cyrilzakka/clinical-trials huggingface dataset:
Efficacy Study of Ifabond in Breast Cancer Surgery

A randomized prospective simple-blind interventional study evaluating the efficacy of the synthetic adhesive solution "Ifabond", in patients undergoing breast cancer surgery. The main objective of this study is to determine if the application of Ifabond, in addition to the conventional method of breast surgery, reduces the postoperative seroma formation. The secondary objective is to assess quality of life immediately after surgery, and the need for needle aspiration of the axilla, when using Ifabond.

Breast cancer patients will be selected at their preoperative visit with the surgeon, who will inform them about the study and answer their questions.

Patients who consent to participate will be randomized to one of two arms:

1. Arm A: Applying Ifabond
2. Arm B: Without Ifabond

Patients will be stratified according to these two criteria:

1. Axillary Lymph Node Dissection planned (ALND)
2. Body Mass Index (BMI)

The following parameters will be measured:

* ECOG status and Blood Pressure at day 3(day 7 in case of ALND), day 15 and day 30 post surgery
* Volume of drainage at day 3 and at (day 7 in case of ALND)post surgery
* Discomfort alleged by the patient at day 3(day 7 in case of ALND), day 15 and day 30 post surgery
* Lymphocele volume measured by ultrasound at day 15 and day 30 post surgery
* If the volume is ≥ 100cc, a needle aspiration will be performed, and the volume of aspirate will be documented.
* Adverse events and concomitant medications will be collected throughout the study until 30 days after the last ultrasound.

Eligibility Criteria:
Inclusion Criteria:

* "Eastern Cooperative Oncology Group" ECOG status ≤ 2
* Diagnosis of invasive or In situ breast cancer
* Patient undergoing partial mastectomy with or without axillary lymph node dissection,(without communication between the two surgical loges)

Exclusion Criteria:

* Pregnant or breast-feeding patient
* Participation at another protocol with an Investigational drug (within the last 4 weeks before enrollment)
* Known hypersensitivity to Cyanoacrylate
* Known hypersensitivity to formaldehyde
* Patient who experience systemic infections preoperatively, or have conditions that are known to interfere with the healing process
* Patient with uncontrolled diabetes
Regional Versus General Anesthesia for Promoting Independence After Hip Fracture

The purpose of this study is to find out if two types of standard care anesthesia are the same or if one is better for people who have hip fractures.

Hip fracture is a clinical condition that involves a break in the femur (hip bone) near where it attaches to the pelvis. Hip fractures occur more than 300,000 times each year in the US and over 1.6 million times each year worldwide.

Over 90% of hip fractures occur in individuals aged 50 or older, most commonly resulting from low-energy traumatic injuries, such as falls from standing in the context of established osteoporosis, chronic illness, or disability. Surgical treatment, via fixation of the fractured bone or partial or total replacement of the hip joint, is indicated for all types of hip fractures and approximately 95% of hip fracture patients undergo surgery.

No evidence-based interventions now exist to improve functional outcomes after hip fracture surgery beyond the immediate postoperative period. Nearly all hip fracture patients require orthopedic surgery and anesthesia, making the anesthetic care episode a major opportunity to impact outcomes.

Spinal and general anesthesia represent the two standard care approaches to anesthesia for hip fracture surgery. Basic and clinical research has identified multiple plausible mechanisms by which spinal anesthesia may improve outcomes after hip fracture; nonetheless, major guidelines and systematic reviews have identified key evidence gaps and anesthesia care for hip fracture varies markedly in practice. While spinal and general anesthesia for hip fracture have been previously compared in retrospective studies and small randomized trials, much of the available prospective trial data is old and may not be reflective of current clinical practice.

REGAIN will be the first pragmatic multicenter prospective randomized trial of spinal versus general anesthesia for hip fracture surgery designed to evaluate the association of anesthesia technique with functional recovery after hip fracture. As such, it will fill critical evidence gaps to inform policy and practice.

Approximately 2,424 subjects will be enrolled (i.e. informed consent for participation will be obtained) in order to yield approximately 1,600 randomized patients. This estimate is based on an assumption that one in three patients (33%) who undergo consent prior to surgery will not be randomized on the day of surgery due to active clinical issues, timing of medication dosing, clinical assessments by treating physicians or the site Clinical Director or their designate, or patient withdrawal of consent.

Eligibility Criteria:
Inclusion Criteria:

* Clinically or radiographically diagnosed intracapsular or extracapsular hip fracture
* Planned surgical treatment via hemiarthroplasty, total hip arthroplasty or appropriate fixation procedure
* Ability to walk 10 feet or across a room without human assistance before fracture

Exclusion Criteria:

* Planned concurrent surgery not amenable to spinal anesthesia
* Absolute contraindications to spinal anesthesia
* Periprosthetic fracture
Centella Asiatica in Older Adults

The purpose of this study is to determine the effects of a dietary supplement containing centella asiatica on on vascular endothelial function in older adults.


Eligibility Criteria:
Inclusion Criteria:

● Age 50 through 85, male or female

* Sufficient proficiency in English to understand study purpose and directions
* Willing and able to give informed consent
* Able to follow protocol and attend visits

Exclusion Criteria:

* History of myocardial infarction, known coronary or carotid disease, or heart failure
* History of stroke, Parkinson's disease, dementia, or other major CNS disorders
* History of hepatic disease (e.g. hepatitis, cirrhosis)
* Recent/recurring history of severe life-threatening medical conditions (e.g. cancer, except non-melanoma skin cancers)
* Active major infectious disease (e.g. pneumonia)
* Heavy alcohol use (15 drinks or more per week for men or 8 drinks or more per week for women) or substance use disorder
* Current use of any medication typically used to treat hypertension or lower blood pressure (e.g. beta-blockers, ACE inhibitors)
* Current use of any medication typically used to prevent the coagulation of blood (e.g. warfarin (Coumadin))
* Chronic NSAID use (\>3 times a week for more than 3 months)
* Current use of any medication or supplement typically used as a sedative (e.g. zolpidem (Ambien), benzodiazepines (Valium, Xanax), valerian root)
* Dietary supplements for improving nitric-oxide synthesis (e.g. L-arginine, L-citrulline)
* Current use of any medication typically used to control hypoglycemia (e.g. biguanides (Metformin))
* Current use of any medication typically used for erectile dysfunction (e.g. sildenafil (Viagra), tadalafil (Cialis))
* Pregnant, nursing, or planning a pregnancy within the next 6 weeks
* Open skin rashes and sores that may interfere with the placement of sensors
An Open-Label, Prospective Study to Assess the Safety and Effectiveness of Adalimumab in Patients With Moderate to Severe Plaque Psoriasis in the Russian Federation

This is an open-label study designed to establish the safety and effectiveness of adalimumab in the treatment of moderate to severe plaque psoriasis after 24 weeks of treatment.

During the treatment period, participants will receive an initial adalimumab 80 milligram (mg) subcutaneous (sc) dose, followed by adalimumab 40 mg sc every other week starting one week after initial dose. Safety and effectiveness assessments will be completed at Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 and Week 24. Participants may discontinue adalimumab treatment at any time during study participation. Participants that end study participation early will have a Premature Discontinuation visit. All participants who do not initiate commercial Humira® will have a follow-up phone call 70 days after the last administration of study drug to obtain information on any new or ongoing Adverse Events (AEs). The 70-day follow-up phone call will not be required for any participant that initiates adalimumab therapy not supplied in the context of the clinical trial after the end of study participation.

Eligibility Criteria:
Inclusion Criteria:

A patient will be eligible for study participation if he/she meets the following criteria:

1. Male and female patients ≥ 18 years of age.
2. Clinical diagnosis of psoriasis for at least 6 months as determined by patient interview of his/her medical history and confirmation of diagnosis through physical examination by the investigator.
3. Stable plaque psoriasis for at least 2 months before Screening and Baseline visits as determined by patient interview of his/her medical history.
4. Moderate to severe plaque psoriasis defined by ≥ 10% Body Surface Area (BSA) involvement at the Baseline visit.
5. PASI (Psoriasis Area and Severity Index) score ≥ 10 at the Baseline visit.

