cyrilzakka/clinical-trials huggingface dataset:
Probiotic Supplementation Among Adults With Recurrent Gastrointestinal Symptoms

Participants experiencing recurrent gastrointestinal symptoms in this double-blind, randomized, controlled trial will receive either a commercially-available probiotic dietary supplement or placebo. The investigators hypothesize that participants in the probiotic dietary supplement group will experience greater improvement in their gastrointestinal symptoms than participants in the placebo group.


Eligibility Criteria:
Inclusion Criteria:

1. Self-reported response of "moderate discomfort" or worse (3 or greater on 1-5 Likert Scale) and "frequent discomfort" or more often (3 or greater on 1-5 Likert scale) from at least 2 of the following gastrointestinal symptoms: gas, indigestion, bloating, abdominal pain, or defecation irregularity as expressed on Likert scale (1=very minor or no discomfort, 2=minor discomfort, 3=moderate discomfort, 4=high discomfort, 5=very high discomfort) over the previous 3 weeks
2. Agree to continue with typical diet and exercise habits during study
3. Agree to use contraception or abstinence throughout study period, unless postmenopausal or surgically sterile (females only)
4. Able to understand and voluntarily consent to the study and understand its nature and purpose including potential risks and side effects

Exclusion Criteria:

1. Current and documented diagnosis of Inflammatory Bowel Disease (Crohn's disease or ulcerative colitis), Celiac disease, active peptic ulcer, active diverticulitis, and other active cases of gastrointestinal diseases that, in the investigators' opinions, may affect participant safety.
2. Current and documented diagnosis of any other non-gastrointestinal disease that, in the investigators' opinions, may affect participant safety or confound the evaluation of the study outcomes. Excluded conditions include congestive heart failure, malignancy, uncontrolled diabetes mellitus, uncontrolled autoimmune disease (lupus, rheumatoid arthritis, eczema), eating disorders, and any other active health condition or disease that the investigators feel contradict the intended study population of participants in good health.
3. Daily consumption of another probiotic supplement or new consumption of fermented dairy products (yogurt, kefir, etc.)
4. Usage of systemic steroids during the past 2 months
5. Usage of antipsychotic medications during the past 2 months
6. Usage of prednisone, 6-mercaptopurine, adalimumab, etanercept, infliximab, leflunomide, golimumab, or mycophenolate mofetil during the past 2 months
7. Uncontrolled anxiety or current medication for anxiety disorder
8. Pregnant or breastfeeding females
9. History of alcohol, drug, or medication abuse
10. Known allergies to any substance in the study product
11. Previous major gastrointestinal tract surgery (colon resection, gastric bypass, etc.)
12. Participation in another clinical trial within 30 days of screening
HPV DNA Self-sampling in a General Practitioner's Office.

One of the limitations of organized cervical screening in the Czech Republic is the lack of participation in preventive gynecological examinations. The aim of the project is to evaluate the benefits of self-sampling for HPV DNA in general practitioners' outpatient clinics to improve population participation in cervical screening.

Organized cervical screening in the Czech Republic has a long-term participation rate of about 56% of the target population. Despite active invitations through health insurance companies, a part of the population is resistant and does not participate in screening visits to gynaecologists in the long term. A significant proportion of such women, however, regularly visit their general practitioner due to other comorbidities. The aim of the ASTRA project is to assess whether an effective way to increase the proportion of women attending cervical screening is to perform self-testing for HPV DNA in the GP's office.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent for statistical data processing and consent to the processing of personal data
* Age 30+
* HPV test never performed or performed more than 3 years ago or patient does not know

Exclusion Criteria:

* Refusal to participate
* Pregnancy and puerperium
* Menses
* History of hysterectomy
* HPV test performed \<3 years ago with negative result
* Regular participation in screening and concurrent age 35, 45 or 55 years (test will be performed in the same year of screening).
COVID-19 in PID Survey

With the emergence of SARS-CoV-2 and the COVID-19 pandemic, there is an urgent need to understand the impact of infection on immunodeficient individuals. Whilst co-morbidities (such as diabetes, cancer, arterial hypertension, heart disease...) have been documented in people infected with SARS-CoV-2, there is currently no information on the consequences and outcomes for individuals with primary immunodeficiencies (PID).

Following the 1st phase of the survey (launched by Isabelle Meyts (ESID), Nizar Mahlaoui (CEREDIH \& IPOPI) and Kate Sullivan with Stuart Tangye (IUIS), that gave an idea of the number of affected PID patients and the impact of SARS-CoV-2 and directly focusing on obtaining this top level of information), we are launching the 2nd phase: "COPID19".

COPID19 survey is a secured online GDPR compliant platform based in Paris (Imagine Institute). It has been approved by the Paris-Necker-Enfants malades IRB and Ethics Committee. However, this retrospective survey is designed for global distribution. Data can be entered by a health care professional (mostly clinicians) through a personal login and password.

Each documenting person will have access to his/her own patients' data. COPID19 require a greater level of information than the 1st phase. The eCRF will be open to evolutions depending on progresses in our knowledge of this pandemic.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with a Primary Immune Deficiency
* COVID-19 (proven or probable)

Exclusion Criteria:

* Secondary Immune Deficiency
* Other Coronovirus infection
Iohexol for Measuring Renal Function

Approximately 25-35% of all children admitted to the paediatric intensive care unit (PICU) or neonatal intensive care unit (NICU) will develop Acute Kidney Injury (AKI) during the first seven days after admission. AKI is associated with a worse outcome, including an increased risk of mortality compared to patients without AKI. However, this AKI prevalence estimation is based on serum creatinine based glomerular filtration rate (eGFR), which is known to be inaccurate. The investigators postulate that measured GFR (mGFR) based on iohexol clearance in critically ill children will detect a higher prevalence of children with AKI than currently used methods based on endogenous markers. This study will additionally provide mechanistic knowledge on the relative contribution of GFR and renal transport to renal function in critically ill children.

Primary objective: To determine the prevalence of AKI in critically ill children based on clearance of iohexol.

Secondary objectives:

1. To determine the prevalence of AKI in critically ill children using serum creatinine, creatinine clearance, cystatin C and/or blood urea nitrogen based eGFR equations as well as urinary iohexol clearances.
2. To determine serum Proenkephalin (PENK) levels in critically ill children.
3. To compare the prevalence of AKI when this diagnosis is based on plasma iohexol clearances with the prevalence of AKI based on serum creatinine, creatinine clearance, serum cystatin C, PENK and/or Blood Urea Nitrogen (BUN) based eGFR and to assess agreement between those methods
4. To determine risk factors for the development of AKI when based on iohexol clearance.

Exploratory endpoint: To explore the relationship of genetic variation with the development of AKI.

Eligibility Criteria:
Inclusion Criteria:

* 0-18 years of postnatal age
* \>37 weeks of gestational age (for infants \< one year postnatal age)
* Bodyweight \>2500g
* Patients admitted to pediatric or neonatal intensive care unit
* PELOD-II (pediatric logistic organ dysfunction score, 2nd version) of 1 or higher (= at least one failing organ)
* Indwelling central line or arterial line in place for clinical purposes, or scheduled regular blood work for clinical reasons (at least once a day)
* Informed written consent

Exclusion Criteria:

* Known medical history of allergic reaction to injection of iodinated contrast material
* Receiving renal replacement therapy
* Language or cognitive inability of parents/caregivers to understand written and oral informed consent.
Maternal and Neonatal Outcomes Following Exposure to Benzodiazepines During Pregnancy

This is a nationwide cohort study to assess maternal and neonatal outcomes following exposure to benzodiazepines during pregnancy.

Benzodiazepines are widely used in pregnant women; however, their safety on congenital malformations in a real-world setting is still uncertain. We aimed to assess the association between benzodiazepine use in early pregnancy and the risk of congenital malformations. We will conduct a retrospective nationwide cohort study using the Health Insurance Review and Assessment (HIRA) database of South Korea, which covers the entire South Korean population.

Eligibility Criteria:
Inclusion Criteria:

* Pregnancies with live birth, 2011-2018
* Pregnancies linked to liveborn infants
* Pregnancies aged 20-45 years at delivery

Exclusion Criteria:

* Pregnancies with a chromosomal abnormality
* Pregnancies with exposure to known teratogenic drugs (e.g. antineoplastic agent, warfarin, lithium, isotretinoin, misoprostol, thalidomide) during the first trimester
* Pregnancies with no benzodiazepine prescription during the first trimester, but with at least one benzodiazepine prescription during the 3 months before the pregnancy onset
Non-interventional Study on the Monthly Administration of 300 mg AliRocumab (PRALUENT®) With the 2 ml SYDNEY Auto-injector

Primary objectives:

* To assess the effectiveness of the PRALUENT® 2 ml SYDNEY auto-injector as measured by the lipid-lowering effect of alirocumab after approx. 12 weeks treatment
* To assess the treatment satisfaction, as well as patient adherence and persistence after approximately 12 weeks of treatment with the PRALUENT® 2 ml SYDNEY auto-injector

Secondary objective:

Safety and tolerability

Study duration per participant is approximately 12 weeks

Eligibility Criteria:
Inclusion Criteria:

* Primary hypercholesterolaemia (heterozygous familial or non-familial) or mixed dyslipidaemia AND confirmed vascular disease(\*) AND other regular risk factors(\*\*), OR confirmed familial heterozygous hypercholesterolaemia
* Documented maximum dietary and drug lipid-lowering therapy within the last 12 months
* Inadequate reduction of low-density lipoprotein cholesterol (LDL-C) despite maximum possible dietary and lipid-lowering therapy
* The decision of the treating physician to use the PRALUENT® 2 ml SYDNEY auto-injector regardless of study enrolment
* No previous therapy with a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor OR prior treatment with a PCSK9 inhibitor every 2 weeks (Q2W) or monthly (Q4W)
* Signed Informed Consent Form

(\*) Coronary heart disease (CHD), cerebrovascular manifestation, peripheral arterial occlusive disease (PAOD)

(\*\*) For cardiovascular events (e.g. diabetes mellitus, renal function glomerular filtration rate (GFR) \< 60 ml/min)

Exclusion Criteria:

* Planned or existing pregnancy, cancer, drug or alcohol abuse, dementia, or general inability to understand the content of the observational study
* Existing treatment by lipid apheresis
* Age \< 18 years
* Contraindications to treatment with alirocumab (PRALUENT®) according to the SmPC
* Current participation in a clinical study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
HELIox CardiOPlegia Trial During Cardiac surgERy

The HELICOPTER-1 Trial is a single centre pilot study to determine the feasibility of administering Heliox in cardioplegia during cardiac surgery and whether it has the potential to reduce the incidence and severity of myocardial ischemia during and after cardiac surgery.

The HELICOPTER-1 Trial is a single centre, randomized trial evaluating the feasibility of administration of Heliox for prevention of myocardial ischemia in patients undergoing cardiac surgery. Half of the study population will be randomly assigned to the receive cardioplegia enriched with a 70:30 (Helium:Oxygen) Heliox mixture, while the other half will be randomized to receive the current clinical standard of care (nitrogen and oxygen in cardioplegia).

Subjects will be followed up daily during their post-operative course in hospital for clinical outcomes. A 30-day phone follow-up will be conducted for vital status and MI.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Cardiac surgery with CPB where use of a coronary sinus catheter is indicated

Exclusion Criteria:

* Patient refusal
* Recent myocardial infarction (less than 7 days old)
* Left ventricular ejection fraction less than 30%
* Known pregnancy on date of surgery
APR-246 in Combination With Venetoclax and Azacitidine in TP53-Mutant Myeloid Malignancies

This clinical trial is a Phase I, open-label, dose-finding and cohort expansion study to determine the safety and preliminary efficacy of APR-246 in combination with venetoclax and azacitidine in patients with myeloid malignancies.

This study will enroll adult male and female patients of age ≥ 18 years with documented diagnosis of AML, according to WHO classification, and documented TP53 mutation which is not benign or likely benign, who also meet the eligibility requirements of this protocol.

The study will include a safety lead-in dose-finding portion followed by expansion portion. During the safety lead-in portion of the study, two cohorts will independently enroll patients following a 3 + 3 design. Each cohort will enroll up to 6 patients.

The expansion portion will begin once the recommended phase II dose (RP2D) of APR-246 in combination with venetoclax and in combination with venetoclax and azacitidine have been determined in order to assess the antitumor activity of these combinations.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent and ability to comply with protocol requirements.
2. Documented diagnosis of AML according to World Health Organization WHO) classification
3. Adequate organ function as defined by the following laboratory values:

   1. Creatinine clearance \> 30 mL/min
   2. Total serum bilirubin \< 1.5 × ULN
   3. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 3 × ULN
4. Age ≥18 years
5. At least one TP53 mutation
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
7. Projected life expectancy of ≥ 12 weeks.
8. Negative serum or urine pregnancy test
9. Females of childbearing potential and males with female partners of childbearing potential must be willing to use an effective form of contraception

Exclusion Criteria:

1. Prior treatment for TP53-mutant AML (\*dependent upon treatment arm assigned).
2. Known history of HIV or active hepatitis B or active hepatitis C infection.
3. Any of the following cardiac abnormalities:

   1. Myocardial infarction within six months prior to registration;
   2. New York Heart Association Class III or IV heart failure or known left ventricular ejection fraction (LVEF) \< 40%;
   3. A history of familial long QT syndrome;
   4. Symptomatic atrial or ventricular arrhythmias
   5. QTcF ≥ 470 msec, unless due to underlying bundle branch block and/or pacemaker and with approval of the medical monitor.
4. Concomitant malignancies for which patients are receiving active therapy
5. Known active CNS involvement from AML.
6. Malabsorption syndrome
7. Pregnancy or lactation.
8. Active uncontrolled systemic infection (viral, bacterial or fungal).
Chiropractic Distraction Spinal Manipulation- Lumbar Stenosis Study

To assess the effect of chiropractic distraction manipulation on postural sway and simple measures of performance in patients with the clinical diagnosis of lumbar spinal stenosis.

This study aims to assess the effect of chiropractic distraction manipulation in reducing postural sway and improving performance-based mobility and disability in patients with the clinical diagnosis of lumbar spinal stenosis. This study will identify if distraction spinal manipulation will reduce postural sway center of pressure (COP) movements as determined by a force plate, if distraction spinal manipulation will improve simple measures of performance-based mobility and if distraction spinal manipulation will improve perception of balance confidence and will reduce self-rated stenosis associated disability.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than 48 years old
* Patient has leg or buttock pain while walking
* Patient feels relief of symptoms with bending (flexing) forward
* Patient feels relief when using a shopping cart of bicycle
* Patient has motor or sensory disturbance while walking
* Patient has normal and symmetrical foot pulses
* Patient has lower extremity weakness
* Patient has low back pain
* Duration of symptoms and signs for more than 1 month
* Able to stand and walk without assistive devices for at least 20 minutes
* Able to give written informed consent and complete interviews and questionnaires in English

Exclusion Criteria:

* Complicated spinal pain due to fracture, tumor, infection, or severe spondyloarthropathy
* Has other severe co-morbidities, including progressive neurological deficit
* Other serious pathologies of the locomotor system
* No correspondence availability through email
* Inability to read/ comprehend English
* Compensation or seeking compensation from a third-party liability or workers' compensation
* Previous spinal manipulation within the past month
Value of FLT PET/CT in Radium-223 Therapy of mCRPC Patients

The aim of the study is to investigate whether positron emission tomography (PET) using the tracer 18F-Fluorothymidine (FLT) can provide information on proliferative activity in bone marrow of patients receiving Radium 223 therapy and potentially be a predictive marker of hematological toxicity


Eligibility Criteria:
Inclusion Criteria:

* Metastatic castration resistant prostate cancer
* Eligible for Radium-223 therapy
* Informed consent

Exclusion Criteria:

* Inability to understand study protocol
* Extensive metastatic involvement of the axial skeleton ("superscan" on bone scintigraphy)
Erector Spinae Plane Block Versus Serratus Plane Block for Breast Surgery

Serratus plane block (SPB) was first described in 2013 by Blanco and designed to primarily block the thoracic intercostal nerves. And this block provides sufficient analgesia lateral anterior and posterior part of thoracic wall.Erector Spinae Plane Block (ESPB) is a newly described and effective interfascial plane block for thoracic and abdominal surgery. It was first described by Forero et al. in 2016, effectiveness being reported in four cases. The aim of this study is to compare Serratus plane block and erector spinae plane block on postoperative pain in patients undergoing modified radical mastectomy and axillary lymph node dissection


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologist's physiologic state I-III patients
* undergoing breast cancer surgery
* 18-65 years

Exclusion Criteria:

* chronic pain
* bleeding disorders
* renal or hepatic insufficiency
* patients on chronic non-steroidal anti-inflammatory medications
* emergency cases
* coagulopathy
Squid Liquid Embolic Agent for the Embolization of Abdominopelvic Arterial Bleeding Syndrome (SQUIDperi Study)

Abdominopelvic bleeding can occur due to numerous causes including for the vast majority, trauma, surgery complications and tumors. Interventional radiologists often exclude arterial acute hemorrhage using cyanoacrylate or a liquid embolic agent, but few prospective results have been published to assess their efficacy and safety. The historic and most studied liquid embolic agent to date is Onyx. Results in the treatment of acute peripheral non-neurologic hemorrhage have been detailed in a meta-analysis published in 2015. This systematic review found 19 articles presenting 131 patient cases and 150 lesions treated with Onyx from 2005 to August 2014. There were 11 case series and 8 case reports but no prospective trial. The most common presenting symptoms were of gastrointestinal (GI) origin (n = 51). Rebleeding of the baseline lesion occurred in 7/131 patients. No deaths resulting from complications of the embolic procedure were reported. One patient died of persistent hemoptysis after treatment with Onyx. No deaths were directly attributable to the use of Onyx.

During a peripheral embolization procedure with available embolic agents other than SQUIDPERI, residual feedings or collateral vessels became gradually less visible to the operator due to the high radiopacity of the liquid. It was therefore essential to develop an embolization system with lower radiopacity, or with radiopacity that decreases over time. Additionally, depending on the angioarchitecture and flow characteristics, it is important to have an embolic agent with various viscosities. SQUIDPERI is a liquid embolic agent with various viscosities and radiopacities. It is indicated for the embolization of lesions in the peripheral vasculature but its use is poorly reported as of today.

The purpose of this prospective non interventional multicenter study is to evaluate the safety and efficacy of SQUIDPERI for the treatment of abdominopelvic arterial acute bleeding or imminent risk of bleeding.


Eligibility Criteria:
Inclusion Criteria:

* Patient presenting with an arterial abdominopelvic bleeding or imminent risk of bleeding, including visceral, muscular or GI territories, requiring embolization, along with angiographic abnormalities
* Patient for whom the use of SQUIDperi had been decided for an embolization
* Patient or authorized representative dully informed and having no objection to the clinical data collection and medical file access
* Patient \> 18 years

Exclusion Criteria:

* Patient with severe live failure
* Patient participating in another interventional study
* Vulnerable patients including pregnant women
* Patient not eligible for treatment with liquid embolic agent
* Patients presenting contra-indications to SQUIDperi as describes in the Informations For Use (IFU)