cyrilzakka/clinical-trials huggingface dataset:
Comparison of the Efficacy of Topical Ibuprofen to Oral Ibuprofen in Adolescent Athletes

This study was made to compare the efficacy of topical ibuprofen in gel form with oral ibuprofen in the treatment of sub-acute soft tissue injuries while comparing the tolerability of the delivery methods


Eligibility Criteria:
Inclusion Criteria:

* Age 12-19yo
* soft tissue injury or flare up of soft tissue injury within 10 days to 8 weeks

Exclusion Criteria:

* Known hypersensitivity to aspirin or any NSAID,
* allergy to eggs or egg products
* history of asthma, renal disease, GI disease, active or suspected bleeding peptic ulcer (past or present), anemia, hypertension, other systemic disease significantly affecting liver or renal function
* serious injury within six months
* currently on anticoagulants
* pregnant or lactating females
* active arthritis in affected limb
* open wounds, infected skin or fractures
* opioid use within 7 days
* severe psychological disorder
* prior topical medication applied to the painful region/area of study
Reference Intervals for Sonoclot Analysis in Chinese

The reference intervals for Sonoclot Analysis may be different between Chinese and American. So far, no reference interval has been established in Chinese for Sonoclot Analysis. This study is going to establish the first Chinese reference intervals for Sonoclot Analysis and test whether they are different from American reference intervals.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 and older
* Han ethnic

Exclusion Criteria:

* Renal dysfunction
* Liver disorders
* Known coagulation disorders
* Patients taking medications in the last month
Gastric Feeding Versus Transpyloric Feeding in Infants with Severe Bronchopulmonary Dysplasia, a Crossover Study

Hospitalized infants with severe bronchopulmonary dysplasia (BPD) and feeding intolerance will be randomized to 2 weeks of continuous gastric feeding or continuous transpyoloric feeding. Subjects will crossover after 2 weeks and receive 4 weeks of each feeding mode. Respiratory status will be assessed to determine the optimal feeding mode for each infant.


Eligibility Criteria:
Inclusion Criteria:

* Patients born \<32 weeks' gestation
* Currently admitted to the Le Bonheur NICU
* Grad 2 or 3 BPD (positive pressure or intubated at 36 weeks PMA)
* Signs of gastroesophageal reflux, chronic aspiration, or other feeding intolerance.

Exclusion Criteria:

* Known gastrointestinal anomalies
* Unable to tolerate ≥100mL/kg/day enteral feeding
* Congenital anomalies likely to alter feeding techniques
* Surgical feeding tube in place or expected within the next 8 weeks
* Expected to remain hospitalized \<8 weeks
Study of the Follow-up of Stroke Treated With Anticoagulants

Stroke is a major public health problem as it is very frequent (140,000 cases/year in France), and very serious (leading cause of death, 2nd leading cause of dementia, 3rd leading cause of handicap). Ischemic cardio-embolic stroke accounts for around 25% of ischemic strokes, and ischemic cardio-embolic stroke in a context of cardiac arrhythmia due to atrial fibrillation (CAAF) is the leading non-atheromatous cause. The aim of this study is to optimise the secondary prevention of CAAF-related stroke identified at the University Hospital of Dijon Burgundy in the framework of the recommendations of the '2010-2014 stroke plan' and the Compulsory Consultation at the 6th month (Directive DGOS//2015/262 of the 3rd August 2015)


Eligibility Criteria:
Inclusion Criteria:

* patients managed for stroke at the stroke unit of Dijon University Hospital for CAAF-related cardio-embolic stroke

Exclusion Criteria:

* NA
Effects of Short-term Therapeutic Fasting on Nausea and Vomiting Due to Chemotherapy

This study aims to estimate the effect of the practice of a short-term partial fasting compared to a usual alimentation on nausea and vomiting within 5 days after the start of a chemotherapy session on 2 successive chemotherapy courses (4 sessions of chemotherapy) in patients starting treatment with highly emetogenic chemotherapy (ABVD or AVD protocol).

Patients in fasting arm will practice partial fasting during 3 days (D-1, D1 (D day of chemotherapy) and D2) following a food guide during 4 chemotherapy sessions. Patients in usual alimentation arm will continue to take food as usual practice.

In each arm, patients will be interviewed at each chemotherapy sessions about nausea and vomiting (number and intensity of nausea and vomiting, treatments taken). Denutrition, quality of life improvement, compliance to partial fasting, treatment response will be evaluate too.

