cyrilzakka/clinical-trials huggingface dataset:
Erlotinib as Neoadjuvant Treatment in Patients With Stage ⅢA N2 NSCLC With Activating EGFR Mutation.

This is a single arm, one center, phaseⅡ study evaluating efficacy and safety of erlotinib as neoadjuvent treatment in patients with EBUS confirmed stage ⅢA N2 NSCLC with activating EGFR mutation in exon 19 or 21.

Screening phase:

Patients clinically diagnosed as stage ⅢA N2 lung caner by CT technique will be pathologically proven as NSCLC with N2 by EBUS. The pathology specimen will be detected EGFR mutation by DNA sequencing. The patients with EGFR mutation in exon 19 or 21 will be enrolled in this study.

Neoadjuvant treatment phase:

Patient will receive erlotinib 150mg/day. Treatment will be scheduled to continue for a total of 8 weeks or disease progression or unacceptable toxicities.

Surgery treatment phase:

Tumor response will be evaluated with CT scan after 8 weeks of induction treatment. The patients with responsive disease considered to be technique resectable will undergo resection.

Post-surgery phase:

It is the discretion of the investigator whether the patient is a candidate for post-operative treatment which is considered to be in the best interest of the patients. It is recommended that patients with positive margins or residual tumor after surgery should receive radiation therapy. Patients after surgery will receive long-term follow-up including chest CT scan every 3 months for up to 2 years.

Eligibility Criteria:
Inclusion Criteria:

Written informed consent provided. Males or females aged ≥18 years. Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.

Stage IIIA N2 NSCLC according to the pathological evidence of endobronchial ultrasound(EBUS).

The biopsy specimen shows EGFR mutation in exon 19 or 21 by DNA sequencing. Measurable disease must be characterized according to RECIST criteria: measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥20cm with conventional techniques (PE, CT, XR, MRI) or as ≥ 10cm with spiral scan.

ECOG performance status 0-1. Life expectancy ≥12 weeks.

Female subjects should not be pregnant or breast-feeding.

Exclusion Criteria:

The biopsy specimen shows EGFR wildtype in exon 19 or 21 by DNA sequencing. Patients with prior exposure to agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab).

Patients with prior chemotherapy or therapy with systemic anti-tumour therapy (e.g. monoclonal antibody therapy).

Known hypersensitivity to Tarceva or any of its recipients.

Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the subject at high risk for treatment-related complications.

Sexually active males and females(of childbearing potential) unwilling to practice contraception during the study.
Technology-Enabled Collaborative Care for Young Adults with Type 1 Diabetes and Diabetes Distress: a Feasibility Trial

The goal of the study is to evaluate the acceptability and feasibility of a co-designed, Technology-Enabled Collaborative Care for Young Adults with Type-1 Diabetes and Diabetes Distress (TECC-T1D3) program. Through this program, the investigators aim to deliver a collaborative care intervention, featuring a health coach and a virtual care team, designed to help participants manage mental health and overall wellbeing.

A total of 60 young adults with Type 1 Diabetes (T1D) will be enrolled in the study. Participants will be randomly allocated to either a coaching intervention or an education intervention for 12 weeks. During the 12-week program, participants in the coaching intervention will take part in 8-10 sessions with a health coach, where experiences living with diabetes and goals related to diabetes management, communication with a support system, and overall wellbeing will be discussed. Participants in the education intervention will receive generalized educational messages about diabetes and diabetes distress exclusively via automated emails. Before and after the program, participants will complete surveys to provide an understanding of how diabetes and diabetes-related distress are being managed. After completing the respective interventions, participants will have a one-on-one interview with the research team to discuss their experience with the program and potential areas for improvement.

The goal of the program is to enhance the quality of life for young adults with T1D who experience significant emotional burdens associated with the condition. The study addresses a critical research gap by integrating mental health support with diabetes management, a need historically underserved in healthcare settings. By developing a structured mental health intervention that is accessible and scalable, the study addresses the need for a model of whole-person care that incorporates psychological aspects as part of standard diabetes management. The model of care and findings could potentially be applied to other chronic conditions, broadening the impact of the study beyond diabetes to other areas of chronic disease management.

Eligibility Criteria:
Inclusion Criteria:

* Young adult (age 18-29 years)
* Resident of Ontario
* Living with a self-reported diagnosis of T1D of at least 1 year
* Individual is community-living (people who live independently in the community and are not residing in a setting that provide institutional care or support)

Exclusion Criteria:

* Unable to participate in English language
* Unable to participate via telephone or web-conferencing
Evaluation of Safety and Efficacy of Glaucoma Shunt (Aurolab Artificial Drainage Implant) in Refractory Glaucoma

The purpose of this study is to evaluate the efficacy and safety of Aurolab Artificial Drainage Implant (AADI) on intraocular pressure reduction in patients with refractory glaucoma.

Aurolab Artificial Drainage Implant is a non resistant tube device based on Baerveldt implant. It reduces intra ocular pressure by draining aqueous from anterior chamber into sub-conjunctival space formed around base of the implant. Reduction of intraocular pressure prevents further damage to optic nerve and functional visual field loss in advanced refractory glaucoma.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Significant optic nerve damage and visual field loss due to glaucoma in eligible eyes
* Eligible eyes is considered at high risk of failure/complication following conventional filtering surgery
* Eyes with uncontrolled glaucoma with prior history of Filtering surgery/Uveitic/ Neovascular/Developmental glaucomas
* IOP≥18 mm of Hg with or without anti glaucoma medications
* If taking glaucoma medications, stable dose for 6 weeks

Exclusion Criteria:

* Age\<18 years
* Eyes with uncontrolled glaucoma expected to have favorable post-operative outcome by conventional trabeculectomy
* Corneal abnormalities that would preclude accurate IOP readings
* Uncontrolled systemic diseases
* Endothelial cell count\<1800cells/mm
* Any other active ocular disease,(active uveitis, ocular infection)
MultiOrgan Inflammatory Syndromes COVID-19 Related Study

The study comprise a nationwide, voluntary, on-line survey of inflammatory syndromes in children for retrospective (since 4th March 2020) and prospective data collection. Our aim was to capture and describe multisystem inflammatory syndrome in children (MIS-C) in Poland.

The voluntary surveillance for retrospective (since 4th March) and prospective data collection was initiated under the National Consultant of Pediatrics auspices. Anonymized patient data from pediatric hospitals from all over the country are extracted from electronic and paper records and collected through online form developed for that purpose. Before the surveillance was launched, reporting clinicians underwent an online training, which included the current state of knowledge about multisystem inflammatory syndrome in children (MIS-C). Patient management is at the discretion of the relevant treating clinicians.

KD and aKD were defined following the American Heart Association (AHA) guidelines.

TSS was established based on modified criteria by the Centers for Disease Control and Prevention.

MAS was diagnosed based on the Paediatric Rheumatology International Trials Organization (PRINTO) criteria for MAS classification.

The definition of the inflammatory syndrome was based on the WHO MIS-C definition with the exclusion of SARS-CoV-2 confirmation.

For patients who met the inclusion criteria, demographic data, past medical history, data on COVID-19 exposure, clinical symptoms, physical examination findings, laboratory, imaging, and cardiologic tests results, treatment, and outcome data are collected.

All study definitions are defined in accordance to relevant guidelines and evaluated automatically with the use of a dedicated software.

Eligibility Criteria:
Inclusion Criteria:

* patients who required hospitalization since 4th March 2020;
* diagnosed Kawasaki disease (KD) or incomplete (atypical) Kawasaki disease (aKD) or toxic shock syndrome (TSS) or macrophage activation syndrome (MAS) or unspecified inflammatory syndrome;

Exclusion Criteria:

* other infectious and non-infectious causes that could be responsible for the disease

SARS-CoV-2 polymerase chain reaction (PCR) or serology result could have been positive or negative. Due to limited availability and reliability of serologic testing, proven or likely COVID-19 criterion was not a condition determining inclusion to the registry.
Treatment of Hairy Cell Leukaemia Variant and Relapsing Hairy Cell Leukaemia With Cladribine Plus Rituximab

The study will test the effectiveness (rate of complete remissions, total remission rate and duration of remission) and toxicity of the combined immuno/chemotherapy with subcutaneous cladribine (LITAK®) plus anti-CD20\* antibody rituximab in patients requiring treatment for relapsed hairy cell leukaemia or hairy cell leukaemia variant independent of any previous therapy.

CD20\* = cluster of differentiation antigen 20

The trial is a prospective, multi-centre, open Phase II study on patients with hairy cell leukaemia variant or with relapsed hairy cell leukaemia.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically verified hairy cell leukaemia (HCL) Hairy cell leukaemia variant (HCLv) or
* Relapse of hairy cell leukaemia after therapy with cladribine or pentostatin
* Need for treatment is indicated (see 4.3 below)
* Age at least 18 years
* General state of health according to WHO 0-2
* Written declaration of consent by the patient
* Current histology, which should not be older than 6 months, is necessary

Exclusion Criteria:

* Patients, who do not fulfil the above-mentioned inclusion criteria.
* Patients with severe functional limitations of the heart according to New York Heart Association III / IV, of the lung according to WHO degree III / IV, the liver (bilirubin \> 2mg/dl, alkaline phosphatase, raised GOT and GPT (glutamate- pyruvate transaminase) values more than twice normal), diseases of the central nervous system, including psychoses. Creatinine \> 2 mg/dl, or creatinine clearance \< 50 mg/min
* Patients with proven HIV infections
* Patients with active hepatitis
* Patients with other florid infections
* Patients with anamnesis / diagnosis of another malignant disease (other than nonmelanoma associated skin tumours or stage 0 in situ carcinoma of the cervix)
* Pregnant or lactating women
Monolithic CAD/CAM Single Tooth Ceramic Crowns

With the development of Computer Aided Design and Computer Aided manufacturing (CAD / CAM) systems, all ceramic restorations have been used with high success rates during the past 30 years in order to eliminate the disadvantages of metal ceramic restorations. Based on these developments, in every passing days new ceramic materials has been added to dental market. The aim of the present study was evaluating clinical results of single-tooth ceramic crowns in the posterior region produced from three different monolithic ceramic materials.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old
* Individuals who have signed the informed consent form
* Periodontally stable patients
* Having devital teeth need to be restored in the posterior region
* Having natural dentition or minimally invasive restoration against the restored tooth.

Exclusion Criteria:

* Diagnosed patients with temporomandibular joint problems
* Insufficient supportive tooth tissue for restoration
Psychotherapy Enhancement for Therapeutic Community (TC) Retention - 1

The purpose of this study is to evaluate the efficacy of Dual Focus Schema Therapy in comparison to Individual Drug Counseling as 6-month manualized individual behavioral therapy enhancements to the orientation/early treatment process of Therapeutic Community (TC) residents.

Therapeutic Community (TC) treatment can be effective psychosocial modality for addiction, but premature dropout remains a major problem. Personality disorders are very common in residential programs, and TCs regard personality disturbance as core to all people with addiction. Severe personality dysfunction is associated with higher dropout rates from TCs, and adding cognitive-behavioral treatments may improve retention and outcome. We hypothesize that severe personality disturbance causes significant problems with an individual?s initial adjustment and effective utilization of TC processes and techniques. We predict that a behavioral therapy that targets personality pathology will result in better early retention and engagement than will a more standard addiction counseling approach.

To begin to improve retention, TC research must begin to systematically evaluate the impact of adding interventions targeted at decreasing premature dropouts through controlled clinical trials. We have developed the first empirically tested treatment manual for the full range of personality disorders in substance abusers and propose to conduct a randomized clinical trial to evaluate the efficacy of Dual Focus Schema Therapy in comparison to Individual Drug Counseling as 6-month manualized individual behavioral therapy enhancements to the orientation/early treatment process of 100 TC residents. In addition to evaluating retention differences, we will analyze the rate and degree of change for these two conditions monthly and at 6, 12, 18, and 24-month follow-up for psychological indicators related to personality disorder and therapeutic processes related to the TC.

Eligibility Criteria:
Admission for residential TC treatment at APT Residential Services Division

Inclusion Criteria:

Adolescent or adult substance abuser; provide 2 or more contacts; ability to read and speak English

Exclusion Criteria:

Acute suicidality, homicidality, psychosis, mania
Erlotinib With Concurrent Brain Radiotherapy and Secondary Brain Radiotherapy After Recurrence With Erlotinib in NSCLC Non-increased-intracranial-pressure Symptomatic Brain Metastases

This project is aim to explore non-increased-intracranial-pressure symptomatic brain metastases of NSCLC, and if the OS of secondary brain radiotherapy after recurrence with Erlotinib is better than Erlotinib with concurrent brain radiotherapy. Treatment group are treated with Erlotinib until brain tumor progression, then gave brain radiotherapy, and continued to take Erlotinib till extracranial lesions progression. Control group are Erlotinib with concurrent brain radiotherapy, and continued to take Erlotinib after radiotherapy until recurrence or termination for other reasons.


Eligibility Criteria:
Inclusion Criteria:

1. Over the age of 18 years old;
2. Tissue or cell pathological diagnosis of NSCLC;
3. Brain CT or MR validated BM;
4. Non-increased-intracranial-pressure symptomatic BM;
5. Haven't received TKI target treatment;
6. Haven't received brain radiotherapy;
7. Patients in initial treatment should be detected EGFR mutation;
8. Expected survival more than 6 months;
9. KPS no less than 70, or KPS less than 70 caused by paralysis due to recent brain metastases;
10. Liver and kidney function requirements: SGOT/SGPT≦2.5 times of the upper limit, Total bilirubin≦1.5 times of the upper limit, serum Creatinine≦1.5 times of the upper limit;
11. Routine blood test requirements: WBC≧3.0×109/L, NE≧1.8×109/L, PLT≧90×109/L，no requirement for Hb;
12. Blood glucose requirements: within the normal range, diabetic patients are receiving treatment and their glucose was being controlled in a steady state;
13. Female patients in childbearing age: HCG (-);
14. Patients signed an inform Consent.

Exclusion Criteria:

1. Those with Erlotinib drug allergies;
2. Those with mathematical understanding of the most simple life questions, such as "walking", those difficult for doctors to communicate;
3. Those without guardians or families;
4. Those with abnormal routine blood test, liver and kidney function, and blood glucose beyond the above boundaries and difficult to correcting for more than 2 weeks;
5. Those with any unstable medical status (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction (within one year before treatment initiation), and severe arrhythmia, liver, kidney or metabolic disease requiring drug therapy);
6. Those with any other disease, neurological or metabolic dysfunction, and physical examination or laboratory test results showed that the study drugs may increase the risk of treatment-related complications;
7. Pregnant women.
Effects of Sucrose Added Blind to the Diet Over Eight Weeks on Body Mass and Weight in Men

Background: Sugar intake, especially in liquid, correlates with obesity. Yet, whether it is a special cause of obesity is less clear. Few experimental studies exist.

Aim: To replicate the investigators' previous 4 week experiments on women with men over 8 weeks to ascertain if: they gain weight given sucrose soft drinks; mood is affected; energy intake is affected.

Participants: 80 men BMI 25-35, aged 30-55. Procedure: After a week of baseline, over eight weeks single blind 40 men received soft drinks containing sucrose (1650 KJ, 97g carbohydrate per day), 40 received control drinks. A three-day food diary with mood ratings and activity levels was completed during baseline and weeks 1, 4 and 8 of the experiment. Body mass was recorded weekly with other anthropometric measures.


Eligibility Criteria:
Inclusion Criteria:

* BMI 25-35

Exclusion Criteria:

* Diabetes,
* other health problems,
* medication,
* dislike of soft drinks
Comparison of Two Silicone Hydrogel Toric Contact Lenses

The purpose of this research study is to compare the performance of two different types of Alcon soft toric study contact lenses to obtain information on study lens orientation.


Eligibility Criteria:
Inclusion Criteria:

* Successful wear of soft contact lenses for vision correction in both eyes during the past 3 months for a minimum of 3 days per week and 8 hours per day
* Astigmatism
* Requires contact lenses
* Best corrected visual acuity of 20/25 or better in each eye
* Other protocol-specified inclusion criteria may apply

Exclusion Criteria:

* Any eye condition that contraindicates contact lens wear, as determined by the Investigator
* Any eye surgery that contraindicates contact lens wear, as determined by the Investigator
* Other protocol-specified exclusion criteria may apply
Intra-operative Hyperspectral Imaging in Neurosurgery

Brain surgery operations include brain tumour removal and blood vessel procedures. Each year in the UK, approximately 70,500 patients are diagnosed with a brain tumour, 5,000 of whom undergo surgery. Approximately 1,000 patients undergo blood vessel brain surgery.

Brain tumour surgery involves removing as much of the tumour as safely as possible. If all tumour is removed, patients have significantly better outcomes and live longer. However, even with the best hands and the most modern technology currently available, it is often not possible to reliably identify tumour during surgery. Moreover, nerves and blood vessels cannot be reliably identified either during surgery. Yet, they need to be preserved to avoid brain damage. Due to this uncertainty and the need to balance risks, tumour is often left behind. Today, close to 30% of brain tumour patients require repeat surgery owing to tumour left behind during their first surgery. Further surgeries are more difficult, pose additional patient risks and lead to increased healthcare costs with often poor patient outcomes.

Newly developed camera systems have the potential to enhance the surgeon's vision to reliably identify tumour and healthy brain structures. Hyperspectral imaging (HSI) is one of the most promising of such technologies. Its core ability is to provide very detailed and rich information that is invisible to the human eye. HSI has demonstrated the potential to provide crucial, but currently unavailable, information about tumour and critical brain structures during surgery. However, HSI data is very complex and requires advanced computer-processing for its interpretation.

In this project, we will use a HSI imaging system to record data in 81 patient undergoing brain including 63 patients with brain tumours and 18 patients suffering from brain vessel abnormalities. Using this data we will develop key computer-processing features to enable real-time image interpretation.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged 18 years and over
* Patients with a diagnosis of a brain tumour (any type), AVM or aneurysm who are scheduled for elective surgery
* Patients able to provide written informed consent

Exclusion Criteria:

* Patients under 18 years of age
* Patients who have previously had brain surgery
Hypofractionated Chemoradiotherapy and Thymosin α1 in Unresectable or Recurrent Thymic Epithelial Tumor

This phase II study was to assess the efficacy and toxicity of hypofractionated radiotherapy (HRT) combined with weekly docetaxel/platinum and thymosin α1 in patients with unresectable or recurrent thymic epithelia tumors (TETs).

HRT using the IMRT technique was administered. For patients with limited pulmonary or pleural metastases (≤3 lesions), stereotactic body radiation therapy (SBRT) could be used.

All patients received weekly docetaxel(25mg/㎡) and nedaplatin or cisplatin (25mg/㎡), each of 1 day's duration, concurrently with hypofractionated radiotherapy .

Meanwhile they received weekly thymosin a1(1.6mg) during and within 2 months after the end of chemoradiotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Pathologic confirmation of thymoma, thymic carcinoma or thymic endocrine tumors.
* Patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
* Unresectable disease or recurrent intrathoracic disease which could be encompassed within radiation fields.
* White blood cell count ≥4×109 /L, neutrophile granulocyte count≥1.5×109 /L, platelet count≥100×109 /L, hemoglobin ≥100 g /L, serum creatinine and bilirubin 1.5 times less than the upper limits of normal (ULN),aminotransferase two times less than the ULN.
* FEV1 \>0.8 L
* CB6 within normal limits
* Patients and their family signed the informed consents

Exclusion Criteria:

* Previous or recent another malignancy, except for nonmelanoma skin cancer or cervical cancer in situ.
* Any contraindication for chemotherapy or radiotherapy(such as a myocardial infarction within 6 months,immunosuppressive therapy,symptomatic heart disease,including unstable angina pectoris, congestive heart failure,and uncontrolled arrhythmia).
* Malignant pleural effusion or pericardial effusion.
* Weight loss \>10% within the past 3 months.
* Recruited in other clinical trials within 30 days
* Drug addiction, long-term alcohol abuse and AIDS patients.
* Uncontrollable epileptic attack or psychotic patients without self-control ability.
* Severe allergy or idiosyncrasy.
* Not suitable for this study judged by researchers.