cyrilzakka/clinical-trials huggingface dataset:
Non-erythroid Effects of Erythropoietin on Cognitive Function and Exercise Capacity in Humans

The blood hormone Erythropoietin (Epo) is not only produced by the kidneys but also by the brain, especially under hypoxic conditions. It has been shown in animal studies and human studies that Epo has neuroprotective properties. Furthermore, there is scientific evidence for central modulatory effects of Epo in the brain but high dose of Epo is needed to overcome the blood brain barrier. In a double blind placebo controlled crossover study we will investigate the effects of a single high dose of Epo on cognitive function and exercise capacity in healthy subjects. The subjects will receive a single high dose of Epo (60.000 IU) and will perform a computerized cognitive test battery, a breathing test, a maximal exercise capacity test (VO2max), and a time trial (TT) 24 hours after the treatment. The primary outcome of the study will be the cognitive function.

* Trial with medicinal product


Eligibility Criteria:
Inclusion criteria:

* Healthy Subjects;
* Age between 18 to 35 years;
* Normal body weight (body mass index of \>= 18.5 kg/m2 \<= 24.9 kg/m2);
* Nonsmokers (\>= 1 year);
* VO2max of \<= 55 ml/kg/min for females and \<= 60 ml/kg/min for males;

Exclusion criteria:

* Persons with abnormal Serum Ferritin levels according to gender dependent reference values of GCP-certificated laboratory;
* Persons with pre-existing genetic hemostatic disorders (Factor V Leiden mutation, Prothrombin mutation);
* Persons which are at risk of deep venous thrombosis (e.g. history of venous thromboembolic events);
* Persons with a hematocrit value of \> 55%;
* Persons being exposed to prolonged (\>= 5 days) high altitude (\>= 2500m above Normal Null) \<= 6 months prior the beginning of the study;
* Persons not willing to maintain their living conditions during the study period (e.g. preparing for a certain competition);
* Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product;
* Pregnant or breast feeding women;
* Intention to become pregnant during the course of the study;
* Lack of safe contraception;
* Treatment with other investigational products;
* Known or suspected non-compliance, drug or alcohol abuse;
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders;
* Participation in another study with investigational drug within the 30 days preceding and during the present study;
* Enrolment of the investigator, his/her family members, employees and other dependent persons;
Clinical Trial to Evaluate the Effect of a Probiotic Mixture on the Rosacea Evolution

The clinical trial has a randomized, double-blind, placebo-controlled design, in which the aim is to evaluate the effect of a probiotic mix, with a 12-week treatment, on the evolution of rosacea.

This 12 weeks of treatment are structured into three visits: Visit 1 (initial; week 0), Visit 2 (intermediate; week 6) and Visit 3 (final; week 12).

The three visits that make up the study and the actions to be carried out in each of them are described below:

Visit 1 (initial; week 0)

Once the informed consent is signed, a doctor trained for the study performs the initial interview where it is verified that the patient meets all the inclusion criteria and none of the exclusion criteria and their medical history.The investigator will proceed to assign the patient the next study participant number and, according to a previously prepared randomization list, the treatment that they will receive during the study will be assigned.

The investigator will assess the severity and symptoms of rosacea according to the Investigator's Global Assessment (IGA) and Clinician Erythema Assessment (CEA) scales. The patient will also complete a questionnaire to assess the impact on quality of life due to the disease: Dermatology Life Quality Index (DLQI).

Visit 2 (intermediate; week 6)

In this intermediate visit, in addition to assessing the symptoms of the disease with the detailed scales, the investigator will record the adverse events reported by the patient, as well as the concomitant treatments used.

Also, the treatment compliance rate will be calculated by counting the capsules returned by the patient.

Visit 3 (final; week 12)

In the final visit, the same actions will be carried out as in the intermediate visit, evaluating the severity of the disease and the remaining capsules will be collected, to calculate treatment compliance, concomitant treatments and adverse events.

