cyrilzakka/clinical-trials huggingface dataset:
IORT-Breast at Medical Center Navicent Health

Intraoperative Breast Radiation Therapy (IORT-Breast) utilizing the Xoft Axxent Electronic Brachytherapy System (Xoft) has been recently introduced as a treatment option for women 50 years of age and older who have early stage, low risk Invasive Breast Cancer (IBC). Clinical trials have shown IORT to be non-inferior to whole breast radiation, however some concern continues with rates of recurrence and clinical outcomes.

Given the recent introduction and continued debate it is an excellent opportunity to observe and monitor outcomes in the patients that are treated at Navicent Health through this prospective, observational registry. The opportunity also permits examination of the participant's thoughts and feeling on Quality of Life and Cosmetic Appearance

Objectives: (primary and important secondary objectives) The primary objective is to determine rates of recurrence at 5, and 10 years following IORT-Breast at Navicent Health.

Secondary objectives include determination of acute and late effects of IORT-Breast at the treatment site, cosmetic outcomes and satisfaction over 10 years.

In addition, the study will determine why patients who were scheduled for IORT-Breast did not receive it after lumpectomy.

Study Design:

Prospective, observational registry.

Setting/Participants:

The study focuses on outpatients/short stay surgery performed at the Medical Center, Navicent Health, Macon, GA only.

Participants have been deemed eligible for IORT-Breast or have received IORT-Breast within the last 6 months. Key eligibility criteria for IORT- Breast includes women, aged 55 years old or greater, diagnosed with clinically node negative, grade 1 or 2 Invasive Breast Cancer with no lymphovascular invasion, that is 20mm or less in greatest dimension, Estrogen Receptor (ER) positive, HER 2 Neu Negative, and with a depth greater than 10mm from skin.

Study Interventions and Measures:

Participants will be eligible for IORT-Breast or have received IORT-Breast in the previous 6 months. Participants who were scheduled for IORT-Breast and do not receive IORT-Breast will have reasons for not receiving IORT-Breast recorded and will not be followed further. Participants receiving IORT-Breast will have treatment parameters recorded and will be followed every 6 months for 2 years and then annually until up to 10 years following treatment.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent and HIPAA authorization
* T1 tumor (less than or equal to 20mm in greatest diameter)
* Unifocal
* Histological Grade 1 or 2
* Node Negative
* ER +ve
* HER-2 -ve

Exclusion Criteria:

* Previous radiation therapy to the involved breast other than IORT within 6 months
* High grade tumors (Histologic grade 3)
* Her-2 Positive
* Lymphovascular invasion
* Metastatic disease
* close proximity to or involvement of skin
* Multifocal cancer
Rehabilitation Glasses for the Treatment of Hemispatial Neglect

This project is designed to test a lightweight, portable, computerized pair of glasses that will help reduce some of the cognitive deficits seen in patients who have suffered damage to their right cerebral hemisphere.

Hemispatial neglect is the inability or failure to attend and respond to the left side of space. Patients suffering right cerebral hemispheric damage from stroke or traumatic brain injury frequently suffer neglect and will ignore all information located in the left side of space. Currently there is no effective rehabilitation technique to treat neglect and many of these patients have severe long-term disability. The goal of this project is to determine whether a prototypical pair of rehabilitation glasses can reduce the symptoms of hemispatial neglect.

Eligibility Criteria:
Inclusion Criteria:

* Presence of hemispatial neglect as defined by Behavioral Inattention Test score of 129 or worse (maximum score 146).

Exclusion Criteria:

* Presence of aphasia at time of testing,
* Recent seizures
* Major psychiatric illness
* Prior unrelated neurological disease
Trial on Impact on the Hospital Stay, of an Early Oral Nutrition Protocol Applied to Patients After Total Gastrectomy. (DOPGT_2015)

This is a prospective randomized controlled clinical trial to clarify the effect of early oral nutrition introduction after total gastrectomy in gastric cancer patients on the length of hospital stay, comparing an experimental group vs control group.

The total gastrectomy is a high complexity surgery that involves a high morbid-mortality. In our center, the postoperative management consisted in 1 week period of non oral intake and total parenteral nutrition. At the 7 day, an oral contrast image is performed to prove the correct function of the anastomosis, in witch case, a progressive oral diet is begin.

In the late 90s, the Fast-track concept (or multimodal perioperative patient care) was introduced in the surgical patients attempting to improve their postoperative course. This new concept includes the preoperative advices related to the surgery, the intensive mobilization after surgery, the early oral diet, and to avoid the routinary use of the nasogastric tube. Some groups have been trying to apply this Fast-track program sporadically in patients submitted to an elective total gastrectomy for gastric cancer, even do, there is still no good evidence to sport these practice.

Based on the reasons exposed before, the investigators design a prospective randomized controlled trial in gastric cancer patients underwent on a total gastrectomy comparing two groups. 24 hours after gastrectomy the investigators will administer oral methylene blue and if no evidence of drainage leakage the participants will be randomized into two groups: one of them with our classical postoperative management, and the other one implements an early oral nutrition protocol, having in considerations its effectiveness, security, and impact on the hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* All patients requiring radical total gastrectomy for gastric cancer.
* 18 or above years old.
* Acceptance and signing the full informed consent.

Exclusion Criteria:

* Patient with poorly controlled diabetes mellitus (glycosylated hemoglobin levels greater than 7%)
* Emergency surgery.
* Total gastrectomy with esophagus-jejunal manual suture.
* Early dehiscence of esophagus-jejunal anastomosis (first 24 hours).
* Reintervention for abdominal complication in the first 24 hours.
* Surgery involving large intestinal or colon resections.
* Proximal resection margin affected requiring a esophagectomy and reconstruction with coloplasty.
Special Drug Use Investigation for ARIXTRA (Fondaparinux) Abdominal (Urology,Obstetrics,Gynecology)

The purpose of this study is to collect and assess information on safety and efficacy of fondaparinux in patients undergoing abdominal surgery in urology, obstetrics and gynecology departments who are at high risk of venous thromboembolism.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing abdominal surgery in urology, obstetrics and gynecology departments

Exclusion Criteria:

* Patients with a history of hypersensitivity to the ingredients of fondaparinux
* Patients with bleeding (bleeding in important organs, sucn as retroperitoneal bleed)
* Patients with acute bacterial endocarditis
* Patients with severe renal impairment
Neurochemical Mechanisms of the Awake vs. Anesthetized Brain

The investigators will be studying the sedative drug dexmedetomidine using hybrid PET/fMRI/EEG imaging to better understand the neuropharmacology of anesthesia/artificially induced sleep.

A group of healthy volunteers will undergo simultaneous PET/fMRI/EEG imaging under two different conditions: while being administered a sedative (dexmedetomidine), and while being administered a normal saline infusion, as a control. The order of these two scans will be randomized, and the study design is open label (ie subjects and investigators know which session will be the control scan and which one will be the sedative scan). Investigators hope that by comparing the results of the sedative and control scans, the different neuromodulatory states involved in the transition from wakefulness to medically induced vs naturally occurring sleep can be better understood.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18-45.
* No contraindications to MRI or PET scanning.

