cyrilzakka/clinical-trials huggingface dataset:
Safety and Pharmacokinetics of Probucol and Cilostazol

to investigate the safety and pharmacokinetics, in healthy adult male subjects

Safety and Pharmacokinetics of Probucol and Cilostazol when co-administered in Health Subjects

Eligibility Criteria:
Inclusion Criteria:

* Korean
* Gender: Male
* Age: Over 20 and Under 40years, at time of informed consent
* body weight: BMI over 19.0 and Under 25.0
* Subjects who meet the following criteria at the time of the screening examination
* Subjects who have given their written informed consent prior to participation in the study
* Subjects who are reliable and willing to make themselves available for the duration of the study and follow the study protocol

Exclusion Criteria:

* History or clinical evidence of significant respiratory, cardiovascular, renal, gastrointestinal, hepatic, endocrine, hematologic, neurologic, psychiatric, or other chronic disease, alcoholism, or drug abuse
* Present or previous significant drug allergy to any prescription or over the counter medication
* Blood collection exceeding 200ml within 4 weeks, 400ml within 12 weeks, or 1200ml within one year prior to scheduled study drug administration
* Body weight: under 50Kg
Caudal Combination of Dexamethasone and/or Dexmedetomidine to Bupivacaine in Pediatric Hypospadias Surgery

One of the most commonly used regional anesthetic techniques in pediatric surgeries is the caudal epidural block. Its main disadvantage remains the short duration of action. Hence, different additives have been used. Dexmedetomidine as an additive to the local anesthetic bupivacaine in caudal epidural analgesia prolongs the duration of postoperative analgesia so is dexamethasone. The investigators aimed to study the effect of combining both additives in the duration of analgesia, decreasing side effects and decreasing anesthetic doses

Sixty three children scheduled for hypospadias randomized into 3 groups. Group I (n=21) (dexamethasone 0.1mg/kg+ 0.5ml/kg bupivacaine 0.25%), group II(n=21)( dexmedetomidine 0.01ug/kg+ 0.5ml/kg bupivacaine 0.25%)and groupIII(n=21)(dexamethasone0.1mg/kg+dexmedetomidine0.01ug/kg +0.5ml/kg bupivacaine 0.25%).intraoperative and postoperative hemodynamics were recorded. In PACU, MOPS scores and sedation scores were recorded at 30min,1,2,3,6and 12hrs. Also the time of first analgesic request was recorded.

Eligibility Criteria:
Inclusion Criteria:

1 - ASA I-II 2- Males only 3- Children aged from 1-6 years 4- Children scheduled for hypospadias surgery

Exclusion Criteria:

1. Contraindication to caudal anesthesia.
2. cardiovascular diseases.
3. drug allergy.
4. Type I diabetes.
5. Clotting disorders.
6. Mentally retarded children or those whose families did not approve inclusion in the study
Cycling-Based Priming Coordination Training for Enhancing Ataxia Recovery and Brain Plasticity

Effective walking and balance require not only lower limb muscle strength but also coordinated movement. For individuals with Spinocerebellar Ataxia (SCA), rehabilitation strategies targeting coordination are essential to improving mobility and reducing the burden on caregivers. However, evidence-based rehabilitation approaches for ataxia remain limited.

Recent studies suggest that improvements in motor learning are often accompanied by changes in cortical excitability. Abnormal cortical excitability in SCA patients may hinder rehabilitation efforts, yet priming strategies-such as exercise or specific stimuli-have been shown to enhance motor learning by modulating cortical excitability. Cycling exercise, in particular, has demonstrated the potential to improve coordination and influence cortical plasticity in individuals with SCA, making it a promising priming strategy for coordination training.

This clinical trial aims to:

1. Investigate the priming effect and neural mechanisms of acute cycling exercise on coordination training in patients with SCA.
2. Explore the long-term impact of priming cycling training on cortical plasticity and functional mobility in individuals with SCA.

This study seeks to provide insights into optimized rehabilitation interventions that could enhance the quality of life and independence for people with SCA.


Eligibility Criteria:
Inclusion Criteria:

- Clinical diagnosis of SCA.

Exclusion Criteria:

* Musculoskeletal injuries on legs
* Osteoporosis.
* Any peripheral or central nervous system injury or disease patients.
Relma-cel Followed by Tislelizumab for the Treatment of Relapsed/Refractory CNS Large B-Cell Lymphoma

This study aims to evaluate the efficacy and safety of Relma-cel in the treatment of central nervous system lymphoma (CNSL), as well as its pharmacokinetic characteristics. Enrolled patients with relapsed/refractory (R/R) CNSL will receive Relma-cel infusion, followed by Tislelizumab treatment (200mg, IV, q4w, for 12 months) starting on day 35 after infusion. Bruton's tyrosine kinase (BTK) inhibitors will be used in combination as needed. The follow-up period will last for 4 years, monitoring drug safety, disease status, survival, and the pharmacokinetic characteristics of Relma-cel.


Eligibility Criteria:
Inclusion Criteria:

1. Age greater than or equal to 18 years old, male or female;
2. Relapsed or refractory CNS-involved large b-cell lymphoma after at least first-line therapy, with an efficacy assessment of CR or PR after salvage therapy, and current stable efficacy status;
3. Eastern Cooperative Oncology Group (ECOG) score of 0-2;
4. Have a life expectancy of ≥ 12 weeks
5. Use contraception
6. Have adequate bone marrow and organ function:

   1. Neutrophil count (anc) ≥1.0 x 109/L;
   2. Hemoglobin ≥ 8.0 g/dl;
   3. Platelet count ≥ 50 x 109/L;
   4. Total bilirubin ≤ 1.5 × upper limit of normal (ULN)
   5. Alanine aminotransferase/aspartate aminotransferase (ALT/AST) ≤ 2.5 x ULN or ≤ 5 x ULN (in the presence of hepatic invasion);
   6. Creatinine clearance ≥40mL/min
   7. Lipase ≤ 1.5 x ULN

Exclusion Criteria:

1. Severe active central nervous system symptoms
2. Prior chimeric antigen receptor cellular immunotherapy targeting cd19
3. Known human immunodeficiency virus (hiv) infection or positive immunoassay;
4. Live vaccination within 30 days prior to study drug administration;
5. Active autoimmune disease requiring systemic therapy in the last 12 months
6. Allergy to the study drug or history of severe allergic reactions
7. Potential risk of malignant cardiac arrhythmia
8. History of stroke or intracranial hemorrhage within 3 months prior to the date of administration of study medication
9. Other malignant tumors presently or within 3 years prior to enrollment
10. Conditions that, in the judgment of the investigator, would interfere with full participation in the study; pose a significant risk to the subject; or interfere with the interpretation of the study data
11. Pregnant or lactating patients;
A Study to Evaluate the Safety and Immunogenicity of RSVpreF Coadministered With Herpes Zoster Vaccine in Adults

This purpose of this phase 3 multicenter, parallel-group, open-label study is to learn about the safety, tolerability, and immunogenicity of RSVpreF and HZ/su vaccine when given together in adults 50 years of age and older.


Eligibility Criteria:
Inclusion Criteria

• Male and female participants 50 years of age and older who are healthy or with stable chronic medical conditions

Exclusion Criteria

* Current clinically suspected or polymerase chain reaction (PCR)-confirmed ongoing episode of HZ and/or history of clinically suspected or PCR-confirmed HZ within the past 12 months.
* Prior history of any subtype of Guillain Barré syndrome of any etiology.
* Serious chronic disorder, including metastatic malignancy, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the participant from participating in the study.
* Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination, and medication list
* Previous vaccination with any licensed or investigational RSV vaccine at any time prior to enrollment, or planned receipt of a nonstudy RSV vaccine during study participation.
* Previous vaccination with any licensed recombinant adjuvant zoster vaccine (Shingrix) at any time prior to enrollment, or planned receipt of a nonstudy licensed VZV vaccine (Shingrix) during study participation.
* History of previous vaccination with live HZ vaccine (Zostavax) in the last 2 years from enrollment, or planned receipt through study participation.
* Previous vaccination with any investigational VZV vaccine at any time prior to enrollment, or planned receipt of a nonstudy investigational VZV vaccine during study participation.
* Individuals who receive chronic systemic treatment with immunosuppressive therapy, including cytotoxic agents, immunosuppressive monoclonal antibodies, systemic corticosteroids (defined as ≥20 mg/day of prednisone or equivalent for ≥14 days), eg, for cancer or an autoimmune disease, or radiotherapy, from 60 days before study intervention administration, or planned receipt throughout the study.
Tipifarnib and Osimertinib in EGFR-mutated Non-Small Cell Lung Cancer

This is a Phase 1a/b, multicenter, open-label, dose escalation (1a) and dose expansion (1b) study. The purpose of this study is to measure safety, tolerability, and preliminary efficacy with the combination of tipifarnib with osimertinib in patients with advanced/metastatic EGFR-mutated non-small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years at the time of signing informed consent.
* Histologically or cytologically confirmed stage IIIB (locally-advanced) or IV (metastatic) adenocarcinoma of the lung.
* The tumor harbors an Ex19del or Ex21-L858R substitution (based on tumor tissue or plasma \[ctDNA\] assessment).
* Treatment-naïve for locally advanced/metastatic EGFR-mutated NSCLC and osimertinib treatment-naïve for NSCLC.
* ECOG performance score of 0 or 1 with no clinically significant deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks.
* Measurable disease by RECIST v1.1 that meets the criteria for selection as a target lesion according to RECIST v1.1.
* Adequate organ function, as evidenced by the laboratory results.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Treatment with any of the following:

  1. Major surgery
  2. Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug
  3. Medications or herbal supplements known to be potent inhibitors or inducers of cytochrome P450 (CYP) 3A4 or uridine 5'-diphospho (UDP)-glucuronosyltransferase (UGT), or inhibitors of breast cancer resistance protein (BCRP).
  4. Investigational therapy within 2 weeks of Cycle 1 Day 1
  5. Concurrent and/or other active malignancy that has required systemic treatment within 2 years of first dose of study drug (excluding non-melanoma skin cancer, adjuvant hormonal therapy for breast cancer and hormonal treatment for castration-sensitive prostate cancer)
* Spinal cord compression or symptomatic and unstable brain metastases requiring steroids over the last 4 weeks prior.
* Evidence of severe or uncontrolled systemic diseases.
* Refractory nausea and vomiting, chronic gastrointestinal (GI) diseases, inability to swallow the formulated product, or previous significant bowel resection.
* Clinically significant cardiovascular symptoms or disease.
* Received treatment for unstable angina within prior year, myocardial infarction within the prior 6 months, cerebro-vascular attack within the prior year, history of New York Heart Association grade III or greater congestive heart failure, or current serious cardiac arrhythmia requiring medication except atrial fibrillation.
* Past medical history of Interstitial Lung Disease (ILD), drug induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.
* Other protocol-defined exclusion criteria may apply.
Immunogenicity and Safety Study of LBVH0101 in Healthy Infants at Two, Four and Six Months of Age

The purpose of this study is to evaluate and compare the immunogenicity and safety of LBVH0101 (Haemophilus influenzae type b tetanus toxoid conjugate vaccine) to that of Hiberix™ at vaccination in healthy infants at their 2, 4, and 6 months of age.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female infants aged from 49 days to 84 days at the time of enrollment.
* The gestation period was 37 weeks or longer, and birth weight was 2.5 kg or more.
* The infants and their parents/legally acceptable representative could comply with all of the scheduled visits in the study and the study requirements related to protocol compliance.
* The parents/legally acceptable representative (LAR) signed the written consent form.

Exclusion Criteria:

* Had previously received Haemophilus influenzae type b vaccine prior to this clinical study.
* Had a plan for vaccination with the vaccine other than those permitted in the protocol based on the standard vaccination schedule.
* Had been contacted with a patient with confirmed Hib infection within 30 days before the study start.
* Had had fever of ≥ 37.5°C within the last 3 days (If measured by tympanic thermometer, fever of 38°C or higher)
* Had or were suspected for immune function disorders; had previously received or were suspected to receive the immunosuppressive therapy; or had received the immunosuppressive therapy within 30 days prior to participating in the study (including systemic corticosteroids or inhalation corticosteroids) (However, it was not the exclusion criteria to have received corticosteroid therapy (prednisolone equivalent ≤ 0.5 mg/kg/day) not more than for 14 consecutive days at least 30 days before their participation in the study).
* Had received the treatment of parenteral immunoglobulin or blood products after birth.
* Had allergic history to be considered due to any component of the vaccine including excipients or preservatives.
* Three preceding generations in an ancestral line were not of Korean heritage.
* Had or were suspected to have significant disorders of blood, heart, liver, kidney, nervous system, respiratory system, or digestive system, or the investigator decided that the evaluation of study objective might be interrupted.
* Had been treated with other investigational drug by participating in another clinical trial within 30 days prior to this study entry, or were participating in another clinical study at that time.
* Had plans to move away from the area of the study site before completing the study.
* Inappropriate to take part in this clinical study in the principal investigator or sub-investigator's opinion, for the reasons other than above criteria.
Bioequivalence Study of Etoricoxib in Healthy Adult Subjects Under Fasting Condition

To evaluate and compare the relative plasma bioavailability and therefore the bioequivalence of two different immediate release products each containing Etoricoxib 90 mg, after administering a single oral dose, to healthy adult subjects under fasting conditions.

Enrolled subjects were randomized in a two-phase, two-sequence, cross-over design to receive a single dose of the test product (T) or the reference product (R) at each phase, under fasting conditions, with a wash-out period of 14 days.

Etoricoxib plasma concentration was determined using a validated LC-MS-MS method, followed by Pharmacokinetics, and statistical analysis using Phoenix WinNonlin® software to determine the average bioequivalence.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent is obtained for the study.
* Age 18 - 55 years,
* Body mass index between 18.5 and 30 kg/m2
* Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination.
* Vital signs without significant deviations.
* All laboratory screening results are within the normal range or clinically non-significant

Exclusion Criteria:

* History or presence of any disorder or condition that would render the subject unsuitable for the study, place the subject at undue risk, or interfere with the ability of the subject to complete the study in the investigator's opinion.
* History of significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, allergic, dermatologic, hematologic, neurologic, psychiatric disease, or cancer.
* Any confirmed significant allergic reactions against any drug or multiple allergies.
* Clinically significant illness 28 days before study phase I.
* Alcohol or any solvent intake.
* Regular use of medication.
* Positive urine screening of drugs of abuse.
* Use of any systemic medications (prescription medications, OTC products, supplements, or herbal preparations) for 14 days prior to dosing and during the study.
* History or presence of significant smoking (more than one pack per day of cigarettes) or refusal to abstain from smoking for 48 hours before dosing until checkout.
* Blood donation within the past 60 days.
* Participation in another bioequivalence study within 60 days prior to the start of phase I of the study.
Predictability of Preoperative Hemoglobin A1c in Diabetic Patients Underwent Off-Pump Coronary Artery Bypass Surgery: A Retrospective Study.

The aim of this study is to evaluate evaluated the impact of preoperative HbA1c in diabetic patients on perioperative glycemic variability and outcome after off-pump coronary artery bypass (OPCAB).

The medical records of patients who had a preoperative diagnosis of diabetes and underwent OPCAB from 2005 to 2017 will be reviewed. Patients are divided by HbA1c levels (\<7.0% or ≥7.0%). Glycemic variability during surgery and up to 24 hours after surgery is assessed by the coefficient of variation. The primary outcome is defined as a composite of postoperative permanent stroke, prolonged ventilation, deep sternal wound infection, renal failure, reoperation, mortality according to the definition of STS (Society of Thoracic Surgery) version 2.81 adult cardiac surgery database. If one or more of the above five morbidity or mortality occur, it is assumed that composite morbidity/mortality had occurred. We compare postoperative complications, mortality and perioperative glycemic variability between patients with HbA1c ≥7.0% and \<7.0%, and examined the effects of perioperative glycemic control on postoperative morbidity and mortality (composite morbidity/mortality).


Eligibility Criteria:
Inclusion Criteria:

* Patients with a history of preoperative diabetes mellitus and with available results of HbA1c test within 3 months before surgery.
* Patients who aged 20 to 89 years

Exclusion Criteria:

* Patient who had a history of previous coronary artery bypass surgery
* Patients whose surgery plan changed to cardiopulmonary bypass during surgery.
Efficacy of Celsi Warmer for the Management of Hypothermic Newborns

The purpose of the study is to evaluate the efficacy of a novel low-cost warming device to provide thermal care for newborn babies with hypothermia in low-resource hospitals. During the study, research participants will receive thermal care via the Celsi Warmer. Aside from thermal treatment, research participants will receive the standard of care from the neonatal unit, and will also be closely monitored by study personnel throughout the study. The results from this study will allow us to determine if the Celsi Warmer is an effective tool for warming and monitoring newborns in wards of low-resource hospitals. The research team hopes to demonstrate that the Celsi Warmer is effective for the appropriate treatment of newborn hypothermia in hospitals in low-resource settings.


Eligibility Criteria:
Inclusion Criteria:

* Is currently being treated at study location
* Is an inborn admission to the neonatal ward
* Whose parents or guardians provided a written informed consent
* Whose parents or guardians providing informed consent are 18 years old or older
* Has a current weight of greater than or equal to 1.0 kg and less than or equal to 4.0kg
* Has been identified as in need of thermal care defined as having a moderate hypothermic temperature (32.0-36.0°C) as the last temperature recorded in hospital chart, or during recruitment procedures; and
* Is unable to be enrolled in KMC for reasons including, but not limited to:

  1. Mother/guardian unable or unavailable to provide KMC
  2. Under observation in NICU before transfer to KMC
  3. No space in KMC
  4. Clinician's discretion
* May be receiving other medical treatments, including but not limited to, CPAP, oxygen therapy, IV fluids, management and monitoring of common newborn conditions such as hypoglycemia, and/or hyperbilirubinemia via LED phototherapy

Exclusion Criteria:

* Requires mechanical ventilation
* deemed in need of intensive care by the hospital staff who is providing care,including but not limited to:

  1. Neonates with severe anemia and/or any suspected hematological disorders, and/or
  2. Neonates with obvious congenital anomalies, and/or
  3. neonates suspected with hypo/hyperthyroidism or any hormonal disorders
* Has been diagnosed with birth asphyxia
* Presents a condition that precludes the use of the temperature sensor and/or abdominal belt including but not limited to, gastroschisis, known umbilical cord infection, known skin infection
* Whose clinician presents concerns about their participation
* Is receiving treatment that participation in the study would interfere with, i.e.transferring to KMC
Effectiveness of Pharmaceutical Care in the Adherence of Systemic Lupus Erythematosus Treatment

This project aims to improve adherence rate through pharmaceutical care in patients with systemic lupus erythematosus (SLE) to help achieving therapeutic goals and finally to improve the quality of life of these patients.

Adherence to treatment is a primary determinant for the effectiveness of health care. Non-compliance may lead to therapeutic failure, make more difficult and complex the management of chronic diseases or cause death. The effectiveness of interventions on adherence has an important impact in the health of the population. Systemic lupus erythematosus (SLE) is an autoimmune disease with high proportion of hospital admissions and deaths and high cost of treatment. The prevalence of adherence in this group of patients in Brazil is very low (31.7%) and the drug treatment is complex. Our aim is to assess the effectiveness of Pharmaceutical Care in the adherence of drug treatment by SLE patients attended in a Rheumatology outpatient clinic in Rio de Janeiro, Brazil.

Randomized clinical trial (pragmatic trial), in which 120 adult patients with confirmed SLE diagnosis will be followed for 12 months, and randomized in two groups: the intervention group (attended by a pharmacist according to the Dader Method for Pharmaceutical Care), and the control group (attended by a non-pharmacist professional with counseling on hygiene/nutrition and reduction of risks in lupus therapy). The main outcome will be adherence to drug therapy and secondary outcomes the improvement of the medical condition and the quality of life of the patients.

Eligibility Criteria:
Inclusion criteria:

* SLE diagnosis according to the 2012 SLICC (Systemic Lupus International Collaborating Clinics Group) SLE classification criteria.
* Treatment with corticosteroids and antimalarials.
* History of biopsy-proven lupus nephritis classes III, IV, or V (2003 International Society of Nephrology / Renal Pathology Society) or nephritic/nephrotic lupus flare not undergone to kidney biopsy.

Exclusion Criteria:

* Current renal replacement therapy.
* Renal transplantation.
* Ongoing pulse therapy with cyclophosphamide and/or methylprednisolone.
* Aid by caregiver.
* Any psychiatric illness.
* Inability to understand the questions of the questionnaire.
* Patients'unwillingness to sign the informed consent.