louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04818580: Progressive Tension Sutures in Gender Affirming Mastectomy
Official title: A Prospective Cohort Study Comparing the Effect of Progressive Tension Sutures and Drains to Drains Alone on Rates of Hematoma and Seroma in Gender Affirming Mastectomy for Transgender Men
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hematoma
Seroma
Keywords: Mastectomy
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2021-03-26
Enrollment: 3
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 50 patients seeking gender affirming mastectomy will be treated with different closure techniques in each side of their chest - one side will receive progressive tension sutures between pectoral fascia and the mastectomy flap, and the other side will not. Both sides will have drains in the mastectomy site. Rates of hematoma, seroma, and other complications will be compared between each chest side via standard statistical techniques for hypothesis testing.


Eligibility criteria: Inclusion Criteria:

1. Being consulted for gender affirming mastectomy with the senior author (AH).
2. \>18 years of age at the time of enrollment.
3. Transgender or gender nonbinary gender identity.
4. All co-morbidities and all indications.

Exclusion Criteria:

1. Age less than 18 years.
2. BMI \< 23.

Primary outcomes:
measure: Total volume of Drain Fluid
timeFrame: Visit 2, Day 7
measure: Total volume of Drain Fluid
timeFrame: Visit 3, Day 14
measure: Total volume of Drain Fluid
timeFrame: Visit 4, Day 30
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Alexes Hazen, MD FACS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05961280: Selective Omission of Sentinel Lymph Node Biopsy in Mastectomy for Ductal Carcinoma in Situ: Identifying Eligible Candidates
Official title: Upstaging and Lymph Node Metastasis Rate in Patients With Ductal Carcinoma in Situ Who Received Mastectomy Regarding the Necessary of Sentinel Lymph Node Biopsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ductal Carcinoma in Situ
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 385
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent mastectomy with sentinel lymphnode biopsy for DCIS.

Brief summary: This study aimed to assess the prevalence of upgrade to invasive breast cancer and axillary lymph node metastasis in patients who were diagnosed with DCIS on biopsy and subsequently underwent mastectomy with axillary surgery to establish the need for SLNB. Furthermore, we explored the clinicopathologic features related to the upgrade to invasive breast cancer and axillary lymph node metastasis.


Eligibility criteria: Inclusion Criteria:

1. Women diagnosed with DCIS in preoperative biopsy samples obtained by core needle biopsy, vacuum-assisted breast biopsy, or excisional biopsy
2. Women underwent curative surgery for DCIS

Exclusion Criteria:

1. Patients who received breast-conserving surgery
2. Patients who had concurrent contralateral invasive breast cancer
3. Patients who were in case of ipsilateral breast tumor recurrence
4. Patients whose invasiveness was uncertain in the biopsy samples

Primary outcomes:
measure: Axillary lymph node metastasis rate
timeFrame: up to 2 weeks after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01799980: Evaluation of Endobronchial Ultrasound (EBUS) for Staging Lung Cancer
Official title: Evaluation of Endobronchial Ultrasound (EBUS) for Staging Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: Lung cancer
Cervical mediastinoscopy
Endobronchial ultrasound
Staging
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2013-02-27
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing a staging procedure for lung cancer (either cervical mediastinoscopy or endobronchial ultrasound).

Brief summary: This study will compare two different methods of staging lung cancer to determine whether endobronchial ultrasound (EBUS) staging of mediastinal lymph nodes will provide good diagnostic yield in detecting lung cancer, when compared to current methods of a staging bronchoscopy and cervical mediastinoscopy.


Eligibility criteria: Inclusion Criteria:

Patients, \> 18 years of age,

Gender- Males and Female

Diagnosis of Non Small Cell Lung Cancer.

Patients who have consented on an Ottawa Hospital consent form to undergo a mediastinoscopy procedure or EBUS-TBNA, and a Positron emission tomography (PET) of the chest for lung cancer staging.

Exclusion Criteria:

Females who are pregnant (or found to be pregnant) during the course of this research study.

Patients who do not provide their Ottawa Hospital consent to undergo a staging bronchoscopy , cervical mediastinoscopy or EBUS-TBNA.

Primary outcomes:
measure: Lung cancer staging
timeFrame: Pre-op and post-op
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Donna E Maziak, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01970280: Low Molecular Weight Heparin in Prevention of Recurrent Arteriovenous Graft Thrombosis in Chronic Hemodialysis Patients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hemodialysis Patients
Lead sponsor: Meir Hospital, Kfar Saba, Israel
Sponsor class: OTHER
First posted: 2013-10-28
Enrollment: 26
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: The aim of the study is to evaluate the effect of Enoxaparin (LMWH) on the incidence of AV graft thromboses in patients on chronic hemodialysis.

Primary efficacy end point of the study: to compare the time of onset of a new thrombotic event after successful angiography of the AV graft.

Pprimary safety outcome of the study: frequency of hemorrhage. Design and methods: Following a first AV graft thrombosis and successful thrombolysis with angioplasty, patients on chronic hemodialysis will be randomized to s.c Enoxaparin (Clexane) 0.5 mg/1kg of body weight per day or control group (not on Clexane). Patients will be followed for a year or till next AV graft thrombotic occlusion, if it occurs before. In both groups we will compare time periods in months between first and recurrent thrombotic events of AVG by evaluation the difference between two sample means. Also interim analysis of AV grafts patency between the two groups will be evaluated at different time points: three, six and twelve months after randomization. Patients in both groups will receive unfractionated heparin during dialysis session to prevent thrombosis of extracorporeal circulation. Patients from Enoxaparin group will receive a half dose (500 units/hour) to prevent possible risk of bleeding during the session. Before randomization all patients will be evaluated for hypercoagulability state which will include: Factor V Laden deficiency, Anti phospholipid antibodies (APLA), Antithrombin III deficiency and Protein C/S deficiency.


Eligibility criteria: Inclusion Criteria:

* hemodialysis patients ≥ 18 years of age after occurrence of AVG thrombosis and successful thrombolysis/thrombectomy with angioplasty.

Exclusion Criteria:

1. Known allergy to enoxaparin
2. Persistent systolic blood pressure 180 or more and/or persistent diastolic blood pressure 100 or more
3. Chronic Warfarin treatment
4. Double antiagregant treatment (aspirin plus clopidogrel)
5. Platelets count below 80000/µl
6. Known HIT (Heparin Induced Thrombocytopenia)
7. Recent bleeding (\<2 weeks)
8. Recent stroke (\<4 weeks)
9. Reduced mental status and inability to give informed consent

Primary outcomes:
measure: To compare the time of onset of a new thrombotic event after successful angiography of the AV graft.
timeFrame: 1 y
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Sava
country: Israel
facility: Department of Nephrology and Hypertension, Meir Medical Center
city: Kfar Sava
country: Israel
facility: Helsinki committee
Study officials:
References:
Clinical trial NCT04806880: Study Evaluating the Olfactory Recovery of Anosmia Post COVID-19 by Olfactory Rehabilitation Assisted by Web-application
Official title: Prospective Study Evaluating the Olfactory Recovery of Anosmia Post COVID-19 by Olfactory Rehabilitation Assisted by Web-application
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: Web-application
Anosmia
COVID-19
coaching
Lead sponsor: Weprom
Sponsor class: OTHER
Collaborators: name: Kelindi
name: Centre National de la Recherche Scientifique, France
name: Hospital of Tours
First posted: 2021-03-19
Enrollment: 1155
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: All users of the application who have not objected to the use of their data

Brief summary: Anosmia is a symptom present in 40 to 80% of patients and usually only lasts 1 to 2 weeks. However, in nearly one in five patients, it can last beyond or even several months with consequences in terms of undernutrition and depression. However, olfactory rehabilitation is a technique validated in post-infectious anosmia since 2014 and recommended by international learned societies to accelerate recovery with nearly 63% improvement in anosmia In the context of the health crisis linked to the coronavirus, approximately 1 million French people will have persistent anosmia following an infection with COVID-19. A web-application to support the olfactory coaching of anosmic patients and help with follow-up seems relevant to promote recovery and the proper conduct of this coaching.

covidanosmie.fr is a web application dedicated to olfactory rehabilitation, accessible free of charge.


Eligibility criteria: Inclusion Criteria:

* Post-COVID anosmia lasting more than 1 month
* Consent to the use of data via the application

Exclusion Criteria:

* Other causes of anosmia than COVID
* Contraindication to olfactory coaching (allergy to one of the aromatic oils)
* Minor

Primary outcomes:
measure: Evaluation of the rate of patients presenting an improvement in their anosmia
timeFrame: 16 weeks
Secondary outcomes:
measure: Evaluation of the time until recovery of at least 1point in 10 (Visual Analog Scale) from anosmia,
timeFrame: 16 weeks
measure: Assessment of the duration of anosmia
timeFrame: 16 weeks
measure: Evaluation of the recovery of at least one point in 10 (Visual Analog Scale) depending on the oils
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Le Mans
country: France
facility: ILC
Study officials:
affiliation: Weprom
name: Fabrice DENIS, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02464280: Tomosynthesis of Pathologies of the Chest and Skeletal Structures in Comparison to CT
Official title: Validation of Tomosynthesis for Indications for Clinical Questions Concerning Pathologies of the Chest and Skeletal Structures: When Can CT Been Omitted?
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Lung Disease
Wrist Fracture
Keywords: Tomosynthesis
osteosynthetic implant
CT
monitoring
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2015-06-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population included in this study are patients who are referred to our hospital for evaluation of lung-changes or evaluation of the wrist after fracture or surgery.

Brief summary: The investigators propose tomosynthesis as a imaging method in between of x-ray and CT. The expected value of this project is the definition of proven indications for tomosynthesis, which allow replacing CT. Specific goals are the early detection of pulmonary consolidations / parenchymal changes as well as the monitoring of patients with ostesynthetic implants.

Detailed description: The investigators propose tomosynthesis as a imaging method in between of x-ray and CT. The expected value of this project is the definition of proven indications for tomosynthesis, which allow replacing CT. Specific goals are the early detection of pulmonary consolidations / parenchymal changes as well as the monitoring of patients with ostesynthetic implants.

This is a prospective, single-center, non-randomised, non-blinded trial with Tomosyntheis of Patients referred to the investigators institution to assess lung alterations and bone structure. All patients will undergo chest x-ray and tomosynthesis after informed consent. In addition they will undergo an ultralow-dose CT, wich is used as standart reference. The radiation dose of each method will be recorded. After completion of these three examinations, the participation in the study is completed.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for evaluation of lung-changes
* Patients scheduled for evaluation of the wrist after fracture or surgery

Exclusion Criteria:

* general contraindications for x-Ray
* general contraindications for CT
* pregnancy

Primary outcomes:
measure: Non-Inferiority CT
timeFrame: when scheduled for x-ray - 52 weeks
Secondary outcomes:
measure: Superiority to x-ray
timeFrame: when scheduled for x-ray - 52 weeks
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich - Diagnostic Radiology
Study officials:
affiliation: University Hospital Zurich, Radiology
name: Thoams Frauenfelder, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02143180: Accuracy of RTE for Evaluating Hepatic Fibrosis in Chronic Hepatitis: a Prospective Multicenter Study
Official title: Accuracy of Real-time Tissue Elastography for Evaluating Hepatic Fibrosis in Chronic Hepatitis: a Prospective Multicenter Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Hepatitis
Keywords: real-time tissue elastography
hepatic fibrosis
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2014-05-20
Enrollment: 500
Sex: ALL
Minimum age (years): 5
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic hepatitis

Brief summary: Our study is a prospective multicenter research and the aim is to explore a variety of suitable evaluation indicators and criteria for diagnosis of diffuse liver fibrosis, to get the corresponding diagnosis threshold, with the domestic common pathological S stages as the gold standard.


Eligibility criteria: Inclusion Criteria:

* 1. Patient has a history of chronic hepatitis on clinical diagnosis; 2. Patient undergoed liver biopsy during study time.

Exclusion Criteria:

* 1. Patient cannot receive examination due to critical condition; 2. Patient refuse the examination.

Primary outcomes:
measure: Liver Fibrosis Index (LFI)
timeFrame: During the examination
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The department of Ultrasound, the third affiliated hospital of Sun Yat-son University
state: Guangdong
Study officials:
affiliation: The department of Ultrasound, the third affiliated hospital of Sun Yat-son University
name: Rogqin RQ Zheng, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06841380: Plaque Reduction Sesame-based Oil
Official title: The Plaque Reducing Efficacy of Oil Pulling with Sesame-Based Oil. a Randomized-controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Plaque
Gingivitis
Oral Microbial Colonization
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2025-02-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this clinical trials to learn about potential additives in reducing dental plaque. The main questions it aims to answer is:

• is there a difference in the plaque reducing effect of oil pulling with sesame-based oil compared to rinsing with distilled water? Participants will rinse with 15 ml of their allocated liquid for 15 min every morning for 8 weeks.

Researchers will compare sesame-based oil against distilled water to see if there is a difference in the plaque reducing effect.


Eligibility criteria: Inclusion Criteria:

age ≥ 18 years contractual capability the presence of ≥ 10 teeth, community periodontal index of treatment needs (CPITN) grade 1 or 2

Exclusion Criteria:

missing consent community periodontal index of treatment needs (CPITN) grade 0, 3 or 4 pregnancy or breastfeeding systemic diseases or conditions that are associated with an increased risk of infection or necessitate concomitant antibiotic therapy with dental treatment mental and behavioral disorders that impede (verbal) communication allergy against sesame(oil) intake of antibiotics 6 months prior to or during study duration intake of medication potentially influencing gingival inflammation or bleeding (e.g. anticoagulants, cortisone) infectious diseases (e.g. HIV, hepatitis B or C) fixed orthodontic appliances ongoing oil pulling or mouth rinsing adult guardianship insufficient nasal breathing

Primary outcomes:
measure: Rustogi Modified Navy Plaque Index (RMNPI)
timeFrame: first follow up after 4 weeks, full study duration 8 weeks
Secondary outcomes:
measure: Gingival Index (GI)
timeFrame: first follow up after 4 weeks, full study duration 8 weeks
measure: microbial analysis
timeFrame: first follow up after 4 weeks, full study duration 8 weeks
measure: Oral Health Impact Profile (OHIP)
timeFrame: first follow up after 4 weeks, full study duration 8 weeks
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medical University Innsbruck
state: Tyrol
Study officials:
References:
Clinical trial NCT02364180: Electromyography in Patients on Chronic Pyridostigmine Therapy
Official title: Electromyography With Repetitive Nerve Stimulation in Patients on Chronic Pyridostigmine Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Weakness
Lead sponsor: University of Toledo
Sponsor class: OTHER
First posted: 2015-02-16
Enrollment: 11
Sex: ALL
Minimum age (years): 12
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All subjects taking Pyridostigmine for at least 6mo, except for myasthenia gravis patients, will be considered for the study.Those that participate will answer a few questions pertaining to their medical history and will then undergo electromyography (CMAP) measurement with repetitive stimulation at 2 sites (ulnar nerve at the wrist and the accessory nerve in the neck). The first and fifth stimuli are delivered 2 seconds apart. Eight percent or greater decrement in the CMAP response on repetitive stimulation will be considered positive.
Primary purpose: SUPPORTIVE_CARE

Brief summary: We intend to measure evoked EMG at two sites in subjects who are chronically taking pyridostigmine.

Detailed description: The investigators are intending to enroll Patients who are chronically treated with pyridostigmine for the treatment of any medical condition and presenting at the investigators' outpatient clinics for follow up appointment. Subjects taking pyridostigmine for the treatment of myasthenia gravis will be excluded. Both adults and children older than 12 years of age will be approached. Those subjects that agree to participate will be asked to sign an informed consent. For the participation of minors a parental (or guardian) consent and subject assent will be obtained. Those that participate will answer a few questions pertaining to their medical history and will then undergo electromyograph (CMAP) measurement with repetitive stimulation at 2 sites (ulnar nerve at the wrist and the accessory nerve in the neck). Evoked electromyogram will be recorded on a computer hard drive. Eight percent or greater decrement in the CMAP response on repetitive stimulation will be considered positive.

Eligibility criteria: Inclusion Criteria:

* Subjects who have been taking pyridostigmine for the treatment of any condition other than myasthenia gravis

Exclusion Criteria

* Subjects taking pyridostigmine for the treatment of myasthenia gravis will be excluded.

Primary outcomes:
measure: Percent Change in the Amplitude of Evoked Compound Muscle Action Potential by Electromyography Between the First to Fifth Response
timeFrame: Baseline measurement only. First and Fifth stimuli delivered 2 seconds apart on the same day. There are no additional days/times.
Secondary outcomes:
Other outcomes:
Locations:
city: Toledo
country: United States
facility: University of Toledo, Health Science Campus
state: Ohio
Study officials:
affiliation: The University of Toledo
name: Shashi Bhatt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06255080: Comparing Skills Acquisition on Different Laparoscopy Software
Official title: Re-defining Proficiency Levels Might be Necessary When Virtual Reality Simulator Software is Updated - a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Simulation Training
Laparoscopy
Lead sponsor: Copenhagen Academy for Medical Education and Simulation
Sponsor class: OTHER
First posted: 2024-02-12
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Simulation based training is a standard part of surgical training. Over the years virtual reality simulator have been more and more integrated into the surgical curriculum for surgical novices.

Evidence shows that practicing using proficiency-based training programs significantly reduces the operation time and complication rates for during intial operations for young doctors.

The aim of this trial is to examine if skills obtained on a newer software version is transferable to the original software.


Eligibility criteria: Inclusion Criteria:

* Medical students without any prior laparoscopy experience in both a clinical or simulated setting

Exclusion Criteria:

* Prior experience with simulation based laparoscopy or clinical experience with laparoscopy

Primary outcomes:
measure: Time to reach proficiency (in minutes)
timeFrame: 1-2 months
Secondary outcomes:
measure: Transferability of skills
timeFrame: 2-3 weeks
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen Academy for Medical Education and Simulation
state: Capital Region
Study officials:
References: