louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04436809: Sentinel Node Biopsy Alone or With Axillary Dissection After Primary Chemotherapy
Official title: Sentinel Node Biopsy Alone or With Axillary Dissection in cT2 cN0/1 Breast Cancer Patients After Primary Chemotherapy: a Prospective Interventional Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasm Female
Keywords: Breast cancer
Sentinel node biopsy
Neoadjuvant chemotherapy
Axillary dissection
Lead sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Sponsor class: OTHER
First posted: 2020-06-18
Enrollment: 353
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Many doctors believe that breast cancer patients scheduled for pre-operative chemotherapy whose cancer has spread to the axilla (determined by palpation plus ultrasound) should not receive sentinel node biopsy after chemotherapy, but proceed directly to removal of all the axillary lymph nodes.

In this study, breast cancer patients with operable medium-size cancer (T2) scheduled for pre-operative chemotherapy, and a disease-free or a metastatic axilla, are prospectively assigned to receive sentinel node biopsy as part of their post-chemotherapy surgical treatment (whose main aim is to remove the cancer in the breast).

Irrespective of whether the axilla is disease-free or metastatic before chemotherapy, if the removed sentinel nodes are disease-free on histological examination (pN0) after chemotherapy, then no further axillary treatment is given. If however the sentinel nodes contain cancer, then the other axillary lymph nodes will be removed surgically.

The study hypothesis is that, irrespective of whether the axilla is disease-free or metastatic before chemotherapy, patients with negative axillary sentinel nodes on histological examination (pN0) after chemotherapy, and who are no given further axillary treatment, will do as well as pN1 patients whose axillary lymph nodes are completely removed (a more aggressive treatment).


Eligibility criteria: Inclusion Criteria:

* cT2 cN0/1 breast cancer
* Scheduled for neoadjuvant chemotherapy,
* Informed consent,

Exclusion Criteria:

* Previous malignancy at another site
* Synchronous breast cancer at diagnosis
* Distant metastasis at diagnosis
* Clinically involved axilla (cN1) after neoadjuvant chemotherapy

Primary outcomes:
measure: Overall Survival (OS) and Disease-Free Survival (DFS)
timeFrame: Ten years
Secondary outcomes:
measure: Rate of axillary failure in those receiving only sentinel node biopsy
timeFrame: Ten years
Other outcomes:
measure: Assessment of pathological response to primary chemotherapy as predictor of outcome
timeFrame: Ten years
Locations:
Study officials:
affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
name: Gabriele Martelli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06831409: Using CTA Measures to Define Cardiac Risk In NFL Alumni
Official title: Using CTA Measures to Define Cardiac Risk In NFL Alumni
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease (CAD)
Heart Disease
Coronary Atherosclerosis
Keywords: NFL
Heart Disease
Lead sponsor: HeartFlow, Inc.
Sponsor class: INDUSTRY
First posted: 2025-02-18
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population is retired NFL alumni. A retired NFL player is defined as any former player who made either a practice squad or an active NFL roster.

Brief summary: The GAMEFILM Registry is a post-market, multi-center, data collection study assessing the presence of CAD in NFL alumni.

Detailed description: The GAMEFILM Registry is a post-market, multi-center, data collection study assessing the prevalence and severity of CAD in NFL alumni. A retired NFL player is defined as any former player who made either a practice squad or an active NFL roster. Approximately 300 participants will be included from approximately 20 sites in the US.

Eligibility criteria: Inclusion Criteria:

* Retired NFL player

Exclusion Criteria:

* CCTA not successfully processed for FFRct and AI-Plaque

Primary outcomes:
measure: Participants with CAD
timeFrame: 24 hours from the time CCTA was taken
Secondary outcomes:
measure: Participants with physiologically significant CAD
timeFrame: 24 hours from the time CCTA was taken
measure: Participants with high coronary plaque burden
timeFrame: 24 hours from the time CCTA was taken
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford
state: California
city: Greenwood Village
country: United States
facility: Boone Heart Institute
state: Colorado
Study officials:
affiliation: Boone Heart Institute
name: Jeffrey Boone
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03684109: Non-invasive Glioma Characterization Through Molecular Imaging
Official title: Pilot Study for Non-invasive Glioma Characterization Through Molecular Imaging
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glioma
Brain Tumor
Primary Brain Tumor
Malignant Glioma
Malignant Primary Brain Tumor
Keywords: Non-invasive glioma characterization
Molecular Imaging
Isocitrate Dehydrogenase (IDH) Mutations
MRI-Based Sequencing
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: MRI-based sequences can provide non-invasive quantification of intratumoral 2-hydroxyglutarate (2HG) distribution and tumor cellularity in human gliomas and help guide the development of novel glioma therapies.

