cyrilzakka/clinical-trials huggingface dataset:
The SPARC Trial: Stereotactic Prostate Ablative Radiotherapy Using Cyberknife

Giving a higher dose of radiation to the dominant tumour nodule within the prostate is hypothesized to improve tumour control. This trial will assess whether this technique, delivered in 5 treatments, can be delivered without increasing side effects.

Aim To assess if a focal boost can be delivered to the dominant tumour nodule alongside 36.25 Gy in 5 fractions to the whole prostate gland.

Primary end-point: Acute toxicity (Radiation Therapy Oncology Group (RTOG), International prostate symptom score (IPSS))

Secondary end-points: Prostate specific antigen (PSA) nadir and 2-year biochemical control Late toxicity (IPSS, RTOG, International index of erectile function (IIEF-5)) Quality of life (EQ5D scale)

Inclusion criteria

* Prostate cancer patients with any of the following:
* PSA\>20
* Gleason grade 4+3 or higher
* Stage T3a
* Exclusion criteria
* Nodal or metastatic disease
* PSA\>40
* Stage T3b or higher

Study interventions

This is a phase II study which will recruit 20 patients. A dose of 36.25 Gy in 5 fractions will be delivered to the whole prostate with a simultaneous integrated boost up to 47.5 Gy in 5 fractions or to the highest dose possible within dose constraints. The boost volume will be defined on the multiparametric magnetic resonance scan by the specialist radiologist.

Eligibility Criteria:
Inclusion Criteria:

Prostate cancer patients with any of the following:

* PSA 20-40
* Gleason grade 4+3 or higher
* Stage T3a

Exclusion Criteria:

* Nodal or metastatic disease
* PSA\>40
* Stage T3b or higher
Influenza Vaccination for Flu Prevention in Patients With Plasma Cell Disorders

This phase IV trial studies how well influenza vaccination works in preventing infections such as influenza in patients with plasma cell disorders. Influenza infections may theoretically support the growth of tumor cells and improving protection against influenza may improve the status of patients' plasma cell disorder. Giving influenza vaccination may reduce influenza-related complications including infections, hospitalizations, and deaths, and improve the status of plasma cell disorders.

PRIMARY OBJECTIVES:

I. Demonstrate an absolute 25% increase in seroprotection, defined as hemagglutination antibody inhibition (HAI) \> 40 against all strains, at week 21 in the experimental arm compared to the control arm.

II. Determine correlation between HAI, predefined risk of influenza-like illness (low, moderate, high), and progression-free survival (PFS).

EXPLORATORY OBJECTIVES:

I. Measurement of B \& T-cell subsets and flu-specific responses as a way of understanding immunosuppression in this patient population, correlating with influenza-like illness.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive trivalent influenza vaccine intramuscularly (IM) at weeks 1, 9, and 17, and pneumococcal 13-valent conjugate vaccine IM at week 5 in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive trivalent influenza vaccine IM at week 1 and pneumococcal 13-valent conjugate vaccine IM at week 5 in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for 4 weeks and then periodically for 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Patient must have a plasma cell dyscrasia that fits in the International Myeloma Working Group (IMWG) diagnostic criteria.
* Both men and women of all races and ethnic groups are eligible for this study.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3 (Karnofsky ≥ 30%) is required for eligibility.
* Patient must be eligible to receive standard of care influenza vaccination. If the patient has a history of egg allergy with symptoms more severe than urticaria, e.g. angioedema, respiratory distress, lightheadedness, or recurrent emesis, they remain eligible to receive influenza vaccination but must receive the vaccine in a facility able to recognize and manage severe allergic reactions. Persons who are able to eat lightly cooked egg (e.g., scrambled egg) without reaction are unlikely to be allergic, although egg-allergic persons might tolerate egg in baked products.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Patients who have already received the seasonal influenza vaccine in the current season.
* History of Guillain-Barré syndrome.
* Patients with a previous severe allergic reaction to influenza vaccination or pneumococcal 13-valent conjugate vaccine (PCV13).
* Expected survival \< 9 months.
* Prisoners.
Effectiveness of Enoxolone on Oral Conditions of Patients With Periodontal Surgery

Abstract Aim:The Enoxolone (18β-glycyrrhetinic acid; BGA) is a bioactive compound in licorice that exhibits potential anti-ulcer, anti-inflammatory, and anti-microbial activities, relieve oral ulcers, pain, improve gingivitis and dental plaque from past relevant experimental studies,but few clinical trials have evaluated its clinical effectiveness. Therefore, the purpose of this study is to evaluate the effectiveness of Enoxolone on oral conditions of patients with periodontal surgery. Methods:This study is a randomized controlled trial. Patients with severe chronic periodontitis who needed to accept periodontal surgery were randomly assigned to two groups, the experimental group was Enoxolone toothpaste, and the control group for Sensodyne toothpaste. After the operation, toothpaste was used three times a day to clean the mouth for 12 weeks . Clinical evaluation was using the patient-reported pain score, painkillers, wound healing index (complete epithelization and color matching score), periodontal pocket depth, gingiva index, plaque index and were recorded before operation and 1st, 2nd, 3rd, 4th, 8th, 12th week after surgery. Data set performs repeated-measures for the change in mean differences by using the two-tailed independent t tests and generalized linear model.

Enoxolone is a toothpaste containing 18β-glycyrrhetinic acid (BGA). In this study, the experimental group used Enoxolone toothpaste, and the control group did not contain BGA toothpaste (Sensodyne), which is used for oral cleaning of patients after periodontal disease surgery. The absorption rate is very low, and it will not cause any interaction with western medicine.

Eligibility Criteria:
Inclusion Criteria:

* Those who are over 20 years old.
* Those whose health or systemic diseases are well controlled.
* Those with severe chronic periodontitis who need to perform periodontal surgery after being diagnosed by a doctor.
* Subjects who are willing to accept this study.

Exclusion Criteria:

* Allergy to licorice.
* Pregnancy or breastfeeding.
* Periodontal surgery completed at the same site within 6 months.
* Severe bone loss in the apical tissue of the surgical site (including poor prognosis).
* Clinical signs of infection, including fistula, suppuration, fever, severe pain and site swelling.
* Platelets less than 50,000.
Open Label Extension Study of Bifeprunox

A one year extension study using flexible doses, 20 or 30 mg daily, of open-label bifeprunox.


Eligibility Criteria:
Inclusion Criteria:

1. Outpatients who have successfully completed Wyeth study 3168A1-311-US.
2. A signed and dated informed consent form for this study.
3. No major protocol violations in previous study.

Exclusion Criteria:

1. Clinically important abnormalities noted in preceding short-term study that have not resolved.
2. Use of prohibited treatments in the preceding short-term study.
3. Meeting any exclusion criteria for the preceding short-term study.
Intra-articular Injections of Platelet-rich Plasma, Hyaluronic Acid, or Corticosteroids for Knee Osteoarthritis

To assess if there are any differences among platelet-rich plasma, hyaluronic acid, and corticosteroid knee intra-articular injection regarding function and pain.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged 35-65 years old
* Patient with knee pain that had been continuing for at least 12 months with no relief using anti-inﬂammatory medications and that deteriorated with weight-bearing
* Knee osteoarthritis that classified as mild-moderate or moderate-severe (Kellgren-Lawrence Grade 2, 3, or 4)

Exclusion Criteria:

* Age \> 65 years
* The recent history of knee trauma
* Autoimmune rheumatic diseases
* Accompanying severe hip OA
* Thrombocytopenia or other blood diseases
* Immunosuppressive or anticoagulant treatment
* The invasive procedure applied to the knee
* Intra-articular steroid injection to the knee within the previous 12 months
* Previous joint infection
* Uncontrolled systemic diseases such as diabetes or hypertension, and cancer
* Excessive varus/valgus knee deformity
Ultrapower; a Minimally Invasive Tool for Evaluation of Total Cardiac Power

The heart is essentially a hydraulic pump which ensures adequate delivery of blood through generating pressure and forward flow of blood. The energy delivered by the heart is uncommonly measured clinically, and todays gold standard involves placing a plastic catheter into the lung arteries. The investigators have developed an ultrasound based approach to calculate this energy without the need for catheters through the heart. This novel approach is called ultrapower. Ultrapower involves the instantaneous multiplication of the cardiac output and the arterial blood pressure. The study aims to use the ultrasound based approach to investigate Cardiac Power in the coronary artery bypass graft population.


Eligibility Criteria:
Inclusion Criteria:

• coronary artery bypass graft operation

Exclusion Criteria:

* Lack of informed consent
* Previous aortic valve replacement
* Inadequate Doppler signal on transthoracic echocardiography
Ixekizumab Concomitantly Administered With Tirzepatide in Adults With Psoriatic Arthritis and Obesity or Overweight

The main purpose of this study is to demonstrate that when participants with psoriatic arthritis and obesity or overweight in the presence of at least 1 weight-related comorbid condition receive ixekizumab and tirzepatide concomitantly administered, participants see improvement in their psoriatic arthritis and achieve weight reduction compared to when receiving ixekizumab.

Participation in this study includes up to 12 visits and could last up to 61 weeks including screening, open label treatment period, and post-treatment follow-up period.


Eligibility Criteria:
Inclusion Criteria:

* Have signs and/or symptoms or documented diagnosis of Psoriatic Arthritis (PsA) for at least 6 months and currently fulfilling the classification of Psoriatic Arthritis (CASPAR) criteria.
* Have active PsA, defined as the presence of at least 3 of 68 tender joints and at least 3 of 66 swollen joints.
* Have obesity, body mass index of ≥30 kilograms per meter squared (BMI ≥30 kg/m²) or overweight (BMI ≥27 to \<30 kg/m²) in the presence of at least 1 of these weight-related comorbid conditions (hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease, or T2DM).

Exclusion Criteria:

Medical Conditions

* Have Type 1 Diabetes Mellitus (T1DM).
* Have insulin-treated Type 2 Diabetes Mellitus (T2DM).
* Have a prior or planned surgical treatment for obesity.
* Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia (MEN) syndrome type 2.
* Have active, or a history of inflammatory bowel disease (Crohn's or ulcerative colitis).
* Have a diagnosis or history of malignant disease within the 5 years prior to randomization, with the following exceptions:

  * basal cell or squamous epithelial carcinomas of the skin that have been resected, with no evidence of metastatic disease for 3 years.
  * cervical carcinoma in situ, with no evidence of recurrence within the 5 years prior to randomization.
* Have a serious disorder or illness other than PsA.
* Have a history of chronic or acute pancreatitis.
* Have any prior use of ixekizumab or tirzepatide.
* Diagnosis of other inflammatory arthritis, such as Rheumatoid Arthritis (RA), ankylosing spondylitis, reactive arthritis, gout, or enteropathic arthritis.
* Have a previous failure or intolerance to an interleukin 17 inhibitor (IL-17i) or glucagon-like peptide 1 (GLP-1) receptor agonists.
The Band-Frail Study: A Provincial Intervention to Outweigh Diabetes and Frailty in New Brunswick

The goal of this study is to test whether psychological, social, and physical health outcomes of older adults living with type 2 diabetes and frailty are improved when participating in the Band-Frail Program.

Individuals considered fragile or frail and living with type 2 diabetes (T2D) have a 5-fold increased risk of being moved to a long-term care facility and a 4-fold increased risk of an emergency department visit. In 2013, the Mid-Frail study found that 16 weeks of combined exercise, diet, and education intervention significantly improved functional abilities in older adults living with T2D and frailty.

The goal of The Band-Frail Study is to implement an adapted version of the Mid-Frail program in New Brunswick (NB), while ensuring its sustainability by leveraging existing resources in the future as NB has one of the highest rates of diabetes in Canada and one of the highest average age of residents.

This project will include adults aged 65 years and above living with T2D and frailty across the province of New Brunswick (NB). Participants will meet in groups of 4-8 people twice a week for 16 weeks. One session will consist of diabetes management education delivered by a Certified Diabetes Educator and elastic band resistance training, while the second session will only involve the elastic band resistance training.

Participants will undergo pre- and post-testing including questionnaires, physical function tests, and interviews to assess the viability of this program in the province and determine the physical and psychological benefits.

Eligibility Criteria:
Inclusion Criteria:

* Aged over 65 years old
* Classified as frail or pre-frail on Fried's Frailty Scale
* Self-reported diagnosis of type 2 diabetes
* Not physically active (3+ days of physical activity per week)

Exclusion Criteria:

* Aged under 65 years old
* Classified as robust of Fried's Frailty Scale
* Not diagnosed with type 2 diabetes
* Regularly physically active (3+ days of physical activity per week)
Evaluation of the Reproducibility of the Measurement of the QSM Signal (Quantitative Susceptibility Mapping)

Many central nervous system pathologies have an inflammatory component, often associated with an accumulation of disability and more severe tissue damage.

In multiple sclerosis, the inflammatory process is in part characterized by the activation of microglia, an entity of the innate inflammatory system, as well as a breakdown of the blood-brain barrier. During inflammation, activated microglia may contain high levels of iron, characterizing its activated state.

Several MRI imaging tools are known to be highly sensitive to tissue iron content and have become the method of choice to study brain iron, including in a pathological context such as multiple sclerosis.

Quantitative magnetic susceptibility mapping (QSM) is an emerging technique to access non-invasively the iron content in brain tissue. For some years this technique has been used in MS to characterize white matter lesions. Changes in the QSM value of the lesions have made it possible to describe lesions surrounded by an iron ring. Susceptibility MRI has also been proposed to highlight lesions according to their chronology.

The study of reproducibility is of particular importance when using QSM in longitudinal studies or in therapeutic trials. A better understanding of intra- and inter-subject variation in QSM measurements may also allow a more accurate estimate of the number of subjects needed to detect changes in studies. In order to be widely applied to various pathologies, it is therefore necessary to evaluate its reproducibility by estimating the intra- and inter-subject variability for future dissemination in clinical and pharmaceutical studies.

In this project, the invstigators propose to study the reproducibility of QSM acquisition.

Eligibility Criteria:
Inclusion Criteria:

* Subject over 18 years old
* Consent to participate in the study
* Beneficiary of a social protection scheme
* Healthy volunteers: Consent to be informed if an unexpected anomaly is revealed by the imagery.
* Patients: With MS defined according to McDonald's revised criteria for spatial dissemination and temporal or clinical or radiological temporal dissemination and who should benefit from MRI in the imaging department

Exclusion Criteria:

* Absolute contraindication to 3T MRI
* Realization of an injected MRI (gadolinium) in the previous year
* Patient benefiting from a legal protection measure
* Pregnant or breastfeeding woman
* For healthy volunteers: History of neurological pathology or neurological pathology in progress
Functional Recovery After Medial Monocompartmental Knee Prosthesis: One Day Protocol Versus Fast Protocol

The study is defined as prospective, randomized, interventional single-center; the general aim is to evaluate the post-operative recovery of the patient who carries out rehabilitation with the one day protocol (Group A), compared to the patient who carries out rehabilitation during the hospital stay with the fast protocol (group B).

The study is defined as prospective, randomized, interventional single-center; the general aim is to evaluate the post-operative recovery of the patient who carries out rehabilitation with the one day protocol (Group A), compared to the patient who carries out rehabilitation during the hospital stay with the fast protocol (group B).

The difference will be evaluated with the Knee Society Scopre (KSS) questionnaire at 1 month after the operation.

The population is made up of two groups of patients:

25 patients Group A: one day protocol; experimental group discharged home the day (24h) after the operation and carrying out rehabilitation according to the clinical standard 25 patients Group B: fast protocol; control group discharged to the rehabilitation department of the Institute 48 hours after surgery which carries out rehabilitation during the hospital stay according to the clinical standard

The subjects will undergo the following assessments:

* Pre-admission
* Knee replacement surgery
* Rehabilitation
* Questionnaires and evaluation scales at 7 and 15 days (+/- 2 days), at 1, 3, 6 months (+/- 7 days) and 12 months (+/- 1 month) after surgery. If necessary, they can be collected by telephone.

Eligibility Criteria:
Inclusion Criteria:

* Age 40\<x\<85 included
* Medial monocompartmental gonarthrosis grade 3-4 sec Kellgren-Lawrence
* Primary medial gonarthrosis
* Signing of the Informed Consent and consent to collaborate in all study procedures.

Exclusion Criteria:

* Cognitive decline
* Psychiatric disorders
* Neuromuscular disorders
* Age \> 85 years or \<40
* Lateral gonarthrosis grade 3-4 sec Kellgren-Lawrence
* Patella symptoms
* Secondary medial gonarthrosis
* Minor age
* Pregnant women (self-declaration)
Maternal and Fetal Outcomes in Pregnant Women With COVID -19,a Cross Sectional Study

The spread of a new coronavirus (SARS-CoV-2) from Wuhan, China, has been fast, and the World Health Organization (WHO) declared a pandemic on March 11th, 2020 .It has now spread worldwide and is one of the most severe public health threats.The clinical characteristics of COVID-19 and the likelihood of transmission vertically or during delivery in pregnant women are still unknown.

In this cross sectional study,the following questions require immediate attention: whether COVID-19 symptoms in pregnant women differ from symptoms in non-pregnant women; whether disease complications and mortality rates are higher in pregnant women than in non-pregnant women; and whether there is a risk of premature delivery, foetal mortality, or even vertical transmission of the disease. These questions must be answered in order to plan optimal obstetrical management for pregnant women with COVID-19

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women of any gestational age with confirmed COVID 19 diagnosis attended and admitted at inpatient ward for management and follow up from April 2020 to December 2021at Kasr El Ainy hospital,Cairo university

Exclusion Criteria:

* there is no exclusion criteria
Single and Double DNA Strand Breaks in Males With Unexplained Infertility Attending Fertility Treatment

The aim of this study is to investigate the extent of double-stranded DNA damage in sperm in men with unexplained infertility.


Eligibility Criteria:
Inclusion Criteria:

* Unexplained infertile men who will undergo 1st or 2nd IVF treatment
* Age over 18 years
* Normal sperm parameters according to WHO criteria
* IVF treatment

Exclusion Criteria:

- ICSI
Femoral or Radial Approach in Coronary Chronic Total Occlusion

Pecutaneous coronary intervention (PCI) of chronic total occlusions (CTOs) is most commonly performed using bilateral transfemoral access and 8 French guiding catheters. However, transfemoral approach (TFA) is associated with higher risk of vascular access complications.5 It has been reported that using transradial approach (TRA) reduces vascular complications and may be associated with a better clinical outcome. Transradial access is also used in complex PCI interventions.There is a growing body of evidence regarding the use of this approach also in CTO procedures. In available literature, all studies comparing TRA vs. TFA in CTO consisted of single center and single operator experience. Besides, none of them is randomized. To fill in the gap, we sought to examine the technique and outcomes of transradial vs. transfemoral CTO PCI in a contemporary multicenter randomized study.

All consecutive patients referred for CTO PCI between August 2017 and July 2021 at Acibadem University Kocaeli Acibadem Hospital, Kocaeli; Erciyes University Medical Faculty, Kayseri; Istanbul University Cerrahpasa Medical Faculty, Haseki Cardiology Institute; Istanbul; Memorial Bahcelievler Hospital, Istanbul were screened for enrollment in the study. The exclusion criteria included: (a) any acute coronary syndrome within 3 months; (b) severe heart failure issues; (c)severe renal failure (d) failure to provide written informed consent.The radial access group consisted of patients with single or bi-radial approach. Any femoral artery puncture was considered a femoral case. For example, a crossover from any radial to femoral access was considered a femoral case. Procedures were performed by 4 interventional cardiologists, who are dedicated radial operators, at 4 different centers. The protocol was approved by the institutional review board and all patients provided written informed consent.

Eligibility Criteria:
Inclusion Criteria:

* Any patient with coronary total occlusion \>3 months and indication for intervention

Exclusion Criteria:

* Acute coronary syndrome within 3 months