cyrilzakka/clinical-trials huggingface dataset:
Aberrant Helix Pomatia Agglutinin Binding Glycan Expression in Follicular Thyroid Tumours

Aberration of glycosylation is a hallmark of cancer cells, and plays an important role in oncogenesis and cancer progression, including metastasis. One of the markers of aberrant glycosylation (O-linked) is the binding of the lectin Helix pomatia agglutinin (HPA), which has been demonstrated in a wide range of human cancers, especially in tumours with a more aggressive phenotype. Data on the role of HPA within follicular neoplasms of the thyroid gland are currently lacking, therefore we sought to investigate possible changes in cell surface glycosylation associated with this type of neoplasms.

Lectin-histochemistry was performed on 37 archival paraffin wax-embedded specimens of various follicular thyroid tumours (10 follicular adenomas (FA), 10 minimally invasive follicular carcinomas (miFTC), 13 widely invasive follicular cancers (wiFTC) and 4 metastatic follicular thyroid cancers (metFTC)). Sections were scored as positive when ≥5% of cancer cells labelled positive, and scored as negative when \<5% labelled positive for HPA binding. Assessments of HPA-binding were performed by two observers, who were blinded to the identity of the sample, and their results were compared.

Eligibility Criteria:
Inclusion Criteria:

* For this retrospective cohort study, 37 patients who underwent thyroid surgery for a thyroid follicular neoplasm between 2005 and 2018 were identified from our institutional database and their tumours, characteristics and outcomes were analysed.

Exclusion Criteria:

* N/A
DNA Methylation in Malar Melasma and Its Change by Sunscreen, Retinoic Acid and Niacinamide.

BACKGROUND: Malar melasma has a chronic and recurrent character that may be related with epigenetic changes.

OBJECTIVE: Recognize the DNA methylation status of the malar melasma and perilesional skin, and its change after treatment with 50 SPF sunscreen (S), 4% niacinamide (N), or 0.025% retinoic acid (RA). METHODS: Fifty-six lesion of 28 female patients without treatment were clinically evaluated, as also the expression of DNA methyl transferases 1 and 3 by real time-PCR (polymerase chain reaction amplification), immunohistochemistry and immunofluorescence. It was initially quantified and after 8 weeks of treatment with S, RA and N. RESULTS: Relative expression of DNA methyl transferases were significantly elevated compared with unaffected skin in all subjects indicating hypermethylation of DNA. Hypermethylation decreased by S (7 vs 3 times relative expression, p\<0.05), RA (7 vs 2 times relative expression p\<0.05), and N (7 vs 1 relative expression p\<0.01) correlated with clinical improvement, this was also supported by immunohistochemistry and immunofluorescence. CONCLUSIONS: The investigators found hypermethylation of DNA in melasma lesions. Environmental factors such as sun radiation may induce DNA hypermethylation triggering hyperpigmentation trough the activation of pathways regulated by epigenetic modifications. Thus, decreasing methylation by sunscreen protection and the genetic transcription modification through N and RA, may allow their clinical improvement regardless its depigmenting effect.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of malar melasma by a specialist. No previous treatment at the beginning of the study.

Exclusion Criteria:

Use of medications associated with the development of melasma. Pregnant or lactating patients. Presence of concomitant diseases associated with the development of melasma. or other facial hyperpigmentations (thyroid, liver).

Have received treatment in the last 2 months. Regular use of sunscreen.
Double-Blind, Double Dummy, Randomized Comparison Study to Evaluate the Efficacy and Safety of Valdecoxib 10 mg Once Daily and Naproxen 500 mg Twice Daily in Treating the Signs and Symptoms of Osteoarthritis of the Knee

This study was performed to demonstrate that treatment with valdecoxib 10 mg daily (QD) was at least as effective as with naproxen 500 mg twice daily (BID), a standard non-steroidal anti-inflammatory drug (NSAID), when taken for 6 weeks in Korean subjects with symptomatic osteoarthritis (OA) of the knee. Secondary objectives were to assess the overall safety and tolerability of valdecoxib 10 mg QD taken for 6 weeks in Korean subjects with symptomatic OA of the knee.


Eligibility Criteria:
Inclusion Criteria:

* Korean outpatients with symptomatic radiologic evidence of OA of the knee (diagnosed according to the modified American College Rheumatology criteria)
* Patient's Assessment of Arthritis Pain measurement of at least 40 mm on VAS
* Patients had not received any NSAIDs or analgesics within 2 days (within 4 days for subjects taking oxaprozin, piroxicam or full dose aspirin) prior to the Baseline Visit

Exclusion Criteria:

* Diagnosis of inflammatory arthritis, gout, pseudogout, Paget's disease, or any chronic pain syndrome that, in the Investigator's opinion, would interfere with the assessment of the Index Knee
* Symptomatic anserine bursitis or acute joint trauma of the Index Knee
* Arthroscopy performed on the Index Knee within the past 12 months
* Complete loss of articular cartilage of the Index Knee
* Administration of oral, or intramuscular, intravenous, or soft tissue injections of corticosterosteroids within 4 weeks prior to screening visit
* Administration of intra-articular injection of corticosteroids or hyaluronic acid preparation in the Index Knee within 3 months or 6 months, respectively
Diagnostic and Prognostic Markers of Endometriosis in Menstrual Blood

The goal of this observational study is to identify diagnostic and prognostic biomarkers for endometriosis using menstrual blood, an easily accessible yet overlooked biological fluid in women of reproductive age, affected or not by endometriosis

The main questions it aims to answer are:

* are there relevant differences in the menstrual blood of women affected by endometriosis compared to women without endometriosis?
* do some of these differences disappear or lessen when the disease is treated by surgery? Participants will answer questions relevant to endometriosis and provide menstrual blood 1 to 3 times (self-collected with a menstrual cup). A subgroup of participants affected by endometriosis that will undergo surgery for their regular care will provide menstrual blood before and after their surgery.

Researchers will compare the menstrual blood of women with and without endometriosis, and before and after surgery to see if they can identify significant differences.


Eligibility Criteria:
Inclusion Criteria:

For all participants:

Women 18-45 of age who

* Have their period
* Have given their written consent
* Have already used a menstrual cup as a method of hygienic protection
* Residing or working in Ile de France (Paris Metropolitan area, France)

For participants with endometriosis:

* diagnosis of endometriosis established by surgery or imaging (ultrasound and/or MRI)
* presence of one or more painful symptoms \> 3 on a visual scale (dysmenorrhea and/or dyspareunia and/or chronic pelvic pain) and/or infertility
* for the surgery subgroup: planned surgery in the next 3 months

For participants without endometriosis:

* painful symptoms \< or equal to 3 on a visual scale (for dysmenorrhea and dyspareunia and chronic pelvic pain),
* absence of intense period pain in adolescence (leading to taking pills to control this pain and/or peri-menstrual school absenteeism)

Exclusion Criteria:

For all participants:

* Autoimmune diseases
* Chronic diseases other than endometriosis (diabetes, hypertension)
* A person who is the subject of a judicial safeguard measure (by declaration)
* Infectious diseases (HIV, HBV, if known)
* History of menstrual toxic shock syndrome

For patients with endometriosis:

* endometriosis surgery within the last 3 months.
Pharmacological Profile of Different Quercetin Formulations

This study aims to evaluate the pharmacokinetics of quercetin in healthy participants after the administration of different formulations in a single- and multiple-dose phase. In the single-dose study, plasma uptake (AUC0-24 and Cmax) of standard quercetin is compared with that of LipoMicel®-a novel food-grade delivery form of quercetin. In the multiple dose study, accumulating plasma concentrations of formulated quercetin are observed over 72hrs, after repeated doses of LipoMicel treatments (AUC0-72).

At least ten healthy adults participate in an open-label, diet-controlled, crossover, plasma uptake study. Participants receive three different doses (250 mg, 500 mg or 1000 mg) of quercetin aglycone orally.

Objective of this study is to investigate the pharmacokinetic profile of formulated quercetin (LipoMicel®), administered at three different doses, in healthy participants and compare it with that of a standard formulation. The pharmacokinetics of the different quercetin treatments are observed over 24hrs after a single orally administered dose of quercetin (e.g., using AUC0-24 and Cmax). Furthermore, the accumulating plasma concentrations of formulated quercetin are monitored over a 72hr period (e.g., using AUC0-72), following multiple orally administered doses of LipoMicel treatments (250 mg-1000 mg) plus the circulating metabolites of quercetin are determined in the human plasma.

Eligibility Criteria:
Inclusion Criteria:

* age 18-65
* healthy, good physical condition

Exclusion Criteria:

* pregnancy or breast-feeding
* gastrointestinal conditions (acute or chronic)
* liver disease (acute or chronic)
* kidney disease (acute or chronic)
* cardiovascular disease (acute or chronic)
* hematological disease
* diabetes
* allergy or intolerance to gluten
* allergy or intolerance to quercetin
* use of any form of nicotine or tobacco, CBD/THC
* alcohol and substance abuse history
* use of medications (e.g., anti-inflammatory)
* use of quercetin supplements
* participation in another investigational study
Use of a Smartphone Application on the Detection of Complications Related to Smoking

Smokers do not know the symptoms of cancer and wait on average 5 months with symptoms before consulting. 80% of lung cancers are diagnosed at too late and incurable stage.

Systematic CT screening of smokers is under evaluation and currently not supported because expensive and little used in real life (in the US 1.8% of smokers after 7 years of establishment in the USA).

An English study showed an increase in the number of operable stage cancers of 3% among smokers by calling them on a trailing cough by a simple poster campaign ("You smoke, you cough for more than 3 weeks, consult").

Regarding COPD, it is linked to tobacco in 85% of cases, affects 3.5 million French and is in 2013 the 4th leading cause of death in France. The evolution of COPD is marked by exacerbations, period of acute aggravation of symptoms, responsible for the deterioration of the quality of life or even hospitalization or death. COPD remains a silent killer responsible, according to this same summary review, of 16,500 deaths per year in France.

Dr DENIS has developed a web application that has shown a 7-month survival benefit by early detection of lung cancer relapses based on the reporting of patient symptoms analyzed by a validated algorithm in 300 patients and 1 randomized trial.

The Applitabac app takes this concept of symptom self-assessment by patients. By multiplying the number of symptoms analyzed compared to the English study, Applitabac should be able to increase the sensitivity of this early detection of COPD and increase the number of operable bronchial cancers and increase the chances of survival of patients.


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years old
* Applitabac user who has received a notification directing him to his doctor
* Smoker or former smoker (current smoking cessation or ≤ 5 years)
* Patient informed of the use of his data and not opposing it

Exclusion Criteria:

* Presence of another evolutionary neoplasia in the past 2 years
* Patient who did not use the Applitabac app
Consolidation Serplulimab Following Concurrent Chemoradiotherapy for LS-SCLC Patients

This study is a multi-center, Single-arm Phase II study to evaluate the clinical efficacy and safety of Consolidation HLX10 (Serplulimab) Following Hypofractionated Radiotherapy With Concurrent Chemotherapy for Patients With Limited Stage Small Cell Lung Cancer

All eligible patients after screening will receive up to four cycles chemotherapy. Recommended regimens are etoposide 100 mg/m2 intravenously on day 1-3 in combination with cisplatin 75 mg/m2 intravenously on day 1 or carboplatin AUC=5 every 3 weeks.

A total of 45Gy in 15 fractions over 3 weeks will be delivered. PCI is routinely scheduled for patients without progression after chemoradiotherapy, and hippocampal avoidance is highly recommended. 25Gy in 10 fractions over 2 weeks to the brain will be prescribed. Intensity modulated radiation therapy (IMRT) or volumetric modulated arc therapy (VMAT) technique are required. Patients without disease progression will receive an intravenous infusion of serplulimab 300mg every 3 weeks. Treatment of serplulimab should be continued until disease progression, intolerable toxicity, withdrawal of consent, or to a maximum of 1 year. Continuation of immunotherapy after disease progression is acceptable per investigators' discretion.

The investigator and IRRC respectively assess the tumor images according to RECIST 1.1.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-75 years; ECOG score 0-1.
2. Histologically or cytologically confirmed small cell lung cancer.
3. Limited stage, defined as the tumor confined to one side of the thoracic cavity including ipsilateral hilar, bilateral mediastinal, and bilateral supraclavicular lymph nodes, (metastatic lymph nodes are defined as short diameter ≥ 1 cm or increased metabolism on PET-CT considering metastatic lymph nodes); unless cytologically confirmed malignant pleural effusion, the thickness of pleural effusion on chest CT is less than 1 cm; (stage I-IIIB without intrapulmonary metastasis in the 7th edition of AJCC staging in 2009) .
4. No other previous anti-tumor history, at least 3 months of expected survival.
5. No serious medical diseases and dysfunction of major organs, such as blood routine, liver, kidney, heart and lung function.

Exclusion Criteria:

1. Histologically or cytologically confirmed mixed SCLC.
2. Subjects suitable for surgery. Subjects who are suitable for surgery but refuse surgical treatment can be included.
3. Patients who have previously received systematic anti-tumor treatments for small cell lung cancer, including but not limited to radiotherapy, chemotherapy, and immunotherapy.
4. Patients with other active malignancies within 5 years or at the same time.
5. Subjects with known history of severe allergy to any monoclonal antibody.
6. Subjects with known anaphylaxis to carboplatin/cisplatin or etoposide.
7. In the judgment of the investigator, subjects who have any other factors that may lead to a premature discontinuation.
Characterization of the Nutritional Status in the Patient With Liver Cirrhosis

In the subgroup of patients with sarcopenia, regardless of their body mass index, we want to verify the real impact of nutritional supplements with branched chain amino acids on the standard treatment based on nutritional intervention and physical exercise.


Eligibility Criteria:
Inclusion Criteria:

* Cirrhotic patients with sarcopenia in abdominal CT.

Exclusion Criteria:

* chronic renal failure or being on hemodialysis
* active hepatitis B or C virus infection
* active alcohol abuse
* coinfection with human immunodeficiency virus
* renal or previous liver transplantation
* history of neoplasia requiring chemotherapy or radiotherapy
* hepatocellular carcinoma outside of Milan criteria
* TIPs
* unwillingness to participate in the study.
LAMELLEYE for the Treatment of Dry Eye Symptoms in pSS Patients

Single-blind, randomised, single centre, 2-way crossover pilot study to investigate the effectiveness of LAMELLEYE for the treatment of dry eye symptoms in patients with primary Sjögren's Syndrome.

The study is a 2-way crossover design comprising 2 treatments: the CE-marked LAMELLEYE dry eye drops, and a CE-marked comparator product. All Participants will be allocated to a treatment group in a random order.

The study design allows observations to be made between the treatments at both an intra- and inter-patient level regarding relationships between the patient's disease specific quality of life, symptoms and adverse events, and satisfaction with treatments.

Eligibility Criteria:
Inclusion Criteria:

To be eligible for inclusion, each Participant must meet each of the following:

1. Male or female aged ≥ 18 years and ≤ 79 years at date of consent
2. Primary Sjögren's Syndrome diagnosed by a rheumatologist
3. Patient has symptoms of dry eye, and has failed to achieve symptom relief on adequate trial of standard topical therapy
4. Willing and able to attend Glasgow Caledonian University Vision Sciences Eye Clinic for therapy assessment; and to comply with all procedures and follow-up visits
5. Participant must have personally given written informed consent to allow anonymised data to be used in publications and presentations.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria are met:

1. Females who are pregnant, planning pregnancy or breastfeeding
2. Active ocular infection or current corneal ulceration
3. Ocular surgery within 6 months of study start date
4. Current contact lens wear
5. Any prior and/or current topical ophthalmic treatments that in the opinion of the CI or PI may interfere with the study outcomes
6. Started or changed the dose of chronic systemic medication known to affect tear production including, but not limited to antihistamines, anticholinergics, antidepressants, diuretics, corticosteroids or immunomodulators within 30 days prior to enrolment
7. Participants with known allergies to ingredients in any of the study treatments, or fluorescein
8. Participants who are judged inappropriate for inclusion in the study by the CI or PI.
Effects of Cognitive Stimulation in Older People With Mild Cognitive Impairment

Mild cognitive impairment is becoming one of the most common cynical manifestations that affect older people. That is why there is a need to investigate non-pharmacological interventions that help to improve or maintain this problem.

Each week for 12 weeks, GE participants will attend three 60-minute sessions of cognitive exercises. Each session is divided into 10 minutes of memory practice, which includes short-term and long-term memory; 10 minutes of language skills, including vocabulary, comprehension, reading and writing exercises; 10 minutes of calculation, in which arithmetic, similar and different operations are carried out; 10 minutes of praxis and gnosis where drawing and recognition and auditory, tactile, spatial, visual attention were promoted; 10 minutes of orientation where knowledge of space, person and place is developed; and 10 minutes of executive functions in which exercises of organization, planning and problem solving are worked.

Eligibility Criteria:
Inclusion Criteria:

* With or without dependency to move.
* People who show mild cognitive impairment.
* That they were able to carry out the different selected questionnaires.

Exclusion Criteria:

* People with visual deficit.
* People already enrolled in a cognitive program.
* Score between 24 and 10 in the Mini Cognitive Exam (MEC).
Trauma-informed, Resilience-based Telehealth Intervention for Improving HIV Prevention and HCV Care for Persons Who Inject Drugs in the Deep South (Formative Phase)

Explore the perceptions of people who inject drugs (PWID) and healthcare providers and policymakers to identify barriers to and facilitators of PrEP uptake and persistence as the primary focus, with HCV care and MOUD uptake as secondary foci, in the context of ACEs and intersectional stigma.

Investigators will recruit 30 PWID (15 in-care for PrEP, HCV, and/or MOUD and 15 not-in-care) for in-depth, one-on-one, semi-structured interviews which will include questions on trauma history; intersecting stigmas; HIV and HCV risk perception; current challenges they face in accessing/using PrEP, DAA, and/or MOUD; how they view service integration in human service settings; knowledge of and preferences for PrEP, DAA, and/or MOUD; and perceived barriers to and facilitators of PrEP, DAA, and/or MOUD uptake and adherence. Interviews will also include questions on barriers to and facilitators of participating in a telehealth program; and preferred features of a telehealth intervention, i.e., number, length, frequency, contents of the sessions, interface, and online resources.

Eligibility Criteria:
Inclusion Criteria:

* People who actively inject drugs verified by visible injection stigmata (needle tracks)
* HIV negative
* Adult (≥18 years)
* lives in rural areas

Exclusion Criteria:

* Living with HIV
* Lives in urban areas
* Not proficient in English
Role of PET/MRI in Head and Neck Cancer

Study aim was to investigate the diagnostic role of Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) in head and neck cancer.

This study was assessed the role of Diffusion weighted imaging (DWI) in discriminating between benign and malignant lesions in Head and neck cancer as well as studying the relationship between glucose metabolism (18F-FDG) and Apparent diffusion coefficient (ADC) for better tumor assessment.

Eligibility Criteria:
Inclusion Criteria:

* Proved Head and neck cancer
* Underwent PET/CT and PET/MRI
* Lymph nodes due to primary Head and neck cancer.

For healthy subject:

* No previous history of malignancy.
* no inflammation or infection in the neck region.
* lymph node size \<10mm.

Exclusion Criteria:

* patients treated before by radiotherapy / chemoradiotherapy
* patients underwent surgery
* artifacts
BOTOX® at the Time of Prolapse Surgery for OAB

The purpose of the study will be to assess the efficacy and safety of bladder BOTOX® for overactive bladder symptoms, such as urinary urgency and frequency, given at the time of prolapse surgery.

After being informed about the study and the potential risks, women scheduled for prolapse surgery will be screened for bothersome overactive bladder symptoms. Those that qualify and choose to enroll will be randomized to receive either bladder BOTOX® or a placebo at the time of their surgery. Neither the patient nor the investigators will know if the patient receives BOTOX® or a placebo. Subjects will complete questionnaires and bladder diaries both before and after surgery to determine efficacy and patient satisfaction. Potential adverse events, such as urinary tract infections and urinary retention, will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Women scheduled for prolapse surgery
* Bothersome OAB symptoms determined by a score of \>20 on the OAB-q SF
* Willingness to perform clean intermittent catheterization (CIC)
* Ability to follow study instructions and complete required follow up

Exclusion Criteria:

* Contraindications or allergy to Onabotulinumtoxin A
* Intravesical Onabotulinumtoxin A within 3 months of the planned surgery date
* Total body Onabotulinumtoxin A dose of ≥ 400 Units in the 3 months prior to the scheduled surgery date.
* Inability or unwillingness to self-catheterize
* Post-void residual ≥ 200mL
* Neurogenic bladder or other neurological diseases that may cause voiding dysfunction
* Concurrent use of other pharmacological treatment for the treatment of OAB symptoms at the time of prolapse repair surgery.
* Females who are pregnant, think they may be pregnant at the start of the study, planning a pregnancy during the active treatment phase of the study, or who are unwilling or unable to use a reliable form of contraception during the active treatment phase of the study.
* Inability to speak or read English