cyrilzakka/clinical-trials huggingface dataset:
Study of CD200 Activation Receptor Ligand (CD200AR-L) and Allogeneic Tumor Lysate Vaccine Immunotherapy for Recurrent Glioblastoma

This is a single-center, open-label, dose-range finding Phase I study of hP1A8, a new adjuvant CD200 activation receptor ligand (CD200AR-L), in combination with imiquimod and the GBM6-AD vaccine to treat recurrent glioblastoma (GBM) in adults.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years and older.
* Confirmed diagnosis of GBM.
* Radiographically or histologically proven progression or recurrence of disease at any time after standard of care therapy (radiation, temozolomide, with or without a tumor treatment field device).
* Tumor debulking or biopsies may be performed to clinical trial enrollment if indicated and feasible.

Exclusion Criteria:

* Bevacizumab or targeted therapy within 45 days of enrollment.
* Intercurrent immune system disorder such as hypoimmunity (marrow failure, HIV) or hyperimmunity (autoimmune disease).
* Unable to complete a standard upfront course of chemoradiotherapy due to disease progression or intolerance of therapy.
* History of Gliadel water, GammaTile or other implanted therapeutic agent.
* Concurrent use of tumor treatment field devices (e.g. Optune).
Hypofractionated Vs Conventional Fractionated Postmastectomy Radiotherapy for High Risk Breast Cancer

The study was designed to investigate whether hypofractionated adjuvant radiotherapy is noninferior to conventionally fractionated adjuvant radiotherapy in terms of efficacy and toxicities for high risk breast cancer patients treated with mastectomy

The randomization is between 50 Gy / 25 fractions and 42.5 Gy/16 fractions, 5 fractions weekly.

Eligible breast cancer patients with mastectomy and axillary dissection will be randomized 1:1 into two groups: conventional fractionated (CF) radiotherapy of 50 Gy / 25 fractions and hypofractionated (HF) radiotherapy of 42.5 Gy/16 fractions, 5 fractions weekly.

The primary endpoint is loco-regional recurrence. Other cancer related events and acute/late radiation morbidities will also be evaluated. The patients will be followed for 10 years.

It is hypothesized that for women operated for high risk breast cancer with indication of postmastectomy adjuvant radiotherapy, hypofractionated radiotherapy is noninferior to conventional fractionated radiotherapy in terms of the efficacy and toxicities.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Age18-75 years
* Pathologically confirmed invasive breast cancer
* Treated with mastectomy and axillary lymph node dissection with more than 10 resected lymph nodes. Immediate or delayed ipsilateral breast cancer reconstruction is accepted
* Negative surgical margins
* Pathologic T1-2N1 with at least one of the following risk factors: \<40 years, Grade 3, lymphovascular invasion positive, ER/PR negative or HER2 overexpression, or pT3-4, or pN2-3 (four or more positive axillary lymph nodes)
* No distant metastases
* No supraclavicular or internal mammary nodes metastases
* ECOG:0-1
* Adjuvant systemic therapy with chemotherapy, endocrine therapy and anti-HER2 treatment is accepted.
* No neoadjuvant chemotherapy
* Fit for postoperative radiotherapy. No contraindications to radiotherapy
* Signed informed consent

Exclusion Criteria:

* Concurrent or previous malignancy excluding basal or squamous cell carcinoma of the skin
* Previous radiotherapy to the chest wall or regional lymph node areas
* Patients with severe non-malignant comorbidity in cardiovascular or respiration system
* Patients with medical contraindication for radiotherapy: systemic lupus erythematosus, cirrhosis
* pT1-2N1 with none of the following risk factors: \<40 years, Grade 3, lymphovascular invasion positive, ER/PR negative or HER2 overexpression
* Patients with supraclavicular or internal mammary nodes metastases
* Known definitive clinical or radiologic evidence of metastatic disease
* Bilateral breast cancer or historically confirmed contralateral invasive breast cancer
* Treated with neoadjuvant chemotherapy
* ECOG: 3-4
* Pregnant or lactating
* Conditions indicating that the patient cannot go through the radiation therapy or follow up
* Unable or unwilling to sign informed consent
The Analysis of Heart Rate Variability With 24hrs Holter ECG and Serum Cardiac Fibrosis Markers in Critical Illness Patients Who Are With Cardiogenic Shock, With ECMO or IABP Support, or With APACH II Score >25)

The study is to show the prognostic factor of HRV parameter and cardiac fibrosis markers in critical illness patients

The analysis of Heart Rate Variability with 24hrs Holter ECG and serum cardiac fibrosis markers in critical illness patients who are with cardiogenic shock, with ECMO or IABP support, or with APACH II score \>25)

Eligibility Criteria:
Inclusion Criteria:

* critical illness patients who are with cardiogenic shock, with ECMO or IABP support, or with APACH II score \>25)

Exclusion Criteria:

* pacemaker rhythm, not sign the permit
Vitamin A With BCG Vaccine

Two studies from Asia have suggested a beneficial effect of vitamin A supplementation given at birth. Hypotheses: Vitamin A supplementation administered at birth together with BCG vaccination is associated with a 30% reduction in infant mortality and morbidity during the first year of life in normal birth weight children in an African setting.

Vitamin A deficiency is common in low-income countries. Vitamin A supplementation to children above 6 months of age reduces all-cause mortality with 23 % to 30 %. Studies on vitamin A supplementation in infants younger than 6 months of age have reported inconsistent effects on mortality. Studies providing supplementation between 1 and 5 months of age have found no effect or even a negative effect. However, the only two studies of supplementation at birth, both conducted in Asia, showed substantial significant reductions in infant all-cause mortality.

The beneficial effect of neonatal vitamin A supplementation may be a result of correcting the congenital vitamin A deficiency resulting from maternal vitamin A deficiency. On the other hand, it has been speculated that the beneficial effect of vitamin A supplementation given at birth may in part be explained by a synergistic effect of vitamin A supplementation and BCG vaccination given at the time of birth.

The protective effect on mortality of vitamin A supplementation given at birth needs to be confirmed in an African population. Furthermore, none of the two previous studies have reported data on vaccination status of the included infants.

In this study, the effect on mortality and morbidity of given vitamin A supplementation simultaneously with BCG vaccination at birth to normal birth weight infants will be investigated in an African population. Furthermore, the effects of vitamin A supplementation will be evaluated with respect to effect on growth, the response to BCG vaccination, infant vitamin A status and infant cytokine profile. Furthermore the effect on specific diseases such as malaria, measles and rotavirus infections. The mechanisms behind the effects of vitamin A will be evaluated.

We will include 4,800 normal birth weight infants (\> 2500 g) infants randomized to 50,000 IU of vitamin A or placebo given simultaneously with BCG vaccine. The study take place in Guinea-Bissau, West Africa. The study area consists of five districts in the capital of Guinea-Bissau. The Bandim Health Project has been working in the study area for almost 25 years, and a demographic surveillance system has been established and functioned for many years.

Eligibility Criteria:
Inclusion Criteria: Belonging to the study area

Exclusion Criteria:Overt illness, signs of vitamin A deficiency, previous BCG vaccination
Relevance of Whole-body Computed Tomography Prescription in the Emergency Department : an Identification Tool for Low Risk Patients

The whole-body scanner (SCE) is a powerful examination that guides the management of patients severely traumatized. However, the systematic use of this examination in emergency departments is responsible for a large proportion of normal examinations. In addition to the non-negligible direct cost, the average irradiation of 20 mSv would give an adult a 1 in 1000 risk of developing a cancer. The Vittel score makes it possible to categorize pre-hospital patients as seriously traumatized to guide the sending of resources and direct them to a center equipped with a suitable technical platform.

The use of this score to condition the prescription of the ECS is at the origin of an over-triage important since one out of two patients who validates at least one criterion has no lesion on imaging. The purpose of this research project is to validate a decision support tool to objectively guide the emergency physician in its use of the ECS. At the same time, the economic impact of such a procedure will be analysed.


Eligibility Criteria:
Inclusion Criteria:

* Any adult patient undergoing an SCE as part of a post-traumatic lesion assessment during a stay in the emergency room.
* Mechanism of injury: road accident or fall.
* Patient having read and understood the information letter and given his oral consent.

Exclusion Criteria:

* Neurological impairment defined by a Glasgow score of less than 8.
* Respiratory failure with SpO2 \< 90% on oxygen or with the use of ventilatory assistance.
* Hemodynamic failure with vascular filling greater than 1000 cc or recourse to catecholamines.
* Acute alcoholism.
* Taking narcotics.
* History of cognitive disorders.
* Current pregnancy.
* Suicidal patient.
* Trauma related to a brawl
* Penetrating trauma.
* Hemophilia.
* Known thrombocytopenia at the time of inclusion.
* Heart, lung, liver or kidney transplant patient.
* Person deprived of liberty by an administrative or judicial decision or person placed under legal safeguard / sub-tutorship or curatorship.
Spectroscopic Assessment of Intramyocardial Oxygen Saturation Feasibility During Open-heart Surgery

This traditional feasibility study aims to capture preliminary safety and effectiveness information on a near-final Investigational Device design to adequately plan the forthcoming pivotal study.

The study design is based on measuring the depth of ischemia during the operation, which is compared to the intraoperative and postoperative morbidity of the patient, especially to the dysfunction of the heart.

A qualified and experienced Monitor is assigned for the study to oversee and document the progress of the trial. The Monitor ensures the trial performance in accordance with the Protocol and Good Clinical Practice (GCP).

The trial team conforms to ISO 13485 quality standards and ISO 14155 GCP. Processes included in the monitoring activities are documented in the quality management system. Below are described the summaries of all these activities.

Source data will be collected and transferred into the electronic CRFs by site staff, and the collected data quality and the conformity to the Good Clinical Practice will be assessed by monitoring. Based on a risk assessment performed, a Data Monitoring Committee shall not be established.

Clinical Research Associate (CRA) is responsible for checking the accuracy and completeness of Case Report Form (CRF) entries, source documents, and other investigation-related records against each other. Other responsibilities of CRA, including detailed Source Data Verification (SDV), are documented by the clinical project manager (CPM) or head of clinical research (HCR)(both are sponsor's representatives). SDVs will be performed and documented during monitoring visits.

Monitoring planning, reporting, and visits are pre-defined and documented with pre-made templates per the sponsor's quality management system. Monitoring visits will be performed to cover data from all study participants, and according to QMS and the Standard Operation Procedures.

The monitoring shall ensure that all source documentation is precise and document control is exercised in all relevant documentation. The monitoring ensures, that the Adverse events are always reported and appropriate authorities or stakeholders are informed.

Eligibility Criteria:
Inclusion Criteria:

* Any 18 to 90-year old patient scheduled for open-heart operation
* The ability to understand the objective of the study and the risks involved.
* Informed consent obtained, including the agreement to authorization to use the protected personal patient records according to privacy legislation.

Exclusion Criteria:

* Inability to obtain an informed consent form
* Patients included as vulnerable population according to Finnish Medical Research Act, including retarded, pregnant women, nursing mothers, prisoners, or forensic patients.
Observational Research on Infectious Disease Outbreaks and Difficult Cases of Unidentified Etiology in Indonesia

This observational study will investigate suspected infectious diseases of unknown etiology prospectively during outbreaks and at healthcare facilities, and retrospectively through historical samples where no etiology was ever determined. The study is designed to rapidly, flexibly, and consistently respond to any potential scenario in Indonesia, and the data collected will provide needed insight into the landscape of infectious diseases in the country. By better understanding the infectious causes of outbreaks and difficult hospitalized cases, the Indonesian Ministry of Health will be able to more accurately and efficiently control infectious diseases and craft healthcare policies.

This is a study to identify the causative agents and describe the clinical characteristics of infectious disease outbreaks and difficult cases of unidentified etiology in Indonesia. It is a retrospective and prospective observational study with an exploratory design. There will be no intervention to the participants that is intended to affect their SoC or clinical outcome.

Retrospective study activities will be ongoing throughout the duration of the study. The INA-RESPOND Reference Lab will perform research tests on various specimens collected as part of historical outbreaks and previous difficult cases where an etiology was never identified.

Prospective study activities will be initiated upon official request from health authorities and health facilities/institutions. Requests are expected to be filtered through and evaluated by the 19 active INA-RESPOND Network sites before inclusion in the study. Samples collected during outbreaks and from difficult cases of unknown etiology will be analyzed at the INA-RESPOND Reference Lab at their own pace. Results from any research tests will be shared with the requesting authorities as research-use-only and are not intended to alter standard of care.

Eligibility Criteria:
Inclusion Criteria:

1. Adult or child of any age hospitalized with a current episode of illness with a presumed infectious disease of unidentified etiology
2. Negative for Dengue virus infection by an antigen-based and antibody-based diagnostic test (i.e. NS1 antigen test and Dengue-specific IgM test)
3. Negative for Salmonella Typhi infection by Standard of Care testing (i.e. blood culture, Widal test, or Tubex rapid test)
4. Able to provide a documented informed consent
5. Agrees to the collection and storage of specimens for laboratory testing and/or future research (participants may decline storage of specimens for future research)
6. For Ongoing patients in outbreak situations: Referral from the MoH as part of a suspected or identified outbreak of infectious disease

Exclusion Criteria:

* Investigators' discretion for patient safety and well being
Linguistic and Cultural Validation in Italian of Female Sexual Function Index (FSFI) Questionnaire

300 italian women will be enroll for linguistic and cultural validation in italian of Female sexual function index (FSFI). This questionnaire is used in most countries to investigate female sexual function. To date there are not validate questionnaires in italian on female sexual function. We decided to start the validation process to give a validated tool to italian investigators.

A linguistic translation from the original language into the target language (Italian) will be carried out in parallel by two independent, native Italian-speaking professional translators, with English as their first foreign language. A first consensus meeting, which will involve the two translators and the research group, to compare the Italian versions and yielded a first-consensus Italian version of the scale. After this first phase the study will conduct in multiple Italian centres located in Northern, Central and Southern Italy. At each centre, the FSFI will administer to a female population of subjects with and without sexual dysfunction. Women will be administer the questionnaire at baseline and 2 weeks later, so as to evaluate the test-retest reliability. The patients will ask whether encountered any difficulty (ease of completion, comprehension, problems, etc). The number of patients who will encounter problems in correctly understanding questions and precoded answers will be recorded and discussed. Will also ask the women to indicate the way to ameliorate the test, and, if possible, the changes will be performed. A back-translation of the Italian consensus version will be carried out by a native American English-speaking professional translator, with Italian as her first foreign language, to control the adherence of translation with the original one. The final Italian version of the FSFI will be obtained.

Eligibility Criteria:
Inclusion Criteria:

* women aged 18-65 years

Exclusion Criteria:

* mental diseases that do not permit to understand questionnaire
Outcome of Allogeneic Hematopoietic Stem Cell Transplantation

To collect baseline and outcome data relating to all bone marrow, peripheral blood, cord blood hematopoietic stem cell transplants and therapies related to hematopoietic stem cell transplantation performed in Queen Mary Hospital.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged 18 years or older who received allogeneic hematopoietic stem cell transplantation (allo-HSCT).

Exclusion Criteria:

* participant who is unable to give informed consent in a prospective cohort.
Effect of Resistant Wheat Starch on Subjective Appetite and Food Intake in Healthy Adults

A randomized, single-blind, cross-over study was conducted to determine the effect of replacing standard wheat flour (SWF) with resistant wheat starch (RWS) on markers of appetite and food intake in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

* BMI 18.5-29.9 kg/m2
* Regular breakfast consumers (\>5 days/week)

Exclusion Criteria:

* not weight stable (?3 kg weight change in previous 3 months)
* use/used tobacco products
* presence of acute or chronic illness
* restrained eater (\>13 on the restraint section of the three-factor eating questionnaire)
Pilot Study to Evaluate the Interest of PDL in the Management of Telangiectasia of the Face and Neckline in Systemic Scleroderma

This single-center, prospective, open-label, quasi-experimental, intra-individual comparative study will include a consecutive cohort of 21 patients with diffuse or limited, minimally active scleroderma with 3 to 30 years of evolution.

Patients will have 4 sessions of pulsed dye laser 595 nm spaced 8 weeks apart. The final quadruple evaluation by several evaluators will be 2 months after the last session, on the following criteria: evolution of the number of telangiectasia; subjective improvement score (LINKERT scale); impact on quality of life (SKINDEX score); visual analog pain scale (VAS); adverse events (AEs), including discontinuation of treatment due to post-session purpura (AT-PPS); patient satisfaction (yes or no).

Primary Objective:

To evaluate the efficacy of pulsed dye laser treatment on facial and neckline telangiectasias in systemic scleroderma by comparing the mean number of telangiectasias.

Secondary Objectives:

Evaluation of the aesthetic efficacy by the patient, observer and adjudication committee Evaluation of the impact on the quality of life after treatment (skindex) Evaluation of treatment tolerance in terms of pain (VAS) and adverse events (purpura, oozing, hyperpigmentation, hospitalization)

Eligibility Criteria:
Inclusion Criteria:

* patient followed in dermatology and/or internal medicine at the University Hospital of Caen for systemic scleroderma
* patient with telangiectasias related to scleroderma
* patient with an aesthetic prejudice

Exclusion Criteria:

* Patient with previous laser treatment for facial telangiectasias.
* Tanned, irritated or traumatized facial skin
* Patient not affiliated to the Social Security system
* Pregnancy
Biomodel in Tetralogy of Fallot

Using biocardiac model in helping the total correction of the Tetralogy of Fallot.

Using biocardiac model in helping the total correction of the Tetralogy of Fallot.

Eligibility Criteria:
Inclusion Criteria:

Tetralogy of Fallot
Computed Tomography (CT) Coronary Angiogram Evaluation in Cancer Patients Having CT Thorax, Abdomen and Pelvis

Currently patients with certain cancer usually have routine follow up (Computed Tomography of Thorax, Abdomen and Pelvis) CT TAP scans to see response to treatment or relapse. The study proposal allows the evaluation of the coronary arteries by modifying the current CT TAP technique without significant additional procedures, intravenous contrast or radiation - i.e. an opportunistic Computed Tomography Coronary Angiogram (CTCA) without any penalty. The question is does performing Computed Tomography (CT) of the thorax in such a way confer important additional information about cardiac risk? At the same time the investigators need to ensure that doing scan as per CTCA protocol produces equivalent image quality to evaluate other structures in the chest. A recent small retrospective study has using a similar technique suggests that it may in fact improve image quality due to less cardiac related motion artefact.

The study is a non-inferiority observational study to primarily ensure that the Computed Tomography of Thorax, Abdomen and Pelvis (CT TAP) technique produces equivalent image quality of the lungs (hence the need to scan with both conventional technique and the Electrocardiograph \[ECG\] gated technique) and secondarily to evaluate the effectiveness of demonstrating the coronary arteries in this cohort of patients who have not received heart rate control.

Eligibility Criteria:
Inclusion Criteria:

* Patients having routine follow up cancer CT TAP scan
* Age more than or equal to 40 years of age at the time of scan.
* Able to provide informed written consent
* Able to hold their breath for at least 10 seconds
* Has regular heart rate
* Able to follow verbal commands for breath holding and remain still for the duration of scanning
* Able to lie supine for the entirety of the scan

Exclusion Criteria:

* Patient unable to give informed consent.
* Patients unable to lie supine
* Patient not able to breath hold for at least 10 seconds.
* Patients not having regular heart rate. Patient with atrial fibrillation or \>2 atrial or ventricular premature beats on a preoperative 12 lead ECG (suboptimal image quality results from irregular heart rhythms)
* Patient having eGFR \<30, to avoid risk of contrast nephrotoxicity in patients potentially at risk) or chronic renal failure on dialysis
* Patient has known contrast reaction.
* Patient is pregnant.
* Patients BMI\>35
* Unavailability of research slot to accommodate for the urgency of the scan requested.