cyrilzakka/clinical-trials huggingface dataset:
Validation of the Rhinitis Control Scoring System (RCSS)

Many patients suffering from allergic rhinitis do not recognize or perceive their symptoms. Instruments have been developed to assess quality of life in rhinitis, asthma or both, but there is a need to develop validated tools or methods to assess rhinitis control among rhinitis and/or asthmatic patients. The aim of this study is to assess the discriminative and evaluative properties of the RCSS in asthmatic patients with allergic rhinitis.

Allergic asthmatic subjects showing seasonal rhinitis symptoms will be recruited. The discriminative (internal consistency, cross sectional construct validity and reliability) and evaluative (responsiveness and longitudinal construct validity) properties of the RCSS will be evaluated as well as the relationship between rhinitis control and asthma control. RCSS will be completed at various time points during the seasonal allergic period.

Eligibility Criteria:
Inclusion Criteria:

* asthma
* seasonal allergic rhinitis

Exclusion Criteria:

* smoking
* nasal polyposis
Preclinical Brain Tumor Models

Background: Primary or secondary brain tumors (metastases) remain associated with a very poor prognosis linked to significant therapeutic resistance. Thus, glioblastoma, which is the most common and aggressive primary brain tumor in adults, is associated with inevitable relapses within 7 to 10 months and median survival of approximately 12 to 14 months. At the same time, brain metastases are increasingly increasing following better systemic control of other metastatic sites and improvement in detection methods. However, they remain resistant to the latest therapeutic innovations such as immunotherapies or targeted therapies.

In this context, innovative strategies are necessary to identify new therapeutic targets and implement new treatments to overcome resistance phenomena in the clinic.

Objective: Our goal will be to generate tumoroids and stem-like cell lines (PDX) from patient tumor samples.

Methods: We will establish tumor tumoroids and stem cell lines from patient samples. These preclinical models will allow us to test a large number of drugs, quickly and efficiently thanks to models as close as possible to patient tumors and limiting the use of animal models (3R).

Overall, this project should enable major advances in the treatment of glioblastoma and brain metastases and enable the rapid testing of new molecules in clinical trials thanks to the homology of our models with our patients' diseases.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Brain tumor neuro-imaging
* Eligible for neurosurgery

Exclusion Criteria:

* unresectable tumor
Non-invasive Continuous Cardiac Output Monitoring in Preterm Infants Study

This is an observational study in newborn term and preterm infants. The study will validate if non-invasive continuous cardiac output monitoring is feasible in newborn infants, if normative values can be constructed and what is the effect of fluid boluses and inotropes on cardiac output and peripheral vascular resistance.

This is a 3-year prospective observational study.

Principal research question:

Is non-invasive continuous cardiac output (CO) measurement a validated tool of comprehensive cardiovascular assessment in neonatal intensive care (NICU)?

Secondary research questions:

1. Can robust normal ranges of CO be constructed for neonates undergoing cardiovascular measurement?
2. How do neonatal interventions (fluid boluses, ventilation and inotropes) affect CO?
3. Does the Non-invasive continuous cardiac output monitoring in children with foetal growth restriction (FGR) differ from normative CO data as above (1)?

A prospective study of stable newborn babies in the postnatal ward and sick term and preterm infants in the NICU in 36 months.

Eligibility Criteria:
Inclusion Criteria:

* Healthy term infants in postnatal ward (within the first 72 hours of age)
* Term and Preterm infants (including those with FGR) admitted to the neonatal unit
* Written informed parental consent (prospective for postnatal ward and retrospective for babies admitted to the neonatal units)

Exclusion Criteria:

* Antenatal or postnatal diagnosis of severe congenital anomaly
* Infants with no realistic chance of survival
* Infants who are \>12 hours of age
* Infants with fragile skin not permitting skin probe placement
Augmented Reality For MRI-Guided Interventions

The purpose of this study is to determine feasibility and safety of using an augmented reality system in patients undergoing MRI-Guided needle procedures.

This pilot clinical study is designed to evaluate the feasibility of using a needle guidance system during MRI-guided procedures in up to 12 patients. The MRI-compatible needle guidance system was developed under an NIH funded SBIR Phase II grant. This system has been evaluated by our Interventional Radiology team in phantom, volunteer, and cadaver studies which showed potential benefit of use in patients. Inclusion of the needle guidance system will not change the standard of care or substantively affect procedural technique as currently performed. This system provides the operator with an augmented reality (AR) display to better visualize the needle entry point and trajectory as it is inserted toward the target. This additional information could improve needle placement accuracy and shorten procedural time.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female, ages 3 to 21
* Patient referred to Interventional Radiology for image-guided needle injection, aspiration, or biopsy.

Exclusion Criteria:

* Patients who are unable to give informed consent themselves or through their parents.
* Patients under 3 years of age
* Patients over 300 pounds.
* Patients who are claustrophobic and unable to tolerate MRI-guided procedure.
* Contraindications to MRI such as MR-unsafe implants.
The Duration of Effects of Massage in Healthy Participants

Massage is a common rehabilitation treatment for musculoskeletal pain. Prior studies indicate massage applied with a deep pressure that induces a moderate amount of pain produces a lessening of pain sensitivity compared to light touch, pain free massage. The investigators now aim to investigate how long pain sensitivity changes last after 4 minutes of moderately painful massage and determine factors that help predict who displays a lessening of pain sensitivity.


Eligibility Criteria:
Inclusion Criteria:

• pain-free

Exclusion Criteria:

* Non-English speaking
* Systemic medical condition known to affect sensation (i.e. uncontrolled diabetes)
* Regular use of prescription pain medication
* Current or history of chronic pain condition
* Currently taking a blood-thinning medication
* Any blood clotting disorder, such as hemophilia
* Contraindications to the application of a blood pressure cuff to the arm, such as: lymphedema or arterial/venous lines
* Contraindications to elevating the arm above the head or exercising the arm with a light weight, such as a recent surgery or fracture
* Investigator is unable to locate myofascial trigger point in the upper trapezius during testing session
HVAD(TM) SMART 1.0 Study

The purpose of HVAD Smart 1.0 study is to collect HVAD device data (i.e., waveform + logfile + pump parameter) in various clinical conditions (e.g., routine follow-up visits, experiencing adverse events) to support development of predictive and actionable algorithms. The collected data will be used to characterize HVAD flow waveform and logfile pattern changes that precede a qualifying adverse event, as well as characterize "normal" HVAD flow waveform and logfile patterns (subjects free from any qualifying adverse event, any hospital readmissions related to a SAE, or any parenteral medical therapy for heart failure management (e.g., inotropes, diuretics, etc.) or ultrafiltration in last 30 days). In addition, the study will collect data to evaluate the utility of CareLink in HVAD patients. The study will not involve any investigational testing and the market-released devices will used as per the approved labelling.


Eligibility Criteria:
Inclusion Criteria:

* Greater than or equal to 18 years of age:
* Refractory, advanced heart failure patient that is either: Prospectively identified as a candidate to receive the commercial HVAD system as their first durable left Ventricular Assist Device (LVAD) implant for approved indications; or within 10 days of receiving the commercial HVAD system as their first durable LVAD for approved indications
* Patient provides written authorization and/or consent per institution and geographical requirements

Exclusion Criteria:

* patient who is, or is expected to be inaccessible for follow up
* patient with previous durable mechanical circulatory support device
* patient with planned Bi-VAD procedure
* patient with exclusion criteria required by local law
* patient is currently enrolled in or plans to enroll in an concurrent drug and/or device study that may confound results (i.e., no required intervention that could affect interpretation of all-around product safety and/or effectiveness). Concomitant observational studies allowed if permitted by IRB/EC
Patient-reported Adverse Events From Osteopathic Manipulative Treatment

Currently, there is a significant deficiency in evidence regarding the safety of osteopathic manipulative treatments (OMT). To address this deficit, this study is designed to systematically evaluate the incidence and severity of OMT adverse events and examine the relationship of these adverse events to the technique(s) used and the body region(s) treated. The study is being conducted at the clinics of participating members of DO-Touch.NET, the only known practice-based research network (PBRN) focused on osteopathic manual medicine research. Eligible patients who receive OMT at one of the participating clinics will be asked to complete either a paper or online survey regarding any adverse events they experience within 1, 3, and 7 days following their treatment. Information regarding their diagnoses, which osteopathic techniques were used in their OMT, and which body regions were treated will be obtained from participant medical records. This data will be used to answer the following research questions:

1. What is the incidence of adverse events from osteopathic manipulative treatment?
2. What types of adverse events occur following osteopathic manipulative treatment?
3. Are there individual osteopathic techniques in particular body regions that have higher incidences of adverse events than other techniques or body regions?
4. Is the incidence of adverse events higher for some patient conditions than others?


Eligibility Criteria:
Inclusion Criteria:

* received osteopathic manipulative treatment at one of participating clinics

Exclusion Criteria:

* unable to communicate in English, Spanish, French, German, or Portuguese
Stress-free Everyday LiFe for Children and Adolescents REsearch

The primary aim is to evaluate the effectiveness of a profound school teacher training programme to teach a mindfulness-based programme (.b) in Danish schools on the pupils self-reported mental well-being at seven months.

The secondary aims are to evaluate i) the effectiveness of the profound school teacher training programme to teach the .b-programme in Danish schools on the pupils self-reported mental well-being post intervention (at five months).

The study is a cluster randomised trial. From May 2018 - May 2019, we recruited the total of 110 Danish schools (27 schools from the Capital Region of Denmark, 18 schools from Region Zealand, 25 schools from Region of Southern Denmark, 30 schools from Central Denmark Region and 10 schools from Region of Northern Denmark).

The schools included the total of 191 school teachers for teacher training (56 teachers from the Capital Region of Denmark, 28 teachers from Region Zealand, 42 teachers from Region of Southern Denmark, 50 teachers from Central Denmark Region and 15 teachers from Region of Northern Denmark). Each included teacher will be asked to recruit a class of pupils (15-25 pupils) to test the effectiveness of the .b-programme (in total approx. 3000 pupils).

Eligibility Criteria:
Inclusion Criteria:

* All pupils in the enrolled school classes

Exclusion Criteria:

* None
Clinical Trial of Gene Therapy for the Treatment of Leber Congenital Amaurosis (LCA)

A clinical trial of AAV2/5 vector for patients with Defects in RPE65

A dose escalation and dose expansion (Phase I/II) trial of adults and children with retinal dystrophy associated with defects in RPE65. ATIMP will be administered to one eye only in a single sub-retinal procedure

Eligibility Criteria:
Key Inclusion Criteria:

* Aged 3 years or older
* Early-onset severe retinal dystrophy consistent with RPE65 deficiency

Key Exclusion Criteria:

* Females who are pregnant or breastfeeding
* Have participated in another research study involving an investigational therapy for ocular disease within the last 6 months.
RN-Led Palliative and Supportive Care Intervention

This single institution feasibility and acceptability study includes patients with acute leukemia which is designed to examine a novel palliative and supportive care intervention (Palliative and supportive Care inTervention; PACT) in which registered nurses (RNs), occupational therapists (OTs), and physical therapists (PTs) address the activity needs of older adults with acute leukemia during their hospital stay.

The primary objective of the study is to assess feasibility, acceptability, and change in pre and post measures of symptoms, function, and QOL by administering the PACT intervention. The first 20 participants in the control group will receive usual care. The next 20 participants will receive the PACT intervention. Each participant in the intervention group will be cared by a collaborative, multidisciplinary, integrated team including RNs, OTs and PTs.

Eligibility Criteria:
\[Patient\]

Inclusion Criteria:

1. ≧60 years of age
2. Diagnosis of acute myeloid leukemia
3. Receive low-dose cytarabine or hypomethylating agent (HMA) in combination with Venetoclax chemotherapy
4. Speak and read English
5. Preference will be given to patients with care partners

Exclusion Criteria:

1. Patients receiving hospice care

\[Caregiver\]

Inclusion Criteria:

1. ≧18 years of age
2. Identified by patient as caregiver
3. Speak and read English
Development of Field Test for Assessing the Human Anaerobic Capability

A test of the validity of repeated sprint test (RST) 4x 30 meters, against the Wingate Anaerobic Test, which is the gold standard for measuring human anaerobic capacity. The following variables will be used: peak power, mean power and fatigue index. In addition, it will be tested against a 50 meter and a 200 meter shuttle run.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Students

Exclusion Criteria:

* Not healthy
Exploring of Serum Biomarkers of Delirium After Cardiovascular Surgery

The incidence of postoperative delirium in patients after cardiovascular surgery is very high, which seriously affects the short-term and long-term prognosis of patients, but its mechanism is not clear. Recent studies have found that lactic acid participates in the process of sepsis by inducing histone lactatation in macrophages. histone H3 lysine 18 lactylation (H3K18la) is significantly associated with the severity of disease and inflammatory response. Inflammation plays an important role in postoperative delirium. We therefore hypothesized that macrophage H3K18la also plays a role in postoperative delirium. At the same time, the latest literature shows that the early markers of Alzheimer's disease (AD), such as Aβ, exosomes and phosphorylated tau, etc. \[5\], can also be detected in the serum of AD patients. Given the obvious correlation between Alzheimer's disease and postoperative delirium \[6\], we hypothesized that serum biomarkers of AD could also be used as serum biomarkers for postoperative delirium.

The objectives of this study were to investigate the correlation between H3K18 in serum monocytes and postoperative delirium and its severity in patients undergoing cardiovascular surgery. Meanwhile, we also detect the serum levels of biomarkers of AD, such as Aβ, tau and exosomes etc., in patients undergoing major cardiac surgery. We aim to find the serum biomarkers of delirium after major cardiac surgery, so as to provide a more convenient diagnostic basis for the prevention of postoperative delirium.


Eligibility Criteria:
Inclusion Criteria:

patients who receive cardiovascular surgery

* Patients participated voluntarily and signed informed consent

Exclusion Criteria:

* past medical history of neurological and psychiatric diseases; severe visual or hearing impairment;
Dose Escalation and Dose Expansion Phase I Study to Assess the Safety and Clinical Activity of Multiple Doses of NKR-2 Administered Concurrently With FOLFOX in Colorectal Cancer With Potentially Resectable Liver Metastases

SHRINK (Standard cHemotherapy Regimen and Immunotherapy with NKR-2) is an open-label Phase I study to assess the safety and clinical activity of multiple administrations of autologous NKR-2 cells administered concurrently with a standard chemotherapy treatment (FOLFOX) in potentially resectable liver metastases from colorectal cancer.

The trial will test three dose levels. At each dose, the patients will receive three successive administrations, two weeks apart, NKR-2 cells. The study will enroll up to 36 patients (dose escalation and expansion phases).


Eligibility Criteria:
Inclusion Criteria:

1. Men or women ≥ 18 years old at the time of signing the ICF
2. Patients with histologically proven colorectal adenocarcinoma with potentially resectable liver metastases,
3. No previous chemotherapy for metastatic CRC,
4. The patient is due to receive first-line metastatic chemotherapy regimen with FOLFOX as a neoadjuvant
5. The patient must have an ECOG performance status 0 or 1
6. The patient must have sufficient bone marrow reserve, hepatic and renal functions

Detailed disease specific criteria exist and can be discussed with contacts listed below

Exclusion Criteria:

1. Patients who have received another cancer therapy within 2 weeks before the planned day for the apheresis
2. Patients who receive or are planned to receive any other investigational product within the 3 weeks before the planned day for the first NKR-2 administration
3. Patients who are planned to receive concurrent growth factor, systemic steroid or other immunosuppressive therapy or cytotoxic agent, other than the treatment authorized per protocol
4. Patients who underwent major surgery within 4 weeks before the planned day for the first treatment
5. Patients with uncontrolled intercurrent illness or serious uncontrolled medical disorder
6. Patients who have received a live vaccine within 6 weeks prior to the planned day for the first NKR 2 administration
7. Patients with a family history of congenital or hereditary immunodeficiency
8. Patients with history of any autoimmune disease
Blood Cell Adhesion to Arterial Filters During Cardiac Surgery

Cardiopulmonary bypass (CPB) is a unique clinical scenario that results in widespread activation of the hemostatic system. Conventional CPB interferes with normal hemostasis by diluting hemostatic cells and proteins, through reinfusion of shed blood, and through activation on the bypass circuit surface of multiple systems including platelets, the kallikrein-kinin system, and fibrinolysis . Besides, deleterious effects of cardiopulmonary bypass (CPB) are partly sequelae of blood-foreign surface reactions. The arterial filter is the part of the CPB circuit where blood cells are exposed to high mechanical stress and where cellular aggregates may fasten in large quantitiesiec.

This is a clinical and observational study. It is being performed in the surgical center and intensive care unit of the Heart Institute (InCor) from Faculty of Medicine, University of São Paulo (FMUSP), on patients undergoing cardiac surgery, who satisfy inclusion and exclusion criteria. In the preanesthetic visit, patient assessment of the criteria described in study methodology is verfied. During the surgery, a blood sample is taken to analyze hemostatic function in the begin of cardiopulmonary bypass, before arterial filter (pre-filter) and in the end of cardiopulmonary bypass, after arterial filter (post-filter). Other routine laboratory exams is being colected until first postoperative day, on the eletronic medical records. At the end of surgery, the arterial filter is withdrawn from cardiopulmonary bypass circuit to be prepared and analysed by SEM. Ten arterial filter samples from pre-determined sites and sizes are sent to the clinical laboratory for evaluation of platelet and leukocyte gene expression in arterial filter. Patients will be followed until hospital discharge or 28 days after surgery, regarding allogeneic transfusion needs, reoperation and thromboembolic events.

Eligibility Criteria:
Inclusion Criteria:

* Cardiac surgeries with extracorporeal circulation in patients older than 18 years
* Written and signed informed consent
* Preanesthetic assessment and preoperatory exams in accordance with study methodology

Exclusion Criteria:

* Active infection;
* Previously coagulopathy;
* Antiplatelet therapy use until 10 days before surgery (except acetylsalicylic acid and enoxaparin that may be used in prophylactic doses until 24h before surgery);
Mesenchymal Stem Cells (MSCs) - Like Cell Transplantation in Women With Primary Ovarian Insufficiency

There is a high incidence of women suffering from Primary Ovarian Insufficiency (POI). So far, there was no treatment sufficient enough to cure POI. Cell therapy is a rapidly developing field and have shown immense promise in the treatment of ovarian dysfunction. In this study, the investigator will evaluate the safety of MSC-like cell therapy in women suffering from POI.

The purpose of this work is to explore the safety and preliminary efficacy of human embryonic stem cell derived MSC-like cell transplantation in women with POI. MSC-like cells were injected directly into bilateral ovaries under transvaginal ultrasound. Patients are subjected into 3 groups, with low (0.2×107), medium (0.5×107) and high dosage (1.0×107) of cells injection for each ovary. The outcomes of patients were followed after the injection every 2 weeks. The investigator mainly follow the safety indexes, and the level of sex hormone and signs of follicle growth will also be monitored. The growing follicles will be stimulated by exogenous hormone, followed by oocyte retrieval and in vitro fertilization (IVF).

Eligibility Criteria:
Inclusion Criteria:

1. Under 40 years of age;
2. Have established regular menstrual cycle, oligomenorrhea / amenorrhea ≥ 4 months;
3. FSH (Follicle-Stimulating Hormone) \> 25 IU/mL;
4. Bilateral ovaries are visible by ultrasound;
5. Have fertility requirement, husband has sperms;
6. Willing to sign the Informed Consent Form.

Exclusion Criteria:

1. Primary amenorrhea;
2. History of serious drug allergy or allergic constitution;
3. Thrombophlebitis and thromboembolia, past and present;
4. Acute or chronic infection, hematologic disease, angiocardiopathy, pulmonary disease, liver disease, nephropathy, pancreas disease
5. Autoimmune disease, history of severe familial genetic disease, etc.
6. Anatomical abnormality of reproductive system;
7. Contraindications for pregnancy;
8. Spouse azoospermia;
9. HIV+, hepatitis B, C;
10. Thyroid dysfunction;
11. History of previous malignant or ovarian tumors, history of ovarian therapy;
12. Abnormal karyotyping (e.g. turner syndrome, fragile X syndrome);
13. During pregnancy or lactation;
14. Alcohol or other substance abuse;
15. Mental disease, communicate obstruction;
16. Unwilling to comply with follow-up schedule or want to take other treatment during the follow-up period;
17. Attending doctor consider inappropriate to take part in.