louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06077799: prehospItal maNagement oF paroxysmaL supraventrICular Tachycardia
Official title: prehospItal maNagement oF paroxysmaL supraventrICular Tachycardia - Gestione Preospedaliera Della Tachicardia Parossistica Sopraventricolare
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tachycardia, Supraventricular
Keywords: supraventricular tachycardia
Lead sponsor: Azienda Usl di Bologna
Sponsor class: OTHER_GOV
Collaborators: name: Azienda Regionale Emergenza Urgenza - AREU Lombardia
name: Azienda Ospedaliero Universitaria Maggiore della Carita
First posted: 2023-10-11
Enrollment: 1234
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients affected by any form of supraventricular tachycardia

Brief summary: Retrospective multicentre study on management of supraventricular tachycardia in prehospital setting.

Detailed description: Supraventricular tachycardia in prehospital setting may be managed with adenosine administration or with synchronised electrical cardioversion and there's no clear advantage between the two, even if international guidelines suggests to practice drug-first method.This study aims to evaluate any difference in outcomes and efficacy of the two methods and possible adverse effects of both.

Eligibility criteria: Inclusion Criteria:

* patients accepting to participate
* patients affected by supraventricular tachycardia that are managed prehospitally by the emergency medical service

Exclusion Criteria:

* not willing to participate, not able to give consent

Primary outcomes:
measure: Efficacy of adenosine versus electric cardioversion in obtaining successful cardioversion of PSVT
timeFrame: Prehospital EMS assistance time
Secondary outcomes:
measure: diagnostic accuracy for supraventricular tachycardia of the emergency medical service personnel
timeFrame: Prehospital EMS assistance time
measure: adverse events
timeFrame: Prehospital EMS assistance time
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Azienda Unità Sanitaria Locale
city: Milan
country: Italy
facility: Agenzia Regionale Emergenza Urgenza (AREU), Dipartimento di Emergenza e Accettazione, ASST Grande Ospedale Metropolitano Niguarda
city: Novara
country: Italy
facility: Azienda Ospedaliera Universitaria Maggiore della Carità, Novara, Italy
Study officials:
References:
Clinical trial NCT01922999: Different Doses of Oral Melatonin Supplements in Chronic Kidney Disease (CKD)-Associated Sleep Disorders
Official title: A Randomized, Prospective, Double Blind, Placebo-Controlled Trial of Two Different Doses of Oral Melatonin Supplements in Chronic Kidney Disease (CKD)-Associated Sleep Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: End Stage Renal Disease
Chronic Kidney Disease
Sleep Disorder
Lead sponsor: Southeast Renal Research Institute
Sponsor class: OTHER
First posted: 2013-08-14
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will evaluate the safety and efficacy of melatonin supplementation in CKD and ESRD patients with sleep disorders to reduce sleep latency times, the number of apnea/hypopneic episodes, and prolong duration in rapid eye movement (REM) sleep in CKD and ESRD patients with sleep disordered breathing.

Detailed description: The study will look at the safety and efficacy of melatonin supplementation given to patients with chronic kidney disease and end stage renal disease who have sleep disorders to reduce sleep latency times, the number of apnea/hypopneic episodes, and prolong duration in rapid eye movement (REM) sleep in CKD and ESRD patients with sleep disordered breathing.

Eligibility criteria: Inclusion Criteria:

1. Patient age \> 18 and \<85 years of age
2. Patients with CKD or ESRD with eGFR \< 30 mls/min
3. If receiving hemodialysis, patients must be on treatment \> 3 months
4. Normal healthy controls must be without a known history of CKD and be willing to have formal PSG test and plasma melatonin measurements

Exclusion Criteria:

1. Patients receiving outpatient hemodialysis for \< 3 months
2. Patients with estimated GFR by Cockcroft Gault \> 30 mls/min
3. Patients receiving beta blocker therapy within one month of randomization
4. Patients receiving Nifedipine therapy within one month randomization
5. Patients on peritoneal dialysis
6. Patient with chronic home oxygen supplementation
7. Patients receiving chronic home CPAP therapy
8. Patients actively receiving outpatient sleep medications
9. Patients with diabetic gastroparesis unresponsive to medication
10. Patients with known pregnancy or unwilling to use contraception during the course of the study
11. Patients with a functioning renal allograft
12. Patient currently receiving long-term immunosuppressive therapy. Patients receiving low dose prednisone (10mg or less per day) will not be excluded from this trial
13. Unable to give informed consent

Primary outcomes:
measure: Primary Objective
timeFrame: Compare sleep duration at the end of 60 days
Secondary outcomes:
Other outcomes:
Locations:
city: Chattanooga
country: United States
facility: Southeast Renal Research Institute
state: Tennessee
Study officials:
affiliation: Southeast Renal Research Institute
name: James A Tumlin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03770299: An Investigational Immuno-therapy Study of Nivolumab Given After Surgery in Non-Small Cell Lung Cancer (NSCLC) Participants With Minimal Residual Disease
Official title: A Phase 2 Multi-Center Randomized Trial to Assess Early Intervention With Adjuvant Nivolumab in Non-Small Cell Lung Cancer Participants With ctDNA-detected Minimal Residual Disease After Surgical Resection
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Non-Small-Cell Lung Carcinoma
Circulating Tumor DNA
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2018-12-10
Enrollment: 0
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: The purpose of this study is to determine if nivolumab added to the standard of care therapy (SOC) given after surgery is more effective than SOC alone in prolonging disease free survival in NSCLC participants with minimal residual disease detected after surgery.


Eligibility criteria: Inclusion Criteria prior to Surgery:

* Suspected or histologically confirmed Stage IIA to IIIB NSCLC with disease that is considered resectable
* Must be deemed eligible for complete resection and must agree to undergo standard of care surgery for complete resection of NSCLC
* Treatment naive (no previous systemic treatment)

Inclusion Criteria prior to Treatment Randomization:

* Must have undergone complete surgical resection of their Stage IIA to IIIB NSCLC
* Must have adequately recovered from surgery at the time of randomization
* Minimal residual disease (MRD) positive results as detected by ctDNA

Exclusion Criteria prior to Surgery:

* Participants with known EGFR mutations which are sensitive to available targeted inhibitor therapy (Prior to treatment randomization in select sites)
* Active, known or suspected autoimmune disease
* Participants with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization

Exclusion Criteria prior to Treatment Randomization:

* Must continue to meet Exclusion Criteria prior to Surgery
* Must have no evidence of metastatic disease after surgery
* Received a live/attenuated vaccine within 30 days of first treatment

Other protocol defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Disease-free survival (DFS)
timeFrame: Approximately 24 months
Secondary outcomes:
measure: Circulating tumor DNA (ctDNA) response rate
timeFrame: Approximately 36 months
measure: ctDNA duration of response (DOR)
timeFrame: Approximately 36 months
measure: ctDNA time to response (TTR)
timeFrame: Approximately 36 months
measure: Incidence of adverse events (AEs)
timeFrame: Approximately 36 months
measure: Incidence of serious adverse events (SAEs)
timeFrame: Approximately 36 months
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT01994499: Randomized Study Comparing Pleural Drainage by Videothoracoscopy to Medical Drainage in Infectious Pleural Effusion
Official title: Randomized Study Comparing Pleural Drainage by Videothoracoscopy to Medical Drainage in Infectious Pleural Effusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infectious Pleural Effusion
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 45
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: Infectious pleural effusion is a classic complication of pneumonia and often require pleural drainage.

There is no consensus between surgical drainage and medical drainage indication in first intention to treat an empyema.

Usually surgery is proposed in second intention after failure of medical drainage.

Videothoracoscopy is well accepted in diagnosis and treatment of pleural pathologies. The morbidity of this approach is very low with good results and become the gold standard in different pleural diseases. The medical drainage can be also very efficient but its results depends of the evolution of the pleural effusion. The rate of failure is estimated around 25%.

Then, the aim of our study is to compare surgical drainage and medical drainage in first intention. The first end-point will be the hospital stay (day). Hospital discharge will be strict, following different objective criteria of healing allowing comparison between these two approaches of drainage.

To answer this question we will randomized 50 patients in 2 years with a multicenter recruitment.


Eligibility criteria: Inclusion Criteria:

* Infectious pleural effusion diagnosed by pleural punction with biologic features of infection: C Reactive Protein level \>5 mg/L, White cells counts \> 10000 G/L, Temperature \>38°c, effusion with a ph\<7,2 or presence of polynuclear, and radiologic features of effusion requiring drainage (\>1/5 thoracic volume)

Exclusion Criteria:

* prior thoracic surgery, past history of pleural effusion
* compressive effusion which should be treated in emergency
* Pregnancy
* No acceptance of the protocol by the informed patient

Primary outcomes:
measure: Hospital Stay in days
timeFrame: patients will be followed for the duration of the hopital stay, an expected average of 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: University Hospital
city: Caen
country: France
facility: University Hospital
city: Rouen
country: France
facility: UH Rouen
Study officials:
affiliation: University Hospital, Rouen
name: jean-marc baste, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04376099: Focus on Analysis of Recovery in Oximetry
Official title: Focus Sur l'Analyse de la récupération en oxymétries transcutanées (French Language)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intermittent Claudication
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2020-05-06
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients referred for exercise oximetry for intermittent claudication

Brief summary: Analysis of localizations for symptoms and ischemia on treadmill and of the recovery profiles of patients that have had an exercise oximetry

Detailed description: Patients referred for exercise oximetry have buttocks thighs and calves recording during exercise and in the recovery period for a minimum of 10 minutes.

