cyrilzakka/clinical-trials huggingface dataset:
Study Evaluating Efficacy and Safety of Crisaborole in Adults With Stasis Dermatitis

This is a Phase 2a, randomized, double blind, vehicle controlled, parallel group, proof of concept study that will include participants with stasis dermatitis without active skin ulceration, who will receive crisaborole ointment 2% or vehicle twice daily for 6 weeks.

Study C3291038 is a Phase 2a, randomized, double-blind, vehicle-controlled, parallel-group, proof of concept study to evaluate the efficacy, safety, and local tolerability of 6 weeks of treatment with crisaborole in adult participants with SD without active skin ulceration. Approximately 70 eligible participants will be randomized into the double blind treatment period in a 1:1 ratio to receive crisaborole ointment, 2% or vehicle twice daily for 6 weeks.

The study will recruit male and female participants aged ≥ 45 years with a clinical diagnosis of SD.

The total duration of participation in the study will be up to 14 weeks, including up to 4 weeks for screening, a 6 week double blind treatment period, and a follow-up period of 4 weeks after treatment completion.

Study enrollment and management will be de centralized, where participants do not visit an investigator or a clinic for clinical assessment. The participants will participate in the study at home. The sponsor (or designee) will provide home visits by qualified home visit practitioners (HVP), remote contact by telemedicine (or telephone), and clinical database electronic case report forms (eCRFs), eDiary, and other electronic data entries from 3rd party vendors for study data collection.

Eligibility Criteria:
Inclusion Criteria:

* Participants who are ≥45 years of age and in generally stable health
* Participants who are in generally stable health and have a known diagnosis of Stasis Dermatitis or newly diagnosed Stasis Dermatitis
* Participants whose mental and physical status allows them to be able to mostly perform their activities of daily living with minimal assistance

Exclusion Criteria:

* Participants with clinically significant active or potentially recurrent dermatitis conditions and known genetic dermatological conditions that are not Stasis Dermatitis or overlap with Stasis Dermatitis
* Participants with active venous stasis ulceration on either lower extremity.
* Participants with current infection or suspected infection of any Stasis Dermatitis lesions
* Women of child bearing potential (WOCBP) are not eligible for this study
The SLIM Study: Sling and Botox® Injection for Mixed Urinary Incontinence

This double-blind randomized controlled trial seeks to find a better treatment for women with mixed urinary incontinence (both stress and urgency incontinence). The primary aim is to determine whether midurethral sling surgery combined with injections of onabotulinumtoxinA (Botox®) into the detrusor muscle of the bladder improves symptoms of mixed urinary incontinence better than sling surgery alone.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing mid-urethral sling surgery
* Have symptoms of both stress and urgency urinary incontinence
* Able to consent, fill out study documents, and complete all study procedures and follow-up visits
* At least 18 years of age
* English speaking
* Be able and willing to learn clean intermittent self catheterization technique

Exclusion Criteria:

* History of recurrent UTI (defined as three culture proven UTIs within last 12 months)
* Systemic neuromuscular disease known to affect the lower urinary tract
* Undergoing concomitant prolapse surgery
* Previous incontinence surgery
* Treatment with anticholinergic medication in the last 2 months
* Previous bladder injection with onabotulinumtoxinA
* Prisoner Status
* Pregnancy
Evaluation of Treatment Methods for Clinically Significant Tinnitus

The investigators propose to evaluate two different approaches to the alleviation of tinnitus symptoms by comparing changes from baseline performance on the Tinnitus Severity Index. They propose to provide an unbiased evaluation of competing methodologies. The design is one in which pairs of prospective subjects are randomly assigned to one of two treatment groups. Changes in group performance will be compared for selected measures.


Eligibility Criteria:
Inclusion Criteria:

Patients with significant tinnitus

Exclusion Criteria:
Study on Periodontal Treatment in Diabetic Patients

Diabetes is a metabolic disorder that affects the uptake of glucose into cells. This causes a cascade of systemic alterations that may lead to kidney failure, cardiovascular complications, altered tissue healing, retinopathies and gangrene. Diabetes is also associated to increased susceptibility to infections and inflammation.

It has been observed that diabetic patients suffer more often from oral infections such as periodontal disease. Periodontal disease is an infectious-inflammatory disease that leads to destruction of the surrounding tissues of the tooth. It is proposed that the mechanisms responsible for systemic complication are implicated in the development of periodontal disease. This has been evaluated in studies where diabetic patients showed increased levels of inflammatory cytokines, subgingival bacteria and limited response to treatment. Its has also been suggested that established periodontitis in the diabetic patient leads to insulin resistance due to infection and liberation of cytokines from periodontal tissues and thus worsening the diabetic condition.

This study is aimed to establish the response to periodontal treatment with antibiotics and the kinetics of glucose levels in diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

* Must be of legal age (≥18 years old).
* Voluntary participation and signed informed consent.
* Confirmed type I and II diabetes.
* At least 10 teeth present in mouth.

Exclusion Criteria:

* Smokers.
* pregnant women.
* Antibiotic consumption 3 months before inclusion.
* HIV positive or AIDS.
* Allergic reactions to macrolides and specifically to azythromycin.
* Periodontal treatment 6 months before inclusion.
Vibrotactile Coordinated Reset for Spasticity After Spinal Cord Injury

The purpose of our study is to evaluate vibrotactile Coordinated Reset (vCR) and its effects on spasticity symptoms in incomplete spinal cord injured patients. vCR will be administered with a device called the Stanford CR Glove. vCR is expected to provide patients with a non-invasive alternative to the most widely used treatments such as oral baclofen and or deep brain stimulation. Patients will be followed for three months and will be asked to come to the lab for clinical testing 4 times during this period. A total of 30 patients will be included in the study.


Eligibility Criteria:
Inclusion Criteria:

1. Age at the time of enrollment: Any adult ages 18 and over
2. Spinal Cord Injury: ASIA C or D injury at level C1-T1
3. Duration of incomplete spinal cord injury minimum 1 years clinical/fundamental
4. Spasticity with a of MAS score \>3 present in upper extremities.
5. Fluent in English
6. If patient is on medication that affects brain function or alters EEG activity, the patient must feel comfortable going off this medication prior to EEG recording.
7. Appropriate social support if required during an off-medication state.
8. Comfortable with technology; can use a computer, check email, and access the internet; can initiate and engage in a virtual meeting for training and monitoring purposes.
9. Feels comfortable going off certain spasticity related medication during in-person study visits
10. Lives in the United States

Exclusion Criteria:

1. Sensory deficits in palma manus resulting in missing inter digit discrimination of the fingertips.
2. Any significant neuro-psychiatric problems, including acute confusional state, ongoing psychosis, or suicidal tendencies.
3. Any current drug or alcohol abuse.
4. Participation in another drug, device, or biologics trial concurrently or within the preceding 30 days. Any other trial participation should be approved by the Principal Investigators.
5. Pregnancy, breast-feeding or wanting to become pregnant.
6. Physical limitations unrelated to spasticity that would affect motor ratings.
7. Craniotomy
8. Brain surgery
9. Patient is unable to communicate properly with staff (i.e., severe speech problems)
10. Medications that may affect relevant synaptic plasticity
11. Concurrent Botox treatment
12. A type of hairstyle that would impede the use of an EEG cap.
Critical Care EEG Course

Knowledge of the basic fundamental skills of electroencephalography would enable medical and nursing staffs to provide efficient and effective bedside EEG monitoring in critically ill patients.

The aim of this study is to evaluate the ability of a 10-points EEG teaching program to allow bedside caregivers (medical and nursing intensive care unit staff) interpreting EEG in the critical care setting.


Eligibility Criteria:
Inclusion Criteria:

* Volunteers among medical and nursing ICU staff of the participating ICUs

Exclusion Criteria:

* Experienced or trained ICU staff members to EEG interpretation (pre-test score \> 5/10)
An Investigation Of The Absorption And Pharmacokinetics Of Multiple Doses Of Two Controlled Release Pregabalin Tablets As Compared To Multiple Doses Of The Immediate Release Pregabalin Capsule

The purpose of this study is to 1) evaluate the extent of absorption of multiple doses of two pregabalin controlled release tablets as compared to multiple doses of the pregabalin immediate release capsule, 2) evaluate the pharmacokinetics of multiple doses of two pregabalin controlled release tablets as compared to multiple doses of pregabalin immediate release capsule and 3) evaluate the safety and tolerability of multiple doses of two pregabalin controlled release tablets as compared to multiple doses of the pregabalin immediate release capsule.

