cyrilzakka/clinical-trials huggingface dataset:
Clinical Assessment of Two Daily Wear Reusable Soft Silicone Hydrogel Contact Lenses

The overall objective of this clinical study is to describe the clinical performance of the TOTAL30® soft contact lens compared to the ACUVUE® OASYS® with HYDRACLEAR PLUS (AOHP) soft contact lens in a daily wear modality.

Subjects will be expected to attend 3 visits and wear the study contact lenses at least 5 days per week and at least 8 hours per day. On Visits 2 and 3, subjects will be expected to wear the study lenses at least 6 hours prior to the study visit. The expected total duration of subject participation in the study will be approximately 1.5 months. This study will be conducted in the United Kingdom (UK).

Eligibility Criteria:
Key Inclusion Criteria:

* Currently wearing any commercial spherical soft contact lenses with at least 3 months wearing experience.
* Willing to wear the study lenses for a minimum of 5 days per week and 8 hours per day.
* Willing to NOT use rewetting/lubricating drops at any time during the study.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Participation in a clinical trial within the previous 14 days or currently enrolled in any clinical trial.
* Habitual AOHP contact lens wearers (in the past 3 months).
* Monovision wear during the study.
* Other protocol-defined exclusion criteria may apply.
A Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy Study of MBS303 in B-Cell NHL

This is a Phase I/Ⅱ, multicenter, open-label, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics(PD) and efficacy of a novel T-Cell bispecific (TCB), MBS303, administered by intravenous (IV) infusion in participants with relapsed or refractory B-cell NHL. This entry-to-human study consists of 2 parts: a dose escalation part (Phase I) and an expansion part (Phase Ⅱ)


Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to provide written informed consent and to comply with the study protocol.
2. Adult patients, ≥18 years of age;
3. CD20+ B-cell Non-Hodgkin Lymphoma who have relapsed after or failed to respond to at least one prior treatment regimen with an anti-CD20 monoclonal antibody and for whom there is no available therapy expected to improve survival;
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
5. Life expectancy ≥3 months;
6. Measurable disease, defined as at lease one bi-dimensionally measurable nodal lesion, defined as \>1.5 cm in its longest dimension, or at least one bi-dimensionally measureable extranodal lesion, defined as \>1.0 cm in its longest dimension
7. Adequate hematologic, hepatic, and renal function.

Exclusion Criteria:

1. Chronic lymphoblastic leukemia, Burkitt lymphoma or lymphoplasmacytic lymphom;
2. History of central nervous system (CNS) lymphoma or other CNS disease;
3. Participants with known active infection, including bacterial, viral, parasite, mycobacterial, or other infections (excluding nail bed fungal infections);
4. Surgery, chemotherapy, targeted therapy, immunotherapy, radiation therapy, tumor embolization, or other antitumor therapy within 28 days prior to the first MBS303;
5. Active or suspected autoimmune diseases;
6. Known severe allergic reaction or/and infusion reaction to monoclonal antibody;
7. Evidence of significant, uncontrolled concomitant disease;
8. Major surgery within 28 days prior to the first MBS303 administration or expected to undergo major surgery during the study treatment;
9. History of another invasive malignant tumors in past 3 years;
10. Participant with history of confirmed progressive multifocal leukoencephalopathy (PML);
11. Severe hemorrhagic diseases such as hemophilia A, hemophilia B, vascular hemophilia, or spontaneous bleeding requiring blood transfusion or other medical intervention;
12. Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C (including HBsAg, HBcAb positive with abnormal HBV DNA or HCV RNA);
13. Pregnant or lactating women; Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual contact during the following time periods related to this study: 1) while participating in the study; 2) for at least 12 months after discontinuation of all study treatments.
Comparison of Topical Treatment for Inflammatory Secretions of the Conjonctiva (Patients With Ocular Prostheses)

We propose to evaluate the efficacy of treatment with Hydrocortisone and Dexamethasone (in a cross-over design) in patients with ocular prostheses and significant functional discomfort.

There are more than 100,000 eye prosthesis wearers in France. Half of these patients are bothered by secretions or sandy sensations, or even chronic pain. Various anti-inflammatory treatments are proposed without scientific basis.

A pilot study on a limited number of patients conducted in 2017 at the University Hospital of Rennes and published in 2019 showed the interest of Dexamethasone eye drops in these patients. However, this study was retrospective and not controlled.

We therefore wish to propose a prospective, placebo-controlled, single-blind clinical study to define the value of anti-inflammatory treatment in patients with ocular prostheses.

We propose to evaluate the efficacy of treatment with Hydrocortisone and Dexamethasone (in a cross-over design) in patients with ocular prostheses and significant functional discomfort.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 years or older;
* Wearing a permanent prosthesis for more than 6 months; - Consultant in the ophthalmology department;
* Modified OSDI score ≥ 20 points out of 40 ;
* Affiliated with a health insurance scheme,
* For women of childbearing age: effective contraception (effective contraception includes oral contraception, intrauterine devices and other forms of contraception with a failure rate \<1%, for the duration of the study and up to 1 week after the last dose administered)
* Have given free, informed and written consent.

Exclusion Criteria:

* Treatment with eye drop(s) (other than artificial tears or antiseptic) \< 1 month;
* Concomitant treatment with CYP3A inhibitors including cobicistat containing drugs,
* Known contraindications to study treatments
* Dermal fat grafting or complicated cavity;
* Gougerot-Sjögren syndrome;
* Allergic conjunctivitis;
* Damaged prosthesis;
* Impossibility of carrying out the various tests required by the protocol for whatever reason (comprehension problems, motor disability);
* Pregnant or breastfeeding woman;
* Person already included in a RIPH1 research protocol with topical treatment of the cavity or systemic anti-inflammatory treatment and/or who could lead to a bias in the present study
* Person under legal protection (safeguard of justice, curatorship, guardianship) or person deprived of liberty.
Effect of Carnitine on Uremic Cardiomyopathy

Patients on chronic hemodialysis without obstructive coronary artery disease identified by coronary angiography were randomly divided into the two groups: carnitine group and control group. SPECT using FFA analogue, BMIPP, was performed before and one year after intravenous administration of L-carnitine (1000 mg on every dialysis session). Control group received the examination of BMIPP SPECT at the same time of the carnitine group. The effects of chronic intravenous administration of L-carnitine on myocardial fatty acid metabolism were investigated among this population.

Patients on chronic hemodialysis in Toujinkai hospital who had no obstructive coronary artery disease identified by coronary angiography and left ventricular dysfunction were randomly divided into the two groups: carnitine group and control group. To evaluate the possible effect of carnitine administration on myocardial fatty acid metabolism, SPECT using FFA analogue, BMIPP, was performed before and one year after intravenous administration of L-carnitine (1000 mg on every dialysis session). Control group received the examination of BMIPP SPECT at the same time of the carnitine group. Circulating concentrations of total, free, and acyl L-carnitine were measured every three months in the carnitine group. Clinical data including blood chemistry, blood pressure, or cardiac functions by echocardiography were obtained every 6 months in both groups. The effects of chronic intravenous administration of L-carnitine on myocardial fatty acid metabolism and cardiac functions were investigated among this population.

Eligibility Criteria:
Inclusion Criteria:

* Patients on chronic hemodialysis without significant obstructive coronary artery disease identified by angiography within one years of the study, and who had left ventricular dysfunction:

  * reduced left ventricular systolic function (left ventricular ejection fraction \<55%) and/or
  * left ventricular hypertrophy evaluated by echocardiography)

Exclusion Criteria:

1. Moderate or worse valvular heart disease,
2. Past histories of acute or old myocardial infarction and/or coronary revascularization by percutaneous coronary intervention or coronary artery bypass grafting within one year of the study.
Alkaline Ionized Water: Sports Recovery and Inflammation Management

The purpose of this study is to determine whether consumption of alkaline ionized water is effective for accelerating sports recovery.

Alkaline ionized water versus tap water is consumed for one week prior to an exercise challenge, using a cross-over study design.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Age 25-40 years (inclusive)
* Body mass index (BMI) between 19.0 and 29.9 kg/m2 (inclusive)
* Not regularly exercising or participating in team sports.

Exclusion Criteria:

* Bariatric surgery
* Diagnosed and medicated for diabetes
* Known serious chronic health condition
* Serious active illness within past 12 months
* Major surgery during past 8 weeks
* Alcohol consumption of more than four standard units/day (for example more than four regular 12-oz beers (5% alcohol), four small 5-oz glasses of wine (12% alcohol), or four 1.5 oz shots of 80-proof spirits) (or more than 28 per week);
* Regular use of marijuana products for the past three months
* Regular consumption of energy drinks
* Diagnosed with any blood clotting disorder or taking clotting factor concentrates.
* Taking any blood thinners or anticoagulants
* Taking anti-inflammatory medications on a daily basis (81 mg aspirin is acceptable)
* Diagnosed with high blood pressure or taking blood pressure medication
* Use of performance enhancing drugs within the last three months
* Having consumed prednisone (or related steroid medication) or received a prednisone injection within the last six months
Gastric Residual Volume Measurement in the Intensive Care Unit

Nutritional support is considered a key component of the treatment strategy for intensive care patients. Malnutrition, energy protein, and inadequate or excessive intake of other nutrients have measurable effects on tissues, body structure, body function, and clinical outcomes of patients receiving treatment. It increases hospital-acquired infections, hospitalizations, and intensive care prolongs and leads to complications. This study aimed to observe the time to reach target calories, nutritional failures, and complications during feeding in measured and unmeasured gastric residual volume patients receiving enteral nutrition under ventilation in the intensive care unite.


Eligibility Criteria:
Inclusion Criteria:

* Mechanical ventilatory support
* open enteral route (nasogastric/PEG)

Exclusion Criteria:

* History of gastrointestinal bleeding,
* parenteral nutrition support,
* hospital stay of fewer than two days,
* under 18 years of age
Radiomics to Identify Patients at Risk for Developing Pneumonitis, Differentiate Immune Checkpoint Inhibitor-induced Pneumonitis From Other Lung Inflammation and Distinguish Tumour Pseudo-progression From Real Tumour Growth

The investigators will develop a radiomics signature for immune checkpoint-induced pneumonitis in 40 patients with a pulmonary event under anti-PD1 or anti-PD-L1 (cases) and 40 patients without a pulmonary event under anti-PD1 or anti-PD-L1 (controls).

On the basis of the case-control study of patients treated with anti-PD1 or anti-PD-L1, they will further optimise the model using reinforcement machine learning. The model will then be validated in 300 prospective patients.

Preliminary analyses on a dataset showed a clear distinction in radiomics features for patients with and without pneumonitis from anti-PD1 or anti-PD-L1. Prior experience of the investigators of training and validating radiomics signatures combined with their preliminary exploratory results presented here, will be used to develop a radiomics signature for immune checkpoint-induced pneumonitis in 40 patients with a pulmonary event under anti-PD1 or anti-PD-L1 (cases) and 40 patients without a pulmonary event under anti-PD1 or anti-PD-L1 (controls).

On the basis of the case-control study of patients treated with anti-PD1 or anti-PD-L1, the investigators will be able to further optimise the model using reinforcement machine learning. The model will then be validated in 300 prospective patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients who receive standard anti-PD1 or anti-PD-L1 treatment in routine clinical practice for first or second line stage IV non-small cell lung cancer

Exclusion Criteria:

* The opposite of the above
Three-dimensional Thyroid Education Model

The purpose of our study is to develop a high-fidelity thyroid education model, that can be utilized for patient education. This model can assist them in gaining a better understanding of the thyroid's structure, providing patients with insights into their own conditions and thyroid fine needle aspiration examinations.

Background： Thyroid nodular disorder is one of the most common diseases in Endocrine clinics. And thyroid fine needle aspiration examination is the most important exam in evaluating the nature of thyroid nodules. In previous studies, 3D thyroid models have been introduced for patient education before thyroid surgery. Nevertheless, thyroid models that can be used to practice thyroid fine needle aspiration examination were scarce.

Study Design： This is a prospective study.

Methods： In our study, 3D printing technology will be used to create the thyroid high-fidelity model. We plan to choose 3D printing materials that explain thyroid fine needle aspiration for patient education efficacy evaluation.

Effect： Through the creation of this thyroid fine needle aspiration model, we hope to enhance patients' comprehension of the thyroid and thyroid nodules. The results of our study could be applied in hospitals to improve patient education.

Key words： 3D printing; medical education model; high-fidelity simulation; thyroid; fine needle aspiration

Eligibility Criteria:
Inclusion Criteria:

* Thyroid nodule detected
* Thyroid ultrasound-guided fine-needle aspiration is needed

Exclusion Criteria:

* Previously underwent thyroid ultrasound-guided fine-needle aspiration
* Refused to participate in the study
a BavaRiAn eValuatiOn of Dorsal Root Ganglion (DRG) Stimulation for the Treatment for Chronic Post Surgical Pain of the Groin

15-SMI-2013 is a post market, observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of chronic post surgical groin pain


Eligibility Criteria:
Inclusion Criteria:

1. The patient is at least 18 years old
2. The patient is willing and able to comply with the examination schedule and the trial schedule.
3. The patient has suffered from chronic post-surgical neuropathic groin pain for at least 6 months
4. Conservative treatments of the chronic pain including medication, physiotherapy and interventions have been exhausted
5. The pain level at the time of the baseline examination is at least 60mm on the visual analogue scale (VAS) in the primary pain area (groin pain)
6. The patient is able to give consent in writing

Exclusion Criteria:

1. Pregnant or breastfeeding patients or those who plan to become pregnant during the study
2. It has been established in an examination by the tester that the pain has significantly worsened or changed its characteristics in the course of the previous month.
3. In the last 30 days, the patient has been treated with corticosteroids on an area scheduled for the stimulation.
4. In the last 3 months, the patient has been treated with radio frequency therapy on an area scheduled for the stimulation.
5. The patient has already been treated with an active implantable device, including an implantable cardioverter defibrillator, pacemaker, spinal cord stimulator or an intrathecal medication pump.
6. The patient is not able to operate the stimulation device
7. The patient is currently suffering from an infection
8. The patient has participated in another clinical study in the last 30 days
9. The patient has a coagulation disorder or is taking anti-coagulants, which would make participation impossible, as per the study doctor
10. The patient has been diagnosed with a malignancy in the past 2 years
Almonds and Diabetes Management

This trial examined the impact of acute and chronic almond ingestion on indicators of glucose control (postprandial glycemia and hemoglobin A1c). Hypotheses:

1. Almonds will stimulate the secretion of GLP-1 in healthy adults and in adults with T2D The investigators were not able to demonstrate a relationship between GLP-1 secretion and almond consumption. Individuals with T2D were characterized with significantly greater GLP-1 secretion than the non-diabetic control subjects.
2. Acute ingestion of almonds will decrease the postprandial glycemia and insulinemic responses in healthy controls and in individuals with T2D The investigators data support the hypothesis: almond consumption by individuals with T2D did attenuate postprandial glycemia; however, almond consumption did not alter glycemia in non-diabetic control subjects
3. Chronic almond ingestion for 12 weeks will reduce fasting glucose (FG) and A1c concentrations in individuals with T2D The investigators data demonstrated modest beneficial effect of almond consumption on A1c in individuals with T2D. Almond consumption was also associated with modest weight loss as compared to the control treatment (low fat cheese sticks).


Eligibility Criteria:
Inclusion Criteria:

* 12 subjects with diagnosed T2D for at least 1 year and 12 healthy individuals without T2D will be recruited for the acute almond trial.
* 24 subjects with diagnosed T2D for at least 1 year will be recruited for the chronic almond trial.
* Subjects from the campus population and nearby communities will be recruited to participate in these trials.
* Men and women must be willing to comply with the experimental protocol including the restriction of nut consumption:

  * subjects recruited for the acute almond study must agree not to consume any nuts or nut butters for 1-week prior to and during the 2-week trial
  * participants in the chronic almond study must agree not to consume nuts or nut butters more than 2 times per week during the 12 week trial.
* Participants must have a body mass index (BMI) from 20 to 35 kg/m2 and are aged 30 to 70 years.
* Subjects with T2D may take oral hyperglycemic agents.

Exclusion Criteria:

* Insulin use
* History of a peanut allergy
* Chronic or unresolved disease
* Current smoking habit
* Pregnant or lactating
* Medication use that may impact incretin secretion. \[Incretins are gastrointestinal hormones secreted at meal-time.\]
A Multicentre, Non-Blinded Study Exploring Self-Administration of Chemotherapy in the Home Environment

This study is to see if the standard of care subcutaneous injection of bortezomib can safely be administered at home by the patient or caregiver. All tests and assessments are based on standard of care procedures.

Chemotherapy for malignancies is predominantly prescribed and delivered in a tertiary hospital and/or cancer centre setting. However, with modern chemotherapy, with a reduced side effect profile, this paradigm should be challenged. Indeed, the use of methotrexate and other biologics (a form of chemotherapy) in the Rheumatologic setting is commonly delivered effectively and safely in the community.

Taken together, a hospital-based model of chemotherapy delivery may not be warranted in all circumstances. Moreover, the use of this current model invariably discounts the time commitments, needs of patients and caregivers, as well as while not addressing the emerging concerns regarding system capacity, efficiency and effectiveness of safe chemotherapy delivery.

Eligibility Criteria:
Inclusion Criteria:

* Patients are aged 18 years old or older with a diagnosis of symptomatic myeloma,
* Stable clinical status as deemed by responsible investigator,
* Personally (or caregiver) willing and deemed capable to self-administer with teaching,
* Previously received more than 4 injections of bortezomib within the hospital and/or cancer centre environment,
* Signed informed consent.

Exclusion Criteria:

* Currently participating in clinical trials that includes the use of bortezomib,
* History of allergic reactions to bortezomib,
* History of bleeding attributable to bortezomib,
* History of greater than or equal to grade 3 side effects attributable to bortezomib,
* Clinically deemed unlikely to be compliant with therapy by responsible investigator,
* Life expectancy anticipated to be less than 6 months,
* Deemed geographically inaccessible to receive care.