louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05056818: Comparison of Synthetic Mammography Versus Full-Field Digital Mammography in Image Interpretation and Performance Metrics
Official title: Comparison of Synthetic Mammography Versus Full-Field Digital Mammography in Image Interpretation and Performance Metrics
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Carcinoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-09-27
Enrollment: 750
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have undergo mammography between August 1, 2018 and August 31, 2020

Brief summary: This study compares synthetic mammography to full-field digital mammography in image interpretation and performance metrics. Digital breast tomosynthesis (DBT) has previously been found to be superior in performance to standard digital mammography in both screening and diagnostic settings for the early detection and improved diagnosis of breast cancers. DBT in combination with full-field digital mammography (FFDM) reduces recall rates and increases cancer detection rates relative to FFDM alone. Synthetic mammography is a 2-dimensional reconstructed image, using the dataset derived from the DBT acquisition, without requiring additional radiation dose. Collecting information from patients' medical records may help doctors analyze the characteristics, utility, and impact of synthetic mammography to compared to FFDM.

Detailed description: PRIMARY OBJECTIVE:

I. To analyze the characteristics, utility, and impact of synthetic mammography (SM), as compared with full-field digital mammography (FFDM).

OUTLINE:

Patients' medical records and past imaging examinations are reviewed.

Eligibility criteria: Inclusion Criteria:

* Female
* Age 18 or older
* Consecutive cases in breast imaging center

Exclusion Criteria:

* Cases demonstrate administrative or technical errors (e.g. missing views, labeling inconsistent with report, etc.)

Primary outcomes:
measure: To analyze the impact of synthetic mammography (SM), as compared with full-field digital mammography (FFDM
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Ray C Mayo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01819818: A Study to Observe the Safety and Tolerability of Paliperidone Palmitate (Invega Sustenna) in Korean Schizophrenic Patients
Official title: Korea Post-Marketing Surveillance of Invega Sustenna
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Keywords: Schizophrenia
Paliperidone palmitate
Invega
Sustenna
Korea
Lead sponsor: Janssen Korea, Ltd., Korea
Sponsor class: INDUSTRY
First posted: 2013-03-28
Enrollment: 3267
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: Participants with schizophrenia and prescribed with paliperidone palmitate for acute or maintenance treatment.

Brief summary: The purpose of this study is to evaluate the safety and tolerability of paliperidone palmitate over a 9-week period for participants with schizophrenia in Korea.

Detailed description: This is an open-label (all people know the identity of the intervention), multi-center, prospective (look forward using observations collected following participant enrollment), non-comparative, non-randomized (the study medication is not assigned by chance), study. Safety and efficacy of paliperidone palmitate will be observed in Korean schizophrenic participants for 25 weeks. Approximately 3000 participants will be observed in this study and the study duration will be 25 weeks. Safety evaluations will include assessment of adverse events, concomitant medications, physical examination, and psychiatric history.

Eligibility criteria: Inclusion Criteria:

* Participants diagnosed with schizophrenia
* Participants prescribed with paliperidone palmitate for acute or maintenance treatment

Exclusion Criteria:

* Participants who received paliperidone palmitate for other than the approved indication

Primary outcomes:
measure: Number of participants with adverse events up to Week 9
timeFrame: Up to Week 9
Secondary outcomes:
measure: Number of participants with adverse events up to Week 25
timeFrame: Up to Week 25
measure: Change from baseline in Clinical Global impression-Severity (CGI-S) scale scores
timeFrame: Baseline (Day 1), Week 5, Week 9, Week 13, Week 17, Week 21, and Week 25
measure: Change from baseline in Personal and Social Performance (PSP) scale scores
timeFrame: Baseline (Day 1), Week 5, Week 9, Week 13, Week 17, Week 21, and Week 25
Other outcomes:
Locations:
city: KyungKi
country: Korea, Republic of
Study officials:
affiliation: Janssen Korea, Ltd., Korea
name: Janssen Korea, Ltd., Korea Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT02452918: A Study to Evaluate the Safety of a Single Intravenous (IV) Dose of Orbactiv (Oritavancin) in Participants on Chronic Warfarin Therapy Being Treated For Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
Official title: An Open-Label Study to Evaluate the Safety of a Single 1200 mg IV Dose of Orbactiv (Oritavancin) in Subjects on Concomitant Chronic Warfarin Therapy Being Treated For Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Bacterial Skin and Skin Structure Infection
Keywords: skin infection
Lead sponsor: The Medicines Company
Sponsor class: INDUSTRY
First posted: 2015-05-25
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This was a Phase 4, multicenter, open-label safety study of a single 1200 milligrams (mg) IV infusion of oritavancin in adult participants on chronic warfarin with acute bacterial skin and skin structure infection (ABSSSI) suspected or proven to be caused by Gram-positive pathogens.

An additional group of participants with ABSSSI, who were not on concomitant warfarin therapy, were also enrolled to obtain additional information following a single dose of oritavancin administration.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of ABSSSI (wound infection, cellulitis/erysipelas, or cutaneous abscess) suspected or confirmed to be caused by a Gram-positive pathogen requiring IV therapy
* Must be currently being treated with chronic warfarin therapy\* \*Participants in the non-warfarin group are not required to be on chronic warfarin therapy.

Exclusion Criteria:

* Known or suspected bacteremia, sepsis or refractory shock
* Participants who are likely to need treatment with IV heparin within 48 hours
* Significant or life-threatening condition
* Women who are pregnant or nursing
* Receiving chronic systemic immunosuppressive therapy such as chemotherapy or prednisone
* CD4 count \<200 cells/mm\^3 in participants with known human immunodeficiency virus or acquired immune deficiency syndrome
* Neutropenia

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Up to 2 weeks after first administration of oritavancin
Secondary outcomes:
measure: Number of Participants With a Clinical Response of Cure
timeFrame: At 48 to 72 hours after start of oritavancin dose and at Day 7
Other outcomes:
Locations:
city: Somers Point
country: United States
state: New Jersey
Study officials:
affiliation: Melinta Therapeutics, Inc.
name: Medical Information
role: STUDY_DIRECTOR
References:
Clinical trial NCT02737618: 14-Day Cumulative Irritation Patch Test in Subjects With Normal Skin - Chameleon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dermal Irritation
Lead sponsor: Church & Dwight Company, Inc.
Sponsor class: INDUSTRY
First posted: 2016-04-14
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: to determine the ability of the test article to cause irritation to the skin of humans under controlled patch test conditions


Eligibility criteria: Inclusion Criteria:

* male or female, 18-70 years of age, in general good health
* normal skin
* free of any systemic or dermatologic disorder which, in the opinion of the investigative personnel, will interfere with the study results or increase the risk of adverse events
* of any skin type or race providing the skin pigmentation will allow discernment of erythema
* agree to complete a medical history and concomitant medication form
* read, understand and sign informed consent

Exclusion Criteria:

* have any visible skin disease at the study site which, in the opinion of the investigative personnel, will interfere with the evaluation
* are receiving systemic or topical drugs or medication which, in the opinion of the investigative personnel, will interfere with the study results
* have psoriasis and/or active atopic dermatitis/eczema
* have a known sensitivity to cosmetics, skin care test articles, or topical drugs as related to the test article being evaluated
* are females who are pregnant or breastfeeding or become pregnant

Primary outcomes:
measure: Number of Subjects That Showed Erythema Based on 5 Point Scoring Scale
timeFrame: 14 days
measure: Number of Subjects That Showed Edema Based on the 5 Point Scoring Scale
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Fair Lawn
country: United States
facility: TKL Research Inc
state: New Jersey
Study officials:
affiliation: TKL Research, Inc.
name: John Dosik, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05583318: Living Conditions After Non-Hodgkin's Lymphoma in France
Official title: Living Conditions After Non-Hodgkin's Lymphoma in France
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-hodgkin's Lymphoma
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2022-10-17
Enrollment: 3209
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: Patients with non-Hodgkin's lymphoma

Brief summary: This is an innovative project, allowing to study for the first time the long-term living conditions of patients after diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) from population data in France. Patients will be selected from the three specialized hematology registries in France: Côte-d'Or, Gironde and Basse-Normandie.

This is also one of the first studies to look at epidemiological indicators of net survival after diagnosis of follicular lymphoma and diffuse large B-cell lymphoma, adjusted for clinical factors such as disease stage, therapeutic management, and comorbidities, apart from the standard adjustment factors of age, sex, and time of diagnosis in real life. In addition, the proportion of cured patients will be estimated.

For component 1, this will be the survival analysis on the initial data. For part 2, questionnaires will be sent out followed by a follow-up if necessary one month after the mailing. There is no physical interview nor any specific biological or imaging examination.


Eligibility criteria: Inclusion Criteria:

* Diagnosis period 2010-2018, according to the 2008 WHO ICD-O-3 classification, from the hematological malignancy registries of Côte-d'Or, Gironde, Basse-Normandie
* Patients with a diagnosis of follicular lymphoma (9690/3, 9691/3, 9695/3, 9698/3, 9597/3)
* Patients with a diagnosis of diffuse large B-cell lymphoma (9678/3, 9679/3, 9680/3, 9684/3, 9688/3, 9712/3, 9735/3, 9737/3, 9738/3)
* For Part 2: Individuals alive at the date of vital status update

Non-inclusion criteria:

* Other forms of malignant hemopathies at diagnosis,
* Minors.

Exclusion Criteria:

* Person under a legal protection measure (curatorship, guardianship)
* Person under a legal protection measure (guardianship, tutorship)
* Pregnant, parturient or breastfeeding women
* Major incapable or unable to express his consent
* Person who did not return the questionnaires following the 1-month follow-up, or patient who expressed refusal to participate.

Primary outcomes:
measure: Progression-free survival
timeFrame: December 2022
measure: Generic SF-12 questionnaire
timeFrame: October 2024
measure: Specific QLQ-C30 questionnaire
timeFrame: October 2024
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourgogne
Study officials:
References:
Clinical trial NCT01393418: Evaluating Erythropoietin as an Indicator for Possible Kidney Injury After Cardiac Surgery
Official title: EPO: A Renal Biomarker After Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Erythropoietin
Acute Kidney Injury
Renal Biomarker
Keywords: Erythropoietin
Cardiac Surgery
Renal Biomarker
Acute Kidney Injury
Hypothermic Circulatory Arrest
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2011-07-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cardiac surgery patients.

Brief summary: The purpose of the study is to evaluate kidney biomarkers and determine if there is a correlation between Erythropoietin (EPO) levels and acute kidney injury after cardiac surgery. An early biomarker for kidney injury may be helpful in identifying, monitoring and managing patients at risk for kidney failure after cardiac surgery. To evaluate Erythropoietin's role as a predictor of poor renal function in the immediate post-bypass period we plan to compare EPO levels to Neutrophil gelatinase-associated lipocalin (NGAL).

Detailed description: Acute kidney injury (AKI) is a serious complication after cardiac surgery and cardio-pulmonary bypass. AKI is associated with high mortality.

Erythropoietin, a hormone produced by the kidneys, will be evaluated as a potential biomarker of kidney injury. Neutrophil gelatinase-associated lipocalin (NGAL) has been studied as a biomarker of kidney injury. Early kidney injury detection has been long sought and NGAL has been shown to be a promising biomarker. A troponinlike biomarker of AKI that is easily measured and capable of both early detection and risk stratification would represent an advancement in our ability to differentiate acute kidney injury from failure.

Investigating EPO as a biomarker may prove to have increased predictive value in the clinical care of cardiac surgery patients.

Eligibility criteria: Inclusion Criteria:

* Cardiac surgery with cardiopulmonary bypass with DHCA
* Normal renal function or renal insufficiency-serum creatinine less than 2.5 mg/dL
* Adult male and female patients 18 years and older

Exclusion Criteria:

* VADS
* Emergent cases
* Prolonged hypoxemia before, during or after bypass
* End stage renal disease
* Patients receive erythropoietin receptor agonists

Primary outcomes:
measure: Renal injury/Failure
timeFrame: 18 Hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Hospital
state: Michigan
Study officials:
affiliation: Department of Anesthesiology, University of Michigan
name: Yasser El Kouatli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04508218: Protein Supplementation and Exercise Training in Burn Patients
Official title: Impact of Adding Protein Supplementation to Exercise Training on Lean Body Mass and Muscle Strength in Burn Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burns
Keywords: Exercise training
Protein supplementation
Muscle strength
Lean body mass
Burn
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-08-11
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Burn injury causes continuous catabolism of the skeletal muscle resulting in decreased muscle strength, muscle mass and impairment of functional mobility. Purpose: The purpose of this study is to investigate the efficacy of combination of exercise training and protein supplementation on lean body mass (LBM) and muscle strength in patients with severe burn.

Detailed description: Sixty participants with severe burn \> 30% total body surface area (TBSA) were randomly distributed into 4 equal groups of 15 participants per group. Group A (Protein+ Exercise group) received oral protein supplementation, exercise program and traditional burn care, group B (Protein group) received oral protein supplementation and traditional burn care, group C (Exercise group) received exercise program and traditional burn care, group D (Control group) received traditional burn care. LBM was measured using Dual-energy x-ray absorptiometry (DXA) while muscle strength was measured using Biodex 3 Dynamometer System before treatment and 12 weeks after treatment.

Eligibility criteria: Inclusion Criteria:

* healed deep partial-thickness thermal burn
* \> 30% of TBSA and
* the exercise program started after healing of the burn (after burn injury by 6 weeks)

Exclusion Criteria:

* conditions that may affect on participation in the exercise program as a recent coronary disease, uncontrolled hypertension, orthopedic problems limiting exercise, abnormal cardiac stress test, pregnant women, refusal to participate in a physical activity program,
* presence of psychological or cognitive disorders (aggressive behavior, impulsivity, dementia)
* food intolerance to milk protein products.

Primary outcomes:
measure: lean body mass
timeFrame: after 12 week of intervention
Secondary outcomes:
measure: muscle strength
timeFrame: after 12 week of intervention
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Nesma Morgan Allam
Study officials:
affiliation: lecturer at faculty of physical therapy
name: Nesma M Allam, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00835718: A Study of MK0594 in Patients With Alcohol Dependence (0594-020)
Official title: A Phase II Multicenter, Randomized, Double-Blind, Two-Stage Clinical Trial to Evaluate the Efficacy and Safety of MK0594 in Patients With Alcohol Dependence
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Alcohol Dependence
Lead sponsor: Vyne Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2009-02-04
Enrollment: 162
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study in patients with alcohol dependence to see if MK0594 is safe and effective in maintaining absence of heavy drinking over a 12-week treatment period.


Eligibility criteria: Inclusion Criteria:

* Patient has Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision diagnosis of alcohol dependence and alcohol addiction
* Patient has two heavy drinking days in the last 30 days
* Patient has 3 days of abstinence from alcohol right before taking study medication
* Patient has lived in the same residence for the last 2 months

Exclusion Criteria:

* If female, patient is pregnant or breastfeeding
* Patient anticipated inpatient alcohol treatment
* Patient has a history of suicide attempt in the last year
* Patient has schizophrenia or bipolar disorder
* Patient has a history of multiple or serious allergies
* Patient has participated in a clinical trial in the last 30 days

Primary outcomes:
measure: no heavy alcohol drinking and safety as measured by adverse experiences, laboratory safety test, vital signs, ECG, and physical examination
timeFrame: week 3 and 12 after starting study medication for efficacy and over 12 weeks and 52 weeks for safety
Secondary outcomes:
measure: no alcohol drinking
timeFrame: week 3 to 12 after starting study medication and over 52 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Vyne Therapeutics Inc.
name: Menlo Therapeutics Inc.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01949818: Treatment of Diffuse Large B Cell Lymphoma
Official title: A Randomized, Controlled Mutiple-center Clinical Research on the Treatment With Yangzhengxiaoji Capsule Combination Chemotherapy for III/IV Diffuse Large B Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diffuse Large B Cell Lymphoma
Lead sponsor: Zhengzhou University
Sponsor class: OTHER
First posted: 2013-09-25
Enrollment: 120
Sex: ALL
Minimum age (years): 14
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of Yangzhengxiaoji Capsule Combination Chemotherapy for III/IV Diffuse Large B Cell Lymphoma.


Eligibility criteria: Inclusion Criteria:

- Age range 14-70 years old; ECOG performance status 0-2; Estimated survival time \> 3 months Histological confirmed Diffuse large B cell lymphoma(III/IV) None of chemotherapy or radiotherapy has been previously used None of chemotherapy contraindication: hemoglobin ≥ 90 g/dl, neutrophil ≥ 1.5×109/L, platelet ≥ 100×109/L, ALT and AST ≤ 2×ULN, serum bilirubin ≤ 1.5×ULN, serum creatine ≤ 1.5×upper limitation of normal (ULN), Serum Albumin ≥ 30g/L At least one measurable lesion None of other serious diseases, cardiopulmonary function is normal Pregnancy test of women at reproductive age must be negative Patients could be followed up None of other relative treatments including the traditional Chinese medicine, immunotherapy,biotherapy except anti-bone metastasis therapy and other symptomatic treatments.

Exclusion Criteria:

* Disagreement on blood sample collection Patients allergic of any of drug in this regimen or with metabolic disorder Pregnant or lactating women Serious medical illness likely to interfere with participation Serious infection Primitive or secondary tumors of central nervous system Chemotherapy or radiotherapy contraindication The evidence of CNS metastasis History of peripheral nervous disorder or dysphrenia patients participating in other clinical trials patients taking other antitumor drugs patients estimated to be unsuitable by investigation

Primary outcomes:
measure: Progression-free survival
timeFrame: up to end of follow-up-phase (approximately 24 months)
Secondary outcomes:
measure: overall survival
timeFrame: up to the date of death (approximately 5 years)
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Oncology Department of The First Affiliated Hospital of Zhengzhou University
state: Henan
Study officials:
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Mingzhi Zhang, Dr
role: PRINCIPAL_INVESTIGATOR
References: