cyrilzakka/clinical-trials huggingface dataset:
Metformin in Non-Alcoholic Fatty Liver Disease

The study evaluates the use of the antidiabetic medicine metformin in nonalcoholic fatty liver disease.

Nonalcoholic fatty liver disease (NAFLD) is a prevalent disorder associated with insulin resistance. Metformin is a drug that has been used for several decades in the treatment of diabetes mellitus. Metformin is known to improve insulin sensitivity. Some authors have reported beneficial effects of metformin in NAFLD, others have not been able to reproduce these findings. Only a few randomized controlled studies have been published so far, and there is still need for controlled trials with sufficient power to assess the efficacy of metformin in this condition.

The aim of this study is to see whether treatment with metformin for 26 weeks results in reduction of liver steatosis (primary endpoint) and reduction in grade of inflammation in those with non-alcoholic steatohepatitis (NASH) (secondary endpoint).

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven NAFLD less than 18 months prior to inclusion. For those with pure steatosis, ALAT or aspartate aminotransferase (ASAT) must be elevated above the upper limits of normal, and impaired glucose tolerance or diabetes mellitus type 2 must be present.
* Body weight within +/- 5 kg compared with the weight at the time of biopsy.

Exclusion Criteria:

* Treatment for more than 1 week with metformin or glitazones the last 6 months before inclusion.
* Treatment with insulin.
* Hypersensitivity to metformin.
* Treatment with cimetidine.
* Heart failure requiring pharmacological treatment.
* Coronary heart disease (New York Heart Association \[NYHA\] class 3 or 4).
* Chronic obstructive lung disease (moderate or severe).
* Breast-feeding or pregnant.
* Metabolic acidosis.
* Renal failure (male \[♂\]: creatinine \> 135 micromol/L, female \[♀\] \> 110 micromol/L).
* Average alcohol consumption \> 24 g/day the last year.
* Serum ALAT or serum ASAT \> 5 x upper limit of normal (ULN) at screening.
* Cirrhosis.
* Platelets \< 100 000.
* Haemochromatosis.
* Alfa-1-antitrypsin-deficiency.
* Wilson's disease.
* Thyroid dysfunction (0.2 mU/L \< thyroid stimulating hormone \[TSH\] \< 5.0 mU/L).
* Chronic infection with hepatitis B or C virus or HIV.
* Autoimmune hepatitis (antinuclear antibodies \[ANA\] \> 1/256 or smooth muscle antibodies \[SMA\] \> 1/128).
* Primary biliary cirrhosis (antimitochondrial antibodies \[AMA\] \> 1/64).
* Primary sclerosing cholangitis.
* Previous participation in another clinical trial the last 6 months.
* Legal incapability.
Comparison of the Effects of Open and Endovascular Aortic Aneurysm Repair on Long-term Renal Function

Compare the renal complication of endovascular and open repair of acute aortic dissection by including patient treated at NTUH in 2010\~2013.


Eligibility Criteria:
Patient underwent endovascular and open repair of aortic aneurysm at NTUH in 2010\~2013 Age \> 20 years old
Exploring Relevant Immune-based Biomarkers and Circulating Tumor Cells During Treatment With Immunotherapy in Genitourinary Malignancies (CTC Immune Based Biomarkers)

This pilot study purpose of this study is to describe peripheral circulating immune cell profiles at baseline and change on treatment with immune checkpoint inhibitors in renal cell carcinoma and urothelial carcinoma.


Eligibility Criteria:
Inclusion Criteria:

Group A Renal Cell Carcinoma:

Patients will be eligible for inclusion in this study if ALL of the following criteria apply:

1. Histologically confirmed or radiological diagnosis of renal cell carcinoma. Clear cell and non-clear cell carcinoma (such as papillary, chromophobe, collecting duct, and medullary) allowed.
2. Evidence of locally advanced, high grade or metastatic disease in any site on most recent imaging scan
3. Planned initiation of treatment with any of the following:

   * Immune modulatory agent targeting any of the following: PD-1, PD-L1, CTLA-4, CD27, OX40, LAG3 or tumor infiltrating lymphocytes (TIL)
   * Immune modulatory agent consisting of any of the following: CAR-T, bispecific antibody or vaccine trial.
4. Age \> 18 years.
5. Ability to understand and the willingness to sign a written informed consent document.

Group B Urothelial Carcinoma:

Patients will be eligible for inclusion in this study if ALL of the following criteria apply:

1. Histologically confirmed diagnosis of urothelial carcinoma. Non-transitional cell carcinoma (such as adenocarcinoma and squamous cell carcinoma) allowed.
2. Evidence of locally advanced, high grade or metastatic disease in any site on most recent imaging scan
3. Planned initiation of treatment with any of the following:

   * Immune modulatory agent targeting any of the following: PD-1, PD-L1, CTLA-4, CD27, OX40, LAG3 or tumor infiltrating lymphocytes (TIL)
   * Immune modulatory agent consisting of any of the following: CAR-T, bispecific antibody or vaccine trial.
4. Age \> 18 years.
5. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

A patient will not be eligible for inclusion in this study if any of the following criteria apply:

1. History of intercurrent or past condition that would make participation in this protocol difficult or not feasible at the discretion of the principal investigator or co-investigator(s).
Gestational Diabetes Mellitus and Cardiometabolic Syndrome in Offspring

Gestational Diabetes Mellitus (GDM) has long been known as leading to macrosomias, neonatal hypoglycemias and other complications which are treatable and preventable. Nowadays, GDM is recognized as an entity with long-term serious sequels to the mother (GDM is considered a forerunner of type 2 diabetes) and her offspring. Indeed, according to the programming hypothesis, GDM sets the stage for metabolic syndrome, obesity, type 2 diabetes and hypertension. However, these cross-sectional studies failed to control for maternal disease history and genetic background although heredity is a major epidemiology risk factor of type 2 diabetes. Also, studies usually refer to traditional markers such as BMI, blood pressure, lipids profile and oral glucose tolerance test (OGTT); none explored inflammatory biomarkers and adipokines in-depth, despite the possible link between their presence and the development of metabolic and cardiovascular diseases in GDM offsprings.

Exclusion of genetic confounding factors will help establish the role of GDM as an independent marker of cardiometabolic risk in GDM offspring. It is highly relevant to identify GDM as a risk factor for cardiometabolic diseases, given the worldwide obesity epidemic, the alarming prevalence increase of GDM and its serious sequels to both mother and offspring.


Eligibility Criteria:
Inclusion Criteria:

* age 4 to 12 years
* Tanner stage \< 2
* to understand French or English

Exclusion Criteria:

* Type 1 diabetes
* weight \< 10 kg
* placenta abnormalities
* gestational age \< 34 weeks
* illness affecting growth and metabolism
* taking medications
Identification of Morphological Characteristics to Predict Difficult Endotracheal Intubation Using a Flexible Fiberscope

This study is designed to identify patients' features predictive of difficult endotracheal intubation using a flexible fiberscope.

Endotracheal intubation is an important act in the practice of anesthesiology. Direct laryngoscopy is the most commonly used technique to accomplish this task. Airway characteristics predicting difficult intubation with direct laryngoscopy are well defined. Physical findings, such as Mallampati classification or measurements of the thyromental distance, mouth opening, and neck extension have been validated to help anticipate difficult situations with the direct laryngoscope. When direct laryngoscopy is difficult, early conversion to an alternative technique reduces the risk of airway compromise and associated morbidity.

Many alternative intubation devices are now available, and part of the anesthesiologist's task is to select the alternative approach best suited to each patient's specific features. Despite its use for both elective and unexpectedly difficult intubation, predictive criteria for successful airway management with the flexible fiberscope have not been developed.

The purpose of this study is to identify patient morphometric or morphological characteristics, if any, that could predict difficult intubation when using the flexible fiberscope for perioperative tracheal intubation in an elective surgical population.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older
* Patients undergoing elective surgery under general anesthesia, requiring endotracheal intubation

Exclusion Criteria:

* Induction planned without neuromuscular blocking agents
* Need for a rapid sequence induction
HCV Genotype 1a Shows a Better Virological Response to Antiviral Therapy Than HCV Genotype 1b

Sustained virological response (SVR) to antiviral therapy in patients with chronic hepatitis C genotype 1 according to subtype (1a vs.1b) has not been extensively investigated. This observational study was carried out on a large group of "naïve" HCV patients to evaluate difference, if any, between HCV genotype 1 subtype 1a and 1b on the response to treatment with peginterferon (Peg-IFN) plus ribavirin.

Despite the challenging perspective of the new antiviral drugs directly acting on hepatitis C viral replication such as protease and polymerase inhibitors, nowadays the standard treatment in genotype 1-chronic hepatitis C (CHC) is the combination of peghylated interferon (PEG-IFN) and ribavirin for 48 weeks. It has been extensively shown that patients infected with HCV genotype 1 have a lower rate of viral response than those infected with genotype 2 and 3. In large randomized multinational trials, sustained virological response (SVR) of around 50% has been obtained with peginterferon α2a plus ribavirin in the more difficult to treat subgroup of patients infected with HCV genotype 1. Furthermore, advanced fibrosis is a predictive factor of non response to antiviral treatment in genotype 1 virus \[5-7\]. Very few studies have evaluated SVR difference, if any, between subtypes 1a and 1b.

We have carried out an observational study on a large cohort of HCV "naïve" patients to evaluate the influence of HCV subtypes 1 on the response to treatment with Peg-INF plus ribavirin.

Eligibility Criteria:
Inclusion Criteria:

* eligible subjects were naïve infected with HCV genotype 1 virus meeting the internationally recognised criteria for treatment (elevation of aminotransferases, inflammation and or fibrosis at liver biopsy).

Exclusion Criteria:

* infection with human immunodeficiency virus (HIV) or hepatitis B virus (HBV)
* alcohol intake greater than 20 gr daily
* the presence of active drug abuse, chronic systemic disease, psychiatric disorders, autoimmune disease, pregnancy or lactation.
Treatment of Aggressive Behavior and Post-Traumatic Stress Disorder

Street children and children of vulnerable families in conflict or former conflict regions are often exposed to multiple traumatic events and situations in which they are forced to engage in violent behavior. The Narrative Exposure Therapy for violent offenders (NETvo) aims to reduce both PTSD symptoms and aggressive behavior. It helps the children to anchor fearful experiences and positive emotions linked to violent behaviour in the past. Additionally, visions for the future are developed in order to foster successful reintegration into society.


Eligibility Criteria:
Inclusion Criteria:

* Positive Emotions concerning aggressive behavior derived from expert interviews with higher Scores of the Appetitive Aggression Scale (AAS)
* children are part of an aid program for reintegration into society

Exclusion Criteria:

* current substance dependance or use of antipsychotic drugs
* chronically ill children
Cartilage Tissue Engineering

In this study, the investigators explored the hypothesis that osteoarthritic cartilage fragments can promote chondrogenesis of MSCs. Non-wearing parts of cartilage tissues were harvested from one osteoarthritic patient during the total knee arthroplasty surgery. Cartilage fragments and MSCs were wrapped into fibrin glue; and the constructs were implanted subcutaneously into nude mice.

Moreover, the investigators will collect the discard cartilage to develop an acellular cartilage ECM-derived scaffold in the joint replacement surgery. In addition, the investigators will harvest the redundant bone marrow from drilling or useless synovium during the surgery to separate the mesenchymal stem cells. Furthermore, these mesenchymal stem cells will be transfected with hTERT for rejuvenation and then will be labeled with fluorescent dye PKH26 for application of animal study. To sum up, the investigators plan to use human, natural, and discard materials from the joint replacement surgery to develop appropriate allograft for cartilage repair and hope that one day this ideal would be apply in clinical.

Extracellular matrix (ECM) is thought to participate significantly in guiding the differentiation process of mesenchymal stem cells (MSCs). In this study, we explored the hypothesis that osteoarthritic cartilage matrix can promote chondrogenesis of MSCs. Cartilage matrix was harvested from the health-like parts of osteoarthritic cartilage tissue. Cartilage fragments and MSCs were wrapped into fibrin glue; and the constructs were implanted subcutaneously into nude mice. Histological analysis showed a round and elongated cell appearance with positive Alcian blue staining of cartilage matrix formation in the constructs. However, the cells in fibrin glue only were condensed like MSCs in pellet culture. Immunohistochemical staining was abundantly positive for type II collagen in neo-cartilage regions of cartilage fragment-fibrin glue-MSC constructs, while the constructs without cartilage fragments were negative in staining for type II collagen. The gene expressions of type II collagen in the constructs with 60 mg fragments were significantly elevated after 4 weeks of implantation. Conversely, constructs without cartilage fragments failed to express type II collagen, which indicated that MSCs could not differentiate into a chondrogenic lineage. In conclusion, we demonstrated the effects of osteoarthritic cartilage matrix in promoting chondrogenic differentiation of MSCs. This was a favorable method without exogenous growth factors induction.

Eligibility Criteria:
Inclusion Criteria:

* 30-70 years old

Exclusion Criteria:

* more than 70 years old
Clinical Use of Baxter Animated Retching Faces (BARF) Scale in Children

Pediatric research in the management of nausea has been limited by the absence of a reliable method to quantify the intensity of this subjective symptom. In adults, the visual analog scale (VAS) is an accurate tool, but this has not been shown to be reliable in young children. By default the most common objective outcome measure used in pediatric studies has been the incidence and number of emetic episodes. This measure, however, correlates poorly with the somatic subjective symptom of nausea.

Pediatric research in the management of nausea has been limited by the absence of a reliable method to quantify the intensity of this subjective symptom. In adults, the visual analog scale (VAS) is an accurate tool, but this has not been shown to be reliable in young children. By default the most common objective outcome measure used in pediatric studies has been the incidence and number of emetic episodes. This measure, however, correlates poorly with the somatic subjective symptom of nausea.

Apfel et al have shown that 30-40% of adult patients undergoing surgery have post discharge nausea and / or vomiting while 12% have vomiting. These data on nausea in adults were based on a visual analog scale for nausea. There are no data on the incidence of postoperative nausea in children since the severity of symptoms are difficult to measure as younger children are known to be unable to use the VAS reliably.

Recently a pictorial scale for measuring nausea, the Baxter Animated Retching Faces (BARF) scale, has been developed and shown to have construct, content and convergent validity as an instrument to measure nausea in children. The clinical usefulness of this scale in determining the incidence of postoperative and post-discharge nausea in children has yet to be determined including the lowest age where it can be used reliably, the score associated with a patient's perception of a need for treatment, the minimum change in the scores of clinical relevance and the test-retest reliability when nausea is rated as not having changed.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 3 years but below 18 years
2. Elective surgery
3. American Society of Anesthesiologists physical status 1-3 (Free from major concurrent disorders)
4. Free from nausea and / or vomiting in the previous 24 hours
5. Cognitive, visual, hearing and communicative ability to use the VAS as shown by the ability to complete a seriation task in which children pick the biggest of 6 cut out shapes, then the smallest, and the biggest remaining until no shapes remain (Beyer et al: J Pediatr Nurs 1992; 7: 335-46)

Exclusion Criteria:

1. Developmental delay
2. Blindness
3. Impaired cognitive or communicative abilities including inability to rate the intensity of symptoms and failure to complete the seriation task
4. Surgical procedures which may result in diminished hearing or vision in the immediate postoperative period
5. Nausea and /or vomiting within 24 hours prior to the procedure
6. Inability to understand English,
7. Patient or parental refusal to participate
8. Pregnant females
Prediction of Clinical Outcome in Axillary Block

The primary endpoint of this study was to identify that Perfusion index (PI) has any predictive value for the treatment outcome of cervical radiculopathy

The interscalene brachial plexus block is an effective intervention for reducing postoperative pain but is related to side effects, Suprascapular nerve block and a block of the axillary nerve have been introduced as alternatives to the interscalene brachial plexus for the control of postoperative pain. Previous study demonstrated new method of axillary block using interfascial plane injection guided by ultrasoud. Axillary block has been used widely for the relief of postoperative arm pain.

Recent study deomonstrated good pain relief when ultrasound guided fascial plane injection was performed in patients with cervical radiuculopathy.

The perfusion index (PI) is a numerical value for the ratio between pulsatile and non-pulsatile blood flow measured by a special pulse oximeter. Although the special probe for PI measurement is relatively more expensive compared with ordinary pulse oximetery probes, its benefit as a marker of peripheral perfusion and as an idex for sympathetic stimulation have increased its use progressively. PI has been used widely for the prediction of success of brachial plexus block or axillary block. Changes of PI ratio value showed an excellent predictive value for the success of block.

There have been no studies demonstrating any predictive value of PI in axillary block for the relief of cervical radiulopathy

Eligibility Criteria:
Inclusion Criteria:

* Cervical foraminal stenosis
* Cervical central stenosis
* Cervical disc herniation
* Cervical spondylolisthesis

Exclusion Criteria:

* Infection
* pregnancy
* allergy to local anesthetic agents
* previous cervical spine surgery
Cholesterol Goal Attainment Rate and Its Associated Factors Among Dyslipidemic Patients on Lipid-lowering Drug Therapy in Korea

This is a multi-centre, cross-sectional, chart review study to investigate cholesterol goal attainment rates defined by modified NCEP-ATP III guidelines and define its possible determinants among Korean dyslipidemic patients

MC MD

Eligibility Criteria:
Inclusion Criteria:

* Patient who has a dyslipidemia with a lipid profile result within 3 months
* Patient who has a dyslipidemia without change of lipid lowering drug dosage during 3 months after lipid profile test.

Exclusion Criteria:

* Patient who involved in this study previously.
* Patient who participated in other clinical study with study drug within 90 days.
Clinical Comparison of DDT2 Contact Lens and a Daily Disposable Contact Lens - Study 2

The purpose of this study was to evaluate visual acuity at distance when wearing DDT2 contact lenses compared to Clariti contact lenses.

Subjects were expected to attend 3 study visits and wear the DDT2 and Clariti study lenses in a crossover design for approximately 14 - 20 days (7 - 10 days for each product).

Eligibility Criteria:
Key Inclusion Criteria:

* Able to understand and sign an Informed Consent Form that has been approved by an Institutional Review Board.
* Willing and able to attend all scheduled study visits as required per protocol.
* Current wearer of spherical soft contact lenses.

Key Exclusion Criteria:

* Any ocular condition that contraindicates contact lens wear.
* Previous or current habitual wearer of clariti® or DAILIES TOTAL1® contact lenses.
Chuna Manual Therapy for Cervicogenic Dizziness

This is a prospective, pragmatic, assessor-blind, randomized controlled trial to explore the effectiveness of an adjuvant Chuna manual therapy (CMT) for cervicogenic dizziness of Dizziness Handicap Inventory (DHI) ≥ 16 at baseline. Participants will be randomized and allocated to either CMT combined with usual care (UC) group or UC group with 1:1 ratio. They will receive 12 sessions of CMT or UC treatment for 6 weeks. UC consists of physical therapy and patients education.


Eligibility Criteria:
Inclusion Criteria:

* male or female aged between 20 and 70
* neck pain and/or stiffness with dizziness, which is related to movement or positioning of cervical spine
* recurring symptom of dizziness over 1 month or more
* Dizziness Handicap Inventory ≥ 16 at baseline
* Informed consent

Exclusion Criteria:

* dizziness induced by vestibular disorders (e.g., benign paroxysmal positional vertigo, peripheral vestibulopathy, Meniere disease, vestibular neuronitis)
* dizziness induced by central nervous system (CNS) disorders (e.g., cerebellar ataxia,cerebellum infarction/hemorrhage, demyelination, vertebrobasilar insufficiency, seizure, increased intracranial pressure, Parkinson's disease, migraines)
* dizziness induced by cardiovascular disorders (e.g., arrhythmia, heart valvular disease, anemia, orthostatic hypotension, coronary artery disease)
* dizziness induced by active or uncontrolled disease (e.g., uncontrolled diabetes mellitus, hypertension, respiratory or endocrinological disorders)
* dizziness induced by side effects of medications
* severe chronic or terminal diseases (malignant cancer, tuberculosis, etc.)
* chronic psychiatric diseases under treatment (epilepsy, depression, panic disorder, etc.)
* conditions where CMT are forbidden (spinal tumor, acute fracture, infectious spondylopathy, congenital malformations of spine, operation history of spine within 3 months, progressive neurological damage, severe neurological symptoms, spinal fixation devices, syringomyelia, hydrocephaly)
* Treatment history within 1 week for cervicogenic dizziness (NSAIDs, steroid, herbal drug, acupuncture, manual therapy)
* Women of (suspected) pregnancy or breast-feeding
* Suspicion of alcohol and/or drug abuse
* Participation in another clinical study within 1 month
* Difficulty in communicating with the investigators
* Other reasons for ineligibility of participation