louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03185260: Registry of Laypeople's CPR Performance
Official title: International Registry of Laypeople's CPR Performance After Training With Feedback Devices
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Quality of Cardio-pulmonary Resuscitation
Keywords: Cardio-Pulmonary Resuscitation
Cardiac Arrest
Training
Lead sponsor: Pavia nel Cuore
Sponsor class: OTHER
Collaborators: name: Robbio nel Cuore
First posted: 2017-06-14
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All the layperson between 18 and 90 years who participate to a BLS/AED course carried out with the use of feedback devices for at least one minute in one of the centers which joined the registry

Brief summary: The aim of the registry is to collect laypeople's performance after a BLS/AED course carried out with the use of feedback devices.

Detailed description: The registry collect all the laypeople's performance of 1-minute of chest-compression only CPR registered at the end of a CPR/AED course in which feedback devices were used for at least 1 minute.

All centers which carry out BLS/AED course for laypeople using CPR feedback devices can join to the registry.

All the centers have to declare the duration of the course, the guidelines followed, the participants' anthropometric variables and the feedback device they used for the course and for the test.

The centers must send the performances of all the participants of a course.

Eligibility criteria: Inclusion Criteria:

* Layperson
* Participating in a BLS/AED course carried out with feedback devices

Exclusion Criteria:

* Healthcare personnel

Primary outcomes:
measure: Percentage of adequate depth compression
timeFrame: 1 minute
Secondary outcomes:
measure: Mean compression depth
timeFrame: 1 minute
measure: Percentage of adequate rate compression
timeFrame: 1 minute
measure: Compression per minute
timeFrame: 1 minute
measure: Percentage of correctly released compression
timeFrame: 1 minute
measure: Percentage of correct hand position
timeFrame: 1 minute
Other outcomes:
Locations:
city: Robbio
country: Italy
facility: Robbio nel Cuore
state: Pavia
city: Palermo
country: Italy
facility: Policlinico P. Giaccone
city: Pavia
country: Italy
facility: Pavia nel Cuore
city: Cortaillod
country: Switzerland
facility: FormaMed
city: Le Mont-sur-Lausanne
country: Switzerland
facility: ES ASUR
Study officials:
References:
Clinical trial NCT06875960: A Study to Continue the Administration of Deucravacitinib in Participants With Systemic Lupus Erythematosus (SLE) or Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) Who Have Completed Study IM011074 or Study IM011132
Official title: A Continuation Protocol for Deucravacitinib in Patients With Patients With Systemic Lupus Erythematosus (SLE) or Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) Who Have Completed Study IM011074 or Study IM011132
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Systemic Lupus Erythematosus (SLE)
Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2025-03-14
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to allow the continued administration of Deucravacitinib in participants with Systemic Lupus Erythematosus (SLE) or Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) who have completed study IM011074 or Study IM011132


Eligibility criteria: Inclusion Criteria

* Participants must have completed Study IM011074 or Study IM011132 through the protocol-required treatment period.
* Participants must be, based on the physician's medical judgement, likely to receive benefit from receiving treatment with deucravacitinib.
* Participants must have received IP within 60 days of enrollment. Exceptions may be granted based upon consultation with BMS.

Exclusion Criteria

* Participants must not have any disease or medical condition that, in the opinion of the physician, would make the subject unsuitable for this protocol, would interfere with the interpretation of subject safety or considered unsuitable by the physician for any other reason.
* Participants must not have any evidence of active Tuberculosis (TB).
* Other protocol-defined Inclusion/Exclusion criteria apply.

