cyrilzakka/clinical-trials huggingface dataset:
Early Resuscitation in Paediatric Sepsis Using Inotropes

Septic shock in children still carries substantial mortality and morbidity. While resuscitation with 40-60 mL/kg intravenous fluid boluses remains a cornerstone of initial resuscitation, an increasing body of evidence indicates potential for harm related to high volume fluid administration. The investigators hypothesize that a protocol on early use of inotropes in children with septic shock is feasible and will lead to less fluid bolus use compared to standard fluid resuscitation. Here, the investigators describe the protocol of the Adrenaline in Early Sepsis Resuscitation in Children- A Randomised Controlled Pilot Study in the Emergency Department (ANDES CHILD)


Eligibility Criteria:
Inclusion Criteria:

* 28 days and \<18 years
* Treated for sepsis
* Received at least 20 ml/kg fluid bolus in the last 4 hours and clinician decides to continue treating signs of shock
* Parental/caregiver consent prior to or after enrolment

Exclusion Criteria:

* Preterm babies born \<34 weeks gestation that have a corrected age of \<28 days
* Received ≥ 40 mL/kg of fluid boluses during the 4 h pre-enrolment
* Inotrope infusion commenced pre-enrolment
* Lack of access (intraosseous, central venous or peripheral) to administer fluids and/or inotropes after 60min of enrolment
* Cardiomyopathy or chronic cardiac failure
* Chronic hypertension due to cardiovascular or renal disease, requiring regular antihypertensive treatment
* Known chronic renal failure (defined as requiring renal replacement therapy)
* Known chronic hepatic failure
* Palliative care patient/patient with limitation of treatment (not for inotropes, cardiopulmonary resuscitation, extracorporeal membrane oxygenation, intubation or ventilation)
* Cardiopulmonary arrest in the past 2 h requiring cardiopulmonary resuscitation of \>2min duration, or death is deemed to be imminent or inevitable during this admission.
* Major bleeding with haemorrhagic shock
* Sepsis is not likely to be the cause of shock
* Previous enrollment in ANDES-CHILD
The Effect of RIC on TIA/Stroke in Children With Moyamoya Disease

Moyamoya disease is a common reason of transient ischemic attack (TIA) and stroke in children. Remote ischemic conditioning (RIC) has been shown to prevent recurrent stroke in intracranial arterial stenosis, but it is unclear whether RIC can prevent TIA or stroke in children with moyamoya disease. This study aims to evaluate the effect of RIC on TIA/stroke in children with moyamoya disease.

This study will provide insights into the preliminary proof of principle, safety, and efficacy of RIC in pediatric MMD patients, and this data will provide parameters for future larger scale clinical trials if efficacious

Eligibility Criteria:
Inclusion Criteria:

* Age: ≥0 and ≤18
* all of the patients underwent digital subtraction angiography and met the current diagnostic criteria recommended by the Research Committee on MMD (Spontaneous Occlusion of the Circle of Willis) of the Ministry of Health and Welfare of Japan in 2012
* The CVR of patients detected by SPECT is not impaired severely
* The patients didn't suffer stroke before.
* Informed consent obtained from patient or acceptable patient's surrogate

Exclusion Criteria:

* Severe hepatic or renal dysfunction
* Severe hemostatic disorder or severe coagulation dysfunction
* Patients with unilateral MMD or the presence of secondary moyamoya phenomenon caused by autoimmune disease, Down syndrome, neurofibromatosis, leptospiral infection, or previous skull-base radiation therapy
* Any of the following cardiac disease - rheumatic mitral and or aortic stenosis, prosthetic heart valves, atrial fibrillation, atrial flutter, sick sinus syndrome, left atrial myxoma, patent foramen ovale, left ventricular mural thrombus or valvular vegetation, congestive heart failure, bacterial endocarditis, or any other cardiovascular condition interfering with participation
* Serious, advanced, or terminal illnesses with anticipated life expectancy of less than one year
* Patient participating in a study involving other drug or device trial study
* Patients with existing neurological or psychiatric disease that would confound the neurological or functional evaluations
* Unlikely to be available for follow-up for 3 months
* Contraindication for RIC - severe soft-tissue injury, fracture, or peripheral vascular disease in the upper limbs.
An Observational Study to Assess Participant-Reported Real-World Experience of Risankizumab On-body Injector (OBI) for the Treatment of Crohn's Disease in Adult Participants in the United Kingdom (UK)

Crohn's Disease (CD) is a chronic condition that causes inflammation of the gastrointestinal tract or gut. This study will assess real-world, adult participant experience of self-injection with the risankizumab OBI.

Risankizumab is an approved drug for the treatment of CD in adults. Approximately 80 participants who are prescribed risankizumab by their doctors and are transitioning from the pre-filled syringe (PFS) to the use of OBI will be enrolled in this study in the United Kingdom (UK).

Participants will receive risankizumab OBI as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 6 months.

There is expected to be no additional burden for participants in this trial. Study visits may be conducted on-site, at home, or virtually as per standard of care.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Eligible for and received risankizumab for maintenance treatment of Crohn's Disease (CD) through United Kingdom (UK) Early Access to Medicines Scheme (EAMS)/Pre-Approval Access (PAA) schemes
* The decision to treat with risankizumab was made independently, in line with usual clinical practice, marketing authorisation and prior to enrolment in the study
* Exits UK EAMS/PAA and switches from risankizumab pre-filled syringe (PFS) to on-body injector (OBI)
* Can physically self-administer risankizumab OBI without carer assistance
* Can read and understand English
* Willing and able to provide voluntary informed consent
* Able and willing to participate in this study.

Exclusion Criteria:

N/A
Effectiveness of Two Preparations of Loratadine + Pseudoephedrine in Patients With Perennial Allergic Rhinitis.

The loratadine-pseudoephedrine combination has proven to be more effective than the use of these individual components. This prospective, randomized, double-blind and paralel study, in which patients with perennial allergic rhinitis receive one of loratadine + pseudoephedrine association drug for treatment of signs and symptoms during 4 weeks.

The effectiveness of treatment in each drug group will be evaluate by global improvement of signs (nasal mucous edema, ocular hyperemia, nasal secretion) and symptoms (itching eye, tearing,itching nose, itching on the palate) of perennial allergic rhinitis, after 4 weeks of treatment. Symptoms as rhinorrhea, nasal congestion, itching nose, sneezing and itching eye were considered as secondary efficacy endpoint, along with the questionnaire of quality of life SF-36. Safety evaluation data will include report of all adverse events (including type, frequency, instensity, seriousness, severity and action taken related to investigational product) reported by patients, parents or legal responsible, ou observed by Investigator.

Eligibility Criteria:
Inclusion Criteria:

* Comply with all the purposes and procedures of the study by signing and dating the IC own free will. In the case of minors, the document should be signed and dated by the parent or legal guardian;
* Have age over 12 years, regardless of gender, ethnicity or social class;
* Present clinical status of perennial allergic rhinitis from mild to moderate;
* Present clinical status with at least 12 months of evolution;
* Submit the examination of IgE elevation (above 100KU / L).

Exclusion Criteria:

* Have participated in any experimental study or have taken any experimental drug in the 12 months preceding the start of the study;
* Pregnant or lactating women;
* Have made use of:

  1. Intranasal or systemic corticosteroids in the month before inclusion;
  2. Intranasal cromolyn in the two weeks preceding inclusion;
  3. Intranasal or systemic decongestants in the 03 days preceding inclusion;
  4. Intranasal antihistamines or systemic in the 03 days preceding the survey;
  5. Loratadine in the 10 days preceding the survey.
* have any disease or anatomical abnormality in the upper airways which could jeopardize the analysis of data, for example, tumors or severe septal deviations;
* History of smoking in the 03 months preceding the inclusion;
* History of alcohol or illicit drugs;
* History of liver disease or kidney disease;
* Electric current asthma or gift last year;
* Table of uncontrolled hypertension;
* Patients with heart disease or who use drugs for the cardiovascular system that is suffering interference of the drugs studied, for example, β-blockers;
* Patients with flu-like symptoms or fever of unknown origin, defined current or within last 07 days;
* Clinical diagnosis of rhinitis is not that kind of allergic and perennial;
* Be patient with sensitivity to loratadine, pseudoephedrine sulfate, or any components of the formula;
* Estimated travel or displacement of the southeast for more than 50% of monitoring.
Effect of H.Pylori Infection on Growth Parameters

