cyrilzakka/clinical-trials huggingface dataset:
Severe Influenza Trial of ARbidol

This is a multicenter, randomised, double-blind, controlled study to assess the efficacy and safety of arbidol plus oseltamivir, compared with oseltamivir alone in approximately 200 hospitalized adults and adolescent patients with confirmed severe influenza. Patients should be randomised as soon as possible after screening (no later than 12 hours), providing they are within 7 days of symptom onset. Patients will be assigned in a 1:1 ratio to receive an arbidol plus oseltamivir, or oseltamivir plus placebo. Rescreening of patients who fail to meet the inclusion and exclusion criteria will be permitted only once, providing the time from symptom onset to randomization is still within 7 days.

Arbidol/placebo will be administrated as 200mg TID from Days 1-7. Oseltamivir will be administered as 75mg twice daily from Days 1-7 (dose to be adjusted for renal impairment). Oseltamivir could be continued till influenza PCR negative. Both drugs, along with the corresponding placebo for arbidol, will be started at the time of randomization.


Eligibility Criteria:
Inclusion Criteria:

1. Hospitalized males or females with a positive PCR test for influenza virus infection
2. Age ≥16 years at the time of signing Informed Consent Form
3. Arterial oxygen saturation (SaO2)/ pulse oxygen saturation (SPO2) ≤94% in room air condition
4. ≤ 7 days since symptom onset. The onset of symptoms is defined as either: Time of the first increase in body temperature (an increase of at least 1ºC from normal body temperature- ≥38℃); Time when the patient experiences at least one general or respiratory symptom.
5. Willingness to use contraception for 7 days after the end of treatment

Exclusion Criteria:

1. Physicians make a decision that trial involvement is not in patients' best interest, or any condition that does not allow the protocol to be followed safely.
2. Patient refusal to accept invasive organ support treatment if needed
3. More than 3 consecutive doses of NAIs within 2 days before enrolment (including oseltamivir, zanamivir, peramivir)
4. Women who are pregnant (including a positive pregnancy test at enrolment), breastfeeding, or within 2 weeks post-partum.

   The following female subjects do not need to undergo a pregnancy test at enrolment: a. Postmenopausal (defined as cessation of regular menstrual periods for 2 years or more and confirmed by a follicle-stimulating hormone test) women. b. Women who are surgically sterile by hysterectomy, bilateral oophorectomy, or tubal ligation.
5. Any condition requiring renal replacement therapy
6. Severe liver disease (Child-Pugh score ≥ C)
7. A history of hypersensitivity to arbidol or oseltamivir (Tamiflu®)
8. Currently or have been involved in another anti-influenza treatment trial in the last 28 days
9. Patients who, in the opinion of the investigator, would be unlikely to comply with required study visits, self-assessments, and interventions
Effective Strategies for Dementia Care

The purpose of this study is to determine whether the interventions of Snoezelen, structured reminiscence therapy and 10-minutes activation are effective to reduce apathy in long term care residents with dementia.

Design:

Cluster-randomized controlled trial with 20 nursing homes in Saxony and Saxony-Anhalt (Germany).

Eligibility Criteria:
Inclusion Criteria:

* Dementia
* Informed consent by legal guardian
* MMSE ≤ 24

Exclusion Criteria:

* Korsakoff's syndrome
* Age ≤ 55 years
* Cognitive impairment other cause than dementia
Study in End-stage Renal Disease Patients Awaiting Kidney Transplant to Investigate the Potential Effect of IVIG Treatment on the Pharmacokinetics and Pharmacodynamics of LFG316

Investigate whether concomitant treatment with intravenous immunoglobulin (IVIG) can alter the pharmacokinetics and pharmacodynamics of LFG316 to an extent which would necessitate dose adaptation for LFG316 in pre-sensitized end-stage renal disease patients awaiting kidney transplantation


Eligibility Criteria:
Inclusion Criteria:

1. Adult men or women 18-70 years of age suffering from end-stage renal disease and who are on chronic dialysis therapy.
2. Candidates for kidney transplantation who are pre-sensitized and will be undergoing desensitization therapy.
3. Written informed consent must be obtained before any assessment is performed.
4. Able to communicate well with the investigator, to understand and comply with the requirements of the study.
5. Recipients who are ABO compatible with donor allograft.
6. Patients awaiting kidney allograft from a living or deceased donor. For patients awaiting transplant from a living donor, kidney transplantation must only occur after 28 days post-LFG316 infusion.
7. History of vaccination with meningococcus and pneumococcus between 2 weeks and 36 months prior to dosing. Documentation is required. If patients have not been vaccinated, they must be vaccinated at least 2 weeks prior to dosing. The choice of vaccine(s) should take into account the serotypes prevalent in the geographic areas in which study patients will be enrolled.

Exclusion Criteria:

1. Patients requiring or undergoing peritoneal dialysis.
2. Patients with a known contraindication to treatment with blood products.
3. Patients with a known pro-thrombotic disorder and/or history of thrombosis or hyper-coagulable state, excluding hemodialysis venous access clotting.
4. Patients who have positive PCR results for hepatitis B and/or hepatitis C, and/or history of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
5. Patients at risk for tuberculosis (TB)
6. Patients with any severe, progressive or uncontrolled acute or chronic medical condition not related to end-stage renal disease (such as uncontrolled infectious disease or sepsis), clinical laboratory abnormalities at screening or baseline that in the investigator's opinion would make the patient inappropriate for entry into this study, or known active presence of malignancies.
7. Pregnant or nursing (lactating) women.
8. Women of child-bearing potential, unless highly effective methods of contraception are used during dosing and for 50 days after the last dose of LFG316, or sexually active males unwilling to use a condom during intercourse while taking investigational drug and for 50 days after the last dose of LFG316.

Other protocol-defined inclusion/exclusion criteria may apply.
CH-EUS in Diagnosis of Inoperable Bile Duct Tumors

VALIDATION OF THE SUPERIORITY OF CONTRAST ENHANCED ENDOSCOPY TO STANDARD ENDOSCOPY IN THE DIAGNOSIS OF BILE DUCT TUMORS


Eligibility Criteria:
Inclusion Criteria:

* Bile duct tumor diagnosed at endoscopic US, CT scan or MRI
* INR\<1.5; platelets \> 50.000
* written consent form

Exclusion Criteria:

* INR\>1.5; platelets \< 50.000
* duodenal invasion or stenosis
* patients denial
* previous treatment for hepato-biliary tumors
Randomized, Double-Blind, Single-Dose, Efficacy and Safety Study of Test Acetaminophen Tablet in Postoperative Dental Pain

To evaluate analgesic onset, efficacy, and safety of 1000 mg acetaminophen administered as two Test Acetaminophen 500 mg tablets (Test ACM) compared with 1000 mg acetaminophen administered as two commercial acetaminophen 500 mg caplets (ACM) and 400 mg ibuprofen administered as two commercial ibuprofen 200 mg liquid-filled capsules (IBU) in the dental pain model following third-molar extractions.

This is a single-dose, randomized, double-blind, placebo- and active- controlled, parallel-group study to evaluate the analgesic onset, efficacy, and safety profile of Test ACM 1000 mg compared with two commercial products over a four-hour period after third-molar extractions. Subjects will undergo dental extraction of three or four third molars.

Eligibility Criteria:
Inclusion Criteria:

1. 17 to 50 years old
2. Weigh 100 lbs. or greater and have a body mass index (BMI) of 18 to 30 (inclusive)
3. Dental extraction of three or four third molars
4. Meets post-surgical pain criteria
5. Females of childbearing age must be willing to use acceptable method of birth control

Exclusion Criteria:

1. Currently pregnant or planning to be pregnant or nursing a baby
2. Known allergy to acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs) including aspirin, as well as hydrocodone or other opioids
3. Inability to swallow whole large tablets or capsules
4. Have other conditions that the investigator feels may impact subject's safety and/or the integrity of the study
5. Use of pain medications 5 or more times per week
6. Have a history of chronic tranquilizer use, heavy drinking, or substance abuse in the last 5 years
7. History of endoscopically documented peptic ulcer disease or bleeding disorder in the last 2 years
8. Have a positive urine drug screen
Measurement of Serum microRNA in Acne Vulgaris Patient

The aim of the study is to:

1. Evaluation of serum microRNA in acne vulgaris and compare to control group
2. Evaluate correlation with acne vulgaris severity

Acne vulgaris is a common chronic skin disease involving blockage and inflammation of pilosebaceous units.

