cyrilzakka/clinical-trials huggingface dataset:
LAG3 Expression in Triple Negative Breast Cancer

This study is the experimental study for relationship between LAG-3 expression / immue checkpoint protein expression and neoadjuvant chemotherapy plus immune checkpoint inhibitor in triple negative breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Planned neoadjuvant chemotherapy
* Triple negative breast cancer

Exclusion Criteria:

* HER2-positive breast cancer
* Hormone receptor positive breast cancer
Ultrasound and MRI Measurement of Quadriceps Femoris Muscle in Critically Ill Children

A vast majority of children admitted to paediatric intensive care (PICU) present with faltering growth during their admission. Muscle mass loss is an early, intense and frequent phenomenon in this setting, which is associated with impaired outcomes. Recent international guidelines recommend monitoring both nutritional status and muscle mass throughout hospital stay. Recent studies have used quadriceps femoris (QF) measurements as a surrogate for lean mass assessment, and monitored them with bedside ultrasound (QF thickness and QF cross sectional area). However, ultrasound cross sectional area inter-operator reproducibility has not been validated so far, and none of these ultrasound measurements has been validated against their gold standard i.e. magnetic resonance imaging measurements. This validation process should be conducted to allow interpreting ultrasound muscle measurements, prior to the implementation of ultrasound measurments into clinical practice.

We hypothesise that ultrasound measurements of QF thickness and cross sectional area are reliable compared to the magnetic resonance imaging gold standard, and that QF cross sectional area has a reliable inter-operator reproducibility.


Eligibility Criteria:
Inclusion Criteria:

* critically ill children from 0 to 17 years old
* magnetic resonance imaging planned for any medical reason
* sedated child for any medical reason
* absence of parental/patient refusal to participate to the study

Exclusion Criteria:

* congenital neuromuscular disease
* no possible access to the thigh (e.g. dressing, drains, gypsum)
* anatomical anomaly of the limb, that would compromise localizing thigh landmarks (patella, groin)
* inability to obtain limb rest and/or thigh muscle decontraction
* risk induced by mobilization of the patient for ultrasound or magnetic resonance imaging purpose
* absence of social insurance
Efficacy and Safety of Super-hyperfractionation Pulse Radiotherapy Combined With ICIs for Advanced NSCLC

Investigators intend to combine low-dose hypersensitivity with high-dose immunopotentiation effect, and use super-hyperfractionation pulse radiotherapy, which is expected to achieve the effect of in situ vaccine that can enhance tumor killing, protect normal tissues, reduce immune cell damage and enhance tumor immunogenicity at the same time, and play a stronger immunopotentiation effect in combined immunotherapy. Thereby inducing a stronger abscopal effect of radiotherapy.


Eligibility Criteria:
Inclusion Criteria

1. Informed consent has been signed and, in the judgment of the investigator, the patient is able to comply with the study protocol and sign a written informed consent.
2. Participants diagnosed with stage IIIB or above non-small cell lung cancer confirmed by histopathology (whether newly diagnosed or not) meet the requirements of SBRT radiotherapy (mass limited, less than 5 cm) and immune checkpoint inhibitor therapy (according to CSCO guidelines).
3. Age ≥ 18 and less than 75.
4. Eastern Cooperative Oncology Group Performance Status Score (ECOG PS) 0-3.

Exclusion Criteria

1. The participant's compliance is poor and the test regulations are violated.
2. Dysfunction of important organs of liver and kidney, such as myocardial infarction, angina pectoris, and significant increase of liver transaminase.
3. Any disease requiring systemic treatment with corticosteroids or other immunosuppressive drugs within 14 days prior to enrollment.
4. Serious infection within 4 weeks before enrollment, including but not limited to hospitalization due to infection complications, bacteremia or severe pneumonia.
5. Severe chronic or active infections (including tuberculosis infection) requiring systemic (oral or intravenous) antibiotic therapy within 14 days before enrollment.
6. Participants with untreated chronic hepatitis B or HBV carriers with hepatitis B virus (HBV) DNA ≥ 500 IU/mL, or patients with active hepatitis C virus (HCV) should be excluded. Note: Inactive hepatitis B, HBsAg carriers, treated and stable hepatitis B carriers (HBV DNA \< 500 IU/mL), and cured hepatitis C patients can be included in the group.
7. Known history of HIV infection.
8. Receive any other investigational drug treatment or participate in other clinical trials within 28 days.
9. There are no contraindications to stereotactic radiotherapy and immune checkpoint inhibitors.
Mulligan Therapy Effects In Healthy Subjects With Induced Vertigo

This analysis aims to evaluate the immediate effect that cervical sustained natural apophyseal glides (SNAGs) have on a group of individuals with induced vertigo by a caloric vestibular stimulation.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects,
* Age 18-44 years.

