cyrilzakka/clinical-trials huggingface dataset:
Pilot Evaluation of CVT-E002 in Pediatric Upper Respiratory Tract Infection.

This is a randomized double-blind three-arm trial to evaluate two dosages of CVT-E002 against placebo in pediatric upper respiratory tract infections (URTI). It is hypothesized that CVT-E002 use at standard doses reduces the duration of URTI in children aged 3-12 years.

The eligible children, for whom parental consent has been obtained, will be randomized to one of three groups (standard dose, low dose, or placebo). The standard dose group will receive an oral aqueous solution using the standard dose of CVT-E002, adjusted according to the child's weight. The second group will receive an oral aqueous solution with half of the standard dose of CVT-E002, adjusted according to the child's weight, and the third group will receive a placebo as an aqueous solution of starch that does not contain any CVT-E002 or active medication, volume adjusted for the child's weight. Parents will be provided with a 3-day supply of study medication according to the randomization schedule. CVT-E002 will be administered by the parent to the child three times daily for three consecutive days following the onset of a URTI. Severity and duration of URTI will be measured using the reliable and valid Canadian Acute Respiratory Infection Flu Score (CARIFS).

Eligibility Criteria:
Inclusion Criteria:

* Children aged 3-12 years who present to their pediatrician with in 48 hours of the onset of an acute upper respiratory tract infection.
* signed informed consent form

Exclusion Criteria:

* Children who have had an immunization in 3 months prior to the study
* Children with known hypoglycemia or diabetes
* Children who have a bacterial illness diagnosed at the same visit (e.g. otitis media, pneumonia, etc.) which will be treated with antibiotic therapy
* Children who have a malignancy or who have undergone treatment for a malignancy in the previous three months
* Children with known active liver disease (e.g. hepatitis)
* Known hypersensitivity to ginseng products
* Concurrent treatment with warfarin, digoxin, ginseng products or phenelzine
* Patients with coagulation disorders
Effect of Tranexamic Acid on Reducing Postoperative Blood Loss in Cervical Laminoplasty

The purpose is to evaluate the efficacy of tranexamic acid in cervical laminoplasty; the surgical procedure used was identical in all cases.

Tranexamic acid, an inhibitor of fibrinolysis, has proven to be effective in reducing perioperative blood loss in patients undergoing total hip and knee arthroplasty. However, limited numbers of well-controlled trials in spinal surgery have been conducted due to heterogeneity in the performed surgical procedures.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were scheduled to undergo cervical laminoplasty from C3 to C6 for cervical multilevel compressive myelopathy with a narrow spinal canal for which nonoperative therapy had failed.

Exclusion Criteria:

* Patients with chronic renal failure, cirrhosis of the liver, serious cardiac disease, allergy to TXA, a history of thromboembolic disease, and bleeding disorders, as well as those who were currently receiving antiplatelet and/or anticoagulant drugs, were excluded from this study.
Carbapenem and Quinolone Resistance in Klebsiella Pneumoniae

Klebsiella pneumoniae is an important pathogen that frequently causes nosocomial community-acquired and infections, including pneumonia, urinary tract infections, bloodstream infections, pyogenic liver abscesses, and septic shock.

An emerging co-existence of carbapenems and fluoroquinolone resistance in Klebsiella pneumoniae is causing major difficulty in treating infections caused by such pathogen

Plasmid mediated carbapenem resistance is mainly due to production of carbapenemase which belong to three classes of β-lactamases, the Ambler class A, B and D β -lactamases, among which the New Delhi metallo-β -lactamase has attracted significant attention in the last five years. New Delhi metallo-β -lactamase-1 is a class B metallo-β-lactamase and was first identified from a Klebsiella pneumoniae strain in 2008.

New Delhi metallo-β -lactamase-1 is frequently associated with other resistance genes, such as extended spectrum β- lactamase genes and plasmid-mediated quinolone resistance genes, which allows bacteria to gain resistance to different classes of antimicrobial agents simultaneously.

Plasmids and Integrons are mobile genetic elements that carry antimicrobial resistance genes. Horizontal transfer of those mobile genetic elements has been considered as one of the most important mechanisms for the dissemination of multi-drug resistance among bacteria.

Classification of plasmids on the basis of molecular typing and phylogenetic relatedness may help understand the distribution of plasmid types, the relationships involving plasmids carrying antimicrobial resistance genes. Plasmids can be classified into incompatibility groups by replicon typing or into types (clusters) by restriction fragment length polymorphism analysis.

Integrons act as genetic platform, which allow capture and expression of antibiotic resistance genes. There are 3 classes of integrons that are responsible for multi-drug resistance, which are classified based on the sequence of the integrase gene. Class 1 integrons are the most widespread class in Gram-negative bacteria.

One approach to preventing multi drug resistant infections is combination of two or more antimicrobial drugs during a treatment regimen . The combination of imipenem plus ciprofloxacin had shown Synergistic effect .

Loading of antibacterial agents into nanoparticles is one of the most promising approaches to reduce anti-microbial resistance. Nano formulations could enhance the intracellular bioavailability of the antimicrobial drugs, and, thus, decreasing the development of resistance. Moreover, the potential antibacterial activity of some nanoparticle-forming polymers might further increase the potency of the antibacterial drugs .

Eligibility Criteria:
Inclusion Criteria:

* admitted to intensive care unite

Exclusion Criteria:

* healthy
Effectiveness of Hand/Eyes/Mouth Behavior Management Technique During Local Anesthesia in Preschool Children

This will be a randomized, controlled, parallel-group clinical trial. The aim of this studio will be to evaluate the effectiveness of "Hands/Eyes/mouth" behavior management technique versus a conventional technique (covering the patient´s vision) during an inferior alveolar and lingual nerve block in preschool children referred for treatment at the School of Dentistry, Cardenal Herrera CEU University (Valencia, Spain). The sample will consist of 52 children from 3 years old to 5 years 11 months old who need dental pulp treatment and/or tooth extraction of primary molars. Preschool children with no history of allergies to Lidocaine or systemic/neurological diseases and who did not take local anesthesia before the study will be include in this research.

Children will be randomly allocated to treatment groups (n=26 for each group) according to the technique: 1)"Hands/Eyes/mouth" and 2) Conventional. Anxiety and pain will be evaluated by the Scale of facial Image (EIF) and Wong-Baker Pain Scale, respectively. The cooperation of the patient will be evaluated by behavioral Scale Frank

Eligibility Criteria:
Inclusion Criteria:

* Preschool children with severe dental caries who need dental pulp treatment and/or tooth extraction of inferior primary molars

Exclusion Criteria:

* Preschool children with history of allergies to lidocaine (local anesthetic)
* Preschool children with systemic or neurological diseases
* Preschool children who have received local dental anesthesia before this study
* Preschool children who do not understand Spanish or Valencian language
Safety and Efficacy of Aflibercept in Proliferative Diabetic Retinopathy.

Proliferative diabetic retinopathy is a serious complication of diabetes mellitus, partly consecutive to upregulation of vascular endothelial growth factor (VEGF) as a consequence of retinal ischemia leads. Aflibercept has been approved by FDA and European medicine agency for treatment of exudative age-related macular degeneration, another retinal disease characterized by choroidal new vessels.

The aim of this pilot study is to evaluate the efficacy and the safety of Aflibercept intravitreal injections compared to panretinal photocoagulation for proliferative diabetic retinopathy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with diabetes mellitus type 1 or type 2 complicated by PDR
* Male or female over 18 years
* HbA1c \<11.6% at study entry
* Systolic blood pressure \<160 mmHg and diastolic blood pressure \<105 mmHg at study entry
* Backgrounds clear eye, pupil dilation and patient cooperation sufficient to allow examination or fundus photographs of good quality

Exclusion Criteria:

* Hypersensitivity to aflibercept or to any of the excipients
* History of retinal laser (macular or panretinal photocoagulation), of intravitreal injections, of vitrectomy in the eye studied
* PDR associated with tractional retinal detachment in the eye studied
* PDR associated with fibrovascular proliferation in the eye studied
* Florid diabetic retinopathy
* Eye infection or periocular active or suspected
* Unbalanced glaucoma in the eye studied
* Other eye disease in the eye studied
* Patients with significant medical problems that may interfere with the evaluation of the safety or efficacy of the treatment studied
Surgery Alone Versus Methotrexate Before Surgery in Cesarean Scar Pregnancy

There are no universal treatment guidelines available. The ultimate purpose of the management of CSP is to simultaneously remove the pregnancy and successfully preserve the woman's fertility (Gonzalez \& Tulandi, 2017). A variety of medical and surgical treatment modalities for CSP have been reported; however, most of these are based on low-level evidence(Sun et al., 2019).

This will be a randomized clinical trial to evaluate the effect of administration of methotrexate before surgery in reducing bleeding, injury to bladder and ureter, operative time and removing of CSP mass.This will be in comparison to surgery alone in cases of first trimester cesarean scar pregnancy

Eligibility Criteria:
Inclusion Criteria:•

* Gestational age before 13 w
* Past history of 1 or more CS
* Presence of GS implanted on cesareans scar

Exclusion Criteria:

* Presence of severe vaginal bleeding (emergency)
* Previous history of uterine surgery other than CS
* The whole mass is interior and the bulge is more in the cavity
* Bleeding disorder
* Patient not candidate for methotrexate (Positive fetal heart pulsation,
* Patient refuse to participate in the study
Select Embryos by Time-lapse System for Single Embryo Transfer

The objective of this study is to establish a hierarchical embryo selection process by using the time-lapse imaging (TLI), combining the embryo cleavage patterns and timing parameters.

The embryos of patients undergoing in vitro fertilization (IVF) treatment is cultured to blastocyst stage and observed by TLI. The association of embryo cleavage patterns/timing parameters and good-quality blastocyst rates are evaluated by logistic regression and to establish a hierarchical embryo selection. The value of the selection process is assess by single embryo transfer (SET) on Day 3.

Eligibility Criteria:
Inclusion Criteria:

* Women undergoing assistant reproduction treatment

Exclusion Criteria:

* Oocyte donation cycles
Influence of Cardiorespiratory Fitness and Body Composition on Resting and Post-exercise Indices of Vascular Health in Young Adults

This research is being done to determine whether acute exercise causes differences in numbers of novel blood factors associated with vascular health in college-aged adults across different physical activity habits. As only \~50% of cardiovascular (CV) events can be explained by traditional CV risk factors such as high blood pressure and high cholesterol, it is anticipated that this research will provide a more comprehensive look into novel risk factors that may better explain CV risk and that may be modifiable through regular physical activity.


Eligibility Criteria:
Inclusion Criteria:

* 18-29 years of age; healthy male and female; Physically inactive, defined as participation in less than 20 min of continuous endurance exercise on fewer than 2 days/week; Recreationally active, defined as participation in 30 min/day of moderate-intensity cardiovascular activity on greater than 4 days/week; Highly active- defined as performing 30-60 min of moderate- to vigorous-intensity endurance exercise greater than 5 days/week.

Exclusion Criteria:

* currently pregnant, previously diagnosed coronary heart disease or congenital heart disease, serum total cholesterol \>200 mg/dl, low-density lipoprotein cholesterol \>130 mg/dl, high-density lipoprotein cholesterol \< 35 mg/dl, fasting glucose \>100 mg/dl, systolic blood pressure \> 130 mmHg, diastolic blood pressure \>90 mmHg, and BMI \>30 kg/m2.
Safety Study of the Novel Drug Dimebon to Treat Patients With Huntington's Disease

This study is being conducted to determine the safety and tolerability of Dimebon in people with Huntington's disease after short-term exposure (one week) and after longer exposure (three months). Also, the study will assess whether or not there is an effect of Dimebon on the symptoms of Huntington's disease, including cognitive (thinking abilities), motor (movement), behavior, and overall functioning.


Eligibility Criteria:
Inclusion Criteria:

* Clinical features of Huntington's disease and a confirmatory family history of HD, or a CAG repeat expansion greater than or equal to 36
* Stage I,II,III HD and a total functional capacity greater than or equal to 5 on the Unified Huntington's Disease Rating Scale

Exclusion Criteria:

* Clinical evidence of unstable medical illness
Supplementation of Dual Probiotic Strains Reduced Fasting Triglyceride and Enhanced Apolipoprotein A-V Levels

The purpose of this study is to evaluate the effect of dual probiotic strains containing Lactobacillus curvatus HY7601 and Lactobacillus plantarum KY1032 on triglyceride and apolipoprotein A-V.

A randomized, double-blind, placebo-controlled study was conducted on 128 nondiabetic and hypertriglyceridemic (Plasma Triglyceride, 150-500 mg/dL) subjects. Over a 12 week test period, the probiotic group consumed 2g of powder daily containing dual probiotic strains, while the placebo group consumed the same without probiotics.

Eligibility Criteria:
Inclusion Criteria:

* nondiabetic (plasma fasting glucose, \<126mg/dL; 2-hour plasma glucose, \<200mg/dL)
* borderline to moderate hypertriglyceridemia (plasma triglyceride, 150-500 mg/dL)

Exclusion Criteria:

* lipid-lowering medications use
* any medications or supplement use
* any probiotics products use for the past 1 months
* dyslipidemia
* diabetes mellitus
* hypertension
* liver disease
* renal disease
* cardiovascular disease
* cerebrovascular disease
* pancreatitis
* cancer
* medication or alcohol abuse
* pregnant or breast feeding
Suprachoroidal Injection of Triamcinolone Acetonide in Subjects With Macular Edema Following Non-Infectious Uveitis

The study is designed to evaluate the safety and efficacy of triamcinolone acetonide, CLS-TA, in subjects with macular edema following non-infectious uveitis. A single suprachoroidal injection of one of two doses of CLS-TA will each be evaluated in subjects with macular edema following non-infectious uveitis.

This is a Phase 2, randomized, masked, multicenter study to assess the safety and efficacy of two different doses of CLS-TA in the treatment of subjects with macular edema following non-infectious uveitis. Each subject will receive a single suprachoroidal injection of CLS-TA.

The subjects enrolled in this study will be chosen from subjects with macular edema following non-infectious uveitis. A single injection will be administered via the Clearside microinjector into the suprachoroidal space. The dose injected will either be 4 mg or 0.8 mg of CLS-TA in a total volume of 100 μL. The dose they receive will depend on what their randomization code dictates.

Subjects will be monitored for safety and efficacy for approximately 8 weeks following treatment.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of noninfectious uveitis
* diagnosis of macular edema associated with noninfectious uveitis

Exclusion Criteria:

* any ocular trauma within the immediate 6 months prior to treatment
* any photocoagulation or cryotherapy in the 6 months prior to treatment
* any IVT injection of anti-VEGF treatment in the 2 months prior to treatment
* any eye diseases other than uveitis and ME that could compromise central visual acuity
* any previous suprachoroidal injection of triamcinolone acetonide in the study eye
Quantitative Versus Qualitative Fecal Immunochemical Tests (FIT) to Prioritize Urgency of Colonoscopy Referral

The main aim of this study is to determine whether there is a difference in time to diagnosis of advanced colorectal neoplasms using quantitative Fecal Immunochemical Tests (FIT) to prioritize referral for colonoscopy (intervention) compared to usual care (qualitative FIT and appointment-based referral).

It is hypothesized that quantitative FIT will enable faster detection of advanced neoplasms compared to qualitative FIT.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 50 years and above

Exclusion Criteria:

* Lower gastrointestinal tract symptoms such as diarrhoea, constipation, per rectal bleeding
* Personal history of colorectal tumour or cancer
* Family history of familial adenomatous polyposis or hereditary non-polyposis colorectal cancer
A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis (UC)

The purpose of this study is to evaluate: a) the efficacy of ustekinumab dosing in inducing clinical remission, b) safety profile of ustekinumab, and c) ustekinumab exposure (pharmacokinetics \[PK\]) in pediatric participants with moderately to severely active UC.


Eligibility Criteria:
Inclusion Criteria:

* Medically stable on the basis of physical examination, medical history, and vital signs, performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and acknowledged by the investigator
* Must have had UC diagnosed prior to screening
* Have moderately to severely active UC, defined as a baseline Mayo score of 6 through 12, inclusive, with a screening Mayo endoscopy subscore greater than or equal to (\>=) 2 as determined by a central review of the video of the endoscopy
* A participant who has had extensive colitis for \>= 8 years, or disease limited to the left side of the colon for \>= 10 years, must: a) have had a full colonoscopy to assess for the presence of dysplasia within 1 year before the first administration of study intervention or b) have a full colonoscopy with surveillance for dysplasia as the baseline endoscopy during the screening period. Results from these surveillance biopsies must be negative for dysplasia (low-grade, high-grade, or indeterminant) prior to the first administration of study intervention
* Females of childbearing potential must have a negative highly sensitive urine pregnancy test at screening and at Week I-0 prior to study intervention administration

Exclusion Criteria:

* Have UC limited to the rectum only or to less than (\<) 20 centimeter (cm) of the colon
* Presence or history of colonic or small bowel obstruction within 6 months prior to screening, confirmed by objective radiographic or endoscopic evidence of a stricture with resulting obstruction (dilation of the colon or small bowel proximal to the stricture on barium radiograph or an inability to traverse the stricture at endoscopy)
* Have a history of latent or active granulomatous infection, histoplasmosis, or coccidioidomycosis, or have had a nontuberculous mycobacterial infection prior to screening
* Presence or history of any malignancy including presence or history of lymphoproliferative disease including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (example, nodes in the posterior triangle of the neck, infraclavicular, epitrochlear, or periaortic areas) and monoclonal gammopathy of undetermined significance, or clinically significant hepatomegaly or splenomegaly
* Has known allergies, hypersensitivity, or intolerance to ustekinumab or its excipients
Deep Neuromuscular Block on Postoperative Delirium in Lumbar Surgery

The effect of deep neuromuscular blockade (NMB) during spine surgery reduced postoperative pain and bleeding in recent studies. Therefore by reducing these two factors, which were the contributing factors for postoperative delirium, deep NMB is expected to reduce the postoperative delirium. This study was designed to determine whether the deep NMB lowered the incidence of delirium after lumbar surgery.


Eligibility Criteria:
Inclusion Criteria:

* Aged 70 and more;
* Scheduled for an elective lumbar spine surgery;
* ASA physical status 1-3

Exclusion Criteria:

* Diagnosed neuromuscular disorder;
* Contraindications to the study drug, e. g. known allergy or hypersensitivity, hypotension, bradycardia, higher grade atrioventricular block;
* Patient with pre-existing cognitive impairment or dementia
The Effect of Atorvastatin and Pioglitazone on Carotid Atherosclerosis With the Use of Positron Emission Tomography-computed Tomography (PET-CT)

This study is a prospective randomized clinical trial and to compare the antiinflammatory effect of atorvastatin single therapy and atorvastatin and pioglitazone combination therapy in carotid arteries of stable and unstable angina patients by PET/CT.


Eligibility Criteria:
Inclusion Criteria:

* The subject who has undergone percutaneous coronary intervention due to coronary artery disease ( stable angina or unstable angina)
* The subject described above who has atherosclerotic plaque in his/her carotid artery by carotid ultrasonography
* The subject who or a legal representative agrees to the clinical trial and gives written permission to the IRB-approved form.

Exclusion Criteria:

* The subjets who have taken statins or thiazolidinedione with 4 weeks
* Marked elevated liver enzyme ( more than 2.5 fold compared to reference range)
* Renal insufficiency patients ( serum creatinine more than 2 mg/dl)
* Congestive heart failure ( NYHA class 2-4)
* Acue myocardial infarction
* Unstable angina with ST segment deviation
* Pregnancy
* The subjects enrolled in another studies