Exclusion Criteria:

* Contraindications to fMRI scanning and PET scanning (including presence of a cardiac pacemaker or pacemaker wires, metallic particles in the body, vascular clips in the head or previous neurosurgery, prosthetic heart valves, claustrophobia);
* Pregnancy or breast feeding;
* Current or past history of major medical, neurological, or psychiatric condition;
* History of major head trauma;
* Any cardiovascular disorders, including heart disorders or high blood pressure \[\>155/95\];
* Breathing problems such as severe asthma;
* Bleeding disorder, or use of anticoagulants;
* Bladder obstruction, urinary problems, or history of impaired elimination;
* Known kidney or liver problems;
* Intestinal blockage;
* Raynaud syndrome
* Peripheral nerve injury;
* Diabetes;
* Glaucoma;
* Sleep disorder, such as sleep apnea, insomnia, or narcolepsy
* Current use of any drugs that affect sleep
* Current or recent use of medications (neurological or psychiatric) affecting brain function
* Current or past history of chronic pain (assessed at discretion of PI);
* History of allergic reactions
* History of chronic obstructive pulmonary diseases
* Ulcerative skin conditions or other dermatologic conditions which could interfere with blood pressure cuff placement
* Body mass index above 30
* Current smoker
* Lack of current health insurance coverage
* Employed under the direct supervision of the investigators conducting the research
* Hair in dreadlocks, twists, or braids that cannot be removed
* Eczema on the scalp or face
Adipose Tissue Content of Fatty Acids Present in Dairy Fat and Risk of Stroke. The Danish Diet, Cancer and Health Cohort

Background: Although low-fat dairy products are an integral part of a diet recommended for stroke prevention, the role of dairy fat in relation to the risk of stroke is not yet clear.

Objective: Therefore the association of adipose tissue content of fatty acids, for which dairy products are a major source (12:0, 14:0, 14:1 cis-9, 15:0, 17:0, 18:1 trans-11 and 18:2 cis-9, trans-11), with incident total stroke and stroke subtypes will be investigated.

Design: The study is a case-cohort study nested within the Danish Diet, Cancer and Health cohort, including all incident stroke cases and a random sample of the total cohort.The fatty acid composition of adipose tissue biopsies was determined by gas chromatography and the content of specific fatty acids was expressed as percentage of total fatty acids. Stroke cases were identified in the Danish National Patient Registry and the diagnoses were individually verified. Cox proportional hazard regression will be used to estimate the association between fatty acids and stroke.


Eligibility Criteria:
Inclusion Criteria: Born in Denmark, aged 50-64 years, residing in the urban and suburban areas of Copenhagen and Aarhus, Denmark.

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Exclusion Criteria: Pre-existing cancer diagnosis. Previous stroke.

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Registry of Patients With Plasma Cell Disorders

The goal of this observational study is to register patients with plasma cell disorders. The main questions it aims to answer are:

* The incidence of plasma cell disorders both before and after malignancy
* Time to progression of monoclonal gammopathy of undetermined significant (MGUS) or smoldering multiple myeloma (SMM) to light chain amyloidosis or multiple myeloma (MM)
* Progression free survival (PFS)
* overall survival
* factors influencing overall survival, progression-free survival, and time to progression
* Symptoms and signs of the disease during the diagnosis and relapse phases, including the causes of mortality in plasma cell disorder patients.
* genetic characteristics of plasma cell disorder
* cost-effectiveness of treatment in Thailand Participants will be collected the data of baseline diagnosis, treatment, treatment results of all admission and follow-up visits from hospital medical record.


Eligibility Criteria:
Inclusion Criteria:

* Both existing and newly diagnosed patients with plasma cell disorders, including monoclonal gammopathy of undetermined significance, smoldering multiple myeloma, POEMS, light chain amyloidosis, solitary plasmacytoma, and multiple myeloma, according to the diagnostic criteria of the International Myeloma Working Group 2014
* Aged 18 years and above

Exclusion Criteria:

* insufficient data needed for analysis
Three-month Clinical Evaluation of Silicone Hydrogel Definitive 65 Contact Lenses

Comparison of different contact lens materials.

This will be a 3-month, open-label, bilateral, parallel-group, randomised, daily wear study. Two-thirds of the subjects will wear the Test lenses in both eyes, and one-third will wear the Control lenses in both eyes.

Eligibility Criteria:
Inclusion Criteria:

* willing and able to sign the informed consent form
* ages 18 years or older
* Subjects must have owned spectacles or contact lenses prior to enrolment for this trial
* spherical power between -10.00 D and +10.00 D (at vertex distance 0 mm)
* astigmatic power equal to or less than 0.75 D

Exclusion Criteria:

* eye injury or surgery within 3 months immediately prior to enrolment for this trial
* pre-existing ocular irritation that would preclude contact lens fitting
* currently enrolled in an ophthalmic clinical trial
* evidence of systemic or ocular abnormality, infection or disease which is likely to affect successful wear of contact lenses use of as determined by the investigator
* any use of medications for which contact lens wear could be contradicted, as determined by the investigator
* current extended-wear users (sleep-in overnight)
* current monovision leans wearers
* pregnant women and nursing mothers
* best-corrected visual acuity worse than 6/9 (logMAR: +0.20; Snellen decimal: 0.63)
Mortality of Cancer Surgery During SARS CoV2 Pandemic

The impact of cancer surgery during covid epidemic is not clear. The published reports show contradictory findings that extend from no change in mortality to increased mortality, further no data on exposure and outcome of health care worker is available. This study is designed to address the above questions

This is a retrospective study from the prospectively collected data that is extracted from the electronic database of Department of Surgical Oncology, IMS, BHU The data is inform of two cohorts one extending from April 2019-April 2020 and other from May 2020 to May 2021 i.e. pre covid and during covid pandemic

Eligibility Criteria:
Inclusion Criteria:

* All patients operated during the study period

Exclusion Criteria:

* None
Secondary Prevention of Depression Through Group-based ACT-Therapy Preceded by an Experimental ABM-Procedure

Depression (major depressive disorder; MDD) is a very common mental disorder. Research suggests that individuals with prior depressive episodes have a risk of the relapse or recurrence of MDD. Secondary prevention has been identified as a key goal in the long-term management of the disease. The current project aims to investigate whether group based Acceptance and Commitment Therapy (ACT) can reduce surrogate and clinical markers of relapse in a group highly vulnerable to depressive episodes. The group intervention will consist of eight sessions, and each group will consist of maximum 12 persons. The project also studies whether Attention Bias Modification (ABM) preceding the ACT intervention will enhance the effect. ABM will be administered over a fourteen days period prior to the ACT-intervention. Effect will be measured over a period of 12 months. The primary outcome is changes in depressive symptoms. ACT-specific secondary outcome measures are also included. Subjects with a history of major depression (n=200), currently in remission, will be recruited from Sørlandet Hospital (100 participants). Matched participants (100 participants) will be recruited at the University of Oslo. In the first phase, participants from Sørlandet hospital will be randomized to ABM treatment or control condition. In the second phase all participants from Sørlandet hospital will receive group based ACT treatment. Group based ACT and ABM represent interventions that are time and cost effective, and that could be made available to large number of individuals struggling with MDD.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with a history of major depression, currently in remission

Exclusion Criteria:

* Current or past neurological illness, bipolar disorder, psychosis or drug addiction.
Immune Mechanisms of Vitamin D to Reduce Chronic Pain After Burn

The goal of this pilot clinical trial is to learn whether vitamin D is able to prevent chronic pain following burn injury and to determine what biological mechanisms are engaged by Vitamin D following burn injury. The main question\[s\] it aims to answer are:

* Is the clinical trial protocol feasible?
* Is Vitamin D administration following burn injury safe?
* How does vitamin D cause changes in the immune system in the aftermath of burn injury?

Following informed consent, participants will be asked to:

* Take 6 capsules by mouth one time following burn injury (Vitamin D or Placebo)
* Provide a blood sample at baseline and 6 weeks following injury
* Fill out surveys daily while in the hospital, weekly through 6 weeks, and at 3 months and 6 months.

Researchers will compare Vitamin D and placebo groups to see if there are differences in adverse effects (side effects), chronic pain, and profiles of immune cells from collected blood samples.


Eligibility Criteria:
Inclusion Criteria

* ≥ 18 years and ≤ 70 years of age
* MThBI severe enough to warrant admission to Burn Surgery Service (NOTE: surgery may or may not be indicated)
* Admission and subsequent enrollment occurs within 1 week of MThBI
* Patients experience a thermal burn injury, not an electrical or chemical burn.
* Has a smartphone with continuous service \>1 year
* Alert and oriented
* Willing to take study medication (6 capsules of Vitamin D or placebo)
* Point of care Vitamin D level \<100 ng/mL
* Able to speak and read English
* Burn survivors with acute pain severity ≥ 7/10 on the Numeric Rating Scale (initial pain severity reported by patient on screening)
* Total Body surface area burned \<30%

Exclusion Criteria

* Substantial comorbid injury (e.g. long bone fracture)
* Pregnancy/Breastfeeding
* Prisoner status
* Active psychosis, suicidal ideation, or homicidal ideation
* Requires an emergency/bedside escharotomy or fasciotomy for the treatment of burn injury.
* Known Child-Pugh liver disease severity classification B or C.
* Known chronic kidney disease stage 4 or higher (GFR≤29).
* No other history or condition that would, in the investigator's judgment, indicate that the patient would very likely be non-compliant with the study or unsuitable for the study (e.g. might interfere with the study, confound interpretation, or endanger patient).
* Intubated and sedated at time of enrollment.
* Hypersensitivity to Vitamin D3, ergocalciferol, calcitriol, alfacalcidol, calcipotriol
* Known hypercalcemia (based on routine admission laboratory assessment).
* Sarcoidosis
* Hyperphosphatemia (based on routine admission laboratory assessment)
* Taking Vitamin D supplements in excess of 800 IU daily.
Study of the Loss of AV Synchrony at Maximum Exercise

Investigators will identify a group of patients with complete heart block and a dual chamber pacemaker who will be expected to be able to exercise on a treadmill. Investigators will utilize symptom logs, cuff and continuous blood pressure monitoring. It is planned to study the symptomatic impact of loss of AV synchrony at significant levels of exercise.


Eligibility Criteria:
Inclusion Criteria:

* Complete AV Block
* Age less than 60
* Easily programmable dual chamber pacemaker

Exclusion Criteria:

* Age \> 60
* Significant Heart Failure
* Significant angina
* History of claudication
* Significant orthopedic issues
* Evidence of sinus node dysfunction
* Taking beta blockers or non-dihydropyridine calcium channel blockers
Plyometric vs Explosive Strength Training on Agility, Power, and Balance in Basketball Players

The study is randomized and single-blinded. Ethical approval is taken from Ethical committee of Riphah International University, Lahore. Participants who meet the inclusion criteria will be enrolled and allocated in groups A \& B through the sealed envelope method by Non-probability Convenient random sampling technique. Subjects in group A will receive plyometric training. Group B will receive explosive strength training.

The objective of the study is to determine the effects of plyometric training versus explosive strength training on agility, power, and dynamic balance in basketball players. The study is randomized and single-blinded. Ethical approval is taken from the Ethical Committee of Riphah International University, Lahore. Participants who meet the inclusion criteria will be enrolled and allocated in groups A \& B through the sealed envelope method by Non-probability Convenient random sampling technique. Subjects in group A will receive plyometric training. Group B will receive explosive strength training. The outcome measures will be assessed by agility T-test, vertical jump test, and star excursion balance test (SEBT).

The data will be analyzed by SPSS, version 25. Statistical significance is p=0.05.

Eligibility Criteria:
Inclusion Criteria:

* Basketball players, both male and female players.
* players aged 17-25 years, players who have been playing basketball for a minimum of two years.

Exclusion Criteria:

* out-of-practice players,
* unwilling participants,
* players with any musculoskeletal injury, and players with any systemic disease.