cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures

This study is to evaluate the efficacy of YKP3089 in reducing seizure frequency when compared to baseline in subjects with partial onset seizures not fully controlled despite their treatment with 1 to 3 concomitant anti-epileptic drugs.

Also to evaluate the safety and tolerability of YKP3089.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of treatment resistant partial epilepsy;
* History of epilepsy for at least 2 years;
* Have at least 3 simple partial with motor component, complex partial or secondarily generalized seizures per month with no consecutive 21 day seizure free period.
* Currently treated on a stable dose of :

  * 1 - 3 AED's for at least 12 weeks prior to randomization.
  * VNS will not be counted as AED; however the parameters must remain stable for at least 4 weeks prior to baseline.
  * Benzodiazepines taken at least once per week for epilepsy, or for anxiety or sleep disorder, will be counted as 1 AED. Therefore only a maximum of two additional approved AEDs will be allowed.

Exclusion Criteria:

1. A history of alcoholism, drug abuse, or drug addiction within the past 2 years.
2. Subject has had status epilepticus within past 1 year.
3. Subject has had greater than 2 allergic reactions to an AED or one serious hypersensitivity reaction to an AED.
4. Subjects taking felbamate with less than 18 months continuous exposure.
5. Subjects receiving phenytoin, phenobarbitone or metabolites of these drugs.
6. No active suicidal plan/intent or active suicidal thoughts in the past 6 months.
7. History of suicide attempt in the last 2 years; not more than 1 lifetime suicide attempt.
8. Subject meets criteria for current major depressive episode (within 6 months).
9. Use of intermittent rescue benzodiazepines more than once/month (1-2 doses in a 24-hour period is considered one rescue) in the one month period prior to Visit 1.
Observational Comparison of Tooth-borne, Bone-borne and Hybrid Distraction Following SARPE.

The investigators will perform a prospective, non-randomized observational study. The aim of this study is to evaluate stability of tooth-borne, bone-borne and hybrid expansion following SARPE by using data collected according to the existing SARPE follow-up protocol. The insights of this study might elucidate the preferred expansion technique and improve surgical technique.

Maxillary transverse discrepancy (MTD) is a difficult deformity to correct. In skeletal immature patients, an orthopedic-orthodontic expansion is the preferred treatment strategy. In case of a skeletal mature patient, a surgical treatment should be considered. A Surgically assisted Rapid Palatal Expansion (SARPE) procedure is a common surgical treatment for MTD in skeletal mature patients. In this procedure the skeletally mature, maxillary sutures are surgically reopened. One week postoperatively, the patient will activate the expander appliance. There are three widely-used expander appliances: tooth-borne, bone-borne and hybrid expanders. The use of the expander appliance is based on surgeon and referring orthodontist's common practice and preference. A tooth-borne expander is an appliance which is supported by the teeth and bridges the palate. A bone-borne expander is surgically placed at the level of the palate during SARPE surgery. Hybrid expansion is a combination of tooth-borne and bone-borne expansion. These appliances progressively widen the maxilla by daily activation of the distractor. The activation is stopped when the surgeon and/or referring orthodontist judge that the maxilla is sufficiently expanded. However, historical research with the use of cast model's and 2D posteroanterior cephalograms suggest that this expansion is not stable. With the emergence of 3D Cone-Beam Computed Tomography (CBCT) and its appliance as standard of care for pre-operative diagnosis and postoperative follow-up, stability and complications can be assessed more accurately. The goal of this study is to prospectively evaluate stability following SARPE, by analyzing the clinical and radiological data collected according to the existing clinical SARPE follow-up protocol. The secondary outcome is to evaluate complications following the three distractors.

Eligibility Criteria:
Inclusion Criteria:

* Maxillary transverse discrepancy
* Skeletal mature patients
* SARPE treatment is indicated

Exclusion Criteria:

* Patients with a syndrome with an influence on head-and-neck morphology (such as Apert, Crouzon syndrome)
* Cleft patients
Selenium to Improve Neurological Outcome After Cardiac Arrest

After cardiac arrest and successful resuscitation it can happen that the brain function of a patient is impaired because the brain was without oxygen for a prolonged period of time. Several strategies have been studied to improve brain function after cardiac arrest. Cooling of the patients is routinely used today. The trace element selenium has several biological functions and is important for defense mechanisms against oxidative stress, which occurs after cardiac arrest and successful resuscitation. critically ill patients have low selenium blood levels. Therefore the investigators hypothesize that giving selenium after cardiac arrest and successful resuscitation might improve brain function.