Exclusion Criteria:

* Consume of antipsychotics, antidepressants, antiarrythmics and/or anticonvulsivants
* Hippoacusia
* Auditory diseases
* Peripheral or central vestibulopathies
* Cerviogenic dizziness
* Balance disorders
* Nistagmus
* Oculomotor nerve dysfunctions
* Migraine
* Cervical osteoporosis, lashing or fracture
* Discal cervical hernia
* Cervical neuropathy
* Psychriatic disorders
* Epilepsy
* Pregnancy
Reliability of Self-reported Concussion History in Current Rugby Union Players

Perhaps no issue in sports medicine has attracted so much media attention and academic interest in recent years as the potential long-term neurodegenerative sequelae of sports-related concussion on athlete's brain health. Rugby has a high incidence of concussion. Recent research findings from a cohort of former professional players found that the number of concussions sustained during their professional careers was associated with the rate of diagnosed clinical depression and late-life cognitive impairment. A limitation of these studies is the use of a self-reported history of concussion. The reliability of professional rugby players to recall and self-report concussion history has never been quantified in the literature to date. Imperfect recall can generate bias in epidemiologic studies when the proportion of events recalled is associated with the health end points of interest. Associations observed may be spurious and due to recall bias if athletes differ in their knowledge and recognition of concussion symptomology in a manner that is associated with the health outcome of interest ie. under/overreporting of concussion. It is difficult to estimate the magnitude of the bias in the absence of any "gold-standard" measure of concussion history. Due to these concerns about the quality of self-reported concussion history, the investigators considered that it was important to evaluate the reliability of self-reported concussion history.

The primary aim of this study is to investigate the reliability of self-reported concussion history in current rugby union players

Objectives:

The objectives will be to:

Investigate player's self-report history of sports-related concussion (number and nature of concussions) in this elite rugby playing group.

Correlate player self-report with established individual player medical data. Repeat this process approximately 6 months later on a sub sample of this cohort, in order to test the reliability of player's reported concussion.

Eligibility Criteria:
Inclusion Criteria:

•\> 18 years old

* Contracted to Leinster rugby as a professional rugby player
* Players who have given informed consent and are willing to participate in the study.
* Players with a history of sports-related concussion/mild traumatic brain injury.

Exclusion Criteria:

• Any players with a history of non-sports related concussion/severe traumatic brain injury due to road traffic collisions etc. will be excluded.
A Study to Assess the Safety and Efficacy of ASP1941 in Combination With α-glucosidase Inhibitor in Type 2 Diabetic Patients

This study is to evaluate long-term safety and efficacy after concomitant administration of ASP1941 and α-glucosidase inhibitor in Japanese patients with type 2 diabetes mellitus.

This is a 52-week multi-center study in subjects with type 2 diabetes mellitus who have inadequate glycemic control on an α-Glucosidase Inhibitor alone. Dosage may be increased during the treatment period if subjects fulfill increasing criteria and the investigators adjudicate that no impact for subjects safety.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic patients receiving with α-glucosidase inhibitor mono-therapy for at least 4 weeks
* HbA1c value between 6.5 and 9.5%
* Body Mass Index (BMI) 20.0 - 45.0 kg/m2

Exclusion Criteria:

* Type 1 diabetes mellitus patients
* Serum creatinine \> upper limit of normal
* Proteinuria (albumin/creatinine ratio \> 300mg/g)
* Dysuria and/or urinary tract infection, genital infection
* Significant renal, hepatic or cardiovascular diseases
* Severe gastrointestinal diseases
The Relationship Between Physical Activity and Falling Risk and Fear of Falling in Elderlies

Aging is a physiological process, and it is a picture in which a decrease in physical functions, regression in cognitive abilities, decrease in social activities, loss of functionality in their lives occur and these are accompanied by many health problems. As a result of the changes in the human body and mind, the productivity of the organism and the ability of the person to adapt to the environment decrease. According to the data of the World Health Organization, this period is considered to be 65 years and over, and according to the data of the United Nations, 60 years and over.

The aim of this study is to investigate the effect of physical activity level on activities of daily living and fear of falling in elderlies.

Physical activity is defined as voluntary movements produced by skeletal muscles that result in increased energy expenditure. Physical activity includes activities that are done as a part of daily life. One of the protective factors against mental and physical diseases in old age is physical activity. There is a linear and strong link between physical activity and health. Physical inactivity accounts for 6% of deaths worldwide and ranks fourth among risk factors. Being physically active has an important place in the protection and development of health, active healthy aging, and protection from diseases caused by inactivity.

Activities of daily living are essential and important vital functions for a healthy or sick individual to survive. The most important wishes of aging individuals are to be able to perform daily living activities such as walking, climbing stairs, and getting up without the need for help. The activities of daily living of the elderly are reduced or prevented, and they begin to lose their independence.

Fear of falling, which is frequently encountered in the elderly, is among the psychological consequences of falling. Fear of falling, which is defined as avoidance of activity or fear of falling leading to decreased activity, is seen in 35-55% of the elderly. Falls are among the most common causes of morbidity and mortality in the elderly. One-third of people over the age of 65 fall each year, and half of the falls are recurrent falls. Depending on the fear of falling, the physical activities of the elderly may be restricted.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the research
* Being 60 years old or older
* Staying in a nursing home for at least 1 month
* Independent mobilization of the participants

Exclusion Criteria:

* Having a problem that prevents communication
* Having multiple comorbidities
* Having a cognitive problem
EN3285 for the Prevention or Delay of Oral Mucositis in Patients With Head and Neck Cancer

Randomized, double-blind, placebo-controlled study for the treatment of head and neck cancer(HNC), to assess the ability of EN3285 to prevent or delay the onset of severe oral mucositis(OM).

This randomized, double-blind, placebo-controlled study will be conducted in patients receiving chemoradiotherapy (ChemoRT) for the treatment of head and neck cancer(HNC), to assess the ability of EN3285 to prevent or delay the onset of severe oral mucositis(OM). The study includes a treatment period of up to 8 weeks, based on the patients' prescribed treatment plan, with a follow-up period of 12 months following completion of radiotherapy (RT).

Eligibility Criteria:
Significant Inclusion Criteria:

* 18 years and older
* newly diagnosed SCC of the oral cavity and/or oropharynx, and are intended for treatment with ChemoRT.
* Have a clinical plan to receive a minimum of 60 Gy to the oral cavity and/or oropharynx
* Chemotherapy: cisplatin
* Have a WBC ≥3500 per cubic millimeter
* Have a platelet count ≥100,000 per cubic millimeter
* Have adequate renal function as determined by the principal investigator prior to enrollment
* Are willing and able to undergo oral assessments
* Have a Karnofsky Performance Status score ≥70

Significant Exclusion Criteria:

* Have OM or other oral conditions at study entry
* Plan to use Amifostine, Pilocarpine, Cevimeline or Bethanechol
* Are using a pre-existing feeding tube for nutritional support at study entry
* Plan to use any drug for the treatment or prevention of OM
* Have had any prior radiotherapy to the head and neck
* Have had prior chemotherapy within 6 months preceding enrollment
* Plan to have concurrent chemotherapy, other than those regimens specified under inclusioncriteria
* Have received other investigational drugs in the 30 days preceding initiation of study drug or during administration of study drug
* Have medical conditions that require the use of chronic steroid therapy
* Have the inability to undergo repeat treatments,
Does Perineural Dexmedetomidine Prolong Duration of a Nerve Block?

Brief Summary: The aim of this trial is to investigate if dexmedetomidine prolongs the duration of an adductor canal block. By using healthy volunteers the investigators can perform a bilateral adductor canal block and thereby control for a systemic effect to clarify if the effect is actually peripheral or systemic. The investigators hypothesis is that dexmedetomidine as an adjunct to a local anaesthetic prolongs the duration of a peripheral nerve block by a peripheral mechanism.

Background:

Efficient pain management promoting mobilization and convalescence is essential in an ideal perioperative course. Regional nerve blocks are a central element in postoperative regimes for many patients and it is therefore important that these nerve blocks are both long lasting and efficient. This trial will investigate whether it is possible to optimize the postoperative pain management when adding dexmedetomidine to the local anaesthetic ropivacaine in peripheral nerve blocks.

The prolonging effect of using dexmedetomidine as adjunct in peripheral nerve blocks have been investigated in several studies. However, it remains uncertain whether the effect is mediated by a systemic-, a peripheral- or a combined systemic/peripheral mechanism. In this trial the adjuvating effect of dexmedetomidine will be investigated using the adductor canal block. This is a nerve block that besides being efficient as pain treatment after knee surgery, is primarily sensory, and therefore augments mobilization after total knee arthroplasty.

Method:

On the trial day the volunteers will receive bilateral adductor canal blocks. In one thigh they will receive the local anaesthetic ropivacaine 20ml 5mg/ml and placebo (saline) and in the other thigh ropivacaine 20ml 5mg/ml and dexmedetomidine 100μg. The allocation is blinded to volunteer and investigator.

The duration of the nerve block will be measured by five different tests: Temperature test, Pinprick, Pain during tonic heat stimulation, Warmth detection threshold and pain detection threshold. All tests are validated within pain research.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists class 1
* Body Mass Index 18-30

Exclusion Criteria:

* Allergy to study medication
* Earlier trauma or surgery to lower limb
* Diabetes Mellitus
* Alcohol or drug abuse
* Daily intake of opioids or steroids last 4 weeks
* Daily intake of any analgesics last 48 hours Heart block Sick sinus node.
Chemoradiotherapy in Elderly Patients With Oesophagus Cancer

Management of elderly patient with cancer is a therapeutic challenge and a public health problem. The mean age of esophageal cancer is 64.5 years and 72.1 years in men and women respectively. Surgery is a standard treatment reserved to about 30 % of patients. The other 70 % are considered unfit for surgery for various reasons, including ageing.

Chemoradiotherapy (CRT) is standard treatment for patients with esophageal cancer unfit for surgery. The validated treatment scheme is external beam radiotherapy (EBRT) 50 Gy over 5 weeks combined with cisplatin and 5FU infusion. However it induces high rates of severe and life threatening toxicities: grade 3 haematologic and esophageal mucositis of 20 and 25 % respectively, in patients with a median age of 64 years. CRT has not been properly evaluated in patients more than 75 years, and other combined chemotherapy are challenging.

Choice of the combined chemotherapy Carboplatin and taxanes delivered concurrently to radiotherapy is attractive. A Dutch randomized study (Cross trial) compared preoperative CRT to surgery in 368 patients with T1-T3 and N0N1. In the preoperative CRT group, patients received 41.4 Gy by EBRT over 5 weeks combined with carboplatin (AUC 2) and paclitaxel (50 mg/m2). A 30 % tumor sterilization rate and a reduction of metastasis considered a distant effect of chemotherapy were observed. The 5-year survival was statistically better with CRT group. The preoperative CRT was well tolerated and few acute toxicities were observed. Intriguingly, in a French randomized study, conducted in less locally advanced disease, the combination of 45 Gy and 5 FU infusion and Cisplatin did not induce more tumor sterilization rate, suggesting carboplatine/paclitaxel is more effective than 5FU/cisplatin in CRT.

Study design Since the optimal doses of each component radiotherapy- carboplatin - paclitaxel are unknown, we plan to conduct a phase I/II study

* Phase I: the objective is to determine the maximum tolerated dose (MTD) and recommended doses for phase II (RP2D) of each component considering the treatment scheme of Dutch study as reference:

  * for chemotherapy 3 levels: 50%, 75% and 100% of the standard Dutch dose (carboplatin AUC 2 and paclitaxel 50 mg/m2)
  * for radiotherapy 3 levels: 41.4 Gy/1.8 Gy/f; 45 Gy/1.8 Gy/f; 50.4 Gy/1.8 Gy/f basel level being : 41.4 Gy and 50% of standard CT doses The phase I is conducted with increasing doses of each component with 9 levels.
* Phase II: after the determination of RP2D of each component, the study is continued as a phase II in order to assess tumor response Secondary objectives: Quality of life, progression free and overall survivals

Eligibility Criteria:
Inclusion Criteria:

* Esophageal cancer, squamous and adenocarcinoma types, T1-3, N0-1, M1a (TNM 6th),
* age \> 75 years,
* WHO status \< 2, Balducci 1, adequate bone marrow reserve, normal renal and hepatic function.

Exclusion Criteria:

* age \< 75 years
Working Well With Back Pain (Feasibility RCT of Vocational Rehabilitation)

Back pain has a major impact on people's ability to work. Health professionals need to know how they can best use their limited resources to address the occupational needs of people with chronic low back pain. Vocational rehabilitation is the process that helps people with health problems to stay at, return to and remain at work. This study comprises the second phase of a three year study of back pain and vocational rehabilitation. The first phase gathered data from patient interviews and postal surveys of GPs and GP practice managers. These findings have been used to inform this second phase; a feasibility randomised controlled trial. The participants will be thirty employed people with back pain who have been offered an NHS rehabilitation programme, and who are concerned about their ability to work with low back pain. Those who consent will be randomised into two groups. One group will receive routine rehabilitation. The other will receive routine rehabilitation plus an individually tailored vocational intervention carried out by the researcher. Following the trial, individual interviews will be carried out with each of the participants by an independent researcher. An economic study will evaluate the possibility of measuring the cost-effectiveness of the intervention. The hypothesis is that an enhanced vocational intervention plus routine rehabilitation will be more effective in improving patients' work ability than routine rehabilitation alone.


Eligibility Criteria:
Inclusion Criteria:

* low back pain
* offered routine rehabilitation
* employed
* concern about work ability due to low back pain
* referral by GP in South Nottinghamshire

Exclusion Criteria:

* not fluent in English