Primary outcomes:
measure: Number of participants treated with BMS-986165
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Farmington
country: United States
facility: Local Institution - 0001
state: Connecticut
city: New York
country: United States
facility: Local Institution - 0002
state: New York
city: Jackson
country: United States
facility: Local Institution - 0003
state: Tennessee
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT05538260: Pediatric Ocular Trauma in Minia Governate
Official title: Epidemiology and Visual Outcome of Pediatric Ocular Trauma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pediatric Ocular Trauma
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2022-09-13
Enrollment: 103
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The most common cause of unilateral blindness in pediatric age groups, especially in developing countries, is ocular trauma. The epidemiology of eye injuries varies in different parts of the world and different age groups and depends on many factors including life style, socioeconomic status, traffic state, sport and creative activities and type of registration and recording of data. About half a million people in the world are blind as a result of eye injuries. About 30-40% of monocular blindness is due to ocular trauma


Eligibility criteria: Inclusion Criteria:

* Age below 16 years

Exclusion Criteria:

* Age above 16 years Previous ocular surgery

Primary outcomes:
measure: Epidemiology of trauma
timeFrame: 2 years
measure: Visual outcome
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Al Minyā
country: Egypt
facility: Minia University Hospital
state: Minia
Study officials:
References:
Clinical trial NCT03654560: Efficacy and Safety of HemoStyp as an Adjunct for Management of Secondary Hemostasis in the Operative Setting
Official title: Efficacy and Safety of HemoStyp as an Adjunct for Management of Secondary Hemostasis in the Operative Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemostasis
Bleeding
Lead sponsor: United Health Products, Inc.
Sponsor class: INDUSTRY
First posted: 2018-08-31
Enrollment: 236
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess efficacy and safety of HemoStyp as an adjunct for management of secondary hemostasis in the operative setting.

Detailed description: This study is a prospective, non-inferiority, multi-center, randomized, open-label trial to compare HemoStyp with Surgicel® in the management of bleeding during surgery.

Eligibility criteria: Inclusion Criteria:

1. Elective procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery);
2. At time of surgery has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical;
3. Ages: Pediatric subjects 2 years to 17 years of age and adult subjects 18 years of age or older; and
4. Subjects or parent or legal guardian of the subject who are willing and able to sign consent.

Exclusion Criteria:

1. Physical or psychological condition which would impair study participation;
2. Indications for emergency surgery;
3. Pre-operative laboratory findings of a hematologic disorder;
4. Subjects with history of moderate to severe allergies;
5. Subjects undergoing minimally invasive laparoscopic surgery;
6. Subjects who will require platelet or fresh frozen plasma transfusion during surgery;
7. Subjects who are pregnant or breast-feeding at the time of surgery; or
8. Subjects on P2Y12 platelet inhibitor (Plavix) less than 5 days prior to surgery, warfarin or Xa inhibitors not withheld per standard protocols for the management of anticoagulants pre-operatively.

Primary outcomes:
measure: The Time to Hemostasis Measured From Start of Study Treatment to the Achievement of Hemostasis at the Target Bleeding Site (TBS), or to the End of the 10-minute Observation Period.
timeFrame: 10 minutes
Secondary outcomes:
measure: Percentage of Subjects Achieving Hemostasis Between 2 Minutes and 10 Minutes
timeFrame: Between 2 minutes and 10 minutes
measure: Rate of Subjects Achieving Intraoperative Hemostasis at the Target Bleeding Site
timeFrame: Intraoperative period
measure: Rate of Subjects With Intraoperative Re-bleeding From the Target Bleeding Site
timeFrame: Intraoperative period post hemostasis
measure: Rate of Subjects Requiring Surgical Re-exploration up to 30 Days After Surgery for Re-bleeding From the Target Bleeding Site
timeFrame: 30 days
Other outcomes:
Locations:
city: Burbank
country: United States
facility: Raymond Schaerf
state: California
Study officials:
References:
Clinical trial NCT06874660: Effects of Surgical Timing on Perioperative Clinical Outcomes in Pancreaticoduodenectomy
Official title: Influence of Timing on Outcomes of Pancreaticoduodenectomy: Complications, Hospital Costs, and Length of Stay
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreaticoduodenal; Fistula
Surgery Timing
Perioperative Complication
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2025-03-13
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who met the surgical guidelines for pancreaticoduodenectomy and underwent pancreaticoduodenectomy during the trial period

