cyrilzakka/clinical-trials huggingface dataset:
A Clinical Trial to Evaluate the Pharmacokinetics and Tolerability of CKD-348

A Clinical Trial to evaluate the Pharmacokinetics and Tolerability of CKD-348

A Phase 1 Clinical Trial to evaluate the tolerability and pharmacokinetics in healthy adult volunteers after administration of CKD-348 and co-administration of CKD-828, D097, D337.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult volunteers aged ≥ 19 years
2. Weight ≥50kg (man) or 45kg (woman), with calculated body mass index (BMI) of 18 to 30 kg/m2
3. Those who meet the blood pressure criteria during screening tests:

   A. Systolic Blood Pressure: 90 to 139 mmHg B. Diastolic Blood Pressure: 60 to 89 mmHg
4. Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings.
5. Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serology, urology) and 12-lead ECG results at screening.
6. Those who agree to contraception during the participation of clinical trial
7. Individuals who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial.

Exclusion Criteria:

1. Those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs.
2. Those who take barbiturate and any related drugs which may cause induction or inhibition of drug metabolism within 1 month before the first administration of investigational products.
3. Those who donated whole blood or apheresis within 2 months or 1 month respectfully, or received blood transfusion within a month.
4. Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.
5. Those who exceed an alcohol and cigarette consumption than below criteria A. Alcohol: Man- 21 glasses/week, Woman - 14 glasses/week (1 glass: Soju 50mL, Wine 30mL, or beer 250mL) B. Smoking: 20 cigarettes/day
6. Those who have any history of diabetic mellitus, nephropathy, biliary obstruction, shock, angioedema, cardiac insufficiency, dihydropyridine sensitivity, unstable angina, hypothyroidism.
7. Those who have genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption.
8. Those who are deemed insufficient to participate in this clinical study by investigators.
9. Woman who are pregnant or breastfeeding.
A Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Chronic Migraine Prevention

To evaluate the effect of erenumab compared to placebo on the change from baseline in the number of monthly migraine days in adults with chronic migraine.

This study consisted of the following phases: screening, 4-week baseline phase, 12-week double-blind treatment, and 12-week follow-up. Participants may have elected to participate in the optional pharmacokinetic substudy and the optional, novel patient-reported outcome (PRO) assessment substudy.

Participants who completed the 12-week double-blind treatment phase of Study 20120295 were eligible to enroll in an open-label extension study (Study 20130255; NCT02174861).

Eligibility Criteria:
Inclusion Criteria:

* History of at least 5 attacks of migraine without aura and/or migraine with visual sensory, speech and/or language, retinal or brainstem aura.
* History of ≥ 15 headache days per month of which ≥ 8 headache days were assessed by the subject as migraine day.
* ≥ 4 distinct headache episodes, each lasting ≥ 4 hours OR if shorter, associated with use of a triptan or ergot-derivative on the same calendar day based on the eDiary calculations.
* Demonstrated at least 80% compliance with the eDiary.

Exclusion Criteria:

* History of cluster headache or hemiplegic migraine headache
* Unable to differentiate migraine from other headaches
* Failed \> 3 medication categories due to lack of efficacy for prophylactic treatment of migraine .
* Received botulinum toxinin head or neck region within 4 months prior to screening.
* Used a prohibited migraine prophylactic medication, device or procedure within 2 months prior to the start of the baseline phase
TAO-Towards Optimal (Neo)Adjuvant Systemic Therapy of Stage III Triple-negative Breast Cancer

This prospective, national, multi-centre study will include patients with stage III triple-negative breast cancer (TNBC) who are planned to start with standard (neo)adjuvant systemic treatment. The study will gather clinico-pathological, treatment and follow-up information of participating patients through Dutch databases. Participating patients will be asked to complete cancer specific and more generic quality of life questionnaires at seven time points during and after their anticancer treatment in a mobile application.

For all patients who have consented to additional blood collection, to assess the course of dynamic ctDNA during (neo)adjuvant chemotherapy and its relation with outcome, two tubes will be collected at four different time points.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older
* Histologically confirmed adenocarcinoma of the breast
* Assumed clinical or pathological stage III (TNM) breast cancer
* Breast tumor must be:

  * HER2-negative: i.e. either score 0 or 1 at immunohistochemistry or score 2 at immunohistochemistry and negative at in situ hybridization (ISH, CISH or FISH)
  * Hormone receptor negative i.e. an estrogen receptor (ER) of \<10% and progesterone receptor (PR) of \<10%.; or in case of a histological grade III tumor an ER of \<50% and a PR of \<50%.
* Patients are planned to receive the complete standard of care in the Netherlands; neo-adjuvant chemotherapy according to local practise
* Participating patients have to be able to use a mobile phone, tablet, laptop and/or computer and understand the Dutch language

Exclusion Criteria:

* Evidence of distant metastases. Staging examinations should have been performed according to Dutch national guidelines.
* Patients who are only treated systemically in the adjuvant setting
* Participation in another clinical study with an treatment intervention during the course of this study.
Identifying Genetic Determinants of Eczema Herpeticum and Other Viral Infections in Individuals With Atopic Dermatitis

People with atopic dermatitis (AD), or eczema, are susceptible to skin infections and inflammations. Some individuals with AD develop a condition known as eczema herpeticum (EH) following exposure to the herpes simplex virus (HSV). The purpose of this study is to identify the genetic determinants that lead people with AD to develop EH and similar conditions caused by other viruses.

AD is a chronic inflammatory skin disorder characterized by recurrent viral skin infections. However, people with AD do not all develop the same infections. For example, some people with AD who receive the smallpox vaccine develop a life-threatening condition known as eczema vaccinatum (EV). This study focuses on individuals with AD who also have a history of eczema herpeticum (ADEH+), a condition similar to EV. It is unlikely that the differences in the development of skin infections are due to differences in viral exposure, and instead due to differences in each individual's response to viruses. The purpose of this study is to determine the genetic pathways which are responsible for the development of viral skin infections in people with AD.

Participants in this study will also be enrolled in the ADVN Biomarker Registry Study. There will be only one clinical visit for this study at which blood and/or skin samples may be collected. The samples will then have high-throughput genotyping to define genetic markers in individuals susceptible to viral infections.

Eligibility Criteria:
Inclusion Criteria:

* Enrollment in ADVN Biomarker Registry Study
* Non-Hispanic and only African American or only Caucasian race
* Parent or guardian willing to provide informed consent, if necessary

Exclusion Criteria:

* History of any systemic illness, excluding AD
* Participation of a first degree relative already enrolled in the genotyping study unless the subject in question fulfills the diagnostic criteria for ADEH+. More information on this criterion can be found in the protocol.
Evaluation of Radiesse® Dermal Filler for Hand Rejuvenation

The purpose of this study is to assess the safety and effectiveness of Radiesse® Injectable Dermal Filler for hand treatment.

This is a prospective, randomized, masked, controlled study to investigate the effectiveness of Radiesse® Dermal Filler for hand treatment.

This is a prospective, randomized, masked, controlled study to investigate the effectiveness of Radiesse® Dermal Filler for hand treatment, comprised of a 3-month main study followed by an open-label extension (OLEX) study through 12 months. At 3 months, untreated controls received Radiesse Dermal Filler for hand treatment and were followed for the remainder of the study. All study subjects were eligible for retreatment 6 months after initial treatment, and all subjects were followed through 12 months from study enrollment in the OLEX.

Eligibility Criteria:
Inclusion Criteria

* Has right and left hands with a rating of 3 or 4 on the Busso Hand Volume Severity Scale (BHVSS) as determined by the treating physician
* Signs a written informed consent
* Understands and accepts the obligation not to receive any other procedures in the dorsum of the hands through 12 month follow up
* Understands and accepts the obligation and is logistically able to present for all scheduled follow-up visits

Exclusion Criteria

* Has history of hypertropic scarring
* Has a known bleeding disorder or receiving medication that will increase the risk of bleeding as the result of injection
* Has a known hypersensitivity to any of the components of Radiesse or local anesthesia
* Has used predefined products or treatments on the dorsum of the hand within last 4 weeks or intends to use during study
* Has had any dermal fillers or surgery in the dorsum of the hand
* Is a female of child bearing potential and not using medically effective birth control or is pregnant or lactating
AZD8075 Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Oral Doses of AZD8075 in Healthy Male Volunteers

The aims of the study are to evaluate the safety, tolerability and pharmacokinetics of AZD8075 in healthy male subjects at increasing doses when given for 14 days


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed, written and dated informed consent prior to any study specific procedures
* Have a body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
* Be non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for \>6 months prior to study start

Exclusion Criteria:

* Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the result of the study, or the subject's ability to participate
* Any clinically relevant abnormal findings in phys.examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline, which, in the opinion of the investigator, may put the subject at risk because of his participation in the study
* Participation in another investigational drug study within 3 months before Visit 2 or participation in a method development study (no drug) 1 month prior to Visit 2
Cinical Trial to Explore the Efficacy of Statin/Choline Fenofibrate Combination Therapy vs Statin Monotherapy in Patients With Inadequately Controlled TG Despite Receiving Statin Monotherapy

A Multi-center, Randomized, Double-blind, Parallel Phase Ⅳ Study to Explore the Efficacy of Statin/Choline Fenofibrate Combination Therapy vs Statin Monotherapy in Patients With Inadequately Controlled TG Despite Receiving Statin Monotherapy


Eligibility Criteria:
Inclusion Criteria:

* both male and female who are over 19-year-old
* 200mg/dl≤TG\<500mg/dl
* Desired value of LDL-c

  1. very high risk \< 70
  2. high risk \< 100
  3. moderate risk \<130
  4. low risk \< 160

Exclusion Criteria:

* patient who is going to have an operation during this study
* patient who has allergy or hypersensitivity of fenofibrate
* patient who has abnormal ECG
The Lymphocyte/Neutrophil Ratio as a Prognostic Index for Short Term Outcome in the ICU Admitted COVID-19 Adult Patients

1. ry outcome includes the correlation between lymphocyre /neurtophll ratio (LNR) and mortality rate during hospital stay in the ICU admitted COVID 19 patients.
2. ry outcome(s) include the LNR and its correlation with ICU stay, the need for mechanical ventilation, renal impairment.

In December 2019,the COVID-19 virus has been mainly breaking out in Wuhan in China as pneumonia affecting patients . Common clinical features During hospitalization started to appear including acute respiratory infection , inflammatory reaction , fever, pneumonia, cough, fatigue , anosmia .

The patient known suspected if he has a clinical picture of viral pneumonia, exposure history, and radiographic findings \[CT\] or \[MRI\] chest consistent with COVID-19 pneumonia. the gold standard and the Final diagnosis (PCR) positivity for the presence of coronavirus .

The immune response to respiratory infection causes neutrophils to collect inside the lung especially the alveoli. Neutrophils aggregation may lead to collateral tissue damage and cytotoxicity. According to Previous studies apoptosis of lymphocytes occurred due to the release of anti-inflammatory cytokines resulting in lymphopenia. high levels of circulating neutrophils have been demonstrated in COVID-19 patients(

A lot of literatures and studies have demonstrated the value of what is called neutrophil/ lymphocyte ratio (LNR) as a simple prognostic ratio correlated to morbidity and mortality. Up to our knowledge, there is no study utilized such ratio in COVID-19 ICU admitted patients, so that, this study has been built

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients (aged ≥18 years)
2. Patients who need non-invasive ventilation (NIV or CPAP) or invasive ventilation (intubation)

Exclusion Criteria:

1. Previous diagnosis of severe liver or kidney failure.
2. Patients with Human Immunodeficiency Virus (HIV) infection.
3. Patients with previous hematological diseases (Leukemia) that condition alterations in blood counts.
4. Consumption of treatments with any type of immunosuppressants prior to admission that conditions low lymphocytes.
5. Patients with bone marrow depression.
A New Measure of Egg Consumption and the Effect of Social Marketing Eggs

About 1600 children 6 to 24 months old will be enrolled from 8 egg hubs. 4 hubs will be receive social marketing campaign to raise awareness about the benefits of eggs while the other 4 will not receive social marketing campaign. Children will provide a urine sample for analysis of metabolites to correlate with egg consumption.


Eligibility Criteria:
Inclusion Criteria:

* Health children between 6 and 24 months of age

Exclusion Criteria:

* acute malnutrition
* congenital abnormalities
* chronic debilitation disease such as heart disease, cerebral palsy, or HIV infection
Biomarkers of Aging as Predictors of Kidney Transplant Function

The primary purpose of this study is to measure the correlation between baseline expression of aging biomarkers, SenesceTest in blood of organ donor and renal graft function. This pilot study will study patients who are undergoing renal transplantation with organs from extended criteria donors, standard criteria donors or donation after cardiac death and compare ability of SenesceTest to predict renal graft function immediately after the transplant and at 1 year followup.

Presently, donated organs are ranked amongst each other based on a formula for Kidney Donor Patient Index (KDPI; a variation of Donor Risk index) 8 which includes donor demographics and clinical history but no molecular markers of kidney function other than serum creatinine. Using KDPI assessment, nearly all ECD kidneys fall into the high-risk category. And while ECD kidneys are associated with higher risk of graft failure, studies note a wide variability in ECD organ quality and the associated graft survival (half-life graft survival 4.5-7.9 years), suggesting that current models of assessing organ quality are inadequate. Furthermore, prior to even being assigned a KDPI, over 37% of all kidneys and over 50% of ECD kidneys are discarded based on biopsy findings. However, recent studies called into question the reliance on procurement kidney biopsy reports in making acceptance decisions by demonstrating significant overlap in the biopsy findings between discarded and transplanted kidneys. The use of ECD kidneys is becoming more widespread and, according to a recent report, 70% adults \>65yo and 50% adults between 50 and 64 yo are willing to accept an ECD kidney. Therefore, new methodology for assessment of graft viability would increase transplantation rates particularly for organs from older or expanded criteria donors, shorten patient's time on wait list (currently 45 months average 50) and improve their outcomes by taking them off dialysis sooner.

Here, we propose a new approach-using molecular age markers (collectively referred to as SenesceTest) to predict kidney graft function.

Eligibility Criteria:
Inclusion Criteria:

* Donor \> 35 years of age

Exclusion Criteria:

* Recipient is HIV positive
A Post-Market Study Evaluating the Safety of Infinity DBS System With MR Conditional Labeling

The Infinity MRI PMCF was conducted as an international, multicenter, observational, prospective, single-arm, post-market clinical follow-up (PMCF) study. The study evaluated the safety of the Infinity DBS system with MR Conditional labeling when an MRI procedure was performed according to the approved guidance. Subjects were followed for 1 month after the MRI procedure. Participation in the clinical study ended at the conclusion of the 1-month follow-up visit where subjects were then followed per standard of care.


Eligibility Criteria:
Inclusion Criteria:

1. Subject or subject's legally acceptable representative must provide written informed consent prior to any clinical investigation related procedure.
2. Subject has been implanted, or is scheduled to be implanted, with a commercially available Infinity DBS system with MR Conditional labeling per locally approved indications for use.
3. Subject is scheduled to undergo a MRI procedure in compliance with the MRI Procedure Information Clinician's Manual. Anxiolytics and patient's regular medications may be administered, provided Instructions For Use (IFU) criteria are met.
4. Subject is willing and able to comply with study requirements.

