cyrilzakka/clinical-trials huggingface dataset:
OA for Breast Cancer NAC Response

This is an early research and development study. The objective of this study is to determine the feasibility of the Imagio OA/US Breast Imaging System to detect complete breast cancer pathologic response to neoadjuvant therapy as assessed by functional optoacoustic features, vascular features and relative degrees of oxygenation/deoxygenation

The use of neoadjuvant systemic therapy in the treatment of breast cancer patients is increasing beyond the scope of locally advanced disease. Imaging provides important information in assessing response to therapy as a complement to conventional tumor measurements via physical examination. Tumor response to neoadjuvant therapy can also provide prognostic information. As stated in the background section, the attainment of pCR after completion of neoadjuvant therapy and surgical resection is associated with improved disease-free survival \[1-3\]. This correlation is especially strong for Triple-receptor negative (ER, PR negative and HER-2 non amplified), and HER-2 positive breast cancer. Studies of neoadjuvant therapy have used a variety of methods for assessing tumor response. Currently, there are no established clinical practice guidelines for how best to assess tumor response to neoadjuvant therapy. Typically, patients undergo conventional breast imaging (mammography and US) and physical examination, and DCE-MRI in selected cases.

The Imagio OA/US technology is an alternative imaging technology that demonstrates both gray scale ultrasound morphologic information, including size measurements, and functional information that includes presence or absence of tumor angiogenesis, degree of angiogenesis, and relative degrees of oxygenation and deoxygenation of hemoglobin.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years and older male or female patients;
2. Ipsilateral intact biopsy-proven invasive breast cancer clinical T1-T4 (by standard of care imaging), including primary or recurrent disease.
3. Patient eligible to receive neoadjuvant chemotherapy

Exclusion Criteria:

1. Known Stage IV disease (breast or other cancer);
2. Have a condition or impediment (i.e., insect bites, poison ivy, open sores, chafing of the skin, scar, tattoos, moles, etc.); that could interfere with the intended field of view (within one probe length or 4 cm of the nodule);
3. Patient has received chemotherapy for any type of cancer within 90 days from date of baseline Imagio OA/US exam;
4. Is experiencing photo-toxicity associated with currently taking, or having taken, photosensitizing agents within the previous 72 hours such as sulfa, ampicillin, tetracycline;
5. Is currently undergoing phototherapy;
6. Has a history of any photosensitive disease (e.g., porphyria, lupus erythematosus);
7. Is undergoing treatment for a photosensitive disease and is experiencing photosensitivity;
8. Pregnancy;
9. Patient has participated in a clinical study of an investigational drug or device within 3 months prior to screening visit that may have an impact on clinical outcomes.
Study Assessing the Position of Cricothyroid Membrane in Relation to Movement of Neck From Neutral to Extended Position

Ability to provide oxygen to patients undergoing general anaesthesia is crucial. This is traditionally provided using face mask, supraglottic airway (breathing tube above voice box) or endotracheal tube (breathing tube in wind pipe). However in some patients it may be impossible to provide oxygen through any of these above means which can be life threatening and lead to permanent brain damage/death. One of the ideal ways of managing this emergency situation is to pass a breathing tube through a membrane in the front of the neck called cricothyroid membrane with the neck in extension position where permitted. Many studies have recommended identifying the cricothyroid membrane before general anaesthesia in high risk patients but with their head in neutral position. This study will be a pilot study to check if the cricothyroid membrane remains in the same place in neutral and extended positions.

This is a non-randomised observational pilot study. The results of the study will be used to determine the size of the sample required for a planned randomised controlled trial in the future. All the volunteers will be asked to lie on a trolley with the head in neutral position- Defined as alignment of external auditory meatus (outer ear canal) to the sternal angle (prominent portion of breast bone) is horizontal. A radiologist trained in ultrasound of the neck will identify the position of upper and lower border of the cricothyroid membrane using ultrasound and then mark these borders and the centre point with a black surgical marker pen. Then the volunteer will be asked to extend the neck and the same steps will be repeated using a red surgical marker pen. The distance between the two centre points will then be measured using a calliper/ measuring scale.

Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Aged 18 years or above.

Exclusion Criteria:

* Age \<18 years
* Inability to communicate or refuses consent
* History of problems with neck movement
* Arthritis of the neck
* Upper limb neurology
The Effect of Self-Management Program Based on the Individual and Family Self-management Theory on Cancer Patients

The purpose of this study is to evaluate the effect of Self-Management Program based on the Individual and Family Self-management Theory on fatigue, daily living activities and well-being of cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Inpatients for symptom management or supportive care in oncology wards
* Patients who were at first two days of hospitalization
* Patients who had score of 3≤ or ≤7 in Fatigue Visual Analogue Scale (VAS)
* Patients who had score of ≤5 in Pain Analog Visual Scale (VAS)
* Patients who had score of ≤5 The Modified Borg Scale
* Patients who had score of 0, 1, 2 or 3 in ECOG Performance scale
* Patients who had metastases
* Patients who were over 18 years of age
* Patients who had orientation of person, place and time
* Patients who had no communication barriers
* Patients who agreed to participate in the study

Exclusion Criteria:

* Patients who had hospitalized for the purpose of receiving chemotherapy
* Patients whose Hb value was ≤8 g / dl
* Patients whose body temperature ≥ 38.5 ° C within the last 24 hours
* Patients who had diarrhea in the last 24 hours (frequency of defecation ≥ 3 / day)
* Patients who had a score of ≤ 16 kg / m2 in Body Mass Index (BMI)
* Patients who had advanced heart failure
* Patients who had untreated hypothyroidism
* Patients who diagnosed with major depression and / or treated for depression
* Patients who had no family member involved in their care
A Community Health Worker-Led Program for Chronic Pain and Loneliness in Older Adults

The goal of this clinical trial is to test a new community health worker-delivered program (Strengthening COnnections to Overcome Pain, or SCOOP) that teaches strategies for managing chronic pain and loneliness to older adults living in rural areas. The main questions it aims to answer are:

1. Does participating in SCOOP result in less pain interference with daily life?
2. Does participating in SCOOP result in decreased loneliness?
3. What is the level of participant engagement in SCOOP? Researchers will compare people who have participated in SCOOP with people who have not participated in SCOOP to see if SCOOP is helpful in decreasing pain interference and loneliness.

Participants will:

1. Watch brief videos teaching strategies to manage pain and boost social connections.
2. Engage in up to 7 weekly coaching sessions with a community health worker.
3. Complete two telephone interviews about health, mental health, and functioning: one at baseline, and one 2 months later.


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 60 years;
* Have a mobile or landline phone;
* Self-reported chronic musculoskeletal pain (pain in muscles or joints for \>= 3 months, \>=4 (0-10 scale) average pain level over last week, \>=1 day/previous 30 when pain made it difficult to do usual activities);
* Self-reported loneliness (Feeling lonely "some of the time" or more often);
* Able to converse comfortably in English.

Exclusion Criteria:

* Serious acute illness or hospitalization in the last month;
* Planned major surgery in the next three months that would interfere with program participation (e.g., knee or hip replacement);
* Severe cognitive impairment or other severe physical or psychiatric disorder judged by study team to pose a significant barrier to participation.
Talent Management Intervention Program for First-Line Nurse Managers

Nurse leaders will be required to manage the rapid change in the healthcare system. Talent management training plays a crucial role in preparing nursing leaders and improving their performance in health care systems.