When cardiopulmonary resuscitation results in the return of spontaneous circulation, intensive care is required to optimize neurological recovery. The pathophysiological reactions that follow hypoxic brain injury are complex, and the mechanisms by which ischemia causes neuronal death leading to postanoxic encephalopathy are only partly understood to date. Therapeutic hypothermia improves brain function after cardiopulmonary resuscitation. Injury however can be ongoing even after the return of spontaneous circulation, giving the clinician an additional window of opportunity to treat and protect the injured brain \[5\]. Therefore there is an unmet clinical need for further therapeutic strategies. Strategies to counteract the deleterious effects of oxygen-derived free radicals after cerebral reperfusion have been studied for long.

The trace element selenium is part of the enzyme glutathione peroxidase which belongs to the endogenous defence mechanisms against oxidative stress. Clinical data suggest that supplementation of selenium may be beneficial in critically ill patients and in neurodegenerative diseases including, among others, Parkinson's disease, stroke, and epilepsy, where oxidative stress plays an important pathophysiological role. In SIRS, sepsis and septic shock doses up to 4000µg per day have been proven to be safe A recent retrospective analysis supported the hypothesis that early administration of selenium may improve neurological outcome after cardiac arrest.

Therefore the purpose of this study is to explore the influence of early administration of selenium on neurological outcome after cardiopulmonary resuscitation by a randomized, placebo-controlled, single-center study.

Eligibility Criteria:
Inclusion Criteria:

* Cardiac arrest
* Successful Resuscitation
* Age \>18

Exclusion Criteria:

* Polytrauma
* Pregnancy
* Any condition that makes it likely that the patient will not survive 24 hours
Colistin Plus Rifampicin in MDR P. Aeruginosa and A. Baumanii

In Siriraj Hospital, Colistin alone for treatment of MDR. A.baumanii or P.aeruginosa contributed to mortality 45%. In vitro studies revealed synergism of Rifampicin and Colistin.

In this study, patients with documented MDR. P.aeruginosa or A.baumanii will be allocated to receive Colistin alone and another group will receive Colistin plus Rifampicin.


Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years
* Hospitalized to Siriraj Hospital
* Infection with MDR A.baumanii or P.aeruginosa
* Nescessary for treatment with Colistin
* Patient agrees to participate by giving written informed consent.

Exclusion Criteria:

* pregnancy or lactating mother
* Colistin or Rifampicin allergy
* Active hepatic disease or abnormal liver function test
* patient who suspected infection with mycobacterium tuberculosis
* patient who can not drug by enteral feeding
A Comparison of Paediatric Weight Estimation Methods for Emergency Resuscitation

The purpose of this study is to study the validity, reliability and practicality of the different weight estimation methods (parent estimation method, Mercy method, Broselow tape, original and update APLS) in Thai children.

A reliable paediatric weight estimation method is crucial for the physician attempting to resuscitate an injured child. When a patient is in a critical, life threatening condition or in mass casualty settings, actual body weight cannot be obtained by weight measurement instrument. Several resuscitation modalities, such as resuscitation medications, fluid replacement, and amount of electrical shock in defibrillation, are calculated according to patient body weight

Besides from weight derived from children's parent which cannot achieve in some situations and vary in accuracy, Broselow tape is the gold standard currently for appraise children's weight from their length. However, this tape tends to underestimate weight and it is limited to use in children are less than 146 centimeters in length. Age- based weight estimation methods are the mathematical formulas to estimate weight from the children's age. The various methods described in the Advanced Paediatric Life support (APLS) both original and updated still have doubts about the accuracy and reliability. Both length- based and aged- based methods fail to resolve the overweight or obese and underweight children who have the same height or the same age. Mercy method is the new weight estimation method that incorporates the humeral length and mid-upper arm circumference to estimate the child weight. This method has been demonstrated both accuracy and reliability over other existing methods. This study will evaluate the validity, reliability and practicality of the previously mentioned pediatric weight estimation methods.

Eligibility Criteria:
Inclusion Criteria:

* Healthy children
* Informed consent and assent (7-12 years) were obtained

Exclusion Criteria:

* Disabling children
* Incapable to stand up or lie down to measure weight or length
* Chronic steroid use
* Edema from known diseases
* Extremities joint contracture
Ultrasound Guided Suprascapular Nerve Block Versus ISB Block in Arthroscopic Shoulder Surgery

Diaphragmatic dysfunction can be detected as a decrease in forced vital capacity (FVC) and forced expiratory volume at 1 s (FEV1) on spirometry or as lower diaphragmatic excursion (DE) on US, the latter having become the gold standard in thoracic assessment.

Severe intraoperative and postoperative pain associated with arthroscopic shoulder surgery has high incidence reaching up to 45%; it is often significant enough to interfere with initial recovery and rehabilitation.

Shoulder arthroscopy is becoming more common, representing the second most common Orthopedic surgery after knee arthroscopy . Interscalene brachial plexus block (ISB) is the gold standard analgesic technique for shoulder surgeries with success rates of 87% to 100%, but it also blocks the phrenic nerve (C3-C5).

Suprascapular nerve block via the anterior approach (SSB-A) is performed distally at the trunk/division level of the brachial plexus, thereby potentially sparing the phrenic nerve and minimising many adverse effects of ISB

Eligibility Criteria:
Inclusion Criteria:

* aged (18-65 years)
* American Society of Anesthesiologists (ASA) physical status I or II
* scheduled for elective arthroscopic shoulder surgery

Exclusion Criteria:

* pre-existing respiratory,
* cardiac, renal, neurological, or hepatic disease, neuropathy affecting brachial plexus
* contraindication to peripheral nerve block (e.g., coagulopathy),
Analysis of Cell-free DNA (cfDNA) During Periodontitis

The purpose of this study was to examine the association between circulating cfDNA concentration and CVD risk in patients with periodontitis, CVD, and periodontitis plus CVD. In addition, the secondary objective was to identify, among other confounders, the impact of periodontitis and cardiovascular disease as potential significant predictors of circulating cfDNA levels in the enrolled population.

Recent emerging evidence has shown that circulating cell-free (cf) DNA are involved in in several epigenetic processes linked with periodontitis, coronary stenosis and systemic inflammation. The present study was aimed at assessing the impact of periodontitis on circulating cfDNA levels and evaluating possible confounders that influenced this association. Healthy controls (n=30) and subjects with CVD (n=31), periodontitis (n=31) and periodontitis+CVD (n=30) were enrolled. All subjects underwent regular periodontal examination and blood sampling. The analysis of the plasma cfDNA concentrations was performed using a dsDNA Assay Kit.

Eligibility Criteria:
Inclusion Criteria:

* Presence of at least 15 teeth
* CP with a minimum of 40% of sites with a clinical attachment level (CAL)

  ≥2mm and probing depth (PD) ≥4mm;
* Presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs
* Presence of ≥40% sites with bleeding on probing (BOP)

Exclusion Criteria:

* Intake of contraceptives
* Intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study
* Status of pregnancy or lactation
* Previous history of excessive drinking
* Allergy to local anaesthetic
* Intake of drugs that may potentially determine gingival hyperplasia such as Hydantoin, Nifedipine, Cyclosporin A or similar drugs.
A Clinical Pharmacology Trial of Brexpiprazole Once-weekly (QW) Formulation Administered as Single and Multiple Oral Doses

To evaluate the pharmacokinetics (PK), tolerability, and safety of brexpiprazole QW formulation administered as single and multiple doses in patients with schizophrenia.

A multi-center, open-label clinical pharmacology trial to investigate the PK, tolerability, and safety of brexpiprazole QW formulation administered as single and multiple doses.

The trial comprises the single-dose period (Cohort 1) and the multiple-dose period (Cohort 2). The dose used in the multiple-dose period (Cohort 2) will be determined based on plasma drug concentrations obtained in the single-dose period (Cohort 1).

Eligibility Criteria:
Inclusion Criteria:

1. Patients with a diagnosis of schizophrenia based on the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5)
2. Patients capable of staying at the trial site from the day before investigational medicinal product (IMP) administration to the 8th day following IMP administration in both Period 1 and Period 2
3. Patients with a body mass index \[BMI = body weight (kg)/height (m)2\] of 18.5 or higher and lower than 35.0 at screening
4. Persons who provide written informed consent before commencement of any trial-related procedures and whom the investigator or subinvestigator judges to be capable of following all the conditions of this trial
5. Patients who, in the judgement of the investigator or subinvestigator, have stable psychotic symptoms maintained by administration of an antipsychotic (other than clozapine) within the dosing range indicated separately, before commencement of investigational medicinal product (IMP) administration"

Exclusion Criteria:

1. Patients with a diagnosis of a concurrent mental disorder besides schizophrenia (schizoaffective disorder, major depressive disorder, bipolar I disorder, bipolar II disorder, general anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder, dementia or mild neurocognitive disorder, personality disorder, etc) based on the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) (However, this exclusion does not apply to caffeine- or tobacco-related disorders)
2. Patients who fail to meet the specified requisite washout periods for the prohibited concomitant drugs and foods before commencement of IMP administration, or patients who are anticipated to take any of these drugs or foods during the study period
3. Patients who have previously undergone gastrointestinal surgery that could affect pharmacokinetic evaluations
4. Patients who are using clozapine at the time of informed consent
5. Patients who have received electro-convulsive therapy within 60 days before commencement of IMP administration
6. Patients with clinically problematic disorders of the nervous system, liver, kidneys, metabolic system, blood, immune system, cardiovascular system, lungs, or digestive system (However, such patients may be included if the condition is mild or well-controlled and is considered to not affect safety or pharmacokinetic evaluations.)
Combining Mechanisms for Better Outcomes (COMBO)

To evaluate the effectiveness of Spinal Cord Stimulation (SCS) with multiple modalities as compared to conventional SCS in patients with chronic pain when using the Boston Scientific Spectra WaveWriter SCS System.

To evaluate the effectiveness of Spinal Cord Stimulation (SCS) with multiple modalities as compared to conventional SCS in patients with chronic pain when using the Boston Scientific Spectra WaveWriter SCS System.

Eligibility Criteria:
Key Inclusion Criteria:

* Chronic pain of the trunk and/or limbs for at least 6 months with back pain greater or equal to leg pain.
* 22 years of age or older at time of enrollment
* Able to independently read and complete all questionnaires and assessments provided in English
* Signed a valid, IRB-approved informed consent form (ICF) provided in English

Key Exclusion Criteria:

* Any pain-related diagnosis or medical/psychological condition that, in the clinician's best judgment, might confound reporting of study outcomes
* Significant cognitive impairment that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to participate in the study
* Breast-feeding or planning to get pregnant during the course of the study or not using adequate contraception
* Participating, or intends to participate, in another clinical trial that may influence the data that will be collected for this study
Neuromonitoring During Rapid Ventricular Pacing in Patients Undergoing Cerebral Aneurysm Surgery

To evaluate the effect of rapid ventricular pacing on the oxygenation of the brain in patients scheduled for cerebral aneurysm clipping surgery or arteriovenous malformation surgery.

Patients scheduled for cerebral aneurysm clipping surgery or arteriovenous malformation surgery(ASA 1to 3 over 18years) receive standard care general anesthesia including central venous line for rapid ventricular pacing technique. A contralateral Foresight sensor is placed on the forehead of the patient at induction. After the craniotomy two micro electrodes(PBtO2 and cerebral blood flow) are placed in the brain and fixated. A subdural strip electrode is placed on the surface of the brain to record the electrical activity. Effect of mild hyperventilation and oxygenation with 100% O2 is evaluated.

Eligibility Criteria:
Inclusion Criteria:

* scheduled for cerebral aneurysm surgery or arterial venous malformation
* American Society of Anesthesiologists classification 1, 2, or 3

Exclusion Criteria:

* non
Omega-3 Polyunsaturated Fatty Acids in Non-surgical Treatment of Periodontitis

Periodontitis is a chronic multifactorial inflammatory disease that lead to the loss of supportive tissues around the teeth with gradual deterioration of masticatory function and esthetics, resulting eventually in the decrease of the quality of life. Host immune response triggered by bacterial biofilm is responsible for the chronic periodontal inflammation and ongoing tissue loss. Polyunsaturated fatty acids (PUFAs) omega-3 eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) have anti-inflammatory properties, thus may be used for the treatment of chronic inflammatory diseases. This study is aimed to evaluate the effect of dietary supplementation with PUFAs omega-3 in the patients with periodontitis stage III and IV.

Periodontitis is highly prevalent oral disease in humans affecting nearly 50% of the population worldwide. Periodontitis is multifactorial disease individually accelerated or decelerated by different factors. One of them, a bacterial biofilm, leads to dysbiosis and raise of Gram-negative bacteria.This results in the activations of immune response and clinical signs of periodontal tissue inflammation. Host modulation therapy seems to be an adequate concept for the treatment of periodontal diseases. The main assumption of this therapy is to reduce by-stander tissue destruction, to ensure rapid resolution of inflammation or even to promote regeneration of the periodontal tissues by modifying or down-regulating the destructive aspects of the host response and by up-regulating the protective or regenerative responses The goal of the present study was to assess the effect of high-dose omega-3 PUFAs EPA and DHA on the clinical outcome of non-surgical treatment of the patients with generalized periodontitis stage III and IV. It was presumed that dietary supplementation with high-dose EPA and DHA would have the potential to induce a measurable clinical outcome as a result of reduction of inflammation and minimizing tissue damage mediated by anti-inflammatory effect of omega-3 PUFAs. To address this issue, a randomized clinical trial was designed in which EPA and DHA were supplemented in adjunction to the standard periodontal therapy, scaling and root planning (SRP). Clinical outcomes of active versus control therapies were measured in addition to the quantifications of saliva cytokines, chemokines, subgingival biofilm composition and serum levels of lipids.

Eligibility Criteria:
Inclusion Criteria:

* at least 18 scorable teeth (not including third molars),
* ≥4 teeth with PD ≥6 mm, CAL ≥5 mm,
* radiographic evidence of bone loss more than one-third of the root length,
* no periodontal treatment performed within last 6 months.

Exclusion Criteria:

* smoking,
* diabetes,
* any diseases or disorders that compromise wound healing,
* chronic inflammatory disease, history of radio- or chemotherapy,
* nonsteroidal anti-inflammatory drug (NSAIDs) intake \> 3 days,
* use of antibiotics or corticosteroids 3 months prior to the study.
Efficacy and Safety of QL1706 Plus Lenvatinib As 2nd Line Theapy in Patients with Metastatic Esophageal Carcinoma After Disease Progression on ICIs Therapy

The purpose of this study is to assess the efficacy and safety of QL1706 plus lenvatinib in second-line therapy for patients with metastatic esophageal squamous cell carcinoma after progression on immune checkpoint inhibitor therapy


Eligibility Criteria:
Inclusion Criteria:

1. Subjects participate voluntarily and sign informed consent.
2. 18-75 years, male or female.
3. Histologically or cytologically verified diagnosis of unresectable locally advanced or metastatic esophageal squamous cell carcinoma
4. Patients who have disease progression verified by imaging on standard first-line immunotherapy with anti-PD-1/PD-L1 antibodies
5. At least 1 measurable target lesion according to Response Evaluation in Solid Tumors (RECIST 1.1).
6. ECOG PS 0-1

Exclusion Criteria:

1. Presence of any active autoimmune disease or history of autoimmune disease (such as: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, nephritis, hyperthyroidism)
2. Those who are taking immunosuppressants or systemic hormonal therapy for immunosuppressive purposes (dose\> 10 mg/day prednisone or other equivalent cortiremonial hormones) and are taking within 2 weeks before recruitment
3. Severe allergic reaction to other monoclonal antibodies
4. Those who terminated treatment due to related toxicity during anti-PD-1/PD-L1 antibody treatment
5. Prior treatment with bispecific anti-PD-1/CTLA-4 checkpoint blockades or VEGFR inhibitors