cyrilzakka/clinical-trials huggingface dataset:
Study Evaluating the Pharmacokinetic and Mass Balance of Single Dose [14C] AZD9291 in Volunteers

Study to evaluate the pharmacokinetic and Mass Balance of single dose \[14C\] AZD9291 in healthy male volunteers

A Single-centre, Non-Randomised, Open-label, Pharmacokinetic and Mass Balance Study of Orally Administered \[14C\]-AZD9291 in Healthy Male Volunteers

Eligibility Criteria:
Inclusion Criteria:

1, Volunteers must be willing to use reliable methods of contraception (condom and spermicide), even if their partners are postmenopausal, surgically sterile, or using an effective hormonal method of contraception or intrauterine coil. 2. In addition, volunteers must agree to continue to take similar contraceptive precautions until 6 months after the last administration of AZD9291 and avoid procreative sex as well as sperm donation for 6 months.

Exclusion Criteria: 1, Any clinically relevant abnormalities in physical examination, vital signs, hematology,clinical chemistry, urinalysis or ECG at baseline in the opinion of the investigator. 2. Radiation exposure from clinical studies, including that from the present study, excluding background radiation but including diagnostic X-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. -
A Comparing Study Between ALT02(Trastuzumab Biosimilar) and Herceptin® in Healthy Subjects

The purpose of this study is to compare ALT02 (Trastuzumab biosimilar) and Herceptin® (US-licensed Trastuzumab and EU-licensed Trastuzumab) in healthy male subjects about the pharmacokinetics, safety, tolerability and immunogenicity.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects
* Have a body weight over 50.0 kg and a body mass index over than 18.5 and less than 30.0 kg/m², inclusive.

Exclusion Criteria:

* Any clinically significant abnormality or abnormal laboratory test results found during medical screening or positive test for hepatitis B, hepatitis C, or HIV found during medical screening.
* Positive urine drug screen or alcohol breath test at screening.
* History of allergic reactions to trastuzumab, benzyl alcohol, murine proteins, or other related drugs.
* Any reason which, in the opinion of the Qualified Investigator, would prevent the subject from participating in the study.
* Clinically significant electrocardiogram (ECG) abnormalities or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at screening.
* History of significant alcohol abuse within one year prior to screening or regular use of alcohol within six months prior to the screening visit (more than fourteen units of alcohol per week \[1 unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol\]).
* History of significant drug abuse within one year prior to screening or use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine \[PCP\], and crack) within 1 year prior to screening.
* Use of trastuzumab or another monoclonal antibody for a medical condition or in the context of another clinical trial.
* Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to dosing, administration of a biological product in the context of a clinical research study within 90 days prior to dosing, or concomitant participation in an investigational study involving no drug or device administration.
* Use of medication other than topical products without significant systemic absorption:

  1. prescription medication within 14 days prior to dose administration;
  2. over-the-counter products including natural health products (e.g. food supplements and herbal supplements) within 7 days prior to dosing, with the exception of the occasional use of acetaminophen (up to 2 g daily);
  3. a depot injection or an implant of any drug within 3 months prior to dose administration.
* Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to dosing.
* Hemoglobin \<128 g/L and hematocrit \<0.37 L/L at screening.
Early Identification of Patients in Surgical Intensive Care With a Risk of Acute Respiratory Distress Following Visceral Surgery

Today there are few studies in the literature involving patients in an ICU following major visceral surgery. There are thus few results about the prognostic value of pulmonary extravascular water in this population of patients, but also the prognostic value of pulmonary extravascular water measured at the bedside using pulmonary ultrasound.

In addition, pulmonary ultrasound will be combined with echocardiography to measure left ventricular function (LVEF) and to study the profile of the mitral valve to assess filling pressure in patients with immediate post-operative ventilation. This will make it possible to distinguish between increases in pulmonary extravascular water associated with high filling pressure and increased pulmonary water associated with low filling pressure: characteristic of lesional oedema.

The aim of this study is to determine the prognostic value of extravascular pulmonary water (PEVW) diagnosed using pulmonary ultrasound in patients admitted to an ICU following scheduled or emergency visceral surgery in the onset of acute respiratory distress requiring invasive mechanical ventilation, or prolonged post-operative intubation, or non-invasive.


Eligibility Criteria:
Inclusion Criteria:

All patients undergoing scheduled or emergency visceral surgery and admitted to an ICU following the intervention.

Exclusion Criteria:

* Chest surgery
* ASA (American Society of Anesthesiologists) 4 or more
* Refusal of the patient
* Pregnant women
* Spontaneously-breathing patients
New Imaging Procedures and Therapeutic Approach in Basal Cell Carcinoma Management

The aim of this study is to show that the Nd:YAG laser could be a promising alternative treatment option in the management of low-risk basal cell carcinomas with similar high efficacy rates to surgery, and low recurrence rates evaluated over a time period of one year. Reflectance confocal microscopy, optical coherence tomography and clinical examination are used prior to confirm the clinical diagnosis of the basal cell carcinoma and for premargination of the tumor. The optical coherence tomography will also be used post treatment to confirm clearance of the basal cell carcinoma and to monitor treatment response.


Eligibility Criteria:
Inclusion Criteria:

Patients with one or more basal cell carcinoma(s) on head, trunk or extremities

* Diagnosed clinically, with a dermatoscope and through noninvasive imaging methods such as reflectance confocal microscopy and optical coherence tomography
* H zone \<6mm, M zone \<10mm, L zone \<20mm
* Tumor thickness \<2mm
* Clearly visible margins

Exclusion Criteria:

* Pregnancy
* \<18 years of age
* Current or history of immunosuppression
* Prior-treatment of the basal cell carcinoma/ recurrent basal cell carcinomas
* History of radiation in the area of basal cell carcinoma appearance
A Study in Patients With Venous Leg Ulcers and Measuring the Effects of Using Geko™ Device

This is a single centre open label study measuring lower limb physiology in patients with venous leg ulcers at the University Hospital of South Manchester.

Ambulatory venous pressure, venous transit times, wound bed tissue oxygenation and changes in microcirculation will be measured at baseline after the gekoTM device is activated. Ambulatory venous pressure and venous transit times will be performed whilst the participant is standing, sitting and supine


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Intact healthy skin at the site of device application
3. Able to understand the Patient Information Sheet
4. Willing and able to give informed consent
5. Willing and able to follow the requirements of the protocol
6. Subjects who had a chronic venous leg ulcer (i.e. CEAP classification of C6 1) greater than 1 cm2 and less than 10 cm in maximum diameter,
7. ABPI of ≥0.8
8. Patient treated with 4 layer compression bandaging

Exclusion Criteria:

1. Wound infection either acute or chronic
2. History of significant haematological disorders or DVT with the preceding six months
3. Pregnant
4. Pacemakers or implantable defibrillators
5. Use of any other neuro-modulation device
6. Current use of TENS in pelvic region, back or legs
7. Use of investigational drug or device within the past 4 weeks that may interfere with this study
8. Recent surgery that may affect the study (such as abdominopelvic, or lower limb) in the opinion of the investigator.
9. Recent trauma to the lower limbs
10. Size of leg incompatible with the geko™ device.
11. Obesity (BMI \> 34)
12. Any medication deemed to be significant by the Investigator
13. Subjects who had an index venous leg ulcer greater in maximum diameter than 10cm in any one dimension, or less than 2cm.
14. Diabetes
15. Clinical evidence of peripheral arterial disease (i.e signs or symptoms, in the opinion of the researcher)
Validation of Texture Changing Coatings for Use in At-Home Rapid Tests

At-home testing is an important part of mitigating the spread of COVID-19, but these tests are not accessible to people with low vision or blindness. Instead of adapting to a technology originally built for sighted people, investigators propose a no-power version that reports test results through a texture change, which people can feel by touch. This platform could be used not only for COVID, but also for other diagnostics, and will promote the independence and privacy for people with low vision or blindness by removing the need for human assistance or an internet connection.

Current at-home COVID tests are not accessible to people with low vision or blindness. To interpret results, people with low vision or blindness may need a sighted assistant, an internet-based image recognition tool, or some other sort of powered implement. Instead of adapting to technologies developed for sighted people, investigators propose a new platform which provides a no-power tactile readout, i.e., a texture change, to interpret test results. Although COVID antigens are at relatively low concentrations in human saliva, by relying on surface chemistry effects, a relatively small amount of sample can be designed to cause a significant texture change. This project will develop a new class of antibody-conjugated polymers which, in a saliva sample, bind to COVID antigen. In conjunction, investigators will also develop a test surface designed to maximize tactile feedback upon antigen binding. Upon binding to the test surface, a COVID positive surface will feel distinctive from the negative control, like distinguishing between plastic and glass. To optimize polymer design and test surface design, investigators use a combination of materials characterization, mechanical testing, human testing, and computational techniques. The project culminates by having low vision or blind users test the device with synthetic saliva solutions containing COVID antigen, present as innocuous protein isolates. Subjects will receive synthetic saliva with and without COVID antigen, and using our platform, will be asked to determine if the synthetic saliva did contain the COVID antigen. As a platform, the technology is not limited to COVID, but could be adapted to either new variants or other use cases, such as pregnancy tests. Investigators expertise combines accessibility experts, synthetic chemists, human psychophysics, computational simulations, surface science, and mechanics. To maximize project success, the project includes people with visual impairments at all stages to ensure practicality.

Eligibility Criteria:
Inclusion Criteria:

* Visual Impairment: Participants should be blind or visually impaired for greater than 10 years, either congenitally or acquired.
* Tactile Aid Usage: Participants must use tactile aids regularly.
* Mathematical Knowledge: Participants should have a basic understanding of mathematical plots, equivalent to at least high school geometry.

Exclusion Criteria:

* Limb Conditions: Participants with amputations or outer extremity conditions affecting hand use will be excluded.
Longitudinal Study to Determine the Effectiveness of the Mobility Checkup for Older Adults

The investigators are developing a new, preventative physical therapy model of care for older adults called Mobility Checkup (MC). Proposed as an annual visit, the MC includes measurement of physical performance and education regarding the importance of maintaining mobility for overall health. The purpose of this study is to determine the feasibility of and begin data collection for, a longitudinal study of the effectiveness of the Mobility Checkup with a small cohort. This activity will evaluate the feasibility of recruitment and implementation of this longitudinal effectiveness study.

Healthy aging is defined as "the process of developing and maintaining the functional ability that enables well-being in older age" and includes mobility. Mobility disability (i.e., the inability to walk 400 meters and climb a flight of stairs without assistance) is the most prevalent form of disability for older adults in the United States. Unlike blood pressure or body mass index, physical performance measures such as walking speed help identify and predict preclinical mobility disability, but are rarely used in routine medical care. This is a missed opportunity, particularly for older adults, who may experience a subtle decline in physical performance that leads to mobility disability.

The position of the American Physical Therapy Association is that all people should have an annual physical therapy visit to optimize movement and promote health, wellness, and fitness; and slow the progression of impairments of body functions and structures, activity limitations, and participation restrictions.

Recommendations support preventive care for maintaining mobility. However, a model of care specific to preventing mobility disability in older adults is not common practice. Evidence suggests routine screening can predict mobility disability in older adults and that activity-based interventions prevent it.

The is year 1 of a longitudinal study that will determine the feasibility of an effectiveness study of a Mobility Checkup, an annual preventive visit within a model of physical therapy care. The Mobility Checkup prioratizes educating older adults on the value of physical performance as an indicator of health and aims to maintain mobility and reduce mobility disability among participants. Ultimately, this new model of care could result in a cost-effective tool to establish baseline physical performance and identify and prevent preclinical and mobility disabilities in older adults.

Eligibility Criteria:
Inclusion Criteria:

* 55 years of age or older
* Walk independently with or without an assistive device

Exclusion Criteria:

* Experiencing short-term condition affecting their mobility
* Cardiac procedure or myocardial infarction (heart attack) in the last 6 months
* Has a guardian who is responsible for their healthcare decisions
Comparison of the Acute Effects of Focused and Radial ESWT on Pain and Balance Performance in Individuals With Plantar Fasciitis: A Randomized Clinical Trial

This study aimed to compare the acute effects of focused and radial ESWT on pain and balance performance in individuals with plantar fasciitis.

This study aimed to compare the acute effects of focused and radial ESWT on pain and balance performance in individuals with plantar fasciitis. The study included 40 individuals (27 females and 13 males) aged between 18 and 63 years, presenting with plantar fasciitis (PF). Extracorporeal shockwave therapy (ESWT) was administered once a week for four weeks. The participants were randomly assigned to two groups (f-ESWT and r-ESWT). Pain levels were assessed using the Visual Analogue Scale, while Static and Dynamic Balance were evaluated using the Biodex Balance System.

Eligibility Criteria:
Inclusion Criteria:

unilateral or bilateral tenderness in the medial tubercle of calcaneus and heel pain in the first few steps in the morning, which gets worse with increased activity, absence of any known systemic disease, absence of any surgical procedure to lower extremity, absence of any treatment for PF in the last 6 months, 18-65 years, and consent to participate in the study.

Exclusion Criteria:

pregnancy, pacemaker, receiving anticoagulant therapy, uncontrolled cardiovascular disease, tumor, acute infection, nerve root compression, local dermatological or neurological problems, diabetes mellitus, taking anti-inflammatory drugs during treatment, or incomplete follow-up.
Corneal Biomechanics During Pregnancy

It is known that intraocular pressure changes during pregnancy. Collagen structure changes during pregnancy to enable softening of the symphysis, whitening of the birth chanel, and, thus, ultimately to enable delivery of a child. The cornea consists of highly structured collagen fibers. Hence, it seams logically that corneal biomechanics also change during pregnancy.

It is known that intraocular pressure changes during pregnancy. Collagen structure changes during pregnancy to enable softening of the symphysis, whitening of the birth chanel, and, thus, ultimately to enable delivery of a child. The cornea consists of highly structured collagen fibers. Hence, it seams logically that corneal biomechanics also change during pregnancy.

Measurement of intraocular pressure is highly dependant on corneal properties. With the Corvis ST device by Ocular Inc. it is possible to measure intraocular pressure and investigated corneal biomechanics. The aim of this study is therefore to compare corneal biomechanical properties during the third trimester with corneal biomechanical properties at 3 months after delivery.

Eligibility Criteria:
Inclusion Criteria:

* females
* pregnant
* age 18 to 38 yo
* uncomplicated singleton pregnancy

Exclusion Criteria:

* any history of ocular disease or surgery other than conjunctivitis, especially no history of glaucoma or corneal disease
* systemic diseases, i.e. diabetes, hypertension, collagenase
* current contact lens wear
* before pregnancy taking any systemic or ocular medications
XParTS II: Capecitabine/CDDP(XP) and S-1/CDDP(SP) as the First-line Treatment for Advanced Gastric Cancer

The aim of this study is to elucidate the efficacy and safety of XP and SP for first-line treatment of Advanced Gastric Cancer.

XP and SP are either standard treatment for advanced gastric cancer. The aim of this study is to elucidate the efficacy and safety of Capecitabine/Cisplatin and S-1/Cisplatin for first-line treatment of Advanced Gastric Cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed gastric adenocarcinoma with unresectable metastatic or recurrent disease
2. Lesions confirmed on imaging within 28 days before registration (not required measurable lesions as defined in RECIST version 1.1)
3. No previous chemotherapy or radiotherapy. However, adjuvant chemotherapy is allowed the case of more than 6 months from the end of adjuvant chemotherapy
4. ECOG Performance Status of 0 to 2
5. Life expectancy of at least 3 months after registration
6. Written informed consent
7. Age of 20 to 74 years with either gender
8. Adequate Major organ functions within 14 days before registration

Exclusion Criteria:

1. Positive HER2 status
2. Previous history of fluoropyrimidines therapy within 6 months prior to registration
3. Previous treatment with platinum agents
4. Previous history of serious hypersensitivity to fluoropyrimidines or platinum agents
5. Previous history of adverse reactions suggestive of dihydropyrimidine dehydrogenase (DPD) deficiency
6. More than one cancer at the same time or more than one cancer at different times separated by a 5-year disease-free interval. However, multiple active cancers do not include carcinoma in situ or skin cancer which is determined to have been cured as a result of treatment.
7. Obvious infection or inflammation (pyrexia ≥ 38.0˚C)
8. Active hepatitis
9. Heart disease that is serious or requires hospitalization, or history of such disease within past year
10. Having complication that is serious or requires hospitalization (intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, poorly controlled diabetes mellitus, renal failure, liver disorders, or hepatic cirrhosis)
11. Being treated or in need of treatment with flucytosine, phenytoin or warfarin potassium
12. Chronic diarrhea (watery stool or ≥4 times/day)
13. Active gastrointestinal bleeding
14. Body cavity fluids requiring drainage or other treatment
15. Clinical suspicion or previous history of metastasis to brain or meninges
16. Women who are pregnant, breastfeeding, or potentially (hoping to become) pregnant
17. Unwillingness to practice contraception
18. Poor oral intake
19. Psychiatric disorders which are being or may need to be treated with psychotropics
20. Otherwise determined by investigators or site principal investigators to be unsuitable for participation in study
Effect Of Static And Dynamic Stretching On Muscle Tendon Unit

The purpose of this study is to investigate the acute effects of two different types of muscle stretching (static and dynamic) on muscle-tendon unit of gastrocnemius muscle by ultrasound and to follow how long the stretching effects are sustained.

Muscle stretching is a very common practice applied in warm-up process in order to enhance performance in sports and to prevent or decrease the risk of sports injury. Muscle stretching is also used for therapeutic purposes in many clinical conditions.

It is generally performed in either static or dynamic manner. Muscle is brought to its lengthened position and is held at that point for a certain period of time in static stretching (SS). In dynamic stretching (DS), however, active movements of muscle take the joint through the range of motion and creates a stretch, but the muscle is not held in the end position.

Although recent studies suggest that static stretching has adverse effects on performance, reduces maximal muscle force and is not successful in preventing non-contact injuries, as believed so; and the dynamic type therefore gaining popularity; it is reported that flexibility and range of motion can be improved by stretching as a consequence of the decrement in muscle stiffness. However, the effects of stretching depend on the type, duration and timing of stretching and there is still debate over which prescription provides the best results in terms of flexibility, power, performance or injury protection. And what happens to the viscoelastic properties of a muscle when it is stretched statically or dynamically is still not well documented. Ultrasound seems to be a good option as it offers an objective and a non-invasive way to expose the alteration in muscles and tendons due to stretching.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males,
* aged between 18-30 years

Exclusion Criteria:

* Cases with history of recent musculoskeletal injuries or neurological diseases.