Detailed description: This is a pilot study aiming at developing and optimizing MRI-based sequences to provide non-invasive quantification of intratumoral 2-hydroxyglutarate (2HG) distribution and tumor cellularity in human gliomas and help guide the development of novel glioma therapies.

Eligibility criteria: Inclusion Criteria:

* Adults (≥18 year old)
* Subjects with suspected or confirmed gliomas and who will have a medically indicated biopsy or resection of his/her brain lesion.

Exclusion Criteria:

* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Patients unable to have MRI done

Primary outcomes:
measure: 2HG Concentration via 3T MRI Scanner
timeFrame: Day 1
measure: 2HG Concentration from tissue samples
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Macarena De La Fuente, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01601756: Joint Line Reconstruction in Navigated Total Knee Arthroplasty Revision
Official title: Joint Line Reconstruction in Navigated Total Knee Arthroplasty Revision
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Revision Total Knee Arthroplasty Because of
Loosening
Instability
Impingement
or Other Reasons Accepted as Indications for TKA Exchange.
The Focus is to Determine the Precision of Joint Line Restoration in Navigated vs. Conventional Revision Total Knee Arthroplasty
Keywords: revision knee arthroplasty
navigation
joint line
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Aesculap AG
First posted: 2012-05-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypothesis: navigated revision total knee arthroplasty results in a more precise reconstruction of preoperatively planned joint line than conventional revision total knee arthroplasty (rTKA).


Eligibility criteria: Inclusion Criteria:

* indication for revision knee arthroplasty

Primary outcomes:
measure: Restoration of Joint Line
timeFrame: postoperatively (6 to 12 weeks after operation, we expect a mean of 9 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Orthopaedic Department, Charité - University Medicine Berlin
Study officials:
References:
Clinical trial NCT03315156: Taste Changes in Acute Otitis Media
Official title: Taste Changes in Acute Otitis Media
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Otitis Media
Keywords: Acute otitis media
AOM
Electrogustometer
EGM
Taste threshold
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Tel Aviv University
First posted: 2017-10-19
Enrollment: 40
Sex: ALL
Minimum age (years): 8
Maximum age (years): 40
Standard ages: CHILD
ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with AOM

Brief summary: Detection of taste changes in Acute Otitis Media (AOM) patients.

Detailed description: Methods:

Taste assessment will be done using Electrogustometer (EGM). Tongue stimulation will be performed using low currents of up to 100uA. Using the protocol as specified in the EGM user manual.

Population: 40 Unilateral AOM patients, aged 8-40. Without chronic otitis media, pregnancy or impaired judgement.

Eligibility criteria: Inclusion Criteria:

* Unilateral AOM

Exclusion Criteria:

* Chronic Otitis Media
* Pregnancy
* Patients with lack of judgment

Primary outcomes:
measure: Taste change in AOM
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: TLVMC
name: Ari DeRowe, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00413556: Changes in the Immune Response and Skin Reactivity of Grass Pollen Allergic Patients Treated With ALK Grass Tablets
Official title: Randomised, Double-Blind, Placebo-Controlled Phase IIIb Study Investigating Changes in Immunological Parameters and Cutaneous Reactivity Induced by a Short Course Immunotherapy With ALK Grass Tablets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergy
Keywords: Rhinitis
Oral tablets
Ig G4
grass pollen
inmunotherapy
Lead sponsor: ALK-Abelló A/S
Sponsor class: INDUSTRY
First posted: 2006-12-19
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We plan to determine changes in the immune system during the allergic response to grass pollen allergens. We have chosen a particular element of the immune response, the immunoglobulin G4 (IgG4) as an indicator.

We hypothesize that treatment with Grazax will increase serum levels of Phleum pratense specific IgG4 and IgE, as well as reduce the cutaneous sensitivity of the early (IgE mediated) and late (cell mediated) allergic response.


Eligibility criteria: Inclusion Criteria:

* A history of grass pollen allergy
* Positive skin prick test to grass
* Positive specific IgE to grass

Exclusion Criteria:

* Treatment with anti-IgE

Primary outcomes:
measure: Difference in serum leves of IgG4
timeFrame: 6 months
Secondary outcomes:
measure: Changes in IgE level
timeFrame: 6 months
measure: Changes in cutaneous response
timeFrame: 6 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
Study officials:
affiliation: Medical Director, ALK-Abello, S.A.
name: Pilar Rico, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02505256: Study Into Treatment of Hyperplasia of Mammary Glands
Official title: Study Into Treatment of Hyperplasia of Mammary Glands
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hyperplasia
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2015-07-22
Enrollment: 5000
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Females who reported breast pain of breast lumps.

Brief summary: Hyperplasia of Mammary Glands is a complex disease, and there is no consensus or guideline for the treatment of this disease. This study was launched to investigate into the problem that which patients should be diagnosed as hyperplasia of mammary glands and which patients should be treated.

Detailed description: Females who meet the inclusion criteria will receive breast ultrasonography, mammography and pathological examinations by core needle biopsy. All participants will receive a follow-up at an 6-month interval for 2 years. During the follow-up period, whether the symptoms relieve will be evaluated.

Eligibility criteria: Inclusion Criteria:

* Reported breast pain or breast lumps.
* Willing to be kept follow-up.
* Functions below are maintained in major organs: liver, renal and heart.
* Written informed consent will be obtained for patients for entering this study.

Exclusion Criteria:

* Typical breast cancer or fibroadenoma.
* Classification by breast ultrasonography of mammography is beyond Breast Imaging - Reporting And Data System (BI-RADS) 4.
* Oral contraceptive or hormone replacement therapy.
* History of breast cancer or other malignancies.
* History of pituitary gland disease.
* Potentially pregnant, pregnant, or breast-feeding.

Primary outcomes:
measure: Clinical manifestations as an substitutive indicator for pathological diagnosis of hyperplasia of mammary glands
timeFrame: 8 months
Secondary outcomes:
measure: Clinical manifestations as an surgical indications for hyperplasia of mammary glands
timeFrame: 8 months
Other outcomes:
Locations:
city: Jinan
country: China
facility: the Second Hospital of Shandong Universtity
state: Shandong
Study officials:
affiliation: The Second Hospital of Shandong University
name: Gang Z Yu, PhD，MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06084156: A Study to Evaluate the DDI of HSK7653 With Metformin
Official title: A Phase I Clinical Study to Evaluate the Drug-Drug Interaction Between HSK7653 and Metformin in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Haisco Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-10-16
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase 1, single center, open-label, single arm, drug-drug interaction study of HSK7653 and metformin in Healthy Subjects.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 and Age ≤60 years
* BMI ≥18 and BMI ≤ 28 kg/m2 (Body Mass Index)
* Able to understand the procedures of the study, and provide written informed consent and willing to comply with the study protocol procedures.

Exclusion Criteria:

* Any finding of the medical examination (physical examination, laboratory examination, 12-ECG, abdominal B-ultrasonography, etc) deviating from normal and of clinical relevance during screening;
* Fasting blood glucose \<3.9mmol/L or ≥6.1mmol/L;
* Has a condition affecting the absorption, distribution, metabolism, and excretion of the drug;
* Has a positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), Treponema pallidum antibody (TP-Ab) or human immunodeficiency virus (HIV);
* Treatment with an investigational drug within 3 months;
* Other protocol-defined exclusion criteria.

Primary outcomes:
measure: The primary pharmacokinetics parameter of Cmax To assess the potential pharmacokinetic interaction between HSK7653 and metformin in health subjects.
timeFrame: Day4, day 27 and day 41
measure: The primary pharmacokinetics parameter of AUC To assess the potential pharmacokinetic interaction between HSK7653 and metformin in health subjects.
timeFrame: Day4, day 27 and day 41
Secondary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: First dose of study drug up to 62 days after last dose of study drug
measure: Pharmacodynamic responses of glucose, insulin and C-peptide will be evaluated
timeFrame: Day 41
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT01916356: Improving Knowledge About Infertility; an Online Educational Tool
Official title: Improving Knowledge About Infertility Etiologies, Risk Factors, Treatments and Fertility Myths; an Online Educational Tool
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: Infertility
Education
Risk Factors
Fertility knowledge
Fertility myths
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2013-08-05
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to determine the effectiveness of an online informational video in improving knowledge about infertility in couples experiencing problems conceiving. A pilot study will be conducted with first and second year medical students.

Detailed description: This study is being conducted to assess how a short, online educational video changes knowledge about fertility and infertility in couples attending an infertility clinic for the first time. Participants will complete a questionnaire testing knowledge about infertility and general demographic information (age, gender, previous information sources on infertility, etc.) will be collected. Participants will then be directed to a short video on infertility. One week later, participants will return to the site to complete the infertility test questions a second time in order to test memory retention. The focus of both the questionnaire and educational video will be basic reproductive biology, infertility risk factors, etiologies and treatments and fertility myths.

Eligibility criteria: Inclusion Criteria:

* Women between the ages of 18 and 60 years
* Men between the ages of 18 and 60 years
* Booking an appointment at the infertility clinic for the first time
* Access to a computer with internet connection
* For pilot study: students must be in first or second year medical school before teaching on infertility

Exclusion Criteria:

* Previous appointment at the infertility clinic/ previous medical specialist counsel about infertility
* Completion of the study surveys after their appointment at the infertility clinic

Primary outcomes:
measure: Mean change in total score on knowledge test
timeFrame: 7 days after viewing educational video
Secondary outcomes:
measure: Effect of demographic characteristics on mean change in total score on knowledge test.
timeFrame: 7 days after viewing educational video
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Department of Obstetrics and Gynecology, Queen's University
state: Ontario
Study officials:
affiliation: Queen's University
name: Robert L Reid, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thomson AA, Brown M, Zhang S, Stern E, Hahn PM, Reid RL. Evaluating Acquisition of Knowledge about Infertility Using a Whiteboard Video. J Obstet Gynaecol Can. 2016 Jul;38(7):646-50. doi: 10.1016/j.jogc.2016.03.010. Epub 2016 May 6.
Clinical trial NCT03131856: Nutritional Intervention in Geriatric Patients
Official title: A Multidisciplinary Nutritional Intervention Programme Across Sectors to Improve the Nutritional Status of Geriatric Patients at Nutritional Risk - A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Keywords: Geriatrics
Nutritional risk
Multi-disciplinary intervention
Randomized Controlled Trial
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2017-04-27
Enrollment: 150
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible patients were randomized to either the intervention group or control group.
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the effect of a multi-disciplinary nutritional intervention program in geriatric nutritional at risk patients. The study is carried out as randomized controlled trial. The intervention consists of an individual dietary plan conducted by a clinical dietician before discharge in combination with three follow-up visits after discharge (1, 4 and 8 weeks).


Eligibility criteria: Inclusion Criteria:

* Age 65 or above
* BMI \<20.5 and/or weight loss within the last 3 months and/or a reduced dietary intake in the previous week and/or severely ill

Exclusion Criteria:

* Terminal illness
* Active cancer diagnosis
* Permanently living in a nursing home
* Not willing or able to give an informed consent.

Primary outcomes:
measure: Nutritional status
timeFrame: Three months follow-up
Secondary outcomes:
measure: Functional status
timeFrame: Three months follow-up
measure: Functional status
timeFrame: Three months follow-up
measure: Self-rated health
timeFrame: Three months follow-up
measure: Re-admission
timeFrame: Up to three months
measure: Mortality
timeFrame: 1) Up to 90 days after discharge 2) Up to 120 days after discharge
Other outcomes:
Locations:
Study officials:
References: