cyrilzakka/clinical-trials huggingface dataset:
Creation of a Bank of Biological Materials and Associated Data Related to Patients With Infectious and Tropical Diseases

This is the protocol that formalizes the establishment of the TROPICA-BIOBANK biobank

Subjects who will access the Department of Infectious and Tropical Diseases for investigations, analyzes or visits on suspicion of infectious or tropical disease, hospitalized patients and/or patients participating in proposed clinical trials from the Department will be enrolled. Healthy volunteer donors may also be enrolled.

The type of samples collected and stored in the biobank consists of human biological matrices liquids and solids, DNA, protein extracts or subcellular fractions, bacterial isolates and arthropods taken from patients. The collection of samples takes place through the support of various professional figures (doctor, nurse, laboratory technician, biologist/biotechnologist) together with associated data.

The samples are de-identified and protected by an encryption system (through the system computer diagnostic data management of the laboratory of the IRCCS Sacro Cuore Don Calabria) and stored at a temperature of -80°C, in the Department's freezers. Samples are stored for 40 years. In order to monitor the quality of the samples over the storage time, a selection of samples used as monthly analytical quality controls will be retested periodically (every 10 years). At the end of the storage time, it will be evaluated whether to extend the storage time of the unused biological samples and associated data or if these will be destroyed. In the first case, an amendment to this Protocol will be submitted to the CESC for approval, in which will specify the duration of the extension of the conservation of the samples and associated data. In the second case, no further data will be collected on the aforementioned samples, without prejudice to their use of those possibly already collected to determine, without altering them, the results of searches already in progress.

The samples will in any case be destroyed if they are not in good condition.

Eligibility Criteria:
Inclusion Criteria:

• Informed consent (for healthy volounteers also: age \> 18 years, health status ascertained by laboratory tests, electrocardiogram and medical examination)

Exclusion Criteria:

* History of alcohol/drug abuse
* Pregnant or breastfeeding women, unless there are justified and documented needs
Regular Physical Exercise and Salt Diet on Coronary Artery Disease in Patients With Prehypertension(RESTRAIN Pre-HT)

The epidemic data shows that prehypertension is associated with cardiovascular disease, and heavy dietary salt intake could improve the developing of hypertension. We detected the risk factors of coronary atherosclerosis of prehypertensive patients with different levels of salt intake.

The aim of this multicenter prospective, randomized controlled study is to evaluate regular physical exercise and salt diet effects on progression of coronary artery disease in patients with prehypertension.


Eligibility Criteria:
Inclusion Criteria:

aged 45-75 Admission systolic BP between 120 and 139mmHg or diastolic BP between 80 and 89mmHg coronary artery stenosis was 30%-70% -

Exclusion Criteria:

with a history of myocardial infarction, coronary revascularization, congenital heart disease and cerebrovascular diseases

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Developing Accessible mHealth Programs for Depression Management in Bolivia

The purpose of the study is to evaluate the feasibility and potential impact of an automated phone system in monitoring and improving self-care and health outcomes among patients with depression in Bolivia.

All patients will receive a weekly 10-15 minute automated phone call to their cell phone for disease assessment and self-care support for up to 12 weeks. During enrollment, the research team will explain how to use the automated phone system. During patients' automated calls, they will be asked questions about their self-care relevant to their diagnosis, symptoms of depression, and medication adherence (if patients are prescribed an anti-depressant). Based on the patient's self-report, they will receive targeted suggestions for how to improve their self-management. At the end of each automated call, patients will hear the phone number of their clinic, which they can call for a health problem or to disenroll from the program. At the time of recruitment, if possible, an initial automated call will be sent to the patient's phone so that they can learn what to expect and have the chance to ask questions of the research associate who will be present.

In the event that the patient reports a health or self-care problem during their call (i.e., the patient reports rarely or never taking their medication), a report will automatically be generated and sent by email to the research team plus the patient's designated clinician so that follow-up can take place. The secure email address will be verified with each clinician, and be password protected.

The intervention will last up to 12 weeks, after which the patient will have a follow-up meeting with the research team and will complete a survey about the program. All follow-ups will take place either in person or over the phone.

Eligibility Criteria:
Inclusion Criteria:

* 21-80 years of age
* PHQ-8 score of 10 or higher

Exclusion Criteria:

* Have diagnoses indicating a six-month life expectancy
* Prior inpatient psychiatric treatment
* Patients with probable bipolar disorder or cognitive impairment as indicated on validated screeners
Rapid Detection of Airway Pathogens for Lung Transplantation

Pneumonias and lower respiratory tract infections can have important long-term consequences, particularly in the context of lung transplantation, where pneumonia is a major cause of death. Candidate organs and lung transplant recipients undergo bronchoscopic inspection to assess for lower respiratory tract infection, but traditional culture methods take time, leading to increased risk from inappropriate therapy. The investigators hypothesize that the rapid detection of lower respiratory tract infection, using a semi-quantitative multiplex molecular assay, can decrease the time to appropriate clinical decision making.

Before and after lung transplantation, clinical decision-making for infection diagnosis can be delayed by the time requirements of traditional culture techniques. This study will enroll lung transplant donor candidates and recipients undergoing assessment for lower respiratory tract infection by bronchoscopic alveolar lavage (or washing). The investigators will record bronchoscopy time and time to test result and clinical management decision based on traditional culture methods. The investigators will perform a semi-quantitative multiplex molecular assay for lower respiratory tract infection using the BioFire Pneumonia Panel and these results will be evaluated by clinicians not directly involved in patient care. Timing and outcome of clinical decision making will be recorded. The investigators will compare the time to result using a paired Student's t-test between traditional and molecular methods. Secondary endpoints include time to clinical decision, postulated changes in clinical decisions, and agreement between methods.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will be included if subjects are able and willing to provide informed consent for this study as part of an ongoing prospective biorepository and clinical data repository cohort study.
* Donors can be included as subjects if families provide informed consent.

Exclusion Criteria:

* Samples from donor organs will be excluded if the organs are unlikely likely to be used based on review of preliminary data.
* Post-transplant samples will be excluded if the suspicion for infection is sufficiently low that lavage samples are not sent for microbiologic workup or there is insufficient sample for research.
Quality of Recovery After Unplanned and Planned Cesarean Deliveries - an Application of ObsQoR-10

In Canada, 29.1% of annual births are via cesarean deliveries (CD). The literature shows that almost 24% of CDs are unplanned. Existing evidence suggests that unplanned cesarean delivery, compared to elective cesarean, may be associated with poor maternal recovery, longer postpartum hospital stays and more opioid requirements after surgery. Since the establishment of the Enhanced Recovery After Cesarean protocols, specific care pathways have been implemented with the aim of optimizing recovery after CD and to reduce the costs to the health care system. However, the majority of unplanned cesarean receive the same postoperative anesthetic, obstetric and nursing care as the elective CDs.

Looking at the actual information about maternal recovery after unplanned CD, the investigators found that there is a paucity of literature examining this topic utilizing validated, patient-oriented quality of recovery tools. Recently, Obstetric Quality of Recovery-10 scoring tool (ObsQoR-10), a new patient-focused outcome instrument for postpartum recovery, it has been validated for all types of deliveries, in the inpatient setting. ObsQoR-10 tool aims to measure quantitatively functional recovery at 24 hours postpartum. It includes 10 questions on a 0 to 10 scale, aimed at pain management, the adverse effects of narcotics and the perception of recovery by the patient.

The aim of this study is to determine the quality of recovery from unplanned cesarean deliveries compared to planned ones using a validated tool for recovery after cesarean delivery (ObsQoR-10 tool).

The investigators hypothesize that quality of recovery as measured by the Obs-QoR10 for unplanned cesarean deliveries will be lower than the planned CDs.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18 years old and over
* Term singleton pregnancy
* Undergoing planned or unplanned caesarean delivery at Mount Sinai Hospital
* Patients who have given informed written consent

Exclusion Criteria:

* Patients who have refused, are unable to give or have withdrawn consent
* Patients unable to communicate fluently in English
* Patients with American Society of Anesthesiologists (ASA) classification of 4 or greater
* Patients scheduled to have a classical vertical incision
* Patients undergoing cesarean hysterectomy
* Patients with history of chronic pain, chronic use of analgesic drugs, or history of opioid or intravenous drug abuse
* Patients who have refused neuraxial anesthesia, or those in whom it is contraindicated.
2D vs 3D Planning for High-Dose Rate (HDR) Gynecological Brachytherapy

Demonstrate the limitations of conventional dosimetry (2D) for the adjuvant brachytherapy treatment and assess whether tridimensional dosimetry relates more faithfully with the occurrence of adverse effects.

Radiotherapy is part of a multidisciplinary strategy to fight cancer in all stages, using ionizing radiation to cause damage in tumor cells. After radical surgical treatment of gynecological tumors, pathological findings, such as extension of the myometrium invasion, histologic grade, and vascular- lymphatic invasion predict the risk of locoregional recurrence of disease and, consequently, the need for adjuvant treatment. There are two main methods of adjuvant therapy after hysterectomy for malignant neoplasm of the cervix or endometrium: external beam radiotherapy with or without booster dose of vaginal vault brachytherapy or brachytherapy alone. There are few data in the literature and clinical experience with brachytherapy dimensional (3D) for adjuvant treatment of vaginal vault .

Objective: To demonstrate the limitations of conventional dosimetry (2D) for the adjuvant brachytherapy treatment and assess whether tridimensional dosimetry relates more faithfully with the occurrence of adverse effect.

Methods: A prospective study in the Department of Radiation Oncology, Antonio Candido Camargo Cancer Center will be developed with an expected duration of 14 months and will include 60 patients. Dosimetric parameters of brachytherapy treatment of vaginal vault, able to influence the incidence of adverse effects will be evaluated. Computed tomography for planning of external beam radiotherapy and brachytherapy planning will be used, after placement of intra- vaginal applicator and urinary catheter. For planning brachytherapy two fast acquisition sequences, one with a urinary catheter not pulled and pulled another with the probe will be obtained. The prescription dose obey the standard indication of document of the International Commission on Radiation Units \& Measurements (ICRU 38).

Eligibility Criteria:
Inclusion Criteria:

* Malignant neoplasm of the cervix or endometrium;
* Tomography scan available in the planning system.

Exclusion Criteria:

* Patients did not undergo surgery as initial treatment;
* Patients without available tomography for planning;
Echinaforce Junior Bioavailability Trial

In this bioavailability trial should be shown that the one of the main active constituent in alcoholic echinacea extracts, the alkylamide dodeca-2E,4E,8Z,10E/Z-tetraenoic acid isobutylamide (short: tetraen) is bioavailable in children of different age groups after intake of 5 Echinaforce junior tablets.

In this bioavailability trial should be shown that the one of the main active constituent in alcoholic echinacea extracts, the alkylamide dodeca-2E,4E,8Z,10E/Z-tetraenoic acid isobutylamide (short: tetraen) is bioavailable in children of different age groups after intake of 5 Echinaforce junior tablets.

Six capillary blood draws are taken at the following time points: Start (0), after 15, 30, 60, 90, 270 minutes and thereafter the bioavailability is measured and calculated.

Eligibility Criteria:
Inclusion Criteria:

* Children in the age group 4-12 years with an uncomplicated common cold (upper respiratory tract infection)
* First symptoms appeared within the last 72 hours
* Written consent given by the parents and verbal consent of children who are capable of judgement

Exclusion Criteria:

* Not able to fast 2 hours prior to the treatment
* intake of another preparation containing echinacea within the last 24 hours
* Participation in a clinical trial within the last 30 days
* any progressive systemic illness, including tuberculosis, leukemia, connective tissue diseases, multiple sclerosis, or other autoimmune diseases; or
* history of relevant allergy, including allergy to Compositae plants
Electrical Inhibition (EI): A Preliminary Study To Inhibit Preterm Labor And Preterm Birth

An electrical-inhibition (EI) uterine pacemaker device similar to an electrical heart pacemaker delivers a weak electrical current to the human uterus during active preterm labor to rapidly and safely inhibit the unwanted premature uterine contractions and possibly a preterm birth.

Electrical intervention (EI) uses bipolar, constant-current (1-20 mA), square-wave pulses in 20% duty cycles. Women in active preterm labor have an electrode catheter placed into the posterior fornix of the vaginal canal. The EI current is given up to 80 minutes while monitoring tocodynamometric (toco) contractions and adjunct electrohysterographic (EHG) activity while continuously monitoring maternal vital signs, fetal heart rate and electrocardiogram (fECG). The study includes a pre-EI control period (C1); the EI period, when a 10-second current burst is delivered only during a contraction; and a post-EI control period (C2). The whole study will take a maximum of two hours.

The uterine toco contraction frequency and adjunct EHG electrical activity are analyzed for changes caused by EI. Changes in maternal vital signs, fetal heart rate and fECG will determine EI side-effects.

Eligibility Criteria:
Inclusion Criteria:

* between 24 to 34 weeks pregnant with a singleton gestation;
* in preterm labor as defined by the American College of Obstetricians and Gynecologists and the American Academy of Pediatrics,78 as follows:

  * persistent uterine contractions (4 every 20 minutes or 8 every 60 minutes)
  * And any one or more of the following:

    * Documented cervical change
    * \> 1cm cervical dilatation and progressing
    * \> 80% cervical effacement
* anticipate a normal spontaneous vaginal delivery (NSVD).
* at least 18 years of age
* signed a written Informed Consent Document
* willing and able to comply with study requirements

Exclusion Criteria:

* severe preeclampsia
* severe abruption placenta
* rupture of amniotic membranes
* frank chorioamnionitis
* fetal death
* fetal anomaly incompatible with life
* severe fetal growth restriction (EFW \<5%)
* mature fetal lung studies
* maternal cardiac arrhythmias
* a permanent cardiac pacemaker
* a fetal cardiac arrhythmia
* contraindication for tocolysis
The Impact of Employee Wellness Programs

There is great public and private interest in the use of workplace wellness programs to reduce health care spending, improve health outcomes, and enhance productivity for employees. However, there is little rigorous evidence on the effects of wellness programs. This study partners with a large multi-state U.S. employer (BJ's Wholesale Club) and an experienced wellness vendor (Wellness Workdays) to evaluate a multi-prong workplace wellness program, including components such as nutrition counseling, fitness challenges, and stress management workshops. The wellness program will be delivered by a team of experts including Registered Dieticians, and will include financial rewards for participation. The program will be available to employees in initially 20 of BJ's 200 worksites, and later expanded to 25 worksites. These worksites have been randomly selected, allowing a randomized controlled trial evaluation of the effects of the wellness program. Data will be collected on a wide array of outcomes from multiple sources, including on-site biometric screenings and surveys, employment records, and health insurance claims for employees at both treatment and control worksites.


Eligibility Criteria:
Inclusion Criteria:

* Employed in one of BJ's clubs during the period of the intervention

Exclusion Criteria:

* Not employed in one of BJ's clubs during the period of the intervention
Evaluation of Cardiac Burden in Patients With Sever Bronchial Asthma

Evaluation of cardiac burden in patients with sever bronchial asthma

Bronchial asthma is chronic bronchial inflammation of variable intensity accompanied by recurrent reversible airflow obstruction and symptoms such as coughing, wheezing, shortness of breath, and chest tightness ,with a worldwide increase over the last several decades (1).

1. Sever asthma :means that asthma is uncontrolled despite adherence with maximal optimized therapy and treatment contributory factors or that worsens when high dose treatment is reduced.
2. Globally. over 260 million people had poorly controlled asthma highest rate on Australia.

Eligibility Criteria:
Inclusion Criteria:

* Patients accepted to be involved in the study.
* Patients \>18 years old .

Exclusion Criteria:

* severe bronchial asthma patients who have other comorbidities as (chronic chest disease as COPD,ILD, bronchiectasis , , diabetic ,hypertensive ,mechanical ventilated patients, tracheostomized patients, ......)
* patients \<18 years old . patients refuse to be involved in the study .
Detection of Lymphnodes Using ICG During RARP

The purpose of this study is to investigate, whether the detection of lymph nodes by means of intraoperative fluorescence lymphography as part of lymphadenectomy in robot-assisted radical prostatectomy is higher than without the use of indocyanine green (ICG).

ICG is a fluorescent dye that fluoresces green bound to proteins under illumination in the near-infrared range. Using this dye allows to visualize lymphatic nodes, by being injected into the tumor or directly surrounding tissue.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed locally limited prostate cancer;
* Intermediate or high risk tumor
* Recommended and planned prostatectomy;
* Completed and signed written consent;
* Voluntarily agreement to participate in this study
* Age of the study participants ≥ 18 years.

Exclusion Criteria:

* Allergic reaction to active ingredient (indocyanine green);
* Iodine allergy;
* Hyperthyroidism;
* High-grade renal impairment;
* High-grade hepatic insufficiency;
* Unwillingness to the storage and disclosure of pseudonymous disease and personal data
* psychiatric pre-existing conditions or other circumstances that make a cooperation by the patient in question
Stop and go Strategy as First-line Treatment for Widely Metastatic Nasopharyngeal Carcinoma

This study aimed to investigate the value of a novel strategy of intermittent systematic chemotherapy (ISC) in widely metastatic nasopharyngeal carcinoma (wmNPC) patients who achieve objective response after systematic chemotherapy (SC).

Widely metastatic nasopharyngeal carcinoma (wmNPC) represented a particular subgroup of patients with the worst prognosis, of which palliative systematic chemotherapy(SC) was recommended as initial treatment, however, palliative systematic treatment was often required to be stopped due to the cumulative toxicities while stopping SC may lead to disease progression, a 'stop and go' approach, namely chemotherapy 'holidays', was a new strategy which may keep a good balance of benefit and risk. This study aimed to investigate the value of a novel strategy of intermittent systematic chemotherapy (ISC) in wmNPC patients who achieve objective response after SC.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with multiple metastases at first diagnosis or multiple metastases after treatment(multiple metastases were defined as more than 5 lesions and/or more than 2 metastasis organs); Histologically or cytologically confirmed multiple metastatic NPC.
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at trial entry, and life expectancy ≥ 6 months as judged by the Investigator;
3. The disease must be measurable with at least 1 unidimensional measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; Adequate organ function;
4. Take adequate contraceptive measures throughout the study, and contraception continues until 12 months after treatment;
5. Able and willing to provide a signed informed consent form, and able to comply with all procedures.
6. The time from the last chemotherapy and/or radiotherapy to randomization must be ≥6 months.

Exclusion Criteria:

1. Patients with a hypersensitivity to any of the drugs used in our study;
2. With any active autoimmune disease or history of autoimmune disease;
3. Clinically significant cardiovascular and cerebrovascular diseases;
4. Have or are suffering from other malignant tumors within 5 years (except non-melanoma skin cancer or pre-invasive cervical cancer);
5. Active systemic infection;
6. Drug or alcohol abuse;
7. No or limited capacity for civil conduct;
8. The patient has a physical or mental disorder, and the researcher considers that the patient is unable to fully or fully understand the possible complications of this study;
9. History of immunodeficiency including seropositive for human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease, or any active systemic viral infection requiring therapy；
10. Use cortisol or other systematic immunosuppressive medications within 4 weeks before the study treatment, and the subject requiring hormone therapy during trials.
11. Pregnancy or breastfeeding.