cyrilzakka/clinical-trials huggingface dataset:
Elderly With Locally Advanced Lung Cancer: Deciding Through Geriatric Assessment on the Optimal Treatment Strategy

There is no detailed information available on benefits and harms of intensified treatment with concurrent RCHT among a subpopulation of elderly patients. Reliable tools are needed to distinguish the subgroup of fit patients from frail patients.

Lung cancer is a problem of the elderly: 30% of the lung cancer patients are aged ≥ 75 years. Due to underrepresentation of elderly patients in clinical trials there is a lack of evidence to select the optimal treatment strategy for these patients. Concurrent radiochemotherapy (RCHT) has been recognised as the standard treatment of stage III NSCLC patients with a good performance status. Evidence for this treatment was gained in clinical trials that mostly excluded elderly patients. Furthermore, the survival gain obtained with combined RCHT, comes with a significant increase in toxicity. Therefore, information on benefits and harms of intensified treatment with concurrent RCHT among a subpopulation of medically fit elderly patients is still lacking. Moreover, reliable tools are needed to distinguish the subgroup of fit patients from frail patients, i.e. those expected to experience important toxicity.

Eligibility Criteria:
* Any subtype of pathologically proven NSCLC, primary UICC Stage III disease;
* Age ≥ 75 years;
* No surgery or adjuvant chemotherapy for NSCLC in the last year;
* No prior radiotherapy to the ipsilateral thorax or mediastinum;
* No clinical superior vena cava syndrome;
* No diagnosis of other cancer within the last 3-years (except in situ carcinoma's and / or non-melanoma skin cancer);
* Written informed consent
Growing Up Milk (GUM) Intake and Nutrient Status of Toddlers

The purpose of this study is to determine the nutritional and cognitive effects of consuming Growing Up Milks (GUMs) and cow's milk.

Single-site, double blind, partially randomized, controlled, 4-arm parallel group clinical trial. The purpose of this study is to determine if consuming nutrient enriched growing up milk improves the nutrition status and cognitive performance in healthy toddlers.

Eligibility Criteria:
Inclusion Criteria:

1. Having obtained his/her parent's(s') or his/her legal guardian written informed consent and signed and dated informed consent.
2. Age 17 - 18 months at enrolment.
3. Singleton, full-term gestational birth (≥ 37 completed weeks of gestation), with a birth weight of ≥ 2.5 kg and ≤ 4.5 kg
4. Toddler's parent(s)/guardian is of legal age of consent, has sufficient command of English language to complete the informed consent and other study documents, and is willing and able to fulfill the requirements of the study protocol
5. Toddler's parent(s)/guardian can be contacted directly by telephone or email throughout the study

Exclusion Criteria:

Toddlers who exhibit one or more of the following criteria are excluded from enrollment in the study:

1. Chronic infectious, metabolic, genetic illness or other disease including any condition that impacts feeding or may impact outcome measures
2. Known or suspected cows' milk protein intolerance / allergy or severe food allergies that impact diet
3. Toddlers fed vegan, vegetarian, or vegetarian plus fish diets
4. Cognitive or developmental disorders
5. Breast milk used exclusively in place of all other milk, and/or milk alternatives at 17-18 months (GUM \& cows' milk group exclusion only, eligible for population group)
6. Consuming supplement(s) of relevance to the study outcome relating diet to status, docosahexaenoic acid (DHA), lutein, and/or choline in amounts \>%10 requirements
7. Toddlers or toddlers' family who in the Investigator's judgment cannot be expected to comply with the protocol or study procedures
The RETRIEVE Study: Use of the FiberNet® Embolic Protection System in Saphenous Vein Grafts

This is a multicenter, prospective study designed to demonstrate the performance and safety of the FiberNet Embolic Protection System when used as an adjunctive device during saphenous vein graft (SVG) intervention.

The study will involve up to 30 patients to be enrolled using the FiberNet device during clinically indicated percutaneous intervention of SVG and followed through 30 days post procedure. Patients will be enrolled at up to 10 Investigative Sites. The study is a prospective multi-center registry with sequential enrollment of qualified patients who consent to participate and meet all entrance criteria.

The Lumen Biomedical, Inc. FiberNet® Embolic Protection System is indicated for use as a guide wire and embolic protection system to capture and remove embolic material (thrombus/debris) produced while performing percutaneous transluminal interventional procedures in saphenous vein grafts with reference vessel diameters of 1.75 mm to 7.0 mm.

Eligibility Criteria:
Inclusion Criteria:

* Candidate for percutaneous transluminal coronary angioplasty (PTCA), stenting and emergent coronary artery bypass graft (CABG).
* Myocardial ischemia as evidenced by one or more of the following:

  * Diagnosis of stable or unstable angina pectoris
  * ECG changes consistent with ischemia
  * Positive functional study
  * Recent myocardial infarction
* Lesion(s) is located within SVG and is ≥ 50% and \< 100% stenosed.

Exclusion Criteria:

Clinical Criteria:

* Myocardial infarction with documented total CK-MB \> 2 times the upper limit of normal within the past 24 hours, or currently experiencing an acute myocardial infarction.
* Undergone cardiac surgery within the past 60 days.
* A planned invasive surgical procedure within 30 days.
* The lesion(s) is in an SVG that is less than 2 months post-implant.
* Left ventricular ejection fraction \< 20%.
* A stroke or transient ischemic neurological attack (TIA) within the past 2 months.

Angiographic Criteria:

* The lesion(s) is in an arterial conduit.
* Lesion is within 10 mm of the proximal anastomosis.
* More than two native lesions \[in addition to the SVG lesion(s)\] that need to be treated at the index procedure.
* More than two SVGs that need to be treated at the index procedure.
* Chronic total occlusion of a target lesion.
* The SVG lesion(s) requires treatment with a large device other than PTCA prior to stent placement (such as, but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, rheolytic thrombectomy or brachytherapy).
Magnetic Resonance Imaging of Breast Cancer

To compare magnetic resonance imaging (MRI) with more well established diagnostic imaging techniques to determine which method best finds and defines breast cancer.


Eligibility Criteria:
INCLUSION CRITERIA

* Female
* Documented breast physical examination,
* Documented mammography within 3 months of the MR studies
* Palpable or mammographically-detected suspect breast lesions
* Women who have already undergone lumpectomy for breast cancer and have post-biopsy/post-radiation changes will be eligible if they have mammographically-detected or palpable breast abnormalities which are sufficiently suspicious to merit core needle or surgical biopsy.

EXCLUSION CRITERIA:

* Male by birth
* Able to complete the MR examination. Subjects will be interviewed by one of the investigators for the usual contraindications to
* MR contraindications including
* Pacemakers
* Metallic implants
* Severe claustrophobia
* Aneurysm clips
* Pregnancy
* Current lactation
* Other conditions precluding proximity to a strong magnetic field.
* Received an enhanced MR procedure within 48 hours,
* Iodinated contrast within six hours,
* Known sensitivity to MR contrast agents,
* Not likely to complete the study in full or
* Other clinical reason which would preclude participation in the protocol.
Effect of Chitosan-N-acetylcysteine on Subjective Pain Sensation in Corneal Abrasion

Aim of this study is to investigate the effect of Chitosan-N-acetylcysteine (C-NAC; Lacrimera®, Croma-Pharma GmbH, Leobendorf, Austria) in patients with corneal abrasion less than one third of the corneal surface on subjective pain sensation.

Commonly, standard of care for corneal abrasion is topical antibiotics. Bandage contact lenses may be used in addition, which significantly decrease pain sensation in a vast majority of patients. Recently, a new preservative-free agent consisting of a novel biopolymer, Chitosan-N-acetylcysteine (C-NAC; Lacrimera®, Croma-Pharma GmbH, Leobendorf, Austria) has been approved for the treatment of dry eye syndrome (DES). This agent electrostatically binds to the mucine layer of the tear film, forming a glycocalyx-like structure. In an animal model, the beneficial effect of Chitosan-N-Acetylcysteine on recovery time has been observed. Aim of this study is to investigate the effect of Chitosan-N-acetylcysteine (C-NAC; Lacrimera®, Croma-Pharma GmbH, Leobendorf, Austria) in patients with corneal abrasion less than one third of the corneal surface on subjective pain sensation. It will further explore the extend of corneal healing after use of Lacrimera® over 5 days in those patients initially treated with Lacrimera®.

Eligibility Criteria:
Inclusion Criteria:

* Age older than 18 years
* Corneal abrasion less than one third of the cornea

Exclusion Criteria:

* Ocular surgery within prior 3 months in the affected eye
* Ocular injury within prior 3 months before abrasion in the affected eye
* Ocular herpes of eye or eyelid within prior 3 months
* Active ocular infection
* Active ocular inflammation or history of chronic, recurrent ocular inflammation within prior 3 months
* Ocular surface abnormality that may compromise corneal integrity
* Presence of diseases that reduce experience of pain (e.g. Diabetes mellitus)
* Pregnancy
MyoRing Implantation With Corneal Collagen Crosslinking for Keratoconus

A complete intrastromal ring, MyoRing (Dioptex, GmbH, Linz, Austria), suggested by Albert Daxer in 2007, is a relatively new technique that has been demonstrated to treat keratoconus safely and effectively.Corneal collagen crosslinking (CXL), introduced by Wollensak et al. in 2003, has become a standard treatment for progressive keratoconus to slow or possibly stop progression of disease.

The formation of the stromal pocket during MyoRing implantation offers the opportunity for simultaneous introduction of riboflavin 0.1% into the pocket followed by UVA irradiation to provide combined treatment in patients with progressive keratoconus.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years old
* a diagnosis of keratoconus, intolerance for contact lenses or glasses
* a documented progression of disease. This progression was defined by the following changes over 1 year: an increase of the steepest K by 1.0 diopter (D) or more in manifest cylinder, or an increase of 0.5 D or more in manifest spherical equivalent (SE) refraction by repeated keratotopography ODP-scan ARK-1000 (Nidek, Japan)

Exclusion Criteria:

* minimal pachymetry of less than 380 μm,
* a history of previous ocular pathology or ocular surgery;
* pregnancy or breastfeeding;
* corneal scarring.
Endostapler Gastric Bypass Study

The goal of this prospective, post-market study is to evaluate safety and efficacy of the AEON™ Endostapler when used in laparoscopic Roux-en-Y gastric bypass surgery.

Stapler performance will be evaluated by incidence and degree of staple line bleeding from endoscopic and laparoscopic images, evaluated by a third-party. The study will include 25 total consecutive cases of individuals undergoing a planned laparoscopic Roux-en-Y gastric bypass (GB). The GB procedure will be performed according to institutional standard-of-care and all subjects will undergo standard preoperative evaluation as well as post-operative care.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing planned laparoscopic Roux-en-Y gastric bypass
* Informed consent for study obtained and signed from each subject

Exclusion Criteria:

* Planned open surgical approach
* Use of staple line reinforcement material (buttress)
* Revision or other bariatric procedure
* Patients with a bleeding disorder: known coagulopathy, or Platelets \<100,000, or PTT \> 45sec, or PT\> 15sec, or INR\>1.5
* Patients with active HIV or Hepatitis B
* Patients under the age of 18 on the date of the surgery
* Patients who are pregnant
* Patients using tobacco products within the last 2 weeks prior to surgery date
* Patients using cortisone or related products within the last 2 weeks prior to surgery date
Effect of Acupuncture on Intraocular Pressure

To evaluate the short-term effect of acupuncture on the intraocular pressure (IOP).

Methods: A randomized controlled trial. Healthy volunteers will be randomly allocated to three groups: Acupuncture group - will be submitted to a 20-minute session of acupuncture with needles inserted in specific points (Tong Zi Liao, Yang Bai and Jing Ming); Sham group - will be submitted to a 20- minute session of acupuncture with needles inserted in false points located 1 cm from true points in areas without acupuncture's meridians; and Control group - no intervention. IOP measurement by a masked investigator using Goldmann applanation tonometry immediately before the intervention, as well as 30 minutes and 24 hours after the acupuncture.


Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* glaucoma
* past intraocular surgery
* corneal alterations
* medications that interferes with the intraocular pressure
Autoimmune Hepatitis Cohort in China

The goal of this observational study is to describe the clinical features and long-term prognosis in patients diagnosed with autoimmune hepatitis (AIH) in China and assess the effectiveness and safety of AIH treatment options in a real-world setting.

Autoimmune hepatitis (AIH) is a chronic autoimmune liver disease that causes liver inflammation and necrosis, ultimately leading to cirrhosis and liver failure. Although relatively rare, the prevalence of AIH in China has been increasing in recent years, highlighting its significance as a public health issue. However, due to the wide variability in the clinical presentation and outcomes of AIH, diagnosing and managing the disease can be challenging. Moreover, our understanding of the epidemiology, clinical features, diagnosis, and treatment of AIH in China is still limited.

To address this gap in knowledge, the investigators are conducting the Chinese AIH Cohort study, which collects data from approximately 20 sites across China on treatment progress and success in clinical routine. The study aims to evaluate the effectiveness and safety/tolerability of different AIH treatment options, including standard therapy, and second and third-line treatment options. The investigators also record the long-term prognosis of patients with AIH, tracking whether they achieve remission, require liver transplantation, or experience mortality. Risk factors associated with long-term prognosis and survival will be analyzed to provide insights that can improve the diagnosis, treatment, and management of AIH in this population.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 14 years
* Probable or definite diagnosis of autoimmune hepatitis according to the International Autoimmune Hepatitis Study Group criteria
* Availability of all following essential parameters at the initial diagnosis of AIH: including alanine transaminase, aspartate aminotransferase, total bilirubin, alkaline phosphatase, immunoglobulin G, and platelet count
* Provide informed consent

Exclusion Criteria:

* Have a concomitant diagnosis of primary biliary sclerosis, primary sclerosing cholangitis, immunoglobulin G 4-related cholangitis
* Have an active infection with hepatitis B virus, hepatitis C virus, hepatitis delta virus, HIV, cytomegalovirus, or Epstein-Barr virus
* Have a concomitant diagnosis of hepatocellular carcinoma or other malignant diseases before the diagnosis of AIH
* Considered ineligible to the enrollment in the clinical study by the researcher
Impact of Radiofrequency Ablation on Left Ventricular Function in Supraventricular Tachyarrhythmias Patient Using Speckle Tracking Echocardiography

In this study, we aimed to evaluate atrial and ventricular function in supraventricular tachyarrhythmia patients before and 3 months after RFA using 2DSTE.

Two-dimensional speckle-tracking echocardiography (2DSTE) is a known technique for the evaluation of myocardial function in many conditions. The longitudinal deformation of the left ventricular (LV) mainly occurs in the subendocardial level which is sensitive to injury and it may be used to identify sub-clinical LV dysfunction in cardiomyopathies. Global longitudinal strain, strain rate (SR), and torsion measurements are very promising to identify patients with mild systolic and diastolic dysfunctions which are not reflected in reduced EF.

Tachyarrhythmias that are persistent and recurrent can lead to LV dysfunction. Dyssynchrony is another mechanism that may cause LV dysfunction, as in the case of Wolf Parkinson Syndrome (WPW ). It might be explained by the "collision" of electric stimuli through the normal atrioventricular conduction system and along the accessory pathway (AP) during the systolic phase. 2DSTE has been used to investigate the characteristics of WPW syndrome and confirm the presence of LV dyssynchrony in this condition.

Lelakowski et al. showed that RFA improves LV systolic and diastolic functions in patients with Atrioventricular Nodal Reentry tachycardia (AVNRT).

Recurrent AVNRT attacks increase atrial pressure, leading to elevated atrial wall stress, which causes negative remodeling and systolic impairment. It has been shown that left atrial(LA) functions improved after Radiofrequency ablation RFA, along with LA volume reduction in atrial fibrillation/flutter patients.

the small number of patients and lacking using advanced accurate techniques lead to currently insufficient data in the literature regarding changes in cardiac function following AVNRT \& AVRT ablation and whether LV dyssynchrony is reversible after ablation therapy of AVRT or not.

Eligibility Criteria:
Inclusion Criteria:

- Patients with AVNRT or AVRT undergoing RF ablation

Exclusion Criteria:

* - Patient with bundle blocks
* Coronary artery disease
* Diastolic dysfunction ≥grade 2
* Left ventricular hypertrophy
* Diabetes mellitus
* Chronic renal failure (GFR\<45ml\\min)
* Moderate to severe valvular heart disease
* Patient with bad echo window
Thyroid Function Among Pediatric Patients With DM

Thyroid function among pediatric patients with type1 diabetes mellitus at the first presentation, from patients' characteristics to disease severity

Type-I diabetes mellitus is an auto immune disease. It is the most common type of diabetes in children and adolescents. It is also the most common chronic disease in children in the developed countries. The illness is characterized by the body's inability to produce insulin due to the autoimmune destruction of the beta cells in the pancreas. Globally, it is estimated that there are almost 500,000 children aged under 15 years with type 1diabetes, with large geographical variations in incidence.

* Furthermore Between 10 to 70% of these children present in Diabetic Ketoacidosis (DKA) as their first presentation of the disease.
* In addition It can be associated with other auto immune disorders that may influence the control of diabetes by disruption of the function of respective organs and enhance the opportunity of developing DKA as the first manifestation of their disease.
* In particular, autoimmune thyroiditis (AIT) is the most common disorder associated with type 1 Diabetes Mellitus.
* AIT and type 1 Diabetes Mellitus have a common genetic background and similar pathogenesis; hence, they could occur in the same individual or family. The prevalence of thyroid autoantibodies in children with type1 Diabetes Mellitus ranges from 3% to 50% in different countries and populations, which is markedly higher than in the general population (range, 1% to 4%).
* Besides thyroid autoantibodies can be detected at the initial diagnosis and after it.
* Thyroiditis is often clinically silent but it may progress to autoimmune thyroid disease (AITD), recognized as overt or subclinical hypothyroidism or hyperthyroidism.
* The American Diabetes Association (ADA) recommended screening Thyroid-Stimulating hormone after diagnosis of diabetes and then after every one to two years. It also recommended that patients found to have positive anti-Thyroid Peroxidase antibodies with normal thyroid function tests should be screened more frequently, every six months to a year .

Eligibility Criteria:
Inclusion Criteria:

* - patients between 2 year and \<18 years of age in both sex
* patients with T1DM that had not been on any thyroid medication

Exclusion Criteria:

* - patients \<2 years and \>18 years of age in both sex
* patient with systemic illnesses, diagnosed thyroid disorders and patients taking medications
To Demonstrate the Relative Bioequivalency Study of Dosage Forms of Clemastine 2.68 mg Tablets

To demonstrate the relative bioequivalency study of dosage forms of Clemastine 2.68 mg tablets.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.