This study aimed to assess the effect H.pylori infection on growth parameter Of primary school-aged children Attending Assuit university chilren hospital

Undernutrition is caused by insufficient intake, malabsorption, inadequate utilization, and increased demand. There is a positive association between undernutrition and various infections. Chronic exposure to pathogens may affect nutrient absorption and increase nutrient consumption, Among many potential pathogens, chronic Helicobacter pylori (H. pylori) infection may be one cause of undernutrition. H. pylori is a gram-negative, helical, and microaerophilic bacterium, which colonizes gastric epithelial cells' surface. The mode of transmission of H. pylori is not known exactly, but the faecal-oral or oral-oral routes via water or food consumption are thought to be a very common cause. The frequency of H.pylori infection increases with age. The rate of development is higher in societies with low socioeconomic status .

The worldwide prevalence of H. pylori in children varies significantly, from 2.5% in Japan to 34.6% in Ethiopia. Gastric mucosal host factors, as well as environmental and virulence factors of the bacteria, are associated with the clinical outcome of H. pylori infection. it is closely related to chronic gastritis, dyspepsia, and chronic diarrhea. H pylori also remains an important risk factor for duodenal ulcers and duodenal and gastric erosions in children.A number of studies identified correlations of H pylori infection in children with a variety of gastrointestinal diseases including autoimmune gastritis and celiac disease. It also produces different biological effects on hormones such as ghrelin and leptin, which control both growth and appetite, causing changes in appetite and food intake, while causing changes in immunological symptoms and responses .H. pylori is a factor that causes malnutrition and growth retardation, due to malabsorption of nutrients and increased susceptibility to enteric infections, especially in developing countries .

Eligibility Criteria:
Inclusion Criteria:

1. Primary school children aged 6 to 12 years old.
2. Children who have tested positive for Helicobacter pylori.

Exclusion Criteria:

1. Children with primary malnutrition due to nutritional deficiency .
2. Children with chronic illness
Pediatric Pneumonia Lung Ultrasound

The purpose of this study is to evaluate the impact of LUS on the diagnosis and management of childhood pneumonia in developing countries


Eligibility Criteria:
Inclusion Criteria (chest indrawing cases):

* Male or female, 2 through 23 months of age
* Cough \<14 days or difficulty breathing
* Visible indrawing of the chest wall, with or without fast breathing
* Ability and willingness of child's caregiver to provide informed consent and to be available for follow-up for the planned duration of the study, including accepting a home visit if he/she fails to return to the study facility for a scheduled follow-up visit

Inclusion Criteria (non-chest indrawing controls):

* Male or female, 2 through 23 months of age
* Cough \<14 days or difficulty breathing
* Ability and willingness of child's caregiver to provide informed consent and to be available for follow-up for the planned duration of the study, including accepting a home visit if he/she fails to return to the study facility for a scheduled follow-up visit
Preventing Premature Death in Patients With Serious Opioid-related Infection

The purpose of this study is to test the efficacy of a combination of motivational interventions and a brief therapy session to increase the adherence to medication-assisted treatment (MAT) for opioids.

We will recruit 30 SORI inpatients ages 18-plus admitted to the University of Rochester Medical Center (URMC). We will administer a battery of validated assessments of substance use, overdose history and risk, opioid-related infection, and suicidal behavior at baseline and approximately 2- and 4-week follow-ups. We will assess both forms of overdose (unintentional, intentional - i.e., suicidal behavior) because each is common in intravenous drug users and they require systematic assessment to disentangle. All recruited individuals will receive one-to-three MI sessions as they begin the MAT that is part of standard hospital care. Patients will be offered computer-based CBT, which they will complete on the unit at their convenience. The CBT program records duration of use of the treatment modules, enabling us to track patients' level of CBT treatment participation. Patient-completed intervention feedback forms and treatment completion will be examined after 15 subjects have participated. Based on this feedback, we will pilot an adapted (MI plus CBT) treatment manual, obtaining additional feedback on acceptability. We will assess psychopathy, a constellation of stable traits and potentially important moderator of treatment effects, at baseline. We will assess potential mediators (i.e., motivation to change, self-regulation) using validated measures at baseline and at approximately 2- and 4-weeks post-discharge.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Willing to provide contact information (e.g., email, phone, address)
* Presence of SORI, including endocarditis, osteomyelitis, septic arthritis, epidural abscess, or serious bacteremia
* Hospital length of stay estimated at \> 3 weeks
* Admitted to URMC and seen by the Toxicology Consult Team. Providers will be informed of inclusion/exclusion requirements so that they can make an informed decision about whether a patient may be approached.

Exclusion Criteria:

* Non-English speaking
* Unwilling to provide informed consent; unable to provide informed consent or participate in study procedures due to lack of comprehension, medical barriers (e.g., intubated), or behavioral (e.g., violence) or severe psychiatric problems (e.g., florid psychosis). Capacity to provide informed consent will be determined by their treatment team or other provider consult team as appropriate. This serves a dual function of both basing consent capacity on the most accurate and current medical information, as well as keeping their treatment team informed of any research involvement of their patient.
* Note that patients may be ineligible initially but become eligible due to stabilization during hospitalization, at which point we would then proceed as usual with the identification and recruitment process. We will seek to recruit every SORI admission who meets eligibility criteria within the recruitment timeframe.
Randomized Trial of Chlorambucil Versus Chlorambucil Plus Rituximab Versus Rituximab in MALT Lymphoma

Assess the therapeutic activity and safety of the combination of Chlorambucil and Rituximab in MALT lymphomas and determine whether the addition of Rituximab to Chlorambucil will improve the outcome of MALT lymphoma in comparison to treatment with Chlorambucil alone.

In April 2006, a third arm of treatment was added to compare the antitumor activity and safety of rituximab alone vs chlorambucil alone


Eligibility Criteria:
Inclusion Criteria:

1. histologically proven diagnosis of CD20-positive marginal zone B-cell lymphoma of MALT type arisen at any extranodal site
2. any stage (Ann Arbor I-IV)
3. either de novo, or relapsed disease following local therapy (including surgery, radiotherapy and antibiotics for H. pylori-positive gastric lymphoma)
4. no evidence of histologic transformation to a high grade lymphoma
5. measurable or evaluable disease
6. age \> 18
7. life expectancy of at least 1 year
8. ECOG performance status 0-2
9. no prior diagnosis of neoplasm within 5 years, except cervical intraepithelial neoplasia type 1 (CIN1) or localized non-melanomatous skin cancer
10. no prior chemotherapy
11. no prior immunotherapy with any anti-CD20 monoclonal antibody
12. no prior radiotherapy in the last 6 weeks
13. no corticosteroids during the last 28 days, unless prednisone chronically administered at a dose \<20 mg/day for indications other than lymphoma or lymphoma-related symptoms
14. no evidence of clinically significant cardiac disease, as defined by history of symptomatic ventricular arrhythmias, congestive heart failure or myocardial infarction within 12 months before study entry
15. no evidence of symptomatic central nervous system (CNS) disease
16. no impairment of bone marrow function (WBC \>3.0x109/L, ANC \>1.5x109/L, PLT \>100x109/L), unless due to lymphoma involvement
17. no major impairment of renal function (serum creatinine \<1,5x upper normal) or liver function (ASAT/ALAT \<2,5 upper normal, total bilirubin \<2,5x upper normal), unless due to lymphoma involvement
18. no evidence of active opportunistic infections
19. no known HIV infection
20. no active HBV and/or HCV infection
21. no pregnant or lactating status
22. appropriate contraceptive method in women of childbearing potential or men
23. absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
24. informed consent must be given according to national/local regulations before randomization
Study of SHR-1209 in the Treatment of Hypercholesterolemia and Hyperlipidemia Ⅲ Stage

The study is ongoing to evaluate the efficacy and safety of SHR-1209 in patients with hypercholesterolemia and hyperlipemia.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 and ≤80 on the date of signing the informed consent, male or female;
2. Fasting LDL-C was ≥2.6mmol/L and \<4.9mmol/L at screening and randomization；
3. Those who understand the study procedures and methods, volunteer to participate in the study, and sign the informed consent in person.

Exclusion Criteria:

1. Have the following diseases or treatment history :(1) Have known allergic reaction to experimental drugs, or have severe allergic reaction to other antibody drugs;(2) previous diagnosis of cardiac function as defined by the New York Heart Association (NYHA) grade III-IV;
2. Any of the laboratory indicators met the following criteria at screening or at random :(1) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeding 2 times the upper limit of normal (ULN), or total bilirubin exceeding 1.5 times the upper limit of normal (ULN);(2) Creatine kinase (CK) exceeds 3 times the upper limit of normal value (ULN);
3. General conditions :(1) the investigator judged that subcutaneous injection was not appropriate;(2) Fertile female subjects who did not use contraception within 4 weeks before screening;Or male or female subjects who do not agree to use high-efficiency contraceptives during the trial and for 24 weeks after the last dosing;(3) Women who are pregnant or lactating.
4. The Investigator determines that the subjects have poor compliance or have any factors that may prevent them from participating in the study, including, but not limited to, the study placing the subjects at unacceptable risk or possibly interfering with the study results.
Apatinib Combined With SOX Neoadjuvant Therapy for Locally Advanced Gastric Cancer

We star a multicentre, one-armed, clinical pilot trial intends to investigate the safety and effectiveness of Apatinib Combined With Oxaliplatin, Gimeracil and Oteracil Porassium Capsules Neoadjuvant Ttherapy for Locally Advanced Gastric Cancer(cT2-4/N+M0)


Eligibility Criteria:
Inclusion Criteria:

1. Age from 18 to 75 years
2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
3. cT2-4N+M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
4. No distant metastasis is observed. And the spleen, pancreas or other adjacent organs are not involved by the tumor.
5. Performance status of 0 or 2 on Eastern Cooperative Oncology Group scale (ECOG)
6. Without previous surgical, chemotherapy,radiotherapy, immunotherapy, or targeted therapy for gastric cancer.
7. Estimate life is equal or greater than 3 months
8. No serious heart, lung, liver dysfunction;no Jaundice and obstruction of the digestive tract; no acute infection
9. The main organ function is normal,and meet the following criteria:

   * blood routine examination( No blood transfusion within 14 days)

     1. HB≥100g/L，
     2. WBC≥3.5×109/L
     3. ANC≥1.5×109/L，
     4. PLT≥100×109/L；
   * blood biochemical examination

     1. BIL \<1.5 Upper Limit Of Normal（ULN），
     2. ALT and AST\<2.5ULN，GPT≤1.5×ULT；
     3. Cr≤1ULN，creatinine clearance\>60ml/min（Cockcroft-Gault formula）
10. Written informed consent

Exclusion Criteria:

1. Pregnant and lactating women
2. Suffering from severe mental disorder
3. History of previous upper abdominal surgery (except for laparoscopic cholecystectomy)
4. History of previous chemotherapy or radiotherapy therapy
5. History of other malignant disease within the past 5 years
6. History of previous neoadjuvant chemotherapy or radiotherapy
7. History of unstable angina or myocardial infarction within the past 6 months
8. History of cerebrovascular accident within the past 6 months
9. History of continuous systematic administration of corticosteroids within 1 month
10. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
11. Patients with a clear tendency of gastrointestinal bleeding,such as: active ulceration,fecal occult blood test(++),The history of hematemesis and melena within 2 months,coagulation disorders(INR\>1.5、APTT\>1.5 ULN).
12. Positive urinary protein(uric albumen check(++),or Twenty-four hours urinary protein content\>1.0g)
13. There are several factors that affect oral medicine,such as unable to swallow, uncontrollable nausea and vomitin, or chronic diarrhea and intestinal obstruction
14. Drug allergy to experimental medicine