Visit 4 (post-treatment follow-up; week 24)

During this visit, the symptoms of the disease will be assessed with the two scales used in the study and the treatments that the patient has required during the 12 weeks after the end of the study treatment will be counted.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes of an age equal to or greater than 18 years.
* Patients diagnosed with papulopustular rosacea with a minimum score of 2 points according to the Investigator's Global Assessment (IGA) index.
* Signature of informed consent by the patient

Exclusion Criteria:

* Pregnant, lactating, and/or women who do not agree to use an effective contraceptive method during the development of the study.
* Allergy and/or intolerance to any of the components of the product under study.
* Consumption of antibiotics in the previous two weeks.
* Consumption of probiotics in the previous two months.
* Isotretinoin use in the previous six months.
* Light procedures (IPL, laser, Kleresca) in the previous three months.
* Participation in other clinical studies in the previous two months.
* Other dermatological pathologies.
A Single, High-Dose Azithromycin Extended Release (60 mg/kg) Compared With 10 Days of High-Dose Amoxicillin Clavulanate in Children With Ear Infections at High Risk of Persistent/Recurrent Ear Infections

A phase 3 randomized, multicenter, double blind, double dummy study to assess the efficacy, safety, and compliance of a single dose of azithromycin extended release compared with a 10-day course of amoxicillin/clavulanate twice daily in children at high risk for persistent or recurrent ear infections


Eligibility Criteria:
Inclusion Criteria:

Outpatients with clinical evidence of acute otitis media who weigh at least 5 kg were included

Exclusion Criteria:

Patients with previously diagnosed disease of immune function, treatment with any systemic antibiotic within the previous 7 days, or cleft lip/palate or other anatomic abnormality predisposing to otitis media were excluded.
Dexamethasone for Treating Severe Hospital-acquired Pneumonia in Critically Ill Patients With a Proinflammatory Phenotype

Determine the efficacy of dexamethasone plus standard of care (SOC) as compared to placebo plus SOC for treating severe hospital-acquired pneumonia in critically ill patients with a proinflammatory phenotype; It's an international phase III, double-blind, placebo-controlled, randomized trial.


Eligibility Criteria:
Inclusion Criteria:

* Hospital-acquired pneumonia (HAP) according to European guidelines (Torres et al. Eur Respir J 2017): Association of two criteria among (body temperature \> 38°C, leukocytosis\>12000 cells per mL, leucopenia \<4000 cells per mL and purulent pulmonary secretions), appearance of a new infiltrate or change in an existing infiltrate on chest radiography, and respiratory sample (Sputum, AET, BAL, mini-BAL or blind BAL) collected for bacteriological diagnosis (results can be pending at inclusion). The diagnosis of HAP can have been made outside of ICU. Diagnosis is done at least 48 hours after hospital admission.
* HAP severity defined as a PaO2/FiO2 ratio \< 200 under invasive mechanical ventilation.
* Biological systemic inflammatory response defined as CPR\> 150 mg/L (15 mg/dL)\*
* Receiving curative antimicrobial therapy for the current episode of HAP pneumonia for less than 48 hours.
* Informed consent from a legal representative, or emergency procedure (when possible, according to national regulation, see below). If it is not possible to obtain the patient consent prior the inclusion (comatose patients), patient consent for the study continuation will be obtained as soon as deemed possible.
* Person insured under a health insurance scheme.
* Female of childbearing age who agree and who are able to comply with effective contraception for the 28 first days of the study:

Exclusion Criteria:

* Pregnant women (serum or urine test), breastfeeding women.
* Patient under legal protection (incl. under guardianship or trusteeship).
* Hypersensitivity to dexamethasone and hypersensitivity to all of its excipients
* Ongoing administration of glucocorticoid at the time of randomisation, such as for COVID-19 infection requiring supplemental oxygen therapy
* Severe septic shock (norepinephrine \> 0.4 microg/kg/min and serum lactate level greater than 2 mmol/L) at the time of randomisation
* Prolonged use of corticosteroids at a mean minimum dose of 0.3 mg/kg/day of prednisone equivalent for \>3 weeks in the past 60 days
* Uncontrolled viral (hepatitis,herpes, zona, varicella) or systemic fungal infection
* Immunosuppression pre-existing to hospitalisation (severe lymphopenia \< 500 lymphocytes/mm3, hematologic cancer, aplasia, chemotherapy/radiotherapy for cancer within 3 months prior to the inclusion, or anti-graft rejection drug).
* Uncontrolled psychotic disorder (acute or chronical)
* Patients not expected to survive for more than 48 hours.
* Participation in another drug clinical trial
Protocols for Magnesium Sulfate Maintenance Dose in Overweight and Obese Women Diagnosed With Preeclampsia

There is still no evidence of the appropriate dose to be used. Serum magnesium sulfate concentration is not measured regularly, thus we may be using sub-therapeutic level or reaching a toxic level.Overweight and obese women have different pharmacokinetics and different drug distribution, therefore, they may need higher doses of magnesium sulfate to reach therapeutic level.

Magnesium sulfate is used in pre-eclampsia to prevent seizures, it is administered in the form of a loading dose and maintenance dose. Maintenance dose of magnesium sulfate in pre-eclampsia varies in literature (1-3gms/hour). There is still no evidence of the appropriate dose to be used. Serum magnesium sulfate concentration is not measured regularly, thus we may be using sub-therapeutic level or reaching a toxic level.Overweight and obese women have different pharmacokinetics and different drug distribution, therefore, they may need higher doses of magnesium sulfate to reach therapeutic level. This study will evaluate whether overweight and obese women need higher maintenance doses to reach therapeutic level of magnesium sulfate in serum.Preeclampsia is a serious pregnancy complication characterized by hypertension, proteinuria and signs of damage to another organ system, often the kidneys, occurring after 20 weeks of gestation

Eligibility Criteria:
Inclusion Criteria:

Women diagnosed with SPET as per criteria of NICE, 2023 guidance

* Age 20-40 years
* BMI \>25kg/m2
* Gestational age \> 28 weeks

Exclusion Criteria:

* Intrauterine Fetal Death (IUFD)
* Hemolysis - Elevated liver enzymes - Low platelets syndrome (HELLP)
* Contraindication to Magnesium Sulfate such as myasthenia gravis, severe renal failure, cardiac ischemia, and heart block
* Serum creatinine levels greater than 1.1 mg/dL.
* Women refusing to participate in the study.
The Debridement To Treat The Traumatic Corneal Abrasion

Patients who signed informed consent to participate in the study will receive corneal epithelial deplasia. The patient was instructed to follow up closely in the following year, and the recurrence of the patient was collected through wechat follow-up.

Traumatic corneal abrasion (TCA) refers to the injury or defect of the corneal epithelium caused by a foreign object (such as a nail, a tree branch, etc.), which is characterized by severe eye pain accompanied by red eyes, blepharospasm, photophobia, tearing, and a distinct foreign body sensation. TCA is one of the common eye injuries and ophthalmic emergencies, accounting for about 5%-10% in ophthalmic emergencies. Methods: The investigators conducted a clinical trial in adult patients with corneal trauma at the Zhongshan Ophthalmology Center of Sun Yat-sen University. Patients who signed informed consent to participate in the study were provided with corneal epithelial debridement. Patients were instructed to follow closely for the following year, and a pain log of the patient was collected at the last ophthalmology clinic visit.

Eligibility Criteria:
Inclusion Criteria:

1. The affected eye is traumatic corneal epithelial abrasion, and the specific criteria are as follows: A: Damage caused by one of the three high risk causes of recurrent corneal epithelial exfoliation defined as fingernails, paper, or plant leaves; B: Monocular disease; C: Eye pain, tears, photophobia and foreign body sensation when injured; D: Local defect of corneal epithelium was found at the time of injury, and fluorescein sodium staining was positive; E: The time from injury to first diagnosis is less than 24 hours.
2. Be between the ages of 18 and 60.
3. Patients volunteered to participate in the study and signed the informed consent, showing good compliance.

Exclusion Criteria:

1. Corneal epithelial defect complicated with infection.
2. Patients with other ocular surface diseases (such as eyelid insufficiency, eyelid gland dysfunction, Sjogren's syndrome, bullae keratopathy, corneal dystrophy, drug induced corneal toxicity, etc.).
3. Pre-existing corneal disease (corneal degenerative disease or viral keratitis, etc.) or history of corneal surgery;
4. Long-term contact lens wearers.
5. Pregnant or lactating women; Severe impairment of heart, liver and kidney function; One who is mentally abnormal; People with other inflammatory or autoimmune diseases. Corneal epithelial defect complicated with infection
A Safety Study For Prevenar 13 Among Chinese Children

This is an observational study based on a population-based EHR database.

This observational study based on a population-based EHR database in Yinzhou district of Ningbo city in China is to estimate incidence rates of seizures (including febrile seizures), urticaria and angioedema, apnea, and fever among Chinese children after receiving Prevenar 13. In addition, a validation study including validation of International classification of diseases, tenth revision (ICD-10) codes or ICD-10 code based algorithm for identifying all safety outcomes of interest and a prospective cohort study in a sub-population of the main study will be conducted in order to offset the potential biased results from the main study because of potential misclassification of the safety outcomes of interest due to miscoding and/or undercoding of ICD-10 codes used to identify these safety outcomes in the EHR database.

Eligibility Criteria:
Inclusion Criteria:

To be eligible for the main study, children in Yinzhou population-based EHR database must be aged 1 to 24 months and receive at least one dose of 13vPnC between May 1st, 2017 and July 24th, 2020 where the first dose is received before or on July 24th, 2020 since a 7-day post-vaccination follow-up for each dose in each child receiving 13vPnC is needed. For the prospective cohort in a sub-population of the main study, eligible children for the main study must receive the first dose of 13vPnC between August 1st, 2018 and July 24th, 2020 and an informed consent must be obtained from parents/legal guardians.

Exclusion Criteria:

There are no exclusion criteria for this study.
Metformin for Antipsychotic-induced Weight Gain in Adults With Intellectual Disability

People with IDD (intellectual and developmental disability) have very high rates of obesity and die prematurely from cardiometabolic disease. While antipsychotics contribute to this problem, their use is necessary and appropriate in a significant subgroup of individuals with IDD. Exercise and diet interventions have limitations and may not be sufficient, requiring effective adjunctive pharmacological approaches to target obesity and related comorbidities in IDD. However, persons with IDD treated with antipsychotics are systematically excluded from clinical trials hindering development of evidence to help guide safe and effective treatment of these comorbidities. Moreover, evidence from other disorders cannot be extrapolated to IDD given inherent biological differences between disorders. This trial will address the identified gaps, which extend beyond cardiovascular morbidity and negatively impact psychosocial outcomes, in a hugely underserviced population.This is the the first RCT (randomized control trial) to examine the efficacy of metformin in overweight or obese adults with IDD who have experienced antipsychotic-induced weight gain. By generating efficacy data for a very accessible and scalable intervention, allows for guideline and implementation strategies to address a recalcitrant health problem.


Eligibility Criteria:
Inclusion Criteria:

* Stable outpatients
* Age 18-65 years
* Diagnosed with IDD
* On maintenance treatment with an antipsychotic (stable dose for ≥3 months).
* BMI must be ≥30 kg/m2, or ≥27 kg/m2 with at least one weight-related comorbidity (treated or untreated) such as: hypertension, dyslipidaemia, obstructive sleep apnea, or impaired fasting glucose.
* Females of child-bearing age must be on one of the following regular contraceptives:

  1. Agree to abstain from sex for the duration of the trial or
  2. A barrier method of a diaphragm with spermicide and/or Latex condom or
  3. An oral contraceptive agent, implantable contraceptive or an injectable contraceptive for at least six months prior to entering the study and will continue its use throughout the study, or
  4. An intrauterine device, or
  5. Partner has had a vasectomy at least 3 months prior to study start

Exclusion Criteria:

* Females who are nursing, currently pregnant, or have a positive pregnancy test
* Clinical or laboratory evidence of uncompensated cardiovascular, endocrine, haematological, hepatic, renal, or pulmonary disease
* Previous treatment and lack of efficacy or tolerability with metformin
* History or diagnosis of Type 1 Diabetes (T1D) or Type 2 Diabetes (TD2) or fasting blood work, HbA1c \> 6.5%
* History of metabolic acidosis or lactic acidosis
* Treatment with weight-lowering agents
* Medications with significant renal impact
* Major medical or surgical event in the preceding 3 months
* Acute suicidal risk.
* Moderate to severe substance use disorder, other than caffein or nicotine use disorder
Mindfulness for Physical Activity Research Project

This study aims to evaluate the feasibility and preliminary effectiveness of a Mindfulness for Physical Activity programme on physical activity outcomes in underactive participants.

In recent years, mindfulness-based approaches have increasingly been used in mental and physical health interventions. There appears to be some consensus about the benefits of standard mindfulness courses, such as Mindfulness-Based Stress Reduction and Mindfulness-Based Cognitive Therapy on stress, anxiety and depression, and other health conditions. In terms of physical activity, however, evidence for the use of mindfulness training to promote and improve physical activity is scarce and shows conflicting results. Evidence suggests that mindfulness training may enhance psychological factors related to exercise, such as intrinsic motivation to engage in physical activity, tolerance of physical activity-related discomfort, and physical activity self-regulation, which could potentially enhance physical activity maintenance in the long run.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* 19-64 years old
* Would like to do more physical activity, but find it boring, uncomfortable, or not enjoyable
* Available and willing to attend all sessions and complete all research measures

Exclusion Criteria:

* Physical disability, cardiovascular condition, or any other illnesses or injuries that would prevent from doing physical activity
* Currently engaging in regular physical activity
* Currently taking medication and/or undergoing therapy for a mental health condition
* Have previously completed a mindfulness course
* Currently engaged in a regular meditation practice
* Away or unavailable on Mondays between 17:30 to 19:30pm for 6 weeks starting 1st October and for other assessment dates up to 17th December 2018
Topical Vitamin B12 in Chronic Plaque Psoriasis

Objective: To test the efficacy and tolerability of a vitamin B12 cream for the treatment of chronic plaque psoriasis.

Design: Multicenter, double-blind, randomized, placebo-controlled trial.

Objective: To test the efficacy and tolerability of a vitamin B12 cream for the treatment of chronic plaque psoriasis.

Design: Multicenter, double-blind, randomized, placebo-controlled trial. Setting: ambulatory patients in research or referral centers. Patients: Volunteer sample of 51 patients with chronic plaque psoriasis. Interventions: All Patients applied vitamin B12 cream twice daily for 8 weeks to one side of the body and placebo to the other.

Main outcome measures: Modified Psoriasis Area and Severity Index (PASI) at weeks 0, 2, 4, 6 and 8. Thickness and density of 3 references plaques determined by 20 MHz sonography. Assessment of efficiency and tolerability by patients and investigators.

Eligibility Criteria:
Inclusion Criteria:

* 18years
* chronic plaque psoriasis

Exclusion Criteria:

* incapability of Vitamin B12
* necessity of systemic therapy
* use of other potentially psoriasis modifying drugs
Daptomycin Pharmacokinetics in Critically Ill Patients Undergoing Continuous Veno-venous Hemodiafiltration, a Dose Finding Study

Daptomycin kinetics in CRRT

* Trial with medicinal product


Eligibility Criteria:
Inclusion criteria:

* male or female of 18 years or older
* females: negative pregnancy test
* Hospitalisation in the medical ICU
* High suspicion or evidence of Gram-positive infections requiring antibiotic therapy
* Subjects receiving standard antibiotic treatment for Gram-positive infection
* Evidence of renal failure
* Clinical necessity for continuous renal replacement therapy
* Written informed consent signed by the patient or a next of kin and an independent physician in case the patient is not able to sign.

Exclusion criteria:

* Skeletal muscle disorders or CPK levels of \> 2 x ULN
* History of hypersensitivity to the drug
* Participation in another study
* Subjects with a history of muscle disease
* Patients with severe liver function impairment (Child
* Life expectancy of less than 5 days