cyrilzakka/clinical-trials huggingface dataset:
Concurrent Chemo-radiation Form NSCLC to a Individualized MLD

Our group has shown in a modeling study that increasing the radiation dose to pre-specified normal tissue dose constrains could lead to increased TCP with the same NTCP in patients with non-concurrent chemo-radiation. In a subsequent phase I trial, in patients receiving non-concurrent chemo-radiation we showed the safety of this approach. Here,we want to investigate its efficacy in a prospective study in patients with stage III NSCLC, who are selected for radical concurrent radiotherapy

Eligible patients (see below) will receive radiotherapy to the primary tumor and the initially involved mediastinal lymph nodes to the following MLD (Mean Lung Dose):

* MLD=19 Gy when Fev1 and DLCO\>50% of the predicted value
* MLD=15 Gy when Fev1 and/or DLCO 40-49% of the predicted value
* MLD=10 Gy when Fev1 and/or DLCO \<40% of the predicted value

Other dose-constrains: spinal cord max: 54 Gy, brachial plexus (Dmax):66 Gy Minimum tumor dose:54 Gy. Maximal tumor dose:69 Gy

Radiotherapy will be delivered as follows:

1. First 3 weeks: 30 fractions: twice-daily fractions of 1.5 Gy, with 8 to 10 h as interfraction-interval, 5 days per week Total dose;45Gy/30 fractions
2. Thereafter: once-daily fractions of 2.0 Gy, 5 days per week until the target dose has been reached.

The radiation doses will be specified according to ICRU 50. Lung density corrections will be applied, as well as all standard QA procedures. Technical requirements are the same as in standard practice at MAASTRO clinic.

Chemotherapy schedules allowed:

1. 1-2 cycles induction chemotherapy; any type will be registered.
2. concurrent part:(day1= first day of radiotherapy)

   1. cisplatin - vinorelbine

      * Cisplatin 50 mg/m2 day 2 and day 9
      * Vinorelbine 20 mg/m2 day 2 and day 9
      * Cisplatin 40mg/m2 day 23
      * Vinorelbine 15mg/m2 day 23 and day 30
   2. cisplatin - docetaxel

      * Cisplatin 50 mg/m2 day 2,9 and 29
      * Docetaxel 20 mg/m2 day 2, 9, 16, 23 and 29
   3. cisplatin - etoposide

      * Cisplatin 60 mg/m2 day 1
      * Docetaxel 120 mg/m2 day 1-3

Q 3 weeks, 3 cycles

When the calculated creatinin clearance is less than 60 ml/min, cisplatin may be substituted for carboplatin

Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological proven NSCLC
* UICC stage I-III
* Performance status 0-2
* FeV 1 and DLCO at least 30% of the age-predicted value

Exclusion Criteria:

* Not NSCLC or mixed NSCLC and other histologies (e.g. small cell carcinoma)
* UICC stage IV
* Performance status 3 or more
* FeV 1 and DLCO \< 30% of the age-predicted value
Nurse Leadership for Hospital Infection Control

The aim is to deliver an intervention to promote nurse leadership and decision-making in the hospital setting, by providing them with training for maintaining minimum service delivery standards for hospital infection control with respect to COVID-19; but also other infectious disease burden management.

Nurses are frontline practitioners in the fight against COVID-19. Empowering nurses through training for infection prevention for COVID-19 is an essential step to facilitate nurse leadership and safety in the hospital. There is immense reliance on nurses with regard to patient safety, yet very little effort is made to invest in interventions for their leadership roles in developing countries, including Pakistan. In this study the aim is to deliver an intervention for COVID-19 preventive protocols to nurses and assess the impact of the intervention through a pre and post-test survey. A total of 200 nurses will be sampled. A 100 nurses each will be part of the control and experiment group each.

The data will be analyzed using SPSS. Pre and post test results will be presented using descriptive data and bivariate regression will be used to present higher odds of confidence in preventive and awareness literacy for COVID-19 in nurses after intervention delivery. Through this research the aim is to improve nurse leadership in maintaining minimum service delivery standards for hospital infection control with respect to COVID-19; but also other infectious disease burden management.

Eligibility Criteria:
Inclusion Criteria:

* The selection criteria will be all currently working staff nurses.

Exclusion Criteria:

* Student nurses or nurses not part of clinical rounds.
Patient Reported Outcome and Experience Measures for Bronchoscopic Procedures

'Patient-reported outcomes' (PROMS) and 'patient-reported experiences' (PREMS) are increasingly important parameters in evaluating and adjusting clinical procedures and strategies in healthcare.

Validated disease-specific PROMS related to bronchoscopic procedures are not available and examples in the medical literature are very scarce.

The potential usefulness of PROM/PREMS is multiple:

1. Quality improvement within the current clinical care structure
2. Monitoring the health status of the population
3. Contribution to decision-making regarding financing of care
4. Increase employee and patient involvement in clinical care pathways
5. Rationalize the deployment of medical personnel and resources
6. Integration of data in electronic patient files and registers

Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years
* Patient referred for diagnostic flexible bronchoscopy
* Procedure performed in outpatient setting

Exclusion Criteria:

* Patient unable to adequately respond to the contents of the patient questionnaire.
* Procedure performed in hospitalised setting
* Patient with active pregnancy
Use of PARniv for Early Diagnosis of LVF in AECOPD

Left ventricular failure (LVF) is a common cause of acute exacerbation of chronic obstructive pulmonary disease (AECOPD).

This association is frequently underestimated with regard to the difficulty of clinical diagnosis .

The investigators expect that the application of pressure support under NIV could be useful in this issue.

Acute heart failure (AHF) is a common cause of COPD exacerbation however its role is very often underestimated. Until now, the use of echocardiography and some invasive hemodynamic exploration techniques such as the Swan-ganz catheter has been stated as reference. Other noninvasive diagnostic methods have been studied, such as systolic time intervals and Valsalva maneuver, but their application still difficult in patients with COPD exacerbation, especially in emergency department (ED) settings. the study aimed to evaluate the performance of a new diagnostic technique based on the measurement of the PAR using non invasive ventilation (NIV) for the early identification of left ventricular failure (LVF) in patients presenting to the ED with acute COPD exacerbation

Eligibility Criteria:
Inclusion Criteria:

* patients with a history of COPD
* consulted the emergency department for AECOPD defined by a respiratory rate \>25c/min, SaO2 \<90%, pH \<7.35 and PaCO2 \>6kPa were included.

Exclusion Criteria:

* hemodynamic instability requiring the use of vasoactive drugs
* patients with contraindications to NIV (Glasgow score \<12, swallowing disorder or severe bronchial obstruction, vomiting, and those with upper airway obstruction or ongoing upper gastrointestinal bleeding and altered bronchial clearance)
* non cooperative patients
* who refused to give consent.
COPD Rehabilitation in Primary and Secondary Health Care

Pulmonary rehabilitation of COPD patients are implemented in a non-randomized manner in two settings: primary and secondary health care. The effect on quality of life and hospitalizations will be evaluated


Eligibility Criteria:
Inclusion Criteria:

* COPD patients

Exclusion Criteria:

* severe concomitant chronic disease
Isoleucine, Leucine, Valine and Tryptophan Requirements in TPN Fed Neonates

This project will be conducted in 2 hospitals in Brazil to assess the requirements for four essential amino acids in TPN fed neonates. Using the Carbon Oxidation method (indicator amino oxidation and direct amino acid oxidation method), the investigators will determine the requirement of each of the 4 amino acids.

The investigators will determine the requirement for Isoleucine, Leucine, Valine and Tryptophan. The investigators will recruit 18- 20 babies per amino acid study. Breath and urine samples will be collected to determine the oxidation of the indicator amino acid. The response of the indicator amino acid to changes in intake of the test amino acid (isoleucine, leucine, valine and tryptophan) will be analyzed by bi-phase linear mixed effect model to determine the breakpoint or mean requirement for each amino acid. It is hypothesized that the requirement for isoleucine, leucine, valine and tryptophan will be at least 50% lower than what is currently available in commercial solutions used for TPN feeding of neonates.

The study is based on the carbon oxidation protocol. Each baby will receive one or two levels of either isoleucine or leucine or valine or tryptophan. Each level will be assessed over a two- day period.

On day 1: each baby will receive a standard pediatric amino acid solution, Primene used in the NICU and L-\[1-13C\]Na Bicarbonate will be given to measure carbon dioxide production.

On day 2: he/she will receive the appropriate TPN Test Solution made up of the appropriate Bulk Amino Acid solution (for Isoleucine/ Leucine/ Valine/ Tryptophan Studies) with a different amount of the amino acid being investigated. To see how these amino acids are used in the body the investigators will add a small amount (calculated based on the body weight of the baby) of the amino acid L-\[1-13C\]phenylalanine to the amino acid solution. Breath and urine will be collected from the baby to study the oxidation of the L -\[1-13C\]phenylalanine. The investigators will take 2 x 0.75 ml blood to measure plasma amino acid concentration. The investigators will aim to coordinate blood taking with routine blood work done for clinical monitoring.

Eligibility Criteria:
Inclusion Criteria:

1. Stable preterm babies that are growing and fully TPN fed (at least 90% of calories and protein).
2. TPN providing adequate calories and protein as determined by attending physician and dietitian.
3. Babies born ≥ 28 weeks gestation,
4. ≤ 28 days chronological age at the time of the study,
5. Birth weight and length appropriate for gestational age,
6. Medically stable as determined by normal blood results and lack of a fever or infection,
7. At least 3 days after surgery, if the baby had a surgery

Exclusion Criteria:

1. Babies on mechanical ventilation, on low flow oxygen and CPAP.
2. Small for gestational age,
3. On medications known to affect protein and amino acid metabolism,
4. Documented infection, fever
5. Unstable medical condition
6. Receiving enteral feeding providing \> 10% of protein intake
Anxiety Levels Before Hemodialysis Catheter Insertion

Determination of anxiety levels after verbal and video informing before hemodialysis catheter insertion

Treatment options for end-stage renal patients are renal transplantation, peritoneal dialysis, or hemodialysis, and the majority of these patients live on hemodialysis dependent. The venous access route required for hemodialysis is provided by dialysis catheters until arterio-venous shunts are performed. The aim of this study was to determine the difference between verbal or video-related anxiety levels of patients with hemodialysis and determine which one is better before the hemodialysis procedure is performed.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18 -65
* Agree to participate ın the study
* No need for emergency hemodialysis
* No previously known psychiatric disorder
* No history of hemodialysis before
* No history of surgical procedures

Exclusion Criteria:

* Refusing to participate ın the study
* \<18 years of age and \>65 years
* Need emergency dialysis
* The presence of previously known psychiatric disorder
* Presence of dialysis and catheter
* Presence of a history of surgical procedure
* Lack of information and documents
Immunologic Features of Respiratory Failure in Pediatric Hematopoietic Cell Transplantation (HCT) Recipients and Pediatric Oncology Patients

This study is being done because researchers want to learn more about genes that control the immune response in the participant's lungs and blood when the participant have lung disease leading to respiratory failure.

Primary Objective

To evaluate the feasibility of performing single cell gene expression analyses on tracheal aspirates from immunocompromised pediatric patients with immune compromising conditions, including HCT recipients.

Secondary Objectives

* To assess whether cell composition and activation states in longitudinally obtained tracheal aspirate and blood samples are able to distinguish unique immunopathology for each of the early post-HCT lung diseases.
* To assess whether cell composition and activation states in longitudinally obtained tracheal aspirate and blood samples are different between two immunodeficient patient populations (alloHCT vs non alloHCT) with lung disease and respiratory failure.
* To test the hypothesis that allogeneic T cell responses are implicated in the pathogenesis of early post-HCT lung diseases.

Exploratory Objectives

To correlate immune cell signaling in the lower respiratory tract and blood of patients with early post-HCT lung diseases with the presence or absence of pathogenic microbes at each site.

To explore HLA testing in Tracheal Aspirates in samples where enough cells are present.

This study involves a Tracheal aspirate, Bronchoalveolar lavage (BAL), and blood samples. The tracheal aspirates and blood samples will be obtained within 24 hours of intubation, then twice more every 3 -4 days, and then once a week until the patient is extubated. If the primary treatment team performs bronchoscopy with BAL, then an aliquot of residual BAL fluid will be obtained.

Eligibility Criteria:
Inclusion Criteria:

* Participant is age 0 to 21 years old
* Participant has acute respiratory failure due to primary pulmonary disease and is expected to receive invasive mechanical ventilation for more than 48 hours

Exclusion Criteria:

* The primary etiology of respiratory failure is not related to primary pulmonary disease
* Aspiration is present
* The participant has a tracheostomy
* If the patient has undergone HCT, they are more than 100 days removed from HCT
* Has a diagnosis of severe combined immunodeficiency syndrome (SCIDS)
* The primary on-service team feels obtaining a study sample would be unsafe for any reason.
* Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
Feasibility Trial of a One-day CBT Workshop ("DISCOVER") for 15-18 Year Olds With Anxiety and/or Depression in Clinics

This is a feasibility trial designed to test the feasibility and acceptability of a one-day Cognitive Behavioural Therapy (CBT) workshop intervention ("DISCOVER") for young people aged between 15-18 years, who are on local child and adolescent mental health services (CAMHS) waiting lists, awaiting treatment for difficulties with anxiety and/or depression. Participants will be randomised to receive either the DISCOVER workshop (in addition usual care) or to continue usual care.

Sclare and colleagues (2015) have developed an open-access intervention ("DISCOVER") for 16-18 year olds experiencing emotional problems, in the form of one-day CBT-based workshops, delivered in schools. DISCOVER has been tested in schools and preliminary outcomes have shown to be positive. Given the lengthy waiting lists of some CAMHS services, the present study seeks to explore whether the DISCOVER programme can be implemented in clinic settings, with a broader age range of 15-18 year olds, with the aim of providing young people with some form of help, whilst they are awaiting more individualised treatment. Fifteen to eighteen year olds awaiting treatment for anxiety and/or depression will be recruited from local CAMHS waiting lists, and randomised to receive either the DISCOVER workshop, delivered in clinic (in addition to usual care), or to continue usual care. The study will assess the feasibility, acceptability and range of outcomes of DISCOVER in clinic settings.

Eligibility Criteria:
Inclusion Criteria:

1. aged 15-18 years;
2. fluent in English;
3. currently on a local CAMHS waiting list for treatment based on a referral for emotional difficulties (anxiety and/or depression);
4. willing and able to attend a one-day workshop within clinic; and
5. their position on the waiting list must indicate that they are unlikely to receive a CAMHS treatment appointment in the 8 weeks following the workshop.

Exclusion Criteria:

1. presenting with acute risk of harm to self or others;
2. have severe learning difficulties; and
3. are unable to provide informed written consent to participate and are unable to complete assessments.
Effects o Laughing Qigong Program on Psychological Outcomes and the Physiological Immunological Responses

Laughter programs are safe, affordable, and age-appropriate activities. Few studies have utilized mixed study designs to look at the impact on resilience in and experiences of participants in such activities.

The laughing qigong program is a physical and mental practice program that combines qigong and laughter. It is influenced by Chinese local culture. It emphasizes the transformation of voice, body, and emotional use so that people can experience relaxation and tranquility, and then the transformation of emotions so that physical and mental energy can be released then to achieve balance. Our research has shown that laughter-related psychological interventions have consistent effects on mental health, reducing mood conditions under life stress (Grace, 2013), depressed mood (Hsieh et al., 2015), and cortisol concentration (Grace, 2013). However, there have only been a few studies where similar protocols focused on positive mental states (e.g. resilience, well-being) and the application of laughing in immune function.

Therefore, the current quasi-experimental trial was to investigate the effects of the LQP on psychological outcomes (resilience and well-being), mucosal immunity (salivary immunoglobulin A, s-IgA), and immune-inflammatory index (interleukins, IL-6) amongst breast cancer survivors. We hypothesized that (a) experimental group participants would have significantly higher levels of resilience and well-being at baseline (before the test) and post-treatment (post-test) compared to the wait list control group; (b) Compared to the control group on the wait list, experimental group participants will have significant differences in mucosal immunity (s-IgA) and inflammatory index (IL-6) before and after the test; and (c) experimental group membership had a significant effect on psychological outcomes (resilience and well-being) as well as mucosal immunity (s-IgA) and immune-inflammatory indices (IL-6) after a 12-week LQP intervention

Eligibility Criteria:
Inclusion Criteria:

1) female adult (18 years old); 2) diagnosed with stage I-III breast cancer; 3) major treatment completed at least 3 months ago (i.e. surgery, chemotherapy, and/or radiotherapy); and 4) no communication difficulties (visual and auditory).

Exclusion Criteria:

1) having recurrent or metastatic breast cancer; 2) being involved in other studies at the same time, 3) patients who are unable to cooperate with the trial and follow-up; and 4) having a history of mental illness in past 3 months (major depression disorder)..
Vaspin Levels Compared With Serum Insulin and Blood Glucose Levels in Neonates

The aim of this study was to investigate circulating concentrations of vaspin in fetal and neonatal samples from SGA, AGA and LGA with the respective insulin concentrations. Serum vaspin concentrations were determined by enzyme immunoassay in 22 SGA and 30 LGA and 30 AGA singleton full-term fetuses and neonates on cord blood and postnatal day 5.


Eligibility Criteria:
Inclusion Criteria:

* Full term healthy infant

Exclusion Criteria:

* sepsis
* congenital anomaly
* sick infant
Probiotics on Stress-associated Gastrointestinal Function in University Students

The purpose of this research study is to evaluate the effect of a daily supplement of probiotics (Lactobacillus gasseri KS-13, Bifidobacterium bifidum G9-1, Bifidobacterium longum MM-2) on stress-associated gastrointestinal function in university students during the time of semester exams.

In this randomized, double-blind, placebo-controlled study, undergraduate students planning to take a fall final exam will receive a daily probiotic combination, individual probiotic, or placebo for 6 weeks. Questionnaires will assess gastrointestinal symptoms, immune health, stress and stress management, quality of life, diet, adverse events, and compliance. In a subset of subjects, stool samples will be collected at baseline and at week 5 of the intervention (the week before final exams) to characterize microbial communities.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Healthy full-time undergraduate student at the University of Florida
* Willing and able to consume a daily supplement (probiotic or placebo) for the duration of the 6-week study
* Willing and able to complete daily questionnaires online regarding general health and well-being, including stress levels and gastrointestinal symptoms (Note: we will recruit participants who will have Internet access for the duration of the protocol, but understand that, once enrolled, situations may change. If this is the case, paper copies of the online forms will be provided)
* Willing to discontinue any immune-enhancing dietary supplements (e.g., prebiotics and fiber supplements, probiotics, Echinacea, fish oil, vitamin E \[\>400% of the RDA or \>60 mg/day\])
* Had a cold/flu within the past year

Exclusion Criteria:

* Currently smoke
* Women who are lactating, know that they are pregnant, or are attempting to get pregnant
* Currently taking any systemic corticosteroids
* Currently being treated for any physician-diagnosed diseases
* Have received chemotherapy or other immune suppressing therapy within the last year
Effectiveness of Cervical Screening in HPV Vaccinated Women

The main objective of the study is to identify whether or not being informed infrequently results about screening is: 1) At least as safe and accurate as frequently obtaining all information from the present combination of opportunistic/organized cervical screening by comparing regimen results of three screening visits at the ages of 22, 25 and 30 years (Arm A1) vs. results of one screening visit at the age of 30 years (Arm A2) in Human papillomavirus (HPV) vaccinated young women.

Altogether 16.500 1992-1995 born women vaccinated with the bi-valent human papillomavirus type 16 and 18 (HPV16/18) vaccine as adolescents either at the age of 12 to 15 or at the age of 18 will be invited to an effectiveness trial at the age of 22 years, and randomized into Arms A1 and A2, and A3, respectively.

Cervical samples and cervico-vaginal self-samples rinsed in first-void urine will be analysed for HPV and C. trachomatis DNA with MGP primer system followed by MALDITOF mass spectrometry on the SEQUENOM platform (HPV) and the Abbott™ PCR (Chlamydia trachomatis), respectively.

With assumed \>50% participation the trial has 80% power to show non-inferiority of the infrequent vs. the frequent screening information.

A one-way (participant) blinded interim analysis among the 1992-born study participants in A1 and A3 arms, who have attended the 2nd study visit at the age of 25 years, will be performed in 2017 for assuring no statistically significant differences in the cervical intraepithelial neoplasia grade 2/3 (CIN2/CIN3) incidences of the two arms.

At the study end testing the null hypotheses of no difference in the incidence of the CIN2/3 end-points between the A1 and A2 intervention arms will be done using the Mantel-Haenszel one degree of freedom chi-square statistics.

Eligibility Criteria:
Inclusion Criteria:

* HPV 16/18 vaccinated. Born 1992-1995.

Exclusion Criteria:

* Immunocompromising disease. HPV 6/11/16/18 vaccination.