louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01072838: Safety Study for Short-course Accelerated, Hypofractionated Partial Breast Radiotherapy (APBI) in Women With Early Stage Breast Cancer Using the Contura MLB
Official title: Safety and Feasibility of Short-Course, Accelerated, Hypofractionated Partial Breast Radiotherapy in Women With Early Stage Breast Cancer Using the Contura MLB Breast Brachytherapy Catheter: A Phase II Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: breast cancer
APBI
brachytherapy
Contura
Lead sponsor: SenoRx, Inc.
Sponsor class: INDUSTRY
Collaborators: name: C. R. Bard
First posted: 2010-02-22
Enrollment: 60
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine local disease control (recurrence) with shorter course of APBI delivered with a breast brachytherapy applicator.


Eligibility criteria: Inclusion Criteria:

* Life expectancy \> 10 years
* Lumpectomy with clear margins (negative per NSABP criteria)
* DCIS and/or invasive carcinoma
* If invasive, nodes must be negative
* T stage is Tis, T1 or T2\<=3 cm max diameter
* ER(+) or ER(-)/PR(+)

Exclusion Criteria:

* Pregnant or breast feeding
* Active collagen-vascular disease
* Paget's disease of the breast
* Prior history of breast cancer
* Prior breast or thoracic radiotherapy
* Multicentric carcinoma
* Synchronous bilateral breast cancer
* Surgical margins that cannot be assessed or that are positive
* T Stage is T2\>3 cm or greater
* ER(-)/PR(-)

Primary outcomes:
measure: Delivery of short-course APBI will result in locoregional disease control that is equal to that reported for conventional fractionation schemes for APBI.
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: New Brunswick
country: United States
facility: Cancer Institute of New Jersey
state: New Jersey
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: Atif Khan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Virginia Commonwealth University
name: Douglas W. Arthur, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: William Beaumont Hospitals
name: Mihai Ghilezan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03697538: Adductor Canal Block (ACB) vs Femoral Nerve Block (FNB) in Revision Total Knee Arthroplasty
Official title: The Effect of Femoral Nerve Block Versus Adductor Canal Block on the Quality of Recovery for Revision Total Knee Arthroplasty, a Prospective Randomized Blinded Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Revision Total Knee Arthroplasty
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2018-10-05
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, randomized, blinded study with a parallel design and an allocation ratio of 1:1 for the treatment groups. The investigators seek to determine if femoral nerve block (FNB) improves the quality of recovery and improve postoperative analgesia compared with adductor canal block (ACBs) for patients undergoing revision total knee arthroplasty.

Detailed description: This is a prospective, randomized, blinded study with a parallel design and an allocation ratio of 1:1 for the treatment groups. A prospective study design will allow both FNBs and ACBs to be accurately assessed in an effective manner without introducing unnecessary confounding factors. Furthermore, randomization and a parallel design with equal allocation ratio will ensure timely enrollment of patients while also minimizing temporal confounders that may occur with institutional changes to clinical care protocols. Patients, nurses on the floor and physical therapists will be blinded to the nature of the patient assignment (FNB or ACB)

Eligibility criteria: Inclusion Criteria:

* Adult male or female patients ages 18-80 scheduled for elective revision TKA.
* American Society of Anesthesiologists (ASA) physical status I -III
* Mentally competent and able to give consent for enrollment in the study.

Exclusion Criteria:

* Patients with any contraindications to regional anesthesia such as infection, nerve injury, anticoagulation.
* Patient refusal.
* Patients with an allergy to local anesthetics or systemic opioids.

Primary outcomes:
measure: Quality of recovery-15 item questionnaire (QoR): QoR-15
timeFrame: 48 hours after surgery
Secondary outcomes:
measure: Opioid consumption
timeFrame: 48 hours post-op
measure: Pain score measurement: we will use Numeric rating scale for measurement (NRS)
timeFrame: 48 hours post-op
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Nabil M Elkassabany, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06830538: Study of the Anatomical and Functional Recovery and Quality of Life of Patients Undergoing Corneal Transplantation
Official title: Prospective Observational Spontaneous Study of Anatomical, Functional and QoL Recovery of Patients Undergoing Corneal Transplantation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cornea Transplant
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-02-17
Enrollment: 2000
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 study population consists of patients with corneal disease who will undergo corneal transplantation.

Brief summary: Evaluate the well-being of patients and clinicl outcomes of the cornea after transplantation

Detailed description: The study aims to evaluate patients affected by corneal diseases who will undergo corneal transplantation.

The evaluation will be carried out pre and post transplantation to evaluate the clinical outcome of the patients and the quality of life and functional anatomical recovery.

Eligibility criteria: Inclusion Criteria:

* be eighteen years old
* diagnosis of corneal disease with prescription of surgical treatment of corneal transplantation
* sign the informed consent

Exclusion Criteria:

* no exclusion criteria

Primary outcomes:
measure: Anatomical recovery after corneal transplant
timeFrame: postoperatively at 7 days, 30 days, 3 months, and 12 months.
measure: Visual-functional recovery after corneal transplant
timeFrame: postoperatively at 7 days, 30 days, 3 months, and 12 months.
Secondary outcomes:
measure: Patients's quality of life
timeFrame: One week before surgery and at seven days, thirty days, three months, six months, one year, two years, three years, and four years after surgery.
measure: Patients's quality of life
timeFrame: One week before surgery and at seven days, thirty days, three months, six months, one year, two years, three years, and four years after surgery.
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Luigi Fontana, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05119738: Immune Response to Third Dose of SARS-CoV-2 Vaccine in a Cohort of Cancer Patients on Active Treatment
Official title: Immune Response to Third Dose of SARS-CoV-2 Vaccine in a Cohort of Cancer Patients on Active Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sars-CoV-2 Infection
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
First posted: 2021-11-15
Enrollment: 122
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: Cancer patients receiving their care at the Red de Salud UC Christus in Santiago Chile will be invited

Brief summary: The Coronavirus Disease 2019 (COVID-19) pandemic has claimed over 5 million lives globally. Fortunately, a substantial and growing number of SARS-CoV-2 vaccines with very high efficacy have been developed, manufactured, and rapidly approved. Novel mRNA vaccines such as the BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna) have reported a stunning \>94% efficacy against COVID-19. However, global access has not been equitable, with many low- and middle-income countries having no vaccine access or access under emergency use mainly to traditional inactivated SARS-CoV2-2 vaccines such as BBIBP-CorV (Sinopharm Beijing), CoronaVac (Sinovac) and BBV152 (Bharat Biotech). Emerging studies have shown that lower concentrations of neutralizing antibodies (Nab) are attained after CoronaVac than after a mRNA-based vaccine in healthy individuals. This difference seems to be more pronounced in immunocompromised patients who are at higher risk of severe COVID-19 and death from COVID-19. As such several countries including United States, Israel and Chile have recommended a third vaccine dose for this vulnerable population.

In this observational study we will explore the humoral response to the BNT162b2 vaccine in patients who received two previous doses of the inactivated vaccine Coronavac or two doses of BNT162b2.


Eligibility criteria: Inclusion Criteria:

* Vaccination with two doses of Coronavac vaccine or BNT162b2 vaccine
* Eastern Cooperative Oncology group performance status \< 3

Exclusion Criteria:

* Previous SARS-CoV-2 infection
* Vaccination with booster vaccine more than 12 weeks before informed consent
* Intravenous inmunoglobulin therapy 60 days before informed consent
* Any condition that could interfere with the paticipant´s participation during the study in the opinion of the treating investigator.

Primary outcomes:
measure: Proportion of positive neutralizing antibodies 8 to 12 weeks after third dose BNT162b2 (booster vaccine).
timeFrame: 8 to12 weeks after third dose BNT162b2.
Secondary outcomes:
measure: Neutralizing geometric mean titers 8 to 12 weeks after third dose BNT162b2 (booster vaccine)
timeFrame: 8 to12 weeks after third dose BNT162b2.
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Red de Salud UC Christus
Study officials:
References:
Clinical trial NCT06357338: Differential Expression and Potential Value of c-MYC in Non-Invasive and Invasive Mammary Carcinoma
Official title: Differential Expression and Potential Value of c-MYC in Non-invasive and Invasive Mammary Carcinoma
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Invasive Breast Cancer
Lead sponsor: Sohag University
Sponsor class: OTHER
Collaborators: name: Qena Oncology Center
First posted: 2024-04-10
Enrollment: 70
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: women with breast lumps administered to oncology center

Brief summary: Retrospective observational study to evaluate c-MYC expression in non invasive and invasive mammry carcinoma

Detailed description: To correlate different levels of c-MYC expressions with variable clinical and pathological parameters of mammary carcinoma (such as patients' ages, tumor grading, staging, laterality, focality and nodal metastasis, co-existing in-situ components). This study will be carried out on archived formalin-fixed and paraffin embedded tissue blocks that were belonged to 70 women with breast lumps.

Eligibility criteria: Inclusion Criteria:

Specimens of Modified Radical Mastectomies from breast carcinoma patients

Exclusion Criteria:

* Cases with insufficient clinical data.

  * Tissue blocks of destroyed or insufficient material, unfit for diagnosis.
  * Cases who received pre-operative chemotherapy.

Primary outcomes:
measure: role of c-MYC in breast cancer
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university
Study officials:
affiliation: Sohag University
name: Afaf Alnashar, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gao FY, Li XT, Xu K, Wang RT, Guan XX. c-MYC mediates the crosstalk between breast cancer cells and tumor microenvironment. Cell Commun Signal. 2023 Jan 31;21(1):28. doi: 10.1186/s12964-023-01043-1.
Clinical trial NCT00963638: Beneficial Effects of Magnesium Supplementation On Idiopathic Muscle Cramps
Official title: Beneficial Effects of Magnesium Supplementation On Idiopathic Muscle Cramps
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Cramp
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2009-08-21
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to evaluate the effectiveness of magnesium supplements (MagTabSR 168 mgs twice daily) for relief and/or improvement in the frequency, duration, and intensity of chronic leg cramps. Improvement in sleep disturbances and quality of life will also be evaluated.

Detailed description: Chronic leg cramps are prevalent among the aging population affecting sleep patterns and quality of life. Magnesium deficiency may cause muscle weakness and cramps. Magnesium supplementation will be evaluated for the relief and/or improvement of symptoms. The primary objective is to evaluate the efficacy of magnesium supplementation, MagTabSR, 168mg's twice a day, for the relief and/or improvement in the frequency, duration, intensity of leg cramps. Secondary objectives are to evaluate the improvement in sleep disturbances and quality of life.

Eligibility criteria: Inclusion Criteria:

* 40-85 Years Old
* No Kidney Impairment
* 2 or more leg cramps per week for last 30 days

Exclusion Criteria:

* \< 40 or \> 85 Years Old
* Kidney Impairment
* \< 2 leg cramps per week for last 30 days
* Enrolled in another research study
* History of seizure disorder
* Current treatment with Lithium
* Malabsorption or major intestinal disorders
* Significantly elevated magnesium level
* History of allergy to magnesium compound
* Use of Quinine for leg cramps
* History of significant diarrhea
* History of drug or alcohol abuse in the last 2 years
* Currently diagnosed with a terminal illness

Primary outcomes:
measure: Change in Frequency of Leg Cramps
timeFrame: 30 days
measure: Frequency/Duration of Muscle Cramps
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Physician
name: Lewis Rosenbaum, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04838938: Personalized Medicine in Patients With Infective Endocarditis
Official title: Personalized Medicine in Patients With Infective Endocarditis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infective Endocarditis
Response, Acute Phase
Treatment
Lead sponsor: Fundación para la Investigación Biosanitaria del Principado de Asturias
Sponsor class: OTHER
First posted: 2021-04-09
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with an active infective endocarditis

Brief summary: The hypothesis underlying this work is the identification of different sub phenotypes of patients with infective endocarditis through the study of the host's response to infection.

Furthemore, metagenomic sequencing may be a helpful supplement to IE diagnostic, especially when conventional tests fail to yield a diagnosis.

Detailed description: Infective endocarditis is a life-threatening infection of heart valves and adjacent structures characterized by vegetations on valves and other endocardial surfaces, with tissue destruction and risk of embolization.

The clinical variability, including the heterogeneous response to infection and the different antibiotic treatments make the identification of the underlying pathogens of infective endocarditis (IE) is critical for precision therapy. Virulence factors mediate tissue adherence, host infiltration, immune resistance/evasion, and dynamic stress responses and confer enhanced pathogen survival, proliferation, and host invasion in animal models of infective endocarditis.

To identify the microorganism and simultaneously considered the response of the host to the infection could improve the management of the infective endocarditis.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of active infective endocarditis according to the modified Duke criteria.

Exclusion Criteria:

* Pregnancy

Primary outcomes:
measure: To characterize a cohort of patients diagnosed with infective endocarditis
timeFrame: 2 year
Secondary outcomes:
measure: Identification of the underlying pathogens of infective endocarditis (IE)
timeFrame: 2 year
measure: Host response classification for infective endocarditis (IE)
timeFrame: 2 year
measure: Host response predictors of sepsis outcomes
timeFrame: 2 year
Other outcomes:
Locations:
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Principado De Asturias
Study officials:
affiliation: HUCA-FINBA, Universidad de Oviedo
name: Guillermo Muñiz Albaiceta, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00512538: Apligraf Versus Standard Therapy in the Treatment of Diabetic Foot Ulcers
Official title: A Randomized, Open-Label, Multi-Center Study to Compare the Safety and Efficacy of Apligraf Versus Standard Therapy (i.e., Saline Moistened Dressing Regimen) in the Treatment of Diabetic (Primarily Neuropathic) Foot Ulcers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Diabetic Foot
Keywords: Diabetic foot
Lead sponsor: Organogenesis
Sponsor class: INDUSTRY
First posted: 2007-08-07
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the ability of Apligraf to improve the time to and incidence of complete wound closure of diabetic foot ulcers, as compared to diabetic foot ulcers treated with standard therapy.

Detailed description: Ulceration of the diabetic foot is a result of multiple problems including repetitive stress on a neuropathic or insensate area that is often associated with an underlying bony prominence. By healing diabetic foot ulcers quickly the risks of infection, osteomyelitis (infeciton of the bone) and limb loss can be reduced.

This study will evaluate the ability of Apligraf to heal diabetic foot ulcers that have been present for at least 2 weeks and are between 1 - 16 cm2 in area. Patients will be randomized to either (50:50 chance) treatment with Apligraf or a saline moistened dressing regimen (standard therapy). All patients will receive standard cares for the ulcers which includes debridement, orthotics and off-loading throughout the treatment period.

Eligibility criteria: Inclusion Criteria:

* diabetic ulcer of primarily neuropathic origin on the plantar region of the forefoot
* ulcer extending through the dermis but without sinus tract, tendon, capsule or bone exposure
* ulcer present for at least 2 weeks and measuring 1- 16 cm2
* diminished sensesation on target extremity/foot
* ulcer is not infected
* Type 1 or 2 diabetes with adequate glycemic control
* Adequate vascular supply to the target extremity

Exclusion Criteria:

* Charcot foot
* Non-neuropathic ulcers
* Skin cancer within or adjacent to the target ulcer
* Osteomyelitis or an infected ulcer
* Clinically significant medical condition that would impair wound healing
* Females who are pregnant
* Received within 4 weeks of study entry systemic corticosteriods, immunosuppresive agents, radiation therapy or chemotherapy

Primary outcomes:
measure: Time to complete wound healing (full epithelialization with no drainage)
timeFrame: through 12 weeks
Secondary outcomes:
measure: Incidence of complete healing
timeFrame: at 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Diabetic Foot Clinic, Kings College Hospital, London UK
name: Michael E Edmonds, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05504538: Coracoid Tunnel Widening After ACJ Tight Rope Fixation
Official title: The Correlation Between Coracoid Tunnel Dilatation and Loss of Reduction After Arthroscopic Acromioclavicular Fixation Using Tightrope System, A CT Based Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthopedic Disorder
Orthopedic Devices Associated With Misadventures
Keywords: Acute acromioclavicular joint injury .
TightRope .
Coracoid tunnel dilatation.
Loss of reduction.
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-08-17
Enrollment: 23
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: studying coracoid tunnel widening after arthroscopic fixation of acute acromioclavicular joint (ACJ) dislocation using TightRope system and its correlation with loss of reduction and the functional scores.

Detailed description: Abstract Purpose: To detect coracoid tunnel widening after arthroscopic fixation of acute acromioclavicular joint (ACJ) dislocation using TightRope system and its correlation with loss of reduction and the functional scores.

Methods: From July 2016 to Dec 2018, a prospective study was performed at our hospital. Twenty-three patients with acute grade III-V ACJ dislocation were included in the study. Arthroscopic double tight-rope repair of the ACJ was performed. Coracoid tunnel widening was measured by computed tomography (CT) and coraco-clavicular distance was measured on the x-ray immediately post-operative and at 12 months. Constant Shoulder Score, Oxford Shoulder Score, Nottingham Clavicle Score and Visual analogue scale were used as outcome measures at 12 months.

Level of evidence IV Keywords Acute acromioclavicular joint injury . TightRope . Coracoid tunnel dilatation. Loss of reduction.

Eligibility criteria: Inclusion Criteria:

* patients with acute (≤ 3 weeks after injury) Rockwood grade III-V ACJ dislocation

Exclusion Criteria:

* Patients with associated coracoid fracture, associated rotator cuff tears or glenohumeral arthritis

Primary outcomes:
measure: Coracoid tunnel diameter difference between immediate postoperative and final follow up
timeFrame: 1 year
measure: Coraco-clavicular distance immediate postoperative and at final follow up
timeFrame: 1 year
Secondary outcomes:
measure: Constant-Murley shoulder score. Ranges from 0 representing worst outcome to 100 representing best outcome
timeFrame: 1 year
measure: Disability of arm shoulder and Hand score ( DASH score) highest is 100 which represents worst outcome while lowest is 0 representing best possible outcome
timeFrame: 1 year
measure: Oxford Shoulder score, a questionnaire of 12 questions each scores from 1 to 5. 1 being the fewest symptoms, 5 being the worst. The total score is 60 marks, the higher the score the worse the outcomes
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References: