cyrilzakka/clinical-trials huggingface dataset:
DW Evaluation of Lotrafilcon B Lenses in a Modified Design

The purpose of this study is to demonstrate that Lotrafilcon B AIR OPTIX® AQUA sphere modified design lenses are noninferior to Lotrafilcon B AIR OPTIX® AQUA in overall lens fit by comparing the percent of subjects satisfying the "no re-fit" criteria in each treatment group.


Eligibility Criteria:
Inclusion Criteria:

* Must sign an Informed Consent Document;
* Myopic, wear AIR OPTIX® AQUA lenses in the range of -1.00 to -5.00 diopters (D) in both eyes, and willing to comply with the wearing schedule;
* Manifest cylinder less than or equal to 0.75 D;
* Able to achieve best corrected visual acuity (BCVA) of 20/25 (Snellen) or better in each eye at distance;
* Able to achieve distance visual acuity of at least 20/40 in each eye with habitual and study lenses;
* Wearing spherical AIR OPTIX® AQUA lenses in both eyes for at least 3 months (at least 8 hours per day, at least 5 days per week), wearing the habitual lenses for a minimum of 4 hours prior to the baseline study visit, and achieving an acceptable or optimal fit at baseline visit with habitual lenses in both eyes;
* Other protocol-defined criteria may apply.

Exclusion Criteria:

* Current soft contact lens wearer who regularly sleeps in lenses (1 or more nights per week);
* Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear within 6 months prior to enrollment;
* Any use of systemic or ocular medications for which contact lens wear could be contraindicated including any use of topical ocular medications that would require instillation during contact lens wear;
* History of herpetic keratitis;
* History of corneal or refractive surgery or irregular cornea;
* A pathologically dry eye that precludes contact lens wear;
* Monocular (only one eye with functional vision);
* Monovision correction;
* History of intolerance or hypersensitivity to any component of the test articles or associated materials;
* Concurrent participation in a contact lens or contact lens care product clinical trial or within the previous 30 days;
* Eye injury or ocular or intra-ocular surgery within 6 months prior to enrollment;
* Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the study lenses or affect the results of this study;
* Other protocol-defined exclusion criteria may apply.
SIS Graft and Traditional Repair in Vaginal Wall Prolapse

The objective of this study is to evaluate surgical treatment of anterior vaginal wall prolapse using the sis graft or traditional repair. This a randomized and prospective study. Clinical patterns that will be evaluated: anatomic results of surgery; impact of surgery in quality of life using the Pelvic Organ Prolapse Questionnaire (P-QoL), sexual function with FSFI and possible complications.

The objective of this study is to evaluate surgical treatment of anterior vaginal wall prolapse using the sis graft or traditional repair. This a randomized and prospective study. Clinical patterns that will be evaluated: anatomic results of surgery; impact of surgery in quality of life using the Pelvic Organ Prolapse Questionnaire (P-QoL), sexual function with FSFI and possible complications

Eligibility Criteria:
Inclusion Criteria:

* anterior vaginal wall prolapse with poin Ba at least at +1;
* pre and postmenopausal patients

Exclusion Criteria:

* patients without surgical indication;
* infection;
* coagulopathy;
* gynecologic cancer;
* liver or kidney active diseases.
Applicability of Uroflowmetry in Children with Cerebral Palsy

Until now, the use of invasive urodynamics with use of catheters is still the gold standard for lower urinary tract evaluation in subjects with CP. This suggests a psychological and physical impact of invasive urodynamics in subjects with CP and further demonstrates the need to avoid standard use of invasive urodynamics in children and adults with CP.

The current study will evaluate usefulness of uroflowmetry, correlation between uroflowmetry parameters and different lower urinary tract symptoms will be investigated. Secondly, results of uroflowmetry indicating possible vulnerability of the upper urinary tract will be defined.

A cross-sectional case-control study comparing children with CP and LUTS and children with CP without LUTS will be conducted with the primary objective to investigate correlation between uroflowmetry parameters and different LUTS.

Children will be evaluated with uroflowmetry and subsequent post void residual measurement and the validated vancouver symptom score for dysfunctional elimination syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cerebral palsy
* Dutch or French speaking child and parent

Exclusion Criteria:

* History of urological surgery
Epigenetics and the Origin of Muscle Insulin Resistance in Humans

The investigators are trying to understand the role of DNA (deoxyribonucleic acid) methylation in insulin resistance in skeletal muscle and blood tissues. DNA methylation is a normal chemical process in the body that modifies DNA. By studying this, the investigators hope to better understand the causes of insulin resistance.

Insulin resistance is defined as the decreased ability of insulin to perform its biological function in the muscle, liver and fat. Genetic and environmental factors are known to influence insulin sensitivity. It is not known how this is mediated. This study looks at the role of epigenetics (modifications of proteins associated with DNA and methylation of DNA) in alterations in insulin resistance. We will study lean healthy people, obese non-diabetic people and people with type 2 diabetes to characterize the DNA methylation patterns in muscle in each group. The second aim of the study is to see how a single bout of exercise affects the DNA methylation in the muscle. The third aim looks at the effect of 8 weeks of supervised exercise on the DNA methylation.

Eligibility Criteria:
Volunteers must be:

* 21 - 55 years old
* must be non-lactating, non-pregnant
* not taking medications known to affect glucose or if taking them, on stable doses.
* free of significant heart or lung disease
The Effect of Trazodone on the Severity of Obstructive Sleep Apnea in Insomnic Stroke Patients With Depression

The investigators hypothesize that trazodone does not worse nocturnal oxygen saturation in insomnic ischemic stroke patients with obstructive sleep apnea (OSA) and depression and has beneficial effect in selected stroke patients with low arousal threshold phenotype OSA.


Eligibility Criteria:
Inclusion Criteria:

* Insomnic ischemic stroke patients with OSA and depression.

Exclusion Criteria:

* unclear consciousness, unstable vital sign or neurologic sign, unstable medical conditions such as delirium, active infection, evidence of overt congestive cardiac failure, liver dysfunction with ascites, thyroid disease, end-stage-renal-disease receiving dialysis.
* overnight mean oxygen saturation (SaO2) nadir is ≤ 70% at baseline
* take monoamine oxidase inhibitors (MAOI), any medication that may affect breathing, sleep, or muscle activity
* any known allergy to trazodone
* sleep disorder other than OSA (e.g., periodic leg movement syndrome, restless legs syndrome, central sleep apnea/Cheyne-Stokes respiration).
Medication Adherence Therapy for Opioid Abusing Pain Patients

The purpose of this study is to develop and pilot test a combined behavioral and pharmacological intervention designed to decrease pain, functional interference, and drug abuse while increasing medication adherence.

Project Pain is a Stage I behavioral therapies development project aimed at developing and pilot testing a novel intervention for patients with chronic non-malignant pain who have experienced difficulty managing prescribed opioids. The goals of the study are to: (1) develop the intervention and training materials; (2) develop therapist adherence and competence scales; (3) train therapists to deliver the intervention per the treatment protocol; and (4) pilot the intervention to assess its feasibility, acceptability and promise. The goals of the intervention are to: (1) improve adherence to prescribed opioids; (2) decrease the severity of patients' pain; and (3) improve patients' functioning and quality of life .

Eligibility Criteria:
Inclusion Criteria:

* Uninterrupted pain of at least 6 months duration
* Pain is continuous, rather than intermittent
* Pain in the severe range (VAS = 7-10) while medicated
* Poor response to non-pharmacological interventions for pain (if appropriate)
* One or more of the following pain diagnoses: (a) back/neck pain; (b) myofacial pain; (c) neuropathic pain (e.g., diabetic or AIDS neuropathy, Complex regional pain syndrome); (d) arthritic pain; (e) MS; or (f) sickle cell (must meet chronicity criteria)
* Evidence of tolerance/physiological dependence on opioid analgesics
* Current opioid use disorder (DSM-IV criteria)
* Continuous use of opioid analgesics for a minimum of 6 months prior to referral. \[Note: This is consistent with minimum 6-month requirement for diagnosis of chronic pain\].
* Minimum of 2 signs/symptoms of medication mismanagement identified by the Referring MD (PROBLEMS WITH PAIN MEDS checklist)

Exclusion Criteria:

* Please contact site regarding exclusion criteria for this study.
Comparison of Topical 0.15% Gancyclovir Gel Versus 0.3% Hypromellose Gel for the Treatment of Herpes Zoster Keratitis

The purpose of this study is to evaluate the efficiency of topical gancyclovir 0.15% in the treatment of herpes zoster keratitis. Half the patients will receive the study drug while the other half of the patients will receive the placebo

Patients with herpes zoster keratitis will be enrolled in the study. All patients will receive oral anti-viral medication as a standard-of-care therapy. The patients will be randomized into two groups and given either the study drug or the placebo at the time of enrollment. The patients will come for weekly visits during which slit lamp photograph of the dendrite will be taken. At week 2, if the dendrite has not healed the drug will by unmasked and rescue therapy will be given. the patients will be examined at week 1, 2, and 3 or until resolution occurs.

Eligibility Criteria:
Inclusion Criteria:

* age 18 and above
* have not been on gancyclovir gel or any other form of topical antiviral therapy for the past month
* able and willing to attend subsequent follow-up visits

Exclusion Criteria:

* Associated retinitis
* patients who are allergic to gancyclovir
* patients who will require systemic or intra-vitreal gancyclovir therapy
* patients who are pregnant or breastfeeding
Photography or Video in Assessing Breast Reconstruction?

Current qualitative methods of assessing the aesthetic result following breast reconstruction are known to be poor.

The investigators believe that real time digital video footage followed by expert panel review would be a superior method of qualitative assessment of breast cancer reconstruction aesthetics. This has never been studied before.

Breast cancer is the commonest cancer to affect women in the UK. Current guidelines state that; disease permitting, all females due to undergo mastectomy for breast cancer should be offered reconstruction. This usually takes place in the form of implant based reconstruction, regional flap based reconstruction +/- implant or free autologous tissue based reconstruction.

Traditional methods of subjectively assessing the aesthetic outcome of any of the forms of breast surgery have been shown to be poor and the assessment of immediate reconstructions a cumbersome task. The qualitative part of the assessment usually relies on standardised clinical photographs and panel ratings. Four to six photographs are usually taken of the patient and their reconstruction from different angles. These photographs are then shown to an expert panel (usually consisting of healthcare professionals familiar with breast reconstruction).

A large degree of both inter and intra-observer bias exists when comparing standardized photographs. The results from expert assessment of cosmesis often do not correlate to the patients opinion with regards to the cosmetic outcome of their reconstruction

Due to the static nature of clinical photography it does not capture the effect which movement and gravity play on a reconstructed breast in comparison to a normal breast.

A large volume of information can be captured from a short digital video clip in comparison to a single photograph. The potential advantages of digital video assessment over photography are only beginning to be explored with regards to aesthetics in other fields associated to medicine.9 However this has never been trialed with regards to breast cancer reconstruction.

We believe that real time digital video footage would be a more valuable tool in the assessment of breast reconstruction. We believe that there may be more accurate correlations between patient's satisfaction and panel opinion and that there will be less inter and intra-observer discordance

Eligibility Criteria:
Inclusion Criteria:

* Female patient
* Minimum 18 years of age
* Due to attend for Nipple areola complex tattooing
* Previous unilateral breast reconstruction following mastectomy

Exclusion Criteria:

* Male patient
* Bilateral Breast Reconstruction
* Reconstruction less than 1year ago
* Breast reconstruction not following breast cancer excision
Optimizing Risk Messages for Waterpipe Tobacco Cessation in Young Adults

The objective of this study is to examine whether messages conveying the harms and addictiveness of waterpipe (i.e., hookah) tobacco delivered by mobile phone multimedia messaging (MMS) are effective for promoting hookah tobacco cessation among young adults ages 18 to 30 years.

The purpose of this study is to test the effects of messages communicating the risks (i.e., health harms, addictiveness) of hookah tobacco delivered via mobile multimedia messaging for promoting hookah tobacco cessation. The study will also compare two messaging approaches, a standard untailored approach where all participants receive the same message content, and a tailored messaging approach where message content is personalized to baseline measures of hookah tobacco use behavior and beliefs and interactively to exchanges that occur via mobile messaging sent and received during the exposure period. The study includes young adults ages 18 to 30 who are current hookah tobacco smokers. Eligible participants are young adults ages 18 to 30 years who have smoked hookah tobacco at least once in the past month, smoke hookah tobacco on at least a monthly basis, and have access to the internet and a personal mobile phone to complete study procedures. Study participants will complete a baseline survey online, and all participants will receive standard information about the risks of hookah tobacco. Then participants will be randomly assigned to one of three groups: control group, untailored message group, tailored message group. Participants in the untailored and tailored message group will receive messages sent to their mobile phones communicating the risks of hookah tobacco for a 6 week period. All participants will complete follow-up surveys online 6 weeks after baseline, 3 months later, and 6 months later.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 30
* Smoked hookah tobacco within the last 30 days and smokes hookah tobacco on at least a monthly basis
* Has access the internet to complete study procedures
* Has personal mobile phone to complete study procedures

Exclusion Criteria:

* Age less than 18 or greater than 30
* Has not smoked hookah tobacco in the last 30 days or does not smoke hookah tobacco on at least a monthly basis
* Does not have access to the internet to complete study procedures
* Does not have a personal mobile phone to complete study procedures
Short-term Sleep Restriction on Taste Preference and Perception

The study aims is to investigate the effects of sleep restriction on sweet and fat taste perception and preference in both fasted and fed states. This is a randomised crossover trial with sleep restriction (4 hours per night for 2 nights) and normal sleep (at least 8 hours sleep for 2 nights) conditions, with a four-week washout period between conditions.

Sleep restriction has been found to dysregulate appetite regulation, leading to an increased food intake, particularly of foods high in sugar and fat. It is unclear why sleep restriction leads to increased fat and sugar intake, but emerging evidence suggests that taste preference and perception may be influenced by the lack of sleep.

Sleep restriction leads to increased preference for sucrose. However it is unclear whether sleep restriction also alters perception of sweetness, or whether it affects preference or perception of dietary fat. It is also unclear, whether any changes in sweet and fat preference and perception due to sleep restriction differ between the fasted and fed states.

This study is a randomised crossover trial where each participant will undertake two conditions (sleep restriction and normal sleep) in a randomised order. In the sleep restriction condition, participants will be asked to restrict their sleep duration to a maximum of four hours per night for two nights, and in the normal sleep group they will be asked to sleep for at least eight hours per night for two nights. There will a 4-week wash-out period between conditions. After each condition (2 nights of normal sleep or 2 nights of sleep restriction), particpants asked to arrive in a fasted state for the assessments. They will initially undertake the Control of Eating Questionnaire (COEQ) and the Leeds Food Preference Questionnaire (LFPQ). Participants will then undertake the sweet and fat taste perception and preference tests (described below). Following this, all participants will be provided with a standardized breakfast meal, and 60 minutes later, the LFPQ and taste preference and perception tests will be repeated in fed state.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and above
* Self Reported sleep of \>7 hours a night

Exclusion Criteria:

* Dairy allergy
* Presence of any serious medical conditions which might influence sleep i.e cardiovascular diseases, diabetes, cancer, respiratory disease, other than mild asthma)
* History of bariatric surgery
* Taking any kind of medication which might affect regular sleep
* Taking any type of medication which might affect appetite
* Participating in any kind of dietary and/or weight loss programs
* Taking antidepressants
* Substance or alcohol abuse
* Shift work
* Currently having to wake up at night to care for another person
* Suffering from and/or receiving treatment for mental health conditions or sleep apnoea.
Dexmedetomidine in Modifying Immune Paralysis In Patient With Septic Shock

in this study the investigators aim to assess the role of using dexmedetomidine as sedative in septic shock patients in comparison with midazolam. The investigators aim to assess the effect on immune response and inflammatory mediators and effect on vasopressors.

Sedation protocol All patients will receive analgesia with fentanyl at ﬁxed dose of 0.5 µg.kg.hr-1. Each patient will receive the study drug within 6 hours after ICU admission. Depth of sedation will be assessed using Richmond Agitation and Sedation Scale (RASS) scores (6), which range from -5 (unarousable) to +4 (combative). Study treatments will be infused without loading dose. Group I patients will have dexmedetomidine (4 µg.mL-1) and group II patients will have midazolam (0.33 mg.mL-1). Both drugs will be prepared in 0.9% sodium chloride in 50-mL syringe. Both the agents will be titrated to maintain the RASS in a range of -3 to -1. Dexmedetomidine infusion will be started at 0.1 µg.kg-1.hr-1 and will be adjusted by 0.1 µg.kg-1.h-1 to a maximum of 0.5 µg/kg/h, while midazolam will be started at 1 mg.h-1 (3 mL.hr-1) and adjusted by 1 mg.h-1 to a maximum of 5 mg.h-1 (15 mL.h-1). All infusions will be adjusted by increments of 3 mL/hr-1. Patients in either group not adequately sedated by study drug titration will receive a bolus dose of fentanyl 0.5-1 µg.kg. Assessment of RASS score will be performed every 2 hours and prior to any dose of rescue therapy. The study drugs will be infused for 24 hours and after that the choice of sedation will be determined according to preference of attending physician.

Eligibility Criteria:
Inclusion Criteria:

* Age more than 18 years old
* All mechanically ventilated patients who will be clinically suspected of having septic shock defined by infusion of at least one vasopressor and lactate \> 2.0 mmol/l (5)

Exclusion Criteria:

* Age \< 18 years old
* Pregnant patient
* Source of sepsis not controlled
* Acute hepatitis or severe liver disease (Child-Pugh class C)
* Left ventricular ejection fraction less than 30%
* Heart rate less than 50 beats/min
* Second or third degree heart block
* Systolic pressure \< 90 mmHg despite of infusion of 2 vasopressors.
* Psychological illness or severe cognitive dysfunction
* Patients who are allergic to dexmedetomidine
Dose-escalation Study of LTX-315 in Patients With a Transdermally Accessible Tumour

The study will evaluate the safety profile for LTX-315 a lytic-peptide that has shown effect in animal models to kill cancer tumours when injected directly in to the tumour. The study will also monitor the immunological response in the body after injection of LTX-315.

A phase I study with an initial concentration/volume escalating part followed by an expanded cohort at the recommended dose (RD). This is an open label, multicentre study assessing the safety, tolerance, PK and efficacy of LTX-315 injected directly into transdermally accessible tumours on days 1 and 8.

Additional weekly injections may be made, for up to a total of 6 injections.

Subjects may be included in the study if they meet all of the following criteria:

1. Histologically confirmed malignant tumour
2. Transdermally accessible lesion (in or close to the skin)
3. Age ≥ 18 years
4. ECOG Performance status (PS): 0 - 2
5. Life expectancy: At least 3 months

The primary objectives of the study are to evaluate the safety profile of LTX-315 by assessment of adverse events and abnormal laboratory values recorded during the study and to determine the recommended dose of LTX-315.

The secondary objectives of the study are to preliminarily assess the anti-tumour activity of LTX-315 in patients with transdermally accessible tumours, monitor immunological response, pharmacokinetic assessment, and determine duration of response.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed malignant tumour. Transdermally accessible lesion (in or close to the skin) of 1 - 5 cm in diameter.
* ECOG Performance status (PS): 0 - 2
* Life expectancy: At least 3 months
Russian Non-Interventional Study on Compliance of Venous Thromboembolism (VTE)

This is a local, prospective, multicenter, non-interventional, observational study. Primary objective is to describe how in "real life" thromboprophylaxis is carried out after the discharge from a hospital in the patients who undergo elective knee and hip replacement and who receive Xarelto during hospitalization.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients ≥ 18 years old
* Elective hip or knee replacement
* Planned VTE prevention with Xarelto
* Written informed consent
* The decision for treatment type and duration is taken by the investigator and is made before inclusion into the study.

Exclusion Criteria:

* Contraindications for the use of Xarelto in accordance with the effective instruction
* Any reasons of medical and non-medical character, which in the opinion of the physician can hamper participation of the patient in NIS, including a potentially low compliance, impossibility of making the final visit due to distant place of residence of the patient.