cyrilzakka/clinical-trials huggingface dataset:
The Use of Point-of-Care Ultrasound in the Diagnosis of Acute Infectious Mononucleosis in the Emergency Department

The purpose of this study is to determine if splenomegaly on point-of-care ultrasound (POCUS) is an accurate and user-friendly surrogate to the heterophile antibody test and Epstein-Barr Virus (EBV) serologies to diagnose acute mononucleosis infection in patients presenting with sore throat to the Emergency Department (ED).

The investigators seek to determine whether the presence of splenomegaly on POCUS can accurately diagnose acute infectious mononucleosis in symptomatic ED patients, and determine the feasibility of performing point-of-care ultrasound for splenomegaly by emergency physicians in the emergency department setting.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 10 and 35 year-old presenting to the ED with suspected acute infectious mononucleosis

Exclusion Criteria:

* Chronic infectious disorders (eg. tuberculosis, malaria, HIV, syphilis)
* Inflammatory disorders (eg. sarcoidosis, amyloidosis, systemic lupus erythematosus, Felty syndrome)
* Proliferative disorders (eg. lymphoma, leukemia, essential thrombocytopenia, polycythemia vera)
* Congestive disorders (eg: cirrhosis, portal hypertension, right heart failure, congenital heart disease)
* Chronic haemolytic anemia (eg. sickle cell, thalassemia, hereditary spherocytosis)
* Storage diseases (eg. Gaucher, Niemann-Pick)
* Splenectomy
* Inability to give informed consent
A Study on How Vedolizumab is Given and the Outcomes for Adults With Inflammatory Bowel Disease (VARIETY-Belgium)

IBD consists of either ulcerative colitis or Crohn's disease.

The main aim of this study is to describe real-world treatment patterns in adults with moderate to severe ulcerative colitis or Crohn's disease when treated with vedolizumab. This will include how vedolizumab is given, which can either be an infusion through a vein (intravenous or IV), or an injection just under the skin (subcutaneous injection, or SC).

This is a non-interventional, prospective study of participants with moderately to severely active IBD (UC or CD) who are initiating or currently ongoing induction or maintenance treatment with vedolizumab according to the current SmPC in the real world setting.

The study will enroll approximately 200 participants. The data will be collected prospectively and will be recorded into electronic case report forms (e-CRFs). All the participants will be assigned to a single observational cohort:

• Participants with IBD

This multi-center study will be conducted in Belgium at specialized gastroenterology centers.

Eligibility Criteria:
Inclusion Criteria:

1. Has moderately to severely active IBD (UC or CD), initiating or ongoing IV induction treatment with vedolizumab in accordance with the current SmPC at baseline OR IBD participants receiving ongoing/maintenance IV vedolizumab treatment, with the option to switch to SC vedolizumab maintenance treatment.

Exclusion Criteria:

1. Prior history of intolerability, hypersensitivity, or other contraindications (active severe infections such as tuberculosis, sepsis, cytomegalovirus, listeriosis, and opportunistic infections such as Progressive Multifocal Leukoencephalopathy) to vedolizumab therapy as defined in the current SmPC.
2. Current or planned participation in an interventional clinical trial for CD or UC.
3. Cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
Evaluation of the Impact of Sports-inspired Onco-coaching on Health-related Quality's Life of the Patients in Cancer Remission After Allogeneic Transplantation of Hematopoietic Stem Cells

To measure the impact of a coaching program on the patient's health-related quality of life 15 months post-transplant (M15/R12).

After signing the consent form and validating the inclusion and non-inclusion criteria, patients will be included in the study. They will be randomized unequally (2:1) into one of the study groups:

* OC (Onco-Coaching) group: patients will undergo onco-coaching sessions at a rate of 1 session/month until 6 months post-inclusion (M9/R6). 73 patients will be randomized in this group
* Group C (Control): Patients will not receive onco-coaching follow-up, but will be able to benefit from classical management in full autonomy. 35 patients will be randomized in this group

Eligibility Criteria:
Inclusion Criteria:

1. Be at least 18 years of age and have a good understanding and practice of the French language,
2. Have been treated by an allogeneic hematopoietic stem cell transplant
3. Signed consent to participate,
4. Affiliation with a social security plan, or beneficiary of such a plan.

Exclusion Criteria:

1. Patients under treatment for complications (infections, GvHD,...) except patients with cGvHD requiring corticosteroid therapy less than or equal to 1 mg/kg daily
2. Patient with progressive or relapsing hematological disease,
3. Person in an emergency situation, adult under legal protection (guardianship, curatorship or safeguard of justice), or unable to express his/her consent,
4. Person requiring psychotherapeutic care
5. Impossibility to submit to the follow-up of the trial for geographical, social or psychological reasons.
The Development and Health of the Intestinal Flora During the First Year of Life

In this research study (PREVENT 1), Alba Health, in collaboration with academic institutions (Uppsala University, COPSAC and University of Antwerp) is investigating the association between the developing gut microbiota (collection of microbes present in the human gut) in the first year of life and lifestyle, wellbeing and health in a Swedish population. The study is the first of its kind in a Swedish population to collect and associate microbiome composition to an extensive family history and health questionnaire, stool colour and crying type, building on learnings from previous studies performed in other countries, such as the HELMI and COPSAC studies (HELMI - Finnish Health and Early Life Microbiota cohort from the University of Helsinki in Finland; COPSAC - Copenhagen Prospective Studies on Asthma in Childhood in Denmark).

The PREVENT 1 study is an observational research study led by Alba Health involving 300 families in Sweden with children between 0 and 12 months of age at the time of the study's start. After providing informed consent, the participating families will be asked to provide three stool samples from their child (the sample collection is not invasive and does not cause discomfort) and will be asked to answer questionnaires on lifestyle, well-being and family health. The participating families will not be asked to change their lifestyle beyond sample and data collection.

From the collected stool samples, we will extract microbial DNA and subject this to deep metagenomic sequence analysis. The study will only analyze microbial DNA, any human related material will be discarded. The stool samples will be destroyed within one month of sequencing (maximum 3 months from collection). The data will be stored according to GDPR and Swedish law, with informed consent in Sweden and with appropriate security measures. All research will be carried out in Sweden.


Eligibility Criteria:
Inclusion Criteria:

* Healthy infants, no preterm and not undergoing antibiotic treatment

Exclusion Criteria:

* Preterm delivered infants or infants undergoing antibiotic treatment
Multiple Oral Dose Safety, Tolerability And Pharmacokinetic Study Of PF-04287881 In Healthy Adult Subjects

This study is a randomized, investigator blind, subject blind, sponsor-open, placebo controlled, multiple dose escalating, sequential, parallel cohort study of PF-04287881. Subjects will undergo screening procedures within 28 days prior to dosing. At least 1 day after the Screening visit, eligible subjects who meet the entry criteria will be admitted to the Clinical Research Unit (CRU) and confined in the unit until discharge on Day 15.

Approximately 60 healthy volunteers (20 volunteers of Japanese origin for Cohorts 5 and 6), 18 to 55 years of age, males and females (women of non childbearing potential only) will be enrolled and randomized in a 4:1 ratio to treatment with either PF-04287881 or placebo within each cohort. Each cohort will have a 10 day dosing period and each will consist of 10 subjects (8 active and 2 placebo). In each cohort, each subject will receive a single daily oral dose of either placebo or PF-04287881 under fasted state for 10 days.

Following a Serious Adverse Event (potential Hy's Law case), a risk-benefit assessment review of all preliminary safety data, and a review by Pfizer's internal hepatic injury advisory panel, it was concluded that PF-04287881 had an unacceptable therapeutic window. The FDA was notified of our intention to discontinue development as of 09April2010.

Eligibility Criteria:
Inclusion Criteria:

* Volunteers willing and able to be confined to the Clinical Research Unit and comply with study schedule.
* Women of non-childbearing potential only.
* Japanese subjects must have 4 Japanese grandparents who were born in Japan.

Exclusion Criteria:

* Previous antibiotic use within 14 days prior to dosing.
* Use of antibiotics during hospitalization within 90 days prior to dosing.
* History of hypersensitivity to macrolides or ketolides.
* Presence of clinically significant eye conditions (other than corrective lenses).
The Effect of Intensive Controlled Exercise in the Early Stages of Amyotrophic Lateral Sclerosis

Amyotrophic Lateral Sclerosis (ALS) is a progressive neurological disorder characterized by amongst others asymmetric muscle weakness, respiratory insufficiency and spasticity. The disease is usually fatal within 2-3 years and until now there is no cure. ALS patients are usually supported by a multidisciplinary team. One of the members of this team is the physical therapist. The aim of physical therapy might be to enhance or to preserve cardiovascular fitness and muscle strength. Some authors suggest, however, that a moderate to high intensive exercise programme might lead to overuse weakness (an undesired fast progression of muscle weakness). The primary objective of this study is therefore to investigate whether regular moderate to high intensity exercise program in ALS can maintain or optimize cardiorespiratory fitness and muscle strength. A secondary objective is to investigate whether such a programme leads to overuse weakness and if there is a positive influence on patient's disability, fatigue and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Older dan 18 years Written Informed Consent Don't use walking adds such as a cane Patients must met El Escorial criteria for probable or definite ALS

Exclusion Criteria:

* Patients who are depending on intermittent or continuous mechanical ventilation Patients who are not able to understand and conform to the instructions Patients who already perform an exercise programme that can compare with our study Patients who have severe cardiopulmonary problems, DM or other problems concerning connective tissue.
Early Targeted Brain Cooling in the Cath Lab Following Cardiac Arrest

The objective of the COOLCATH study is to compare the effect of the RhinoChill transnasal cooling system to current standard Blanketrol III cooling blanket in its ability to achieve therapeutic hypothermia (TH) induction for patients undergoing TH after cardiac arrest.

The COOLCATH study will be a prospective, open-label randomized controlled trial comparing induction of TH efficacy and outcomes of patients following cardiac arrest. Any patient with return of spontaneous circulation (ROSC) following a cardiac arrest within the Essex Cardiothoracic Centre (CTC), or who is brought to the Essex CTC and is a candidate for TH will be considered for this study.

According to standard practice patients will be fully anaesthetised, intubated and ventilated. Patients will have a baseline tympanic temperature measurement taken and then will be randomized to receive induction of TH by either RhinoChill Transnasal cooling system, or standard care using the Blanketrol III cooling blanket.

All patients will have tympanic and oesophageal temperature measurement every 10 minutes until they reach TH (\<34 degrees centigrade). Once TH is achieved, the RhinoChill will be discontinued, and all patients will then receive the Blanketrol III cooling blanket for maintenance of TH for the standard 24 hour period. If a patient achieves a core body temp of 34 degrees centigrade while undergoing RhinoChill cooling and is still on the cath lab table, the device will be turned to low flow to ensure that the temperature is maintained until a transfer to the Blanketrol system is possible. For patients that arrive in the ICU on RhinoChill with a temperature \>34 (i.e. have not reached TH), these patients will have RhinoChill and blanket therapy until they reach \<34 degrees centigrade when the RhinoChill will be discontinued.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years old
2. Post cardiac arrest with Return of Spontaneous Circulation
3. Receiving therapeutic hypothermia as part of post-cardiac arrest care

Exclusion Criteria:

1. Cardiac arrest caused by trauma, head injury, massive haemorrhage, drug overdose, cerebrovascular accident, drowning, electric shock or hanging
2. Already hypothermic
3. Nasal obstruction preventing the insertion of a nasal catheter
4. Do Not Attempt to Resuscitate (DNAR) orders
5. Known terminal illness (eg. malignancy in the end stages)
6. Known or obvious pregnancy
7. Known coagulation disorder (except those induced by medication eg. Thrombolytics)
8. Known O2- dependency
iControl Chronic Kidney Disease

The proposed study is responsive to the call for obtaining enhanced preliminary data for an external grant resubmission. The goal is to demonstrate a novel approach using digital health tools to help preserve kidney function. The investigators aim to adapt a previous behavioral intervention and conduct formative testing among patients with CKD. Specifically, the investigators will:

Aim 1: Modify an existing technology platform to build the iControl CKD system and adapt intervention content to reflect behavioral guidelines for patients with mild to moderate CKD.

Aim 2: Conduct qualitative interviews and user testing among patients with CKD to obtain feedback on the design of the intervention.

Aim 3: Conduct a prospective cohort feasibility trial to assess the feasibility and initial acceptability of the iControl CKD intervention.


Eligibility Criteria:
Inclusion criteria:

Qualitative interview:

* Age 18 or older
* Diagnosed with CKD (self-report)
* Proficient in English

Inclusion criteria:

Pilot Groups:

* Age 18 or older
* Diagnosed with mild to moderate CKD (documented eGFR ≥60 ml/min/1.73m2 plus albuminuria or eGFR 45-59 ml/min/1.73m2 )
* Diagnosed with diabetes and/or hypertension
* Proficient in English
* Access to a test-enabled mobile phone
* Willing to receive and send multiple text messages in a week
Safety and Efficacy of Conivaptan for the Correction of Hyponatremia in Neurological Patients

Low sodium levels (hyponatremia) are a frequent occurrence in medically ill patients, and in particular those with neurological injury. Hyponatremia has been associated with worse outcome, problems with memory and concentration and impaired balance. Standard treatment for low sodium (salt) levels is to give the patient a salt containing solution thru a catheter (small flexible tube) in a vein in the arm or leg. One of the major complications of this treatment is excess body fluid which may cause heart problems or accumulation of fluid in the lungs and may require additional medications to remove extra water from the body.

FDA approval has recently been granted for a new drug - Conivaptan - for use in hyponatremic conditions. Conivaptan works by excreting free water from the body and thereby produce concurrent rise in serum sodium concentrations. Conivaptan has not been evaluated specifically in patients with brain injuries. The primary objective of this study is to demonstrate the safety and efficacy of intravenous Conivaptan for the treatment of hyponatremia in patients with brain injury. If effective, Conivaptan may represent a safe treatment option.


Eligibility Criteria:
Inclusion Criteria:

* Acute neurological injury
* Euvolemia or hypervolemia (defined clinically by examination, recent I+Os, BUN/creatinine ratio and CVP \[if available\])
* Serum sodium less than or equal to 132 mEq/L (confirmed as hypoosmolar hyponatremia by a concurrent source: osmolality measurements \[\<280 mosoms/L\] or by a preceding serum Na+ value \<135 mEq/L0

Exclusion Criteria:

* Patients who have uncontrolled hypertension; significant orthostatic hypotension or supine systolic blood pressure less than 85 mm Hg;
* Uncontrolled arrhythmias;
* Untreated severe hypothyroidism, hyperthyroidism, or adrenal insufficiency;
* Estimated creatinine clearance less than 20 ml/min;
* Urinary outflow obstruction unless catheterized;
* Alanine aminotransferase (ALT) \>3x ULN
* Aspartate aminotransferase (AST) \>3x ULN
* Serum albumin of 1.5 g/dl or less;
* Prothrombin time greater than 22 sec or an international normalized ratio (INR) greater than 2.0 without anticoagulant therapy or 3.0 or more with therapy; a white blood cell count less than 3000/µl;
* HIV infection;
* Active hepatitis.
* Pregnant or nursing
* Participation in a clinical trial of an investigational drug or device within 30 days of screening
* Unable to obtain written consent
Portal Vein Resection in Pancreatic Neuroendocrine Tumours

The limited evidence on the value of portal vein resection in patients with borderline resectable and/or locally advanced PanNENs is an incentive to carry out a retrospective multicentre study amongst centres with specific interest in the management of PanNENs and with experience on vascular reconstruction. Unlike previous studies on pancreatic cancer, it is more difficult to standardise the comparative parameters as the definition of borderline resectable disease has never been published for PanNENs. Similarly, different histological classifications make impossible to collect data exclusively on T3 tumours. Therefore, we aim to compare the short and long-term outcomes (including the impact of the histological depth of vascular invasion on survival) between patients undergoing standard PD and PD with portal vein resection for PanNENs, (regardless of T stage), by collecting and analysing retrospective data in this single centre study


Eligibility Criteria:
Inclusion Criteria:

All patients undergoing pancreaticoduodenectomy (Whipple's or Pylorus Preserving Pancreaticoduodenectomy) for sporadic PanNENs of the head of the pancreas of any stage (R0 or R1 resections) operated from 1st January 2007 up to 31st December 2016 inclusive.

Exclusion Criteria:

* Multiple Neuroendocrine Neoplasia (MEN) syndrome or other genetic background
* Age \<18 years old
* Total pancreatectomy or different operation rather than PD
* R2 Resections
Cohort Event Monitoring for Dengvaxia®, CYD-TDV Dengue Vaccine

The aim of this study is to evaluate the safety profile of Dengvaxia® when used in the real-world immunization setting

Primary Objective:

* To measure the incidence of selected adverse events (AEs) and serious AEs (SAEs) occurring over a period of six (6) months after each Dengvaxia® dose administration;
* To quantify the association between Dengvaxia® and each of the selected AEs and SAEs for which a risk window after vaccination can be defined, using estimates of relative risk
* To monitor the occurrence and frequency of hospitalized dengue disease as well as any other SAEs leading to hospitalization or death, including new and previously unrecognized SAEs, following Dengvaxia® administration on a longer term (up to 5 years after the first Dengvaxia® dose administration.

Secondary objectives:

* To identify risk factors for hospitalized dengue disease (severe or not) among subjects vaccinated with Dengvaxia®;
* To describe the frequency of hospitalized dengue disease and/or other SAEs or selected AEs according to the number of Dengvaxia® doses and/or interval between doses.

This is a prospective multi-national non-interventional study that includes two components of Cohort Event Monitoring (i) Short-term safety surveillance with a follow-up of 6 months after each Dengvaxia® dose administration and (ii) a long-term safety surveillance with a follow-up of five years after the first dose.

No vaccine will be provided as part of this study.

Study population will be identified in a convenient sample of sites as representative as possible of vaccination centers in each country. Subjects who received their first dose of Dengvaxia® at participating sites during the recruitment period and who meet the eligibility criteria will be asked to participate. After enrollment, vaccinees will be contacted periodically by telephone, e-mail, or Short Message Service (SMS) during follow-up for the identification of outcomes and Dengvaxia® vaccination status.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who received the first dose of Dengvaxia® across all age groups, even if vaccination was given outside of local specific label indications or recommendations
* Informed consent form (ICF) or Assent form (AF) has been signed and dated by the subject (based on local regulations), and/or ICF has been signed and dated by the parent(s) or another legal acceptable representative (and by an independent witness if required by local regulations)
* Subjects for whom a telephone contact or an e-mail address is available.

Exclusion Criteria:

* None
Using Microfluidic Separation Sperm Selection for Unexplained Infertility and Reccurrent Implantation Failure

In order to increase the likelihood of achieving IVF-treated pregnancy, good quality embryo transfer is important. To get good quality embryos, good quality gametes are needed. The selection of sperm is regulated according to the changing and mobility characteristics of today's conditions. The choice of multi-fluid sperm is thought to provide better sperm to obtain the environment in physiological conditions. Better embryo transfer to achieve better sperm elongation will increase the likelihood of pregnancy.

Patients will be treated with conventional IVF treatment. A vaginal ultrasound (US) examination will be perform on day 3 of the cycle for assessment of ovarian size and to exclude patients with large ovarian cysts. If a cyst \>20 mm is present, the cycle will cancel. At an initial dose of 225 IU, hMG will be given daily by IM injection commencing on day 3 of the cycle. The dose will be adjusted as re- quired depending on the E2 (estradiol) level. Daily endovaginal US examinations for follicle growth assessment will be started when the E2 level reached 275 pg/mL (1,000 pmoljL). When at least two follicles would reach 18 mm in diameter, 5,000 IU of hCG will be administered intramuscularly. Oocyte retrieval will be performed vaginally under US guidance 36 hours later. Sperm for ICSI procedure of oocytes will be prepared by a standard swim-up technique using for control group and sperm chip method will be used for study group for Unexplained Infertility and Recurrent Implantation Failure group. Uterine transfer of embryos will be carry out fifth day after oocyte retrieval using a catheter.

Eligibility Criteria:
Unexplained Infertility Group; The inclusion criteria are;

1. normal HSG,
2. normal hormone levels,
3. normal over functions,
4. having normal uterine cavity and endometrial thickness determined by office hysteroscopy
5. no endometriosis (determined by transvaginal ultrasonography and / or diagnostic laparoscopy)
6. normal spermiogram result Recurrent Implantation Failure The inclusion criteria are;

1-The inclusion criteria of the working group are: 2-Failure of embryo transfer at least twice after high quality embryo transfer after 3-IVF treatment, 4-having normal hormone reserve (FSH \<8 mIU / mL), 5-respond well to hormone stimulation (\> 8 oocyte collection), 6-having normal uterine cavity and endometrial thickness determined by office hysteroscopy