Brief summary: With the advancement of surgical techniques and the increase in pancreatic oncologic diseases, the volume of pancreaticoduodenal surgeries has been increasing year by year in our center, and multiple pancreaticoduodenal surgeries are often performed on the day of surgery. This study will compare the effect of pancreaticoduodenal surgery performed at different times on patient prognosis. This study plans to divide the patients into morning group, afternoon group, and night group through the start time of surgery, and this study plans to analyze subgroups such as laparoscopic pancreaticoduodenal surgery. The outcome indicators include perioperative complications such as pancreatic fistula, bleeding, abdominal infection, hospitalization cost, and length of hospital stay. The conclusions drawn from this study will suggest to surgeons whether pancreaticoduodenal surgery performed at different times of the day will have different outcomes for patients and will guide surgeons on the timing of pancreaticoduodenal surgery.


Eligibility criteria: Inclusion Criteria:

1. Patients must be required to sign an informed consent form;
2. Age 18-80 years, male and female;
3. ECOG Physical Status Score (PS Score) 0 or 1.
4. Pancreaticoduodenectomy at our center without contraindications related to the surgery.

Exclusion Criteria:

1. Pre-existing or concurrent other malignant tumors
2. Severe cardiopulmonary and renal dysfunction.
3. Autoimmune disease or history of immunodeficiency
4. Active infections and infectious diseases requiring systemic therapy.
5. History of psychotropic substance abuse, alcoholism or drug addiction.
6. Failure to meet the inclusion criteria as determined by the investigator.

Primary outcomes:
measure: perioperative complication
timeFrame: perioperative
Secondary outcomes:
measure: Length of hospitalization
timeFrame: perioperative
Other outcomes:
measure: Cost of hospitalization
timeFrame: perioperative
Locations:
city: Changzhou
country: China
facility: Xinrui Zhu
state: Jiangsu
Study officials:
References:
Clinical trial NCT00130260: Evaluation of a Third and Fourth Dose of StaphVAX® in Adults With End-Stage Renal Disease
Official title: Phase 3b Multicenter, Randomized, Placebo-Controlled, Double-Blind Study Evaluating Immunogenicity and Safety of a 3rd and 4th Dose of StaphVAX®, a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine in Adults With End-Stage Renal Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Staphylococcal Infections
Chronic Kidney Failure
Keywords: Staphylococcus aureus
Vaccine
Randomized Controlled Trial
Lead sponsor: Nabi Biopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-08-15
Enrollment: 99
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: This study is a continued evaluation of the immune response to StaphVAX , a Staphylococcus aureus type 5 and 8 capsular polysaccharide conjugate vaccine, in end-stage renal disease patients, by giving a 3rd and 4th dose to a subset of the participants in the previous efficacy trial. Participants continue to receive the vaccine or placebo in a blinded manner, and are also randomly assigned to 1 of 2 different intervals between the doses. The immunogenicity is measured by the antibodies in the blood, and typical vaccine safety information is also collected.


Eligibility criteria: Inclusion Criteria:

* Participation in prior study Nabi-1371
* Written informed consent
* Negative serum pregnancy test, where appropriate
* Expect to comply with protocol procedures and schedule

Exclusion Criteria:

* Known HIV
* Immunomodulatory drugs
* Malignancy (other than basal cell or squamous cell carcinoma, carcinoma in situ of the cervix, or early stage prostate cancer)
* Active infection in the 2 weeks prior to study injection
* Serious S. aureus infection within the last 2 months prior to injection
* Hypersensitivity to components of StaphVAX

Primary outcomes:
measure: serotype-specific antibody concentrations
timeFrame: 6 weeks after each dose
Secondary outcomes:
measure: serotype-specific antibody concentrations
timeFrame: at several other time points up to 12 months after dose
measure: elicited vaccine reactogenicity
timeFrame: daily for 7 days after each dose
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: multiple sites: contact Central Study coordination
state: Alabama
Study officials:
affiliation: Nabi Biopharmaceuticals
name: Matt Hohenboken, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05007860: Vaccine Responsiveness in Patients With Chronic Lymphocytic Leukemia
Official title: Vaccine Responsiveness in Patients With Chronic Lymphocytic Leukemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2021-08-17
Enrollment: 36
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 CLL/SLL receiving PCV13 +/- COVID19 vaccination.

