louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02096185: Is Any Additional Information Gained Regarding Margins Using 3D Tomosynthesis Vs 2D Conventional Digital Imaging When Imaging Operative Breast Specimens?
Official title: Is Any Additional Information Gained Regarding Lesion to Margin Measurement Using 3D Tomosynthesis Imaging Versus 2D Conventional Digital Imaging When Imaging Specimens of Breast Tissue Removed at Therapeutic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: Breast cancer
Surgery
Specimen imaging
Lead sponsor: Sandwell & West Birmingham Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2014-03-26
Enrollment: 50
Sex: FEMALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Patients who are diagnosed with breast cancer will have surgery to remove the tumour. Where this is a local excision not mastectomy, the tissue removed is sent for x-ray imaging to assess that the abnormality has been removed and give an estimation of the distance from lesion to specimen edge. This allows the surgeon to decide whether to remove more tissue or not at the time. This study is designed to compare whether more accurate information about lesion to margin measurement can be obtained using 3 dimensional tomosynthesis imaging compared to 2 dimensional conventional digital imaging which is the type of imaging currently used. This has the potential to prevent some patients requiring a second operation to remove more tissue if the margins of the specimen are still involved with tumour.

The study involves x-raying the specimen under both conditions when it arrives from theatre. Only the 2D image will be reviewed at the time as is current practice. The 3D image will be reviewed later and the measurements for lesion to specimen margin compared. The lesion to margin measurement as recorded by the pathologist will be taken as the 'gold standard' and the imaging measurements will also be compared to that.

In theory, the use of 3D tomosynthesis should allow more accurate lesion to margin measurement because 3D can provide better visualisation of the lesion edges by removing the effect of superimposed tissue.

The hypothesis states that the use of 3 dimensional tomosynthesis imaging should provide better lesion visualisation compared to 2 dimensional conventional digital imaging thus allowing more accurate lesion to margin measurement.


Eligibility criteria: Inclusion Criteria:

* Patient requires surgery to remove breast cancer and operative specimen needs to be x-rayed

Exclusion Criteria:

* Patients with breast cancer who need mastectomy

Primary outcomes:
measure: Shortest distance in mm from visible lesion to specimen margin
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Sandwell and West Birmingham Hospitals NHS Trust
state: West Midlands
Study officials:
affiliation: Sandwell & West Birmingham Hospitals NHS Trust
name: Jennifer Waldron
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03418285: Trimethylamine N-oxide in Myocardial Infarction
Official title: Microbiota-derived Trimethylamine N-oxide as Residual Risk After ST-elevation Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Infarction
Lead sponsor: Yokohama City University Medical Center
Sponsor class: OTHER
First posted: 2018-02-01
Enrollment: 112
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: STEMI

Brief summary: Trimethylamine-N-oxide (TMAO) is produced from the metabolism of gut microbiota and is reportedly pro-atherogenic and associated with cardiovascular events. The purpose of this study is to investigate the sequential change in TMAO levels by current optimal secondary prevention therapies in patients with ST-elevation acute myocardial infarction (STEMI) and the clinical impact of TMAO levels on the progression of atherosclerosis and subsequent cardiovascular events.

Detailed description: This study includes patients with their first STEMI. The investigators measure plasma TMAO levels using the frozen plasma at the onset of STEMI and 10 months later (the chronic phase). To assess plaque progression, residual SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score and chronic-phase SYNTAX score are measured. After the chronic-phase assessment of TMAO and SYNTAX score, patients are followed for cardiovascular events including death, myocardial infarction, ischemic stroke, and unstable angina pectoris with coronary revascularization.

Eligibility criteria: Inclusion Criteria:

* Patients who admitted to the Yokohama City University Medical Center with the diagnosis of their first STEMI and who underwent primary percutaneous coronary intervention within 12 hours after onset and received follow-up coronary angiogram 10 months after the index intervention.

Exclusion Criteria:

* none

Primary outcomes:
measure: MACE
timeFrame: 6 years
Secondary outcomes:
measure: Coronary plaque progression
timeFrame: 10 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01889485: Screening and Access to Health Care for Vascular Disease
Official title: Screening and Access to Health Care for Vascular Disease in Urban and Suburban Patient Populations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Aneurysm, Abdominal
Carotid Stenosis
Peripheral Arterial Disease
Keywords: Aortic Aneurysm, Abdominal
Carotid Stenosis
Peripheral Arterial Disease
Health Services Accessibility
Lead sponsor: Endeavor Health
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2013-06-28
Enrollment: 190
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Volunteer subjects age 55 and over who sign informed consent will be enrolled in three separate neighborhoods in the Chicago area (North, South, West).

Brief summary: This is a pilot study designed to validate our methods of recruitment, screening and data collection in the community. The project will help to establish the feasibility of the study design to lay the groundwork for a potentially larger study. The final study will allow us to estimate the incidence and prevalence of abdominal aortic aneurysm (AAA), carotid artery stenosis, and peripheral artery disease (PAD) in different geographic areas in a large urban setting, as well as determine patient access to healthcare and treatment for vascular disease as related to geographic and racial differences.


Eligibility criteria: Inclusion Criteria:

* age 55 or older
* willing/able to provide consent
* willing to participate in follow-up phone calls at defined intervals for up to 5 years

Exclusion Criteria:

* unable to provide consent to participate
* unwilling/unable to participate in the follow-up phone call

Primary outcomes:
measure: Geographic and racial differences in access to follow-up care if significant disease is identified through the screening event
timeFrame: 5 years
Secondary outcomes:
measure: Geographical and racial differences in patterns of accessing healthcare prior to the screening events.
timeFrame: 1 year
measure: Differences in rates of interventions throughout the 5 year follow-up period.
timeFrame: 5 years
measure: Differences in the rates of complications related to treatment of vascular disease in the various geographic areas in which the events are held.
timeFrame: 5 years
Other outcomes:
Locations:
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
Study officials:
affiliation: Endeavor Health
name: Omar Morcos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02855385: Barriers to Care in Patients With Rectal Bleeding in Nigeria
Official title: Health-seeking Behavior and Barriers to Care in Patients With Rectal Bleeding in Nigeria
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Keywords: Rectal bleeding, , ,
Attitude
Health seeking behaviour
Nigeria
Screening
high risk patients
Lead sponsor: Obafemi Awolowo University Teaching Hospital
Sponsor class: OTHER
Collaborators: name: Memorial Sloan Kettering Cancer Center
name: University of Ilorin Teaching Hospital
name: University College Hospital, Ibadan
First posted: 2016-08-04
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with Rectal bleeding who consented to the study

Brief summary: This study sought to find the health seeking behavior of patients with rectal bleeding as related to their risk to develop colorectal cancer and also assess the general practitioner's perceived barriers to colonoscopy for patients with bleeding per rectum.

Detailed description: Patients who had rectal bleeding are invited to electronic media and print media will be invited for free medical consultation. Consented patients will complete a purposely design questionnaire for the study to assess the knowledge, attitude and practice of patient with rectal bleeding as regard the possibility of occurrence of colorectal cancer.

General practitioners in three cities will be contacted to assess their screening strategy for patients with rectal bleeding

Eligibility criteria: Inclusion Criteria:

* All adult patients with rectal bleeding that persisted for up to one month

Exclusion Criteria:

* Patient that has the cause of rectal bleeding already determined before presentation

Primary outcomes:
measure: Knowledge score in relations to the demographics of patients with rectal bleeding
timeFrame: 60 days
measure: Colonoscopy referral triggers among General Practitioners (GP)
timeFrame: 60 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01079585: The Effect of 40gr Okara on Gastric Emptying
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy People
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Nutrigal LTD
First posted: 2010-03-03
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The effect of 40gr Okara, on gastric emptying of standard meal (Muffin cake)

Detailed description: This trail will be a single blinded, cross-over design. The study population will include 10 subjects. The patients will be randomly assigned to receive one of two Muffin cakes, with or without 40 grams Okara on three occasions (three visits). In two visits the subject will receive a Muffin cake with 40 grams Okara (but with similar caloric value), and in one visit a Muffin cake without Okara.

Postprandial gastric emptying time will be measured for each subject, by 13C Breath Test.

Okara is a natural water extracted food grade soy product, contains approximately 35% protein (mfb), and about 43% of dietary fibers.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Age 20-65 years old
* Written Informed Consent

Exclusion Criteria:

* History of gastro-intestinal surgery
* On medication that may influence gastric emptying, or medication for weight loss
* Patient on PPI treatment, H2 Blockers or medication for weight loss
* Known allergies to soy
* Pregnancy or breast-feeding
* Smoking
* Athletes
* Metabolic syndrome or diabetes mellitus
* Family history of metabolic syndrome or diabetes mellitus
* Weight loss \> 2 kg during two months before the study

Primary outcomes:
measure: To investigate the influence of 40 gram Okara on gastric emptying
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Medical Center
Study officials:
References:
Clinical trial NCT01746485: Three Times Daily Dosing of UT-15C
Official title: A PK Evaluation of Three Times Daily Dosing of UT-15C SR Tablets in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Volunteers
Lead sponsor: United Therapeutics
Sponsor class: INDUSTRY
First posted: 2012-12-11
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: To evaluate the pharmacokinetics of three-times daily dosing of UT-15C in healthy volunteers


Eligibility criteria: * Healthy male and female subjects
* aged 18-55 years of age;
* weight between 50 and 100 kg, with a body mass index (BMI) between 19.0 and 29.9 kg/m2, inclusive for female subjects and
* weight between 50 and 120 kg, with a BMI between 19.0 and 32.0 kg/m², inclusive for male subjects.

Primary outcomes:
measure: Area under the curve (AUC) from 0-24hrs after 6 days of TID dosing.
timeFrame: 6 days
Secondary outcomes:
measure: PK profile of UT-15C after a single 0.5mg dose on Day 1
timeFrame: 1 day
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD Development
state: Texas
Study officials:
affiliation: PPD Development, LP
name: Theresa Pham, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jones A, Wang-Smith L, Pham T, Laliberte K. Pharmacokinetics of 3 times a day dosing of oral treprostinil in healthy volunteers. J Cardiovasc Pharmacol. 2014 Mar;63(3):227-32. doi: 10.1097/FJC.0000000000000039.
Clinical trial NCT00693485: Safety and Effects of Brimonidine Intravitreal Implant in Patients With Glaucomatous Optic Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glaucoma, Open-Angle
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2008-06-09
Enrollment: 70
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: A multicenter, randomized, patient-masked, sham-controlled evaluation of the safety and effects on visual function of brimonidine intravitreal implant in patients with glaucomatous optic neuropathy. Patients will be followed for up to 1 year.


Eligibility criteria: Inclusion Criteria:

* Primary open-angle glaucoma in one eye
* Visual acuity 20/80 or better
* Intraocular pressure in the study eye ≤ 24 mm Hg
* Glaucomatous visual field loss - 7 dB to - 25 dB

Exclusion Criteria:

* Known allergy to brimonidine tartrate
* Uncontrolled systemic disease or infection of the eye
* Recent eye surgery or injections in the eye
* Female patients who are pregnant, nursing or planning a pregnancy

Primary outcomes:
measure: Percentage of Patients With a Visual Field Improvement in the Study Eye
timeFrame: Baseline, Month 6
Secondary outcomes:
measure: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
timeFrame: Baseline, Month 6
Other outcomes:
Locations:
city: Artesia
country: United States
state: California
city: Tel Aviv
country: Israel
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05273385: Efficacy of the Nanodropper Device on Intraocular Pressure in Patients With Glaucoma
Official title: Efficacy of the Nanodropper Device on Intraocular Pressure in Patients With Glaucoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glaucoma
Ocular Hypertension
Open Angle Glaucoma
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Nanodropper, Inc.
name: Icare Finland Oy
First posted: 2022-03-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Glaucoma is the leading cause of irreversible blindness worldwide. Previous studies demonstrate that smaller eye drops used in the treatment of glaucoma are just as efficacious as their larger counterparts. The proposed study hopes to demonstrate the non-inferiority of using Nanodropper to lower intraoccular pressure (IOP) in glaucoma patients compared to standard of care eye drops.

Detailed description: The proposed study strives to demonstrate the non-inferiority of using Nanodropper to lower IOP in glaucoma patients compared to standard of care (SOC) eye drops in a randomized trial.

Primary Aim: Demonstrate non-inferiority of using Nanodropper to lower IOP compared to standard of care eye drops in glaucoma patients.

Stable glaucoma participants and ocular hypertension participants of ages 18+ will be randomized to either use Nanodropper for eye drop administration in both eyes OR administer drops regularly (standard of care) in both eyes. Participants will be followed-up at 1 month and 3 months.

Eligibility criteria: Inclusion Criteria:

1. 18 years old or older
2. Diagnosis of open-angle glaucoma (OAG) or ocular hypertension (OHT)
3. Use of prostaglandin analogue (PGA) eye drop
4. Stable disease status (no visual field loss progression or increase in IOP-lowering medications in the last 6 months)

Exclusion Criteria:

1. Uncontrolled glaucoma
2. Have had eye surgery (including laser procedures) within the past six months
3. Have a diagnosis of acute angle-closure glaucoma and/or other retinal diseases
4. Use of non-PGA class of IOP-lowering medication

Primary outcomes:
measure: Intraocular pressure (IOP) at Baseline
timeFrame: At Baseline
measure: Intraocular pressure (IOP) at Month 1
timeFrame: 1 month
measure: Intraocular pressure (IOP) at Month 3
timeFrame: 3 months
Secondary outcomes:
measure: Survey
timeFrame: 3 months
measure: Conjunctival Grading at Baseline
timeFrame: At baseline
measure: Conjunctival Grading at Month 3
timeFrame: 3 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Julius Oatts, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04952285: The Efficacy and Safety of the Loading Dose of Tranexamic Acid in Scoliosis Surgery During Perioperative
Official title: The Efficacy and Safety of the Loading Dose of Tranexamic Acid in Scoliosis Surgery During Perioperative
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tranexamic Acid
Keywords: tranexamic acid
Blood conservation
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-07-07
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: age:18-60 years old；American Society of Anesthesiologists (ASA):I-II；The spinal orthopedic undergoing elective surgery

Brief summary: This study intends to make full use of the advantage of spinal orthopedic surgery in our medical center.Analyze the blood loss and blood coagulation function and the influence of safety of load dose tranexamic acid (TXA) in scoliosis surgery during perioperative.


Eligibility criteria: Inclusion Criteria:

* age:18-60 years old
* American Society of Anesthesiologists (ASA):I-II
* The spinal orthopedic undergoing elective surgery

Exclusion Criteria:

* Severe cardiopulmonary dysfunction
* Blood coagulation dysfunction
* Disorders of liver and kidney function
* Tranexamic acid allergies
* The history of pulmonary embolism and venous thrombosis of lower limbs
* Anticoagulant drugs and nonsteroidal anti-inflammatory drugs in 7 days

Primary outcomes:
measure: Intraoperative blood loss
timeFrame: At the end of the surgery
measure: Incision drainage Incision drainage Incision drainage after surgery
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Autologous blood doping
timeFrame: At the end of the surgery
measure: red blood cell transfusion
timeFrame: At the end of the surgery
measure: Plasma infusion
timeFrame: At the end of the surgery
measure: HB
timeFrame: Within 1 week before surgery；1 day after surgery
measure: WBC
timeFrame: Within 1 week before surgery；1 day after surgery
measure: PTL
timeFrame: Within 1 week before surgery；1 day after surgery
measure: PT
timeFrame: Within 1 week before surgery；1 day after surgery
measure: APTT
timeFrame: Within 1 week before surgery；1 day after surgery
measure: INR
timeFrame: Within 1 week before surgery；1 day after surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02569385: Examination of Cardiovascular Function/ Cardio Respiratory Interaction on Spontaneous Breathing Trials in Patients in the Prolonged Weaning
Official title: Examination of Cardiovascular Function/ Cardio Respiratory Interaction on Spontaneous Breathing Trials in Patients in the Prolonged Weaning
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiovascular Disease
Keywords: Weaning TTE
patients in prolonged weaning
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2015-10-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in prolonged weaning (Group 3 by Boles) with NYHA I-II, who come to the Department of Intensive Care Medicine RTWH Aachen University, will be recruited in the study. Recruitment will be performed in accordance to the inculsion and exclusion criteria.

Brief summary: The aim of the present study is to determine the cardiovascular function/ cardio respiratory interaction on spontaneous breathing trials in patients with prolonged weaning.


Eligibility criteria: Inclusion Criteria:

* legal Age (≥18 years)
* written informed consent Prior to study participation
* patient in prolonged weaning with NYHA I-II and an actual positive Ventilator Screening test:

  1. PaO2 ≥ 60 mmHg at FiO2 ≤ 0.4
  2. PEEP ≤ 8 cmH2O
  3. Glasgow Coma Scale \> 13
  4. Temp. \< 38°C
  5. Hb \> 80-100 g/L
  6. less requirement on catecholamines (\<0.1µg/kg/min)
* and on these patients are already performed a spontaneous breathing trial with following result:

  1. abortion this spontaneous breathing trial \< 30min, but possible \> 10min
  2. reason for an abortion was NOT hypercapnia

Exclusion Criteria:

* weaning patients are assigned on Group 1-2
* patient with heart failure (NYHA III-IV) and/ or other cardiac comorbidity
* acute NSTEMI (non-ST-segment elevation myocardial infarction)
* pregnancy and breast-feeding

Primary outcomes:
measure: Baseline measurement (Modus "CPAP-PS") in patient with prolonged weaning
timeFrame: 12 months
Secondary outcomes:
measure: Intervention measurement in patient with prolonged weaning
timeFrame: 12 months
Other outcomes:
Locations:
city: Aachen, 52074
country: Germany
facility: University Hospital RWTH Aachen, Department of Medical Clinic I
Study officials:
affiliation: Uniklinik RWTH Aachen, Med. Klinik I
name: Michael Dreher, MD
role: PRINCIPAL_INVESTIGATOR
References: