary purpose: DIAGNOSTIC

Brief summary: The main objective is to expand screening for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by evaluating the diagnostic accuracy of the RT-PCR test (Cobas® Roche, Switzerland) and the ELISA Point of Contact Testing (PORTABLE COVID-19 ANTIGEN LAB® Stark, Italy) on buccal swab compared to the reference test, the RT-PCR test (Cobas® Roche, Switzerland) on nasopharyngeal swab.

Secondary objectives

* To evaluate the diagnostic accuracy of oral swab RT-PCR and POCT relative to the quantitative amplification (Ct) values of the NP Swab RT-PCR assay.
* Analyze RT-PCR amplification cycle thresholds (Ct) and POCT diagnostic accuracy as a function of the presence and timing of symptoms.
* Among symptomatic participants, compare clinical presentations between positive and negative participants on the NP swab RT-PCR test.
* The RT-PCR test may be imperfectly sensitive, ranging from 71 to 98%3. Using a Bayesian latent class model, the investigators will assess the true accuracy of POCT as it does not require the assumption that any one test or combination of tests is perfect14,15.


Eligibility criteria: Inclusion Criteria:

* 18+ patient eligible for COVID-19 testing in Monaco
* symptoms suggestive of COVID-19
* contact with a confirmed case of COVID-19

Exclusion Criteria:

* refusal to participate in the study
* preventive screening of professional groups
* inability to return to the screening center within 48-72 hours of the first visit.

Primary outcomes:
measure: Proportion of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) positive patients for the two different sampling types (buccal vs nasopharyngeal) and two methods (ELISA POCT vs RT-PCR)
timeFrame: 48 Hours
Secondary outcomes:
measure: Comparison of Ct values in buccal and nasopharyngeal swabs
timeFrame: 48 Hours
Other outcomes:
Locations:
city: Monaco
country: Monaco
facility: Centre National de Depistage - Espace Leo Ferre
Study officials:
References:
Clinical trial NCT01205945: The Effect of Abdominal Aortic Aneurysm Screening on Mortality in Asian Population
Official title: The Effect of Abdominal Aortic Aneurysm Screening on Mortality in Asian: A Randomized, Controlled Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Aneurysm, Abdominal
Keywords: Aortic aneurysm, abdominal
Screening
Mortality
Lead sponsor: Kyunghee University Medical Center
Sponsor class: OTHER
First posted: 2010-09-21
Enrollment: 12000
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Popultaion who reside in Korea as an Asian

Brief summary: Abdominal aortic aneurysm(AAA) occurs when the infrarenal aorta expands to a maximal diameter of 3.0cm or greater. Although AAA may asymptomatic for many years, almost one third eventually rupture if left untreated.

Several randomized trials showed that ultrasonographic screening for AAA could reduce the frequency of acute operations and AAA-related mortality.

However, all of randomized trials were performed in Western countries. There was no randomized trials for AAA screening in Asian countries.

This randomized, controlled trial is to analyze the benefits of screening old population for AAA in Korea.

Detailed description: Old population, aged from 60 to 85 years, are randomized into two groups; one group is invited for ultrasonographic screening for AAA, and the other acts as age- and sex-matched controls.

For screening group, The anterioposterior and transverse diameter of the infrarenal aorta is measured at their maximal sizes. The subsequent surveillance of screened patients is done as follows

* Aortic diameter less than 3.0cm, no further testing
* AAA 3 to 4cm, ultrasonographic follow-up every year
* AAA 4 to 5cm, ultrasonographic follow-up every 6 months
* AAA greater than 5cm, referral to a vascular surgeon

For control group, the information for any causes of death is collected every year.

Eligibility criteria: Inclusion Criteria:

* all men aged 60 to 85 years
* women aged 60 to 85 years with cardiovascular risk factors such as hypertension, hyperlipidemia, peripheral arterial occlusive disease, coronary artery disease, cerebrovascular attack.
* men and women older than 50 years with a family history of AAA

Exclusion Criteria:

* people who was diagnosed with AAA
* people who underwent aneurysm repair such as open aneurysm repair or endovascular aneurysm repair
* People who underwent abdominal aortic surgery such as aortobifemoral bypass
* People whose life expectancy is less than 2 years
* People who appear unfit for repair of AAA
* people who do not agree with this study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Vascular Surgery, Kyung Hee University East-West Neo Medical Center
Study officials:
affiliation: East West Neo Medical Center
name: Jin Hyun Joh, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06955845: Efficacy of Eye Movement Desensitization and Reprocessing (EMDR) Therapy Versus Selective Serotonin Reuptake Inhibitors (SSRIs) in the Treatment of Post-Traumatic Stress Disorder
Official title: Efficacy of Eye Movement Desensitization and Reprocessing (EMDR) Therapy Versus Selective Serotonin Reuptake Inhibitors (SSRIs) in the Treatment of Post-Traumatic Stress Disorder: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: PTSD
PTSD - Post Traumatic Stress Disorder
Keywords: PTSD
EMDR
SSRIs
Trauma
Mental Health
Randomized controlled trial
Post-traumatic stress disorder
Eye Movement Desensitization and Reprocessing
Lead sponsor: Combined Military Hospital Nowshera
Sponsor class: OTHER_GOV
First posted: 2025-05-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial aims to compare the efficacy of Eye Movement Desensitization and Reprocessing (EMDR) therapy versus Selective Serotonin Reuptake Inhibitors (SSRIs) in the treatment of Post-Traumatic Stress Disorder (PTSD). Adult patients diagnosed with PTSD will be randomly assigned to receive either EMDR therapy or SSRIs for a period of six weeks. The primary outcome is the rate of remission as measured by validated PTSD symptom severity scales at Week 6. Secondary outcomes include changes in functional impairment and patient-reported quality of life. The study seeks to determine whether EMDR therapy is a non-pharmacological alternative to SSRIs for achieving symptom remission in PTSD.


Eligibility criteria: Inclusion Criteria:

Age 18-60 years

Clinical diagnosis of Post-Traumatic Stress Disorder (PTSD)

Duration of illness ≥ 6 months

Able to provide informed consent

Exclusion Criteria:

Current substance abuse or dependence

History of psychotic disorder or bipolar disorder

Active suicidal ideation

Concurrent psychotherapy or psychiatric medication (except study-assigned SSRI)

Primary outcomes:
measure: Remission rate at Week 6
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in functional impairment score
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Nowshera
country: Pakistan
facility: Combined Military Hospital
state: KPK
city: Nowshera
country: Pakistan
facility: Department of Psychiatry, Combined Military Hospital Nowshera
state: Kpk
Study officials:
affiliation: CMH Nowshera
name: Asad Ullah Jan, MBBS,FCPS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04130945: Cost Effect of Erector Spina Plane Block
Official title: Effect of Erector Spina Plane Block on Cost of Laparoscopic Cholesistectomy Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cost Effectiveness
Lead sponsor: Kırıkkale University
Sponsor class: OTHER
First posted: 2019-10-18
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Use of erector spina plane (ESP) block for postoperative analgesia is continuously increasing. However, few studies have investigated intraoperative effects of ESP block. The investigators aim to study the effects of ESP block in terms of cost-effectiveness, consumption of inhalation agents and opioids in perioperative and postoperative period.

Detailed description: Erector spina plane (ESP) block has analgesic efficiency and its popularity is growing steadily. ESP block forms a sensorial block by local anesthetic infiltration between the musculus erector spina and facia. ESP block given to participants undergoing laparoscopic cholecystectomy for postoperative opioid analgesia resulted in a decrease of postoperative pain scores in the first 24 h. Due to increases in health expenditure, cost control is becoming more and more important. Cost-effective studies are important in healthcare economics. Inhaled anesthetics used in anesthesia departments account for about 20% of total anesthetic agents. Local anesthetic agents decrease the minimum alveolar concentration (MAC) value of inhaled agents. And also in perioperative and post operative period, the anesthetic management often need to be supported with opioid drugs. The investigators think that ESP block has analgesic effects and decreases the consumption of inhalation agents. The investigators aim to investigate the cost-effectiveness of ESP block in anesthetic applications in laparoscopic procedures.

Eligibility criteria: Inclusion Criteria:

1. American Society of Anesthesiologist (ASA) physical status I-II,
2. ages 18-75 years,
3. undergoing laparoscopic cholecystectomy

Exclusion Criteria:

1. Patients with cardiac, endocrinological, neurological diseases,
2. patients with coagulation disorders
3. allergy to local anesthetics
4. Operations that started as laparoscopy but transitioned to open surgery for a surgical reason

Primary outcomes:
measure: the formula of consumption of inhaled agent
timeFrame: 30 minute after the operation
Secondary outcomes:
Other outcomes:
Locations:
city: Kırıkkale
country: Turkey
facility: Kırıkkale Univercity Faculty of Medicine Hospital
Study officials:
affiliation: Kırıkkale University Faculty of Medicine
name: Kevser Peker
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05749445: Appropriate Evaluation of Antiviral Therapy With Nirmatrelvir-ritonavir in Hospitalized Patients
Official title: Appropriate Evaluation of Antiviral Therapy With Nirmatrelvir-ritonavir in Hospitalized Patients: a Multicenter Retrospective Study in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hospitalized Patients
Lead sponsor: First People's Hospital of Hangzhou
Sponsor class: OTHER
Collaborators: name: Hangzhou Cancer Hospital
name: First People's Hospital of Lin'an District
name: First People's Hospital of Yuhang District
First posted: 2023-03-01
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: hospitalized patients receiving at least one dose nirmatrelvir-ritonavir

Brief summary: The primary objective of the study was to assess the appropriateness of antiviral therapy with nirmatrelvir-ritonavir in hospitalized patients.


Eligibility criteria: Inclusion Criteria:

* hospitalized patients receiving at least one dose nirmatrelvir-ritonavir

Exclusion Criteria:

* None

Primary outcomes:
measure: The prevalence of inappropriate use of nirmatrelvir-ritonavir
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Changcheng Shi
state: Zhejiang
Study officials:
affiliation: First People's Hospital of Hangzhou
name: Changcheng Shi
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lamb YN. Nirmatrelvir Plus Ritonavir: First Approval. Drugs. 2022 Apr;82(5):585-591. doi: 10.1007/s40265-022-01692-5.
citation: Akinosoglou K, Schinas G, Gogos C. Oral Antiviral Treatment for COVID-19: A Comprehensive Review on Nirmatrelvir/Ritonavir. Viruses. 2022 Nov 17;14(11):2540. doi: 10.3390/v14112540.
Clinical trial NCT04212845: Erector Spinae Plane Block vs Transforaminal Epidural Injection
Official title: Erector Spinae Plane Block Versus Transforaminal Epidural Injection in Chronic Discogenic Low Back Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Discogenic Low Back Pain
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2019-12-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Lumbar disc herniation is the main cause of low back pain and radicular leg pain. Steroids administered to the epidural area reduce the inflammatory response and pain by inhibiting the synthesis of proinflammatory agents. Epidural steroid injections are used in the treatment of lumbosacral radicular pain with various techniques including fluoroscopy-guided transforaminal and interlaminar injection.

Ultrasound-guided erector spina plan block (ESPB) was first described in 2016 and has been used for postoperative analgesia in many surgeries including thoracic and lumbar dermatomes. The distribution of local anesthesia in the ESPB from the paravertebral area to the transforaminal and epidural space has been shown in studies.

The aim of this study was to compare the efficacy of ultrasound-guided ESPB and fluoroscopic guided transforaminal epidural steroid injection in chronic discogenic low back pain.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologist's physiologic state I-III patients
* Patients with unilateral radicular pain and low back pain persisting despite medical treatment.

Exclusion Criteria:

* Spinal cord disease or spinal mechanical instability,
* Previous low back surgery,
* More than two levels of lumbar disc hernia,
* Allergic to local anesthetic drugs to be used,
* Use of oral anticoagulants,
* Uncontrolled diabetes mellitus type I and II

