cyrilzakka/clinical-trials huggingface dataset:
Post-marketing Surveillance (PMS) Use-Result Surveillance With SPIKEVAX BIVALENT and SPIKEVAX X Injection.

The main objective of the surveillance is to evaluate the incidence of the adverse events (AEs), and other safety related information in South-Korean population.


Eligibility Criteria:
Inclusion Criteria:

* Participants should be 18 years or older for Spikevax bivalent BA.1, SPIKEVAX BIVALENT BA.4/5 vaccine, and 12 years or older for Spikevax XBB.1.5 injection.
* Participants of any age which is approved for the use of SPIKEVAX BIVALENT BA.1, SPIKEVAX BIVALENT BA.4/5 or SPIKEVAX XBB.1.5 for active immunization to prevent COVID-19 caused by SARS-CoV-2.
* Participant who will be vaccinated with SPIKEVAX BIVALENT BA.1, SPIKEVAX BIVALENT BA.4/5 or SPIKEVAX XBB.1.5 following local label approved by Ministry of Food and Drug Safety (MFDS).
* Participant who will be vaccinated with at least one dose of SPIKEVAX BIVALENT BA.1, SPIKEVAX BIVALENT BA.4/5 or SPIKEVAX XBB.1.5.

Exclusion Criteria:

* Participant whose participation is deemed inappropriate at the investigator's discretion.

Note: Other protocol-defined inclusion/exclusion criteria may apply.
Efficacy of Desonide (Desonatetm) Gel 0.05% in Younger and Older Subjects With Atopic Dermatitis

The purpose of this research study is to better understand how this study drug works when people use it to treat atopic dermatitis. Desonate has been approved by the US Food and Drug Administration (FDA) for atopic dermatitis.

To assess the efficacy of a desonide hydrogel 0.05% in both young children (age \<13) and older subjects (ages 13 and up) with mild to moderate atopic dermatitis

Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 3 months or greater.
* Subjects must have diagnosis of mild to moderate atopic dermatitis by an investigator (a 2 or 3 on the IGA scale).
* Subjects must have \>2% BSA involvement to be enrolled.
* Informed consent of participation must be given by parent or guardian if he or she is \<7 years old. Children who are 7 to 18 years old will be given an assent form to sign.
* Moisturizers will be allowed during the study as long as the use remains stable from screening/baseline throughout the study.

Exclusion Criteria:

* Known allergy or sensitivity to topical desonide hydrogel in the subject.
* Inability to complete all study-related visits.
* Introduction of any other prescription medication, topical or systemic, for atopic dermatitis while participating in the study. Other than stable use of over the counter non-medicated moisturizers, all other topical treatments for AD must be stopped prior to study drug initiation. There will be no required washout for any topical therapies. Stable use of systemic therapies may be continued throughout the study.
* Requiring \>130 gm of cream in a 4 week period.
* Pregnant women and women who are breastfeeding are to be excluded. Women of childbearing potential will be allowed to participate in the study, and these subjects will be required to use at least one form of birth control. Use of desonide in pregnant subjects is controversial and is only to be used when benefits outweigh the risks.
Nutraceuticals and Vascular Remodelling

Aim of the study is to assess the effect of a long-term nutraceutical multitarget approach on lipid profile, inflammatory mediators and vascular remodeling in primary cardiovascular prevention in a setting of controlled dietary habits. The nutraceutical combination used in this study consists of a single pill containing 333 mg of RYR, equivalent to 10 mg of Monacolin K, and 30 mg of Coenzyme Q10 (CoQ10).


Eligibility Criteria:
Inclusion Criteria:

* Total Cholesterol \> 150 mg/dl and \< 250 mg/dl;
* Triglycerides \> 150 mg/dl and \< 500 mg/dl;
* Fasting glucose \< 126 mg/dl;
* Stable antihypertensive treatment (at least for 6 months) in presence of hypertension.

Exclusion Criteria:

* Total Cholesterol \> 250 mg/dl
* Triglycerides \> 500 mg/dl
* Previous statin therapy (last 6 months);
* Treatment with hypoglycemic agents and/or fasting glucose \> 126 mg/dl;
* Chronic gastrointestinal disorders;
* Chronic kidney disease (eGFR \< 60 ml/min/1.73 m2);
* Concomitant treatment with drugs potentially interfering with glucose and lipid metabolism; - History of cardiovascular diseases;
* Proven intolerance to any component of the nutraceutical product;
* Pregnancy or breastfeeding.
Videoendoscopic Pilonidal Sinus Surgery

This study examines performing pilonidal sinus surgery minimal invasively with videoendoscopic approach.

Lots of surgical techniques are performing on pilonidal sinus disease treatment. Lately large flap techniques are popular but causing anatomical distortions and bad cosmesis. In this new approach the investigators concluded that two 1cm diameter holes are enough to surgical treatment. One hole is for videoendoscopic camera and the other one for grasper to extract piluses and granulation tissues.

Eligibility Criteria:
Inclusion Criteria:

* symptomatic pilonidal sinus disease
* primer pilonidal sinus disease
* noncomplicated pilonidal sinus disease

Exclusion Criteria:

* Asymptomatic pilonidal sinus disease
* Recurrence pilonidal sinus disease
* complicated pilonidal sinus disease
Dimethyl Fumarate (DMF) in Systemic Sclerosis-Associated Pulmonary Arterial Hypertension

A double-blinded, placebo-controlled study of Dimethyl fumarate (DMF) in 34 Systemic Sclerosis-Pulmonary Hypertension (SSc-PAH) patients. The study will determine safety and the primary outcome variability for DMF in treating SSc-PAH; the primary outcome of clinical efficacy in this pilot trial will be improvement in 6-minute walk distance (6MWD).

A double-blinded, placebo-controlled study of Dimethyl fumarate (DMF) in 34 Systemic Sclerosis-Pulmonary Hypertension (SSc-PAH) patients. The study medication will be added to stable background PAH medication(s). Subjects will be dosed for 24 weeks, will undergo examination every 8 weeks, and will be finally evaluated 12 weeks after completion of treatment. Dosage will begin at once daily oral doses of 120mg for the first 7 days and follow the up-titration schedule to a maintenance dose of 240mg twice a day (or highest tolerated dose of a minimum of 120mg twice a day by the start of Week 8) for the remainder of the study. Participation will be for a total of 40 weeks, including a 4-week screening period, 24 weeks of drug, and a safety follow-up 12 weeks after the last dose. The study will determine the safety and the primary outcome variability for DMF in treating SSc-PAH; the primary outcome of clinical efficacy in this pilot trial will be improvement in 6-minute walk distance (6MWD).

Eligibility Criteria:
Inclusion Criteria:

1. Signed inform consent prior to any study-mandated procedures
2. Adult patients 18-80 years of age
3. World Health Organization Group 1 PAH associated with scleroderma (SSc-PAH)
4. WHO functional Class II-III
5. 6MWD 150 to 450 meters
6. Right heart catheterization demonstrating mPAP≥ 25 mmHg and PCWP or left ventricular end diastolic pressure ≤15mm Hg and pulmonary vascular resistance ≥240 dynes/cm-5 (3 Wood units) within 12 weeks prior to study entry.
7. ACR defined systemic sclerosis

Exclusion Criteria:

1. Pulmonary hypertension associated with

   * PAH of any etiology other than scleroderma
   * PH of any etiology other than WHO Group I PAH
   * Pulmonary venous hypertension defined as PCWP or LVEDP \>15 mHg
   * Untreated sleep apnea with AHI \>20 or SaO2 Nadir \<87%
   * Chronic thromboembolic disease
   * Sarcoidosis
2. Participation in a clinical investigational study within the previous 30 days
3. Moderate to severe hepatic impairment (e.g., Child-Pugh Class B or C)
4. Renal failure defined as:

   * estimated creatinine clearance \<30 m/min
   * serum creatinine\>2.5 mg/dl
5. Serum aspartate aminotransferase (AST) and or alanine aminotransferase (ALT) \> 1.5 times the upper limit of normal
6. Systolic blood pressure \< 90mmHg
7. Recently started (\< 8 weeks prior to randomization) or planned cardiopulmonary rehabilitation program based on exercise
8. Pregnant or lactating women
9. Need for HAART therapy
10. Planned treatment or treatment with another investigational drug within 1 month prior to start
11. Moderate to severe interstitial lung disease, defined by FVC \< 80% or evidence on HRCT of fibrosis or ground glass changes involving more than 30% of lung parenchyma
Gene Expression In Pregnancies Complicated by Preeclampsia

The purpose of this study is to figure out some of the differences in bodily function between women who have preeclampsia and those who do not.

* This may eventually lead to an understanding of its cause. At this time, there is no known way to prevent preeclampsia, and the cause is not known.
* The only treatment is delivery of the baby, even if it is premature, in order to decrease the risk to the mother.

* Preeclampsia is a pregnancy-related disorder that occurs in about 6% of all pregnancies.
* In its mild for, preeclampsia involves high blood pressure. More severe forms of preeclampsia can lead to more serious pregnancy complications.
* At this time, there is no known way to prevent preeclampsia, and the cause is not known. The only treatment is delivery of the baby, even if it is premature, in order to decrease the risk to the mother.
* The purpose of this study is to figure out some of the differences in bodily function between women who have preeclampsia and those who do not. This may eventually lead to an understanding of its cause.

Eligibility Criteria:
Inclusion Criteria:

* Gravidas at 32-42 weeks gestation,who have preeclampsia as defined by Sibai et al, 1997.
* Control patients: Gravidas without history of hypertension of any kind, and matched to cases for parity, gestational age, labor status, maternal age, and race.

Exclusion Criteria:

* Prior betamethasone administration, fetal growth restriction (\<3%ile), prior chronic hypertension (nonpregnant or \< 20 weeks gestation any pregnancy), chorioamnionitis, major fetal anomaly or chromosome abnormality, multiple gestation, and maternal diabetes (any class except diet-controlled gestational).
Determining Drug Levels of Beta-lactam Antibiotics in Severe Burned Patients

At antibiotic stewardship of the University Hospital of Schleswig-Holsten it was noticed that there are much less studies measuring drug levels in severe burned patients than are required. Especially, severe burned patient developing a capillary leak might show lower drug levels than patients without a capillary leak. To compare drug levels of beta-lactam antibiotics, it is the aim of this study to measure pharmacokinetics of Piperacillin/Tazobactam in ICU patients with and without severe burns.


Eligibility Criteria:
Inclusion Criteria:

General

* Adult
* Receiving beta-lactam antibiotic Piperacillin/Tazobactam
* Antibiotic therapy of 3 or more days
* Given informed consent Group 1
* Severe Burn Group 2
* No Severe Burn

Exclusion Criteria:

* Already in another Study
* No useful blood sample
A Metabolomic Approach to Probing Myocardial Fuel Shifts in Human Heart Failure

This proposal is designed to test the hypothesis that humans shift to reliance on ketone bodies as a cardiac fuel source during the development of HF. The investigator also propose that this shift to ketone utilization can be detected by metabolomic profiling of blood.

Specific Aim 1: To determine if the failing human heart exhibits increased extraction of blood-borne ketone bodies. Ketone bodies will be measured in coronary sinus, arterial, and central venous blood samples to determine AV differences. The HF group will be comprised of patients undergoing cardiac resynchronization therapy with an implantable cardioverter-defibrillator. The Control group will be compromised of patients without evidence of structural heart disease who are undergoing catheter ablation for supraventricular tachycardia.

Specific Aim 2: To determine whether blood samples from humans with HF display metabolomic signatures indicative of increased myocardial ketone body utilization. Quantitative targeted metabolomics will be performed on the samples described in Aim 1 to determine if metabolite markers (e.g. C4-OH acylcarnitine, acetylcarnitine, succinate) found to be associated with increased myocardial ketone body oxidation in animal models are increased in the human HF group compared to the controls.

After subjects agree to participate in this study and are scheduled to have cardiac resynchronization therapy, the research personnel will take 1 teaspoon of blood before and after the scheduled cardiac procedure for comparison.

Once subjects agree to participate in this study and are scheduled to have a catheter ablation procedure, research personnel will take 1 teaspoon of blood during the scheduled cardiac procedure.

These samples will be taken from catheters already placed during the scheduled cardiac procedure.

Blood will be sent to a lab at the Sanford-Burnham Metabolomics Core Facility in Orlando, Florida for analysis.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing cardiac resynchronization therapy
* Undergoing sinus cannulation

Exclusion Criteria:

* NYHA class II-IV heart failure
Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML

This study will compare the effects of Quizartinib versus placebo in combination with chemotherapy in participants with newly diagnosed FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) negative acute myeloid leukemia (AML).

This is a clinical trial to compare the effect of quizartinib versus placebo (administered with standard induction and consolidation chemotherapy, then administered as maintenance therapy for up to 36 cycles) on the primary endpoint of overall survival (OS) in adult patients with newly diagnosed FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) negative acute myeloid leukemia (AML). Participants will be tested for FLT3-ITD mutation status in a central laboratory using a validated assay.

Eligibility Criteria:
Key Inclusion Criteria:

* Must be competent and able to comprehend, sign, and date an Ethics Committee (EC)- or Institutional Review Board (IRB)-approved Informed Consent Form (ICF) before performance of any trial-specific procedures or tests.
* ≥18 years or the minimum legal adult age (whichever is greater) and 70 years (at Screening).
* Newly diagnosed, morphologically documented primary AML based on the World Health Organization (WHO) 2016 classification (at Screening)
* Eastern Cooperative Oncology Group (ECOG) performance status (at the time the participant signs their ICF) of 0-2.
* Participant is receiving standard "7+3" induction chemotherapy regimen as specified in the protocol

Key Exclusion Criteria:

* Diagnosis of acute promyelocytic leukemia (APL), French-American-British classification M3 or WHO classification of APL with translocation, t(15;17)(q22;q12), or BCR-ABL positive leukemia (ie, chronic myelogenous leukemia in blast crisis); participants who undergo diagnostic workup for APL and treatment with all-trans retinoic acid (ATRA), but who are found not to have APL, are eligible (treatment with ATRA must be discontinued before starting induction chemotherapy).
* Diagnosis of AML secondary to prior chemotherapy or radiotherapy for other neoplasms or autoimmune/rheumatologic conditions.
* Diagnosis of AML secondary to myelodysplastic syndrome (MDS) or a myeloproliferative neoplasm (MPN) or MDS/MPNs including CMML, aCML, JMML and others.
* Participants with newly diagnosed AML with FLT3-ITD mutations (FLT3-ITD \[+\]) present at ≥5% VAF (or ≥0.05 SR) based on a validated FLT3 mutation assay.
* Prior treatment for AML, except for the following allowances:

  1. Leukapheresis;
  2. Treatment for hyperleukocytosis with hydroxyurea;
  3. Cranial radiotherapy for central nervous system (CNS) leukostasis;
  4. Prophylactic intrathecal chemotherapy;
  5. Growth factor/cytokine support.
Plasma Proteomic Biomarkers for Early Diagnosis of Lung Cancer

We will identify plasma proteomics biomarkers for early diagnosis of lung cancer.

We will use TMT-based proteomics approaches to analyze more than 2000 proteins in plasma samples from lung cancer patients and controls. Artificial intelligent (AI) assisted proteomics classifier will be developed for early diagnosis of lung cancer.

Eligibility Criteria:
Inclusion Criteria:

* CT screening results showed that the size of pulmonary nodules was more than 5mm
* No treatment related to pulmonary nodules/lung cancer (including surgery, chemotherapy, radiotherapy, targeted therapy, immunotherapy, interventional therapy, etc.)
* Complete clinical and imaging data
* Chest CT/ low-dose spiral CT reports can be provided in the last 3 months
* Voluntarily sign informed consent

Exclusion Criteria:

* There is a history of tumor
* Clinically uncontrolled active infections, such as acute pneumonia, tuberculosis, etc.
* Received any treatment related to pulmonary nodules, such as antibiotics and hormones, in the past 4 weeks
* Complicated with other tumors and serious diseases of the heart, liver, kidney, brain, blood and other systems
* Participated in other clinical trials within the last 3 months
* Combined with liver and kidney insufficiency, hypoproteinemia and other diseases affecting protein content
* You are pregnant or breastfeeding
ARROW:identificAtion of postpRandial biomaRkers tOWards Cardiovascular Prevention

The purpose of this study is to better understand the association between the postprandial biomarker responses after a food challenge with the development of cardiovascular diseases in healthy subjects


Eligibility Criteria:
Inclusion Criteria:

1. Willing and able to sign written informed consent in English or Chinese prior to trial entry
2. 40-54 years old
3. Both male and female subjects
4. Chinese ethnic group (having both grandparents Chinese)
5. Low Framingham risk of CHD (\<10%)
6. Apparently healthy (i.e. no chronic or ongoing acute disease), based on investigator's clinical judgement

Exclusion Criteria:

1. Food allergy to any of the constituents of the meal challenge (milk proteins, lactose, soy).
2. Subjects not willing or not able to comply with scheduled visits and the requirements of the study protocol.
3. Contraindication to MRI
4. Pregnant or lactating women based on investigator's clinical judgement.
5. Morbid obesity (BMI ≥ 40 kg/m2).
6. Previous myocardial infarction (MI). This will include ST-elevation MI (STEMI) and non-ST-elevation MI (NSTEMI).
7. Known coronary artery disease - prior coronary revascularization.
8. Known documented peripheral arterial disease.
9. Previous stroke (defined as new focal neurological deficit persisting more than 24hours).
10. Use of anti-hypertensive agents.
11. Prior history of cancer (excludes pre-cancerous lesions).
12. Life expectancy less than 1 year.
13. Known definite diabetes mellitus or on treatment for diabetes mellitus.
14. Known autoimmune disease or genetic disease.
15. Known endocrine and metabolic diseases, even on treatment, including hyperlipidemia.
16. Psychiatric illness.
17. Asthma or chronic lung disease requiring long term medications or oxygen.
18. Chronic infective disease, including tuberculosis, hepatitis B and C; and HIV.
19. Currently participating or having participated in another clinical trial within 4 weeks prior to trial start (except for Biobank Study and SingHeart).
A Comparison of Two Multi-Drug Therapies in HIV-Infected Patients Who Have Never Received Anti-HIV Treatment

The purpose of this study is to compare 2 combination drug therapies in HIV-infected patients who have never received anti-HIV treatment.

In this open-label study antiretroviral-naive patients are randomized to one of two drug regimens:

Arm I: 141W94 (amprenavir), 1592U89 (abacavir), and Combivir (3TC/AZT tablet). Arm II: Nelfinavir and Combivir.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* CD4 count \> 50.
* HIV RNA \> 5,000.
* No active AIDS (excluding CD4 count \< 200).
* Ability to comply with dosing schedule and protocol evaluations.

Prior Medication:

Allowed:

* 3TC or any protease inhibitor, if \< 1 week of therapy.
* Other nucleoside analogs, if \< 4 weeks of therapy.

Exclusion Criteria

Co-existing Condition:

Patients with any of the following symptoms or conditions are excluded:

* Active AIDS (not including CD4 count \< 200).
* Malabsorption syndrome affecting drug absorption.

Concurrent Medication:

Excluded:

Enrollment in any other investigational drug protocol.

Prior Medication:

Excluded:

Non-nucleoside reverse transcriptase inhibitors.
Multimodal Vasopressor Strategy in Septic Shock

The goal of this prospective randomized controlled trial is to compare the effects of classic stepwise vs. early balanced multimodal vasopressor strategies in septic shock.

CONTROL GROUP(Classic stepwise vasopressor administration):

Patients will be started on norepinephrine with increases of 0.05-0.1 mcg/kg/min up to 0.5 mcg/kg/min, followed by vasopressin (administered at a fixed dose of 0.03 IE/min). If MAP remains \< 65 mmHg, norepinephrine will be titrated above dose of 0.5 mcg/kg/min until MAP ≥ 65 mmHg. Initiation of additional vasoactive drugs (epinephrine, methylene blue, dobutamine, or dopamine) as per clinical team decision.

EXPERIMENTAL GROUP(Balanced multimodal vasopressor administration):

Early, simultaneous start of norepinephrine, angiotensin II and vasopressin at equivalent starting doses (equivalent to approximately 0.05 mcg/kg/min of norepinephrine). Increments of 0.05 mcg/kg/min of equivalent doses of all three vasopressors every 3-5 min until MAP ≥ 65 mmHg is reached (vasopressin will be administered at a maximum dose of 0.03 IE/min, AT II will be administered at maximum dose of 100ng/kg/min).

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥18 years).
* Sepsis (an acute change in total Sequential Organ Failure Assessment (SOFA) score ≥2 points consequent to infection) with persisting hypotension requiring vasopressors to maintain MAP ≥65 mm Hg and having a serum lactate level \>2 mmol/L despite adequate volume resuscitation (20-30ml/kg in 3 hours).
* Vasopressor requirement of ≥0,15 μg/kg/min equivalent of norepinephrine base.
* Patients are required to have central venous access and an arterial line present, and these are expected to remain present for at least the initial 72 hours of study.
* Patients are required to have an urinary catheter present, and it is expected to remain present for at least the initial 72 hours of study.
* Patients must have cardiac index (CI) \>2.3 L/min/m2 (measured by bedside echocardiography, pulse contour cardiac output (PiCCO) or Swan-Ganz catheter).

Exclusion Criteria:

* Death expected \<24 hours.
* Pregnancy (suspected or confirmed).
* Surgery expected for source of infection.
* Inter-hospital transfer expected during first 72 hours of hospitalization.
* Liver failure with a Model for End-Stage Liver Disease (MELD) score of ≥30.
* Patients with acute mesenteric ischemia or a history of mesenteric ischemic.
* Patients with Raynaud's phenomenon, systemic sclerosis or vasospastic disease.
* Patients with active bleeding and an anticipated need (within 48 hours of initiation of the study) for transfusion of \>4 units of packed red blood cells.
* Patients with a known allergy to mannitol.
* Patients on veno-arterial (VA) ECMO.