cyrilzakka/clinical-trials huggingface dataset:
Real-world Treatment Patterns and Associated Outcomes in Patients With Resectable Early-stage Non-small Cell Lung Cancer

This is a non-interventional, multi-country, multicentre, retrospective study designed to determine the treatment patterns and associated survival rate in patients with primary stage IA to IIIB resectable NSCLC diagnosed between 01 January 2013 and 31 December 2017 and followed until at least 31 December 2020 The main objective of this study is to describe the treatment patterns and determine their associated 3-year survival rate according to clinical and pathologic staging in patients with resectable early-stage (IA to IIIB as per AJCC seventh edition) NSCLC.

This is a non-interventional, multi-country, multicentre, retrospective study designed to determine the treatment patterns and associated survival rate in patients with primary stage IA to IIIB resectable NSCLC diagnosed between 01 January 2013 and 31 December 2017 and followed until at least 31 December 2020. This study will also determine the prevalence of EGFR mutations and PD-L1 expression, and the clinical outcomes as per the treatment patterns and clinico-pathological staging. Data will be collected retrospectively from the patients' medical records from the date of initial diagnosis of early-stage NSCLC (index date) to the end of follow up ie, until death, the last medical record entry, or date of data extraction, whichever is the earliest. The data on treatment modalities, sociodemographic, clinico-pathological characteristics, and exposure and outcome variables (ie, medical and treatment history, disease staging, biomarker assessments, radiological findings, concomitant medications, survival), factor(s) for prescribing neo-adjuvant and/or adjuvant treatment and reason(s) for discontinuation will be extracted from patients' medical records.

Eligibility Criteria:
Inclusion Criteria:

1. Adult female and male patients aged ≥18 years or 'adults' according to age of majority as defined by the local regulations on index date
2. Patient or next of kin/legal representative (for deceased patients at study entry, unless a waiver is granted) willing and able to provide written or electronic informed consent according to the local regulations, where applicable
3. Patients diagnosed with primary stage IA to IIIB NSCLC as per seventh edition AJCC whose tumour was deemed resectable between 01 January 2013 and 31 December 2017 and followed up until at least 31 December 2020, as per the medical records with availability of at least 12 months of follow-up data from the index date (date of diagnosis of early-stage \[IA to stage IIIB\] resectable NSCLC), unless patient died within 12 months of diagnosis.

Exclusion Criteria:

1. Patients with a concomitant cancer at the time of diagnosis of NSCLC, except for nonmetastatic nonmelanoma skin cancers, or in situ or benign neoplasms; a cancer will be considered concomitant if it occurs within 5 years of NSCLC diagnosis
2. Patients diagnosed with stage IV NSCLC
3. Histology of the tumour is small cell lung cancer, neuroendocrine in origin, or a mixed histologic type with small cell and non-small cell lung cancers.
Safety and Efficacy Study of Extracorporeal Shockwave Therapy in the Treatment of Patients With Resistant Hypertension

Low intensity shockwaves have been proven in animal and human studies to increase tissue perfusion, promote angiogenesis and tissue regeneration and improve neural function.

The hypothesis of this study is that shockwave therapy could improve the symptoms of patients with resistant hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have provided written informed consent.
* Age ≥18 and ≤80 years old.
* Office systolic blood pressure that remains ≥160 mmHg (≥150 mmHg for patient with type 2 diabetes) despite the stable use of ≥3 antihypertensive medications concurrently at maximally tolerated doses, of which one is a diuretic (unless there is a tolerance or a contraindication for a diuretics).
* Able and willing to comply with the required follow-up schedule.

Exclusion Criteria:

* Subjects who have participated in a clinical study involving another investigational drug or device within 4 weeks prior to Screening.
* Have hypertension secondary to an identifiable and treatable cause or take medication that can raise the BP.
* Prior renal artery intervention (balloon angioplasty or stenting).
* Pregnancy.
* Uncompensated heart failure.
* Chronic Liver Disease.
* Patients with skin wound / infection at the treatment area.
* Subjects who take oral anti-coagulants.
* Local tumor of treatment area.
Comparability of Hemodynamic Parameters Measured by Non-invasive Echocardiography and by Right Heart Catheterization

This study is to compare transthoracic Echocardiography TTE to the gold standard Right Heart Catheterization in Terms of accuracy to measure hemodynamic parameters.

Chronic heart failure is a progressive disease in Western population. Echocardiography and right heart catheterization are important tools in the diagnosis and progress monitoring of heart failure.

Gold standard in diagnosis of hemodynamic parameters in patients with heart failure is right heart catheterization. However, this diagnostic device represents an invasive method that is additionally associated with high risks such as infections, vessel and nerve injuries. Echocardiography is probably in a position to determine hemodynamic parameters as reliably as right heart catheterization without additional health risk due to its non-invasive character. All procedures performed are part of clinical Routine. Patients do not undergo any study-specific procedure at all.

Eligibility Criteria:
Inclusion Criteria:

* Chronic heart failure NYHA I - IV

Exclusion Criteria:

-
Depression Screening in Patients With Lung Cancer

RATIONALE: Screening tests may help doctors find depression in patients with lung cancer, allow doctors to recommend treatment for depression, and improve the patient's quality of life.

PURPOSE: This randomized clinical trial is studying how well depression screening works when the results are or are not shared with patients with lung cancer and their doctor.

OBJECTIVES:

Primary

* Determine the impact of depression screening in patients with lung cancer when the results of the screening are made available to the patient, the physician, both, or neither on detection of depression, provision of depression treatment recommendations, and the quality of the doctor-patient interaction from the patient's perspective.

Secondary

* Determine psychological and demographic subsets for the impact of depression screening in these patients when the results of the screening are made available to the patient, the physician, both, or neither on the detection of depression, provision of depression treatment recommendations, and the quality of the doctor-patient interaction from the patient's perspective.

OUTLINE: This is a multicenter, randomized, double-blind, single-blind, factorial study. Patients are stratified according to participating center (Memorial Sloan-Kettering Cancer Center vs University of Kentucky Markey Cancer Center). Patients are randomized to 1 of 4 screening arms.

* Arm I (control): Patients complete screening questionnaires about their mood and experience with lung cancer once before and once after a visit with their physician. Neither the patient nor physician receives the screening results before the visit.
* Arm II: Patients complete screening questionnaires as in arm I. Only the patient receives the screening results before their visit with the physician; the physician remains blinded to the results.
* Arm III: Patients complete screening questionnaires as in arm I. Only the physician receives the screening results before their visit with the patient; the patient remains blinded to the results.
* Arm IV: Patients complete screening questionnaires as in arm I. Both physician and patient receive the screening results before the visit.

All patients and physicians are notified of the screening results before the patient leaves the clinic. All patients are offered supportive counseling.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of lung cancer
* Prescreening distress thermometer score \> 3
* Zung Self-Rating Depression Scale (ZSDS) score ≥ 44

  * No ZSDS response indicating suicidality

PATIENT CHARACTERISTICS:

* Able to understand English
* No evidence of cognitive dysfunction that would impair giving consent

PRIOR CONCURRENT THERAPY:

* Not specified
Evaluation of Early Conversion to Everolimus From Cyclosporine in de Novo Renal Transplant Recipients

This study is designed to evaluate if early conversion to everolimus from cyclosporine in de novo renal transplant recipients can improve long-term renal function and slow down the progression of chronic allograft nephropathy


Eligibility Criteria:
Inclusion Criteria:

* First or second single renal transplant from deceased or living donor

Exclusion criteria

* Recipient of organs other than a renal transplant
* Present malignancy (within the last 2 years) other than excised basal cell or squamous cell carcinoma of the skin
* Severe liver disease
* At the time of randomization 7 weeks after transplantation

In addition to the above criteria the following must be met at time of randomization:

Inclusion Criteria:

* Patients maintained on a triple immunosuppressive regime consisting of cyclosporine, Enteric coated mycophenolate, and corticosteroids
* Patients completed the first 7 weeks without experiencing any rejection

Exclusion Criteria:

* Graft loss
* Low hemoglobin value, low number of white blood cells or platelets
* High cholesterol values
* Proteinuria
* Wound healing problems
* Current severe major local or systemic infection
* Renal insufficiency

Other protocol-defined inclusion/exclusion criteria may apply.
A Patient Navigation Program to Increase Access to Early Supportive Care in Patients With Stage IV Solid Tumors

In this randomized clinical trial, patients with Stage IV solid tumors will be enrolled in a patient navigator-led generalist palliative and supportive care intervention or in usual care led by their treating physician. The patient navigator will assess the patient's palliative and supportive care needs using standardized quality of life and symptoms questionnaires and present this assessment to a multidisciplinary team composed of oncologists and palliative care specialist. The multidisciplinary team will develop a personalized supportive care plan for the patient which will then be presented and discussed by the patient navigator. Those interventions which are accepted by the patient will be implemented by the patient navigator, who will also provide education and teaching. The patient navigator will also help eligible patients complete advanced directives according to local rules and regulations. The patient navigator will follow the patients both in person and by telephone to ensure that the recommended interventions have been implemented. Three months after enrollment the patients will undergo quality of life and symptom assessment once again, and the implementation of interventions will be recorded.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients 18 years of age and older
2. Newly diagnosed stage IV solid tumor
3. Recurrent stage IV solid tumor

Exclusion Criteria:

1. Homeless persons
2. History of drug abuse or alcoholism
3. Patients suffering from major psychotic disorders or uncontrolled psychiatric disorders
4. Mentally disabled patients
5. Incarcerated patients
Comprehensive Assessment in a Longitudinal Study on Young Men Who Have Sex With Men Attracting to chemseX-2

CLYMAX is a two-phase observational study that assess multiple aspects of chemsex and young men who have sex with men (YMSM).

Phase I of the study (CLYMAX,IRB No. 0695/65) was a cross-sectional descriptive study using a mixed methods data collection (focusing on qualitative data collection) assessing multiple aspects of chemsex, including the patterns of chemsex use and the perspectives on factors influencing chemsex initiation/discontinuation, effects on physical health, mental health and social outcomes, and the necessary services for a comprehensive chemsex clinic among YMSM; and the acceptability and feasibility of developing a comprehensive chemsex clinic from the perspective of YMSM, their family members or peers, and clinic staff.

This phase II study (CLYMAX-2) will be a prospective cohort study using a quantitative data collection exploring the effectiveness of the implementation strategy of harm reduction models and consist of a larger number of YMSM, important baseline and follow-up information on multiple aspects of physical, psychological, and social harms.


Eligibility Criteria:
Inclusion Criteria:

1. Men who have sex with men
2. Aged 16-35 years
3. Current chemsex users (defined as last chemsex used within 3 months)
4. Able to read and communicate in Thai
5. Provide informed consent

Exclusion Criteria:

None
Advanced Glycation End Products as a Biomarker for Accelerated Ageing

Globally primary open angle glaucoma (POAG) affects over 60 million people. The exact pathogenesis of POAG is poorly understood. A significant risk factor for glaucoma is advancing age. The rate of ageing is not the same in all age matched individuals. The concept of accelerated ageing suggests that the presence of a number of specific genetic, environmental or systemic risk factors may cumulate to accelerate the ageing process in some individuals and lead to the development of age-related disease. Understanding the factors that influence accelerated ageing is vital.

Advanced glycation end products (AGEs) are a complex group of compounds that are naturally formed. They accumulate gradually with age in cells, tissues and blood vessels throughout the body where they adversely affect structure and function. Circulating AGE levels can be influenced by oxidative stress levels and dietary intake. Recent research has found that sustained exposure to high levels of circulating AGEs could be a major factor in the development of a number of chronic age-related degenerative disorders, including POAG.

To date there have been few clinical studies that have been able to non-invasively explore the association between AGE levels and the development and progression of glaucomatous optic neuropathy (GON), or to explore the possible contribution that oxidative stress and dietary intake make to total tissue AGE levels in such patients. Furthermore little is understood about the relationship between AGE levels and retinal vascular function, a parameter known to be altered in GON that also could be influenced by AGE levels.

The proposed study will aim to evaluate whether tissue-bound AGE levels are associated with parameters of retinal vascular function, oxidative stress, dietary intake and the presence of GON. Establishing this association could increase our understanding of the pathogenesis of GON and allow a new biomarker for accelerated ocular ageing to be realised


Eligibility Criteria:
Inclusion Criteria:

* Must have had an eye test within the last two years
* Aged 50+
* Informed, written consent
* Have adequate understanding of English language to be able to comprehend the oral and written instructions.
* Participants must be able to complete a 12-hour overnight fast, which includes no alcohol or caffeine.

Inclusion criteria for Ocular hypertension, Primary open angle glaucoma and normal tension glaucoma:

- Follows guidelines set out within the protocol and used at Derriford REI

Exclusion Criteria:

* Diabetes
* Current smokers
* History of stroke/TIA
* Coronary artery disease/heart failure/arrhythmia/angina
* Peripheral vascular disease
* Severe dyslipidaemia
* Hyper/hypothyroidism
Sonographic Assessment of Fetal Deglutition Associated With Hydramnion:Its Absence is Indicative of Central Nervous System (CNS) Pathology

310 singleton pregnancies (22-35 weeks) enrolled into the study. We assessed sonographically the fetal larynx in an axial plane through the mandible and observed the fetal deglutition movements .

310 singleton pregnancies (22-35 weeks) enrolled into the study. We assessed sonographically the fetal larynx in an axial plane through the mandible and observed the fetal deglutition movements .We encountered two cases of hydramnios were no deglutition movements could be noted. In all other cases the deglutition was normal. The motivation to conduct the current observational prospective study was to assess whether there is a link between absence of fetal deglutition and CNS pathology of the fetus. In the first case the fetus deceased at 35 weeks of gestation; obduction was declined by the parents. In the second case caesarian section at 33 weeks was carried out recently due to fetal distress. The infant is still in uncapable of swallowing and there for is under investigation at the neonatal center of our hospital.

Eligibility Criteria:
Inclusion Criteria:

* singleton pregnancy(22-35 weeks)

Exclusion Criteria:

* positive toxoplasmosis screening,drug and/or antidepressants addiction.
BLI Based Adenoma Surveillance Strategy

Bowel cancer is the third most common cancer in the UK. It develops through smaller growths in the bowel called polyps. Early recognition and removal of these polyps result in prevention of developing bowel cancer in an individual. However, not all polyps will lead to cancer, certain polyps are just growths of normal tissue and can be left in the bowel. We therefore need to know which polyps to remove and which ones to leave. One way of doing this is to have a better look at these polyps. This can be done by new technologies. One of them is called Blue Light Imaging (BLI). This is a new light source at the end of the camera which is activated by the push of a button. It will help us in looking at these polyps more closely.

This helps us decide which polyps to remove and which ones are safe to leave as there is always a small risk in removing a polyp. It would also give us a better idea as to when to repeat the camera test if necessary (endoscopic surveillance). By reducing the number of polyps resected and sent to the pathology labs for diagnosis, the work load on the pathology department is also reduced and in the process, providing cost savings to the Trust, The study aims to see if using Blue Light during endoscopy helps us to identify and characterize small polyps better

Advanced endoscopic imaging can facilitate the characterisation of neoplastic and non-neoplastic polyps. Accurate identification of small non-neoplastic polyps (e.g. rectosigmoid hyperplastic polyps) that do not harbour malignant potential can lead to future implementation of a 'resect and discard' or 'diagnose and leave' strategy. However, there is insufficient evidence that endoscopists are able to attain high enough levels of optical diagnostic performance in-vivo in order to implement this strategy safely. Blue Light Imaging (BLI) is a new enhanced imaging technology that enhances mucosal surface and vessel patterns. A specific BLI classification was recently developed to enable better characterisation of colorectal polyps (BLI Adenoma Serrated International Classification - BASIC). The use of this technology with the appropriate classification to enhance its performance has not yet been tested in clinical settings of polyp surveillance and screening colonoscopy amongst general endoscopists.

BLAST is a multicentre prospective observational study which will compare BLI optical diagnosis with histological assessment (as a reference standard) for patients with small polyps (\<10mm) identified at colonoscopy.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years of age Able to provide informed consent

Exclusion Criteria:

* History of polyposis syndrome History of Inflammatory bowel disease History of poor bowel prep
Evaluation of PK and Safety of D-0120 and Allopurinol

Evaluation of safety and PK interaction between D-0120 and Alopurinol in healthy adult subjects


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects between the ages of 18-55
* Required evaluation by Investigator for screening and enrollment
* Agreement and compliance with the study and follow-up procedures

Exclusion Criteria:

* Significant medical history or current comorbidly determined by the Investigator.
* Pregnant or nursing women
Safety and Preliminary Anti-Tumor Activity of TYRA-300 in Advanced Urothelial Carcinoma and Other Solid Tumors With FGFR3 Gene Alterations

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of TYRA-300 in cancers with FGFR3 activating gene alterations, including locally advanced/metastatic urothelial carcinoma of the bladder and urinary tract and other advanced solid tumors.

This is a single arm, multi-part, phase 1/2 global trial studying TYRA-300, a novel, potent fibroblast growth factor receptor (FGFR) 3-selective tyrosine kinase inhibitor, in advanced/metastatic urothelial carcinoma of the bladder and urinary tract, that contain activating gene alterations of FGFR3. Phase 1 is a dose-escalation study to evaluate the safety, tolerability, and PK of TYRA-300 to determine the optimal and maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D). Phase 2 will evaluate the preliminary antitumor activity of TYRA-300 in cancers with FGFR3 activating gene alterations, including locally advanced/metastatic urothelial carcinoma of the bladder and urinary tract and other advanced solid tumors.

Eligibility Criteria:
Inclusion Criteria:

Phase 1 Part A and Part B

* Men and women 18 years of age or older.
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.
* Histologically confirmed advanced solid tumor who have exhausted standard therapeutic options.
* Evaluable (Part A) or measurable (Part B) disease according to RECIST v1.1.
* Histologically confirmed advanced solid tumor with an eligible FGFR3 gene mutation or fusion (Part B).

Phase 2

* Men and women 18 years of age or older.
* ECOG performance status of 0-2 or Karnofsky Performance Scale (KPS) \>70.
* At least 1 measurable lesion by RECIST v1.1.
* Histologically confirmed locally advanced/metastatic tumor in one of the following categories:

  * Urothelial carcinoma with an eligible FGFR3 gene mutation or rearrangement who have progressed on a prior FGFR inhibitor and presence of a resistance mutation or other kinase domain mutation.
  * Urothelial carcinoma with an eligible FGFR3 gene mutation or rearrangement who has not received a prior FGFR inhibitor.
  * Any solid tumor with an eligible FGFR3 gene mutation or rearrangement.

Exclusion Criteria (All Phases):

* Has a serum phosphorus level \> upper limit of normal (ULN) during screening that remains \>ULN despite medical management.
* Any ocular condition likely to increase the risk of eye toxicity.
* History of or current uncontrolled cardiovascular disease.
* Active, symptomatic, or untreated brain metastases.
* Gastrointestinal disorders that will affect oral administration or absorption of TYRA-300.
* Females who are pregnant, breastfeeding, or planning to become pregnant and males who plan to father a child while enrolled in this study.