cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Intrarectal Versus Intravenous Quinine for the Treatment of Childhood Cerebral Malaria

Cerebral malaria is the most lethal complication of P.falciparum infection with a mortality rate between 5 and 40%. Intravenous quinine remains the recommended treatment for cerebral malaria. However its administration is often not feasible due to lack of simple equipment or trained staff. When referral is not possible, a viable alternative is needed. The intrarectal route is of interest in children since it is painless and simple. Studies of the efficacy of intrarectal quinine in the treatment of cerebral malaria are limited. The study aims to establish the efficacy of intrarectal quinine in the treatment of childhood cerebral malaria.

Cerebral malaria is the most lethal complication of P.falciparum infection with a mortality rate between 5 and 40%. Intravenous quinine remains the recommended treatment for cerebral malaria. However its administration is often not feasible due to lack of simple equipment or trained staff. When referral is not possible, a viable alternative is needed. The intrarectal route is of interest in children since it is painless and simple. A few studies in Francophone Africa have reported clinical efficacy and tolerance of intrarectal quinine. Although the studies were randomized trials, they were not blinded and did not use the WHO definition of cerebral malaria as selection criteria.

The current study aims to establish whether intrarectal quinine is as effective and as safe as intravenous quinine in the treatment of childhood cerebral malaria.

To address the shortcomings of the Francophone African studies, the investigators have designed a randomized, double blind placebo controlled clinical trial to include patients who meet the WHO definition of cerebral malaria.

Hypothesis:

Intrarectal quinine (15mg/kg every 8 hours) given to children with cerebral malaria, will lead to a shorter parasite clearance time (39.9 hours) than intravenous quinine (55.0 hours).

The investigators calculated a sample size of 54 patients in each group for 90% power and 95% confidence. In the calculation, the researchers assumed that the children receiving intrarectal quinine would have a mean parasite clearance time of 39.9 (SD 24.3) hours and those receiving intravenous quinine would have a mean parasite clearance time of 55.0(SD 24.3) hours (27.5% effect size), according to a study by Aceng, Byarugaba and Tumwine in the same hospital.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 6 months to 5 years admitted to Mulago hospital during the study period who satisfy the World Health Organization (WHO) case definition of cerebral malaria (Unarousable coma lasting more than 30 minutes after a seizure, with peripheral asexual P.falciparum parasitaemia and absence of other causes of coma) and whose caretakers give informed consent.

Exclusion Criteria:

* Patients with diarrhea (more than 4 motions/24 hours)
* Any recent anal pathology (such as rectal bleeding, rectal prolapse)
* Documented quinine treatment in previous 48 hours.
WAL 801 CL Dry Syrup in Paediatric Atopic Dermatitis Patients

Study to investigate the safety and efficacy of WAL 801 CL Dry Syrup on pruritus associated with paediatric atopic dermatitis in comparison with that of Ketotifen Fumarate Dry Syrup and to confirm the appropriateness of dosage of WAL801 Dry Syrup.


Eligibility Criteria:
Inclusion Criteria:

For inclusion in this study, patients must be pediatric atopic dermatitis patients that meet the following criteria and thus be appropriate for observation of pruritus. Diagnosis of atopic dermatitis was conducted in accordance with the "Definition and Diagnostic Criteria of Atopic Dermatitis" issued by the Japanese Dermatological Association.

* 15 years of age or younger
* Body weight of 14 kg or more
* Outpatients
* One week or longer has passed since the patient started to use an external steroid preparation at "Strong" or lower grade, or stopped using any external steroid preparation, at the time of obtainment of consent from the patient
* Pruritus with "2" or higher grade, immediately before initial administration

Exclusion Criteria:

* Use of sustained release adrenocorticotropic hormone (Kenacort® A, Depo-medrol®, etc.), oral preparation of methotrexate, or oral preparation of ciclosporin, within 4 weeks before initial administration of the investigational product
* Oral intake, inhalation and injection of any steroid within 2 weeks before initial administration of the investigational product
* Use of any external steroid preparation at "Very Strong" or higher grade in any sites other than the face or scalp within 2 weeks before initial administration of the investigational product
* Undergoing phototherapy
* Undergoing specific desensitization therapy or modulation therapy
* Past history of contact dermatitis caused by external steroid preparation
* Possibility of exacerbation by an external steroid preparation of infectious skin disease caused by bacteria, fungi, or virus
* Present and past history of convulsive disorder, such as epilepsy (convulsion threshold values may be lowered by the reference drug, Ketotifen Fumarate)
* Clinically significant hepatic, renal, or cardiac disease or other complications: therefore, judgement that the patient is ineligible for inclusion in this study (Please note that patients must be excluded from the study if the patients fell under Grade 2 or more, in the MHW (Ministry of health and welfare) Adverse Reaction Severity Classification Criteria.)
* Past history of allergy to any drug
* Participation in any other clinical study, or history of participation in any other clinical study within 6 months before the date when the patient gave consent to participate in this study
* Judgement by the Principal Investigator or Investigator that the patient is ineligible for inclusion in this study
A Phase IIa Study Investigating the Tolerance, Efficacy and Safety of HSK3486

This is a Phase IIa, open-label, propofol-controlled ,dose-escalation, multi-center Study to evaluate the tolerance, efficacy and safety of HSK3486 for induction of general anesthesia in elective surgery patients.This study is consisted of two cohorts, dose-escalation and dose-expansion cohorts. The doses in dose- expansion cohort were selected from dose-escalation results.


Eligibility Criteria:
Inclusion Criteria:

1. Inpatients required tracheal intubation under general anesthesia and a non-emergency non-cardiothoracic and non-extracranial elective surgery for an estimated duration of ≤ 3 h ;.
2. Males or females, aged ≥ 18 and ≤ 65 years old;
3. Body mass index (BMI) ≥ 19 and ≤ 30 kg/m2;
4. ASA grade I\~II;
5. Capable of understanding the procedure and method of this study, willing to sign an informed consent form and to complete this study in strict accordance with the study protocol.

Exclusion Criteria:

1. Patients were contraindicated in general anesthesia.;
2. Patients with a known sensitivity to propofol, opioids, naloxone, eggs, soy products or a medical condition such that these agents were contraindicated
3. Patients in receipt of any investigational drug within 30 days before screening.
4. Patients in receipt of propofol, opioid , other sedative or anesthetic or analgesics within one month prior to the screening period.
5. Patients in receipt of general anesthesia surgery within two weeks prior to the screening period.
6. The patient has some history or evidence of increased risk of sedation or anesthesia, such as cardiovascular disease, respiratory disease, cerebrovascular disease, liver, kidney, blood system, or metabolic system disease prior to the screening period.
7. Abnormal laboratory results consisting of any of the following: :

1) AST and ALT≥ 2×ULN； 2）TBIL≥ 1.5×ULN； 3）Hb≤ 90g/L; 4）ANC≤1.5×109/L; 5) PLT≤80×109/L； 6） serum creatinine≥ 1.5×ULN.

8. Patients with a history of drug or ethanol abuse with the past 3 months. 9. Pregnant women or female patients with a positive serum or urine human chorionic gonadotropin pregnancy test at screening or baseline or lactating female patients. . 10. 10. Patients with a positive Allen 's test who collected arterial blood for PK study.

11. Patients with respiratory management difficulties. 12. Patients with an inability to communicate well with the investigator, or deemed unsuitable according to the investigator (in each case providing a reason).
Biological Markers for Professional COPD

Chronic obstructive pulmonary disease (COPD) is a frequent disease, mainly linked to tobacco smoking leading to chronic respiratory failure. It is characterized by an inflammatory spate with modification of protease-antiprotease and oxidant-antioxydant balances. Local modifications are associated with systemic changes. Many occupational factors have been associated with an excess of COPD in epidemiological studies, however without identification of any specific clinical or biological phenotype.

Pathophysiological pathways involved in COPD might be different according to etiologic agents. Therefore, it is important to focus research on blood biomarkers associated with some well-characterized occupational COPD.

The objectives of MB2PROF project are:

1. To build the first multicentric cohort of cases of occupational COPD, with collection of plasma and DNA samples,
2. To study the evolution of clinical and lung function parameters of occupational COPD in comparison with non occupational COPD during a follow-up study,
3. To identify biological phenotypes of COPD associated to a given etiological agent.

The methodology includes:

1. The constitution of a cohort with a clinical and biological follow-up during 5 years. Subjects will be recruited in 7 occupational diseases departments, with the collaboration of Pneumology departments.

   Four groups of males subjects will be recruited (G1 : occupational COPD (6 groups of 60 subjects, corresponding to 6 groups of occupational agents) ; G2 : non occupational COPD (n = 60) ; G3 : subjects with similar occupational exposure to G1 subjects but without COPD (6 groups of 60 subjects) ; G4 : subjects free of occupational exposure and of COPD (n = 60)), paired on tobacco-smoking and age. For each subject, information on clinical data, lung function parameters, occupation history and blood samples will be collected.
2. The identification of biomarkers, using proteomic and genomic approaches according to subgroups (with different etiologies) of occupational COPD,
3. The study of molecular pathways identified in these subgroups, with in vitro and in vivo studies The MB2PROF project is an original and ambitious multidisciplinary and translational project. The constitution of well-characterized COPD cases cohort should allow the identification of biomarkers and molecular pathways associated with some subgroup of subjects, and improve the knowledge of mechanisms involved.


Eligibility Criteria:
Inclusion Criteria:

* COPD

Exclusion Criteria:

* Other obstructive disease
Feasibility Study of Transcranial Ultrasound Stimulation (TUS) on Stroke Patients

Currently, the main treatment method for Intracerebral Hemorrhage (ICH) is medication or surgery. However, the effectiveness of medicines is moderate and there are several side effects. In this clinical trial, we would like to enhance the protein levels of brain derived neurotrophic factor in the brain by the transcranial ultrasound stimulation (TUS). By this technology, the symptoms of ICH could be alleviated and the side effects of medicines might be avoided. Preclinical trials have also shown that low-intensity pulsed ultrasound can alleviate the degree of neuroinflammation, neurodegeneration and significantly improve motor and cognitive deficits after brain injury. The purpose of this clinical trial is to evaluate the safety and feasibility of TUS for the treatment of patients with hypertensive intracerebral hemorrhage. The primary safety assessment indexes are brain magnetic resonance imaging (MRI) and brain magnetic resonance angiography (MRA). The secondary safety assessment indexes include weight, vital signs, electrocardiogram, general blood biochemical tests, adverse reaction events, and concurrent drug tracking. The feasibility assessment includes blood specific biomarker expression and neurological function \& quality of life scales.


Eligibility Criteria:
Inclusion Criteria:

* Age between 20 and 65 years old
* hemiplegia or hemiparesis
* has a history of hypertension
* a victim of first episode of hypertensive intracerebral hemorrhage at basal ganglion
* 3 to 12 months after the episode of hypertensive intracerebral hemorrhage
* medically stable
* the blood flow of middle cerebral artery (M1) could be detected by transcranial doppler

Exclusion Criteria:

* severe heart failure (New York Heart Association class 4)
* severe angina pectoris (canadian cardiovascular society class 4)
* chronic kidney disease stage 5
* hepatic encephalopathy stage 2 or more advanced
* uncontrolled diabetes mellitus in recent 6 months (HbA1c \> 8.5)
* combined with intraventricular hemorrhage causing hydrocephalus and underwent ventriculoperitoneal shunt placement surgery
* high-dose radiation exposure in recent 1 year
* blood flow of middle cerebral artery (M1) could be not be detected by transcranial doppler at either side
* major psychological disease in recent 6 months (for example, uncontrolled depression, schizophrenia, and bipolar disease)
* has evidence of any autoimmune disease, neurodegenerative disease (such as parkinsonism, Alzheimer's disease), or epilepsy
* has clinically significant systemic disease or severe infection (pneumonia, sepsis)
* pregnant or lactating women
* allergy to MRI contrast
* uncontrolled hypertension (systolic blood pressure higher than 160 mmHg or diastolic blood pressure higher than 100 mmHg) transcranial doppler
* aneurysm, brain tumor, or arteriovenous malformation identified by MRA
* has coagulation disorders or other coagulation problems identified by blood test (abnormal complete blood count, prothrombin time, or partial thromboplastin time)
Effects of LP28 on Immunity Enhancement in the Elderly

Due to the increasing attention on aging-related health issues, this study focuses on the elderly population as participants. The aim is to investigate whether supplementation with Lactobacillus plantarum LP28 can effectively enhance immunity, reduce the frequency and severity of common cold infections, and ultimately promote overall health in the elderly.


Eligibility Criteria:
Inclusion Criteria:

* Those who had symptoms of common cold or tonsillitis at least twice in the past year.

Exclusion Criteria:

* People who have liver, kidney, immune, or neoplastic diseases diagnosed by doctor.
* People with mental illnesses such as schizophrenia or depression.
* People who have allergic rhinitis.
* People who have a current condition of drug or alcohol dependence.
* Any person is deemed inappropriate by the researcher for the clinical trial.
Brain Protection Effect of Selective Head Cooling and Dexmedetomidine in Patients Undergoing Liver Transplantation

The investigators investigated in the present study whether selective head cooling and dexmedetomidine has an effect on cerebral oxygenation during liver transplantation and has cerebral protective effect in patients undergoing liver transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for OLT, selected from the Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, China.
* Sign the informed consent

Exclusion Criteria:

* The patients with a history of neurological or psychiatric disorders which impair cognitive processes, including previously established de-mentia, stroke, schizophrenia and depression were excluded from the study.
* Patients diagnosed with hepatic encephalopathy or had a low Mini-Mental State Examination (MMSE) score (below 24) preoperatively.
* With concurrent diseases such as renal insufficiency, diabetes mellitus were also excluded.
* Patients were excluded if severe reperfusion syn-drome (mean arterial pressure below 60mmHg sustained over 15minutes) occurred perioperatively.
The Role of B Cells in Kidney Allograft Dysfunction

The purpose of this study is to understand the role of specific B cells in activating or repressing an anti-allograft immune response after kidney transplantation. In this study, blood will be collected from kidney transplant patients during different timepoints, prior to and after their transplant. Knowledge gained from study findings will be used to develop therapeutic strategies to prevent antibody-mediated rejection, which is a major cause of long-term graft loss in kidney transplant patients.

The purpose of this study is to understand the role of specific B cells in activating or repressing an anti-allograft immune responses after kidney transplantation. This study aims to address two major challenges in kidney transplantation: 1. to guide physicians when immunosuppressive drugs are weaned, and 2. to identify patients who are at risk or in the process of developing antibody-mediated rejection. In this study, blood will be collected from kidney transplant patients during different timepoints, prior to and after their transplant. Knowledge gained from study findings will be used to develop therapeutic strategies to prevent antibody-mediated rejection, which is a major cause of long-term graft loss in kidney transplant patients.

Eligibility Criteria:
Inclusion Criteria:

* Ability to understand and willingness to sign the written informed consent form (ICF). For pediatric patients, a parent or legal guardian must sign ICF
* Either a Kidney or Liver transplant patient: 1) on the waitlist or 2) transplanted
* Healthy volunteer samples collected to use as the control group for statistical validity

Exclusion Criteria:

* Inability to make all of the required long-term post-transplant visits.
* Females who are pregnant or nursing a child
* Liver patients with hepatitis C virus
Avacostar - (PASS)

The Avacostar PASS is a non-interventional, multi-national, prospective cohort study that will collect data from 2 cohorts of patients: those treated with avacopan for active severe AAV, and a second cohort treated with a cyclophosphamide or rituximab-based induction regimen without avacopan for active severe AAV. The overall study duration is anticipated to be up to 7 years, including a recruitment period of approximately 3 years.

The Avacostar PASS is a non-interventional, multi-national, prospective cohort study that will collect data from 2 cohorts of patients: those treated with avacopan for active severe AAV, and a second cohort treated with a cyclophosphamide or rituximab-based induction regimen without avacopan for active severe AAV. The overall study duration is anticipated to be up to 7 years, including a recruitment period of approximately 3 years. Enrolled patients will be followed until the last patient last visit (LPLV) milestone, which will be 4 years after the last participant is enrolled.

Germany and the United Kingdom (UK) have been selected for the study. Additional countries may be considered according to availability of avacopan and suitability for the study. Patients will be enrolled prospectively, but up to 6 months of data may be collected retrospectively if necessary. Baseline visit is defined as the day that induction treatment (avacopan or non-avacopan standard of care (SoC) cyclophosphamide or rituximab) is started for active severe AAV. Patients who started avacopan/SoC induction therapy for active severe AAV within 6 months of the enrolment visit and fulfil eligibility criteria may be enrolled in the PASS. Individual participant follow-up data will be collected periodically at routine clinic visits until the LPLV, which will be 4 years after the last participant is enrolled.

The primary objective of the study is:

To evaluate the incidence of defined Medical Events of Special Interest (MESIs) in patients with AAV commencing avacopan.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of AAV (MPA or GPA), as determined by the Investigator according to their usual practice.
* Active, severe AAV at the time of commencing avacopan or non-avacopan SoC induction therapy, in the opinion of the Investigator.
* Age ≥18 years of either sex.
* Has provided written informed consent.
* Has commenced within the previous 6 months, or is planned to commence avacopan, cyclophosphamide or rituximab for the treatment of severe, active AAV outside of an interventional clinical study.

Exclusion Criteria:

• Concurrent participation in an interventional study, unless prospectively discussed and agreed with the Medical Monitor.
Effect of Music Therapy in Pain and Anxiety Management for Patients Treated With Stitches

The aim of this study is to measure the effect of music therapy on pain and anxiety levels during stitches procedure in an adult emergency department.

Wounds represent a frequent reason for admission to emergency department (5 to 7% of visits), inducing pain and anxiety due to the trauma itself and also to the treatment, stitches being the most frequently used procedure.

Alternative, non-pharmacologic strategies may help reduce pain and anxiety associated with painful bedside procedures. Music is one of them, easy to use and without any side effects.

Music therapy has already been shown to reduce pain and anxiety levels in children during medical procedures (blood test, vaccination, lumbar puncture) and in adults during surgical or anaesthetic procedures.

Our objective is to apply this technic to adults in emergency departments during stitches wound management.

This is a study before / after the implementation of a music therapy protocol during stiches wound management. During the music period, the participant will choose and listen to one of the five playlists (vocal jazz, instrumental jazz, piano, world music, Mozart) created by a professional music therapist, via headphones. There will be no change in stitches wound management.

Pain and anxiety levels will be measured by visual analog scale before, during and after the stitches procedure.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* Acute skin wound with need for stitches
* National health service coverage
* No opposition

Exclusion Criteria:

* Conditions interfering with consent or measures (no French-fluent, acute intoxication, neurologic or psychiatric pathology)
* Wound requiring surgical exploration
* Wound localized on or around an ear
* Major insufficiency of auditory function
Comparison of Fluid Requirements in Pancreatectomy: Laparotomy vs. Laparoscopy

In this retrospective cohort study, the investigators reviewed and analyzed the electronic medical records of consecutive patients who underwent distal pancreatectomy either via laparotomy or laparoscopy. Intraoperative fluid administration amount, postoperative complications, length of hospital stay, and readmission rate were evaluated. The total fluid amounts were calculated using the sum of colloids multiplied by 1.5 or 2.0 and crystalloids.

There has been recent progress in intraoperative fluid therapy. However, little is known about intraoperative fluid therapy in laparoscopic surgery. The purpose of this study is to determine whether there are differences in the basal fluid requirements during surgery between laparotomy and laparoscopic distal pancreatectomy. This study analyzed the records between June 2006 and March 2016. And 253 patients who underwent distal pancreatectomy via either laparotomy (73 patients) or laparoscopy (180 patients). This study was based on a retrospective review and analysis of the electronic medical records. The volume of intraoperative fluid administered, postoperative complications, length of hospital stay, and readmission rate were evaluated. The total volume of fluids was calculated as the sum of the volume of crystalloid plus the volume of colloid multiplied by 1.5 or 2.0.

Eligibility Criteria:
Inclusion Criteria:

* indication of distal pancreatectomy

Exclusion Criteria:

* transfusion
* ASA physical status over 4
* co-operate other surgery