cyrilzakka/clinical-trials huggingface dataset:
AYA STEPS RCT: AYA Self-Management Via Texting, Education & Plans for Survivors

The proposed project will leverage two programs of research at UPenn and CHOP that are delivering technology-based interventions to adolescent and young adult (AYA) cancer survivors.

In the proposed study, all AYA survivors will receive a care plan via a tool (Smart-ALACC). They will then be randomized to receive (or not) a mobile health application (AYA STEPS) that will provide tailored messages to enhance uptake of their care plan.


Eligibility Criteria:
Inclusion Criteria:

* AYA is 15-29 year old with a history of a malignant cancer diagnosis;
* Completed cancer treatment and are currently in remission or receiving cancer survivorship care;
* Seen for follow-up oncology care at CHOP or Penn;
* For AYA less than 18 years old, must have a caregiver to provide informed consent.

Exclusion Criteria:

* Cognitive impairments that would limit AYA ability to independently care for health as determined by the medical team.
* Absence of the inclusion criteria
The Use of Drugs to Improve Kidney Function in Patients With Liver and Kidney Dysfunction

We will address the hypothesis that refractory ascites and Type 2 hepatorenal syndrome are mediated in part by diminished circulatory volume and that treatment with midodrine, octreotide and albumin can improve renal and patient outcomes by restoring effective circulating volume and systemic perfusion.

Our primary objective is to assess change in creatinine clearance using inulin. We will enroll 15 patients with Type 2 hepatorenal syndrome or refractory ascites once inclusion and exclusion criteria are satisfied. They will be treated for 1 month with octreotide LAR, albumin and midodrine. Renal, serum and neurohormonal parameters will be measured before, during, and after initiation of drug and compared.


Eligibility Criteria:
Inclusion Criteria:

* Cirrhosis (biopsy or compatible clinical (ascites, varices), laboratory (low albumin, elevated bilirubin, elevated INR) and radiologic data (nodular appearing liver on ultrasound)).

Type 2 hepatorenal syndrome and/or refractory ascites

Exclusion Criteria:

* Secondary causes of renal dysfunction (proteinuria \>500 mg/day, active urinary sediment, abnormal renal ultrasound, nephrotoxic medications) Bacterial infection (positive blood, urine or ascites cultures) within the past 2 weeks Gastrointestinal hemorrhage or encephalopathy within the past 2 weeks Age \<18 Transvenous intrahepatic portosystemic stent shunt (TIPS) Hepatocellular carcinoma beyond the Milan criteria
Expression of Tuberculosis in the Lung

The purpose of this study is to assess lung immune responses in patients with active pulmonary tuberculosis (TB) and in healthy control persons who are exposed to Mycobacterium tuberculosis in households of patients with TB or who are unexposed.

BACKGROUND:

M. tuberculosis infects a third of the world's population, and TB is the leading cause of morbidity and mortality due to a single infectious agent. However, only 5% to 10% of M. tuberculosis-infected subjects without an underlying immunodeficiency develop disease during their lifetimes. Therefore protective immunity is induced in the majority of subjects. Understanding correlates of protection against M. tuberculosis in humans is needed to better direct efforts in the development of antituberculosis vaccines.

DESIGN NARRATIVE:

Patients are treated according to good clinical practice; however, no study medications are given as part of the research study. This study involves a one-time bronchoalveolar lavage and venipuncture to obtain immune cells for laboratory studies of immune responses.

Eligibility Criteria:
Inclusion Criteria:

* TB patients who are 18 to 65 years old
* Clinical and radiographic signs and symptoms consistent with pulmonary TB
* Start date of antituberculous chemotherapy less than 10 days prior to procedures
* Sputum smear positive for acid fast bacilli
* Drug-sensitive, culture-confirmed growth of M. tuberculosis from sputum
* Willing to provide informed consent for participation in bronchoalveolar lavage and venipuncture studies

Exclusion Criteria:

* TB patients who have HIV-1 coinfection
* History of any chronic medical condition requiring daily medication (including diabetes mellitus, hypertension, chronic infections, renal or cardiac failure, and peptic ulcer disease)
* History of asthma or upper or lower respiratory tract infection within 2 months of the study
* Hemoglobin level less than 10g/dl
Analysis of Human Movement With Assistive Devices

The purpose of this research is to evaluate how people move about in different settings with different assistive devices or components, and to understand how people interact with different assistive technologies. Individuals that have limb weakness, limb paralysis, limb loss, and movement disorders are often provided assistive devices such as prostheses and orthoses to assist with mobility or use assistive technologies for purposes such as to regain muscle strength or retrain movements. It is important to understand the impact of these different assistive technologies on human movement for technology improvement and in preparation for commercialization.

Because this research focuses on evaluating how different people move about in different settings with different assistive devices/components, there are different activities that may take place. These activities have been classified as (1) Movement Analysis in the Laboratory, (2) Movement Analysis Outside the Laboratory, (3) Usability Testing, and (4) Focus Groups. Each participant may or may not complete the same activities as the other participants. Each participant may or may not complete all of the activities. Participants may complete the activities more than once.


Eligibility Criteria:
Inclusion Criteria for Nondisabled Participants:

* Age 18 - 90 years
* Has bilateral normal range of motion
* Able to perform a variety of movement activities
* Able to communicate and write individual perceptions in English
* Able to provide written informed consent
* Participants that will use a treadmill during data collection must also be able to walk independently and safely on a treadmill

Exclusion Criteria for Nondisabled Participants:

* Health issues (e.g., confounding injury, musculoskeletal, or cognitive) or other issues (e.g., transportation or schedule issues) that limit effective participation and/or may not represent a nondisabled condition
* Pregnancy
* Not able to read and understand English

Inclusion Criteria for Participants with a Disability:

* Age 18 - 90 years
* Has a condition or diagnosis that results in limb weakness, limb paralysis, limb loss, or movement disorders
* Medically stable
* Has stable balance
* Able to perform a variety of movement activities
* Able to communicate and write individual perceptions in English
* Able to provide written informed consent
* Participants that will use a treadmill during data collection must also be able to walk independently and safely on a treadmill
* Able to safely complete the movements being tested and/or safely use the assistive devices being tested

Exclusion Criteria for Participants with a Disability:

* Health issues (e.g., confounding injury, musculoskeletal, or cognitive) or other issues (e.g., transportation or schedule issues) that limit effective participation and/or may result in mixed effects of multiple sources of disability
* Pregnancy
* Not able to read and understand English
Left Bundle Branch Area Pacing in AVB Patients

Right ventricular pacing (RVP) causes left ventricular mechanical dyssynchrony by inducing electrical interventricular and intraventricular dyssynchrony. His bundle pacing may restore the the atrioventricular, interventricular and intraventricular electrical synchronization, however, Increased pacing threshold might result in the early depletion of the pacemaker, and finally brought on pacemaker replacement, which was one of the major causes of device infection. Pacing the left bundle branch beyond the conduction block site might achieve a low and stable output and narrow QRSd. The investigators were prepared to consecutively include patients with atrioventricular block, divided into the left bundle branch area pacing(LBBAP) group and the conventional right ventricular pacing group. The electrophysiological characteristics of LBBAP and right ventricular pacing were compared with ECG characteristics. The left and right ventricular synchrony and left and right cardiac function were evaluated by 3D ultrasound, and the short-term and long-term safety and efficacy of LBBAP were evaluated.

This study is intended to be included in Fuwai hospital for admission to the atrioventricular block, with permanent pacemaker implant indications recommended by current guidelines. Patients were assessed for preoperative electrocardiogram, quality of life scores, cardiac function, and left and right ventricular synchrony. Patients were followed up by regular outpatients. The electrocardiogram, quality of life score, echocardiographic function, left and right ventricular synchrony, pacing parameters and pacing ratio were evaluated immediately after surgery, 3 months, 6 months, and 12 months after surgery. At the same time, the left bundle branch area pacing success rate, complications during intraoperative and postoperative follow-up were recorded.

Eligibility Criteria:
Inclusion Criteria:

1. Age over 18 years old;
2. Atrioventricular block patients with indication for permanent ventricular pacing;
3. LVEF\> 40%;
4. With informed consent signed

Exclusion Criteria:

1. Persistent atrial fibrillation;
2. Moderate or more severe valvular disease;
3. Hypertrophic cardiomyopathy；
4. Myocardial amyloidosis；
5. With indication for CRT or ICD implantation according to the current guideline;
6. Poor condition of the acoustic window because of emphysema or other reasons;
7. Patients refused postoperative follow-up.
Collection of Blood Samples in Patients With Non-small Cell Lung Cancer

This pilot research trial studies the collection of blood samples in monitoring tumor specific mutations in patients with non-small cell lung cancer that has spread to other places in the body or cannot be removed by surgery. Collecting blood samples may help measure the changes in lung cancer, better learn methods to track cancer in the bloodstream, and improve cancer treatments.

PRIMARY OBJECTIVES:

I. To evaluate the ability of next generation sequencing (NGS) to monitor the evolution of cancer-specific mutations in patients undergoing treatment for non-small cell lung carcinoma and for whom the molecular profile of the tumor cells prior to treatment is known.

II. Compare the sensitivity of digital droplet polymerase chain reaction (ddPCR) to that of NGS for detecting the appearance of EGFR T790M mutations in patients treated with an EGFR tyrosine kinase inhibitor.

OUTLINE:

Patients undergo collection of blood samples at baseline and every 12 weeks for up to 6 times.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of non-small cell lung carcinoma for which the molecular profile of the primary tumor has been obtained from a block of paraffin-embedded, formalin-fixed tissue that remains available
* Zubrod performance status 0 or 1
* Patients must have metastatic or unresectable disease and be starting a new line of systemic treatment at the time of enrollment; there are no constraints regarding the time interval between the initial collection of samples for molecular profiling studies at the time of diagnosis prior to treatment and subsequent collections of circulating cell-free deoxyribonucleic acid (DNA) or circulating tumor cells
* Patients must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1
* Ability to understand and the willingness to sign a written informed consent; Note: There will be no discrimination between type of treatment or whether they are on continuous versus intermittent therapy

Exclusion Criteria:

* Known severe anemia (hemoglobin \[Hb\] \< 8g/dL)
* Patients will be excluded if trackable driver mutations are not identified in the primary tumor tissue
High Flow Oxygen VERSUS Non Invasive Ventilation Associated to Automated Flow Oxygen Titration After Patient Extubation

Extubation stay at high risk of reintubation even scheduled and in the best condition of hematosis. Re-intubation's rate in main studies in chronic obstructive diseases reach to 20% and it is associated to a higher mortality, higher pneumonia under mechanic ventilation, and higher duration of hospitalization especially in intensive care units.

Place of NIV in this situation is still on evaluation. A recent meta-analysis demonstrates that use of NIV in post-extubation in COPD seems to decrease re-intubation rate.

HFO, thanks to its properties (oxygen, humidification and heat with high flow) could be useful in this population in ventilatory weaning. Compared to oxygen conventional therapy with high-concentration mask, HFO seems to be as efficient and better tolerated. A recent study shows that HFO is non-inferior to NVI in post-extubation in patient with high risk of re-intubation.

Furthermore, oxygenation in post-extubation should be optimized to avoid hypoxemia and hypercapnia in this patient at risk of hypoventilation. Place of AFOT could improve hematosis by providing adapted flow of oxygen to each patient.

The investigator choose the hypothesis for this study that HFO is as effective and tolerated in post-extubation than NIV with AFOT.

A recent meta-analysis demonstrates that use of NIV in post-extubation in obstructive chronic bronchopathies seems to decrease re-intubation rate.

High Flow Oxygen, thanks to its properties (oxygen, humidification and heat with high flow) could be useful in this population in ventilatory weaning. Compared to oxygen conventional therapy with high-concentration mask, High Flow Oxygen seems to be as efficient and better tolerated . A recent study shows that High Flow Oxygen is non-inferior to Non Invasive Ventilation in post-extubation in patient with high risk of re-intubation.

Furthermore, oxygenation in post-extubation should be optimized to avoid hypoxemia and hypercapnia in this patient at risk of hypoventilation.

Eligibility Criteria:
Inclusion Criteria:

* Patient with respiratory disease suspected or proved (COPD, asthma, bronchiectasis, cystic fibrosis, interstitial pneumonia, obstructive insufficient respiratory, restrictive insufficient respiratory) when an extubation is scheduled.
* Patient who signed the informed consent
* Patient affiliated to social insurance

Exclusion Criteria:

* Pregnant woman
* Terminal extubation
* NIV at home before intubation (non-exclusion of continue positive airway pressure: CPAP)
* Tracheotomy
* Patient under trusteeship, guardianship or safeguard of justice
Epicardial Fat Pads Ablation During Coronary Surgery

The aim of this prospective randomized study was to assess the efficacy of ablation of the ganglionated plexi localized in the epicardial fat pads for preventing recurrences of atrial tachyarrhythmia in patients with paroxysmal atrial fibrillation undergoing coronary artery bypass grafting.


Eligibility Criteria:
Inclusion Criteria:

* History of paroxysmal atrial fibrillation (recurrent episodes for at least 1 years, with 2 documented episodes over the last 6 months)
* Indication for cardiac surgery (e.g. coronary artery bypass grafting, valve repair/replacement) according to the American College of Cardiology/American Heart Association (ACC/AHA) guidelines for cardiac surgery

Exclusion Criteria:

Previous heart surgery or atrial fibrillation ablation procedure Emergency coronary artery bypass grafting Unstable angina or heart failure Persistent atrial fibrillation Planned maze procedure or pulmonary vein isolation Unwillingness to participate
Noninvasive Estimation of Work of Breathing

This study will evaluate the correlation between invasively measured parameters (work of breathing/power of breathing, resistance and elastance), derived using esophageal pressure measurements, and their corresponding non-invasive estimated values (noninvasive work of breathing/power of breathing, resistance and elastance), computed using airway pressure and flow measurements only.

This study will evaluate the correlation between invasively measured parameters (work of breathing/power of breathing, resistance and elastance), derived using esophageal pressure measurements, and their corresponding non-invasive estimated values (noninvasive work of breathing/power of breathing, resistance and elastance), computed using airway pressure and flow measurements only. Vent settings will be adjusted to test accuracy over a range of respiratory support conditions.

Eligibility Criteria:
Inclusion Criteria:

* Adult medical/surgical ICU patients (Age≥18) on mechanical ventilation for respiratory failure, spontaneously breathing and receiving eligible for pressure support ventilation (PSV).

Exclusion Criteria:

* Prisoners and patients with closed-head injury (e.g., trauma), hemodynamic instability, multiple organ system failure or late term pregnancy will not be studied.
Clinical Trial of Clinical Efficiency and Safety of Ergoferon in Treatment of Influenza

The purpose of this study is:

* to assess clinical efficiency of Ergoferon for treatment of influenza
* to assess safety of Ergoferon for treatment of influenza
* to compare efficiency of Ergoferon and Tamiflu for treatment of influenza


Eligibility Criteria:
Inclusion Criteria:

1. Patients of both sexes aged from 18 to 60 inclusively.
2. Patients with body temperature \>37,8°C at the moment of examination by the doctor; with at least one catarrh symptom (cough, rhinitis, sore throat) and one intoxication symptom (myalgia, fever/hyperhidrosis, malaise, weakness, headache) during seasonal influenza morbidity.
3. Diagnosed influenza confirmed by express diagnostics (presence of antigens of influenza virus in nasal passages epithelium and proved by QuickVue immunological test).
4. The possibility to start therapy within 24 hours after the onset of the first influenza symptoms.
5. Signed Informed Consent form for participation in the study.

Exclusion Criteria:

1. Patients aged below 18 years and above 60 years.
2. Suspected invasive bacterial infection or presence of severe disease requiring use of antibacterial drugs (including sulfanilamides).
3. Vaccination against influenza prior to epidemic season onset.
4. Medical history of polyvalent allergy.
5. Allergy/ intolerance to any of the components of medications used in the treatment.
6. Exacerbation or decompensation of chronic diseases affecting the patient's ability to participate in the clinical trial.
7. Chronic renal insufficiency.
8. Intake of medicines listed in the section "Prohibited concomitant treatment" for 15 days prior to the inclusion in the trial.
9. Pregnancy, breast feeding, unwillingness to keeping to contraception method during the study.
10. Drug addiction, alcohol usage in the amount over 2 units of alcohol per day.
11. Patients, who from investigator's point o view, will fail to comply with the observation requirements of the trial or with the intake regimen of the investigated medicines.
12. Participation in other clinical trials in the course of 1 month prior to the inclusion in the trial.
13. The patient is related to the research personnel of the investigative site, who are directly involved in the trial or are the immediate relative of the reseacher. The immediate relatives includes husband / wife, parents, children, brothers (or sisters), regardless of whether they are natural or adopted.
14. The patient works for OOO "NPF "Materia Medica Holding" (i.e. is the company's employee, temporary contract worker or designated official responsible for carrying out the research) or the immediate relative.
The Prone XLIF. A Pilot Study

Observational prospective study to evaluate the feasibility, effectiveness and the rate of complications of the XLIF (Extreme Lateral Interbody Fusion) performed in prone position to treat spinal diseases of the lumbar region.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Patients suffering from lumbar spinal disease that requires a circumferential fusion
* Patients suitable to undergo spinal fusion with an XLIF technique (according to the label indication/contraindications)
* Patients who are willing and able to provide written informed consent to surgery and study

Exclusion Criteria:

* a congenital or post-traumatic vertebral abnormality at the target level
* patients with a previous abdominal retroperitoneal surgery
* patients that refuses/not suitable to undergo a XLIF surgery in prone position
* subjects that are unable to provide a written informed consent to surgery and study
* subjects that are unable to will or intend
* pregnant women (declared before surgery)
Analgesic Effect of Ropivacaine Plus Fentanyl vs Ropivacaine for Continuous 3-in-1 FNB After Total Knee Arthroplasty

The postoperative analgesic effect of the continuous 3-in-1 femoral nerve block (FNB) with ropivacaine/fentanyl or with ropivacaine were compared in total knee arthroplasty.

Forty patients of American Society of Anesthesiologist physical status Ⅰor Ⅱ undergoing total knee arthroplasty under spinal anesthesia would be enrolled and randomly divided into two groups (R, "3-in-1" using a 30 ml of ropivacaine 0.375% and a continuous 3-in-1 with a ropivacaine 0.2%(8mL/h) for 48 h after operation, RF: Fifty ug of fentanyl will be added to a bolus(30ml ropivacaine 0.375%) and 1ug/ml of fentanyl will be mixed to a continuous infusion(8mg/h, ropivacaine 0.2%). Spinal anesthesia will be done after the insertion of femoral catheter. IV PCA with hydromorphone(0.15mg/ml, 0-1-10), will be used for rescue analgesics. Visual analgesia scale, hydromorphone consumption, side effects until 48h after operation and satisfaction will be compared.

Eligibility Criteria:
Inclusion Criteria:

* ASA PS 1 to 3 undergoing total knee arthroplasty under spinal anesthesia

Exclusion Criteria:

* Patients were excluded from this study if they had contraindications to a regional anesthetic technique (e. g., local infection, sepsis, coagulation abnormality), allergy to local anesthetic or fentanyl, preexisting neurologic deficit in the lower extremities, and inability to comprehend the pain scales or use IV patient-controlled analgesia (PCA) device.
Innovative Methods to Reduce Emissions and Health Impacts of Deep-frying

Cooking oil fume (COF) is a significant source of PM2.5 for poorly ventilated space indoors and in urban streets near restaurants or night markets. Modern Chinese cooking produces high concentration of COF especially from deep-frying foods and stirred frying. Emission from high-temperature frying has been classified by the IARC as Group 2A carcinogen. Cooks are at high risk of exposure to toxic compounds from cooking fumes. However, more of the COF-related studies focused on the home kitchen and less addresses the problems in the restaurants. Studying health hazards and biomarkers of cooks may provide opportunities to understand biological mechanisms and to search and test efficacy for measures to overturn such risks.

The investigators will recruit 80 cooks who handle deep-frying and stirred frying on daily basis. The 80 cooks will be randomized to 4 groups: (1) control, (2) vegetable and fruits extract (V\&F) group, (3) fish oil group, and (4) V\&F-fish oil group will be provided to the participants for 2 months V\&F capsules (equivalent to 4 servings a day) and fish oil capsules (1\~1.5 serving a day) and placebos of the same appearance. Heart rate variability (HRV), pulmonary functions, bio-markers, oxylipins and metabolomics profile will be measured as outcomes.


Eligibility Criteria:
Exclusion Criteria:

1. Acute diseases in the past 2 weeks
2. Taking anti-oxidant supplements in the past month
3. Taking steroid or non-steroidal anti-inflammatory drugs (such as Aspirin and Panadol) in the past week
4. Under hormone replacement therapy
5. Cancer and other severe diseases