louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01928992: Pilot 3D Mammography Reader Study to Assess Breast Cancer Detection in 3D Versus 2D Digital Mammography
Official title: A Multi-reader, Multi-case, Controlled Clinical Trial to Evaluate the Fuji Film 3D Digital Mammography System Used in Conjunction With 2D Digital Mammography in the Detection of Breast Cancer / A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Mammography
3D
Breast Cancer Detection
Lead sponsor: Fujifilm Medical Systems USA, Inc.
Sponsor class: INDUSTRY
First posted: 2013-08-27
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with screening and diagnostic 3D or 2D mammography

Brief summary: The purpose of this pilot study is to provide credible performance estimate information in order to properly plan, design, and power a larger clinical study.


Eligibility criteria: Inclusion Criteria:

* Female subjects participating in prior FMSU protocol with known clinical status

Exclusion Criteria:

* Subjects with unkown clinical status
* Subjects not truthed in prior FMSU study

Primary outcomes:
measure: Per Breast AUC
timeFrame: 1 Day
Secondary outcomes:
measure: Subject Recall Rate
timeFrame: 1 Day
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: ACR / Image Metrix
state: Pennsylvania
Study officials:
affiliation: Emory University
name: Carl D'Orsi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02747992: Paravertebral Block (PVB) Combined Pectoral Musculature Blocks for Modified Radical Mastectomy (MRM)
Official title: Comparisons the Analgesia of Paravertebral Block Combined With Thoracic Wall Block Versus Paravertebral Block Alone for Modified Radical Mastectomy in Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mastectomy, Modified Radical
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2016-04-22
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible patients were that diagnosed to have unilateral breast cancer and undergone modified radical mastectomy using regional anesthesia during Jun 1, 2012 and May 31, 2015.

Brief summary: Previous studies have shown that PVB reduces pain and postoperative nausea and vomiting after breast cancer surgery when used in addition to general anesthesia or sedation. However, major breast cancer surgery involves areas beyond the breast tissue, such as pectoral musculature.


Eligibility criteria: Inclusion Criteria:

* The American Society of Anesthesiologists (ASA) Physical Status classification I to III
* 20 - 75 years of age
* female gender

Exclusion Criteria:

* body mass index (BMI) ≥ 35 kg/m2
* modified radical mastectomy not performed by the single surgeon (Ben Long Yu)
* anesthesia not performed by the single anesthesiologist (Nai Liang Li)

Primary outcomes:
measure: intraoperative sedation requirement
timeFrame: during operation
Secondary outcomes:
measure: time to first request of analgesics
timeFrame: postoperative 12 hours
measure: postoperative analgesic requirement
timeFrame: postoperation to discharge
measure: side effects
timeFrame: postoperation to within 24 hours after discharge
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04484792: Green Tea Mouthwash on Generalized Plaque- Induced Gingivitis
Official title: Green Tea Mouthwash on Generalized Plaque- Induced Gingivitis: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Plaque Induced Gingivitis
Lead sponsor: Taibah University
Sponsor class: OTHER
First posted: 2020-07-24
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This investigation will study the effect of green tea mouthwash as an adjunctive therapy to mechanical treatment on gingival health, and whether it has any side effects. This study also aims at increasing the awareness among health professionals and the community regarding the benefits of natural herbal products such as green tea on oral health, opposed to common chemical products. This may provide an efficient alternative for people who are sensitive to certain chemical products or who have limited sources of income and cannot afford expensive treatment of dental problems.


Eligibility criteria: Inclusion Criteria:

* Patients attending the clinics at the Taibah University Dental College and Hospital (TUDCH)
* Age from 18 - 35 years
* Generalized plaque-induced gingivitis (GBI \> 85%)

Exclusion Criteria:

* Patients with any systemic diseases
* Patients under regular medication (e.g. Contraceptives, Hormone- Replacement Therapy)
* Pregnant or breast-feeding patients
* Smokers
* Periodontitis patients
* Patients who received any form of periodontal therapy within the last 6 months
* Patients who were under antibiotic therapy the past month
* Patients using regular mouthwash or other chemical plaque control agents (e.g. Miswak) except for regular toothpaste (Note: toothpastes with specific anti-inflammatory properties are excluded)