Nurse leaders will be required to manage the rapid change in the healthcare system. Talent management training plays a crucial role in preparing nursing leaders and improving their performance in health care systems. This study aimed to examine the effect of the talent management intervention program for first-line nurse managers on their job performance

Eligibility Criteria:
Inclusion Criteria:

* First-line nurse managers

  * willing to participate in the study
  * work in all inpatient care units of Alexandria University hospitals
  * Sign a consent

Exclusion Criteria:

* First-line nurse managers

  * work in outpatient units
  * Did not sign a consent
  * Absent from training
Heme Oxygenase (HO) Activity and Adenosine Induced Vasodilation

The purpose of this study is to determine whether heme oxygenase 1 induction by heme arginate treatment is of influence on adenosine induced vasodilation in healthy individuals.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 and no older than 65 on the day of first dosing
* healthy
* Quetelet Index (Body Mass Index) of 18 to 30 kg/m2
* In general, results of haematology and chemistry should be within the laboratory's reference ranges. Determinants of renal and hepatic function should be within twice the upper limit of normal range.

Exclusion Criteria:

* Documented history of sensitivity / idiosyncrasy to medicinal products or excipients
* history of smoking within the past year
* history of or current abuse of drugs, alcohol and/or solvents
* Current use of any (over the counter) medication potentially influencing heme oxygenase or the cardiovascular system
* Inability to understand the nature and extent of the trial and the procedures required
* Participation to a drug trial within 60 days prior to the first dose
* Febrile illness within 3 days before the first dose
* Heterozygosity (LS) or homozygosity (LL) with regard to the number of GT repeats in the HO-1 promoter region
Gastrointestinal Functional Outcome Ivor Lewis

This study focuses on the prevalence of functional complications and their impact on QOL in patients who underwent an Ivor Lewis Oesophagectomy.

This study will assess the prevalence of gastrointestinal symptoms and QOL from beyond the first year following surgery up to 5 years. The aim is to determine whether gastrointestinal side effects and QOL are compromised in the long-term.

This study will also explore in details, the impact of surgery on their quality of life and gastro intestinal symptoms that patients has experienced post operatively.

Oesophago-gastric (OG) cancer is the fifth most common malignancy in the United Kingdom, affecting approximately 16,000 people each year. Although surgery offers the best prospect for potential cure of OG cancers, radical treatment may result in increased treatment relate mortality, high treatment-induced morbidity, and reduced quality of life. Traditionally, many centres managing OG cancers focused on mortality and morbidity as their key outcome measures. However, a growing body of opinion considers that a measure of broader effects of ill health and treatment on the patients quality of life (QOL) is necessary. Such considerations are important as it is questionable if patients are subjected to treatment merely to offer them a few extra months of life, particularly if this is at the expense of quality of life. These includes physical, functional, social and physiological aspects of life.

More than half of the operated patients will develop significant functional disorder after surgery affecting QOL. The most common problems observed are dysphagia, dumping syndrome, delayed gastric emptying, and reflux. These functional disorder are not always detected immediately post operatively, but may become more troublesome as time goes by.

The purpose of this study is

* to evaluate mid to long term HRQL in patients that underwent Ivor Lewis esophagectomy (ILE) with gastric pull-up in Royal Leicester Infirmary with minimum of 12 months follow up and up to 5 years.
* to identify clinical factors influencing quality of life post operatively.
* explore patients' experiences of their quality of life and how they handle their new life situation from a long-term perspective after oesophagectomy The outcome of this study would benefit both surgeons and patients in terms of pre-operative counselling and planning.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent Ivor Lewis Oesophagectomy in Leicester Royal Infirmary with minimum follow up of 12 months.
* Age more than 18

Exclusion Criteria:

* Disease recurrence within the follow up period
* Age less than 18
A Prospective Virtual Study of Patient Reported Behaviors and Health Outcomes in Individuals With COVID-19

The primary objective of this study is to identify and describe patient behaviors and clinical outcomes among patients who have tested positive for mild to moderate COVID-19.

This virtual observational cohort study will describe patient behaviors and clinical outcomes of subjects who tested positive for COVID-19. Among those with positive tests, predictors of time to recovery, post-COVID function and outcomes will be identified. Individuals who test negative and positive for SARS-CoV-2 will be enrolled in the study.

Eligibility Criteria:
Inclusion Criteria:

* Age \>=18 years
* Individuals with a valid diagnostic COVID-19 test result

Exclusion Criteria:

- Unable or unwilling to provide informed consent
Diabetes and Palliative Care

Diabetes prevalence in palliative care is 10-15%. Most hospice patients are treated with insulin. The target glucose level is high in order to decrease the risk of hypoglycemia. Glucose level is usually monitored using capillary blood glucose once to three times daily.

The aim of the research is to simplify this pattern of care in end-of-life patients. It will evaluate whether the non invasive measurement of glucose in urine could replace the measurement of capillary blood glucose. The first objective will be to assess the performance of the measurement of glucosuria using urinary dip stix to predict that the blood glucose level is within the target range.

Due to the high glucose target, hyperglycemia is extremely frequent. However, symptoms of hyperglycemia are unfrequently reported. They may be unspecific and/or masked in end-of-life patients due to terminal disease and medication. The second objective of the study will be to define symptoms of hyperglycemia in these patients.

This is a prospective study involving several palliative care units in France. Glycemia and glycosuria will be measured in the same patients. Symptoms that could be related to hyperglycemia will be assessed in relation with the concomitant blood glucose level.

Main investigations :

Glycosuria and cetonuria will be measured using a dip stix during each nursing care.

Glycemia will be measured before breakfast and before diner. Pain caused by finger pricking for the measurement of glycemia will be evaluated using a verbal scale.

Symptoms will be evaluated at the time of each glucose measurement first with open questions then with a list of potential symptoms of hyperglycemia.

Eligibility Criteria:
Inclusion Criteria:

* diabetic patients
* hospitalised in a palliative care unit
* terminally ill with cancer
* with blood glucose measurement at least twice daily over 5 days
* agreeing to participate in the study

Exclusion Criteria:

* patient unable to communicate, to understand information about the study or to decline participation in the study
Radiation Therapy After Lumpectomy in Treating Women With Ductal Carcinoma in Situ or Invasive Breast Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation during surgery followed by external-beam radiation to the entire breast may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of radiation therapy during surgery followed by whole-breast radiation therapy in treating women who have undergone lumpectomy for ductal carcinoma in situ or invasive breast cancer

OBJECTIVES:

* Determine the effect of intraoperative radiotherapy boost to the tumor bed on acute complications after lumpectomy (before whole breast irradiation) in women with ductal carcinoma in situ or invasive adenocarcinoma of the breast.
* Determine the local recurrence rates in patients treated with this regimen.
* Determine the cosmetic outcome in patients treated with this regimen.

OUTLINE: Patients undergo excisional biopsy or surgery followed by an intraoperative dose of radiation to the tumor cavity. Postoperatively, patients undergo external beam radiotherapy to the entire breast 5 days a week for 5-6 weeks.

Patients are followed at 1 month and then every 3 months for 2 years.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed ductal carcinoma in situ or invasive adenocarcinoma of the breast

  * Primary tumor classified as T1, T2, or T3
* Candidate for breast-conserving surgery
* Must have undergone lumpectomy with negative margins or minimal margin involvement
* Currently undergoing re-excision of the biopsy cavity and/or sentinel lymph node biopsy or axillary lymph node dissection
* No evidence of metastatic disease
* Hormone receptor status:

  * Not specified

PATIENT CHARACTERISTICS:

Age

* Adult

Sex

* Female

Menopausal status

* Not specified

Performance status

* ECOG 0-2

Life expectancy

* Not specified

Hematopoietic

* WBC greater than 3,500/mm\^3
* Granulocyte count greater than 1,500/mm\^3
* Platelet count greater than 100,000/mm\^3

Hepatic

* Not specified

Renal

* Not specified

Other

* Not pregnant
* No other malignancies within the past 5 years except carcinoma in situ of the cervix or nonmelanoma skin cancer

  * Prior contralateral breast cancer allowed if curatively treated more than 5 years previously
* No severe psychiatric or medical illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* No prior radiotherapy to the involved breast

Surgery

* See Disease Characteristics
Continence After Vaginal Prolapse Surgery

Urinary incontinence after surgical correction of pelvic organ prolapse (POP) could occur. This is a condition that decreases both patients' satisfaction and quality of life. Reports on the prevalence of urinary incontinence after POP surgery are controversial. Concomitant surgery for incontinence could reduce this prevalence, whereas it increases treatment costs and the likelihood of surgical complications. Therefore, it is of paramount importance to know the exact prevalence of urinary incontinence after POP surgery in our population and the potential risk factors associated with this condition.


Eligibility Criteria:
Inclusion Criteria:

* Women who will undergo vaginal surgery for pelvic organ prolapse.

Exclusion Criteria:

* Inability to give consent to the study.
Diagnosis of Renal Osteodystrophy in Patients With Reduced Renal Function

The aim of the study is to

1. To describe the bone morphology in patients with reduced renal function and high or low parathyroid hormone (PTH) respectively.
2. To investigate if the non-invasive method 18-Fluoride Positron Emission Tomography (18F-PET) can describe the bone turnover and reflect the bone histomorphologic changes
3. To investigate if non-oxidized PTH reflects bone turnover

Patients with reduced renal function and suspected high turnover or low turnover bone disease are recruited.

A bone biopsy and a 18F-PET scan are performed and it is investigated if the 18F-PET can discriminate high turnover from low turnover bone disease

Eligibility Criteria:
Patients with reduced renal function:

Inclusion Criteria:

-≥ 18 years

* estimated Glomerular Filtration Rate (eGFR) ≤ 20 ml/min/1,73m2
* PTH \< 150 pg/ml or PTH \> 300 pg/ml

Exclusion Criteria:

* ongoing malignancy
* Allergy towards tetracyclin
* Pregnancy

Control Group:

Inclusion Criteria:

-≥ 18 years

* eGFR \>= 60 ml/min
* under examination for c prostata
* Prostatic Specific Antigen (PSA) total \<40 µg/l

Exclusion:

* Former kidney disease
* ionized calcium or PTH outside normal range
* Known metabolic bone disease
* treatment with anticoagulants
* Disturbed thrombosis and hemostasis
VITAMin Insufficiency in Esophagogastric Neoplasms

Rationale: Esophageal cancer and gastric cancer are among the top ten most common cancers worldwide. Both diseases have major impact on the nutritional status of patients and their quality of life. Studies investigating post-operative nutritional status are limited and postoperative identification and treatment of micro- and macronutritional deficiencies are currently lacking in (inter-)national guidelines.

Objective: To identify and target vitamin deficiencies after surgery for esophagogastric neoplasms.

Study design: Single centre intervention study. Study population: Patients aged 18 years and older that underwent esophagectomy or (sub- )total gastrectomy for esophagogastric neoplasms.

Intervention (if applicable): Two tailormade supplements for patients; one for that underwent esophagectomy and one for (sub-)total gastrectomy.

Main study parameters/endpoints: Baseline micronutrient deficiency measurements and after 6, 12, 24 months supplementation,.

Secondary study parameters/ endpoints: Occurrence of exocrine pancreatic insufficiency (n,%), occurrence of diarrhoea (n,%), steatorrhea (n,%), bloating (n,%), time between surgery and start of supplementation (mean in months), quality of life experienced (questionnaires) at baseline and after 6, 12, 24 months supplementation.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: In this study, no health-related risks are present for participants due to the administration of supplementation that is already used as in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

A potential subject who meets any of the following criteria will be included for participation in this study:

* Patients ≥18 years of age who underwent an esophagectomy or (sub)total gastrectomy for malignancy with no signs of postoperative recurrence of disease.
* Written voluntary informed consent (IC).

Exclusion Criteria:

-

A potential subject who meets any of the following criteria will be excluded from participation in this study:

* Patients that underwent a wedge resection of the stomach
* Malignant disease recurrence
* Metastases
* Patients that are not capable to take supplementation due to altered mental status or swallow difficulties
* No signed informed consent
* Patients who are receiving chemotherapy
* Patients with high vitamin status at baseline