Exclusion Criteria:

1. Diagnosis of erythrodermic psoriasis, pustular psoriasis, medication induced or medication-exacerbated psoriasis or new onset of guttate psoriasis.
2. Diagnosis of other active skin diseases or skin infections (bacterial, fungal, or viral) that may interfere with evaluation of psoriasis.
3. Patient who cannot discontinue topical therapies for the treatment of psoriasis such as corticosteroids, vitamin D analogs, or retinoids at least 14 days prior to the Baseline (Week 0) visit and during the study. Participants are allowed to use:

   * Shampoos that contain no corticosteroid;
   * Bland (without beta or alpha hydroxy acids or containing no psoriasis treatment) emollients;
   * Low potency topical corticosteroids on the palms, soles, face, inframammary area, and groin only.
4. Patient who cannot avoid UVB (Ultraviolet-B) phototherapy for at least 14 days prior to the Baseline (Week 0) visit and during the study.
5. Patient who cannot avoid PUVA (psoralen + ultraviolet A) phototherapy for at least 28 days prior to the Baseline (Week 0) visit and during the study.
Efficacy and Safety Study of Bendamustine With or Without Rituximab in Chronic Lymphoproliferative Disorders

The purpose of this study is collect and evaluate the clinical experience reached in Italy on the use of bendamustine alone or combined with rituximab as treatment of patients with relapsed or refractory chronic lymphoproliferative disorders.

All patients who meet the criteria for inclusion will be included in the study. A specific database will be created to collect the following information: personal data, medical history, histology related to the underlying disease, comorbidities, laboratory data, initial staging, data on the dosage and the number of cycles administered, the recorded toxicity data, the clinical response and the main events (relapse, progression, death, and cause of death). These data will then be retrospectively examined in order to obtain information about the life-saving treatment.

Eligibility Criteria:
Inclusion Criteria:

* patients with relapsed or refractory chronic lymphoproliferative disorders
* salvage treatment with Bendamustine +/- Rituximab
* age ≥ 18 years

Exclusion Criteria:

* previous treatment with Bendamustine
Behavioral Exercise TRaining for Men Undergoing Androgen Depr Therapy for Prostate Ca

To refine a remote behavioral exercise training intervention for testing in a larger randomized trial.

Determine feasibility of recruiting a sample of medically underserved prostate cancer patients undergoing treatment with Androgen Deprivation Therapy (ADT) to a remotely delivered (i.e., home-based) exercise intervention and determine the interventions acceptability.

Eligibility Criteria:
Inclusion Criteria:

To be eligible men, transwomen or non-binary individuals must meet the following criteria:

* Be diagnosed with stage II/III/IV prostate cancer
* Be currently undergoing treatment with ADT (intermittent or prolonged)
* Have completed local curative-intent treatment, including prostatectomy or definitive radiation
* Be \>40 years of age if non-Hispanic Black or rural dwelling; Otherwise \>60 years of age up to 85
* Be willing to give an informed consent and sign a HIPAA authorization form
* Not have any hearing or sight impairments that result in the inability to use the telephone or hear normal conversation
* Must be able to join an intervention group by personal computer, smartphone or telephone call and should agree to recording of an interview
* Be without any serious medical condition that precludes safe participation in an exercise program
* Speak English.
* Meet protocol definition of medically underserved: which is consider medically underserved patients to be a) older men (\>75 years), b) men who live in rural zip code areas, or c) men who identify as being non-Hispanic Black. They may also be at the intersectionality of these groups (i.e., older Black men living in a rural zip code area).
Peer Navigator Education in Improving Survivorship Care in African American Breast Cancer Survivors

This randomized clinical trial studies peer navigator education in improving survivorship care in African American breast cancer survivors. An educational intervention involving peer groups may help to improve the well-being and quality of life (QOL) in breast cancer survivors

PRIMARY OBJECTIVES:

I. To evaluate the ability of peer navigation (PN) to improve understanding of survivorship care planning (SCP) at 6 months.

II. To promote adherence to the SCP schedule of follow-up examinations at 12 months.

SECONDARY OBJECTIVES:

I. To evaluate the effect of PN on change from baseline in medical efficacy, preparedness for life as new survivor, and physical and health related QOL at 6 months.

OUTLINE: PNs are trained on medical issues and resources, and SCP. Participants are then randomized to 1 of 2 treatment arms.

ARM I: Participants receive 4 PN sessions tailored to their needs followed by a 6 month booster session and American Cancer Society (ACS) materials.