Evaluate the absorption, pharmacokinetics, safety/tolerability of multiple doses of two pregabalin controlled release tablets as compared to multiple doses of pregabalin immediate release capsule

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or females
* Between the ages of 18 and 55 years, inclusive
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2

Exclusion Criteria:

* Illicit drug use
* Pregnant or nursing females
* Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception
Aptus at Home: Co-design of a Home-based Monitoring System for Anaemia

Co-design of a home-based anaemia monitoring system with participants who have previous diagnosis of anaemia.

The device/ monitoring system being developed is called Aptus home. Aptus home measures the haemoglobin and haematocrit levels in blood from a single drop of blood. By measuring these blood parameters, participants are able to monitor anaemia in participants' homes.

The use of the device will take place in the participant's home to simulate what the investigators believe will be the ideal location for people who would prefer to self-manage their condition.

This study is a unique opportunity to gain feedback on the future design and development of a home-based monitoring system through user evaluation. As this is an adaptive/ iterative study design, this will give the Sponsor the opportunity to make changes to the user interface and user platform based on the feedback received from the end user.

Eligibility Criteria:
Inclusion Criteria:

* Prior diagnosis of anaemia
* Commitment to perform finger pricking to use the device every two weeks and complete 2 monthly questionnaires
* Participant's willingness to participate in 1 to 1 interviews and, or focus groups
* Understands and has a good level of spoken and written English

Exclusion Criteria:

* No prior diagnosis of anaemia
* Not committed to perform two weekly finger pricks to use device and complete 2 monthly questionnaires
* Unwilling to attend interviews and focus groups
* Doesn't have a good level of written and spoken English
Treating Anxiety After Stroke (TASK)

The TASK (Treating Anxiety after StroKe) trial is a feasibility randomized controlled trial. It aims to evaluate the feasibility of i) web-enabled trial procedures, and ii) the TASK intervention in stroke and TIA patients

Anxiety after stroke and transient ischaemic attack (TIA) is common. It is distressing and potentially debilitating. Currently, post-stoke psychological care is inadequate. There is no definitive evidence to guide treatment of anxiety post-stroke.

The TASK intervention is a centralized model for delivering personalised therapy for treating anxiety post-stroke using telephone and web-technology.

The TASK intervention includes:

* Treatment website and telephone support
* Learning ways to overcome anxiety after stroke/'mini-stroke'
* Relaxation techniques
* Weekly online tasks
* Therapeutic videos
* Text reminders and participant record card
* Useful links to stroke resources and websites

The investigators designed the TASK trial to be web-enabled, so that it can be conducted entirely remotely.

In the TASK feasibility randomized controlled trial, the investigators aim to evaluate the feasibility of:

i) web-enabled trial procedures: online recruitment, remote eligibility checking, electronic informed consent, online self-reported outcome surveys

ii) feasibility of the TASK intervention in stroke and TIA patients

This trial received a favourable opinion from the South East Scotland Research Ethics Committee (ref: 17/SS/0143)

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 or above
2. A diagnosis of stroke (ischaemic, primary haemorrhagic) or TIA-probable, definite, or ocular
3. At least one month after being discharged to the community from clinic or hospital ward
4. Has anxiety symptoms

   a. at least one anxiety symptom should be present on the 6-item anxiety screening questions derived from GAD-7 and modified Fear Questionnaire(ref).
5. Have capacity to give informed consent
6. Able to communicate in English on the telephone
7. Can access the internet via a computer/ tablet/ smartphone
8. Residents within NHS Lothian regions (EH postcodes and FK1)

   Exclusion Criteria:
9. People already taking part in a clinical trial of treatment intended to improve psychosocial outcomes e.g. emotional distress, anxiety, depression, emotionalism, fatigue, social functioning, quality of life are excluded.
A Study to Evaluate ALN-XDH in Healthy Subjects and Patients With Gout

The purpose of this study is to:

* Part A: Evaluate the safety and tolerability of single ascending doses of ALN-XDH in healthy adult participants
* Part B: Evaluate the safety, tolerability and efficacy of ALN-XDH as monotherapy in adult patients with gout
* Part C: Evaluate the safety, tolerability and efficacy of ALN-XDH as add-on therapy in adult patients with gout


Eligibility Criteria:
Inclusion Criteria:

* Part A: has serum uric acid (sUA) level ≥4 mg/dL and ≤7 mg/dL
* Parts B and C: meets the American College of Rheumatology criteria for acute arthritis of primary gout
* Part B: has an sUA level ≥8 mg/dL while not receiving urate-lowering therapy (ULT) or following a 1-week washout period of prior ULT
* Part C: has been on a stable dose of allopurinol for gout for ≥6 weeks prior to screening
* Part C: has an sUA level ≥6 mg/dL

Exclusion Criteria:

* Parts A, B and C: Has received an investigational agent within the last 30 days
* Parts A, B and C: Has experienced or is being treated for acute gout flare(s) within 14 days prior to randomization
Reappraisal of the Therapies of Refractory Autoimmune Hemolytic Anemia in Systemic Lupus Erythematosus

There is a deficiency in guidelines about the treatment of autoimmune hemolytic anemia in systemic lupus erythematosus (SLE), especially in refractory cases. Mycophenolate mofetil (MMF) showed promising results in those patients but still, the data available are in form of case reports. So, investigators will investigate the efficiency of MMF against a well-established treatment Rituximab in the treatment of refractory autoimmune hemolytic anemia in SLE patients.

There is a deficiency in guidelines about the treatment of autoimmune hemolytic anemia in systemic lupus erythematosus (SLE), especially in refractory cases. Mycophenolate mofetil (MMF) showed promising results in those patients but still, the data available are in form of case reports. So, the investigators will investigate the efficiency of MMF against a well-established treatment Rituximab in the treatment of refractory autoimmune hemolytic anemia in SLE patients.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of erythematosus (SLE) according to The American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) guidelines.
* secondary autoimmune hemolytic anemia (AIHA) that does not respond properly to corticosteroid or when the patients are intolerant to treatment, or refuse standard treatment.

Exclusion Criteria:

* Pregnant or breastfeeding women.
* any contraindication of the used drugs.
* any known hypersensitivity of the used drugs.
* congenital hemolytic anemia.
* chronic renal failure.
Pudendal Nerve Block for Post-Episiotomy Pain Relief

Unilateral vs. Bilateral Pudendal Nerve Block for Post-Episiotomy Pain Relief: A Randomized Clinical Trial


Eligibility Criteria:
Inclusion Criteria:

* Term (37 to 42 weeks gestation), primigravid women with singleton vertex fetus

Exclusion Criteria:

* Women with bleeding disorders, known hypersensitivity to local anesthetics, chronic use of pain medication, had previous vaginal surgery, extensive vulvovaginal infection, malposition or malpresentation were excluded from the study. Also, women who failed to deliver vaginally, had extensive perineal or cervicat tears, or had instrumental delivery were excluded from the final analysis of the study
Spectralis OCT Repeatability and Reproducibility Study

This single-center, prospective, interventional clinical study is conducted to evaluate the repeatability and reproducibility of structural parameters of the optic nerve head, the peripapillary retinal nerve fiber layer, and the macula using the Heidelberg Spectralis OCT (Optical Coherence Tomography) device. Data obtained from healthy volunteers in this study are compared to those from a previous, larger healthy volunteer study that was conducted in the United States and Europe (S-2012-1), and data from glaucoma patients are compared to those from the healthy volunteers.

The study will include approximately 15 normal subjects and approximately 15 subjects who have glaucoma of varying degree. All subjects will undergo Spectralis OCT imaging and other study procedures in one single visit. All examinations performed on the subjects are non-significant risk procedures because the medical devices are cleared for marketing in Europe and in the U.S. Total study duration is anticipated to not exceed 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Subject is not an employee of the eye clinic.
* Age ≥18
* Able and willing to undergo the test procedures, give consent, and to follow instructions.
* For "normal subjects": Healthy eye without prior intraocular surgery (except cataract surgery and Lasik - laser-assisted refractive surgery) and without clinically significant vitreal, retinal or choroidal diseases, diabetic retinopathy, or disease of the optic nerve.
* For "glaucoma subjects": Early to advanced glaucoma according to existing medical charts.
* Refraction between +6 and -6 diopters and astigmatism ≤ 2 diopters.
* When both eyes are eligible, one randomly selected eye will enter the study.

Exclusion Criteria:

• Insufficient quality of Spectralis OCT images (this is not determined until after Spectralis OCT examination, and is an unusual circumstance). Minimum requirements are:

* Retina completely included in image frame,
* Quality Score ≥ 20 in the stored ART mean images
Sterile Water Injections For Pain Relief İn Labor

ABSTRACT Introduction: In addition to pain caused by uterine contractions in labour, in 33% of women, continuous and severe back pain is observed. In management of this pain, sterile water injection is considered to be an effective method. Aim of this study is assessment of effectiveness and satisfaction of this method among Turkish women in which analgesic methods are not extensively used in labour and rates of cesarean section exponentially increases.

Material and Methods: 168 termed, healthy women who admitted to Istanbul Gaziosmanpaşa-Taksim Training and Research Hospital with labour pain and had severe back pain were randomized into 4x0.1 ml sterile water and 4xdry Injection groups. Injections were applied to Michaelis Rhomboid region in sacral region. Pain scores were assessed at 10th, 30th, 60th, 120th and 180th minutes with Visual Analog Scale (VAS). Additionally, need for epidural analgesia, APGAR score, mode of delivery, time of delivery, maternal satisfaction and breastfeeding scores were assessed.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 18-35
* 37-42 weeks of gestation
* Expecting vaginal delivery
* Cephalic presentation
* Single, healthy fetus
* Spontaneous onset of labor
* Active phase of first stage of labor (3-7 cm cervical dilatation)
* Severe low back pain (VAS\>7cm)
* Required pain relief

Exclusion Criteria:

* Gestation \<37 weeks
* Multiple pregnancy
* Malpresentation
* Second stage labour
* Pharmacological analgesia prior to SWI
* Back pain assessed by VAS \<7
* Women whose labour would be considered high risk
Ultrasound-guided Femoral Puncture to Reduce Access- Related Complications After TAVR: (ACCESS-TAVR SIRIO)

Recent observational data showed a marked reduction of vascular and bleeding complications by the use of ultrasound(US)-guided femoral artery puncture to gain the vascular access and guide the implantation of the Perclose ProGlide® vascular closure system.

We aimed to compare in a 1:1 randomized fashion the effect of US-guided femoral puncture and Perclose ProGlide® implantation optimization vs fluoroscopy-guided puncture followed by Perclose ProGlide/ ProStyle implantation (standard approach) during TAVR.

Transfemoral approach has become the standard route for a transcatheter aortic valve replacement (TAVR) procedure. Despite the technology improvements, vascular complications and access-related bleeding are frequently observed after TAVR and emerge predominantly within 30 days after TAVR. Recent observational data showed a marked reduction of vascular and bleeding complications by the use of ultrasound(US)- guided femoral artery puncture to gain the vascular access and guide the implantation of the Perclose ProGlide® vascular closure system.

We aimed to compare in a 1:1 randomized fashion the effect of US-guided femoral puncture and Perclose ProGlide® implantation optimization vs fluoroscopy-guided puncture followed by Perclose ProGlide/ ProStyle implantation (standard approach) during TAVR.

Eligibility Criteria:
Inclusion Criteria:

* Eligible Patients are male or female with severe aortic stenosis evaluated by the Heart Team as candidate to TAVR based on the current cardiology guidelines.

Exclusion Criteria:

* Refusal to participate in the study;
* Inability to provide written consent to the study protocol;
* Chronic immuno-suppressant therapy;
* Any concomitant condition which, in the opinion of the Investigator, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse, emotional/psychological disorder);
* Enrolment in another study that could confound the results of this study;
* Life expectancy \< 1 year;
* Any contraindication to TAVR procedure;
* Non transfemoral TAVR.