Primary outcomes:
measure: plaque control record
timeFrame: over 27 days
measure: gingival bleeding index
timeFrame: over 27 days
Secondary outcomes:
Other outcomes:
Locations:
city: Al Madīnah
country: Saudi Arabia
facility: Taibah University
Study officials:
References:
Clinical trial NCT06229392: A Study to Evaluate the Intratumoral Influenza Vaccine Administration in Patients With Breast Cancer
Official title: A Phase I Study to Evaluate the Intratumoral Influenza Vaccine Administration in Patients With Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Breast Cancer
Breast Cancer Triple Negative
Keywords: Breast cancer
Breast cancer triple negative
Breast cancer HER2+
Flu vaccine
Intratumoral flu vaccine
Intratumoral vaccine
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2024-01-29
Enrollment: 18
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: This Phase 1 study will assess the safety and efficacy (usefulness) of administering 2 doses of seasonal flu vaccine directly into breast cancer tissue (primary tumor), and will study the tumor and whole body response to the vaccine. If the tumor is palpable (able to fee by touch), the vaccine will be administered by a Surgeon/oncologist in the outpatient floor - both experienced and trained. If not palpable, the procedure will be done via guided Ultrasound by our Breast Radiologist -- both experienced and trained. Women with triple-negative (TNBC) and HER2+ types of breast cancer will be eligible for enrollment. Up to 18 subjects may be enrolled at Rush. Successive groups of 3 subjects per breast cancer type will be given increasing doses of vaccine. There are 3 potential dosing groups (half-dose, full dose, and high dose). Blood, stool (optional), and tumor tissue samples will be collected and tested. The active participation period is from one week prior to starting chemotherapy through three months post surgery.


Eligibility criteria: Inclusion Criteria:

* ECOG 0-2
* Patients must be planning to receive standard of car e neoadjuvant chemotherapy as defined by the most recent version of NCCN guidelines (www.nccn.org)
* Patients must have histologically or cytologically confirmed invasive breast cancer that is either triple-negative or HER2+ (regardless of hormone receptor status)

Exclusion Criteria:

* Patients with any uncontrolled intercurrent illness.
* Patients who have any underlying medical condition for which, in the investigator's opinion, participation would not be in the best interest of the participant
* History of egg allergy
* Patients currently on anticoagulant therapy, corticosteroids, or immunosuppressive agents
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the seasonal flu vaccine.
* History of Guillain-Barré syndrome

Primary outcomes:
measure: Dose- limiting toxicity (DLT)
timeFrame: 3 months post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Ruta Rao, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04634292: Dual Tasking in Children With Cerebral Palsy and Healthy Children: an EEG Study
Official title: Processus Attentionnels impliqués Dans la Locomotion Chez l'Enfant à développement Typique et l'Enfant Atteint de Paralysie cérébrale : Une étude EEG.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Child Development
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2020-11-18
Enrollment: 84
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy children and children with cerebral palsy

Brief summary: Simultaneous execution of motor and cognitive tasks is embedded in the daily life of children. An EEG study will be conducted on healthy children and children with cerebral palsy to study the neural correlates during dual tasking while walking

Detailed description: Children will walk at their preferred speed on a treadmill. During dual tasking, they will listen to animals cries and will have to count the number of specified animals cries.

Eligibility criteria: Inclusion Criteria:

* normal walking

For children with cerebral palsy: diplegia or hemiplegia, GMFCS 1 or 2, no botulinium injection since 4 months

Exclusion Criteria:

* medical problem

Primary outcomes:
measure: Neural correlates during dual tasking in children
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01800292: Characterization of LV Strain Patterns in Mildly Elevated PCWP and PAH.
Official title: Echo Study - Characterization of LV Strain Patterns in Patients With Mildly Elevated PCWP and Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension, Pulmonary Artery
Ventricular Dysfunction, Left
Keywords: Pulmonary Artery Hypertension
pulmonary capillary wedge pressure
sildenafil
echocardiography
left ventricular longitudinal wall strain
strain rate pre and post medical therapy
speckle tracking
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2013-02-27
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine if patients with pulmonary hypertension and mildly elevated heart pressure known as PCWP will exhibit different patterns on echocardiography and that these patterns will predict treatment response to sildenafil, a drug given for this condition.


