cyrilzakka/clinical-trials huggingface dataset:
DUPIlumab Dose REDUCtion in Patients With Controlled Atopic Eczema

The goal of this randomized controlled trial is to study the (cost)effectiveness of extending the intervals between dupilumab doses in patients with well-controlled atopic eczema, while considering physician- and patient-reported disease severity, quality of life, and dupilumab serum trough levels. Patients will be divided randomly into three groups, receiving dupilumab 300 mg every 2 weeks, every 3 weeks, or every 4 weeks. Researchers will then compare the outcomes among these three groups.

While dupilumab is an effective treatment for atopic eczema, it is expensive and not without the risk of unwanted adverse events. Aiming for the lowest possible dose is important. The currently approved dose is a single loading dose of 600 mg, followed by 300 mg every 2 weeks. However, there is evidence that the intervals between doses could be extended in disease-controlled patients while maintaining the same effectiveness. The objective of this study is to assess the (cost)effectiveness and safety of dupilumab dose reduction in patients with controlled atopic eczema. A multicenter, single-blinded, non-inferiority randomized controlled trial will be performed, that is embedded in the TREatment of ATopic eczema (TREAT) NL registry. Adult patients who are already undergoing dupilumab treatment and meet the Treat-to-Target criteria will be assigned randomly to one of three groups: receiving dupilumab 300 mg every 2 weeks, every 3 weeks, or every 4 weeks. The study will cover a duration of 24 weeks, during which participants will have three hospital visits (at week 0, week 16 and week 24) and one telephone appointment (at week 8). These sessions will involve assessments of both physician and patient-reported disease severity, quality of life and the evaluation of dupilumab serum trough levels. Please refer below for a comprehensive overview of the outcome measures.

Eligibility Criteria:
Inclusion Criteria:

* The subject is an adult,
* Has a diagnosis of AE,
* Receives dupilumab 300 mg q2w for the treatment of AE,
* Has controlled disease according to the Treat-to-Target criteria,
* Agrees to the possibility that the dosage of dupilumab will be lowered,
* Has voluntarily signed and dated an informed consent prior to any study related procedure.

Exclusion Criteria:

* The subjects uses or initiates another systemic immunomodulating therapy for AE or another diagnosis.
Isolated Vascularized Gastric Tube Biliary Enteric Drainage: A Paediatric Case Series Experience.

This was a retrospective case series experience of paediatric patients who had an Isolated vascularized gastric tube biliary enteric drainage procedure for biliary obstruction over the past five years. We reviewed our experience and outcomes.

Background

Despite the enormous surgical advancements in the last century, access to the biliary system is lost when a Roux-en-Y (RY) biliary drainage procedure is performed. Attempts have been made to overcome this inconvenient sequel of RY biliary drainage by the use of variations in the RY anastomosis, small bowel grafts and vascular grafts. These have been predominantly unsuccessful. The use of an Isolated Vascularized Gastric Tube (IVGT) graft has been reported in the literature, and this was successfully used for adult patients with common bile duct injuries. The investigators have adopted the technique of using an IVGT graft for bile duct reconstruction in the paediatric patients at their institution.

Method

The investigators reviewed theirr experience at Greys Hospital, Pietermaritzburg. This was a retrospective review of all paediatric patients who had undergone an IVGT graft procedure for biliary tract anatomical obstruction in the past five years. The investgators looked at the indications for surgery, the demographic profile of the patients, outcomes following surgery and outlined the surgical technique used.

Eligibility Criteria:
Inclusion Criteria:

* All patients from birth to 12 years with biliary tract obstruction requiring surgery.