Acne vulgaris is characterized by non-inflammatory, open or closed comedones and by Inflammatory lesions include papules, pustules and nodules. Affecting mostly the face but also the back and chest.

Acne vulgaris may have a psychological impact on any patient, regardless of the severity or the grade of the disease.

Prevalence of self-reported acne was 34.7%. Females significantly reported acne more frequently than males (39.1% vs. 30.3%) Prevalence of clinically confirmed acne was 24.4%, with higher rates among females (28.6%) than males (20.2%).(4) the pathogenesis result from increased sebum production (due to increased activity of androgens and (IGF-1), excessive deposition of keratin in pilosebaceous follicles leading to comedo formation, colonization of the follicle by Propionibacterium acnes bacteria, and the local release of pro-inflammatory chemicals in the skin through certain inflammatory mechanisms.

recently, Inflammation is a key feature in the pathogenesis of acne vulgaris , with various chemokines and cytokines that contribute to fuel a vicious cycle.

In addition, genetics is also a key factor in the pathophysiology of acne. MicroRNAs(MiRNAs) are a class of endogenous, short (19-23 nucleotides in length), which regulate the expression of genes via translational repression or degradation of target messenger RNAs.Recently, the role of miRNAs has also been reviewed for the pathogenesis of various inflammatory skin conditions such as psoriasis, eczema, atopic dermatitis and toxic epidermal necrolysis.

MiRNAs are present not only in the intracellular space, but also in extracellular spaces such as serum, urine, and saliva. This study is the first to evaluate microRNA in serum of acne vulgaris patients.

Eligibility Criteria:
Inclusion Criteria:

* 1. Healthy persons of both sexes with mild, moderate and severe acne vulgaris.
* 2. Patients with acne vulgaris not receiving any topical or systemic treatments for acne at least 6 months

Exclusion Criteria:

* 1. Pregnant and lactating women
* 2. Patients with history of cardiovascular disorder, renal disease, malignancy, chronic liver disease
* 3. Patients with history of depression or mental illness
* 4. Diabetes type 2
* 5. Obesity
* 6. Patient with history of melasma, psoriasis, eczema, atopic dermatitis and toxic epidermal necrolysis.
Comparison of the Effectiveness of the Outpatient Classical Ketogenic Diet and Modified Atkins Diet on Seizures Frequency, Nutritional Status and Some Biochemical Factors in Children and Adolescents With Intractable Epilepsy

Epilepsy is one of a common neurological disorder. Antiepileptic drugs (AEDs) are usually the primary treatment of epilepsy. However, almost 30% of patients do not respond to AEDs and other treatments including ketogenic diet (KD) are used. The Ketogenic Diet (KD) is a low-carbohydrate, high fat, adequate-protein diet. In this study, investigators are going to compare two kinds of the ketogenic diet namely classical ketogenic diet and modified Atkins diet. Fifty children and adolescents with intractable epilepsy will be included, 25 patients in each group, and will receive the diet for three months on non-randomised basis. In the classical ketogenic diet, the diet with a ratio of 4 to 1 (4:1), each 4 grams of fat to each gram of carbohydrate plus protein, will be introduced. Classical ketogenic diet will be established on outpatient setting, without fasting and gradually. The modified Atkins diet will be applied by the ratio of 1:1 or 2:1, each 1 or 2 grams of fat to each gram of carbohydrate plus protein.


Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents age 1 to 18 years Have not responded well to at least two primary and one secondary antiepileptic drugs Have not received ketogenic diet therapy previously Absence of renal diseases history Absence of cardiovascular diseases history Absence of thyroid function disorders history Absence of cholesterol level more than 300 mg/dl and Triglyceride level more than 200 mg/dl Absence of inherited metabolic disorders that are contraindicated for ketogenic diet therapy including fatty acid oxidation disorders

Exclusion Criteria:

* Onset of complications that threat the life of the patient Inability to continue the diet Unwillingness to adhere the diet
Confounding Factors in Ocular Surface Microbiome Research

To elucidate confounding factors in ocular surface microbiome research and to confirm the presence of a core ocular surface microbiome and its temporal stability.

The investigator will take a conjunctival sample of both eyes of a group of volunteers together with an extensive questionnaire. Furthermore, 50 volunteers will be sampled repeatedly during one year or two years.

Eligibility Criteria:
Inclusion Criteria:

* The subject is fluent in written and verbal Dutch
* The subject is capable of giving informed consent

Exclusion Criteria:

* Use of glaucoma drops
* Use of antibiotic drops \< 1 month before sampling
Biological Collection for Marfan and Related Syndromes

The present study will establish a collection of biological samples from Marfan patients or with associated diseases to be used for research purposes only, with due respect for confidentiality.

Marfan syndrome is an autosomal dominant disease (incidence 1/5000) characterized by ocular, cardiac and skeletal abnormalities. More recently, a decrease in fat and muscle mass has been demonstrated, associated with a decrease in exercise endurance, causing a significant deterioration in the quality of life. Little is known about the pathophysiology of these symptoms. Patients with Marfan syndrome or related diseases are followed at the children's hospital as part of the Rare Diseases Reference Centre (CRMR) for Marfan syndrome at the Toulouse University Hospital. During regular check-up visits, an extra sample of blood and urine will be collected and stored for research utilisation with the patient's consent. The ultimate objective of this collection is to provide available biological resources to facilitate the development of subsequent studies aimed at better characterizing the multisystemic disorders in Marfan syndrome, to understand the pathophysiology of the disease, and to identify biological factors that predict the severity and progression of the disease. The possibility of having systematically collected biological resources will make it possible to answer certain questions more quickly depending on the progress of research.

Eligibility Criteria:
Inclusion Criteria:

* Children aged at least 3 years old or adult with Marfan syndrome or related syndromes
* Patients affiliated to or beneficiaries of a social security scheme
* Patients able to receive information on the progress of the study and understand the information form to participate in the study. That implies to master the French language and not to be subject to a restriction of rights by the judicial authorities
* Patients or legal representative who have given their consent to participate in the study (expression of no objection)

Exclusion Criteria:

* Patients subject to a legal protection measure (guardianship, curators, or safeguard of justice)
* Pregnant or breastfeeding women
HMPL-760 in Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma

A Multicenter, Open-label, Phase I Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of HMPL-760 in Patients with Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of HMPL-760 administered orally in subjects with relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL). Patients with relapsed/refractory B-NHL, including chronic lymphocytic leukemia/small cell lymphoma (CLL/SLL), diffuse large B-cell lymphoma (DLBCL), follicular cell lymphoma (FL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), and lymphoplasmacytic/macroglobulinemia (LPL/WM).

Eligibility Criteria:
Inclusion Criteria:

1. Signed Informed Consent Form (ICF)
2. Age ≥18 years
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. In the expansion stage, ECOG performance status 0-2
4. Relapsed/refractory patients with histologically confirmed lymphoma

   * CLL confirmed by cytology (flow cytometry)
   * LPL/WM diagnosed by relevant tests including serum, bone marrow, and pathological examinations.
5. Except for CLL and WM, at least one bidimensionally measurable lesion is required by CT scan, which means the largest diameter of lymph node lesions \>1.5 cm or extranodal lesions \>1.0 cm; For lesions that cannot be well displayed by CT due to anatomical location (such as limb or soft tissue lesions), MRI measurement can be used.
6. Expected survival longer than 24 weeks

Exclusion Criteria:

Patients who met any of the following criteria are excluded from the study:

1. Lymphoma patients with central nervous system (CNS) or leptomeningeal invasion
2. Inadequate organ function of liver and kidney
3. Carcinoma in situ of the breast History of liver disease, including cirrhosis, alcoholism, or currently known active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
4. Any anti-tumor therapy including chemotherapy and radiotherapy within 3 weeks prior to the first dose of study drug
5. Within 7 days or approximately 5 half-lives (whichever is longer) prior to the first dose of the investigational drug, received any corticosteroids or approved small molecule targeted anti-cancer therapies.
6. Any monoclonal antibody used for anti-tumor therapy within 4 weeks or 2 half-lives prior to the first dose of study drug, whichever is longer
7. Prior use of any anti-tumor vaccine
8. Prior administration of radioimmunotherapy within 3 months prior to the first dose of study drug
9. Any uncontrolled active infection
10. History of drug-induced interstitial pneumonia
Efficacy and Safety of Stellate Ganglion Block With Lidocaine Combined Platelet-rich Plasma to Treat Chronic Migraine

This is a multicenter, prospective, observational, propensity score matching, cohort, and assessor-blinded study designed to compare the effectiveness and safety of lidocaine combined Platelet-rich plasma (PRP) acting on SGB versus lidocaine alone acting on SGB in patients with CM.

Chronic migraine (CM) is a disabling disease that causes serious physical and emotional consequences. Previous studies had suggested the efficacy of stellate ganglion block (SGB) with lidocaine in the treatment of CM. However, the side effects related to repeated procedures limit its applications. Platelet-rich plasma (PRP) as an intervention treatment for chronic pain, has shown promising results to alleviate headache within the distribution range of the greater occipital nerve after trauma. So far, there has not been any report on PRP combined with lidocaine acting on SGB for CM. the investigators will conduct this multicenter, prospective, observational, propensity score matching, cohort, and assessor-blinded study to evaluate the efficacy and safety of lidocaine combined PRP acting on SGB versus lidocaine alone acting on SGB in patients with CM

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 to 75 years;
2. BMI between 15 and 35 kg/m2 ;
3. Diagnosed with CM in accordance with the International Classification of Headache Disorders, 3rd Edition (ICHD-3) criteria (Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211);
4. Visual Analogue Scale (VAS; range, 0-10; 0 = no pain and 10 = worst possible pain; higher scores indicate more severe pain) score≥7;
5. Scheduled for lidocaine acting on SGB treatment for CM；
6. Signed informed consent.

Exclusion Criteria:

1. Previously received SGB treatment;
2. Combined with other types of headaches;
3. Platelet count \<105\*109/L, use of anticoagulants or antiplatelet agent, coagulation disorders or bleeding disorders;
4. Infection or mass near the puncture site;
5. A history of other neurological disorders;
6. A history of severe cardiopulmonary, hepatic or renal dysfunction;
7. A history of psychological disorders;
8. A history of narcotic drug abuse;
9. Changes in neck anatomic structure caused by radiotherapy or surgery;
10. A history of allergies to any research drugs;
11. Pregnancy or lactation period.
Sustained onabotulinumtoxinA Therapeutic Benefits in Patients With Chronic Migraine

To assess whether there is a sustained benefit and good safety with repeated onabotulinumtoxinA sessions in chronic migraine over more than three years of treatment.

We prospectively enrolled 65 chronic migraine patients, who were classified as responders after three sessions of onabotulinumtoxin A and were eligible to further continue treatment.

Evidence on whether the therapeutic effect and good safety profile of onabotulinumtoxinA (Botox®) in chronic migraine (CM) patients is maintained over long term treatment is still limited. This study aims at assessing whether there is a sustained benefit and good safety with repeated onabotulinumtoxin A sessions in CM over more than three years of treatment.

This study prospectively enrolled 65 CM patients, who were classified as responders after three sessions of onabotulinumtoxinA and were eligible to further continue treatment. Data documenting longitudinal changes from the trimester after the third onabotulinumtoxinA administration (T1) to the trimester after completing two years of treatment (T2) and eventually to the trimester after completing three years of treatment (T3) in (i) mean number of monthly headache days (ii) migraine severity as expressed by the mean number of days with peak headache intensity of \>4/10, and (iii) mean number of days with use of any acute headache medication, were prospectively collected from patients' headache diaries.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with chronic migraine according to IHC-III with or without medication overuse.
* Responders defined as patients that after 3 sessions of treatment with onabutulinum toxin A, having experienced a ≥50% reduction in their average monthly migraine days

Exclusion Criteria:

-