cyrilzakka/clinical-trials huggingface dataset:
CIRSE Registry for SIR-Spheres Therapy

The administration of SIR-Spheres microspheres (yttrium-90 resin microspheres) is a form of selective internal radiation therapy (SIRT) for the treatment of patients with primary and secondary liver tumours. The primary objective is to observe the real-life clinical application of radioembolisation with SIR-Spheres and the impact of the treatment in clinical practice. Secondary objectives are to observe safety and effectiveness of SIR-Spheres treatment in terms of adverse events, Overall Survival (OS), Progression-free survival (PFS), technical considerations, liver PFS and Quality of Life (QoL) + subgroup analyses

Selective internal radiation therapy (SIRT), also called radioembolisation (RE), with SIR-Spheres microspheres is an endovascular procedure, included within the interventional oncologic technologies to treat primary and secondary liver tumours. Using a microcatheter, a precise dose of resin microspheres is released in the hepatic artery, where they are carried into the arterioles and selectively lodge in the tumour microvasculature. The microspheres are loaded with the radioactive yttrium-90, a high-energy beta-emitting isotope with a half-life of 64.1 hours. Following administration, 94% of the radiation is delivered in 11 days. Previous reports on the safety and efficacy of yttrium-90 resin microspheres for the treatment of primary and secondary liver tumours are very promising. In order to further improve the understanding of this therapy in its true clinical setting, the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) initiated the CIRSE Registry for SIR-Spheres Therapy (CIRT), a phase 4 observational study that aims to collect robust data on the real-life clinical practice of radioembolisation with SIR-Spheres microspheres. Further, using the quality of life questionnaire QLQ-C30 with its hepatocellular carcinoma module (developed and verified by the European Organisation of Research and Treatment of Cancer (EORTC)), CIRT aims to collect data on the quality of life of patients treated with SIR-Spheres microspheres.

Eligibility Criteria:
Inclusion Criteria:

* Treatment of liver tumour with SIR-spheres microspheres
* Primary or secondary liver tumours
* Signed informed consent form
* 18 years or older

Exclusion criteria

* Under 18 years
Risk Factors, Clinical Characteristics and Outcomes of Acute Infection With Coronavirus 2019 (COVID-19) In Children

Patient are being asked to provide respiratory and blood samples for a clinical research study because the patients have a virus called the novel coronavirus, or SARS-CoV-2, that causes the disease known as Covid-19.

Investigators do not know a lot about this virus, including all the ways it travels from person to person. Investigators also do not know if a person will get sick or not from the virus after being in close contact with someone who has the virus. Because of this, investigators are performing research on the virus found in respiratory secretions to get more information on how investigators can best detect and treat this new virus in the future.

Primary Objective

* To determine the clinical characteristics and outcomes of Covid-19 in children.
* To characterize the clinical risk factors of Covid-19 in children..

Secondary Objectives

* To characterize the immunological risk factors and serologic response to SARS-CoV-2 infection in children.- To evaluate the duration of viral shedding in children.
* To evaluate the duration of SARS-CoV-2 viral shedding in children. Exploratory Objective

Nasal swabs will be collected from positive patient participants on Day 0. Timing of follow-up swabs will be guided by standard of care procedures.

Whole blood will be collected at Days 0. Follow-up blood sampling will be guided by standard of care procedures. Samples will be stored at -80oC.

Nasal swabs and whole blood will only be obtained at the same time standard of care procedures are performed. If a patient is not getting a blood draw, no sample will be collected.

Eligibility Criteria:
Patient Participant Inclusion Criteria:

* Less than 24 years old at the time of enrollment on study.
* St. Jude patients with laboratory confirmed Covid-19.

Exclusion Criteria:

* NA
Inferior Vena CAVA and Lung UltraSound-guided Therapy in Acute Heart Failure

Between 25% and 30% of patients hospitalized for acute heart failure (AHF) are readmitted within 90 days after discharge. Mostly due to persistent congestion on discharge. However, as the optimal evaluation of decongestion is not clearly defined, it is necessary to implement new tools to identify subclinical congestion to guide treatment.


Eligibility Criteria:
Inclusion Criteria:

- Hospitalization of 24 hours or greater for decompensated heart failure defined as new-onset of symptoms or worsening of previous symptoms (including orthopnea, progression to FC III-IV, bendopnea or fatigue) or signs of volume overload.

and - Jugular venous distension, hepatojugular reflux, lower extremity edema or signs of pulmonary congestion.

and

* Chest X-ray with signs suggestive of pulmonary congestion. and
* Elevated ´pro-B-type natriuretic peptide (NT-proBNP) levels of 450 pg/mL, 900 pg/mL, and 1800 pg/mL for ages \< 50 years, 50 to 75 years, and \> 75 years, respectively, within 24 hours of admission (53,54).

and

- Sufficient ultrasound visualization to assess IVC and lungs.

Exclusion Criteria:

* Not willing to participate.
* Life expectancy of less than 6 months.
* Uninterpretable lung or inferior vena cava ultrasound.
* Transfer to another hospital before hospital discharge.
* SBP \< 90 mm Hg.
* Chronic kidney disease (creatinine clearance \<30 mL/min calculated with the MDRD equation or hemodialysis).
* Requirement for invasive or noninvasive ventilator support.
* Pregnancy.
* Low cardiac output syndrome/cardiogenic shock.
* Death during index hospitalization.
* Acute coronary syndrome, myocardial revascularization or heart valve replacement within the previous 3 months.
* Being on heart transplant waiting list.
* Cardiac resynchronization therapy device implanted within the previous 3 months.
* Severe tricuspid valve regurgitation.
* Heart failure secondary to causes amenable to invasive correction: cardiac surgery, percutaneous interventions or pacemaker implantation.
* Heart failure secondary to significant arrhythmias (advanced atrioventricular block or sinus arrest, sustained ventricular tachycardia or any sustained arrhythmia other than atrial fibrillation causing hemodynamic instability according to the discretion of the treating physician).
* Heart failure secondary to severe systemic infection
* Severe psychiatric illness
* Palliative care
* SARS-CoV-2 infection
Sleep and Exercise in Rheumatoid Arthritis

Regular physical activity is important for people with rheumatoid arthritis (RA). Sleep requirements for adults should be on a 'sleep needs spectrum' of between 7 to 9 hours per day. Poor sleep is a common complaint among people with RA, which may have an effect on their activity levels and well-being. There is evidence that physical activity and exercise can improve sleep quality and disturbances in other chronic disease populations therefore, examining how same affects sleep in RA is important.

Sleep is an important aspect in maintaining the body's circadian rhythm. In general getting fewer than 5 hours sleep per day has been associated with cardiovascular problems, diabetes and obesity and can also be linked to depression and anxiety. Poor sleep is a common complaint among people with rheumatoid arthritis (RA) with disturbed sleep and fatigue known to affect up to 70% in this population. Poor sleep quality may contribute to the feelings of pain, fatigue and poor psychological well-being which in turn may further deteriorate functional ability and reduced activity.

It is known that exercise improves a person's psychological state which can also be an additional factor in improving or indeed disrupting quality of sleep. Exercise has been identified as an important part of the nonpharmacological management of poor sleep and in improving sleep quality however, people with RA were previously cautioned about undertaking exercise. Therefore, changes in sleep quality during exercise intervention should be evaluated so that society can understand more the potential for long-term changes in overall health status, in people who have RA. Indeed the intensity level of the activity in people with RA may be of additional importance.

Eligibility Criteria:
Inclusion Criteria:

* Participants will be eligible to participate if they are aged 18-70; have a diagnosis of RA (defined by the American College of Rheumatology 1987 criteria); have poor sleep (Pittsburgh Sleep Quality Index global score \>5); have a low disease score on 28 joints (DAS28) \<3.2; Health Assessment Questionnaire result of \<2.4 and are able to provided informed consent, understand and speak English. All the above will be determined should the person be interested in participating and before any fitness testing will be place.

Exclusion Criteria:

* Participants will be excluded from the study if they have severe physical disability (HAQ score \> 2.5); are pregnant; participate in regular physical activity in their leisure time (self-reported aerobic exercise \> 5 times per week); have cardiac symptoms corresponding to New York Heart Association (NYHA) functional classification \> 2;
Treatment of Early Immunoglobulin A Nephropathy by Angiotensin Converting Enzyme Inhibitor - A Randomized Controlled Trial

Immunoglobulin A (IgA) nephropathy is the most common type of primary glomerulonephritis in the world. The treatment of IgA nephropathy with normal renal function and minimal proteinuria is unknown. Since angiotensin-converting enzyme (ACE) inhibitors reduce proteinuria and retard the rate of decline of renal function in chronic proteinuric nephropathies, including IgA nephropathy. The investigators conduct a randomized control study to evaluate the efficacy of ACE inhibitor in the treatment of early IgA nephropathy. Sixty patients with biopsy-proven IgA nephropathy and minimal proteinuria are recruited. They will be randomized to ramipril for 5 years or no treatment. Blood pressure, proteinuria and renal function will be monitored. This study will explore the effects of ACE inhibitor in the treatment of early IgA nephropathy, which is a major cause of dialysis-dependent renal failure.


Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 65
* biopsy-confirmed IgA nephropathy
* proteinuria less than 0.5 g per day, normal blood pressure, and serum creatinine below 120 umol/l
* willingness to give written informed consent and willingness to participate in and comply with the study protocol

Exclusion Criteria:

* expected survival less than 2 years
* pregnant or nursing mother, or women of childbearing potential without an effective method of birth control
* history of myocardial infarction, congestive heart failure, or any other medical indication that necessitate the use of ACE inhibitor
* evidence of clinically significant hepatic, gastrointestinal, autoimmune disease
* history of malignancy, drug or alcohol abuse
* participation in any previous trial on ACE inhibitor
* taking other investigational drugs within the past 30 days
* history of non-compliance to medical regimens and patients who are considered potentially unreliable
* known history of sensitivity / allergy to ACE inhibitor
Multimodality Imaging Assessment of the Severity of Mitral Regurgitation

To investigate to assess the severity of mitral regurgitation by multimodality imaging.

In the single-center and open-label study, the researcher will compare the changes of ultrasonic cardiography (UCG) parameters when patients in fasting, anaesthesia and rehydration firstly. The aims are to clarify the effect of fasting and anaesthesia on the assessment of mitral regurgitation (MR) severity and the corrective effect of intravenous rehydration. The researcher then will investigate the correlation and consistency of multimodality imaging in assessing the severity of mitral regurgitation. The aim is to acquire more accurate, objective and reproducible parameters, to provide new solution for the precise assessment of MR severity and to guide the selection of clinical treatment and timing.

Eligibility Criteria:
Inclusion Criteria:

1. age ≥ 18 years old
2. all-caused moderate or severe MR assessed by Trans-Thoracic Echocardiography (TTE) : 1) EROA ≥0.3cm\^2; 2) RVol ≥45ml
3. The patient has signed an informed consent form.

Exclusion Criteria:

1. unstable angina, acute myocardial infarction and surgical history of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) within 3 months before recruit
2. acute heart failure or acute worsening of chronic heart failure requiring vasoactive drug therapy
3. severe infections, septicaemia
4. severe hepatic insufficiency ( Child-Pugh class C)
5. severe renal insufficiency ( chronic kidney disease (CKD) stage 5: estimated glomerular filtration rate (eGFR) \<15ml/min or dialysis)
6. hypotensive state, shock ( systolic blood pressure \<90mmHg or mean arterial pressure \<70mmHg with tissue hypoperfusion and urine output \<30ml/h)
7. uncontrolled diseases of the haematological system: acute gastrointestinal bleeding, intracranial haemorrhage or haemorrhage from other organs, acute pulmonary embolism or deep vein thrombosis, congenital or acquired haemorrhagic disease such as haemophilia, anaphylactic purpura and acute leukaemia, severe abnormalities in haematological parameters such as platelet count \<20\*10\^9/l and international normalized ratio (INR) \>3
8. contraindication for Trans-Esophageal Echocardiography (TEE) such as oesophageal constriction, oesophageal tumour, oesophageal fistula, oesophageal varices, cervical vertebral instability
9. contraindication for CMR such as metal foreign matter in the body, claustrophobia
10. contraindication for intravenous anaesthesia such as allergy to anaesthetics
11. pregnancy or breastfeeding
12. The patient does not sign an informed consent form.
13. Due to other reasons the patient is not suitable for enrollment assessed by the researcher.
Clinical Utility of SUDOSCAN in the Pediatric Population

The main purpose of this study is to evaluate whether SUDOSCAN is a valid, accurate clinical device for the the determination of sweat gland function in the pediatric population.

Primary Objective: To measure sweat gland function in a pediatric population

Secondary Objective: To determine thresholds on the SUDOSCAN scale for abnormal sweat gland function in the pediatric population


Eligibility Criteria:
Inclusion Criteria:

* Males and females ages 8 to 17 years
* Able to give assent as well as parental consent

Exclusion Criteria:

* History of type 1 or type 2 diabetes
* Chronic autoimmune condition
* Taking chronic immunosuppressive or anti-inflammatory medications
* Unable to apply palms of the hands and soles of the feet on the sensor plates during a 3 minute Sudoscan test
* Presence of hepatitis B or C
* Presence of HIV
* Presence of known neurological disorder
* Pregnancy and/or breastfeeding
* Any open wound on the soles of the feet or palms of the hands
* Participation in an ongoing clinical investigational drug trial
* Other serious medical conditions that in the opinion of the investigator, would compromise the subject's participation in the study
Losartan and Inflammation in Cystic Fibrosis

The purpose of the study is to examine if a specific drug called losartan (Cozaar ®), generally used to treat high blood pressure and to protect kidneys from damage in patients suffering from Diabetes Mellitus, will have any effect on the nasal inflammation in patients with cystic fibrosis (CF). The study will be performed at the Pulmonary Division at the University of Miami, Cincinnati Children's Medical Hospital Center, University of Kansas Medical Center and University of Alabama-Birmingham.


Eligibility Criteria:
Inclusion Criteria:

* CF patients homozygous for F508del and on current treatment with Orkambi™ for at least 3 months
* Age \>12 years
* Forced expiratory volume at one second (FEV1) \>/= 40% of predicted

Exclusion Criteria:

* Female patients not willing to adhere to strict birth control (combination of two methods)
* Pregnancy
* History of intolerance to angiotensin receptor blockers (ARBs)
* Treatment with angiotensin converting enzyme (ACE) inhibitor
* NPD response to zero chloride (0Cl)/isoproterenol of \> - 6.6 mV at screening (evidence of detectable CFTR activity at baseline)
* Regular use of NSAIDs or potassium supplementation, treatment with aliskiren, on anticoagulation
* Oral corticosteroid use within 6 weeks
* Exacerbation requiring treatment within 6 weeks
* Active treatment for mycobacterial infections
* Significant hypoxemia (oxygen saturation \<90% on room air and rest or use of continuous oxygen treatment), chronic respiratory failure by history (pCO2 \> 45 mmHg), clinical evidence of cor pulmonale
* Untreated arterial hypertension (systolic blood pressure \>140 mm Hg, diastolic blood pressure \> 90 mmHg)
* Blood pressure less than 90 mm Hg systolic while standing
* Cardiac, renal (creatinine 1.5 times normal limit), hepatic (LFTs \> 3x normal upper limit), neurological, psychiatric, endocrine or neoplastic diseases that are judged to interfere with participation in study
* Known renal artery stenosis
* Concomitant airway disorders other than CF, such as allergic bronchopulmonary aspergillosis (ABPA).
* Subjects with prior thoracic surgery
A LM-302 Combined With Toripalimab Phase II Study

A Phase II, Open-Label, Multicenter Study Evaluating the Efficacy, Safety, and Tolerability of LM-302 Combined With Toripalimab in CLDN18.2 Positive Patients advanced gastro-Intestinal Cancer

Primary Objective:

To evaluate the efficacy of the LM-302 + Toripalimab regimen in subjects with CLDN18.2-positive advanced gastro-Intestinal cancer

Secondary Objectives:

To evaluate the correlation between CLDN18.2 and PD-L1 expression levels and the antitumor activity of the LM-302 + Toripalimab regimen.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects who fully understand the purpose, nature, methods, and possible adverse reactions of the trial, voluntarily participate in the trial, and have signed the Informed Consent Form (ICF) before any procedure begins.
2. Male or female subjects aged 18-80 years (both inclusive) at the time of signing the ICF.
3. ECOG performance score of 0-1.
4. Subjects with an expected survival ≥ 3 months.
5. Diagnosed histologically or cytologically with local advanced gastro-Intestinal cancer
6. CLDN18.2-positive subjects.
7. Subjects with at least 1 measurable lesion according to RECIST v1.1.
8. Subjects must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose.
9. Subjects who are able to communicate well with investigators and understand and adhere to the requirements of this study.

Exclusion Criteria:

1. Participate in any other clinical trial within 28 days prior to 1st dosing of investigational medicinal product (IMP).
2. Subjects with anti-tumor treatment within 21 days prior to 1st dosing of IMP.
3. Any adverse event from prior anti-tumor therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0.
4. Subjects with uncontrolled pain.
5. Use of any live attenuated vaccines within 28 days prior to 1st dosing of IMP.
6. Subjects with current or previous interstitial lung diseases or pneumonia requiring oral or intravenous glucocorticoids for adjuvant therapy.
7. Subjects on anticoagulants, such as heparin and vitamin K antagonists.
8. Subjects who have undergone major surgery or received interventional therapy (excluding tumor biopsy or aspiration) within 28 days before the first dose.
9. Subjects with a history of malignancies other than the tumors investigated in this study within 2 years prior to the first dose.
10. Subjects who have severe cardiovascular disease.
11. Subjects with a known history of autoimmune diseases.
12. Subjects who have a history of immunodeficiency disease.
13. Subjects with HIV infection, active HBV or HCV infection.
14. Child-bearing potential female who have positive results in pregnancy test within 7 days before the first dose or are lactating.
15. Subjects who have psychiatric illness or disorders that may preclude study compliance and subject who is judged as not eligible to participate in this study by the investigator.
Use of Normal Saline With or Without Dextrose During Induction of Labor in Nulliparous

The objective of this study is to compare the effects of use of normal saline (250 cc / h), with or without dextrose supplement, on the evolution of labor in nulliparous.

There is some controversy regarding intravenous hydration of patients during labor. While the use of a fast flow of hydration appears to be recognized beneficial, the addition of glucose is less well accepted. However studies on exercise physiology clearly demonstrates improved performance of skeletal muscle by increased hydration and carbohydrate replacement during prolonged exercise. This situation is similar to the condition of the uterus in labor especially since it is now established that glucose represents its principal source of energy.

However, the effect of an additional carbohydrate intake on the evolution of labor has not been extensively studied until now, and there are several schools of thought on this subject. While some studies show that such glucose addition could reduce the total duration of labor as well as its second stage, others claim that this glucose supplement offers no benefit and may even be harmful to the fetus.

It therefore seems imperative to conduct a study to compare the use of hydration with normal saline with or without dextrose during labor, as recommended in current flow (250 cc / h). To our knowledge, this has never been done.

Eligibility Criteria:
Inclusion Criteria:

* nulliparous woman
* monofetal pregnancy
* delivery at term
* elective induction
* favorable cervix (Bishop score of at least 6)
* cephalic presentation

Exclusion Criteria:

* diabetes
* preeclampsia
* maternal heart disease
An mHealth Intervention to Improve Outcomes for Women With HIV/AIDS

The purpose of this study is:

1. To develop a new mobile health (mHealth) system that will send text messages to remind both pregnant and non-pregnant women with HIV to adhere to their treatment plan (like keeping appointments, fillings prescriptions, and taking their medication) and address individual barriers to HIV care (like stigma, medical mistrust and resilience).
2. The intervention will also include patient navigation and motivational interviewing

2) Investigators also want to see if the mHealth system is feasible, easily accepted and if it will impact patient health in a positive way.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed HIV diagnosis as per the clinic standard
* Female \>= 18 years old at enrollment
* Currently active or recently returned into care or newly enrolled
* With two or more previously scheduled visits (12 months prior to study enrollment
* in the 12 months prior to enrollment:
* missed one or more visits or
* viral load detectable (\>20 mL) or
* not taking prescribed HIV anti-retroviral medications

Exclusion Criteria:

* men
* women who are cognitively impaired or are not able to consent for themselves
* non-working cell phone
* adolescents \< 18 years old at enrollment