Exclusion Criteria:

* biliary atresia
Red Grape Polyphenol Oral Administration to Women Affected by Nickel-mediated Allergic Contact Dermatitis

Nickel (Ni)-mediated allergic contact dermatitis (ACD) is a very common disease worldwide. Our previous findings demonstrated that in vitro supplementation of polyphenols, extracted from seeds of red grape (Nero di Troia cultivar), to peripheral lymphomonocytes from Ni-mediated ACD patients could reduce release of T helper (h)1 \[interferon (IFN)-\] and Th2 \[interleukin (IL)-4\] cytokines, on the one hand. On the other hand, IL-10 (an anti-inflammatory cytokine) levels increased with a reduction of IL-17 (an inflammatory cytokine). Also levels of nitric oxide (NO) decreased in response to polyphenol pretreatment.

Nickel (Ni) is a transitional metal largely distributed in the environment whose continuous exposure is able to provoke local and systemic allergic contact dermatitis (ACD). Ni-mediated ACD is characterized by loss of epidermal integrity, urticaria/angioedema, flares, and itching, whose extent depends on many variables such as genetic, time of sensitization and environmental exposure.The aim of the present research is to verify whether the oral administration of polyphenols (NATUR-OX®) to patients with Ni-mediated ACD is able to modify immune parameters.

Eligibility Criteria:
Inclusion Criteria:

* Female patient; Age: 25-60 Years; Ni-mediated ACD (positive reaction to the nickel patch test)

Exclusion Criteria:

* Absence of other pathologies such as immune-mediated diseases, metabolic diseases (diabetes and obesity)
* infectious episodes in the last month and intake of immunosuppressive drugs or drugs influencing the immune response.
Effect of Administration of Resveratrol on Glycemic Variability in Individuals With Type 2 Diabetes Mellitus

Type 2 diabetes mellitus \[ T2DM \] has quickly become the epidemic of the XXI century and challenging global health . Estimates of the World Health Organization \[ WHO \] indicate that globally , from 1995 to date has nearly tripled the number of people living with diabetes mellitus \[DM \]. Resveratrol has been extensively studied as a regulator of glucose through its antioxidant effects and protecting pancreatic β cells by activation of sirtuin -1 \[ SIRT1 \] dependent deacetylase nicotinamide adenine diphosphate \[ NAD \]. Therefore, it is important to know the effect of resveratrol on the glycemic variability \[GV \] in patients with T2DM who are not in control with metformin monotherapy based.

The objective is to evaluate the effect of administration of resveratrol on GV in individuals with T2DM inadequately controlled on metformin, for which we will conduct a double-blind trial, randomized, placebo control group, each group 11 male and female patients 30-60 years of age with T2DM inadequately controlled with metformin \[2000 mg / day and glycosylated hemoglobin A1c (A1C) ≥% 7\], with body mass index \[BMI\] form 25.0 to 34.9 kg / m2. Randomization will determine who will receive the intervention during the 8-week trial \[resveratrol capsules, 500 mg 3 times daily with the first bite of each meal or approved placebo capsules\], both groups also continue with metformin. The clinical findings and laboratory tests include a metabolic profile and biosafety, which will be made at baseline and at 8 weeks. Body weight, body fat, BMI and blood pressure will be determined during the initial and final visit, likewise, plasma glucose concentrations every hour recorded over 72 hours by continuous monitoring system outpatient glucose \[MACG\] via iPro ™ 2 \[Medtronic MiniMed, Northridge\] system, through which the mean amplitude of glucose excursions \[MAGE\] is calculated and AUC glucose, which will serve to assess the GV. Adverse events and adherence to treatment will be documented. Statistical analysis: Mann-Whitney U test, Wilcoxon and Fisher exact test. It is considered with significance at p \<0.05.

Eligibility Criteria:
Inclusion Criteria:

* BMI from 25.0-34.9 kg/m2
* Diagnosis of T2DM
* Fasting plasma glucose \>130 and \<250 mg/dl at the time of scrutiny
* A1C between 7 and 10%
* Metformin monotherapy
* Written informed consent

Exclusion Criteria:

* Women pregnant or breastfeeding
* Untreated thyroid disease and/or uncontrolled hypertension \[≥150 systolic and diastolic ≥90\]
* Consumption of oral agents or other medications or supplements, unlike metformin, with proven properties that modify the behavior of glucose
* Total cholesterol \>400 mg/dL
* Triglycerides ≥400 mg/dL
* Liver enzymes \[ALT and AST\] more than twice the normal range
* Glomerular filtration rate \<60 mL/min \[Cockcroft-Gault\]
Quantifying Steatosis in Liver Transplant Donors

Non-alcoholic fatty liver disease is the most common chronic liver disease in Hong Kong. Its presence among donors of living donor liver transplants could affect the outcomes of recipients of liver transplantation. By using controlled attenuation parameter (CAP) measurements, the investigators aim to investigate the association of CAP measurements and severity of fatty liver among liver donors in the recipient outcomes of living donor liver transplantation.

Living donor liver transplantation (LDLT) has been increasing worldwide due to the critical shortage of cadaveric donors and the rising number of patients awaiting liver transplantation. The long-term survival rates of LDLT are now comparable to that of deceased donor liver transplantation. Currently, two-thirds of all liver transplants performed in Hong Kong are LDLT.

The ultimate goal of LDLT is to guarantee donor safety while optimizing the best possible recipient outcome. Donor liver steatosis is a well-known factor which could influence graft function and long-term outcomes of the recipient allograft, and also affects donor hepatic recovery. When needed, pre-operative liver biopsy is often used for the quantitative assessment of donor steatosis, with LDLT not recommended when steatosis exceeds 30%. Nonetheless, liver biopsy is limited by its invasive nature, sampling error and intra-observer variations. Imaging evaluation for the quantification of steatosis via ultrasonography or computed tomography also has various pitfalls. There is currently no universal consensus on the ideal method in assessing donor steatosis.

Controlled attenuation parameter (CAP) is a novel non-invasive method to quantify hepatic steatosis using ultrasonic attenuations to postulate fat content. It has been demonstrated to have good correlation with the degree of hepatic steatosis in both Western and Asian populations. The investigators aim to evaluate the application of CAP in the donor workup of LDLT and to investigate for its association with post-transplant outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-60 LDLT donor who has completed donor workup
* Consents to study entry

Exclusion Criteria:

* Concomitant liver disease, including chronic hepatitis B and C infection, autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, Wilson disease, and increased alcohol intake (30g per week for male, 20g per week for female).
Acupuncture With Deqi And Psychological Effects in Treatment of Bell's Palsy

The purpose of this study is to observe the influence of Deqi and neuropsychological factors on effects of acupuncture treatment for Bell's Palsy.

Through long-term clinical practice，acupuncture treatment on facial paralysis has been generally proved effective；the large number of ancient and modern medical literature also have suggested that acupuncture is beneficial for facial paralysis. However,a scientific basis is still needed to be established to make sure the efficacy of acupuncture be recognized internationally.This study will adopt a series of international practice scales ,such as House Brackmann Scale,Facial Disability Index(FDI),World Health Organization Quality of Life-BREF (WHOQOL-BREF), Cattell Personality Factors (16PF),and Cancellation test to evaluate the role of deqi and neuropsychological factors in the acupuncture treatment for Bell's Palsy.

Eligibility Criteria:
Inclusion criteria:

1. Patients who were diagnosed to have unilateral facial-nerve weakness without any identifiable causes within 168 hours after onset of symptoms;
2. aged 18 to 65 years.

Exclusion criteria：

1. illiterate;
2. the facial paralysis is caused by herpes zoster;
3. recurrent facial paralysis;
4. noticeable asymmetry of the face before the illness which may affect the evaluation;
5. history of peptic ulcer disease, severe hypertension, uncontrolled diabetes, liver and kidney dysfunction, pregnancy, mental illness, or serious systemic diseases which may affect the treatment.
Examining the Effectiveness of Multiwave Locked System Laser Treatment in Chronic Low Back Pain

Patients who come to Tavşanlı Assoc. Prof. Dr. Mustafa Kalemli State Hospital, Physical Therapy, and Rehabilitation Department who have been diagnosed with Chronic Low Back Pain by a physician will be included. Patients will be divided into two groups by the physician: conservative treatment and patients whose treatment program is determined as multi-wave locked system laser treatment in addition to conservative treatment. Pain intensity will be measured with a numerical pain rating scale. The Roland-Morris disability questionnaire will be used to evaluate the functionality of the participants, and the esthesiometer will be used to assess tactile acuity. Pressure pain threshold will be evaluated with the MicroFET 2 device. The Turkish Form of the SF-12 Quality of Life Scale will be used to assess the participants' quality of life. Pittsburgh's sleep quality index will be used to evaluate sleep quality. Patient satisfaction will be evaluated with a numerical rating scale.


Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-65
* Volunteering to participate in the study
* Having low back pain that has persisted for at least 3 months

Exclusion Criteria:

* History of surgery in the waist area
* Discopathy at a different level of the spine (Modic Type 3)
* Presence of tumor in the spine
* Infection in the discs
* Having an inflammatory disease
* Presence of neurological involvement
* Fracture
* Spondylosis
* Spinal Stenosis
* Spondylolisthesis
* Radiculopathy
* Having received treatment for low back pain in the last 3 months
The Effect of McGrath Video Laryngoscope on the Glottic View at Thyroid Surgery Position

For thyroid surgery, the special body position (thyroid surgical position) to exposure the patient's neck should be needed. For intraoperative neuromonitoring (IONM) in thyroid surgery, the tube should be placed at a specific position. A video laryngoscope can have advantages in tracheal intubation on thyroid surgical position for thyroid surgery. The purpose of the study is to investigate the effect of McGrath video laryngoscope on the glottic view when tracheal intubation is performed at the thyroid surgical position.

For thyroid surgery, the special body position (thyroid surgical position) to exposure the patient's neck should be needed. Meanwhile, the tracheal tube can be moved in the trachea from the supine position to thyroid surgical position if tracheal intubation is performed at the supine position. For intraoperative neuromonitoring (IONM) in thyroid surgery, the electrode of the tracheal tube must be placed at a specific position, that is between the vocal cords. To perform initially tracheal intubation on the thyroid surgical position, therefore, can have advantage in terms of stability of tube position in the trachea without displacement by body position change. However, tracheal intubation on thyroid surgical position might be hard in terms of obtaining a good glottic view. It is well known that video laryngoscopes can improve the glottic view. Therefore, a video laryngoscope can have advantages in tracheal intubation on thyroid surgical position for thyroid surgery in obtaining the good glottic view as well as minimal displacement of the tracheal tube because there is no need to change the patient's position. The purpose of the study is to investigate the effect of McGrath video laryngoscope on the glottic view when tracheal intubation is performed at the thyroid surgical position.

Eligibility Criteria:
Inclusion Criteria:

* patients schedule to thyroid surgery

Exclusion Criteria:

* disagree to participate
* patients with weak teeth
Evaluation of Etafilcon A Daily Disposable Lenses

To evaluate the clinical performance of daily disposable etafilcon A lenses.


Eligibility Criteria:
Inclusion Criteria:

* The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
* The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
* The subject must be at least 18 and not more than 70 years of age.
* The subject's refractive cylinder must be \< 1.00 Diopters (D) in each eye.
* The subject must have best corrected visual acuity of 20/25 or better in each eye.
* The subject's required spherical contact lens prescription must be in the range of -0.50 to -7.50 D in each eye.
* The subject must be a habitual and adapted wearer of daily disposable contact lenses in both eyes.
* The subject must self-report their race as Asian
* The subject must have normal eyes (i.e., no ocular medications or infections of any type).
* The subject must demonstrate adequate mobility and 20/30 vision oculus dexter (OD) and oculus sinister (OS) with the study contact lenses.