Exclusion Criteria:

1. Subject has another implanted device (active or passive implanted device) that prohibits safe scanning.
2. Subject has previously experienced an MRI-related adverse event or cannot undergo MRI for any other reason.
3. Subject is pregnant or nursing, or plans to become pregnant during the clinical investigation follow-up period.
4. Subject has other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
5. Subject is currently participating in another clinical investigation that may confound the results of this study.
Establishment of Reference Intervals of Complete Blood Count and Coagulation Tests in Pregnant Women at Hung Vuong Hospital

Rationale: Pregnancy has major effects on physiology in women. There have been many studies that established reference intervals but none was done in Vietnam. The recommendation by CLSI C28-A3 is that if possible, each laboratory establishes its own reference intervals.

Objective: To establish the reference intervals of complete blood count parameters and Prothrombin time (PT), activated partial thromboplastin time (aPTT), fibrinogen.

Study design: This is a cross-sectional study.

Study population: Pregnant women with no history of disease and normal clinical findings.

Reference intervals (RI) is defined as the central 95% interval of the distribution of values taken from a biological reference population. RI is established for each trimester. The sample needed for each trimester is at least 258 which adds up to 774 when combining three trimesters.

Pregnant women are selected if eligible from obstetrics clinics after history taking and clinical findings. After consent, their blood are then drawn by phlebotomist into an EDTA (ethylenediamine tetraacetic acid) and a trisodium citrate 3.2% blood tube. EDTA samples are run on DxH 900 hematology analyzer, manufactured by Beckman Coulter and citrate samples are run on ACL TOP 550 coagulation analyzer, manufactured by Werfen. The analyzers are verified by laboratory procedure, recommended by CLSI (Clinical and Laboratory Standards Institute) method and quality control is checked before in accordance to the laboratory procedure.

Statistical analysis: CLSI document C28-A3c recommend establishing reference intervals using the 2.5th and 97.5th percentile of the distribution. The preferred method is nonparametric procedure, which does not need to exclude outliers. Each trimester RI will be compared to each other using z-test to determine if they are significantly different so that there must be seperate RI for each trimester.

Eligibility Criteria:
Inclusion Criteria:

* Singleton Pregnancy

Exclusion Criteria:

* Hypertension, Diabetes, Preeclampsia, Gestational Diabetes, Hemoglobinopathy, Current Infection, Positive Screening for Treponema pallidum, Hepatitis B Virus, HIV, usage of anticoagulant drug.
Caspofungin for the Treatment of Non-blood Candida Infections (0991-045)

Candida is the most common fungal pathogen identified in hospitalized patients. This study will seek to enroll adult patients (18 years of age or older) with invasive Candida infections (involving deep tissues and organs). The study will not enroll patients whose only site of Candida infection was the bloodstream. Patients that fulfill all study entry criteria will receive a single daily dose of caspofungin. Caspofungin, an intravenous echinocandin antifungal agent, is already approved for the treatment of invasive candidiasis. The dosage strength and duration of caspofungin will be individualized for each patient based on disease, severity of disease and extent of infection.


Eligibility Criteria:
Inclusion Criteria:

* All patients must have at least 1 positive culture for Candida species obtained from an otherwise sterile, non-blood body site within 96 hours of the study entry.
* The patient must also have clinical evidence of Candida infection (e.g., oral temperature \>100 degrees Fahrenheit, signs of inflammation from infected site, systolic blood pressure \<90) within 96 hours of study entry.
* The patient must be at least 18 years old, and if a woman of child bearing potential, must have a negative serum or urine pregnancy test sensitive to 25 IU HCG prior to enrollment.

Exclusion Criteria:

* Patients whose only site of Candida infection was the bloodstream.