Brief summary: Assessment of SARS-CoV2 (mRNA and adenovirus-based vaccines) and Conjugated Pneumococcal (PCV13) in Patients with Chronic Lymphocytic Leukemia


Eligibility criteria: Inclusion/Exclusion Criteria:

* Age \>18 years.
* Diagnosis of CLL or SLL according to WHO criteria.
* For patients receiving BTK inhibitor (Cohorts 1 and 2):

  * Patient must have no history of cytotoxic chemotherapy within 1 year (no prior history of bendamustine or fludarabine is permitted) and no history of CD20 monoclonal antibody within 6 months.
  * Patient must have no known clinical or radiographic evidence of CLL progression.
* For patients not on active therapy (Cohort 3):

  * Patient must have no history of cytotoxic chemotherapy within 1 year (no prior history of bendamustine or fludarabine is permitted) and no history of CD20 monoclonal antibody within 6 months.
  * The treating investigator must have no intention to initiate CLL therapy within 2 months.
* Patients must have not received PCV13 within 2 years. For patients with PCV13 within 5 years, S. pneumonia IgG antibody concentrations must be less than the reference value for at least 50% of S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A,19F and 23F. Patients can have received prior PPV23 within any time frame.
* Patient must have no known history of HIV or primary immune deficiency disorder, nor be taking a concurrent immune suppressing medication (e.g. steroids, methotrexate, etc.).

Primary outcomes:
measure: Effective immune response (EIR) to PCV13 vaccination
timeFrame: 35 days (+/- 14 days) after vaccination
measure: Effective immune response (EIR) to COVID19 vaccination
timeFrame: 35 days (+/- 14 days) after vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
Study officials:
References:
citation: Haydu JE, Maron JS, Redd RA, Gallagher KME, Fischinger S, Barnes JA, Hochberg EP, Johnson PC, Takvorian RW, Katsis K, Portman D, Ruiters J, Sechio S, Devlin M, Regan C, Blumenthal KG, Banerji A, Judd AD, Scorsune KJ, McGree BM, Sherburne MM, Lynch JM, Weitzman JI, Lei M, Kotton CN, Dighe AS, Maus MV, Alter G, Abramson JS, Soumerai JD. Humoral and cellular immunogenicity of SARS-CoV-2 vaccines in chronic lymphocytic leukemia: a prospective cohort study. Blood Adv. 2022 Mar 22;6(6):1671-1683. doi: 10.1182/bloodadvances.2021006627.
Clinical trial NCT03105960: Garlic With Lime Juice and Chlorhexidine Mouthwash
Official title: Evaluation of Garlic With Lime Juice and Chlorhexidine Mouthwash on Gingival Bleeding in Group of Egyptian Children: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gingival Bleeding
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-04-10
Enrollment: 36
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Randomized Clinical Trial parallel
Primary purpose: TREATMENT

Brief summary: the study about herbal mouthwash. it is clinical trial .the investigator will compare between chlorhexidine mouthwash and garlic with lime juice mouthwash.and their effect on gingival bleeding and plaque and salivary bacteria.

Detailed description: the study about herbal mouth wash. it is clinical trial .the investigator will compare between chlorhexidine mouthwash and garlic with lime juice mouthwash.and show their effect on gingival bleeding and strepococcus bacteria present in saliva and plaque.