Exclusion Criteria:

* Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
* Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
* Any systemic disease, autoimmune disease, or use of medication that may interfere with contact lens wear.
* Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia.
* Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser in-situ keratomileusis (LASIK), etc.).
* Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.
* Any ocular infection.
* Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
* Monovision or multi-focal contact lens correction.
* Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
* History of binocular vision abnormality or strabismus.
* Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV, by self report).
* Suspicion of or recent history of alcohol or substance abuse.
* History of serious mental illness.
* History of seizures.
* Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)
Treatment of Complex Anal Fistula With Draining Seton With or Without Rerouting of Track

This randomized trial aimed to compare conventional draining seton with or without rerouting of the fistula track in treatment of complex anal fistula

Placement of seton is typically employed when the fistula track is involving more than 30% of the external anal sphincter. However, attempts to reroute the seton and the involved fistula track were made to preserve the external anal sphincter fibers and hasten healing of the anal wound. Mann and Clifton first introduced a transposition technique for the management of high anal and anorectal fistulas by re-routing the extrasphincteric portion of the track into an intersphincteric position with immediate repair of the external sphincter and reported successful outcomes of five patients in terms of quick healing and preserved anal continence.

The present study aimed to evaluate the outcome of draining seton with or without rerouting of the fistula track in treatment complex high anal fistula regarding healing time, postoperative pain, and incidence of recurrence and FI postoperatively. We hypothesized that rerouting the seton to include the fistula track and the internal anal sphincter only, preserving the external anal sphincter muscles, would serve to hasten healing and decrease the incidence of recurrence and continence disturbances.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients of both genders aging below 60 years old with complex crypto-glandular anal fistula were included. Complex anal fistula were defined as high trans-sphincteric anal fistulas involving more than 30% of the external anal sphincter fibers, suprasphincteric, extrasphincteric, and horse-shoe fistula

Exclusion Criteria:

* Patients with simple anal fistula.
* Patients with acute anorectal sepsis.
* Patients with secondary anal fistula caused by inflammatory bowel diseases, sexually transmitted diseases, malignancy, or irradiation.
* Patients with associated anorectal conditions as hemorrhoids, anal fissure, rectal prolapse, or malignancy.
* Patients with history of previous surgical treatment of anal fistula.
* Patients with symptomatic preoperative fecal incontinence.
Study Comparing the Efficacy and Safety of ABT-874 to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Compare the efficacy of ABT-874 versus etanercept in subjects with moderate to severe plaque psoriasis


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Psoriasis for 6 mo.
* BSA 10%, PASI 12 or above, PGA 3 or above

Exclusion Criteria:

* Previous exposure to either etanercept or ABT-874
Hypothermia in Cesarean Sectio Patients in Regional Anaesthesia

To study the core temperature perioperatively in patients due for elective cesarean sectio in spinal anaesthesia.

Core temperature will be registered by a zero-flux (SpotOn. 3m) probe on the forehead, starting in the holding area and continued until normotemperature post-operatively.


Eligibility Criteria:
Inclusion Criteria:

* Elective patients
* planned spinal anaesthesia

Exclusion Criteria:

* Conversion of procedure to general anaesthesia
* allergy to temperature probe (adhesive)
4G/5G Polymorphism of Plasminogen Activator Inhibitor-1 Gene and Disseminated Intravascular Coagulation in Severe Sepsis and Septic Shock

Data on 4G/5G polymorphism of plasminogen activator inhibitor-1 (PAI-1) gene are limited in Asian patients with sepsis. Therefore, the investigators aim to prospectively investigate the incidence of 4G/5G polymorphism and its relationship with disseminated intravascluar coagulatin in patients with severe sepsis and septic shock.


Eligibility Criteria:
Inclusion Criteria:

* Adult patinents aged \> 18 years, Patients satisfying the criteria by 2008 Surviving Sepsis Campagin, Patients who are determined as having a sepsis within 24 hours of ICU stay

Exclusion Criteria:

* Do-not-resuscitate, cardiopulmonary resuscitation, ICU stay \< 1 day, Refusal to participate in the study, Hematologic malignancy or liver cirrhosis (Child C), Congenital abnormality in coagulation system, Transfer from other ICUs or hospitals