ARM II: Participants receive ACS materials.

After completion of study treatment, patients are followed up at 6 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* TRIAL SUBJECTS:
* Patient age 18 years or older who self-identifies as African-American
* In early survivorship phase, defined as being 1-12 months post completion of treatment for stage 0-3 breast cancer
* Receiving health care primarily through an health maintenance organization (HMO)
* Patients with metastatic cancer or a second primary cancer, because their medical characteristics (e.g. disease progression) are significantly different
* Breast cancer survivors (BCS) with other major disabling medical, psychiatric, or substance abuse conditions (e.g., anxiety, depression, alcohol/tobacco problems) will be excluded
* PEER NAVIGATORS:
* At least 25 years of age who self-identifies as African-American
* Previously participated in any type of research study
* Has at least high school education
* Has been diagnosed with breast cancer, currently in remission or eradicated
* Belongs to a breast cancer support group
* Has a valid driver's license
* Owns an operational vehicle
* Has access to a personal computer with internet access
Relationship Between Coronary Microvascular Dysfunction and Improvement of Left Ventricular Systolic Function in Patients With Heart Failure With Reduced Ejection Fraction Caused by Non-ischemic Etiology

This study aims to evaluate the incidence of coronary microvascular dysfunction (CMD) and its prognostic implication for the improvement of left ventricular function in patients who have been diagnosed with heart failure with reduced ejection fraction (HFrEF) caused by non-ischemic etiology.

HF is a clinical syndrome characterized by dyspnea or exertional limitation due to impairment of ventricular filling or ejection of blood or both. HFrEF occurs when the left ventricular ejection fraction (LVEF) is 40% or less and is accompanied by progressive left ventricular dilatation and adverse cardiac remodeling. Among them, a substantial portion of patients had non-ischemic etiology.4 The CMD, defined by impaired coronary flow reserve (CFR), is commonly observed in patients with cardiomyopathies caused by non-ischemic etiology and is well-known to be associated with poor prognosis independently of the degree of left ventricular functional abnormality. However, the presence of CMD can be more specifically evaluated by invasive physiologic assessment using both CFR and the index of microcirculatory resistance (IMR) than by non-invasive methods (doppler echocardiography, positron emission tomography, or cardiac magnetic resonance imaging \[MRI\]) measuring CFR alone. Considering that CMD, defined by depressed CFR with elevated IMR, reflects the impaired myocardial flow and microvascular damages, there was a possibility that it may be a predictor of irreversible myocardial damages in HFrEF patients with non-ischemic etiology. Nevertheless, there has been limited data regarding the association between the improvement of LV function and CMD for patients with HFrEF caused by non-ischemic etiology after guideline-directed medical treatment (GDMT). Therefore, the investigators sought to evaluate the incidence of CMD and its prognostic implication for the improvement of left ventricular function after GDMT in patients who have been diagnosed with HFrEF caused by non-ischemic etiology.

Eligibility Criteria:
Inclusion Criteria:

* a) Subject must be at least 19 years of age. b) Subject with symptoms or signs of HF (NYHA ≥2 dyspnea) and reduced ejection fraction (LVEF ≤ 40%) c) Subject who clinically need coronary angiography d) Subject who can voluntarily sign informed consent form

Exclusion Criteria:

* a) Subject with significant coronary artery stenosis on coronary angiography (diameter stenosis ≥90% or 50-90% with fractional flow reserve \[FFR\] ≤0.80) b) Subject scheduled for cardiac replacement therapy (heart transplantation or left ventricular assisted device \[LVAD\] implantation) c) HF due to restrictive cardiomyopathy, active myocarditis, or constrictive pericarditis d) Significant valvular heart disease requiring surgery e) Subject who have non-cardiac co-morbid conditions with life expectancy \<1 year
Outcomes of Using LNMES on Tracheostomized Children

Tracheostomy tubes are known to have a negative impact on swallowing. Dysphagia treatment includes using laryngoneuromuscular electrical muscular stimulation (LNMES). Evidence exist on the efficacy of LNMES in the treatment of dysphagia in adults, and scarce in pediatrics. There is no literature available for the efficacy of LNMES in the treatment of dysphagia on patients with tracheostomy tubes. The purpose of this study to determine the outcomes on dysphagia on children with tracheostomy tubes when treated using LNMES. Furthermore, the investigators aim to determine the relationship between parental stress and a child's modified diet.


Eligibility Criteria:
Inclusion Criteria:

PATIENT COHORT

* Children between 0-4 years 11 months
* Currently have tracheostomy tubes
* MBSS must indicate penetrations of more than 50% of swallows or aspiration of thin, ½ nectar-thick, nectar-thick or honey-thick liquids.
* The child must be on a modified diet of honey-thick liquids, nectar-thick liquids, ½ nectar-thick liquids, or no liquids by mouth.
* Able to tolerate a voice valve PARENT COHORT
* At least one primary caregiver of a qualifying child (see Child cohort).
* Parent/caregiver must be at least 18 years of age or older, provide primary care, and have medical decision making rights for the child.

Exclusion Criteria:

PATIENT COHORT

* Children who are not on modified diets or using a g-tube as an alternate means of nutrition
* Children with suspected or diagnosed heart problems
* Children with suspected or diagnosed epilepsy
* Children with a tendency to hemorrhage following acute trauma or fracture
* Children who have undergone recent surgical procedures when muscle contraction may disrupt the healing process
* Children for whom the LNMES would be: 1) over carotid sinus, 2) over neoplasm, 3) over active infection and 4) over areas of skin which lack normal sensation
* Children with difficulty tolerating tactile stimulation and tolerate the whole duration of the LNMES sessions.
* Children with difficulty tolerating tactile sensory stimulation such as tape and electrodes on the anterior aspect of the neck.

PARENT COHORT

* The caregiver that does not provide the primary care of the child and does not have medical decision making right
* Parents under 18
Ranibizumab Versus Dexamethasone Implant in Diabetic Macular Edema

Between December 2016 and June 2017 a total of 40 eyes from 40 diabetic retinopathy patients with diabetic macular edema were recruited at the Ophthalmologic Clinic of University "G. d'Annunzio", Chieti-Pescara, Italy.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years old
* BCVA greater than 0.5 LogMAR in the study eye at baseline examination
* Presence of recent DME
* CMT \> 300µm as measured using the SD-OCT at the baseline examination

Exclusion Criteria:

* Any previous ocular surgery in the last 6 months
* Laser treatments
* Prior ocular trauma
* Retinal vascular diseases
* Vitreo-retinal interface diseases
* Medium lens opacities (according to Lens Opacities Classification System)
Enhancing Clinical and Cultural Virtual Encounter in Health Professional Students: 3 Is (Internationalization, Innovation, Interdisciplinary) in Action

This is a cross-over randomized control study with 3 time-points' measurement. This study is mainly to evaluate if the online pedagogic innovative learning modules could benefit students through their interprofessional and intercultural virtual encounters, with a focus on assessing their cultural awareness, interprofessional attitude and online learning engagement.

This study aims to promote and implement internationalization, innovative and intedisciplinary teaching and learning strategies through the set up of online modules of selected topics of interest. The specific objectives are: :

To enhance the educational outcomes of students from respective health disciplines in interdisciplinary learning via case-based clinical scenarios adopted in the online modules; To develop internationalization experience among students of different countries in terms of intercultural learning through the cultural exchange; To assess level of students' empowerment in active learning via 'student-as-partner' initiatives in the cultural exchange; To evaluate the effectiveness of online learning engagement among students through participating in the online modules.

Based on the Phase of Engagement Framework, two online orthopaedic modules focusing on interprofessional and intercultural educations on low back pain (LBP) and adolescent idiopathic scoliosis (AIS) are developed. The students (n=104) are randomized into two groups using SNOSE. In the first module, one group receives a virtual reality (VR)-enhanced LBP education (intervention group), while the other group engages with a case study on LBP (control group). After a 3-week washout period, the groups cross over: the intervention group receives the VR-enhanced education on AIS, and the control group focuses on an AIS case study. Interprofessional learning experience, cultural awareness, and online learning engagement are measured using validated tools at three time points (baseline, after first and second modules).

Eligibility Criteria:
Inclusion Criteria:

* undergraduate healthcare students

Exclusion Criteria:

* cannot communicate in English