louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05294315: Bi-level vs. Single Level ESB in VATS
Official title: The Analgesic Efficacy of Bi-level Versus Single Level Erector Spinae Block in Video Assisted Thoracoscopic Surgery: a Randomized Patient Blinded Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Pain
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2022-03-24
Enrollment: 90
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: Video assisted thoracoscopic surgery (VATS) is a minimally invasive surgery to remove lesions from the thoracic cavity. It is associated with moderate pain which can lead to pulmonary complications after surgery. The Enhanced Recovery After Surgery (ERAS) and the European Society of Thoracic Surgeons recommended a multimodal analgesia approach to manage pain after VATS. Erector spinae block (ESB) is a popular analgesic block due to its ease of performance and wide coverage. It has been shown to be effective in randomized control trials. Recently, case reports on bi-level ESB are emerging, suggesting more effective analgesia compared to single level ESB. As there is no available data, the investigators are interested in conducting a randomized pilot study, comparing bi-level to single level ESB to gather baseline data for sample size calculation for a formal randomized trial.


Eligibility criteria: Inclusion Criteria:

* adult patients (at least 18 years old)
* elective unilateral wedge resection, segmentectomy, lobectomy or bilobectomy via VATS

Exclusion Criteria:

* history of malignant hyperthermia
* BMI \> 40, chronic pain condition
* Daily opioid consumption of more than 60 mg oral morphine equivalents
* Conversion to thoracotomy
* Insertion of epidural
* postoperative admission to ICU

Primary outcomes:
measure: Opioid use in first 12 postoperaive hour
timeFrame: First 12 hour from arriving at postoperative recovery
Secondary outcomes:
measure: Pain score area under curve first 12 hour
timeFrame: First 12 hour from arriving at postoperative recovery
measure: Pain score area under curve first 24 hour
timeFrame: First 24 hour from arriving at postoperative recovery
measure: Incidence of Acute block complication - based on clinical assessment
timeFrame: First 12 hour since block placement
measure: Incidence of Delayed block complication - based on clinical assessment
timeFrame: First 5 days
Other outcomes:
Locations:
city: London
country: Canada
facility: Cheng Lin
state: Ontario
Study officials:
References:
Clinical trial NCT05445115: The Mollie Study, a Study to Evaluate the Safety and Efficacy of the Mollie Medical Device
Official title: DAT: Dyspareunia Alleviation Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dyspareunia
Lead sponsor: JSP Innovations
Sponsor class: OTHER
First posted: 2022-07-06
Enrollment: 111
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Treatment arm and sham arm
Primary purpose: TREATMENT

Brief summary: Study to evaluate the use of a medical device in relieving collision dyspareunia


Eligibility criteria: Inclusion Criteria: Females 18 years of age and older with a diagnosis of collision dyspareunia -

Exclusion Criteria:

-

Primary outcomes:
measure: Dyspareunia Alleviation
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Decatur
country: United States
facility: Vero Clinics
state: Illinois
Study officials:
References:
Clinical trial NCT00762515: Clinical Study to Evaluate the Treatment of Gingivitis of Two Toothpastes
Official title: Clinical Study to Evaluate the Treatment of Gingivitis of Two Toothpastes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dental Plaque
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2008-09-30
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective is to compare two commerical oral products for the treatment of gingivitis.


Eligibility criteria: Inclusion Criteria:

1. Male or female volunteers 18-65 years of age
2. Good general health
3. Must sign informed consent form
4. Minimum of 16 natural uncrowned teeth (excluding third molars) must be present.
5. No history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study.
6. Dental Selection Criteria: Gingivitis patients with a minimum of 16 gradable teeth with a minimum of 6 sites with a GI score of ≥ 3. Subjects will be stratified according to gingivitis severity. Average full mouth GI score should be in the range of 2.0 - 2.5. heavy plaque formers should be avoided. Target a full mouth PI (Quigley-Hein) to be in the range of 1.5-3.0

Exclusion Criteria:

1. Subjects unable or unwilling to sign the informed consent form.
2. Medical condition which requires pre-medication prior to dental visits/procedures
3. Moderate or advanced periodontal disease
4. History of allergy to iodine
5. History of thyroid disease
6. History of diabetes
7. 2 or more decayed untreated dental sites at screening.
8. Other disease of the hard or soft oral tissues.
9. Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).
10. Use of medications that are currently affect salivary flow.
11. Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.
12. Pregnant or nursing women.
13. Participation in any other clinical study within 1 week prior to enrollment into this study.
14. Use of tobacco products
15. Subjects who must receive dental treatment during the study dates.
16. Current use of Antibiotics for any purpose.
17. Presence of an orthodontic appliance.
18. History of allergy to common dentifrice ingredients
19. Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
20. Women of childbearing potential and not on birth control (Diaphragm, birth control pills or implants, IUD (Intrauterine device), condoms).
21. Smoker

Primary outcomes:
measure: Control Established Plaque in Adults
timeFrame: 6 weeks
Secondary outcomes:
measure: Control Gingivitis in Adults
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville, School of Dentistry
state: Kentucky
Study officials:
name: Denis Kinane, BDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01983215: Effects of Prevena Therapy on Obese and or Diabetic Patients With Surgical Groin Sites
Official title: EFFECTS OF PREVENA THERAPY ON REDUCTION OF GROIN SURGICAL SITE INFECTIONS IN OBESE PATIENTS UNDERGOING VASCULAR SURGERY
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Diabetes
Peripheral Vascular Disease
Keywords: groin incisions
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2013-11-13
Enrollment: 276
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine the effects of Prevena therapy on decreasing groin surgical site infections in patients who are obese and /or diabetic having vascular surgery.

Detailed description: Patients who are obese and/or diabetic may have poor surgical healing and infection rates higher. The PREVENA therapy will be used to evaluate possible reduction of infection rates in this patient population

Eligibility criteria: Inclusion Criteria:

* subjects over 18 years old
* obese (BMI \> 30) and or diabetic

Exclusion Criteria:

* current infected surgical field, hemodialysis, immunosuppressive therapy, allergy to adhesive, sensitivity to silver

Primary outcomes:
measure: number of patients with infections
timeFrame: 30 day post surgical procedure
Secondary outcomes:
measure: infection rates
timeFrame: 1 year
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State Division of Vascular Diseases and Surgery
state: Ohio
Study officials:
affiliation: The Ohio State Medical Center
name: Jean E Starr, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04420715: 3D Printed Silicone Coronary Artery Simulator for Percutaneous Coronary Interventional Training
Official title: 3D Printed Silicone Coronary Artery Simulator for Percutaneous Coronary Interventional Training
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Percutaneous Coronary Intervention
Keywords: percutaneous coronary intervention
3D printing
silicone
coronary artery simulator
training
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2020-06-09
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study is aim to evaluate the feasibility and effectiveness of 3D printed silicone coronary artery simulator for percutaneous coronary interventional training.

Detailed description: With the aging of the population, the incidence of cardiovascular diseases has exceeded that of respiratory diseases and cancer, corresponding to the rapid increase in the number of coronary stent implantation. Therefore, the standardized training of interventional cardiologists is particularly important. Nowadays percutaneous coronary intervention (PCI) training mode is mainly for the trainees to operate on the patients under the experienced operator. Although this kind of training method can truly show the operation process, it has obvious limitations. For beginners, it takes repeated training and revision to achieve proficiency and accuracy.Learning only through real surgery may result in longer operative times, increased radiation exposure, and increased complications.This study is aim to evaluate the feasibility and effectiveness of 3D printed silicone coronary artery simulator for percutaneous coronary interventional training.

Eligibility criteria: Inclusion Criteria:

* Previous experience in coronary intervention
* Understand the process of trail and be willing to participate

Exclusion Criteria:

* No previous experience with coronary intervention
* Unwilling to participate the trail
* Unable to complete the trail due to other problems

Primary outcomes:
measure: Change of the time taken in operation
timeFrame: Through study completion, an average of 4 hours
measure: Change of the amount of contrast agent used
timeFrame: Through study completion, an average of 4 hours
measure: Change in assessment scores
timeFrame: Through study completion, an average of 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital
state: Beijing
Study officials:
affiliation: Fuwai Hospital, Beijing, China
name: Shubin Qiao, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004915: Raloxifene in Treating Patients With Persistent or Recurrent Endometrial Cancer
Official title: Phase II Study of Raloxifene in Recurrent Endometrial Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Endometrial Cancer
Keywords: recurrent endometrial carcinoma
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-08-30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Estrogen can stimulate the growth of endometrial cancer cells. Hormone therapy using raloxifene may fight endometrial cancer by reducing the production of estrogen.

PURPOSE: Phase II trial to study the effectiveness of raloxifene in treating patients who have persistent or recurrent endometrial cancer.

Detailed description: OBJECTIVES: I. Determine response rate and time to disease progression in patients with recurrent endometrial cancer treated with raloxifene. II. Determine overall survival in these patients treated with this regimen. III. Determine the toxicity of raloxifene in this patient population.

OUTLINE: Patients receive oral raloxifene daily. Treatment continues indefinitely in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 13-50 patients will be accrued for this study within 2.5 years.

Eligibility criteria: DISEASE CHARACTERISTICS: Recurrent endometrial cancer Evidence of persistent or recurrent disease 4 weeks following primary treatment with radiation and surgery Bidimensionally measurable disease Not a candidate for curative salvage radiotherapy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-3 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: No history of unexplained or uncontrolled thromboembolic disease No active thromboembolic disease Other: No active or uncontrolled second malignancy HIV negative

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy for early stage or advanced endometrial cancer Endocrine therapy: At least 4 weeks since prior hormonal therapy for early stage or advanced endometrial cancer Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Robert H. Lurie Comprehensive Cancer Center, Northwestern University
state: Illinois
Study officials:
affiliation: Florida Gynecologic Oncology - Fort Myers
name: Phillip Y. Roland, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06121115: Norepinephrine Administration Through a Midline Catheter in an Intermediate Care Unit
Official title: Norepinephrine Administration Through a Midline Catheter in an Intermediate Care Unit - a Retrospective Study of Complications and Patient Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Septic Shock
Norepinephrine Adverse Reaction
Hypotension and Shock
Keywords: vasopressor
norepinephrine
septic shock
midline catheter
thrombosis
extravasation
catheter-related bloodstream infection
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 473
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: The study population are critically ill patients in need of vasopressors, primarily with septic shock.

Brief summary: This is a single-center study retrospectively evaluating a local clinical routine to administer norepinephrine in midline catheters, with regard to complications and patient outcomes

Detailed description: Se attached study protocol

Eligibility criteria: Inclusion Criteria:

* Administration of norepinephrine in a midline catheter in an intermediary care unit
* In Skåne university hospital
* From 2019 to 2023-03-31

Exclusion Criteria:

* Patients who have actively disabled review of their electronic medical record

Primary outcomes:
measure: Proportion of patients with a major complication of norepinephrine administration in midline
timeFrame: day 30
Secondary outcomes:
measure: Proportion of patients with a minor complication of norepinephrine administration in midline
timeFrame: day 30
measure: Proportion of patients receiving a CVC after midline
timeFrame: day 30
measure: Proportion of patients with different intermediary care unit outcomes
timeFrame: day 30
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Skåne University Hospital
Study officials:
affiliation: Region Skåne
name: Gustav Torisson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03704415: Aggravated Airway Inflammation: Research on Genomics and Optimal Operative Treatment (AirGOs Operative)
Official title: Aggravated Airway Inflammation: Research on Genomics and Optimal Operative Treatment (AirGOs Operative)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sinusitis, Chronic
Asthma
Nasal Polyps
Aspirin Sensitivity
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2018-10-12
Enrollment: 97
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: This randomized study compares operative techniques in chronic rhinosinusitis with polyposis (CRSwNP) surgery. It aims to evaluate outcomes in asthma and CRSwNP, safety and costs. The investigators want to see if patients with certain clinical and/or genetic predispositions will benefit from extended surgery. They also aim to find biomarkers for detection and management models for of severe airway inflammation and to further develop markers for progressive disease forms.

Detailed description: Please see study protocol

Eligibility criteria: Inclusion Criteria:

* Patient not responding to conservative treatment of 3 months of nasal steroid drops
* Nasal polyp score ≥ 4/8
* SNOT-22 ≥ 30
* Lund-Mackay CT score ≥ 14
* One previous endoscopic sinus surgery or at least one peroral corticosteroid course or at least 3 courses of antibiotics within 2 years

Exclusion Criteria:

* Age \<18 years, age \> 65 years
* Complication of CRS (f.e. mucocele, invasive fungal rhinosinusitis)
* Other diagnosis than CRSwNP (inverted papilloma, antrochoanal polyp etc.)
* Previous external sinus surgery or Draf 3 procedure (or indication for external approaches or Draf 3
* Bleeding diathesis
* Pregnancy/ breastfeeding
* Cystic fibrosis
* Primary ciliary dyskinesia (PCD)
* Sarcoidosis
* Granulomatosis with polyangitis (GPA)
* Eosinophilic granulomatosis with polyangitis (EGPA)
* Immunosupression (diagnosed Spesific Antibody Deficiency (SAD), common variable immunodeficiency (CVI), HIV or use of biologicals/immunosuppressive medication)
* Immunotherapy
* Daily use of systemic corticosteroids
* Communication problems (f.e. neurological/psychiatric disease, language skills)
* Unlikely to comply
* Other severe disease
* Inability to be operated.

Primary outcomes:
measure: Sino-nasal outcome test (SNOT-22)
timeFrame: Baseline, Post-intervention every 3 months during 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Department of Otorhinolaryngology, Helsinki University Hospital
city: Kuopio
country: Finland
facility: Kuopio University Hospital
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
Study officials:
affiliation: Helsinki University Central Hospital
name: Paula Virkkula, Docent
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06810115: Respiatory Viral Infections in Patients with Multiple Myeloma
Official title: Incidence and Clinical Significance of Respiratory Viral Infections in Patients with Multiple Myeloma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Mieloma
Respiratory Viral Infections
Keywords: Respiratory viral infections
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2025-02-05
Enrollment: 219
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with multiple myeloma on observation/receiving treatment at outpatient clinuc

Brief summary: Respiratory viruses are known to be a major cause of morbodity in multiple myeloma patients but prospective long-term sudies are lacking. We analysed 219 multiple myeloma patients that had 554 nasopharingeal swabs with 58 documented viral episodes. Respiratory viruses studied were rhinovirus, enterovirus, parainflienza, respirator, syncytial virus, metapneumovirus, coronavirus, bocavirus, influenza A, influenza B. Clinical data were extracted from a prospectively entered database, medical records were reviewed. We have prospectively studiend patients until May 2019 when we gathered survival data. Lastly because of Covid-19 pandemic when almost no other viral infections were isolated, we analysed clinical course of respiratory infections in patients with multiple myeloma after the pandemic.


Eligibility criteria: Inclusion Criteria:

* Patients with multiple myeloma

Exclusion Criteria:Other hematological malignancies

-

Primary outcomes:
measure: Number of respiratory viral infections in patirnts with multiple myeloma
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Blimark C, Holmberg E, Mellqvist UH, Landgren O, Bjorkholm M, Hultcrantz M, Kjellander C, Turesson I, Kristinsson SY. Multiple myeloma and infections: a population-based study on 9253 multiple myeloma patients. Haematologica. 2015 Jan;100(1):107-13. doi: 10.3324/haematol.2014.107714. Epub 2014 Oct 24.
Clinical trial NCT04858815: Using Yogic Breathing to Reduce Stress in Anesthesia Personnel As Measured by Hair Cortisol
Official title: Using Yogic Breathing to Reduce Stress in Anesthesia Personnel As Measured by Hair Cortisol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Burnout, Professional
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2021-04-26
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single arm longitudinal trial
Primary purpose: TREATMENT

Brief summary: Mind body exercises have long been used as a way for individuals to reduce stress and improve well-being. Recent studies indicate that yogic breathing (YB, also known as pranayama) could potentially impact both the mind and body by engaging both the physiological and neural elements and can thus be a specific tool that can be utilized by healthcare workers to combat burnout and decrease perceived levels of stress. Our aim is to understand and measure both subjectively and objectively the effects of long-term yogic breathing on stress levels in anesthesia personnel. This will be a single arm longitudinal trial designed to evaluate the feasibility and estimate the efficacy of implementing a yogic breathing program for stress reduction among anesthesiology practitioners at one academic medical center. The primary aim of the trial is to estimate the correlation between participant stress with average duration of yogic breathing over time. Secondarily the feasibility of implementing yogic breathing practices among anesthesiology practitioners will be evaluated. Feasibility measures will include recruitment rates, retention at 1year follow-up, and adherence to the yogic breathing program at 12 months.


Eligibility criteria: Inclusion Criteria:

* All clinical members of the MUSC anesthesia department (Attending physicians, resident physicians, and CRNAs)

Exclusion Criteria:

* Pregnancy (or anticipated pregnancy)
* chronic steroid use
* inadequate hair length for testing (less than 3cm at the back of the head)
* residents with anticipated graduation within the next one year.

Primary outcomes:
measure: Correlation of participant stress with average duration of yogic breathing over time
timeFrame: baseline & 12 month visit
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Grayce Davis, MD
role: PRINCIPAL_INVESTIGATOR
References: