cyrilzakka/clinical-trials huggingface dataset:
Study to Compare Efficacy of Topical ARYS-01 (Sorivudine) Cream 3%, Oral Valaciclovir and Combination ARYS-01 Cream 3%/Oral Valaciclovir for Treatment of Herpes Zoster (Shingles)

A multi-center, randomized, 4-arm, placebo-controlled, double-blind efficacy study of ARYS-01 (sorivudine) cream 3%.

More than 95% of people are infected with varicella Zoster virus (VZV) at one time of life or another. Primary VZV infection manifests as varicella (chicken pox). The virus then establishes a latent infection of the sensory ganglia from which it may reactivate years later to produce the clinical syndrome of Herpes Zoster (shingles). The initial cutaneous VZV lesions are pruritic, erythematous macules; and the lesions progress through maculopapular stage to vesicular, ulceration and crusting phases. The crusting phase signals the beginning of the healing process, and begins with clouding of the vesicular fluid, within about 24 to 48 h after the appearance of each lesion. This is a Phase 2 study to assess: 1) the overall benefit of ARYS-01 (sorivudine) cream 3% vs. Placebo cream (with immediate or delayed use of Valaciclovir therapy) on Herpes Zoster rash healing rates and postherpetic neuralgia (PHN), 2) the efficacy of ARYS-01 cream 3% vs. Placebo cream, prior to initiation of Valaciclovir, to build evidence for monotherapy treatment benefit of ARYS-01 cream on the initial onset of Herpes Zoster symptoms, 3) the efficacy of ARYS-01 cream 3% vs. Placebo cream, with immediate or delayed initiation of Valaciclovir, for synergetic effects on the initial onset of Herpes Zoster symptoms.

The primary efficacy endpoint is the effect of ARYS-01 cream (with or without Valaciclovir) on the reduction of the crusting stage of VZV rash present at Day 8. Secondary endpoints include time to cessation of new lesion formation, and time to cessation of Zoster-associated pains, pain intensity, rash healing and size reduction, and lesion dissemination.

Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age
* diagnosed with herpes zoster
* confirmed for VZV with lesion swab at screening and subsequent PCR test.
* contraception for women of child-bearing potential
* be able to communicate with investigator and compliant

Exclusion Criteria:

* cytotoxic or immunosuppressive drugs within 3 mos, 5-FU or its pro-drugs, tricyclic antidepressants, probenecid, topical or systemic antiviral drugs or immunomodulatory agents for viral infection
* herpes zoster ophthalmicus
* female patients who are pregnant and/or nursing or planning a pregnancy
* congenital, acquired or corticosteroid-induced immunodeficiency, including malignancy
* renal insufficiency or creatinine level \>2mg/dL
* clinical significant liver enzyme abnormalities and any other laboratory abnormalities determined by the screening lab
* history of intolerance or hypersensitivity to the cream components
* current significant skin disease within affected dermatome
* history of positive result for hepatitis B surface antigen, hepatitis C virus, or HIV
* current participation in another clinical drug research study
Phase II Long Term, Randomized Study of Recombinant Human Insulin-like Growth Factor I in Children With Hyperinsulinism

OBJECTIVES:

Evaluate the safety and efficacy of long term recombinant human insulin-like growth factor I in children with hyperinsulinism.

PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, cross-over study.

Patients are randomized to receive recombinant human insulin-like growth factor I (IGF-I) or placebo subcutaneously twice daily for 4 weeks. After a 2 week washout period, patients are crossed over to the other regimen for an additional 4 weeks.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Diagnosis of hyperinsulinism (i.e., evidence of fasting hypoglycemia with inadequate suppression of insulin, normal pituitary and adrenal function, and increased insulin action) Suboptimal control of blood sugar (i.e., inability to fast at least 10 hours with a blood sugar of 60 mg/dL or greater) --Prior/Concurrent Therapy-- See Disease Characteristics --Patient Characteristics-- Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other major medical conditions No known adverse reaction to recombinant human insulin-like growth factor I
Survival Model for Preterm Infants

Study Title Predictive Model of Mortality and Major Morbidity in Preterm Neonates in the Perinatal Period Internal ref. no. / short title Survival Model Study Design Observational Population-based Cohort Study Planned Sample Size Retrospective analysis of Database Planned Study Duration 6-months Primary Objectives To derive a mathematical model for predicting mortality and the composite of mortality/major-morbidity before and immediately after birth in preterm infants Secondary Objectives Statistical Methodology and Analysis Mixed-model multivariable logistic regression analysis


Eligibility Criteria:
Inclusion Criteria:

1. Preterm infants born alive at or less than 34 weeks of gestation.
2. Born in Welsh maternity and admitted for care to a Welsh neonatal unit.
3. Mother normally resident in Wales

Exclusion Criteria

1. The mother is normally resident in England (detailed maternal data not available)
2. Congenital anomaly noted at birth (alters the natural probability of outcomes)
3. Duplicate episodes for an individual infant
Correlation Between Macular Ischemia and Peripheral Ischemia in Patients With Diabetes

The contribution of OCT- angiography (OCT-A) allows to consider, in a more or less long term, a drastic reduction in the use of fluorescein angiographies in diabetic retinopathy. The accuracy of the analysis of the vascularization of retinal layers of the posterior pole of the eye by the OCT-A , will detect, early and in a quantifiable manner, whether or not there are areas of macular ischemia in a patient. However, current technical limitations (small field analysis) of OCT-A imaging only allow a limited study of retina at the posterior pole of the fundus.

This study seeks to demonstrate whether there is a link between macular ischemia detected by the OCT-A and peripheral retinal ischemia detected by the fluorescein angiographies, in diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

* diabetes type I or type II
* follow-up with fluorescein angiography

Exclusion Criteria:

* known allergy to fluorescein
* contra-indication to fluorescein angiography
* pregnant or breast-feeding patient
* technical impossibility to analyse retinal ischemic areas on fluorescein angiography or OCT-A.
Early Tracheotomy for Switching Between Invasive and Noninvasive Ventilation to Facilitate Weaning

The aim of this study is early tracheotomy to facilitate weaning by switching between invasive and noninvasive ventilation.

When a patient is eligible to this study, he or she is randomly assigned to intervention or control group.In intervention group,tracheotomy is performed. And then, patient is switched to noninvasive ventilation by masking the tracheotomy tube. If the patient presents distress in noninvasive ventilation, he or she is switched to invasive ventilation. If the distress relieves, patient is switched to noninvasive ventilation again until the patient successfully weans from ventilator. In control group, the patient is weaned as the conventional methods.

Eligibility Criteria:
Inclusion Criteria:

* duration of invasive ventilation 5 to 7 days
* anticipation of difficult weaning
* Glasgow Coma Scale ≥13
* no upper airway obstruction
* presence of spontaneous breath

Exclusion Criteria:

* age less than 18 or more than 85 years;
* contraindications for noninvasive ventilation;
* anticipation of survival less than 6 months;
* refusal of tracheotomy
Biochemical and Histological Comparison of Nasal and Auricular Cartilage in the Fetus and Newborn With Cleft Lip Carrier

We seek to compare biochemically and histologically the nasal cartilage and ear in the newborn cleft lip and slot carrier in order to improve the quality of care and patient comfort after surgery of cheilorhinoplasty which is the primary treatment slots .

The concentration of hyaluronic acid as well as in type 1 collagen and 3 are assayed by immunohistochemistry and study of mRNA and then they are compared according to the type of cartilage.

This comparison is done on nasal cartilage samples and atrial newborns holders of cleft lip and operated in the neonatal period.

Given the difficulty and constraint of time it takes to reach the 20 subjects of our study , we will also add to our population the stillborn babies before 25SA and newborns who die before the age of 28 days and having had an autopsy.


Eligibility Criteria:
Inclusion Criteria:

* Infants aged 0 to 5 weeks with an isolated cleft lip and palate, that is to say non-syndromic, and that will be operated for cheilorhinoplasty neonatal, whose parents have read and understood the document Information and accepted and signed informed consent,
* Children born without life before 25SA and whose parents have read and understood the Information and accepted and signed informed consent for diagnostic purposes permission to autopsy and scientific purposes and / or therapeutic.
* Newborns who died before 28 days of life and whose parents have read and understood the Information and accepted and signed informed consent for diagnostic purposes permission to autopsy and scientific purposes and / or therapeutic.
* Patients And relatives of patients who received clear information and having signed an informed consent,
* Patients Benefiting from a health insurance plan

Exclusion Criteria:

* Patient with no lip slots ( bike palate only or other Tessier slot ) )
* Patient having slots syndromic cleft lip
* Patient whose parents refuse entry into the study.
* Children born without life before 25SA
* Newborns who died after 28 days of life
Cancer-related Fatigue and Symptom Clusters - Effects of Virtual, Imagined and Real-life Nature-based Therapy in Cancer Survivors

This is a randomized, controlled, bicenter trial comparing the effects on symptoms and quality of life in cancer survivors. Three nature-based therapies will be compared with a wait-list group. The therapies are: virtual reality simulated forest, guided imaging and classic forest bathing. Each intervention lasts 30 minutes and takes place once a week for 8 weeks. All interventions involve different stimulus types: visual, olfactory, auditory and tactile.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have completed treatment for cancer (\*with the exception of long-term adjuvant endocrine therapy).
* Subjective Impairment due to Cancer-Related Fatigue (CrF) . NCCN-recommended questions are used for screening ("How exhausted do you feel on a scale of 0 to 10?" and "How impaired do you feel by this fatigue on a scale of 0 to 10?" (threshold \>4 on either scale).
* At the time of study inclusion, it must be expected that no further antitumor therapy measures will be started within the next 6 months.
* Patients must be able to refrain from smoking up to 15 minutes before the intervention (smoking within 15 minutes before therapy impairs the participant's ability to perceive the aroma of the phytoncides).
* Written and valid informed consent from the patient.

Exclusion Criteria:

* Presence of inadequately controlled major depression in the opinion of the investigator.
* Asthma (inhaled phytoncides may cause airway irritation, exacerbation of asthma, or bronchoconstriction).
* Known allergy to pine or citrus fragrance.
* Anosmie.
* Medical history of seasickness (virtual reality can cause nausea/vomiting with no improvement after 5-10 minutes).
* History of seizures (virtual reality may increase susceptibility to seizures due to the changing light in the forest video).
* Visual and hearing impairments that are not corrected by visual or hearing aids.
* Unwillingness to store and share personal medical data as part of the protocol.
* Participation in another clinical trial focusing on behavioural or complementary medicine interventions.
* Missing or incomplete consent form.
Evaluation of Safety and Efficacy of Using EndoClear-Endoscopic Lens Cleaning Device

Virtual Ports, Ltd., has developed a lens cleaning device, EndoClear, which is attached to the internal abdominal wall at the beginning of a surgical case and remains in position until completion of the surgery, enabling the surgeon to clean the camera lens without removing it from the abdominal cavity. The purpose of this study is to evaluate the efficacy and safety of using the EndoClear device as a laparoscopic lens cleaning device.

The ability to perform laparoscopic surgery safely and effectively depends on the uninterrupted progression of the operation. Any interruptions to the normal workflow of the procedure threatens to cause distraction which in the least can lengthen the operative time leading to increased hospital operating costs and exposing the patient to unnecessary excess anesthesia and associated risks. At worst, interruptions can cause errors in judgment and/or technique resulting in injury to the patient.

Interruptions in the operating room can take many forms, from conversations to equipment malfunction. The goal of this study is to focus on one particular type of interruption unique to laparoscopic surgery - lens cleaning. It is quite common during the course of the procedure for the laparoscopic scope lens to become obscured by bodily fluids or steam from cautery devices. This necessitates having to remove the camera from the patient, cleaning it outside of the body, applying de-fog solution, reinserting it into the body, and having to reacquire the original camera position and image. This can be quite dangerous particularly in the middle of operative step, such as when there is ongoing bleeding, or when there are sharp or hot instruments within the body. Pilot data from own group demonstrates that the camera may have to be cleaned up to 20 times during a case adding upwards of 10-15 minutes to an operation.

Eligibility Criteria:
Inclusion Criteria:

1. \>18 years of age
2. Patients undergoing laparoscopic abdominal surgery

Exclusion Criteria:

1. Patients with known coagulopathy or bleeding tendencies
2. Intra-abdominal abscesses
3. Pregnancy
4. Non-elective laparoscopic surgery.
Clinical Efficacy and Mechanism of rTMS Based on dlPFC in the Intervention of Generalized Anxiety Disorder With Insomnia

To investigate the intervention effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on insomnia symptoms of generalized anxiety disorder patients.

Stimulation was performed using a figure 8-shaped focal coil attached to a MagPro 100 magnetic stimulator (MagVenture, Copenhagen, Denmark). All patients received 1 Hz (10 s trains, 1 s inter-train interval, 1,360 pulses per session) rTMS treatment once daily on weekdays for 2 consecutive weeks. rTMS was delivered over the right DLPFC (F4 electrode site according to the International 10-20 EEG system) at 100% of the resting motor threshold (RMT) . To determine the RMT, stimulus intensity was gradually increased until 5 out of 10 trials elicited motor evoked potentials with peak-to-peak amplitudes over 50 μV in the contralateral abductor pollicis brevis muscle. Adverse events attributed to rTMS were documented and reported. All participants received a pre-treatment assessment with the PSQI, HAMA, and HAMD. We used the PSQI to measure sleep quality, as well as HAMA and HAMD to assess participant's anxious and depressive states. Likewise, the PSQI was measured post-treatment (upon completion of the final treatment session) and at 1-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. age between 15 and 65 years;
2. clinically diagnosed with anxiety according to the Diagnostic and Statistical Manual of Mental Disorders-V (DSM-V);
3. no previous application of any insomnia pharmacological therapy for at least one week before baseline visit.

Exclusion Criteria:

1. current or history of serious brain and body diseases;
2. current or history of schizophrenia, behavioral problems, post-traumatic stress disorder, mania, obsessive-compulsive disorder, and social phobia;
3. substance abuse or other comorbid psychological diseases.
A New Ligation Using the Double-loop Clips Technique Versus Traditional Techniques in the Treatment of Large Wounds After Endoscopic Resection

Studies have shown that postoperative inflammation can be relieved by clipping the wound, and can reduce the bleeding rate and perforation rate.Scholars at home and abroad have proposed the use of adhesives and circular surgical lines to clamp the wound.In 2019, Satoshi Abiko and others proposed the use of double-loop clips technology to clamp the wound, and make double-loop clips of appropriate length outside the body.Therefore, our study is a prospective randomized controlled study to explore whether the double-loop clips technique is safe and effective for larger wounds in daily clinical work.


Eligibility Criteria:
Inclusion Criteria:

* Patients with wounds larger than 20mm
* Patients aged 18 to 75 years old

Exclusion Criteria:

* Have a serious medical condition, such as heart failure, acute liver failure, severe kidney disease (dialysis or predialysis patients) or New York heart association class iii-iv.
* Pregnant or breastfeeding.
* Allergy or intolerance to any study drug.
* Patients who have taken anticoagulant drugs (aspirin, clopidogrel, etc.) in the past week but are contraindicated for endoscopic polyp treatment.
* Other imaging findings suggest patients with advanced cancer.
* Patients with severe gastrointestinal diseases, such as intestinal obstruction or perforation, active ulcerative colitis, toxic colitis, and toxic megacolon
A Comparison of the Ease of Tracheal Intubation Using a McGrath MAC Laryngoscope and a Standard MacIntosh Laryngoscope

Videolaryngoscopes offer the potential to make tracheal intubation easier for the anaesthetist and less traumatic for the patient. This study aims to compare the intubation difficulty scores (a validated scoring system for ease of intubation) using the McGrath MAC as a videolaryngoscope, the McGrath MAC only as a direct laryngoscope (without video screen) and the MacIntosh laryngoscopes.


Eligibility Criteria:
Inclusion Criteria:

* Elective procedure requiring oral tracheal tube intubation
* Over 16 years of age
* Airway assessment suggests to the anaesthetist that a standard MacIntosh laryngoscope approach to intubation would be appropriate.

Exclusion Criteria:

* Emergency procedure
* Less than 16 years of age
* Unable to consent
* Requiring Rapid Sequence Induction (a specialised anaesthetic induction technique)
* Predicted difficult intubation
* Not suitable for the standardised induction technique
Quality and Outcome Measurements of Urological Patients

Prospectively, all available parameters of urologic patients treated at the study sites will be acquired and stored in multilayered databases. Upon a given samples size, neuronal networks will be trained to define clinical endpoints. Beside uro-oncological patients also patients with other urological diseases will be enrolled.


Eligibility Criteria:
Inclusion Criteria:

* All patients treated at the study sites, signed informed consent

Exclusion Criteria:

* No consent to record medical history
Vitamin D in Patients With Heart Failure

To investigate the prevalence of vitamin D deficiency in patients with Heart Failure.

To investigate if vitamin D levels are correlated to the degree of Heart Failure.


Eligibility Criteria:
Inclusion Criteria:

* Patient in the Heart Failure Clinic, Hvidovre Hospital
* Willing to participate and sign informed consent over 18 years of age
Glycogen and Appetite

Obesity is the outcome of chronic excessive energy intake and reduced energy expenditure leading to energy imbalance. It is a risk factor for many preventable diseases such as metabolic disease and its consequences such as type 2 diabetes and cardiovascular disease. Sedentary adults have been shown to have an increased appetite in excess of energy requirements and adults who are more active are able to better regulate energy intake. It is thought that carbohydrate availability and specifically hepatic glycogen utilisation during exercise is a regulator of appetite. However, the majority of research so far does not support this theory, potentially due to research not examining the tissue-specific link between glycogen use and appetite. The aim of this study is to assess whether altering substrate utilisation during exercise by suppressing lipolysis influences GLP-1 levels and caloric intake post exercise. Additionally, the study will explore if there is a tissue specific link between substrate utilisation and post exercise energy intake and examine potential sex differences.


Eligibility Criteria:
Inclusion Criteria:

* Males aged 18-60 and premenopausal women
* Physically active (at least 30 minutes of exercise 3 times a week)
* Body mass index 18.0-30.0 kg·m-2

Exclusion Criteria:

* Weight instability (\>5kg change in body mass over last 6 months)
* Restrained eater (e.g. limiting food intake, calorie counting)
* Current smoker
* Aversion or allergy to test meal foods
* Pregnant or lactating
* Amenorrhoea in women
* Any medical condition or medication that could introduce bias into the study (e.g., diabetes, CVD, lipid or glucose metabolism altering medications)
* Any cardiopulmonary condition prohibiting exercise testing
* Any contraindication to niacin or aspirin (e.g., diabetes, gout, clotting disorders, allergy to non-steroidal anti-inflammatory drugs)
PIRLONG-PD Safety and Efficacy of Piribedil in Parkinson's Disease During Long Term Therapy

Non-Ergot Dopamine agonists are meanwhile the drugs of first-choice in the treatment of Parkinson's disease. The receptor profile of the non-ergot dopamine-agonist piribedil is unique. In addition to agonistic effects on dopaminergic D2- and D3-receptors piribedil has adrenergic alpha-2A- and alpha-2C-receptors antagonisic properties. There is evidence from the literature that the antagonistic properties of piribedil are correlated with an improvement of cognitive function and vigilance parameters in parkinson's disease. The aim of the present non-interventional study is to investigate the safety and efficacy of piribedil during long-term therapy of patients with M. Parkinson under consideration of cognitive functions and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed or advanced idiopathic Parkinson's disease
* male and female patients over 18 years of age
* indication for treatment with piribedil according to Summary of Product Characteristics (SmPC)

Exclusion Criteria:

* in line with piribedil SmPC
* in particular hypersensitivity to piribedil or to any of the excipients and pregnancy and lactation as stated in the SmPC