cyrilzakka/clinical-trials huggingface dataset:
A Prospective Clinical Study of Transthoracic Single-hole Assisted Laparoscopic Radical Gastrectomy for Siewert Ⅱ AEG

Objective: To evaluate the safety, feasibility and clinical efficacy of transthoracic single-hole assisted laparoscopic radical gastrectomy for Siewert Type Ⅱ adenocarcinoma of esophagogastric junction.

Methods: A prospective, single-center, one-arm study will be performed. Patients who have been diagnosed with Siewert type Ⅱ esophagogastric junction adenocarcinoma and meet the eligibility criteria will be included in the study and undergo the transthoracic single-hole assisted laparoscopic radical gastrectomy. The data of preoperative, intraoperative, postoperative and follow-up will be recorded and analyzed.

Primary study endpoints: The incidences of early postoperative complications and mortality.

The secondary study endpoints:(1) Surgery and oncology indicators ;(2) Early postoperative recovery information ;(3) 3-year disease-free survival and overall survival rate;(4) 5-year disease-free survival and overall survival.

1. Surgery and oncology indicators,such as length of operation, intraoperative blood loss, transit thoracotomy or laparotomy rate, length of proximal tumor from esophageal resection margin, number of mediastinal lymph node dissections and the positive, number of abdominal lymph node dissections and the positive, tumor type and pathological stage, etc.;
2. Early postoperative recovery information ,such as time of first exhaust and defecation, time of leaving the bed, time of recovery of full and half-flow diet, time of removal of chest drainage tube, time of postoperative hospitalization, etc.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent of patients;
* The tumor invaded the anatomy esophagogastric junction (EGJ), with the tumor center located at the EGJ line from 1cm above to 2cm below(SiewertⅡ).
* The endoscopic biopsy was diagnosed with adenocarcinoma;
* Preoperative clinical staging was cT1-4aNanyM0
* No distant metastasis and invasion of surrounding organs were found;
* ECOG score ranged from 0 to 1;
* ASA score ranged from I to III.

Exclusion Criteria:

* Pregnant or lactating women
* Have a severe mental illness
* History of esophagectomy and gastrectomy (including EMR / ESD for gastric and esophageal cancer)
* History of other malignant tumors within 5 years
* History of unstable angina pectoris or myocardial infarction within 6 months
* FEV1% of pulmonary function test was less than 50% of expected value
* History of cerebral infarction or cerebral hemorrhage within 6 months
* Have severe liver and kidney damage
Altering Toenail Biomechanic in Managing Ingrown Toenail.

Ingrown toenail is commonly met in clinical practice.treatment may be non-operative and operative treatment.operative trestment depends on lateral wedge resection of the nail. The idea is to change toenail biomechanics by central toenail resection.

The aim of this study is to compare between central toenail resection with ordinary lateral wedge resection in managing ingrown toenail. This study was performed on 100 patients divided into 2 groupd each is 50 patients. Group A underwent central resection while group B underwent lateral toenail resection.

Eligibility Criteria:
Inclusion Criteria:

* patient with ingrown toenail
* Patients from 10 years up to 35 years

Exclusion Criteria:

* patients with concurrent toe deformity
* patients less than 10 years or more than 35 years
Effects of AFQ056 and Nicotine in Reducing Cigarette Smoking

The purpose of this study is to assess the safety and efficacy of AFQ056 and nicotine compared to placebo on craving and withdrawal symptoms during voluntary smoking stoppage in healthy smokers. This study will also assess how the body interacts with AFQ056.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, male \& female subjects at least 18 years and ≤60 years of age
* In good health
* Female subjects must be surgically sterilized or postmenopausal.
* Current smokers not intending to quit
* Smoke on average 15 cigarettes or more and less than 60 cigarettes a day for the past year
* Fagerström Test for Nicotine Dependence score of at least 5 (indicates moderate to heavy smokers)
* Willing to refrain from smoking as required
* Written informed consent before entering the study

Exclusion Criteria:

* History of heart disease, septum defect and/or cardiac valves surgery; clinical relevant abnormality in the ECG
* Investigational drug treatment within 4 weeks prior to screening unless local health authority guidelines mandate a longer period
* Women of childbearing potential, pregnant or lactating females
* Donation of one unit (400mL) or more of blood, significant blood loss equaling at least one unit of blood within the past 2 months or a blood transfusion within 8 weeks prior to screening.
* Coffee consumption of more than 6 cups coffee/day
* Use of a medication within 2 weeks prior to Day 1 of each treatment period

Other protocol-defined inclusion/exclusion criteria may apply
Efficacy, Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients With Motor Fluctuations

The purpose of this study is to evaluate the efficacy, safety and tolerability of PF-06649751 in Parkinson's disease patients who experience motor-fluctuations.

The study has a randomized, double-blind, placebo-controlled parallel group design. Approximately 198 subjects will be randomized to 5 treatment groups. Each subject will participate in the study for approximately 23 weeks including a 30 day screening period, 15 week double blind treatment period, and an approximately 28 day follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Females of non-childbearing potential and/or male subjects between the ages of 40 and 85 years, inclusive.
* Clinical diagnosis of Parkinson's disease.
* Able to refrain from any Parkinson's disease medication not permitted by the protocol.

Exclusion Criteria:

* Female of childbearing potential
* History or presence of atypical Parkinsonian syndrome.
* History of surgical intervention for Parkinson's disease.
* Severe acute or chronic medical or psychiatric condition or laboratory abnormality.
* Any condition possibly affecting drug absorption.
* Participation in other studies involving investigational drug(s), or treatment with any investigational drug within 30 days.
High-Intensity Laser Therapy for Eosinophilic Fasciitis

Eosinophilic fasciitis (EF) is a rare musculoskeletal disorder characterized by inflammation and thickening of the fascia, leading to pain, stiffness, and functional impairment. Conventional treatment options include immunosuppressive medications, corticosteroids, and physical therapy. This case report will describe use of high-intensity laser therapy (HILT) using the Mectronic Exand MY high-intensity laser system in a patient with EF, highlighting its potential as an alternative or adjunct treatment option.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Eosinophilic fasciitis.

Exclusion Criteria:

* a diagnosis unrelated to Eosinophilic fasciitis
Allergology: Information, Data and Knowledge Organization

Digital technology is essential in the field of health, via connected objects, the medical Internet or even telemedicine; and the info-communication practices (ways of getting information and communicating) of the actors go through digital devices. In addition, at present, the mass of activity documents to be managed in healthcare establishments and an abundant supply of documentary resources in health, available on the Internet, lead to infobesity, information pollution, and work overload. These phenomena lead to an increase in the time spent searching for relevant information and even to the burnout of healthcare professionals. A contextualization of the information communication systems through which the practices of health professionals pass therefore seems necessary so that the tools for managing, extracting and organizing knowledge can support these actors in their work.

In the field of allergies, there are many players, and the information that is useful to them is abundant and heterogeneous. This study is based on the hypothesis that a knowledge organization model, developed from existing practices, could make it possible to obtain satisfactory results when searching for information, and be integrated into the daily practices of actors by linking up with other already existing systems and tools.


Eligibility Criteria:
Inclusion criteria:

* Professionals from the Allergy Unit (doctors, interns, paramedics, study coordinators), in total around 20-30 people.
* Observations will be conducted during their team meetings and will not impact their workflow.
* Subjects publishing information on allergy on public web sites

Exclusion criteria:

* Professional not willing to participate to the research.
* Users publishing information on private web sites or forums.
Vscan Access R2 Feasibility Evaluation

This study is being done to evaluate if the Vscan Access R2 Ultrasound System can measure Fetal Heart Rate (FHR) in humans when compared against a reference device (GE Corometrics 170 Series Fetal Monitor), and to gather feedback from device operators on the usability of the device.

This study is being done to evaluate whether the Vscan Access R2 Ultrasound System Assisted FHR phantom testing conclusions can be extrapolated onto human fetal heart rate measurements, where CTG (GE Corometrics 170 Series Fetal Monitor) is to provide a reference value. It should be noted that the Vscan Access R2 Ultrasound System with Assisted FHR has a different intended use than CTG (momentary FHR value versus continuous monitoring of FHR patterns and trends) and this aspect is out of scope of this research.

Usability data will be gathered for further user experience optimization.

Eligibility Criteria:
Inclusion Criteria:

1. Women aged 18 years or older at the time of consent;
2. By self-report, are in the 2nd or 3rd trimester of pregnancy;
3. Able and willing to provide written informed consent for participation;
4. Provide a completed Healthcare Verification Form which confirms the subject has received at least one diagnostic ultrasound during this pregnancy and has an uncomplicated pregnancy.

Exclusion Criteria:

1. Are direct employees/contractors of General Electric (GE);
2. Are potentially put at additional risk by participating, in the opinion of study staff;
3. Twin pregnancies identified in patient medical history.
Development of a Therapeutic Education Program for Patients With Metastatic Prostate Cancer Treated With New Generation Hormone Therapy

The development of a personalized therapeutic education program dedicated to patients with metastatic prostate cancer and receiving next-generation hormone therapy would improve their knowledge of the disease, medication adherence and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Patients with metastatic prostate cancer treated with enzalutamide or abiraterone acetate for at least 3 months
* The patient must have given their free and informed consent and signed the consent form
* The patient must be insured or the beneficiary of an insurance policy

Exclusion Criteria:

* The subject is not in a fit state to express their consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
Non-Interventional Study (NIS) In Patients With Advanced And/Or Metastatic Renal Cell Carcinoma (mRCC) Treated With SUTENT®

Primary objective: to increase knowledge about safety, tolerability, quality of life and efficacy under conditions of routine use of SUTENT®. Secondary objectives: treatment response, hypothyroidism prevalence.The efficacy will be assessed using the Objective Response Rate, Time to Progression based on the RECIST criteria and the ECOG performance data.

180 patients will be enrolled at 20 key oncological centres, the sample size is sufficient for exploratory analysis.

Eligibility Criteria:
Inclusion Criteria:

* Patients with advanced or metastatic renal cell carcinoma.

Exclusion Criteria:

* No previous cytokines therapy.
Parent Training in Child Safety Practices

This project completed an intervention designed to teach parents of children aged 0-2 years of age how to prevent injuries to their child. The intervention consisted of a two DVD package with information on creating a safe home environment and correctly choosing and installing an appropriate car safety seat. The study hypothesis was that parents who used the intervention would score significantly higher on measures of knowledge, motivation, intention and self-efficacy in implementing injury prevention strategies.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Parent whose oldest child is 0-24 months old
* Speak and read English
* Have internet access (online study only)

Exclusion Criteria:

* Parents who do not have legal or physical custody
* Subjects live in a household in which a family member had an overnight stay in the hospital as a result of an injury in the last 2 years
The Effect of Short-term Atorvastatin Treatment on Immune Responses to Pneumovax 23

The purpose of this research study is to: Improve the effectiveness of vaccinations by identifying the effect of cholesterol medication, statins, on immune responses.

Due to the anti-inflammatory action of statins, it was proposed that statin treatment would decrease the efficacy of vaccination. This response has yet to be explored following a primary vaccination such as pneumococcal pneumonia. In this study, healthy volunteers will be divided into 2 arms receiving treatment for 28 days: 40 mg atorvastatin or placebo.

Antibody titer for 23 serotypes, complete blood count (CBC), high-sensitivity c-reactive protein (hsCRP), erythrocyte sedimentation rate (ESR), lipids, cytokines (TNF-alpha, IFN-gamma, interleukins, etc.) and key membrane receptors (toll-like receptors, etc.) will be measured for baseline before statin or placebo treatment. On day 7 of treatment, pre-vaccination measures of the above parameters will be taken and an immune response will be induced in all groups using Pneumovax 23 at Day 7. On days 8, 14, 21, and 28 post-vaccination measures will be compared to baseline and between groups.

Eligibility Criteria:
Inclusion Criteria:

24 subjects are healthy volunteers between the ages of 21 and 40.

Exclusion Criteria:

1. Pregnant, planning to become pregnant, breastfeeding
2. Taking any of the following medications at time of study: antacids, antifungals, antioxidants, colestipol, cyclosporine, digoxin, erythromycin, fibric acid derivatives, niacin, oral contraceptives containing norethindrone or ethinyl estradiol, statins, steroids
3. Taking any immunosuppressive drugs including azathioprine, methotrexate, TNF inhibitors, cyclophosphamide, antimalarials, or sulfasalazine
4. Currently have or history of cardiovascular disease, diabetes, diphtheria, high blood pressure, high cholesterol, immunodeficiencies, kidney disease, liver disease, low blood pressure, muscular disease, seizure disorders, systemic lupus erythematosus or other systemic autoimmune disorders
5. Not immunized in childhood against streptococcus pneumoniae; received pneumovax vaccine within past year, or received 2 or more pneumovax boosters within the past 5 years
6. Latex allergy or previous allergic reaction or severe side effects from any vaccine
7. Heavy drinking (more than 15 drinks/week), illegal drug use within past six months, unwillingness to abstain from alcohol, unwillingness to abstain from tobacco products (dip, cigarettes, cigars, electronic cigarettes, etc.), illegal drugs, or grapefruit juice for duration of study
8. BMI over 30, abnormal values on lipid panel or liver function test
9. Failure to pass pre-study medical screening
Special Investigation in Patients With Ankylosing Spondylitis (All Patients Investigation)

This study of adalimumab (Humira) will be conducted to clarify the following with regard to the treatment of ankylosing spondylitis with this drug:

* Unknown adverse drug reactions (especially important adverse drug reactions)
* Incidence and conditions of occurrence of adverse reactions in the clinical setting
* Factors that may affect the safety and effectiveness of Humira


Eligibility Criteria:
Inclusion Criteria:

* Patients with ankylosing spondylitis who are not responding well to conventional therapy and receive adalimumab will be enrolled in the survey

Exclusion Criteria:

* Contraindications according to the Package Insert

  * Patients who have serious infections
  * Patients who have tuberculosis
  * Patients with a history of hypersensitivity to any ingredient of Humira
  * Patients who have demyelinating disease or with a history of demyelinating disease
* Patients who have congestive cardiac failure
Outcomes of an Intraoperative Bispectral Index Monitor

This pilot study is being conducted to determine whether the intraoperative presence of a Bispectral Index Monitor (BIS), a non-invasive monitor, affects the perioperative and postoperative indices and outcomes. The BIS monitor is an adhesive sensor that is applied to the forehead to monitor EEG waves. This monitor is not a Standard of Care Monitor, yet in adult and pediatric studies it has been shown to decrease time to emergence, decrease volatile anesthesia requirement, decrease recovery time and in some cases, decrease post-operative morbidity (REFS). The effect on intra-operative and post-operative parameters, when BIS is present but not specifically designated to be used as a monitor to guide anesthesia delivery, has not been specifically examined. This will be the first pediatric study which applies BIS on all patients and randomizes the anesthesiologists to either be or not be privy to seeing the BIS values during intra-operative period.

The BIS monitor is an adhesive sensor that is applied to the forehead to monitor EEG waves. In adult and pediatric studies, the BIS monitor has been shown to decrease time to emergence, decrease volatile anesthesia requirement, decrease recovery time and in some cases, decrease post-operative morbidity (REFS). The effect on intra-operative and post-operative parameters, when BIS is present but not specifically designated to be used as a monitor to guide anesthesia delivery, has not been specifically examined. This will be the first pediatric study which applies BIS on all patients and randomizes the anesthesiologists to either be or not be privy to seeing the BIS values during intra-operative period.

Eligibility Criteria:
Inclusion Criteria:

* orthopedic or urologic day surgery
* 2 to 12 years old

Exclusion Criteria:

* anesthesiologist refusal
* patient/parent refusal
* allergy to the BIS adhesive
* history of seizures
CAPACITY (Cardiac Amyloidosis and Physical ACtivITY) Study

Exercise training in patients with heart failure and preserved ejection fraction (HFpEF) has been associated with an improvement in cardiorespiratory fitness and quality of life.

The Atrium Health cardiac rehabilitation program delivers a comprehensive approach to improve cardiac performance including supervised exercise programs and has the ideal infrastructure to offer cardio-oncology rehabilitation (CORE) to all our cancer patients in the future. Currently neither CORE nor cardiac rehabilitation for HFpEF are covered by insurance, and hence the targeting of a higher risk cancer and non-cancer population of cardiac amyloidosis patients to objectively measure the benefits of a supervised exercise program ultimately to expand eligibility to all cancer patients and shape the treatment and payor landscape in the future.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* New York Heart Association (NYHA) Class I-III Heart Failure
* Able to Exercise
* On stable treatment for their cardiac amyloidosis or under active surveillance
* Life expectancy of at least 6 months
* Ability to understand and the willingness to sign a written informed consent document in English, and the willingness/ability to comply with the protocol activities
* Participant must be able and willing to follow the cardiac rehabilitation activities

Exclusion Criteria:

* Inability to provide informed consent
* Inability to commit to in-person supervised exercise sessions for three one-hour sessions a week for 12 weeks
* NYHA Class IV Heart Failure
* Pulmonary disease requiring home oxygen
* Gait instability or history of prior falls
* In the opinion of the Principal Investigator, have a clinically significant comorbid disease that is likely to affect the ability of the patient to complete the trial, interfere with their ability with measurement of self-reported outcomes.
Clinical Effectiveness of(VistaProof)in Comparison With ICDAS-II & Histological Validation for Detecting Occlusal Caries

a diagnostic accuracy study control trial is to be held to evaluate the Clinical performance of quantitative light fluorescence based device (Vistacam Proof) in comparison with the visual examination and histological validation in detection of initial pits and fissures caries


Eligibility Criteria:
Inclusion Criteria:

* Patients aged from 15 to 50 years.
* Patient at least has one posterior pits and fissure occlusal caries.
* No gender restriction
* Co-operative patients who signed the informed consent.
* Good general health
* Acceptable oral health

Exclusion Criteria:

* Pregnancy.
* Disabilities.
* Systemic disease or severe medical complications.
* Allergic history concerning methacrylate.
* Rampant caries.
1 Year Post Discharge Prognostic Model From the National Heart Failure Audit (NHFA)

The aim of the study is to develop and assess a prognostic model for patient's survival up to 1 year after unscheduled acute heart failure hospital admission in England and Wales.

There is a need for a prognostic model for 1 year survival of patients discharged alive after an unscheduled hospital admission for heart failure. This study aims to develop and validate a prognostic model that will enable management planning and facilitate the identification of therapeutic needs or targets. Also, it will assist care providers to predict or quantify patients' survival based on their baseline characteristics.

The National Heart Failure Audit (NHFA) held by National Institute for Cardiovascular Outcomes Research (NICOR) is one of the largest available national heart failure registry. It includes data from unscheduled heart failure admissions in England and Wales. In the audit, heart failure diagnosis is defined as a diagnosis that has been confirmed by imaging or brain natriuretic peptide (BNP) measurement. This study will use NHFA data to develop and validate the proposed model.

Eligibility Criteria:
Inclusion Criteria:

* aged 18 and above
* survived to discharge
* have mortality status at 1 year post-discharge

Exclusion Criteria:

Non-index heart failure admissions during the study period will be excluded from the study sample.