1. Preparation of garlic with lime juice will occur under aseptic condition.and give it to the first group.

   provide chlorhexidine to the second group.
2. Collection of plaque and saliva samples will be obtained from children who fulfilled the inclusion criteria.
3. Asses gingival condition by asking patient.
4. Subjects will be instructed to rinse for 14 days, twice daily.
5. Morning after breakfast and night before going to bed.
6. With 10 ml (undiluted) of the assigned mouthwash for 30 s and then expectorate the rinse.
7. Again after 14 days, the saliva and plaque samples will be taken and inoculated on blood agar plates to determine the colony count and the gingival index by loe and illness will be assessed.

Eligibility criteria: Inclusion criteria:

1. Children aged between 9 and 12 years.
2. Children are having normal occlusion (no crowding), non-compromised oral health (brushed their teeth once-daily) using toothbrush and non-fluoridated toothpaste. And practicing no other oral hygiene measures.
3. Medically free history.
4. Absence of orthodontic appliances.

Exclusion criteria:

1. History of current or recent (at least for the past 1 month) antibiotic usage or other medications.
2. Presence of Abscess, draining sinus, cellulitis, or other conditions requiring emergency dental treatment.
3. not willing to comply with the study.

Primary outcomes:
measure: gingival bleading
timeFrame: 15 day
Secondary outcomes:
measure: Streptococcal count in saliva and plaque
timeFrame: 15 day
Other outcomes:
Locations:
city: Helwan
country: Egypt
facility: Manal Sayed Abdel Latief
state: Cairo
Study officials:
affiliation: Cairo univaesity
name: sherif B eltweel, Ass.prof
role: STUDY_DIRECTOR
References:
citation: Tulsani SG, Chikkanarasaiah N, Siddaiah SB, Krishnamurthy NH. The effect of Propolis and Xylitol chewing gums on salivary Streptococcus mutans count: a clinical trial. Indian J Dent Res. 2014 Nov-Dec;25(6):737-41. doi: 10.4103/0970-9290.152182.
Clinical trial NCT05475860: Biomarkers Predicting Atrial High Rate Episodes in Cardiac Implantable Electronic Device Recipients
Official title: Predictors of Atrial High Rate Episodes in Patients Implanting Cardiac Implantable Electronic Device Based on Biomarkers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial High Rate Episode
Cardiac Implantable Electronic Device
Lead sponsor: Pusan National University Hospital
Sponsor class: OTHER
First posted: 2022-07-27
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients receiving cardiac implantable electronic device for any clinical indication (pacemaker, implantable cardioverter-defibrillator, cardiac resynchronization therapy)

Brief summary: This study is sought to investigate any predictors including biomarkers for atrial high rate episodes (AHRE) occurrence in patients without prior history of atrial tachyarrhythmias receiving cardiac implantable electronic device (CIED).

Detailed description: Atrial high rate episodes (AHRE) are noticed up to 70% in patients receiving cardiac implantable electronic device (CIED) even in the absence of prior history of atrial tachyarrhythmias. AHRE is clinically important because it is considered to be associated with clinical atrial fibrillation, stroke, mortality, and heart failure hospitalization. Therefore, predictors of AHRE might be useful for early detection of AHRE susceptable CIED recipients. Biomarkers as well as clinical characteristics will be analyzed.

Eligibility criteria: Inclusion Criteria:

* patients receiving cardiac implantable electronic device

Exclusion Criteria:

* patients who disagree for blood sampling to analyze not commonly used clinical biomarkers
* patients not followed-up at least 12 months after implanting device

Primary outcomes:
measure: The occurrence of atrial high rate episode
timeFrame: 12 months
Secondary outcomes:
measure: Factors predicting the occurrence of atrial high rate episode
timeFrame: 12 months
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Jinhee Ahn
Study officials:
affiliation: Clinical associate professor
name: Jinhee Ahn, MD
role: PRINCIPAL_INVESTIGATOR
References: