louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01042132: Intramedullary Femoral Reaming, Human Study
Official title: Pathophysiological Effects of- and Inflammatory Response to Intramedullary Femoral Nailing in Patients With Femoral Shaft Fracture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Complications
Organ Failure
Systemic Inflammatory Response Syndrome
Keywords: intramedullary reaming
inflammatory response
human
femoral shaft fracture
Reamer-irrigator-aspirator
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2010-01-05
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To what extent the cardiopulmonary and inflammatory response is affected by initial femoral intramedullary nailing in the already traumatized and inflammatory activated patient was analyzed in the present study with the attention to survey the additional burden of this operative treatment. The patients are monitored with a pulmonary catheter, and blood samples for coagulation, fibrinolysis, complement and cytokine response are withdrawn pre-, per- and postoperatively. The study is partly randomized 1)where delayed intramedullary nailing is compared with primary nailing of the femur, and 2) a new reaming technique (RIA) is compared with a standard reaming technique (TR).

Detailed description: To what extent the cardiopulmonary and inflammatory response is affected by initial femoral intramedullary nailing in the already traumatized and inflammatory activated patient was analyzed in the present study with the attention to survey the additional burden of this operative treatment. The patients are monitored with a pulmonary catheter, and blood samples for coagulation, fibrinolysis, complement and cytokine response are withdrawn pre-, per- and postoperatively. The study is partly randomized 1)where delayed intramedullary nailing is compared with primary nailing of the femur, and 2) a new reaming technique (RIA) is compared with a standard reaming technique (TR).

Eligibility criteria: Inclusion Criteria:

* femoral shaft fracture suitable for intramedullary nailing
* \< 24 hours postinjury

Exclusion Criteria:

* previous fracture of the femur
* pathological fracture
* femur deformities
* pregnancy
* previous intramedullary nailing or external fixation

Primary outcomes:
measure: cardiopulmonary alterations
timeFrame: the first three postoperative days
measure: coagulation, fibrinolytic and cytokine response
timeFrame: pre-, per- and first 3 days postoperatively
Secondary outcomes:
measure: fracture healing
timeFrame: 1 year
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Orthopedic Center, Ullevål University Hopspital
Study officials:
affiliation: Orthopedic Centre, Ullevaal University Hospital, Oslo, Norway
name: Olav Røise, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00126932: Reduction of Topical Anesthetic Onset Time Using Ultrasound
Official title: Reduction of Topical Anesthetic Onset Time Using Ultrasound: A Randomized Controlled Trial Prior to Venipuncture in Young Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Lead sponsor: Connecticut Children's Medical Center
Sponsor class: OTHER
First posted: 2005-08-05
Enrollment: 70
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Children ages 3-7 who are undergoing blood drawing receive either standard care, topical medicine for numbing (LMX4), or the study intervention which utilizes ultrasound to speed the onset of LMX4 from 30 minutes to 5 minutes. The child's pain with the blood drawing procedure is evaluated.


Eligibility criteria: Inclusion Criteria:

* Ages 3-7, requiring venipuncture

Exclusion Criteria:

* Emergent procedure
* Allergy to lidocaine or sodium lauryl sulfate

Primary outcomes:
measure: pain associated with venipuncture
Secondary outcomes:
measure: safety
measure: skin effects
measure: tolerability
Other outcomes:
Locations:
city: Hartford
country: United States
facility: CT Children's Medical Center
state: Connecticut
Study officials:
affiliation: CT Children's Medical Center
name: William T. Zempsky, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06312332: Michigan Emergency Department Improvement Collaborative (MEDIC) Alert; Pulmonary Embolism (PE)
Official title: Michigan Emergency Department Improvement Collaborative (MEDIC) AltERnaTives to Admission for Pulmonary Embolism
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pulmonary Embolism
Keywords: Emergency Department
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-03-15
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: cluster-randomized stepped-wedge design with two or more sites assigned at each of four steps
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study is a quality improvement project to evaluate health care management of pulmonary embolism (PE) patients. The researchers are testing an intervention to determine if it prevents unnecessary hospital admissions.

Detailed description: The study team anticipates that there will be 5800 acute PE patients over multiple sites.

Eligibility criteria: Inclusion Criteria:

* Participation in MEDIC collaborative
* Identified site physician champion
* Annual volume of acute PE ≥80 (measured in 2022)

Exclusion Criteria:

* Pediatric-only hospital/ED
* No site physician champion identified
* Annual volume of acute PE \<80 (measured in 2022)
* Existing formal clinical pathway for outpatient management of low-risk PE

Primary outcomes:
measure: Change in proportion of patients discharged home from Emergency Department (ED)
timeFrame: 3 months Pre-intervention, Up to 18 months Post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Michigan Emergency Department Improvement Collaborative partners
state: Michigan
Study officials:
affiliation: University of Michigan
name: Geoff Barnes
role: STUDY_CHAIR
References:
Clinical trial NCT02208232: Observation of Rotation of an Intraocular Lens
Official title: Observation of Rotation of the MC 6125 AS Intraocular Lens
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Keywords: IOL rotation
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2014-08-05
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eyes of patients with uni- or bilateral cataract applying for cataract surgery at the Department of Ophthalmology, Medical University Vienna.

Brief summary: The purpose of this study is to assess the axial IOL rotation after surgery with an MC 6125 AS IOL.

At the end of surgery the orientation of the IOL is documented with a short video clip via the operating microscope unit. Follow-up examinations are performed 1 hour, 1 week and 6 months after surgery. Rotational stability of the IOL is assessed using retroillumination images with a method to avoid bias from cyclorotation or head tilt.


Eligibility criteria: Inclusion Criteria:

* Uni or bilateral age-related cataract necessitating phacoemulsification extraction and posterior IOL implantation

Exclusion Criteria:

* Preceding ocular surgery or trauma
* Recurrent intraocular inflammation of unknown etiology
* Uncontrolled glaucoma
* Uncontrolled systemic or ocular disease
* Blind fellow eye
* Microphthalmus
* Corneal abnormality
* History of uveitis/iritis
* Iris neovascularization
* Pseudoexfoliation
* Proliferative diabetic retinopathy

Primary outcomes:
measure: IOL rotation
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Ophthalmology and Optometry of the Medical University Vienna
state: Viena
Study officials:
References:
Clinical trial NCT06126432: Beneficial Effects of Probiotics on Improvement of Gut Dysbiosis and Ascending Cholangitis in Patients Received Pancreaticoduodenectomy
Official title: National Cheng Kung University Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Precancerous Lesions
Keywords: Ampullary
Pancreas
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single intervention arm with trial treatment
Primary purpose: TREATMENT

Brief summary: To determine whether probiotics have beneficial effect on gut dysbiosis and postoperative ascending cholangitis in patients with pancreaticoduodenectomy.

Detailed description: Gut dysbiosis and postoperative ascending cholangitis (POAC) occurred after pancreaticoduodenectomy (PD). To date, no clinical trial has evaluated the association between gut dysbiosis, POAC and probiotics. POAC is a common morbidity after pancreaticoduodenectomy or in obstructive jaundice patients with endoscopic retrograde biliary drainage (ERBD). It frequently induces longer hospital stay and makes the major obstacle for postoperative chemotherapy. This phenomenon reveals the important role of ampullary vater in control of retrograde bacterial inflow into bile duct. However, the exact difference of gut microbiota after pancreaticoduodenectomy is still unknown. Probiotics is reported efficacy in restore the normal flora of gut microbiota. So, this study is to evaluate the effects of probiotics consumption, Yugart 2 bottles per day for 1 month on gut microbiota in control of ascending cholangitis before and after pancreaticoduodenectomy through the analysis of microbial community by next generation sequencing.

Eligibility criteria: Inclusion Criteria:

* Subjects with peri-ampullary lesions and scheduled to receive pancreaticoduodenectomy (PD) were designed as experimental group; subjects with pancreatic lesions and scheduled to receive distal pancreatectomy (DP) were designed as control group.
* Subjects that already received PD for more than 6 months to join the study and aim to evaluate the effect of probiotics on gut microbiota and postoperative ascending cholangitis (POAC).
* Subjects with the amount of two bottles a day (one provided in the morning and the other in the afternoon) for a duration of 4 weeks.

Exclusion Criteria:

* Subjects are currently participating in any other clinical trials or studies.

Primary outcomes:
measure: The effects of probiotics on the postoperative ascending cholangitis
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
References:
Clinical trial NCT04805632: Immune Response in Dialysis Patients Vaccinated Against COVID-19
Official title: A Comparison of Short-term and Mid-term Immune Response in Dialysis Patients and Staff Vaccinated Against SARS-CoV-2 Using Gam-COVID-Vac (Sputnik V) Vaccine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Chronic Kidney Disease 5D
Lead sponsor: Saint Petersburg State University, Russia
Sponsor class: OTHER
First posted: 2021-03-18
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects ≥ 18 years old who were vaccinated twice against SARS-CoV-2 using Gam-COVID-Vac (Sputnik V) vaccine.

Brief summary: This is a prospective cohort study aimed to evaluate short- and mid-term immune response after SARS-CoV-2 vaccination using Gam-COVID-Vac (Sputnik V) vaccine in dialysis patients compared to the control group (medical staff).

Detailed description: Background and aims: Patients receiving kidney replacement therapy with dialysis are at high risk of infection and death from COVID-19. There is a lack of evidence whether SARS-CoV-2 vaccination is effective in this immunocompromised group.

Study design: this is a prospective cohort study. Two cohorts will be included: dialysis patients and controls (medical staff), both vaccinated with Gam-COVID-Vac (Sputnik V) vaccine.

Blood samples will be collected at 28 days and 22 weeks after after the second SARS-CoV-2 vaccine dose administration.

The primary outcome is the level of SARS-CoV-2 IgG antibodies on day 28 after the second vaccination as compared to controls.

The secondary outcomes are: 1) the level of SARS-CoV-2 IgG antibodies on week 22 after the second vaccination; 2) T cell subtype immunity measured by SARS-CoV-2 interferon-γ release assays (IGRA) 28 days and 22 weeks after the second vaccination.

Eligibility criteria: Inclusion Criteria:

* Age of 18 years or older
* Previously vaccinated against SARS-CoV-2 with two administrations of Gam-COVID-Vac (Sputnik V) vaccine
* Written informed consent.

Exclusion Criteria:

* A history of previous COVID-19 disease
* Active malignancy of any localization
* Human Immunodeficiency Virus (HIV) infection
* Maintenance treatment with immunosuppressive therapy.

Primary outcomes:
measure: Humoral response to vaccination against against SARS-CoV-2 as compared to controls
timeFrame: 28 days after the second vaccination
Secondary outcomes:
measure: Humoral response to vaccination against against SARS-CoV-2
timeFrame: 22 weeks after the second vaccination
measure: T-cell response against SARS-CoV-2
timeFrame: 28 days after the second vaccination
measure: T-cell response against SARS-CoV-2
timeFrame: 22 weeks after the second vaccination
measure: SARS-CoV-2 incidence
timeFrame: 22 weeks after the second vaccination
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: Saint-Petersburg State University Hospital
Study officials:
References:
Clinical trial NCT01593332: Low Dose Rituximab as a First Line Biologic Therapy for the Treatment of DMARD Resistant Patients With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: DMARD Resistant Rheumatoid Arthritis
Keywords: Rituximab
Rheumatoid arthritis
Biologics
Anti-tumour necrosis factor
Disease-modifying anti-rheumatic drugs
DAS28
European League Against Rheumatism response
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
First posted: 2012-05-08
Enrollment: 44
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this project the investigators decide to evaluate the efficacy and safety of half dose mabthera (it means 500 mg infusion two weeks apart) in conventional drug resistant cases of rheumatoid arthritis. The investigators choose this drug because the use of anti-TNF drugs limited in the investigators refractory patients as the first line drugs because of its cost.


Eligibility criteria: Inclusion Criteria:

* 1987 ACR criteria for classification of RA
* Positive for rheumatoid factor(RF)
* Active RA despite therapy with conventional for at least 3 months as evidenced by DAS 28 \> 3/2
* Patients with active, resistant RA who didn't receive anti TNF agents.

Exclusion Criteria:

* Patient with hypogammaglobulinemia
* Patient with congestive heart failure (classIV)
* Active current bacterial,viral,fungal,myocardial or other infections
* Chronic hepatitis B or hepatitis C carriers
* History of severe allergic reaction to human,humanized or murine monoclonal antibodies
* History of malignancies
* Pregnant women or lactating mothers 8) Patients with Chronic renal failure and hepatic disease.

Primary outcomes:
measure: change in 28-joint disease activity index( DAS28)
timeFrame: Study duration was 6 months and the subjects were assessed for DAS 28 change at baseline, after 2 , 16 and 24 weeks.
measure: Change in European league against rheumatism(EULAR) response criteria
timeFrame: Change in EULAR 2,16,24 weeks
Secondary outcomes:
measure: Rituximab side effects
timeFrame: 0,2,16,24 weeks
Other outcomes:
Locations:
city: Mashhad
country: Iran, Islamic Republic of
facility: Rheumatic Diseases Research Center, Mashhad University of Medical Sciences
state: Khorasan Razavi
Study officials:
References:
Clinical trial NCT06212232: A New Piezoelectric Technique in Third Molar Surgery
Official title: Efficacy of a New Piezoelectric Technique in Third Molar Surgery and Evaluation of Postoperative Sequelae: a Randomized Split-mouth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Diseases
Piezoelectric Technique
Tooth, Impacted
Tooth Extraction Status Nos
Tooth Avulsion
Facial Swelling
Keywords: third molar surgery
facial swelling
3D facial swelling evaluation
Piezoelectric technique
tooth impacted
piezosurgery
Lead sponsor: University Magna Graecia
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 32
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The present study aims to analyze the effect of the piezoelectric technique in third molar surgery in terms of facial swelling, trismus and pain in a split-mouth randomized controlled clinical trial

Detailed description: The present study aims to analyze the effect of of the piezoelectric technique n third molar surgery in terms of facial swelling, trismus and pain in a split-mouth randomized controlled clinical trial. Facial swelling will be assessed using an innovative three-dimensional digital technique.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 to 32 years who required both M3M extractions were recruited
* Good health status
* Indication to surgical extraction of both M3M
* Complete root formation
* Surgical risk level classified as "Conventional" or "Moderate" according to - Daugela et al. classification

Exclusion Criteria:

* Person under the age of 18 or over 32
* Allergy or contraindications to administration of corticosteroids
* Acute infection in any of the teeth to be extracted
* Patients with chronic liver disease, diabetes, immune system dysfunction, or haematological disease
* Pregnancy or breastfeeding
* History of treatment with antiresorptive drugs
* Chronic kidney disease

Primary outcomes:
measure: Facial swelling qualitative analysis
timeFrame: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
measure: Facial swelling quantitative analysis - volumetric differences
timeFrame: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
measure: Facial swelling quantitative analysis - linear differences
timeFrame: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
Secondary outcomes:
measure: Trismus analysis
timeFrame: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
measure: Pain analysis with Visual analogue scale (VAS)
timeFrame: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: Magna Graecia University of Catanzaro
Study officials:
References:
Clinical trial NCT05551832: Prevalence of Marginal Ulcer After PPPD and Preventive Effect of Proton Pump Inhibitor in Korea: A Prospective Multicenter Study
Official title: Prevalence of Marginal Ulcer After PPPD and Preventive Effect of Proton Pump Inhibitor in Korea: A Prospective Multicenter Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pancretic Dissease (Benign/Malignancy)
BIle Duct Diseae(Benign/Malignancy)
Ampulla of Vater Disease (Benign/Malignancy)
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2022-09-23
Enrollment: 360
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Placebo after Pylurus preserving Pancreaticoduodenctomy (PPPD) for 6 months
Primary purpose: TREATMENT

Brief summary: This research is to determine which medication, Esmesol (PPI) or Placebo works best at reducing the chance that a patient will get an marginal ulcer after pancreaticoduodenectomy.


Eligibility criteria: Inclusion Criteria:

* Subject is age ≥ 19 years Patient meets the criteria for Open/MIS PPPD Females only: Patient is willing to take a urine pregnancy test

Exclusion Criteria:

- Subject allergic to ESMESOL Patient receiving antifungal (i.e. ketoconazole or itraconazole) Hepatic insufficiency History of Crohns disease History of Zollinger-Ellison disease Patient received an investigational drug within 30 days of enrollment Previous Gastric Surgery HX

Primary outcomes:
measure: Marginal ulcer incidence
timeFrame: Time Frame: during first 6 months after surgery
Secondary outcomes:
measure: QOL
timeFrame: Time Frame: during first 6 months after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: GangnamSeverance Hospital
Study officials:
References: