cyrilzakka/clinical-trials huggingface dataset:
Clinical Observation of S1 Capsule for Stage Ⅱ-ⅢA Non-small Cell Lung Cancer After Complete Resection

The purpose of this study is to evaluate S1 capsule plus Cisplatin as adjuvant treatment in stageⅡ and Ⅲa non-small cell lung cancer. It is the first study in the world to investigate the safety and efficacy of S1 capsule using in stageⅡ and Ⅲa non-small cell lung cancer patients after the complete resection.

Lung cancer is the leading cause of cancer death worldwide. Only about 15.6% of all lung cancer patients are alive 5years or more after diagnosis. Non-small Cell Lung Cancer (NSCLC) accounts for more than 85% of all lung cancer cases.

For individuals with stage Ⅱ-ⅢA NSCLC after complete resection, platinum-based chemotherapy is the mainstay of first line treatment. Various treatment regimens have been developed to improve survival.

S-1 capsule is an novel oral anticancer drug that combines tegafur, a prodrug of 5-fluorouracil, with gimeracil and oteracil potassium. S-1 capsule was considered to be an active single agent against NSCLC.

Eligibility Criteria:
Inclusion Criteria:

* Patient with completely resected stage ⅢA non-small cell lung cancer(NSCLC)
* Must be able to receive the therapy of the study within four weeks after the completely resection

Exclusion Criteria:

* Systemic anticancer treatment
* local radiotherapy
Efficacy of Macrolide and Glucocorticoid in the Treatment of Chronic Rhinosinusitis After Endoscopic Sinus Surgery

Endoscopic sinus surgery (ESS) is widely considered to be the gold standard in the surgical management of chronic rhinosinusitis (CRS) that has failed maximal medical therapy. Nevertheless, the postoperation medical therapy was considered as a crucial procedure for the success of ESS. Both glucocorticoids and macrolide antibiotics have been recommended for the treatment of CRS, but their effect as postoperation medical therapies of ESS need more clinical data to clarify.

The purpose of this prospective, randomized,study is to determine the effect of glucocorticoids and macrolide antibiotics for the postoperation medical therapy of ESS in different subtypes of CRS.

Chronic rhinosinusitis (CRS) is a multifactorial inflammatory disorder that causes various symptoms including nasal obstruction, rhinorrhea, olfactory dysfunction, facial pain, and headache . Endoscopic sinus surgery (ESS) is usually recommended for patients who do not response well to conservative treatments. Although surgery is effective to alleviate symptoms and improve the quality of life of CRS patients, a followed long-term postoperative medical treatment is indispensable. Current European and American guidelines recommend glucocorticoids and antibiotics as the primary pharmacotherapeutic approaches for CRS before and after ESS. However, there are a number of CRS patients not responding well to glucocorticoid treatment and conflicting results exist regarding the efficacy of long-term, low-dose macrolide treatment. One potential reason is that CRS is a heterogeneous group of disorders unified by similar clinical presentations and its phenotypes and/or endotypes may be important factors determining the efficacy of treatments.

Eligibility Criteria:
Inclusion Criteria:

* Meeting the CRS diagnostic criteria including CRSsNP and CRSwNP based on the EP3OS definition
* Age ≥16 and ≤70 years
* Chinese of either sex
* Failure to conventional medical therapies according to EP3OS recommendation

Exclusion Criteria:

* Pregnant or breast-feeding women
* Cystic fibrosis
* Congenital ciliary dyskinesia
* Sinonasal fungal disease
* Systemic vasculitis
* Granulomatous disease
* Tumor
* Immunodeficiency
* Allergic to clarithromycin or topical corticosteroid
* With an upper respiratory tract infection within 4 weeks of entering the study
* With serious metabolic, cardiovascular, autoimmune, neurology, blood, digestive, cerebrovascular, respiratory system disease, or any disease interfering with the evaluation of results or affecting subjects' safety such as glaucoma and tuberculosis
* With emotional or mental problems
* Have received immunotherapy within the previous 3 months
* Have had a history of local or systemic medications, such as glucocorticoids and macrolides within 4 weeks
* Have had an acute asthmatic within the 4 weeks before entering the study
A Study Developing a Non-invasive Urine-based Proteomic Model for Early Lung Cancer Detection.

Brief Summary:

The goal of this observational study is to develop a non-invasive urine proteomic diagnostic model to improve early-stage lung cancer detection. The study aims to answer the following main questions:

Can urine proteomics reliably differentiate early-stage lung cancer from benign conditions? How does the diagnostic model compare to current clinical and imaging methods in accuracy?

Participants will:

Provide preoperative urine samples. Undergo proteomic analysis of urine samples. Have clinical, imaging, and proteomic data integrated into an AI-assisted diagnostic model.

The study will evaluate the sensitivity and specificity of this innovative diagnostic approach.

Detailed Description:

This study focuses on developing a urine proteomic-based diagnostic model to improve the early detection of lung cancer. It leverages non-invasive urine sampling, proteomic analysis, and artificial intelligence to create a high-sensitivity, high-specificity diagnostic tool.

The study will recruit 480 participants with suspected early-stage lung cancer (I-IIIA, non-N2). Urine samples will be collected before surgery, and participants will undergo standard imaging and diagnostic evaluations, including chest CT, abdominal ultrasound or CT, brain MRI or CT, and bone scans.

The primary objectives of the study include:

1. Biomarker Identification: Identifying differentially expressed urine proteins associated with early-stage lung cancer.
2. Diagnostic Model Construction: Combining proteomic findings with clinical and imaging data to construct a diagnostic model using AI-based algorithms.
3. Validation: Evaluating the model's diagnostic accuracy compared to current clinical practices.

Participants will contribute to the advancement of a novel diagnostic method that aims to minimize unnecessary invasive procedures and improve lung cancer prognosis through early and accurate detection.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female participants aged 18 to 75 years.
2. Diagnosed or highly suspected early-stage (I-IIIA, non-N2) non-small cell lung 3.cancer (NSCLC) based on imaging or clinical assessment.

4.No prior anti-cancer treatment, including surgery, chemotherapy, radiotherapy, targeted therapy, or immunotherapy.

5.Able to provide informed consent and willing to comply with the study protocol, including urine sample collection before surgery.

6.Diagnosis confirmed within 42 days post-imaging or preoperative assessment through biopsy or surgical specimen.

Exclusion Criteria:

1. History of any cancer treatment prior to study enrollment.
2. Presence of metastatic disease (N2 or more advanced staging).
3. Severe comorbid conditions or organ dysfunctions (e.g., renal failure) that could affect urine sample quality or interpretation.
4. Pregnancy or lactation.
5. Participation in another clinical study that could interfere with the outcomes of this study.
6. Inability to comply with the study protocol, including language barriers or cognitive impairments.
Evaluation of Radiation Induced Pulmonary Hypertension Using MRI in Stage III NSCLC Patients Treated With Chemoradiotherapy. A Pilot Study

In the radiotherapeutic treatment of lung cancer, the dose that can be safely applied to the tumour is limited by the risk of radiation induced lung damage. This damage is characterized by parenchymal damage and vascular damage. In rats, we have found that radiation-induced vascular damage results in increased pulmonary artery pressure. Interestingly, the consequent loss of pulmonary function could be fully explained by this increase in pulmonary artery pressure. We hypothesize that also in patients a radiation induced increase in pulmonary artery pressure can be observed after radiotherapy, which may contribute to the development of radiation pneumonitis.

The objective is to test the hypothesis that radiotherapy for lung cancer induces an increase in pulmonary artery pressure.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* WHO PS 0-2
* Histological or cytological confirmation of non-small cell lung cancer or an 18F-FDG-positive, growing mass on CT-thorax suggestive of NSCLC.
* Stage IIIA or IIIB
* Patients with extensive mediastinal lymph node involvement (such as N3), or large primary tumour size
* Adequate pulmonary function estimated by flow volume curves
* Life expectancy of at least 6 months
* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol; those conditions should be discussed with the patient before registration in the trial.
* Planned for 25 x 2.4 Gy, with concomitant chemotherapy
* Before patient registration, written informed consent will be obtained.

Exclusion Criteria:

* Presence of contra-indications for undergoing MRI
Micra Atrial TRacking Using A Ventricular AccELerometer 2

The purpose of the Micra Atrial TRacking Using A Ventricular AccELerometer 2 (MARVEL 2) study is to demonstrate safe and effective operation of the MARVEL 2 features for providing AV synchronous pacing in patients with normal sinus node function and AV block

The MARVEL 2 study is an acute, prospective, global, multi-center, software-download clinical study. The study is planned to be conducted in US, Europe, and Asia. The study is expected to be conducted at approximately 15-20 centers in up to 100 subjects to obtain at least 70 usable Holter datasets to meet the objectives of the study. The expected total study duration (from first subject enrollment to the exit of the last subject) is approximately 6-months; this represents the time necessary to enroll the target sample size of at least 70 subjects with usable Holter datasets. Software will be downloaded into patients implanted with a Micra device to allow the new algorithm performance to be measured in patients where a Micra device has already been chosen as most appropriate for the patient.

Most enrolled subjects will complete the study procedures during a single study visit. However, subjects enrolling in the study at the time of their Micra implant (anticipated to be approximately 10 subjects) will have the investigational algorithm downloaded following Micra implant, prior to hospital discharge, and approximately 1-month post-implant. This subset of subjects with de novo Micra implants will allow the MARVEL 2 features to be tested at multiple points in the device life cycle.

Since the download algorithm running in a Micra device significantly increases current drain, a 2-4 hour acute study is used to limit the reduction in device longevity.

Eligibility Criteria:
Inclusion Criteria:

* Subject has been implanted with a Micra TPS (Model MC1VR01) with remaining device longevity of 6 years or more or is expected to be implanted with a Micra TPS.
* Subject has history of AV block\*
* Subject is ≥ 18 years old and as per required local law.
* Subject (and/or witness as applicable per local regulations) provides signed and dated authorization and/or consent per institution and local requirements.
* Subject is willing and able to comply with the protocol. \*This includes subjects with normal sinus function and persistent 3rd degree AV block and subjects with other forms of AV block.

Exclusion Criteria:

* Subject is currently enrolled or planning to participate in a potentially confounding drug or device trial during the study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic Clinical Research Specialist.
* Subject is pregnant (if required by local law, women of child-bearing potential must undergo a pregnancy test within seven days prior to MARVEL 2 study procedures).
* Subject meets any exclusion criteria required by local law (age or other).
Algorithm Guided DBS Programming in Parkinson's Patients

Patients undergoing Deep Brain Stimulation for Parkinson's disease will be subjected to standard of care programming and compared with the algorithm based programming (StimSearch). Various parameters including the effectivity and efficiency of algorithm programming will be compared against the standard of care programming.

Patients of Parkinson's disease undergoing bilateral subthalamic nucleus stimulation (STN), we have already been adequately programmed and have achieved good outcome, will undergo an exploratory study to evaluate the effectiveness of algorithm based programming (Phase 1). Subsequently, patients undergoing STN DBS will be randomly allocated to algorithm based programming/ standard of care programming and after adequate stabilisation evaluated for motor improvement. They will be switched over to the alternative technique of programming and evaluated again after a similar period. Data regarding the time consumed, effectivity and several secondary endpoints will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Have a confirmed diagnosis of bilateral idiopathic Parkinson's disease
* Exhibit a UPDRS subset III score of ≥ 25 while in the preoperative medication off state
* Demonstrate an improvement of Parkinson's disease symptoms by ≥30% in the medication off state following a pre-operative levodopa challenge, as assessed by the UPDRS subset III score
* Possess the ability to comprehend the study's demands, treatment protocols, and procedures, and provide written informed consent before undergoing any study-specific tests or procedures

Exclusion Criteria:

* Patients with notable psychiatric conditions, including unrelated clinically substantial depression as assessed by the investigator, will be excluded from participation.
Relationship Between Functional Health Status and Ventricular Performance After Fontan--Pediatric Heart Network

The purpose of this cross-sectional study was to determine the interrelationships between health status and measures of cardiac performance in children 6 to 18 years of age with congenital heart disease who have undergone a Fontan procedure as surgical treatment for functional single ventricle. The goal was to develop a data set that will permit identification of a clinically relevant endpoint for subsequent trials of medical management of the Fontan patient.

BACKGROUND:

Children born with one functional ventricle and who undergo a Fontan procedure, have a higher incidence of late complications than other congenital heart patients. While the Fontan procedure results in restoring near-normal systemic oxygen saturation, there are recognized problems and little information about the overall health status, functional status and ventricular performance in these children.

DESIGN NARRATIVE:

This cross-sectional observational study included children 6-18 years of age who had undergone a Fontan procedure for a congenital cardiac defect. Prospective data collection for each patient occured within a 3 month time period and included cardiac MRI, echocardiography, serology and exercise testing. Historical clinical and surgical data, as well as parent and child self reports of health status, was collected.

Eligibility Criteria:
Inclusion Criteria

* Age 6 through 18 years at the time of enrollment.
* Fontan surgery of any type at least 6 months prior to the time of testing.
* Agreement and ability to have all of the following testing completed:

  1. An echocardiogram at the study center,
  2. Parent health status questionnaire, and
  3. Blood testing.
* Planned or ongoing cardiac care at the study center that will allow completion of study testing within 3 months of study enrollment.
* Informed consent of a parent or guardian, and assent of the study participant if he/she is able to provide it, according to institutional guidelines.

Exclusion Criteria

* Non-cardiac medical or psychiatric disorder that would prevent successful completion of planned study testing or would invalidate the results of study testing.
* Ongoing or planned participation in another research protocol that would either prevent successful completion of planned study testing or invalidate the results of study testing.
* Lack of reading fluency by the primary caregiver in both English and Spanish, languages for which the parental report health status questionnaire has been validated.
* Pregnancy at the time of enrollment or pregnancy planned prior to completion of study testing.
The Effects of Nanocurcumin on Serum Oxidative Stress,Inflammation,Adiponectin and NF-kB in Blood Mononuclear Cells in Metabolic Syndrome Patients (Nuclear Factor-κB)

Metabolic syndrome is a public health challenge that includes a range of conditions including abdominal obesity, dyslipidemia, hyperglycemia, and hypertension. The syndrome is associated with an increase in the risk of Cardiovascular disease and death. Curcumin is a very active compound obtained from turmeric root. Curcumin has antioxidant and anti-inflammatory effects, and is also involved in the regulation of several signaling pathways. Since curcumin powder has low bioavailability, fast metabolism and low absorption, nanomicielle curcumin will be used in this study. Therefore, this study is planned to determine the effects of supplementation of nanomicielle curcumin on oxidative stress, systemic inflammation, adiponectin in serum and NF-kB in peripheral blood mononuclear cells in patients with metabolic syndrome.


Eligibility Criteria:
Inclusion Criteria:

* 25\<body mass index \>40
* waist circumference \>102 cm in men or \>88 cm in women
* Fasting blood glucose \>100 mg/dL
* Triglycerides (TG) \> 150 mg/dL
* High density lipoprotein cholesterol (HDL-C) \<50 in women or \<40 in men
* Systolic blood pressure (SBP) \>130 mmHg and diastolic blood pressure (DBP) \>85mmHg

Exclusion Criteria:

* insulin administration for diabetes control
* hypo- or hyperthyroidism,
* renal failure or other chronic diseases
* pregnancy and breastfeeding
* taking weight loss supplements and obeying unusual weight loss plans
SAD and MAD Study to Evaluate Safety, Tolerability, and Pharmacokinetics (PK) of TD-1473 in Healthy Subjects

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single ascending doses and multiple ascending doses of the investigational drug TD-1473 compared to placebo in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female 19 to 55 years old
* Willing and able to give informed consent
* Body Mass Index (BMI) 18 to 30 kg/m2
* Women of child bearing potential must have a negative pregnancy test and either abstain from sex or use a highly effective method of birth control
* Additional inclusion criteria apply

Exclusion Criteria:

* Positive for hepatitis A, B, or C, HIV, or tuberculosis (TB)
* Clinically significant abnormalities in baseline results of laboratory evaluations
* Evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease
* Participated in another clinical trial of an investigational drug (or medical device) within 30 days prior to Screening (or within 60 days prior to Screening if investigational drug was a biologic), or is currently participating in another trial of an investigational drug (or medical device)
* Use of prescription drugs or any chronic over the counter medications within 14 days prior to clinic admission or requires continuing use during study participation, with the exception of hormonal contraceptives or hormone replacement therapy.
* Additional exclusion criteria apply
Clinical Performance of Extended Wear Silicone Hydrogel Lenses

The primary purpose of this study is to investigate the clinical performance of a new silicone hydrogel contact lens over a period of 6 months of extended wear.


Eligibility Criteria:
Inclusion Criteria:

* Is correctable to at least 6/9 distance visual acuity in each eye with spherical contact lenses.
* Is a current daily wear soft contact lens wearer.
* Has no clinically significant anterior eye findings.
* Has no other active ocular disease.

Exclusion Criteria:

* Has any systemic disease that might interfere with contact lens wear
* Is using any systemic or topical medications that will affect ocular health.
* Has any pre-existing ocular irritation that would preclude contact lens fitting.
* Has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that would affect the wearing of contact lenses.
* Has undergone corneal refractive surgery.
* Is pregnant, lactating or planning a pregnancy.
10cmH2O Peep Application and Cerebral Oxygenation in Laparoscopic Surgery: a Comparative Study With Invos and Foresight Devices

In this study the investigators investigated changes in hemodynamic parameters and cerebral oxygen saturation (rSO2) associated with 10 cmH2O PEEP, which is assumed beneficial for the respiratory functions and oxygenation during the laparoscopic cholecystectomy (LC) applied at the 30°head-up left side position, is compared with using two individual devices (INVOS-FORESIGHT).

Methods: Afterwards the ethics committee approval of the hospital and receiving the written patients' consents, patients to undergo ASA I-II group elective laparoscopic surgery were randomly divided into two groups. Sensors of INVOS and FORESIGHT devices were placed on the right side forehead region. Totally 11 evaluation periods were formed, respectively: Pre-induction (1st Period), post-induction (2nd period), abdominal insufflation outset (3rd period): post-insufflation 5-minute intervals (4th, 5th, 6th, 7th 8th period), end of insufflation (9th period), end of operation (10th period) and end of anaesthesia (11th period). While one of the groups was not applied PEEP(ZEEP), the other group was applied 10 cmH2O simultaneously with the abdominal insufflation proceeding. Demographic data, hemodynamic values and rSO2 values were recorded for both groups at all 11 periods.


Eligibility Criteria:
Inclusion Criteria:

* ASA(American Society of Anesthesiologist) class I and II
* Patients undergoing laparoscopic cholecystectomy

Exclusion Criteria:

* ASA class III and IV
* Morbid obesity
* Emergency cases
* Cases returned to laparotomy
The Effects of a 3-Part Skin Care Regimen on Facial Wrinkles and Biophysical Attributes

The purpose of this study is to analyze various cosmetic endpoints, subjective assessments, and skin parameters such as hydration, transepidermal water loss, fine lines, and wrinkles with the use of a 3-part skin care regimen.


Eligibility Criteria:
Inclusion Criteria:

* Men and women between the ages of 35 years old and 65 years old.
* Must have facial fine lines and wrinkles.

Exclusion Criteria:

* Individuals who are pregnant or breastfeeding.
* Prisoners
* Adults unable to consent
* Individuals who have changed any of their hormonal based contraception within 1 months prior to joining the study.
* Subjects using any topical retinoid, bakuchiol, hyaluronic acid or benzoyl peroxide containing topical product within 2 weeks of starting study or any subject unwilling to refrain from washout prior to enrollment.
* Subjects with any cosmetic treatments in the past 6 months and who are unwilling to withhold facial cosmetic treatments during the study including botulinum toxin, injectable fillers, microdermabrasion, intense pulsed light (IPL), peels, laser treatments, acid treatments, tightening treatments, facial plastic surgery, or any other medical treatment administered by a physician or skin care professional which is designed to improve the appearance of facial skin.
* Current tobacco smoker or a tobacco smoking history of greater than 10 pack-years