cyrilzakka/clinical-trials huggingface dataset:
Outflow Reconstruction in Right Lobe Living Donor Liver Transplantation

Modified Right Lobe Graft(MRLG) is one of the most common used graft in liver transplantation .Anterior sector of allograft in MRLG usually congested to decrease this congestion tributaries of middle hepatic vein should be drained to inferior vena cava .

There are too many techniques available for this drainage using either cryopreserved or synthetic graft for vascular anastomosis .In this study we will compare between two different technique using ringed synthetic polytetrafluoroethylene (PTFE) graft to assess outflow adequacy in both technique.

Comparative, prospective, observational, two-groups study. group 1 : Middle Hepatic Vein(MHV) will reconstructed by fashioning a PTFE graft of suitable size positioned parallel to the cut surface of the Modified Right Lobe Graft.This position theoretically make the PTFE graft in a position similar to MHV.Any vein \>4mm will be connected end to side fashion to the PTFE graft.The distal end of the PTFE graft will be closed by hemolock just distal to segment 5 vein .The proximal end of PTFE graft will be anastomosed to the recipient MHV orifice or MHV/lift orifice group 2: The end of segment 5 vein will be anastomosed to the end of suitable size PTFE graft which will be anastomosed to Inferior Vena Cava (IVC) directly and The end of segment 8 vein will be anastomosed to the end of suitable size PTFE graft which will be anastomosed to MHV or MHV/Lift orifice directly.the study will not be randomized .All operation will be done by tha same team .Choice of technique at surgeon discretion .Outflow adequecy will be assessed by Doppler Ultrasound intraoperatively and daily for 5 day once per week for 4 week and ,2,3,6,month.Progressive diminished flow or absent flow both will be considered as graft not patent .Markers of venous congestion will be considered as secondary outcome measure.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing Living Donor Liver Transplantation(LDLT) accepted according to hospital protocol
* Written informed consent obtained
* patient undergoing venous reconstruction either segment 5 or segment 8 vein or both

Exclusion Criteria:

* Acute fulminant liver failure
Association Between Child's Psychological Resilience and Practicing Oral Habits

The aim of the present study is to determine the effect of psychological resilience on practicing oral habits among a group of 5- to 7-year-old children.

Psychological pressure has been thought to be a predisposing factor that might result in deleterious oral habits practicing. Shahraki et al. stated that increased stress levels are associated with oral habits as thumb sucking and nail biting. Leme et al. concluded that children and adolescents with DOH presented more symptoms of depression than their counterparts. Moreover, they were more likely to report symptoms of anxiety.

Ability to cope (or resilience) includes a person's sense of agency and their ability to think and behave, to make positive decisions, and to apply skills and knowledge to life challenges. The term resilience has come to mean an individual's ability to overcome adversity and continue his or her normal development.

The association between psychological resilience and practicing oral habits in children remains unclear, this study aims to reveal that association, if present.

Eligibility Criteria:
Inclusion Criteria:

* Medically free children

Exclusion Criteria:

-
Long Term Safety of Cooling Anesthesia for Intravitreal Injection

The purpose of this clinical study is to evaluate the long term safety and efficacy of cooling anesthesia application to the eye as anesthesia for intravitreal injection using a novel cooling anesthesia device.

Intravitreal injections have become the standard of care for administering medications for retinal diseases such as age related macular degeneration and diabetic macular edema.

There is considerable apprehension among patients receiving these injections, primarily revolving around adequate anesthesia during the injection. Current methods of anesthesia involve topical anesthetic drops, lidocaine gels, or subconjunctival injections of lidocaine, which suffer from either poor anesthetic effect, corneal irritation, or subconjunctival hemorrhage, as well as significant time for the onset of anesthesia.

Recens Medical has developed a novel medical device which can precisely and rapidly cool the surface of the eye This device cools to a temperature around -5 to -15 degrees Celsius, about the temperature of a cold ice cube, and thus has an excellent safety profile compared to conventional ophthalmic cryotherapy units. The value of such a device is both improved patient comfort, as well as increased efficiency and workflow for retina specialists administering intravitreal injections.

This device has been extensively tested in animal safety studies as well as pilot human studies and has not demonstrated any serious adverse effects and has shown anesthetic effects comparable to current standard of care.

The purpose of this clinical study is to evaluate the long term safety and efficacy of cooling anesthesia application to the eye as anesthesia for intravitreal injection using a novel cooling anesthesia device.

Eligibility Criteria:
Inclusion Criteria:

* Men and women \> 18 years old at screening visit.
* Men and women who are undergoing intravitreal injections in either one eye or both eyes with either Lucentis or Eylea as part of their normal standard of care with a 30 gauge needle.
* Subject has received a minimum of 3 intravitreal injections in the study eye prior to the study visit.
* Subject is willing and able to sign the study written informed consent form (ICF).

Exclusion Criteria:

* History of presence of scleromalacia
* Preexisting conjunctival, episcleral or scleral defects
* Less than 18 years of age
* Unable to provide informed consent
* Has received less than 3 injections in the study eye
* Active severe eye disease not controlled with artificial tears and requiring Restasis or other prescription drugs for dry eye.
* History of Endophthalmitis with intravitreal injection
* History of uveitis
* History of retinal detachment in either eye
* History of vitrectomy
* Subjects who received administration of cooling anesthesia as part of the COOL-1 study will not be excluded and are eligible to participate in this study.
Underlying Abnormalities in Fat and Muscle Leading to Lipodystrophy Syndrome

With the advent of highly active anti-retroviral therapy(HAART), patients with HIV disease are developing a series of metabolic abnormalities including peripheral fat wasting, increase in truncal fat, high serum triglyceride levels, insulin(a hormone that controls blood sugar) resistance with an increased incidence of Type 2 Diabetes Mellitus and elevated blood pressure. The premise of this study is that abnormalities in the ability of fat and muscle tissue to respond to the hormone insulin may be the cause of the diabetes mellitus, high serum triglyceride levels and abnormal fat distribution. The purpose of the study is to assess how insulin resistant patients with HIV disease are and if their fat and muscle tissue are responding abnormally to insulin. This is done by administering insulin and taking small tissue samples of fat and muscle from the upper thigh and assessing how good insulin acts in these tissues.

Patients with HIV disease will be admitted into the study after undergoing a screening medical history and examination. Once patients qualify, they will have their insulin resistance measured as well as the response of their fat and muscle to insulin; blood levels of glucose (sugar), cholesterol and triglycerides will be measured; body fat will be assessed using radiological tests; a detailed medical history will be obtained to assess risk factors for developing this syndrome.

Patients who are found to be insulin resistant will be offered a trial of an insulin sensitizing agent, called Avandia, for 6-12 weeks. It is hoped that the Avandia will restore the body's ability to respond normally to insulin (as it does in patients with Diabetes) and perhaps improve the fat abnormalities as well. All the same measures will be performed at the end of the course of Avandia as were done at baseline.

Patients who are not insulin resistant will be asked to come back yearly to assess whether they develop insulin resistance over time. This study will continue to recruit patients over the next 3 years.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Diagnosis of HIV or AIDS

Exclusion Criteria:

* Positive pregnancy test
* Diagnosis of cancer
* Acute illness (patients can be enrolled once stable)
* Hemoglobin less than 7.0 g/dl or acute heart problems
* Renal function greater than creatinine 1.5 mg/dl
* Liver dysfunction 3 times normal
* Use of medications like glucocorticoids and birth control pills
* Untreated hypertension
* Diabetes mellitus
Intravenous Acetaminophen for Craniotomy Patients

Adding intraoperative IV acetaminophen, in addition to standard analgesics, will decrease opioid requirements over the first 12 hours of postoperative recovery following craniotomy. Opioids exacerbate symptoms of nausea and vomiting. Reducing postoperative opioid use hopefully will reduce incidence of nausea and vomiting in patients after craniotomy.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Weigh at least 50 kg (110.23 lbs)
* Undergoing open, elective intracranial procedure for

  * tumor resection
  * aneurysm clipping
  * revascularization
* Have an ASA (American Society of Anesthesiologists) physical status of 1, 2, 3, or 4
* Able to provide written informed consent

Exclusion Criteria:

* Significant medical disease, laboratory abnormality, or condition that, in the opinion of the investigator, would compromise patient welfare or would otherwise contraindicate study participation
* Unable to communicate symptoms
* Current daily opioid use (\>40 mg morphine equivalent)
* Tramadol use
* Treated with MAO (monoamine oxidase inhibitors) inhibitors within 10 days of surgery
* Treated with any amount of acetaminophen within 8 hours of anesthesia for surgery
* Allergic or hypersensitive to acetaminophen or any contraindications per manufacturer's guidelines
* Pregnancy
* Impaired liver function
* Participation in interventional clinical study within the last 30 days
* Known or suspected history of alcohol or drug abuse
* Surgery for resection of acoustic neuroma
* Transphenoidal tumor resection
Population Pharmacokinetic Study of the Effect of Polymorphisms in the ABCB1 and CES1 Genes on the Pharmacokinetics of Dabigatran

According to published studies, the effects of genetic polymorphisms in the ABCB1 and CES1 genes on the blood concentration of dabigatran are controversial, and it is not clear whether dabigatran dosage and dosing intervals need to be adjusted according to genotype or other covariates in Chinese subjects. For these purposes, we will include patient demographics, genetic polymorphisms, and PK data based on a population pharmacokinetic study of dabigatran ester in healthy Chinese subjects to analyze the effect on dabigatran pharmacokinetics.

The aim of this study was to develop a population pharmacokinetic model to understand the relationship between dabigatran-related genes and dabigatran plasma levels after a single oral dose in healthy Chinese subjects and patients, and to analyze the effects of genetic variation on the efficacy and safety of dabigatran etexilate.


Eligibility Criteria:
Inclusion and exclusion criteria for healthy subjects were consistent with bioequivalence studies.

Inclusion Criteria:

1. Age 18-89 years;
2. ECG meeting the diagnostic criteria for atrial fibrillation;
3. Provide at least one valid blood sample for SNP testing;
4. no contraindication to anticoagulation, blood counts and coagulation times within normal reference values, and negative urine and stool occult blood;
5. not have had any stroke in the 6 months prior to enrollment.

Exclusion Criteria:

1. Cardiac ultrasound suggestive of moderate-to-severe mitral stenosis or after mechanical valve replacement;
2. severe hepatic injury or renal insufficiency (estimated glomerular filtration rate \[eGFR\] \<30 mL/(min\*1.73m2))
3. History of stroke or peripheral arterial embolism during dosing;
4. patients at high risk of bleeding, such as history of bleeding, hematologic disorders, other disorders requiring anticoagulant therapy, peptic ulcer and other bleeding, and blood pressure \>180/110 mmHg;
5. Combination of other serious diseases, such as malignant tumors, severe hepatic and renal insufficiency;
6. history of allergy to dabigatran and warfarin.
Predictive Value of Multimodal MRI in Parkinson's Disease

Deep brain stimulation (DBS) is recognized as the most safe and effective neurosurgical method for the treatment of advanced Parkinson's disease. However, the mechanism of relieving motor and non-motor symptoms of Parkinson's disease has not been fully clarified, and the prognosis is significantly different. This study is based on multimodal MRI technique to clarify the mechanism of DBS in relieving motor and non-motor symptoms of Parkinson's disease, and to explore imaging indicators that can predict prognosis, so as to guide the individual and accurate treatment of Parkinson's disease (PD).

1. Preoperative and postoperative multimodal MRI scanning 1) equipment: 3TGE 750 MRI 2) sequence: resting state fMRI, DTI, 3DTI, ESWAN, ASL 3) scan status: drug shutdown period ( discontinuation of drugs for Parkinson's disease for at least 12 hours), for patients who can not adhere to MRI scanning after drug withdrawal. Record the dosage of drugs before scanning
2. Evaluation of motor and non-motor symptoms: pre-operation and 1-year post-operation 1) motor symptoms: pre-operation medication opening and closing period. Postoperative medication off/stimulation off (Med-OFF/DBS-OFF);Med-ON/DBS-OFF;Med-OFF/DBS-ON;Med-ON/DBS-ON

   1. overall evaluation of motor function: MDS-UPRDS, H\&Y stage
   2. balance: Berg balance scale
   3. dyskinesia: abnormal involuntary movement scale(AIMS)
   4. end-of-dose phenomenon: WOQ19 end-of-dose phenomenon questionnaire
   5. daily activity ability: SCHWAB\&ENGLAND daily activity scale 2) non-motor symptoms: preoperative drug shutdown period. Postoperative drug shutdown / DBS opening

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   1. Cognitive function: Mini Mental State Examination scale (MMSE), Montreal Cognitive Assessment scale (MoCA)
   2. emotion: Hamilton Depression scale (HAMD), Hamilton anxiety scale (HAMA)
   3. Sleep: PD Sleep scale (PDSS), Appleworth sleepiness scale (ESS), REM Sleep Behavioral Disorder questionnaire-Hong Kong (RBDQ-HK)
   4. pain: King Parkinson's disease pain scale (KPPS)
   5. fatigue: fatigue severity scale (FSS)
   6. autonomic nervous function assessment: autonomic nervous scale (SCOPA-AUT) h) quality of life: 39 items Parkinson's disease quality of life questionnaire (PDQ-39) 3.other records: changes in type, dose and mode of use of drugs. Daily equivalent dose of levodopa (tomlinson2010 conversion)

Eligibility Criteria:
Inclusion Criteria:

* Patient with Parkinson's disease
* age\< 70 years
* Underwent bilateral STN-DBS or not
* Having complete medical history and clinical follow up
* All MRI examination performed according to study protocol
* Imaging data can be processed
* Signed informed consent obtained from the patient or patient's legally authorized representative;

Exclusion Criteria:

* Parkinson-plus syndrome or secondary parkinsonism
* Patients with severe mental disorders such as psychosis, liver and kidney dysfunction, poor blood pressure or blood glucose control, severe depression and substance abuse, low IQ, and acute phase of severe stroke with definite limb dysfunction should also be excluded.
Treatment for Eye Bag Using Micro-insulated Needle Device

The investigators treated twenty-four subjects with lower eyelid fat bulging using the needle radiofrequency system. After treatment, a three-dimensional photogrammetry system was used to objectively measure the change in height of the fat bulge.

Materials and Methods

Subjects

Twenty-four volunteers (4 males and 20 females) with lower eyelid fat bulging were enrolled in this study. The average age of these subjects was 56±6.28 years. The exclusion criteria were as follows: Prior cosmetic facial surgery within the past 1 year, placement of tissue fillers within the last 6 months, laser therapy or chemical peeling of midface within the preceding 3 months, and the use of topical retinoids for the face within the past 1 month. The study protocol was approved by the institutional review board Seoul National University Bundang Hospital and informed consent was obtained from all subjects prior to participation.

Treatment protocol

All treatments were performed under local anesthesia with 1% lidocaine and 1:100,000 epinephrine. To minimize the impact on the treatment area, the least amount of anesthesia required was injected. The amount of AGNES micro-insulated needles with radiofrequency applicators (Gowoonsesang Cosmetics Co, Seongnam, Gyeonggi, Korea) were used to treat the lesions. This device is a monopolar radiofrequency system with 1MHz wavelength. The needles were composed of two parts: The proximal insulated area and the distal non-insulated area. Proximal insulation preserves the epidermis from thermal damage, allowing the procedure to be non-ablative and minimally-invasive.

Subjects were treated in two separate sessions, at intervals of four weeks. Two types of needle tips were used sequentially in each session; one is a tip with three 1.5mm-length short needles with proximal 0.3mm insulation, while the other is a tip with single 5mm-length long needle with proximal 2.5mm insulation. First, periorbital area was treated with the short needles (exposure time 150ms, power 9W) to tighten the overlying dermis. Then, the fat pocket itself was treated additionally with the long needle (exposure time 400ms, power 9W) to tighten the orbital septum and directly damage the fat cells. Each insertion site was about 1mm apart. After treatment, the treated areas were cooled with ice packs for 20min and topical antibiotic was applied. All subjects were instructed to cleanse their face gently with tap water and avoid sun exposure until next day.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult with age of 40s or more
* Who has lower eyelid fat bulging

Exclusion Criteria:

* History of keloid or hypertrophic scar
* Pregnant woman,
* On breast feeding
* Active skin disease on lesional skin
* Who has severe allergy
* History of bleeding disorder
Study of the Sars-Cov2 Neuroinvasiveness - COVID19

Sars-Cov2 (COVID-19) may invade the CNS inducing neurological diseases such as anosmia, ageusia, encephalitis, ischemic or hemorrhagic stroke. Management of severe neurological complications in COVID-19 patients may require ventricular cerebrospinal fluid drainage and cranial decompression. During surgery, cerebrospinal fluid, meninges and brain parenchyma can be safely removed from the patient. In this study, COVID-19 patients will be evaluated first, for the presence of Sars-Cov2 in the cerebrospinal fluid and/or biopsies and second, for the consequences of Sars-Cov2 neuroinfection in terms of inflammatory and immune responses.


Eligibility Criteria:
Inclusion Criteria:

* COVID-19 patients requiring an external ventricular drain, a decompressive craniectomy or an intracranial hematoma surgery

Exclusion Criteria:

* Pregnant or lactating women
Sofosbuvir, Daclatasvir, Ribavirin for Hepatitis C Virus (HCV) Cirrhotics

The investigators will treat 100 patients with cirrhosis due to hepatitis C with sofosbuvir 400 mg daily, daclatasvir 60 mg daily and weight-based ribavirin (1000 mg/d if \<75 kg, 1200 mg/d if \>75 kg, divided in two daily doses) for 12 weeks and calculate the sustained viral response rate at 12 weeks.

Cirrhosis due to Hepatitis C presents a rather difficult treatment problem as many cannot tolerate interferon, the previous standard of treatment. The new direct acting antivirals have provided these patients with a new hope. One such combination is sofosbuvir (SOF) 400 mg and daclatasvir (DCV) 60 mg given once daily with or without weight-based ribavirin (RBV) for 12 or 24 weeks. The current recommendation for cirrhotics is SOF/DCV/RBV for 24 weeks but that recommendation is based on the lack of data for shorter periods. In order to evaluate the response rate to the combination of SOF/DCV/RBV the investigators decided to treat 100 HCV cirrhotics with this combination for 12 weeks. Subjects include genotype 1 and 3 patients, the prevalent genotypes in Iran. Patients with Model for End stage Liver Disease (MELD) \> 20 are excluded. The investigators will calculate the sustained viral response rate at 12 weeks (SVR12).

Eligibility Criteria:
Inclusion Criteria:

* Positive qualitative HCV RNA test on two occasions at least 6 months apart
* Cirrhosis proven by either of: 1. Liver biopsy, 2. Liver elasticity \> 12 kilopascal (KPa), 3. Clinical certainty (ascites, splenomegaly, small liver, low albumin, low platelet)

Exclusion Criteria:

* Renal failure (eGFR \< 30 cc/min),
* MELD score \> 20,
* Child's C (CTP score \> 12),
* Heart rate \< 50/min,
* Taking amiodarone
Correlation and Clinical Utility of Urinary Biomarker in Membranous Glomerulonephritis

To assess the correlation of these urinary biomarkers with the serum sample and evaluated the clinical utility of using urinary sample in the detection and prognostication of MGN. Fifty patients with newly diagnosed biopsy proven MGN would be recruited and followed up for 1 years. Serum and urinary biomarkers would be collected every 4 months and their antibody titres measured with ELISA assay.

The uses of phospholipase A2 receptor and thrombospondin domain containing 7A antibodies have transformed the management of membranous glomerulonephritis (MGN). However, these are mostly based on serum and the utility of urinary biomarkers are yet to be established.

The aim of this study is to assess the correlation of these urinary biomarkers with the serum sample and evaluated the clinical utility of using urinary sample in the detection and prognostication of MGN. Fifty patients with newly diagnosed biopsy proven MGN would be recruited and followed up for 1 years. Serum and urinary biomarkers would be collected every 4 months and their antibody titres measured with ELISA assay.

The primary outcome would be the correlation of the urinary biomarkers with the corresponding serum markers. The secondary outcome would be the correlation of the urinary biomarkers with clinical parameters such as the slope of eGFR decline, composite renal events such as time to need for renal replacement therapy or renal death and response to treatments.

By establishing the clinical correlation of these urinary biomarkers, the use of such biomarkers would be a more attractive option given its non-invasive nature and conveniences as compared to serum samples.

Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed biopsy proven primary membranous glomerulonephritis

Exclusion Criteria:

* secondary causes of membranous nephropathy, e.g. lupus nephritis, viral hepatitis B and C and malignancy