Eligibility criteria: Inclusion Criteria:

* Patients with New York Heart Association/World Health Organization(NYHA/WHO)functional class II-III
* Patients with mean pulmonary artery pressure \>25 mmHg, pulmonary capillary wedge pressure \>15 mmHg ≤18, and pulmonary vascular resistance \>3 wood units
* Age \>18 and \<80
* Stable on antihypertensives and diuretics\>3 months
* No evidence of active ischemic heart disease
* 6 minute walk distance \>150 meters and \<450 meters

Exclusion Criteria:

* - Left ventricular ejection fraction \<50%
* Patients with significant restrictive lung disease (FVC\<60% predicted) and/or significant obstructive lung disease (FEV1 \<55% predicted) within 1 year of enrollment
* Poorly interpretable grey scale echocardiographic images
* Contraindications to right heart catheterization
* Nitroglycerin therapy
* Moderate-severe aortic and mitral valve abnormality
* Contraindications to submaximal exercise testing

Primary outcomes:
measure: exercise capacity not on/on sildenafil therapy
timeFrame: 3 months
Secondary outcomes:
measure: Echo parameters:left ventricular septal and lateral wall longitudinal strain and strain rate, RV strain and strain rate, and LV lateral wall/septal strain and strain rate
timeFrame: 3 months
Other outcomes:
measure: World Health Organization functional class
timeFrame: 3 months
measure: BNP (brain natriuretic peptide)
timeFrame: 3 months
Locations:
city: Tucson
country: United States
facility: University of Arizona Medical Center
state: Arizona
Study officials:
affiliation: University of Arizona
name: Aiden Abidov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01015092: Cardiovascular Risk Evaluation and Antiretrovirals in HIV
Official title: Predicted 10-year Coronary Heart Disease Risk in HIV and Implications for Clinical Management: the CREATE Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Risk
HIV Infections
Keywords: HIV
Cardiovascular
Coronary hear disease
HAART
antiretroviral
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: Guy's and St Thomas' NHS Foundation Trust
First posted: 2009-11-17
Enrollment: 1024
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All HIV outpatients patients attending two London Hospitals

Brief summary: The purpose of the study is to determine the main factors contributing to predicted 10 year cardiovascular risk in an HIV infected cohort, and the role of anti-HIV drug use in altering this risk


Eligibility criteria: Inclusion Criteria:

* Serologically proven HIV infection
* Attending general HIV outpatient clinic

Exclusion Criteria:

* Attending a specialist outpatient clinic which might lead to recruitment bias

Primary outcomes:
measure: 10 year predicted cardiovascular risk
timeFrame: AT time of clinic attendence
Secondary outcomes:
measure: coronary heart disease risk
timeFrame: at time of clinic attendence
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guys & ST Thomas' Foundation Hospitals
Study officials:
affiliation: King's College London
name: Barry S Peters, MB BS. MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01620892: Study of Patient Outcomes 5 Years After Partial Knee Replacement
Official title: Outcomes of Patients With Unicompartmental Arthritis of the Knee Five Years After Treatment With Partial Knee Replacement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis, Knee
Keywords: unicondylar knee arthroplasty
partial knee replacement
Lead sponsor: Athens Orthopedic Clinic, P.A.
Sponsor class: OTHER
Collaborators: name: Arthrex, Inc.
First posted: 2012-06-15
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The potential study population consists of all patients who have undergone implantation of a specific unicondylar knee arthroplasty device under the care of the principal investigator between December, 2006 and December, 2008. This is a clinic-based sample of consecutive cases.

Brief summary: The study seeks to evaluate the condition of patients 5 years after having undergone partial knee replacement for localized osteoarthritis of the knee. Participating patients will voluntarily undergo detailed evaluation of clinical and radiologic outcomes 5 years after surgery. The aims of the study are to describe the survivorship of the prostheses and the clinical results of patients, and to elucidate and describe the natural history disease of the untreated knee joint compartments after a partial replacement. Patients who were operated by the principal investigator 5 years previously will be invited to participate. The study is observational in nature; there is no element of experimentation or test of an intervention.


Eligibility criteria: Inclusion Criteria:

* All individuals who have undergone unicondylar knee replacement of a single tibio-femoral compartment using iBalance prosthesis (Arthrex, Inc, Lakeland Florida) under the care of the principal investigator between December, 2006 and December, 2008 will be invited to participate in the study.

Exclusion Criteria:

* There are no restrictions to inclusion in the study based on surgical or medical criteria; however, individuals who are pregnant, incarcerated, less than 18 years of age, or unable to give valid informed consent on their own behalf will be excluded from the study.

Primary outcomes:
measure: Time to revision of the partial total knee prosthesis
timeFrame: 5 to 7 years after original implantation
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: United States
facility: Athens Orthopedic Clinic, P.A.
state: Georgia
Study officials:
affiliation: Athens Orthopedic Clinic, P.A.
name: Ormonde M Mahoney, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05922592: Different Techniques of Crestal Sinus Lift
Official title: Balloon Technique Versus Densah Bur in Crestal Sinus Lift Operation With Simultaneous Implant Placement. A Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crestal Sinus Lift
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-06-28
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sixteen patients will be selected from those attending the outpatient clinic of the Oral \& Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University with age range from 20-50 years seeking implantation of their lost posterior maxillary teeth, \[premolar and molars\] with limited bone height below the floor of the maxillary sinus, secondary to sinus pneumatization.

Group I (N = 8): The sinus membrane will be elevated by using balloon technique with simultaneous Implant placement.

Group II (N = 8): The sinus membrane will be elevated by using Densah burs with simultaneous Implant placement.


Eligibility criteria: Inclusion Criteria:

* Patent ostium of maxillary sinus.
* Patient with missing one or more posterior maxillary teeth.
* A ridge height at the site of implantation of 4-7 mm.
* A ridge width at the site of implantation of 6 mm.
* Good oral hygiene.
* Patients in the age frame between 20 years and 50 years old.
* No gender preface in selection of the patients.
* Acceptable inter-arch space for the future prosthesis.

Exclusion Criteria:

* Any pathological condition at the site of surgery.
* Patients with systemic diseases that contra-indicate the surgical procedure such as uncontrolled diabetes mellitus, bleeding disorders, serious osseous disorders, and mental disorders.
* Heavy smoking and alcoholism.
* Parafunctional habits such as bruxism and clenching.
* Signs of acute infection or pus discharge
* Disturbed occlusion.
* Maxillary sinus inflammation.

Primary outcomes:
measure: Height gain
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mohamed Mahmoud
Study officials:
References:
Clinical trial NCT01414192: A Study to Design a Model Cohort for Analysis of Dyslipidemia (MK-0653A-204)
Official title: Model-Observation Bridging Study (MOBS) for Ezetrol® and Inegy®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dyslipidemia
Hypercholesterolemia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2011-08-11
Enrollment: 3215
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: The resident population of Continental France being treated for hypercholesterolemia in a general practice setting.

Brief summary: This study is being done to provide valid data on the evolution of a cohort of French participants treated with ezetimibe, alone or in combination with a statin, to be used in simulation models for cardiovascular disease (CVD). Patterns of drug use, evolution of risk factors for CVD, cardiovascular morbidity and mortality, and goal attainment in low density lipoprotein cholesterol (LDL-C) levels over time will be analyzed.


Eligibility criteria: Inclusion criteria:

* Resident of Continental France
* Treated by ezetimibe either as monotherapy (Ezetrol®), or co-administered with a statin or administered in a fixed combination of ezetimibe and simvastatin (Inegy®)
* Incident treatment with ezetimibe at the time of recruitment into the study

Exclusion criteria:

* Unlikely to be followed-up for the next 6 months after recruitment due to a planned change of residence
* Participating in a clinical trial
* Unable to read the information letter in French and/or unable to participate in the telephone interview in French

Primary outcomes:
measure: Rate of Cardiovascular (CV) Events
timeFrame: up to 48 months
Secondary outcomes:
measure: Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Levels at 12 Months
timeFrame: Baseline and Month 12
measure: Percentage of Participants With CV Risk Factors
timeFrame: At enrollment (baseline)
measure: Percentage of Participants Who Continued Treatment for 12, 24, 36, and 48 Months
timeFrame: up to 48 months
measure: Percentage of Participants With at Least 1 Discontinuation of Study Drug
timeFrame: up to 48 months
measure: Mortality Rate
timeFrame: up to 48 months
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Ferrieres J, Dallongeville J, Rossignol M, Benichou J, Caro JJ, Getsios D, Hernandez L, Abenhaim L, Grimaldi-Bensouda L. Model-observational bridging study on the effectiveness of ezetimibe on cardiovascular morbidity and mortality in France: A population-based study. J Clin Lipidol. 2016 Nov-Dec;10(6):1379-1388. doi: 10.1016/j.jacl.2016.08.015. Epub 2016 Sep 7.