Eligibility Criteria:
Inclusion Criteria:

* patient starting a treatment by chemotherapy ABVD or AVD
* patient affiliated to a social security scheme
* patient who gives his informed consent before any procedure related to the study

Exclusion Criteria:

* patient with diabetes
* patient with recent gastric ulcer
* patient with low BMI (less than 18,5 for patients under 70 or less than 21 for patient over 70)
* albuminemia \<35
* patient wiht loss weight \> 10% in 6 months
* pregnant or lactating women
* chronic alcoholism
* unable to understand the objectives and risks of the study
* patient with psychiatric desorder, under guardianship or under judicial protection
* patient who cannot read
Study of Herbmed Plus in Ureteral Stent Discomfort

The purpose of this study is to compare the efficacy and safety of the Ayurvedic formulation ,Herbmed Plus against placebo and anti-cholinergic drugs in relieving the ureteral stent discomfort.

* To evaluate the tolerability of ayurvedic preparation, Herbmed Plus in management of ureteral stent discomfort
* To know whether the ayurvedic preparation Herbmed Plus ,can reduce the requirement of analgesics or not
* To know whether the ayurvedic preparation ,Herbmed Plus can replace the use of analgesics/ anti cholinergics in relieving ureteral stent discomfort ?

Eligibility Criteria:
Inclusion Criteria:The following patients would be enrolled in the study:

1. Age 18-75 years (Both inclusive)
2. Absence of urinary tract infection
3. Absence of lower urinary tract symptoms
4. Absence of urethral catheter
5. Patients with unilateral/bilateral ureteral stentSize of the stent ranging from 4/16 to 6/26.
6. Patients of reproductive potential (males and females) and willing to use a reliable means of contraception (e.g. hormonal contraceptive patch, intrauterine device and physical barrier) throughout study participation.

7Able and willing to give written informed consent and comply with the requirements of the study protocol

Exclusion Criteria:

1. Patients having evidence of urinary tract infection.
2. Chronic medication with α-blockers or anticholinergics and severe complications during the procedure
3. Uncontrolled diabetes, hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction.
4. Any other urogenital disorders.
5. Liver dysfunction, defined as total bilirubin \>1.5 x the upper limit of Normal (ULN),Aspartate aminotransferase (AST/SGOT) \> 2.5 x ULN, or alanine aminotransferase (ALT/SGPT) \>2.5 x ULN.
6. Kidney disease, including serum creatinine level \>1.5 x ULN.
7. Subjects on herbal supplements (plant extracts preparations or herbal medicines etc.) within previous 3 months.
8. Participated in another clinical drug trial within 3 months before recruitment.
9. Pregnancy or breast feeding.
10. Evidence of significant uncontrolled concomitant disease which in the Investigator's opinion would preclude patient participation.
11. Currently active alcohol or drug abuse or history of alcohol or drug abuse within 24 weeks prior to baseline.
12. Patients with psychiatric illness or other condition that would limit compliance with study requirements.
Aripiprazole Pharmacokinetics (PK) and Tolerability Study in Children and Adolescents

The purpose of this trial is to assess the safety, tolerability and pharmacokinetics of aripiprazole tablets following oral administration to children and adolescents.


Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents between 10-17 years, in good physical health, preferentially with a primary schizophrenia spectrum diagnosis or bipolar spectrum disorder

Exclusion Criteria:

* History of mental retardation
* Any neurological disorder with the exception of Pervasive Developmental Disorder (PDD), Attention Deficit Hyperactivity Disorder (ADHD), and Tourette's Syndrome
Pulmonary Hypertension in Patients With Myeloproliferative Neoplasms

This is an observational prospective study aiming to clarify the prevalence of pulmonary hypertension in patients with Myeloproliferative Neoplasms and their prognosis.

All patients attending our department with the above mentioned neoplasms will be offered inclusion in this study. All will have an echo performed and patients identified as being at risk of pulmonary hypertension will be offered complete investigation as specified by the European Cardiology Association.

All patients will be followed up for a total of five years to identify prognosis.


Eligibility Criteria:
Inclusion Criteria:

* Myeloproliferative Neoplasms (PV, ET, PMF according to WHO classification)

Exclusion Criteria:

* Pregnancy
* Lack of informed consent
* Age \< 18 years
* Cognitive dysfunctions
Analytical Validation of the abioSCOPE Device With the IVD CAPSULE PSP Test: Comparison of PSP Values Measured With Venous Whole Blood and Those Measured With Arterial Whole Blood.

Abionic has developed a targeted, rapid test for pancreatic stone protein (PSP) in human K2-EDTA venous whole blood using the abioSCOPE instrument.

Currently no PSP study comparaison has been done between venous and arterial whole blood. Abionic would like to confirm the equivalence of the PSP between venous whole blood and arterial whole blood.


Eligibility Criteria:
Inclusion Criteria:

1. Provide signed and dated written informed consent by patient or close / family / trusted person prior to any mandatory study-specific procedures, sample collection, or analysis;
2. Male or female, 18 years of age or older;
3. Patient admitted to hospital
4. Need for venous and arterial blood samples as part of standard of care
5. Covered by a social security scheme.

Exclusion Criteria:

1. Subject suffering from a hematological pathology (coagulation disorder, severe anemia) that could interfere with the blood draw procedure;
2. Subject under juridical protection.
Vebreltinib Plus PLB1004 in EGFR-mutated, Advanced NSCLC With MET Amplification or MET Overexpression Following EGFR-TKI

Efficacy and Safety Evaluation of Vebreltinib Plus PLB1004 in EGFR TKI Relapsed MET Amplified or MET Expression in NSCLC

Open label, multicenter Phase Ib/II clinical study to evaluate the safety, efficacy, and pharmacokinetics of Vebreltinib in combination with PLB1004 in patients with locally advanced or metastatic non-small cell lung cancer with MET overexpression or MET amplification following EGFR-TKI treatment failure.

Eligibility Criteria:
Inclusion Criteria:

1. Ability to understand and willingness to sign a written informed consent document.
2. Aged at least 18 years old.
3. Histologically or cytologically confirmed locally advanced or metastatic NSCLC (stage IIIB\~IV).
4. EGFR mutations, including exon 19 deletion and exon 21 L858R.
5. C-Met overexpression and/or c-Met amplification confirmed after treatment with EGFR-TKI.
6. At least one measurable lesion as defined by RECIST V1.1.
7. ECOG performance status 0 to 1.

Exclusion Criteria:

1. Previous treatment with MET inhibitors or HGF-targeted therapy.
2. There are mutations of ALK or ROS1.
3. Have symptomatic and neurologically unstable central nervous system (CNS) metastases or CNS disease that requires increased steroid doses for control.
4. Pregnant or nursing women.
Dynamic Assessment of the Risk for Language and Reading Disorders in Monolingual and Multilingual Children

The project represents the completion of a part of the recently concluded European project MultiMind, in which a computer platform called MuLiMi was developed and validated. The platform hosts screening tests for the identification of the risk of Language and Learning Disorders in preschool and primary school children, respectively. The aim is to validate the Dynamic Assessment (DA) tests (a first test assessing the capacity to learn new words for preschool children and a second one assessing the capacity to learn a new spelling code for school-age children) in a population of monolingual and bilingual children attending preschool and primary school. The main goal of the study is to complete the validation of the two Dynamic Assessment tests implemented in the MuLiMi platform developed for the MultiMind project.

Dynamic Assessment tests are characterized by their emphasis on the learning process activated during the test itself, focusing on measuring the improvement achieved from the beginning to the end of the test rather than the absolute level of performance. They are thus considered measures of the learning potential (in this case, language and spelling) of the assessed subject. This type of testing is used as an integration of static assessment (traditional, aimed at detecting absolute performance level) and has proven particularly useful in the assessment of multilingual children.

However, computerized tests that can also be used remotely are not currently available. For these reasons, it was found particularly useful to include this type of task within the MuLiMi computerized battery. While the other tests hosted on the MuLiMi platform concern specific L1-L2 pairs, DA tests can be applied regardless of the L1 (provided a minimum L2 mastery is present so as to understand the requests) because they assess the capacity to learn new information and are thus rather independent of previous knowledge. This study will provide baseline data for the MuLiMi battery applied to children belonging to any language minority group and thus enable it to be used comprehensively in the future for the purpose of risk assessment of language and learning disorders.

Eligibility Criteria:
Inclusion Criteria:

* age 4-6 years (Kindergarten) or 7-9 years (Primary school);
* Attendance at an Italian-language school in Italy or Switzerland.

For the multilingual group only:

* (i) At least one parent speaks at least one language other than Italian in the family;
* (ii) Continuous exposure to the Italian language for at least two years.

Exclusion Criteria:

* Intellectual disability, major psychopathological disorders, exposure to Italian language for less than two years.
The Effect of Dexmedetomidine in the Management of Pain After Uterine Artery Embolization

The investigators examined the effect of dexmedetomidine in the management of pain after uterine artery embolization.

Leiomyoma are the most common female reproductive tract tumors. Uterine artery embolization(UAE) is a minimally invasive treatment alternative to hysterectomy and myomectomy. However, post-procedural pain control after UAE remains a major problem. Therefore, the aim of study is to evaluate the efficacy of dexmedetomidine in pain control after UAE.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 20,
* ASA class I and II

Exclusion Criteria:

* bradycardia (\< 45 bpm)
* heart block
* liver failure
* renal failure
* uncontrolled hypertension
* body mass index ≥ 30 kg/m2
Defining Response Criteria for PET Scans for People With Neuroendocrine Tumors

People with neuroendocrine cancer typically have imaging scans before and after treatment, including positron emission tomography (PET) scans. The scans are analyzed using a set of criteria that describes how the disease has responded to treatment. The purpose of this study is to establish new criteria for doctors to use when evaluating these PET scans. Researchers are testing whether these new criteria are useful for predicting whether a person's cancer gets better, gets worse, or stays the same. Researchers will also compare these new criteria to the current standard criteria for evaluating imaging scans.


Eligibility Criteria:
Subjects affected by histologically proven, somatostatin-receptor positive, metastatic or inoperable well-differentiated G1, G2 or G3 neuroendocrine tumors (NETs) candidate to receive PRRT with 177Lu-DOTATATE per standard of care.

Inclusion Criteria:

1. Histologically proven or cytologically confirmed, metastatic or inoperable NETs
2. Measurable disease as defined by RECIST 1.1.
3. Overexpression of somatostatin receptors of the target lesions at somatostatin receptor imaging (68Ga-DOTATATE or 64Cu-DOTATATE PET/CT) with SUV of lesions greater than normal liver at least in 1 metastasis.

Exclusion Criteria:

1. Neuroendocrine Carcinoma), small and large cell type; MIxed Neuroendocrine-Nonneuroendocrine Neoplasm (MiNEN).
2. Presence of somatostatin receptor negative lesions.
Statin Treatment for UnruptureD Intracranial anEurysms Study

This study was designed to identify whether there is a measurable reduction in inflammation in walls of intracranial aneurysms with oral atorvastatin.

Unruptured intracranial aneurysms (UIAs) are increasingly detected and often remain clinically asymptomatic for a long time before rupture. However, once the UIAs ruptured, the incidence of mortality rate varies from 30% to 60% within 6 months. Thus, the risk of UIAs rupture should be weighed, and need an individual criterion for predicting rupture in clinical decision making.

Histopathological studies indicated that inflammation may play an important role in the formation, growth, and rupture of UIAs. Wall enhancement of a saccular aneurysm on high resolution magnetic resonance (HRMRI) is a proven sign of inflammatory change and might predict an unsteady state of an intracranial saccular aneurysm.

Statins inhibit 3-hydroxy-3-methylglutaryl coenzyme A reductase and are established first-line treatments for hypercholesterolemia. Statins produce a range of pleiotropic effects in addition to inhibition of cholesterol synthesis, especially to reduce inflammation, which may be important in reducing the growth and rupture of UIAs.

In the study, participants known to have UIA that is not planned for treatment and has not yet ruptured, take atorvastatin daily for six months, and have an HRMRI scan before and after to look for the role of atorvastatin in inflammation.

Eligibility Criteria:
Inclusion Criteria:

1. Be aged 18 or over, male or non-pregnant female;
2. patients have a saccular UIA identified on imaging (CT, MRI or DSA), and the aneurysm ≥3mm;
3. patients with wall enhancement of aneurysm by MRI VWI before treatment;
4. patients who is able to understand the objective of the trial, agrees and signs the written informed consent form.

Exclusion Criteria:

1. Patient with MRI contraindications: metallic implant, contrast allergy, claustrophobia, etc.;
2. Planned treatment of the aneurysm within 6 months;
3. Patient taking the drugs, which might have an anti-inflammatory effect, such as aspirin, statin, immunosuppressive drug, etc.
4. Dyslipidemia or severely impaired liver or renal functions
5. Retreatment of recurrent aneurysm;
6. Pregnant or lactating women;
7. Patients with malignant diseases, such as liver disease, kidney disease, congestive heart failure, malignant tumors, etc;
8. Poor compliance patients.
Mesoglycan for Acute Hemorrhoidal Disease

Hemorrhoidal disease (HD) is the most common proctological disease with a prevalence rate that can reach approximately 4.4% of the population, with a particular peak in individuals aged between 45 and 65 years. The most common presentation of HD is painless rectal bleeding occurring during or immediately after defecation. Pain is rare in case of uncomplicated HD and may be present in case of external hemorrhoidal thrombosis.

The decision-making to treat Hemorrhoidal thrombosis usually depends on the timing of the onset of symptoms, with the surgical treatment favored if the onset of symptoms occurs within 72 hours.

Mesoglycan, a natural preparation of glycosaminoglycans (GAGs), is a polysaccharide complex rich in sulfur radicals.

It is composed of heparan sulphate (47.5%), dermatan sulphate (35.5%), chondroitin sulfate (8.5%) and slow heparin (8.5%).

Mesoglycan exerts antithrombotic activity (activation of antithrombin III and heparin cofactor II) and profibrinolytic (stimulation of the activator tissue plasminogen) decreasing plasma concentrations of fibrinogen without affecting the prothrombin time, the time of partial thromboplastin or the remaining coagulation parameters. The rationale of this double-blind randomized controlled clinical trial is to confirm/evaluate the efficacy and safety of mesoglycan versus placebo in reducing the symptoms of hemorrhoidal disease and their impact on quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of grade I-III hemorrhoidal disease classified according to Goligher classification or diagnosis of external hemorrhoid thrombosis
* Female patients of childbearing age with a negative pregnancy test
* Patients able to understand informed consent
* Signed Informed Consent.

Exclusion Criteria:

* Blood coagulations disorders
* Patients undergoing chemoradiation
* intake of anticoagulants
* pregnancy
Diabetes Risk Communication Tool Evaluation

Prevention for Type 2 Diabetes (T2D)has been vast but with limited success. While Singaporeans have high knowledge about T2D, its symptoms, and risk factors, healthy practices are still sub-optimal. Upon a qualitative investigation, it was found that there is little to no urgency to engage in T2D preventative behaviour due to to the low perceived threat, and high costs from required lifestyle changes relative to the benefits. Hence, this project targets to communicate the risk of diabetes in a more salient and effective way to improve the intention of preventative behaviour by targeting the constructs of Protection Motivation Theory (PMT) and increasing the threat and coping appraisals. The current available diabetes risk assessment tool's result page provides a binary output: "Higher vs Lower" Risk of being pre-diabetic. This aligns with the usual care practiced in clinics currently; patients are told if they are pre-diabetic or not. It does not provide any personalized or relevant tips on how to reduce risk. Hence, there was a demonstrated need to develop risk assessment tools that increase threat appraisal and communicate T2D risk in a more salient way to motivate the intention of behaviour change. The investigators developed two tools: Relative Risk, and Metabolic Age. The Relative Risk prototype demonstrates the user's relative risk on a scale of 1 to 10, in comparison to someone of the same age and sex. The number 1-10 represents their position in the percentile distribution of their risk scores. The Metabolic Age is identified by matching the risk score's percentile position to percentile of the incidence of T2D. The median age of the people in that percentile is reflected as the metabolic age. The primary objectives of this study is to evaluate which of these risk presentations (Usual care, relative risk, or metabolic age) evoke (i) effective cognitive and emotional responses to risk results and (2) motivation for the intention of behaviour change. The secondary objective is to provide empirical evidence for using PMT constructs in intervention development. The hypothesis is that those who are exposed to the Metabolic Age risk assessment and communication tool will have the most effective cognitive and emotional response, and the highest intention of engaging in behaviour change, followed by those exposed to relative risk, and then standard of care.


Eligibility Criteria:
Inclusion Criteria:

* Aged 30-60 years;
* Singapore citizen, or permanent resident
* Able to read and understand English,
* Have had a health screening with blood pressure, triglycerides, and HbA1C done within the last 3 months
* At least one risk factor for Type 2 Diabetes (BMI ≥ 23 kg/m2, blood pressure ≥130/85 mmHg or receiving therapy for hypertension, triglycerides ≥1.7mmol/L or HbA1c ≥5.7%)

Exclusion Criteria:

- Diagnosis of any event of cardiovascular disease, kidney issues, or type 2 diabetes