Primary outcomes:
measure: Visual analog pain score
timeFrame: Post injection sixth month
Secondary outcomes:
measure: Oswestry Disability Index
timeFrame: Post injection first, third and sixth month
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University
Study officials:
References:
citation: Celik M, Tulgar S, Ahiskalioglu A, Alper F. Is high volume lumbar erector spinae plane block an alternative to transforaminal epidural injection? Evaluation with MRI. Reg Anesth Pain Med. 2019 Apr 16:rapm-2019-100514. doi: 10.1136/rapm-2019-100514. Online ahead of print. No abstract available.
citation: Makkar JK, Gourav KKP, Jain K, Singh PM, Dhatt SS, Sachdeva N, Bhadada S. Transforaminal Versus Lateral Parasagittal Versus Midline Interlaminar Lumbar Epidural Steroid Injection for Management of Unilateral Radicular Lumbar Pain: A Randomized Double-Blind Trial. Pain Physician. 2019 Nov;22(6):561-573.
Clinical trial NCT02594345: Effect of Exosomes Derived From Red Blood Cell Units on Platelet Function and Blood Coagulation
Official title: In Vitro Study of the Effect of Exosomes Derived From Red Blood Cell Units on Platelet Function and Blood Coagulation in Healthy Volunteers' Blood
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Coagulation
Platelet Function
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2015-11-03
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study is designed to analyze the effect exosomes derived from red blood cell units have on blood coagulation and platelet function. It is an in vitro study using healthy volunteers' blood.

Detailed description: The blood of 25 healthy volunteers will be exposed to exosomes derived from red blood cell units. The effects on coagulation and platelet function will be measured using thromboelastometry (ROTEM®) and FACS analysis.

Eligibility criteria: Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* pregnancy
* drug use

Primary outcomes:
measure: clotting time
timeFrame: 2 months
Secondary outcomes:
measure: clot formation
timeFrame: 1h after exposure
measure: clot stability
timeFrame: 1h after exposure
measure: clot lysis
timeFrame: 1h after exposure
measure: CD62P
timeFrame: 3h after exposure
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: University Hospital Frankfurt
state: Hessen
Study officials:
affiliation: Goethe University
name: Dania P Fischer, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05043545: Long Pressure Autoregulation Index
Official title: Evaluation and Application of Experimental Indices for the Study of Potential Prognostic Factors in Patients With Acute Neurological Injury, Using Low-frequency Sampled Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Brain Injury
Lead sponsor: Papa Giovanni XXIII Hospital
Sponsor class: OTHER
First posted: 2021-09-14
Enrollment: 263
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute neurological injury admitted to ICU of the ASST Papa Giovanni XXIII requiring ICP monitoring during the study period (January 2013 - June 2022). For Traumatic Brain Injury (TBI) it is estimated that medical records from approximately 210 TBI subjects requiring ICP monitoring will be reviewed. The final number of subjects to be included will be determined based on available medical records obtained within the timeframe of the estimated duration of the study.

Brief summary: The pressure reactivity index (PRx) has emerged as a surrogate method for the continuous bedside estimation of global cerebral autoregulation and a significant predictor of unfavorable outcomes. However, calculations require continuous, high-resolution monitoring and are currently limited to specialized ICUs with dedicated software. To overcome this problem, new indices calculated using one-minute average data, instead of 10-second average data as performed by the PRx, have been proposed.

The study aims to test new physiological indices appropriately modified to adapt to the scarcity of output data generated by standard hospital systems (frequency \~0.0033 Hz, approximately a 5-minute period) and to evaluate their association with outcome measures.

Detailed description: Data preparation and index calculations were performed using an in-house algorithm.

Data extracted and processed with the algorithm:

Ultra-low pressure reactivity index (UL-PRx), Intracranial pressure (ICP), Cerebral perfusion pressure (CPP), Arterial blood pressure (ABP), heart rate (HR), respiratory rate (RR), temperature, end-tidal CO2 (EtCO2), saturation (SpO2).

Eligibility criteria: Inclusion Criteria:

* Patients with a clinical diagnosis of acute neurological injury requiring intracranial pressure (ICP) monitoring.
* Availability of continuous intensive care monitoring of physiological data.

Exclusion Criteria:

Patients with less than 8 hours of physiological data monitoring.

Primary outcomes:
measure: mortality
timeFrame: 12-months
measure: Glasgow Outcome Scale - Extended (GOSE)
timeFrame: 12-months
Secondary outcomes:
Other outcomes:
Locations:
city: Bergamo
country: Italy
facility: Paolo Gritti
Study officials:
References: