cyrilzakka/clinical-trials huggingface dataset:
Comparative Study on the Efficacy and Safety of Microwave Ablation and Lobectomy in the Treatment of Ground Glass Nodules Located in the Pulmonary Hilar Region

GGO is a characteristic focus of early lung cancer. Due to the abundant peripheral blood vessels and bronchial tissues around the GGO lesions located in pulmonary hilar, only lobectomy could be used for the surgical treat of hilar GGO lesions which will make the significantly decline of the pulmonary function after surgery and affect the quality of life to a great extent. Our previous study has reported a new blunt-tip MWA electrode (MTC-3CA-II3, Vison Medical Inc.) for the treatment of GGO lesions. The blunt-tip MWA electrode could improve the safety of GGO ablation, significantly reduce the occurrence of bleeding and hemoptysis, which made it possible to ablate GGO in the hilar region safely. In this study, the blunt-tip MWA electrode was used in the treatment of patients with hilar GGO lesions, and the efficacy and safety of microwave ablation and lobectomy in the treatment of ground glass nodules located in the pulmonary hilar region were evaluated and compared.


Eligibility Criteria:
Inclusion Criteria:

1. The age ranged from 18 to 75 years old, male or female;
2. GGO lesions in the hilar region were diagnosed by imaging examination (CT / PET-CT). During the follow-up of 6-12 months, the lesions increased by more than 2mm, the solid components increased, or there were obvious solid components, or the GGOs were judged to be highly malignant by imaging.
3. The size of GGO lesions was 8mm-3cm, and the number of nodules was ≤ 3.
4. There was no lymph node metastasis, intrapulmonary metastasis or distant organ metastasis;
5. After multidisciplinary evaluation, the patients were feasible for lobectomy and CT guided microwave treatment;
6. No bleeding tendency, normal coagulation function or coagulation dysfunction can be corrected after treatment;
7. Patients and /or family members agreed to join the clinical trial and signed informed consent.

Exclusion Criteria:

1. The general condition of the patient is very poor, ECOG physical fitness score \> 2, unable to tolerate lobectomy and MWA treatment, or has relevant contraindications;
2. The lesions had received other treatments before; patients with regional lymph node metastasis or distant metastasis or with pleural fluid and ascites;
3. Patients with poor compliance;
4. Severe heart, lung, kidney, brain and other important organ diseases;
5. The researcher believes that it is not suitable for inclusion
Selective 5-HT4 Receptor Agonist and Proton Pump Inhibitor (PPI) in Subjects With Gastroesophageal Reflux Disease (GERD)

The aim of this study is to establish a dose-related effect of a selective 5-HT4 receptor agonist compared to placebo on residual symptoms (regurgitation with or without heartburn) in subjects with GERD who have persistent symptoms while on PPI therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Written Informed Consent Form signed voluntarily before the first study-related activity.
2. Aged between 18 and 70 years, inclusive.
3. Subjects with a history of the cardinal symptoms of GERD (both heartburn and regurgitation) prior to PPI therapy.
4. Subjects with symptoms of GERD for at least 6 months prior to the Screening Visit.
5. Subjects who have persistent symptoms of regurgitation for 3 or more days over the past week with or without heartburn while on PPI.
6. Subjects have at least some improvement to the symptom of heartburn while on PPI therapy.
7. Subjects on PPI therapy for at least 8 weeks prior to the Screening Visit of which the last 4 weeks are on a stable labeled dose for any GERD indication according to the country label, where a change of PPI therapy would not impact the symptoms (twice-daily dosing of PPI is not allowed in the last 4 weeks)

Exclusion Criteria:

1. Subjects who show no response to heartburn while on PPI therapy.
2. Subjects with dyspepsia symptoms that are more predominant than their GERD symptoms (heartburn and/or regurgitation).
3. Subjects with prior endoscopic anti-reflux procedure or major GI surgery or subjects with major GI disorders.
4. Presence of severe and clinically uncontrolled cardiovascular, liver, lung or neurologic disease, cancer or AIDS.
5. Alarm symptoms suggestive of malignancies or organic disease.
Safety and Efficacy of IONIS-FB-Lrx in up to 120 Patients 55 and Older With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

The purpose of this study is to assess the Safety and Efficacy of IONIS-FB-Lrx for up to 120 patients with Geographic Atrophy secondary to Age Related Macular Degeneration

This study will assess changes in complement factor B over a 69-week treatment period in a patient population 55 and older with well-demarcated Geographic Atrophy secondary to Age Related Macular Degeneration

Eligibility Criteria:
Key Inclusion Criteria:

1. Must have given written informed consent and be able to comply with study requirements
2. Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal. Males must be surgically sterile or, if engaged in sexual relations with a female of child bearing potential, the subject must be using an acceptable contraceptive method from the time of signing the informed consent form until at least a period of 13 weeks after the last dose of Study Drug (ISIS 696844 or placebo)
3. Well-demarcated Geographic Atrophy due to Age Related Macular Degeneration

Key Exclusion Criteria:

1. Clinically-significant abnormalities in medical history
2. Diagnosis of primary or secondary immunodeficiencies of B lymphocyte function, splenectomy, glomerulonephritis or history of recurrent meningococcal disease
3. Diabetes mellitus or thyroid disease unless well controlled for a period of at least 3 months
4. Clinically-significant abnormalities in screening laboratory values
5. Unwillingness to be administered, or history of a serious reaction to protocol required vaccines
6. Known history of or positive test for human immunodeficiency virus (HIV), hepatitis C or chronic hepatitis B
7. History or presence of a disease other than AMD in study eye
Accuracy of Cardiac Acoustic Biomarkers Recorded by the Wearable Cardioverter Defibrillator

Evaluate data accuracy of cardiac acoustic biomarkers (CABs) recorded by the Wearable Cardioverter Defibrillator (WCD) as compared to the AUDICOR AM acoustic cardiography recorder.

Single arm, prospective, non significant risk device study to evaluate data accuracy of cardiac acoustic biomarkers (CABs) recorded by the Wearable Cardioverter Defibrillator (WCD) compared with the CABs data simultaneously recorded by an acoustic cardiography recorder, the AUDICOR AM device.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* heart failure or a history of heart failure
* ischemic or non-ischemic cardiomyopathy
* ejection Fraction less than or equal to 40% as measured within the last 6 months

Exclusion Criteria:

* implanted left ventricular assist device
* pacemaker dependency
* currently hospitalized
* atrial fibrillation on their last ECG or having an irregularly irregular pulse
Venoarterial PCO2 Difference /Arteriovenous O2 Content Difference Ratio as Goal of Early Septic Shock Therapy

Reducing tissue hypoxia is the ultimate goal of severe sepsis and septic shock therapy.Venoarterial PCO2 difference /arteriovenous O2 content difference ratio (△PCO2/Ca-vO2) is considered to be a good indicator of global anaerobic metabolism.The purpose of this study was to compare the efficacy of △PCO2/Ca-vO2 and central venous oxygen saturation (ScvO2) in the treatment of severe sepsis and septic shock.


Eligibility Criteria:
Inclusion Criteria:

* severe sepsis and septic shock patients

Exclusion Criteria:

* \<18 years old
* pregnant and breast-feed woman
* AMI
* cerebral hemorrhage
* contraindication for central venous catheter or arterial catheter;
* brainstem death
The Impact of Family Financial Support on Parental Stress

The investigators have partnered with financial coaching organizations to establish what the investigators have termed a "Medical-Financial Partnership (MFP)" that offers financial coaching to improve financial and mental health. The investigators will evaluate the MFP's impact on family economic strain and parental stress.

Financial coaching is a new tool in the field of community development, but it has already demonstrated significant financial impact in a number of studies, including one randomized trial conducted by the Urban Institute. Financial coaching improves participant financial literacy, budgeting, saving for financial emergencies, and debt level. The investigators' project will help clinicians and the field of community economic development understand health and well-being through a new economic lens and assess the health-related impacts of the emerging field of financial coaching. The investigators have partnered with financial coaching organizations to establish what they have termed a "Medical-Financial Partnership (MFP)" that offers financial coaching to improve financial and mental health. The investigators will evaluate the MFP's impact on parental strain and stress.

Community-based participants will be recruited from South Los Angeles and randomized to receive either monthly financial coaching plus access to referral for social services (intervention) or access to referral for social services alone (control). Inclusion criteria include having dependents under age 18, having some form of income, and having a tax identification number (social security number or Individual Tax Identification Number). Participants will be surveyed quarterly regarding their economic strain using the Family Economic Strain Scale and their individual stress using the Parenting Stress Index.

Eligibility Criteria:
Inclusion Criteria:

* Participants will include caregivers and parents with one or more dependents, some form of income, and a tax identification number.

Exclusion Criteria:

* Inability to partake in the financial coaching or primary language other than English or Spanish.
Safety, Tolerance and Efficacy of an Oral Nutritional Supplement in Lung Cancer Patients

To test the compliance, tolerance, safety and to get preliminary insights into the efficacy of a new oral nutritional supplement (containing n-3 fatty acids, amino acids and antioxidants) designed to prevent or delay cachexia and anorexia in lung cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* non-small cell lung cancer patients stage IIIb or IV
* planned chemotherapy or combined chemo-/radiotherapy
* current body weight less than 6 months ago
* abnormal CRF level
* BMI \>=20 kg/m2 and \<=30kg/m2

Exclusion Criteria:

* significant oedema in the time of screening and randomisation
* concomitant inflammatory diseases
* active infections including HIV and AIDS
* liver failure
* chronic renal failure or cardiac pacemaker
* chronic heart failure
* insulin treated diabetes mellitus
* medications that impair sex hormone synthesis, secretion or function
* acute or chronic infections
* body weight loss \> 5% during the last 6 months or \> 10% during the last 10 months
* fish oil supplementation within 3 months prior to study entry
* taking vitamins in doses greater than recommended daily allowance
* life expectancy less than 6 months in the opinion of the investigator
Effects of Intramuscular (IM) Oxytocin on Pupil Diameter and Heart Rate Variability (HRV)

The goal of this study is to test the effects of oxytocin on heart rate variability and pupil diameter, both of which have subtle effects on the activity rate of the autonomic nervous system.

This protocol focuses on two measures of autonomic control to quantify central actions of oxytocin. First, the study team proposes to examine the influence of oxytocin on heart rate variability with focus on its effect on high frequency variability, most commonly ascribed to parasympathetic nervous system activity acting to brake sympathetic tone. Intranasal oxytocin has been demonstrated to have a large effect size on this measure which can be repeated at frequent intervals. As a secondary assessment of parasympathetic activity, the study team will measure low frequency fluctuation in pupil diameter, termed hippus, which also reflects parasympathetic nervous system activity. This outcome measure can be assessed in 3 seconds using equipment currently being used under Institutional Review Board (IRB) approved protocols.

Eligibility Criteria:
Inclusion Criteria:

* Male or female \> 18 and \< 66 years of age,
* Body Mass Index (BMI) \<40
* Generally in good health as determined by the Principal Investigator based on prior medical history
* Normal blood pressure and resting heart rate without medication

Exclusion Criteria:

* Hypersensitivity, allergy, or significant reaction to any ingredient of Pitocin®
* Any disease, diagnosis, or condition (medical or surgical) that, in the opinion of the Principal Investigator, would place the subject at increased risk
* Women who are pregnant (positive result for serum pregnancy test at screening visit),
* Women who are currently nursing or lactating, women that have been pregnant within 2 years.
* Neuropathy, chronic pain, diabetes mellitus, or taking benzodiazepines or pain medications on a daily basis.
* Previous eye surgery, eye medications, cataracts
Intestinal Microbiota and Antimicrobial Resistance

Antimicrobial resistance is regarded as one of the major global public health threats, causing at least 700,000 deaths per year. It has been estimated that if the current problem of antimicrobial resistance is not effectively tackled, it would cause the death of 10 million people worldwide by 2050. Multi-drug resistant pathogen is the single most important contributing factor for inappropriate antibiotics therapy, and this in turn lead to higher mortality in patients with sepsis. The slow pace of development of new classes of antimicrobial agents limits the availability of effective therapy for multi-drug resistant organisms, both currently and in the near future. It is therefore of utmost importance to look for strategies to reduce the spread and burden of antimicrobial resistance.

Intestinal microbiota probably played a dominant role in determining the risk of acquisition of multi-drug resistant organisms. For instance, findings from a mouse model showed that Barnesiella species conferred resistance to intestinal colonization by vancomycinresistant Enterococcus. Such findings were subsequently confirmed in human subjects.

This is a prospective longitudinal observational study evaluating the correlation between changes in intestinal microbiota and acquisition of antimicrobial resistance in patients hospitalized for stroke.

Adult patients admitted to the Medical unit of the Prince of Wales Hospital with a diagnosis of acute stroke will be screened for eligibility and will be invited to participate in this study. Data collected from this study will determine the correlation between antibiotics use and changes in intestinal microbiota in a cohort of hospitalized patients as well as the correlation between intestinal microbiota and acquisition of intestinal colonization or infection caused by resistant pathogens.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years or above, and
* Radiological evidence of acute ischaemic or hemorrhagic stroke
* Within two days of hospital admission

Exclusion Criteria:

* Use of antibiotics within 4 weeks prior to the time of screening
* Underlying gastrointestinal diseases, including gastrointestinal malignancy, inflammatory bowel disease, resection of small or large bowel
* Pregnancy
Hepatitis B Virus Vertical Transmission From HIV-HBV Co-infected Women

Vertical HIV transmission has been dramatically reduced by the use of combined antiretroviral therapy in HIV-infected pregnant women. Among the most often used drugs, several have dual activity, against HIV and HBV: lamivudine, emtricitabine, tenofovir. Studies about vertical HBV transmission from HIV-HBV co-infected pregnant women are rare in developed countries. The study hypothesis is a major reduction of the risk of HBV vertical transmission.

Mother-to-Child HIV transmission has been dramatically reduced by the use of combined antiretroviral therapy in HIV-infected pregnant women, both in developed and in developing countries. Among the most often used drugs, several have dual activity, against HIV and HBV: lamivudine, emtricitabine, tenofovir; they can be used as a combo, as tenofovir+emtricitabine for instance. Studies about vertical HBV transmission from HIV-HBV co-infected pregnant women are rare in developed countries. The study hypothesis is a major reduction of the risk of HBV vertical transmission in this context, justifying this retrospective study.

Eligibility Criteria:
Inclusion Criteria:

* children born in the Maternity Department from HIV-HBV co-infected women
* whose mother was given a treatment with dual activity (HIV and HBV) during pregnancy

Exclusion Criteria:

* no
Use of Telemedicine to Address 'Off Target' Symptoms in Psoriatic Arthritis (PsA)

This will be a single-arm interventional study to test the acceptability, feasibility, and effectiveness of structured telemedicine visits to encourage lifestyle changes that will improve quality of life, disease impact, and disease activity in patients with psoriatic arthritis (PsA).

The proposed trial will be embedded within clinical care. This is a 2-year interventional trial that will enroll patients with active psoriatic arthritis despite stable therapy among three centers (the University of Pennsylvania, University of Utah, and University of Oxford). The intervention employs PsOWellTM, a program that trains clinicians to utilize motivational interviewing to help patients set goals and make lifestyle/behavior changes for holistic management of psoriasis.

Eligibility Criteria:
Inclusion Criteria:

* Population: Patients with Psoriatic Arthritis

  * Age 18-89.
  * Active symptoms of PsA as defined by a PsA Impact of Disease (PsAID) questionnaire score \>4 (range 0-10, 4 is the patient acceptable symptom state) or a patient global assessment of greater than 4 (scale 0-10).
  * Patients should be stable on therapy (i.e., not planning to switch therapy at the current visit).
  * Meet CASPAR criteria.
  * Provision of signed and dated informed consent form.
  * Willingness to comply with all study procedures and availability for duration of the study.
  * Has access to a mobile phone or other mobile device.

Exclusion Criteria:

* Inability to provide informed consent.
* Plan to change systemic treatment for psoriasis or PsA in the next 4-8 weeks.
* PsAID score ≤4
Screening and Molecular Diagnosis-based Individualized Precision Management of Monogenic Diabetes

The goal of this observational study is to establish a registry, screening, and individualized management platform for patients with monogenic diabetes mellitus(MDM) using internet-based and mobile application software. The main questions it aims to answer are:

* What are the genetic mutations causing MDM in China (genetic landscape)?
* How effective and safe is the individualized, molecular-diagnosis-based management platform for MDM in improving patient outcomes?

Participants will:

* Register in the MDM platform via mobile app or internet-based software
* Undergo genetic screening for MDM diagnosis
* Participate in follow-up visits for individualized management and monitoring of blood glucose control and outcomes


Eligibility Criteria:
Inclusion Criteria:

1. Diabetes patients who developed before 25 years old; Or they were diagnosed with diabetes before the age of 35, and two or more immediate relatives were diagnosed with diabetes before the age of 45;
2. Body mass index (BMI) at diagnosis \< 28 kg/m2;
3. Anti glutamic acid decarboxylase antibody (GAD Ab), anti islet cell antibody (ICA Ab), and anti insulin autoantibody (IAA Ab) were all negative;

Exclusion Criteria:

1. Secondary diabetes patients with other endocrine diseases, such as hyperthyroidism or hypothyroidism, hyperparathyroidism or hypothyroidism, acromegaly, Cushing's syndrome, autoimmune multiple endocrine diseases, etc.;
2. Systemic use of corticosteroids, immunosuppressants, and other drugs within the past 6 months;
3. Patients with malignant tumors.
A Prospective Cohort Study to Evaluate Molecular pRognostic Factors and Resistance Mechanisms to Osimertinib in Adjuvant Treatment of Completely Resected pIB-IIIA Non-small Cell Lung Carcinoma With Common EGFR Mutations (L858R and Del19)

IFCT-2202 ROSIE study aims to incorporate a broad-panel centralized NGS testing at baseline in all patients with completely resected NSCLC with common EGFR mutation after confirmation of an optimal preoperative extension assessment and with a centralized review of the quality of the surgical excision. Furthermore, the IFCT-2202 ROSIE study also aims to study the molecular events associated with relapse on, or after osimertinib exposure, that should result in the opportunity to accede to optimal treatment in case of metastatic relapse.


Eligibility Criteria:
Inclusion Criteria:

1. Signed Informed consent.
2. Age ≥ 18 years.
3. Pre-surgical disease evaluation including brain MRI/CT-scan and total body PET-FDG CT-scan prior to surgery.
4. Histologically complete anatomical resection (R0) of stage pIB-IIIA (pTNM 8th edition) NSCLC.
5. Presence of a common EGFR mutation (Del19 or L858R).
6. Archival tumour tissue FFPE blocks from surgery available for centrally molecular analyses.
7. Patient eligible to receive osimertinib adjuvant therapy in a 3-year intent to treat decision; patients could receive if necessary adjuvant chemotherapy before starting osimertinib treatment.
8. Patient who is capable, according to the investigator, of complying with the study's requirements and restrictions.
9. Patient followed in the institution on a regular basis (every 3 to 6 months) according to standard recommendations.
10. Estimated life expectancy \> 3 years.
11. Woman patients who are of childbearing potential are eligible:

    * They must have a negative pregnancy test before the first dose of osimertinib.
    * They must agree to use effective methods of contraception throughout the course of treatment and should be maintained for 2 months after the end of treatment.
12. Male subjects who are sexually active with a woman of childbearing potential are eligible if an efficacious contraception method should be used during the treatment and during the 4 months following the last dose.

Exclusion Criteria:

1. History of cancer, except for the following situations:

   Patients with history of cancer for more than 3 years are eligible if they have been treated and considered cured. Patients with history of in situ carcinoma of the cervix or non-melanoma skin carcinoma are eligible.
2. Neoadjuvant anti-cancer treatment (osimertinib and/or chemotherapy or other anti-cancer treatment).
3. Incompletely resected NSCLC (R1 or R2).
4. Any medical condition that would, according to the investigator's judgment, prevent the patient's participation in the clinical study.
5. Active infection (e.g. patients receiving treatment for infection) including hepatitis C virus (HCV) and human immunodeficiency virus (HIV), or active uncontrolled hepatitis B infection except for the situations described in APPENDIX I. Screening for chronic conditions is not required.