cyrilzakka/clinical-trials huggingface dataset:
Prospective Multicenter Observational Study of Atezolizumab Combination Therapy in Lung Cancer (J-TAIL-2)

This is a multi-center observational study of atezolizumab combination therapy in patients with unresectable, advanced and recurrent non-small cell lung cancer(NSCLC) or extensive disease small cell lung cancer(ED-SCLC). 800 patients in NSCLC cohort and 400 patients in ED-SCLC cohort will be enrolled in this trial to assess the efficacy and safety of this combination.

Primary endpoint: 12 months OS, Secondary endpoints: Overall Survival(OS), 6 months survival rate(6mo OS), 12 months survival rate(12mo OS), Progression-Free Survival(PFS), Time to treatment failure (TTF), Objective Response Rate(ORR), Disease Control Rate(DCR), Duration of Response(DOR) ,Safety and Comprehensive geriatric assessment(G8)

Eligibility Criteria:
Inclusion Criteria:

\< non-small cell lung cancer cohort\>

1. Patients 20 years of age or older at the time of signed consent.
2. Patients with unresectable, advanced and recurrent non-small cell lung cancer.
3. Patients who are scheduled to start atezolizumab combination therapy in clinical practice, based on the atezolizumab package insert and the Optimal Use Promotion Guideline.
4. Patients who signed informed consent form before enrolling the study. The consent from a legally acceptable representative is required for the patients with uncertain capacity of judgments.

\<extensive disease small cell lung cancer cohort\>

1. Patients 20 years of age or older at the time of signed consent.
2. Patients with extensive disease small cell lung cancer.
3. Patients who are scheduled to start atezolizumab combination therapy in clinical practice, based on the atezolizumab package insert and the Optimal Use Promotion Guideline.
4. Patients who signed informed consent form before enrolling the study. The consent from a legally acceptable representative is required for the patients with uncertain capacity of judgments.

Exclusion Criteria:

\< non-small cell lung cancer cohort\> (1) Patients who are unsuitable for enrolment into the study by the investigator's judgment.

\<extensive disease small cell lung cancer cohort\>

(1) Patients who are unsuitable for enrolment into the study by the investigator's judgment.
High Light Intensity Bleaching Versus Descending Light Intensities Bleaching on Post Bleaching Teeth Sensitivity

Compare teeth sensitivity using bleaching protocol with different light intensities (Philips Zoom!™ White Speed whitening gel and lamp, Discus Dental, Inc., Culver City, CA, USA.) versus bleaching protocol with the same light intensity (Philips Zoom!™ Advanced Power whitening gel and lamp, Discus Dental, Inc., Culver City, CA, USA.).

This study will be applied to patients suffering from teeth discolorations. Nowadays, vital tooth bleaching is one of the most requested cosmetic dental procedures asked by patients who want and aesthetically more pleasing smile. The American Dental Association (ADA) has advised patients to ask the dentists to adamant the most suitable bleaching treatment, especially for those complaining of tooth sensitivity, dental restorations, extremely dark discolorations, and single dark teeth.

Tooth sensitivity (TS) is the most common clinical side effect of tooth bleaching. Tooth sensitivity (TS) caused by bleaching procedures usually results in mild and transient pain; however, it can occasionally cause significant discomfort that is a main deterrent to patients successfully completing bleaching treatments. Considering that TS has been reported as a common side effect, affecting more than 60% of the patients that undergo this cosmetic treatment. Greater tooth sensitivity has been reported with in-office bleaching with adjunct light compared with no light. Existing literature reveals that activation of bleaching agents by heat or light may have an adverse effect on pulpal tissue. It was already reported that the use of intense lights does elevate bleach temperature, but it results in increased intrapulpal temperatures, which may further impact patient sensitivity and pulpal health.Hence, in this study different light intensities bleaching protocol will be used aiming at overcoming this complication.

Eligibility Criteria:
Inclusion Criteria:

1. Patients included in this clinical trial were at least18 years old.
2. Patients should be free from any systemic disease that may affect normal healing and predictable outcome.
3. Patients who will agree to the consent and will commit to follow-up period.
4. Willing to refrain from tobacco products and any colored liquids or food (e.g. coffee, tea, tomato sauce etc.) during the active study period.

Exclusion Criteria:

1. Patients with any systemic disease that may affect normal healing.
2. Patient with bad oral hygiene.
3. Pregnant females.
4. Patients who could/would not participate in a 3month follow-up.
5. Untreated periodontal disease were not allowed.
6. Active caries or defective Restorations in 6 anterior teeth.
7. Sensitive Teeth
8. Bleaching history
9. Patients participating in more than 1 dental study.
Neointimal Coverage After Implantation of Biolimus Eluting Stent With Biodegradable Polymer: Optical Coherence Tomographic Assessment According to the Treatment of Dyslipidemia and Hypertension and the Types of Implanted Drug-eluting Stents

There has been little research on neointimal coverage and malapposition after BES implantation using OCT in human coronary artery. Furthermore, specific drug may possibly influence the vascular healing after stent implantation. Therefore, this study will investigate 1) neointimal coverage and malapposition on OCT after BES versus SES implantation and 2) relationship of specific drug treatment and neointimal coverage or late malapposition by the prospective, randomized study.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 20 year old
2. In the case that the blood pressure at rest is greater than systolic 140mmHg or more than diastolic 90mmHg
3. When someone is taking Anti-Hypertensive medication
4. If total cholesterol is more than 200mg/dL and LDL-cholesterol is greater than 130mg/dL or if you are taking a statin
5. Significant coronary de novo lesion (\> 70% by quantitative angiographic analysis)
6. Patients with stable angina or acute coronary syndrome considered for percutaneous coronary intervention.
7. Reference vessel diameter of 2.5 to 3.5 mm by operator assessment
8. Stent size of 2.5 to 3.5 mm and stent length ≤ 24 mm

Exclusion Criteria:

1. Contraindication to anti-platelet agents
2. Proximal leison within 15 mm from ostium
3. Creatinine level 2.0 mg/dL or end stage renal disease on dialysis
4. Pregnant women or women with potential childbearing
5. Life expectancy less than 1 year
6. Complex lesion morphologies (aorto-ostial, bifurcation with \>2.0 mm side branch, unprotected Left main, thrombus, severe calcification, chronic total occlusion)
7. Vein graft lesion
Study of Circulating Tumor Cells Before and After Treatment in Patients With Metastatic Melanoma

Circulating tumor cells (CTC) are the subject of increasing interest in clinical oncology as a prognostic factor and predictor of therapeutic response. The detection of CTC by immunomagnetic method has proved its reliability and its usefulness for monitoring breast cancer, colon and prostate in the metastatic and immunomagnetic detection system (CellSearch, Veridex LLC) was approved by the FDA in these indications. However, to date there is no reliable method to detect CTCs in melanoma (CMC). Studies based on PCR amplification of mRNA by reverse specific melanoma is disappointing. Recently, a new detection system of CMC immunomagnetic was presented (CellSearch, Veridex LLC, United States). This system has the advantage of combining immunomagnetic selection step and a step of identifying by immunofluorescence. A preclinical study on serial dilutions of melanoma cells has shown encouraging results. The investigators propose a prospective study of the CellSearch system in patients with melanoma.

Primary objective: To determine the effect of treatment on the number of circulating melanoma cells in patients with metastatic melanoma.

Secondary objectives:

* determine the percentage of patients with metastatic melanoma with melanoma cells circulating
* seek a relationship between the number of circulating melanoma cells and prognosis in patients with metastatic melanoma
* seek a relationship between the change in the number of circulating melanoma cells before / after treatment and tumor response in patients with metastatic melanoma


Eligibility Criteria:
Inclusion Criteria:

* Patients \> or = 18 years
* Patients with advanced melanoma stage IIIC (unresectable) or stage IV
* Patient not treated or not responding to chemotherapy with chemotherapy session last\> 1 month
* Patients who signed informed consent
* Patients presenting no socio-economic, psychological, familial or geographical allow proper understanding of the information leaflet of the protocol or the regular monitoring in the department of dermatology
* Patients with a life expectancy greater than 3 months
* Patients with melanoma measurable by RECIST version 1.1
* Patients with venous good for venipuncture

Exclusion Criteria:

* Patients with contraindication for treatment with chemotherapy or V600E BRAF inhibitor or ipilimumab or have conditions concomitant heavy may interfere with the treatment of metastatic melanoma
* Pregnant women or nursing
* People vulnerable detainees, adults under guardianship or curatorship, minors.
The Rise in Robotic Atypical Segmentectomies

This study investigates the increased rate of robotic atypical segmentectomies. Segmentectomy refers to removing a section of a lobe of the lung. Reviewing patients' data retrospectively may help researchers determine whether robotic surgery has led to an increase in atypical segmentectomy.

PRIMARY OBJECTIVES:

I. To evaluate the rate of increase in robotic segmentectomies performed at our institution per year.

II. To evaluate the rate of typical and atypical segmentectomies performed at our institution per year.

III. To characterize the differences in robotic versus other types of resections such as open and VATS (video-assisted thoracic surgery).

OUTLINE:

Patients' medical records are reviewed retrospectively.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent a lung resection from 2004 to 2019
Glaukos® iStent® Trabecular Micro-Bypass Stent System In Conjunction With Cataract Surgery Postmarket Registry

The purpose of this study is to observe the safety of the Glaukos® iStent® Trabecular Micro-Bypass Stent Model GTS100 in conjunction with cataract surgery in subjects with mild to moderate open-angle glaucoma.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive subjects in whom implantation of the iStent is attempted

Exclusion Criteria:

* Please refer to approved indications in Directions for Use
Low-dose Combination of Mycophenolate Mofetil (MMF) and Tacrolimus (Tac) for Refractory Lupus Nephritis

A trial of combination of two drugs for the treatment of refractory lupus nephritis.

Low-dose combination of mycophenolate mofetil and tacrolimus for refractory lupus nephritis: a 12-month prospective study

Eligibility Criteria:
Inclusion Criteria:

1. Active nephritis documented by renal biopsy within 24 months of entry;
2. Failure to respond to 2 or more immunosuppressive regimens which consisted of high-dose prednisolone combined with other non-corticosteroid immunosuppressive agents together with ACE inhibitors plus or minus angiotensin receptor blockers (ARB) for at least 4 months for each regimen at the maximally tolerated drug dosages;
3. Serum creatinine (Scr) less than 200umol/L.

Exclusion Criteria:

1. Previous intolerance to either MMF/Tac;
2. Scr \>200umol/L;
3. Informed consent unavailable.
The Effectiveness of Coconut Oil Cream as a Prevention Treatment for Occupational Hand Dermatitis Among Batik Workers

Empirically, mosturizer is used to prevent and treat many occupational dermatoses that has skin barrier impairment. Evidence based medicine about the effectivity of mosturizer in occupational dermatoses is limited. Coconut oil is one of traditional substance that is used as a skin care. There is study shows that coconut oil is effective for atopic dermatitis treatment in children. Other studies are needed to assess the effectivity coconut oil mosturizer cream to overcome occupational hand dermatitis.

The aim of this study is to measure the effectivenes of coconut oil cream for batik workers who suffer from occupational hand dermatitis. The gloves that used as a protective equipment are made from rubber which have its own limitations. Therefore other interventions are needed to improve barrier skin.

Eligibility Criteria:
Inclusion Criteria:

* signing the informed consent document before the study start
* adult population include patients between the ages of 18 and 64 years who work in the dyeing and washing process more than 6 months.
* suffering from occupational hand dermatitis that meet Mathias Criteria.
* willing to obey the research protocol
* willing to fill in diary periodically

Exclusion Criteria:

* having history of allergy or irritation caused by coconut oil or other mosturizer
* suffering from symptoms including edema, exudation, crust, fissures, liver problems, and signs of infection
* on corticosteroid treatment ( medium to high potency) or on systemic immunosuppressive therapy
Non-interventional Study of Seroprevalence of Pre-existing Antibodies Against Adenovirus-associated Virus Vector (AAV9) and the Progression of Disease in Patients With Plakophilin 2 (PKP2)-Associated Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)

This is a multicenter, non-interventional study to observe the natural progression of the disease and to study the prevalence of pre-existing antibodies to AAV9 used for gene therapy in a population of patients with PKP2 gene-associated ARVC. Participation from all patients is encouraged regardless of interest in or eligibility for gene therapy.

Patients will receive standard of care treatments and assessments under the care of their healthcare provider. Biologic samples will be collected annually to measure cardiac and other related biomarkers. Clinical and observational data will be collected prospectively for up to 5 years from the date of enrollment, or until the patient withdraws consent/assent, undergoes heart transplantation, or dies.

If consent is provided, there may be a one-time sample collection to evaluate genetics for research purposes. Quality of Life (QoL) questionnaires will be used to assess a patient's wellbeing and quality of life. If not included as part of a patient's standard of care, diagnostic Holter (or equivalent) monitoring will be required annually. No investigational product will be administered. Participation from all patients is encouraged regardless of interest in or eligibility for gene therapy.

Eligibility Criteria:
Inclusion Criteria:

* Ages 14-65 years, inclusive, at the time of consent
* Pathogenic or likely pathogenic PKP2 gene mutation
* Diagnosed with ARVC and meet 2010 Modified Task Force Criteria for ARVC as affected.
* Functioning ICD

Exclusion Criteria:

* Currently receiving systemic immunosuppressive therapy, cytotoxic chemotherapy, immunoglobulin therapy or monoclonal antibody therapy
* History of clinically significant liver disease, hepatitis B virus, hepatitis C virus, human immunodeficiency virus, or tuberculosis infection
* Previously dosed with any investigational or approved gene therapy product at any time
* Concurrent participation in another interventional clinical trial unless approved by the Sponsor. Participation in a noninterventional study may be allowed at the investigator's discretion.
* History of cardiac transplant.
Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism

The objective of the trial is to evaluate the efficacy of dasiglucagon in reducing glucose requirements in children with persistent congenital hyperinsulinism (CHI) requiring continuous intravenous (IV) glucose administration to prevent/manage hypoglycemia.


Eligibility Criteria:
Inclusion Criteria:

* CHI diagnosis established based on the following:

  1. Hyperinsulinemia: plasma insulin above the limit of detection of the assay documented during an event of hypoglycemia, and/or
  2. Hypofattyacidemia: plasma free fatty acid \<1.7 mmol/L, and/or
  3. Hypoketonemia: Beta-hydroxybutyrate \<1.8 mmol/L, and/or
  4. Glycemic response: an increase in plasma glucose (PG) of \>30 mg/dL (1.7 mmol/L) after 1 mg IV or intramuscular (IM) glucagon administration
* Male or female, age ≥7 days and \<12 months at screening
* Body weight of ≥2.0 kg (4.4 lbs.)
* Continuous IV glucose requirement to prevent hypoglycemia

Exclusion Criteria:

* Is suspected of having a transient form of CHI (e.g., transient hyperinsulinism due to maternal diabetes or perinatal stress)
* Was born preterm below 34 weeks of gestational age
* Presence of hypertension or hypotension, including circulatory instability requiring supportive medication or presence of pheochromocytoma
* Known or suspected presence of severe brain damage
* Evidence of metabolic, endocrine, or syndromic causes of hypoglycemia not due to hyperinsulinism
* Use of systemic corticosteroids, e.g., hydrocortisone \>20 mg/m\^2 body surface area or equivalent within 5 days before screening
* Prior use of lanreotide, sirolimus (mechanistic target of rapamycin \[mTOR\] inhibitors), anti-inflammatory biological agents, or other immune modulating agents. Prior use of octreotide is allowed after a minimum of 48 hour washout before randomization.
* Any clinically significant abnormality identified on echocardiogram that in the opinion of the investigator would affect the subject's ability to participate in the trial
* Any recognized clotting or bleeding disorder
* The use of prescription or non-prescription medications known to cause QT prolongation
Shear Stress Endothelial/Hemodynamics in Aortic Dissection and Endothelial Shear Stress-biological Profile

Aortic dissection (AD) is a clinical condition belonging to the broader spectrum of Acute Aortic Syndromes, with high morbidity and mortality and characterised by the sudden formation of a breach within the tonaca intima of the aortic wall, from which the so-called false lumen originates.The most common risk factor for AD is hypertension, present in more than 70% of.

Imaging, biomarkers and genetic predisposition are critical in confirming a suspected diagnosis and in determining the appropriate intervention for each patient. Specific features influencing management decisions are the presence of rupture, extent of dissection, origin of true or false lumen vessels and signs of organ ischaemia.

The aim of this study is to investigate the diagnostic value of circulating biomarkers and in aortic tissue in patients with AD and to assess the prognosis of patients with AD and its complications in relation to the aforementioned markers, integrating biological data with clinical and instrumental data relating to the patient's hospitalisation.

The study involves a comparison between two arms, one experimental and the other control (healthy outpatients). A longitudinal evaluation will be carried out on the experimental arm with a follow-up visit (FUp) at 3, 6 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* partecipants admitted to our Department of Cardiovascular Sciences with a radiological diagnosis of AD within 14 days of the onset of symptoms;
* healthy outpatient or inpatient controls at our Department with another diagnosis and no evidence of AD, matched for demographic and clinical characteristics

Exclusion Criteria:

* evidence of inflammatory diseases, infectious diseases, neoplasms, immunological or haematological disorders;
* treatment with anti-inflammatory drugs with the exception of low-dose aspirin (75-160 mg);
* age \> 85 years;
* advanced chronic kidney disease with glomerular filtration rate (eGFR) estimated by MDRD equation \<30 ml/min./1.73 m2; 5) pregnancy;
* dissection with traumatic aetiology;
* failure to sign informed consent;
Comparing NAVA Levels in Intubated and Recently Extubated Neonates to Determine Optimal Non-invasive Ventilatory Support

Neurally adjusted ventilatory assist (NAVA) is a mode of mechanical ventilation that uses the diaphragm's normal electrical activity to deliver a mechanically supported breath. The amount of support provided is determined in part by the NAVA level, where a higher NAVA level will provide higher level of support and unload more of the work of the diaphragm. The purpose of this study is to compare the optimal NAVA level in neonates while on mechanical ventilation while intubated and after being extubated.

Baseline measurements will be taken. The NAVA titration study will then be done. The NAVA level will be set at a starting value of 0.1 cm H2O/mcV and systematically increased by 0.5 cm H2O/mcV every three minutes to a maximum of 3 cmH2O/mcV. Once the NAVA titration study has been completed, the patient will be extubated. There will be a stabilization period following extubation (15-30 minutes), and then the NAVA titration study will be repeated.

Eligibility Criteria:
Inclusion Criteria:

* Neonates on NAVA ventilation

Exclusion Criteria:

-
Effect of MBCT Applied to Asthma Patients on Anxiety, Depressıon and Dyspnea

In this study, short-term MBCT will be applied to asthmatic patients receiving hospital treatment and its effects on anxiety, depression and dyspnea will be determined. A quasi-experimental study was planned for this purpose.

In the study, cognitive behavioral therapy will be applied to the intervention group, which is determined as the experimental group, and a group of asthma patients who did not receive any application during the same periods will be included and the dyspnea, anxiety and depression levels of the patients in these two groups will be compared.

Eligibility Criteria:
Inclusion Criteria:

Over 18 years old, Inpatient treatment in the chest ward volunteer participants with no communication problems

Exclusion Criteria:

Under 18 years old, with communication problems, not willing to participate hospitalized with diseases other than asthma
M3VAS Validation in Polish Population

Low mood and anhedonia represent the fundamental symptoms of major depressive disorder (MDD). Nevertheless, there is currently no standardized visual analogue scale available to assess the extent of both symptoms concurrently. The Maudsley 3-item Visual Analogue Scale (M3VAS) is a newly developed tool for participants to self-assess core symptoms of depression: mood quality, pleasure experience (anhedonia), and suicidality. Despite suicidality not being a primary symptom, it is included due to its critical relevance to safety. Participants will be instructed to rate the intensity and frequency of their experiences over the preceding two weeks by marking a 100 mm ungraded line. A researcher will then assign a numerical value based on the mark's position, utilizing the left edge as 0 and the right as 100. The total score range, combining the three symptoms, ranged from 0 (minimum) to 300 (maximum). The M3VAS exhibited good psychometric properties in British population. In this study, the objective is to assess the psychometric properties of the scale within the Polish population diagnosed with major depressive episode within major depressive disorder or bipolar disorder.


Eligibility Criteria:
Inclusion Criteria:

Diagnosis as provided by DSM-5 criteria:

Major depressive disorder (MDD) Bipolar disorder (BD)

Exclusion Criteria:

Diagnosis as provided by DSM-5 criteria:

Psychotic disorders Current Mania or hypomania within bipolar disorder (BD)