For each limb probe the decrease from rest of oxygen pressure (DROP) index is calculated as a subtraction of chest changes from limb changes throughout rest, exercise and recovery. DROP was measured as a routine on buttocks, thighs and calves and a minimal DROP lower than minus 15 mmHg considered indicative of the presence of regional blood flow impairment (ischemia) in the considered area.

Recordings and patients characteristics are recorded on a institutionally validated database.

A comparison will be performed of symptoms by history to symptoms reported on treadmill and hemodynamic results attained through DROP values.

Re-analysis of the recordings after ethical approval will be performed in an aim at estimating the duration of 50% and 90% recovery of DROP at the different levels (buttocks tigh and calves) to account for hemodynamic impairmenty not only at the calf (calves) level.

Eligibility criteria: Inclusion Criteria:

* Available exercise oximetry recording

Exclusion Criteria:

* Deny of the use of the medical file from the patient

Primary outcomes:
measure: Transcutanesous oximetry DROP index 50% recovery time
timeFrame: Maximum 30 minutes (duration of the recovery phase)
Secondary outcomes:
measure: Transcutanesous oximetry DROP index 90% recovery time
timeFrame: Maximum 30 minutes (duration of the recovery phase)
measure: Concordance of pain and ischemia during the treadmill test
timeFrame: Maximum 60 minutes (duration of each test)
Other outcomes:
Locations:
city: Angers
country: France
facility: University Hospital
Study officials:
affiliation: UH in Angers (FRANCE)
name: Pierre ABRAHAM, MD; PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04105699: Evaluation of Immunoassay Measurements of Pancreatic Stone Protein Performed on abioSCOPE® Device With the PSP Assay on ICU Patients at Risk of Sepsis as an Aid in Identifying Sepsis
Official title: A Multicenter, Prospective, Biomarker-result-blinded Observational Study Evaluating Immunoassay Measurements of Pancreatic Stone Protein Performed on Abionic's abioSCOPE® Device With the PSP Assay on ICU Patients at Risk of Sepsis as an Aid in Identifying Sepsis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Keywords: Sepsis
Pancreatic Stone Protein
Point-of-care device
Immunoassay
Intensive care unit
Abionic
Lead sponsor: Abionic SA
Sponsor class: INDUSTRY
Collaborators: name: Avania
First posted: 2019-09-26
Enrollment: 544
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: ICU admitted patients at risk of developing sepsis.

Brief summary: This is a multicenter, prospective, biomarker-result-blinded observational study evaluating immunoassay measurements of pancreatic stone protein (PSP) performed on Abionic's abioSCOPE device with the PSP assay on ICU patients at risk of sepsis as an aid in identifying sepsis.


Eligibility criteria: Inclusion Criteria:

* 1. Provision and understanding of signed and dated written informed consent by patient or legally designated representative prior to any mandatory study-specific procedures, sample collection, or analysis.
* 2. Male or female, aged ≥ 18 years.
* 3. Admitted to ICU on the day of screening, with expectation that patient will require ICU management for a minimum of 24 hours.

Exclusion Criteria:

* 1. Expected to die within 24 hours no matter what therapy is given, from the time of screening.
* 2. Suffering on ICU admission or study entry from or known acute or chronic pancreatitis or pancreatic cancer).
* 3. Admitted to ICU due to elective cardiac surgery with an uncomplicated stay anticipated.
* 4. Patients having a valid Do Not Resuscitate order.
* 5. Previous ICU admission during this hospital stay
* 6. Confirmed COVID-19 as reason for ICU admission

Primary outcomes:
measure: Ability of the abioSCOPE PSP assay performed on day 1 of a participant's ICU admission to correctly identify those with sepsis.
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Toledo
country: United States
facility: Mercy Health St. Vincent
state: Ohio
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
References:
Clinical trial NCT05633199: Cytoreductive Surgery in Platinum-resistant Recurrent Ovarian Cancer
Official title: Cytoreductive Surgery in Platinum-resistant Recurrent Ovarian Cancer：a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cytoreductive Surgery
Lead sponsor: Women's Hospital School Of Medicine Zhejiang University
Sponsor class: OTHER
First posted: 2022-12-01
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This novel study was specifically designed for platinum-resistant recurrent ovarian cancers with PFI\<6 months and aimed to compare prognosis of patients who received cytoreductive surgery followed by chemotherapy versus chemotherapy alone.


Eligibility criteria: Inclusion Criteria:

1. Patients with diagnosis of epithelial ovarian carcinoma, peritoneal carcinoma, or fallopian tube carcinoma within 3 lines recurrence;
2. Recurrence occurred within 6 months since platinum-based chemotherapy;
3. R0 ideal debulking in initial surgery; PET-CT indicate the recurrence lesion is almost in abdominal cavity, which is isolated and not exceed 5 sites, and the ascites is less than 500ml;
4. ECOG/WHO Performance score of 0 to 1;
5. Hematology function: Leukocyte≥ 3,5x10⁹/L, neutrophil≥ 1,5x10⁹/L, platelets ≥ 100x10⁹/L;
6. No Renal insufficiency: serum creatinine \< 1,5 time the normal limit, creatinine clearance \> 60 mL/min;
7. No hepatic failure: bilirubin ≤ 1,5 time the Normal limit;
8. Patients with good compliance;
9. Patients having read, signed and dated Informed consent before any study procedure.

Exclusion Criteria:

1. Platinum-refractory/uncontrolled epithelial ovarian cancer;
2. Mucous carcinoma or low-grade serous carcinoma;
3. Suffering from other malignant tumors that have not achieved complete remission in the past 2 years;
4. Patients have received abdominal or pelvic radiotherapy;
5. General conditions cannot tolerate cytoreduction;
6. Severe hypersensitivity reactions (≥ grade 3) to paclitaxel or platinum and/or any of its excipients;
7. Unable or unwilling to sign the informed consent form;
8. Patients judged by the investigator to be unlikely to follow the research steps, restrictions and requirements.

Primary outcomes:
measure: PFS
timeFrame: month 6
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Women's Hospital, Zhejiang University School of Medicine
city: Hangzhou
country: China
facility: Women's Hospital, Zhejiang University School of Medicine
Study officials:
References:
Clinical trial NCT06573099: A Real-World Study on Extranodal Lymphoma
Official title: A Real-World Study on Extranodal Lymphoma
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Lymphoma
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Extranodal Lymphoma
Diffuse Large B Cell Lymphoma
Keywords: LYMPHOMA
EXTRANODAL
DLBCL
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2024-08-27
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with histologically confirmed diagnosis of non-Hodgkin lymphoma with extranodal involvement.

Brief summary: The aim of this study is to prospectively collect clinical information on patients with extranodal lymphoma, and to explore the best therapeutic strategies in the real-world population.

Detailed description: Lymphoma is a common hematological malignancy. Many different pathologic types of lymphoma can originate in extranodal organs or be associated with extranodal organ involvement. For lymphoma with extranodal involvement, conventional regimens often cannot provide satisfactory results for patients. This study aims to prospectively collect clinical information on patients with extranodal DLBCL, including the distribution of involved sites, clinical and molecular characteristics of different lymphoma subtypes, clinical treatment protocols, and prognosis, to explore the the best therapeutic strategies in the real-world population.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years (including 18 years old).
2. Patients newly diagnosed with non-Hodgkin lymphoma with extranodal involvement, whether it is primary, secondary, or cannot be determined.
3. Patients who have received systematic clinical treatment.
4. Patients with measurable lesions, at least containing one effective evaluation of efficacy.

Exclusion Criteria:

1. Patients who only receive supportive treatment.
2. Patients who cannot obtain effective evaluation data of efficacy.

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Baseline up to data cut-off (up to approximately 1 year)
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Baseline up to data cut-off (up to approximately 1 year)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05093699: Dual-plane Ultrasound Imaging During Vascular Access Procedures
Official title: Dual-plane Ultrasound Imaging During Vascular Access Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vascular Access Complication
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-10-26
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Researchers are evaluating the clinical efficiency of utilization of a dual-plane simultaneous view ultrasound probe (Butterfly iQ+; Butterfly Network, Inc.) during arterial catheter placement in the operating room


Eligibility criteria: Inclusion criteria

* Patient: Elective surgical patients requiring non-emergent ultrasound-guided radial arterial catheter placement
* Providers: Anesthesia providers to include trainees, certified registered nurse anesthetists (CRNA) and attending anesthesia providers.

Exclusion Criteria

* Patient
* Pregnant
* Patients in a moribund state or palliative care only
* Vulnerable patients (i.e. Severe mental handicap, non-decisional)
* History of peripheral arterial disease
* Placement of arterial catheter without ultrasound guidance
* Provider: Medical students or CRNA students.

Primary outcomes:
measure: Time to Successful First Stick in Minutes
timeFrame: Baseline
Secondary outcomes:
measure: Number of Attempts for Successful Cannulation
timeFrame: Arterial line placement episode for surgery
measure: Amount of Time Required for Successful Arterial Catheter Cannulation
timeFrame: Baseline
measure: Number of Failed Attempts for Cannulation
timeFrame: Baseline
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Robert Anderson, APRN, CNP, DNP
role: PRINCIPAL_INVESTIGATOR
References: