louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06008301: Comparing Breast Magnetic Resonance Imaging (MRI) and Contrast-enhanced Mammography (CEM)
Official title: Comparing Impact of Contrast-enhanced Mammography (CEM) to Breast MRI on Barriers to Breast Cancer Treatment
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Cancer Female
Keywords: Contrast enhanced mammography (CEM)
Breast MRI
Financial costs
Time costs
State-trait anxiety inventory (STAI)
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Breast Cancer Alliance
First posted: 2023-08-23
Enrollment: 0
Sex: FEMALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The investigators will study the financial, time, and psychologic benefit of Contrast Enhanced Mammography (CEM) compared with Magnetic Resonance Imaging (MRI) for breast cancer evaluation and ultimately encourage practices and referring providers to use it more routinely in practice.

Specific research objectives are to:

* determine financial costs of performing a CEM to breast MRI
* compare time costs involved with CEM to breast MRI
* compare psychologic costs involved with CEM to breast MRI.


Eligibility criteria: Inclusion Criteria:

* Age \> or equal to 30 years
* Clinically eligible for CEM or breast MRI
* Newly diagnosed cancer

Exclusion Criteria:

* Pregnant as verified by patient report. Given that this test is being performed for clinical purposes, the determination of pregnancy status will be resolved via the standard clinical pathway.

Primary outcomes:
measure: Institutional financial costs
timeFrame: 24 months
measure: Patient financial costs
timeFrame: 24 months
measure: Time from diagnosis to imaging modality (CEM or MRI)
timeFrame: 24 months
measure: Time from diagnosis to first treatment
timeFrame: 24 months
measure: Number of patient visits generated from the imaging modality
timeFrame: 24 months
measure: Psychologic costs to patients
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Boston Medical Center, Dept of Radiology
name: Jordana Phillips, MD FSBI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00804401: Bioequivalence Study Between Two Oral Formulations of Naproxen 500 mg Tablets Under Fasting Conditions
Official title: Randomized, 2-Way Crossover, Bioequivalence Study of Two Oral Formulations of Naproxen 500 mg Tablets Administered as 1 x 500 mg Tablet in Healthy Subjects Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bioequivalency
Keywords: bioequivalency
Naproxen
Lead sponsor: Perrigo Company
Sponsor class: INDUSTRY
First posted: 2008-12-08
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Compare the rate and extent of absorption of two oral formulations of Naproxen Tablets, administered as a 1 x 500 mg tablet under fasting conditions.


Eligibility criteria: Inclusion Criteria:

* healthy men or women, non-smoker, 18 years of age or older
* willing to participate and sign a copy of the informed consent form

Exclusion Criteria:

* clinically significant illnesses or surgery within 4 weeks prior to study dosing
* body mass index greater than or equal to 30.0
* recent history of drug or alcohol addiction or abuse
* pregnant or lactating women
* history of allergic response to naproxen, NSAIDs, or other related drugs, or to heparin
* history of allergic reactions such as asthma, rhinitis, nasal polyps, urticaria, and hypotension associated with the use of aspirin or other NSAIDs
* history or known presence of gastrointestinal ulceration, bleeding and perforation
* use of tobacco products within 6 months prior to study dosing
* evidence of a clinically significant disorder or whose laboratory results were deemed to be clinically significant
* receipt of any drugs as part of a research study within 30 days prior to study dosing

Primary outcomes:
measure: Bioequivalence was assessed on the pharmacokinetic variables Cmax, AUC,0-t, and AUC,0-infinity
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06549101: NLR and Emergency Surgery
Official title: Neutrophil-to-Lymphocyte Ratio and Mortality After Emergency Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Emergency Surgery
Keywords: Neutrophil-to-lymphocyte ratio
Emergency surgery
NLR
Lead sponsor: University of Chile
Sponsor class: OTHER
First posted: 2024-08-12
Enrollment: 851
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Emergency patients operated on at the Clinical Hospital of the University of Chile between January and December 2021

Brief summary: In the immune system, it has been observed that the preoperative neutrophil-to-lymphocyte ratio (NLR) is an index that reflects the state of inflammation and oxidative stress. In the perioperative period, NLR has been described as a predictor for patients who will develop renal injury, ischemic stroke, and myocardial injury. Since preoperative inflammation is a predictor of morbidity and mortality in patients undergoing non-cardiac surgery, a retrospective analysis of the inflammatory status of patients undergoing surgery at the center is proposed.

Detailed description: A retrospective analysis of patients operated on at the Clinical Hospital of the University of Chile is proposed. The search will be conducted in the electronic medical records of all patients operated on between January and December 2021, with no exclusion criteria for this analysis. Demographic data, complications, length of hospital stay, and specific characteristics such as the need for mechanical ventilation, time spent in intermediate care units, and ICU as well as total hospitalization time will be recorded. For the purpose of this study, the preoperative complete blood count of the patients will be analyzed to search for hematological variables that reflect the state of preoperative systemic inflammation.

Eligibility criteria: Inclusion Criteria:

* Availability of complete blood count in electronic medical records of all patients operated on between January and December 2021

Exclusion Criteria:

* None

Primary outcomes:
measure: NLR
timeFrame: Day of surgery
measure: Mortality
timeFrame: 6 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital Clínico de la Universidad de Chile
Study officials:
affiliation: Hospital Clínico de la Universidad de Chile
name: Felipe Maldonado, M.D., M. Sc.
role: STUDY_CHAIR
References:
Clinical trial NCT02025101: Characterization of Slow Coronary Flow
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiovascular Abnormalities
Vascular Diseases
Keywords: Slow Coronary Flow
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-12-31
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who were hospitalized with anginal pain

Brief summary: Description of the phenomena "Slow Coronary Flow" (SCF), according to the data that has been collected from patients hospitalized with specific criteria. Clinical follow-up of these patients to determine whether they suffered from any cardial or psychological disorders that might be a result of SCF.


Eligibility criteria: Inclusion Criteria:

* anginal pain
* laboratory markers
* pathological ECG for ischemia

Exclusion Criteria:

* obstructed coronary artery during catheterization
* very narrow coronary artery

Primary outcomes:
measure: Collection of characteristics of slow coronary flow from approximately 90 patient records
timeFrame: Six months
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Aaron Frimerman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02825901: Efficacy Testing of Djulis-Buckwheat Drink on Cardiovascular Protection
Official title: Efficacy Testing of Djulis-Buckwheat Drink on Cardiovascular Protection
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Prehypertension
Hypertension Stage 1
Lead sponsor: Taipei Medical University Hospital
Sponsor class: OTHER
First posted: 2016-07-07
Enrollment: 0
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the trial is to evaluate the effect of Djulis-Buckwheat drink on cardiovascular protection after ingesting for 8 weeks. In addition, the correlation between the supplement and the cardiovascular disease-related gene expression is evaluated. The results will be used for the application of functional products for cardiovascular protection.

Ninety subjects (age 30\~65) with Prehypertension or Hypertension stage 1 will be included and randomly allocated into 3 groups: Placebo, Djulis-Buckwheat and Buckwheat. The subjects will take sample (100 ml/day) for 8 weeks. Blood pressure will be measured on week 0, 1, 2, 4, 6 and 8. The blood biochemical parameters and gene expression analysis will be examined on week 2, 4, 6, 8 and 10 (the follow up).


Eligibility criteria: Inclusion Criteria:

* Systolic blood pressure 121-159 mmHg or Diastolic blood pressure 81-99 mmHg
* Age: 30-65

Exclusion Criteria:

* Have diagnosed and documented critical illness(NHI specification)
* Had emergency record or admission note in the past three months
* Not be pregnant or breast-feeding a child

Primary outcomes:
measure: Change of blood pressure
timeFrame: Baseline, 1, 2, 4, 6, and 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01306201: Novel Non-Invasive Monitoring Parameter in a Hospital Setting
Official title: A Novel Cardio-Respiratory Parameter in a Hospital Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Insufficiency
Respiratory Failure
Keywords: Hospital Setting
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2011-03-01
Enrollment: 63
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: General Care Floor Patients

Brief summary: Data collected from this study will be used to evaluate the performance of a monitoring algorithm.

Detailed description: The goal of this study is to assess equivalency, performance, and accuracy of a new monitoring algorithm in a hospital setting.

Eligibility criteria: Inclusion Criteria:

1. Subjects 18 years old or older
2. Written informed consent from the patient or their legally authorized representative before initiation of any study-related procedures
3. Subjects on general care floor

Exclusion Criteria:

1. Severe contact allergies to standard adhesive materials
2. Abnormalities that may prevent proper application of the device
3. Women who are pregnant or lactating
4. Subjects with significant arrhythmia

Primary outcomes:
measure: The Covidien Nellcor Respiration Rate Software Shall Determine Respiration Rate Measured as Mean and Standard Deviation With Accuracy That is Non-inferior to Predicate Device.
timeFrame: Participants were monitored for average of 30 minutes
Secondary outcomes:
measure: The Covidien Nellcor Respiration Rate Software Shall Calculate Respiration Rate With a Root Mean Square Difference (RMSD) of < 3 Breaths Per Minute Compared With a End-Tidal Carbon Dioxide Waveforms, With 95% Confidence.
timeFrame: Participants were monitored on average for 30 minutes
Other outcomes:
Locations:
city: Denver
country: United States
facility: The University of Colorado Health Sciences Center (UCHSC)
state: Colorado
city: Columbus
country: United States
facility: The Ohio State University Medical Center (OSUMC)
state: Ohio
Study officials:
affiliation: The Ohio State Medical Center, Dept of Anesthesia
name: Sergio Bergese, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado Denver, School of Medicine dept of Surgery Division of GI, Tumor and Endocrine Surgery
name: Robert McIntyre, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03651401: Scapular Muscle Endurance, Shoulder Pain, and Functionality
Official title: Scapular Muscle Endurance, Shoulder Pain, and Functionality in Patients With Rotator Cuff Related Shoulder Pain: A Matched, Case-Control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rotator Cuff Syndrome of Shoulder and Allied Disorders
Keywords: Scapula
Endurance
Disability
Rotator cuff lesions
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2018-08-29
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 23 patients and 23 age-gender matched healthy subjects who met the inclusion criteria were included to the study

Brief summary: The purpose of this study is to compare scapular muscle endurance (SME), shoulder pain, and functionality of patients with rotator cuff related shoulder pain (RCRSP) with those in the age-gender matched healthy controls and to evaluate the relationship between SME with shoulder pain, and functional impairments in patients with RCRSP.

Detailed description: Patients with RCRSP (n:23), and age-gender matched healthy controls (n:23) were included in the study. SME were measured by a one-kilogram dynamometer while the shoulder and elbows are flexed 90°. Self-reported pain intensity (activity, night, after SME and FIT-HaNSA) was assessed visual analog scale (VAS). Functionality was also assessed using the Functional Impairment test-hand, neck, shoulder, and arm (FIT-HaNSA).

Eligibility criteria: Inclusion criteria:

* Positive sign in two or more specific shoulder clinical tests;
* The presence of RCRSP in magnetic resonance imaging (MRI);
* At least 120° flexion, 25° abduction, and 30° external rotation movements of the shoulder;
* Being right arm dominant;
* No surgical history in the shoulder region.

Exclusion criteria:

* Patients with shoulder pathology other than RCRSP such as glenohumeral instability (capsular and ligamentous lesions, labral lesions, or bone lesions), bicipital tendon lesions, acromioclavicular joint osteoarthritis, glenohumeral joint osteoarthritis, adhesive capsulitis, shoulder or cervical surgery history,
* Neurological and systemic inflammatory diseases,
* Bilateral shoulder complaints,
* Cardiovascular system diseases,
* Pregnancy,
* Underwent shoulder-related physical therapy within the past three months.

Primary outcomes:
measure: Scapular muscle endurance
timeFrame: Baseline assessment, no follow-up
measure: Pain intensity
timeFrame: Baseline assessment, no follow-up
measure: Upper Limp Functional Performance
timeFrame: Baseline assessment, no follow-up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Gazi University
name: Selda BAŞAR
role: STUDY_CHAIR
References:
Clinical trial NCT00809601: Study of Different Kinds of Ear Tubes
Official title: Randomized Controlled Study of Transmyringeal Tubes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Recurrent Acute Otitis Media
Otitis Media With Effusion With Hearing Impairment
Lead sponsor: Danderyd Hospital
Sponsor class: OTHER
Collaborators: name: Centre for clinical research Vastmanland
First posted: 2008-12-17
Enrollment: 400
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There are different kinds of ear tubes that may be inserted into the tympanic membrane to relieve recurrent acute otitis and hearing impairment due to otitis media with effusion. The tubes differ in size, shape and material.

No-one knows if there are differences between the different kinds of tubes regarding complications.

The investigators' hypothesis is that there is differences between the different kinds of tubes regarding complications.

To test the investigators' hypothesis, the investigators are about to conduct a randomized controlled study of four kinds of tubes having two different material and two different shapes.


Eligibility criteria: Inclusion Criteria:

* Children aged 1-10 planned for bilateral ventilation tubes

Exclusion Criteria:

* Ongoing ear infection
* Previous insertion of ventilation tube

Primary outcomes:
measure: Time to complete expulsion of the ventilation tube from the tympanic membrane
timeFrame: 45 months
Secondary outcomes:
measure: Persistent tympanic membrane perforation
timeFrame: 45 months
measure: Need for tube extraction (pain or infection)
timeFrame: 45 months
measure: Pain leading to health care contact
timeFrame: 45 months
measure: Tube related ear infection
timeFrame: 45 months
measure: Obstruction of the tube
timeFrame: 45 months
measure: Presence of myringosclerosis
timeFrame: 45 months
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Danderyds Hospital
Study officials:
affiliation: ENT-dept Karolinska Hospital
name: Magnus von Unge, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre for clinical research Vastmanland
name: Johan Knutsson, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00999401: A Study of Oral Sapacitabine and Oral Seliciclib in Patients With Advanced Solid Tumors
Official title: A Phase I Study of Oral Sapacitabine and Oral Seliciclib in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: Cyclacel Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2009-10-21
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A study of sequential administration of oral sapacitabine and oral Seliciclib in patients with advanced solid tumors.

Detailed description: The primary objective of this study is to determine the maximum tolerated dose (MTD) or recommended phase II doses of sapacitabine and seliciclib administered sequentially or concomitantly. The secondary objectives are to evaluate antitumor activity of this sequential or concomitant treatment and to explore the pharmacodynamic effect of this treatment in skin and peripheral blood mononuclear cells.

Eligibility criteria: Inclusion Criteria:

* Incurable advanced solid tumors that are no longer responding to conventional therapy or for which no effective therapy exists; at the RD of Part 1, an extension cohort up to 20 patients with metastatic breast cancer who are known to be BRCA mutation carriers will be enrolled.
* Age 18 years or older
* ECOG 0-2
* Life expectancy ≥ 3 months
* Evaluable disease
* Adequate bone marrow function
* Adequate renal function
* Adequate liver function
* At least 3 weeks from prior systemic treatments including investigational anti-cancer therapy, radiation therapy; and have recovered from prior toxicities
* Able to swallow capsules
* At least 3 weeks from major surgery
* Agree to practice effective contraception
* Ability to understand and willingness to sign the informed consent form

Exclusion Criteria:

* Previously untreated CNS metastases or progressive CNS metastases
* Currently receiving radiotherapy, biological therapy, or any other investigational agents
* Uncontrolled intercurrent illness including
* Pregnant or lactating women
* Known to be HIV-positive
* A history of active hepatitis B and/or hepatitis C infection

Primary outcomes:
measure: maximum tolerated dose
timeFrame: 1-3 months
Secondary outcomes:
measure: tumor response rate
timeFrame: 1-3 months
measure: pharmacodynamic effects in skin and peripheral mononuclear cells
timeFrame: 1-3 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Geoffrey Shapiro, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Dana-Farber Cancer Institute
name: Sara Tolaney, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shapiro GI, et al. Responses to sequential sapacitabine and seliciclib in patients with BRCA-deficient solid tumors. Cancer Res April 15, 2013 73; LB-202.
Clinical trial NCT06215001: Individualized Selection of PEEP in Patients Affected by Expiratory Flow Limitation
Official title: Individualized Selection of PEEP in Patients Affected by Expiratory Flow Limitation: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postoperative Complications
Mechanical Ventilation Complication
Lead sponsor: Università degli Studi di Ferrara
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 1536
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare different mechanical ventilation settings in Patients undergoing laparoscopic surgery and affected by Expiratory flow limitation. The main question\[s\] it aims to answer are:

* If individualizing mechanical ventilation on expiratory flow limitation can reduce pulmonary postoperative complications;
* If patients with expiratory flow limitation have a higher incidence of pulmonary postoperative complications as compared to patients with no expiratory flow limitation;

Participants will be screened for expiratory fow limitation and patients with positive screening will be randomized into two groups. Each group will receive a different intraoperative mechanical ventilation:

* Personalized positive end-expiratory pressure based on EFL
* Standard of care positive end-expiratory pressure

Researchers will then compare the two groups to see if the incidence of pulmonary postoperative complications in the first 7 days after surgery is different.


Eligibility criteria: Inclusion Criteria:

* Ages between 18 and 90 years old;
* Patients undergoing laparoscopic, robotic surgery
* Surgery performed in elective regimen;
* Length of mechanical ventilation more than 120 minutes;
* Presence of invasive pressure monitoring for clinical purposes;

Exclusion Criteria:

* Age \< 18 or \> 90;
* Severe chronic obstructive pulmonary disease with GOLD stage 3 or 4;
* Length of mechanical ventilation less than 120 minutes;
* Unplanned conversion to laparotomy surgery;
* Refusal to participate by the patient;
* Anesthesia maintenance using Desflurane.

Primary outcomes:
measure: Postoperative pulmonary complications
timeFrame: First 7 days after surgery
Secondary outcomes:
measure: Postoperative Oxygenation
timeFrame: Within 2 hours after surgery
measure: Need for intubation or non-invasive ventilation
timeFrame: First 7 days after surgery
measure: Days of hospitalization
timeFrame: From hospital entrance to hospital discharge, assessed up to 30 days
measure: Need for Intensive Care admission
timeFrame: From hospital entrance to hospital discharge, assessed up to 30 days
measure: Length of stay in ICU
timeFrame: From intensive care entrance to intensive care discharge, assessed up to 30 days
Other outcomes:
Locations:
Study officials:
References: