cyrilzakka/clinical-trials huggingface dataset:
An Investigation Into the Efficacy of Provodine Topical Cream as Compared to 10% Benzoyl Peroxide Wash for the Treatment of Hidradenitis Suppurativa.

The purpose of this study is to compare the efficacy of Provodine™ topical cream to 10% benzoyl peroxide topical body wash for the treatment of early stage hidradenitis suppurativa.

Hidradenitis suppurativa (HS) is a chronic, recurrent inflammatory disease of the skin. It typically manifests as nodules and abscesses that ultimately can progress to form deep sinus tracts, fistulas, and scarring. It affects areas of the body with apocrine gland bearing tissue, including the anogenital, axillary and inframammary regions. The lesions are often very painful and can chronically drain malodorous fluid, which can leave affected individuals uncomfortable and self-conscious, or even debilitated. The pathogenesis of this disease process is not fully understood, and the HS can be difficult to treat. Measures such as topical antibiotic and antiseptic washes are generally thought to be beneficial for the treatment of early stage HS. Although there have been no controlled trials for the treatment of HS, commonly used topical washes currently include benzoyl peroxide and chlorhexidine gluconate.

Provodine™ topical cream was designed to actively kill microbes on the skin for up to 6 hours without resulting in the irritation often associated with repetitive use of antimicrobial products. A blinded controlled comparison of Provodine™ versus the current standard of benzoyl peroxide wash will not only allow for an alternative treatment for early stage HS but also provide an additional tool in the arsenal of treatments for this disease process.

Eligibility Criteria:
Inclusion Criteria:

* For inclusion, the subject must:

  1. Be at least 13 years old.
  2. Be otherwise healthy.
  3. Have a diagnosis of HS.
  4. Patients must have Hurley stage I or Stage II HS
  5. Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form.
  6. Agree to follow and undergo all study-related procedures.
  7. If applicable, minors must have permission of legal guardian for participation in the study.

Exclusion Criteria:

* Subjects who meet the following criteria will be excluded:

  1. Patients with HS Hurley stage III will be excluded from participation in the study
  2. Patients who are pregnant or breast feeding will not be able to take part in the study due to the unknown effects of the topical medications.
  3. Concomitant use of systemic or other topical treatments for HS not involved in current study. For cohort I, no washout period for systemic and/or topical medications will be required. For Cohort II, there will be a 14 day minimum washout period for systemic and topical treatments for HS.
  4. Any reason the investigator feels the patient should not participate in the study.
  5. If a patient misses ≥ 2 consecutive study visits, the patient will be excluded from further participation in this trial.
  6. History of allergy to iodine or benzoyl peroxide.
Understanding the Importance of Plasticity in the Brain Mechanisms of Dyspnoea Perception

Dyspnoea is the uncomfortable shortness of breath that debilitates millions of patients with lung disease, heart failure and cancer. It is often very difficult to treat. The sensations of dyspnoea are processed in the brain, and we believe that psychological factors modify and amplify these sensations, frequently exacerbating symptoms.

This study aims to identify the importance of learning in the brain mechanisms of dyspnoea by investigating a cohort of patients with chronic breathlessness undergoing pulmonary rehabilitation . Pulmonary rehabilitation is a six-week course of exercise, education and group therapy that improves dyspnoea but does not improve lung function. This leads us to hypothesise that some of the beneficial effects of PR maybe due to changes in brain processing, potentially relating to a learning effect.

Therefore to probe whether learning is important in the beneficial effects of pulmonary rehabilitation, we intend to modify learning with the drug d-cycloserine. D-cycloserine is an antibiotic that enhances learning due to its effects at N-methyl D-aspartate (NMDA) receptors in the hippocampus. Our previous study in a similar group of patients demonstrated the importance of the hippocampus in breathlessness perception, and we now wish to investigate this in more depth.

The study involves collecting physiological, psychological and clinical measures on in conjunction with brain scanning, before, during and once after pulmonary rehabilitation. Subjects will either receive d-cyloserine or placebo before the first four pulmonary rehabilitation sessions.


Eligibility Criteria:
Inclusion Criteria:

* Males and females with chronic lung disease, aged between 45 and 85 years old who have been referred for pulmonary rehabilitation.
* The subject is able and willing to give fully informed consent.

Exclusion Criteria:

Any of the commonly accepted contraindications to MRI scanning, for example, severe claustrophobia, presence of metallic implants, a pacemaker etc.

* Pregnancy. The risk to foetus of radiofrequency energy of the MRI scan is unknown.
* Inadequate understanding of verbal and written information in English, sufficient to complete an MRI safety screening.
* Unable to lie flat and still for 1/2 hour
* Requirements for oxygen therapy
* Significant cardiac, neurological, psychiatric or metabolic disease
* Contra-indications to d-cycloserine: Alcoholism, known hypersensitivity, severe renal failure
* Regular therapy with prescribed opioid analgesics
* Antidepressant therapy (this may alter hippocampal plasticity)
* Previous pulmonary rehabilitation (because the learning may be different on repeat pulmonary rehabilitation treatments)
Quantifying Myofascial Dysfunction in Post-Stroke Pain

The purpose of this study is to quantify the extent of GlycosAminoGlycan/Hyaluronic Acid (GAG/HA) accumulation using T1rho (T1ρ) MRI in the paretic versus non-paretic shoulder rotator muscles, and correlate the T1ρ Magnetic Resonance Imaging (MRI) measurements with US echo texture measurements to develop a clinic-friendly tool to infer the extent of HA accumulation; and to distinguish between latent versus active Post Stroke Shoulder Pain (PSSP) using ultrasound (US) shear strain mapping of the same muscles on the paretic side compared with the non-paretic side.

Shoulder pain is extremely common after stroke and occurs in 30-70% of patients. Chronic post stroke shoulder pain (PSSP) contributes to depression, interferes with motor recovery, and decreases quality of life. Although PSSP is thought to be caused by damage to the myofascial tissues around the shoulder joint, the pathophysiology of myofascial dysfunction and pain in PSSP has not been elucidated, leading to missed opportunities for early diagnosis, and variable success with pain management. The accumulation of HA in muscle and its fascia can cause myofascial dysfunction. HA is a GAG and a chief constituent of the extracellular matrix of muscle. In physiologic quantities, it functions as a lubricant and a viscoelastic shock absorber, enabling force transmission during muscle contraction and stretch. Reduced joint mobility and spasticity can result in focal accumulation and alteration of HA in muscle, leading to the development of taut bands, dysfunctional gliding of deep fascia and muscle layers, Reduced Range of Motion (ROM), and pain. Muscle HA concentrations can be imaged using T1ρ MRI, and myofascial dysfunction can be assessed using echo texture analysis and shear strain mapping on quantitative US, which may serve as useful biomarkers to elucidate the pathophysiology of myofascial dysfunction in PSSP.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Hemiparesis from Ischemic or Hemorrhagic Stroke
* 4-120 months post-stroke with Hemiparesis since the incidence and intensity of PSSP
* Show a difference of more than 10 degrees of passive ER-ROM between non-paretic and paretic shoulders with or without pain
* Able to provide informed consent and comply with testing protocols

Exclusion Criteria:

* Received treatment for spasticity with Botulinum Toxin or Intrathecal Baclofen within the past three months
* Have another neurologic condition that may affect motor response (e.g. Parkinson's disease, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS))
* Have a contraindication to MRI (claustrophobia, magnetic pacemakers and clips)
* Have non-musculoskeletal PSSP such as only central pain or Chronic Regional Pain Syndrome (CRPS)
* Have a complicated medical condition, or significant injury to either upper limb.
Toxicity Attributed to Genetic Polymorphisms in Testicular Germ Cell Tumor Survivors

The purpose of this study is to identify genetic variations in survivors of testicular cancer and connect these variations to differences in risks of late effects.

Identification of late-effects through questionnaires and linkage to national registries. DNA samples will be gathered through buccal swabs or saliva kits and analysed with whole exome-sequencing.

Eligibility Criteria:
Inclusion Criteria:

* Danish citizen
* Diagnosed with germ cell cancer from 1984 to 2007
* Treated initially at a Danish hospital
* Treated with standard treatment regimens.

Exclusion Criteria:

* Treated initially at a foreign hospital
Detection of Occult Paroxysmal AF in Cryptogenic Stroke or TIA Patients Using an Implantable Loop Recorder and Correlation With Genetic Markers.

Atrial fibrillation (AF) is the significant risk factor of ischemic stroke with incidence about 20% of all ischemic strokes. The undiagnosed AF in cryptogenic stroke patients could be present but not revealed by rutinne ECG.

The subcutaneous Insertable Cardiac Monitor - Reveal® XT ICM, which provides long-term monitoring ( for 3 years), in selected stroke and TIA population on the basis of age, stroke etiology, and prescreening for cardiac arrhythmias helps to increase a detection of AF to 16.7% (range, 14.3% to 20.0%) in compare to ambulatory ECG detection of AF 6.4% (range, 5.3% to 9.0%). The AF detection after stroke and TIA strategically changes the therapeutic approach. In correlation with mentioned above the incidence of both specific genetic markers of AF and occurance of AF in this population and healthy volunteers are interesting.

Eligibility Criteria:
Inclusion Criteria:

* 1. Cryptogenic stroke or TIA within 72 h of onset symptoms according to the criteria for the Trial of Org 10172 in Acute Stroke Treatment (TOAST ) 2. National Institute of Health Stroke scale (NIHSS ) score ≤ 15 3. Modified Rankin Scale (mRS ) score ≤ 3 4. Ability and willingness of patients or their relatives or legal representatives to understand study instructions both verbal and written in accordance with ICH GCP and legislation applicable in the Slovak Republic

Exclusion Criteria:

* 1. Known etiology of stroke or TIA 2. Untreated hyperthyreosis 3. Myocardial infarct within 1 month of onset stroke or TIA 4. Coronary bypass within 1 month of onset stroke or TIA 5. Valvular disease requiring urgent surgery 6. Documented atrial fibrillation or flutter . 7. Patent Foramen Ovale (PFO) 8. Permanent indication to oral anticoagulation therapy 9. Long-term steroid therapy \> 30 days 10. Participation in another clinical trial oriented to experimental pharmacologic therapy .

  11. Chronic inflammatory disease ( rheumatoid arthritide, IBD (Inflammatory bowel diseases ), lupus, vasculitis) 12. Severe co-morbidity not likely to complete to follow-up one year 13. Pregnant and breastfeeding women 14. Indication to pacemaker implantation, implantable cardioverter defibrillator (ICD) or Cardiac Resynchronization Therapy IPG or ICD implantation 15. Unabillity provide or unconsent with requiring protocol procedures
A Study to Evaluate the Safety, Tolerability, and Effects of Anatabloc® Crème in Rosacea

This is a multi-site, four-visit, eight-week, double-blind, randomized, vehicle-controlled, parallel-group study followed by an eight-week open-label extension to evaluate the safety, tolerability, and potential effects of Anatabloc Facial Cream. The secondary aim is to evaluate if Anatabloc Facial Cream improves the appearance of the skin in subjects with mild to moderate rosacea.


Eligibility Criteria:
Inclusion Criteria:

* age between 25-70 years
* diagnosed with mild to moderate rosacea

Exclusion Criteria:

* allergy or sensitivity to the study products or their components
* severe rosacea
* current use of glucocorticoids, anti-acne products, antibiotics, topical retinoids, or vasoactive drugs
* recent oral isotretinoin use
* current use of anatabine-containing supplements (ie. Anatabloc, Anatabloc Unflavored, CigRx)
Trial Assessing Safety and Efficacy of Gammanorm® in Autoimmune Diseases

This observational trial assesses the safety and efficacy of Gammanorm® in autoimmune diseases.


Eligibility Criteria:
Inclusion Criteria:

1. Adult man or woman older than 18 years,
2. Patient with autoimmune disease such as CIDP, MMN, PM, DM, MI, ITP, NAM or any other off-label use of Gammanorm®,
3. Patient who has a prescription of Gammanorm® treatment for immunomodulation,
4. Patient accepting to participate in the study by oral consent after having received oral and written information on the study.

Exclusion Criteria:

1. Patient treated with Gammanorm® for immune substitution, or other authorized use
2. Patient who refuses to participate in the study.
PRetest prObability of Infectious ENDOCARDITIS for Appropriate Criteria Regarding Transesophageal ECHOcardiography in Tertiary Care Facilities (PRO ENDOCARDITIS ECHO-Study)

Infective endocarditis is a potentially lethal disease that has undergone major changes over the last decades. The Duke Criteria are recommended for evaluation of probability of presence of infective endocarditis by current ESC guidelines. However, since the introduction of Duke criteria in 1994, characteristics of patients presenting with potential infective endocarditis have substantially changed, especially in tertiary care facilities, towards a high proportion of patients with immune deficiency (caused by illness or medically induced), critically ill patients, patients with prosthetic valves and patients with long-lasting intensive care treatment. Likewise, with the increasing interventional therapy of structural heart disease and device implantation in older and multi-morbid patient cohorts, the frequency of endocarditis on prosthetic material and devices increased over the last decades. While Duke criteria overall misclassify a substantial proportion of patients with endocarditis, Duke criteria are difficult to apply in these patients because of lower sensitivity. Therefore, several modifications of the Duke criteria have been proposed. In addition, the uncertainty regarding potential infective endocarditis of treating physicians due to clinical characteristics of their patients leads to an increase in requests for transthoracic and transesophageal echocardiography, overcoming echocardiography laboratories. In the present study the investigators aim to identify (I) the precision of the Duke score in predicting presence of infective endocarditis in patients examined at the echocardiography laboratory of the West German Heart Center (II) determine characteristics, not including echocardiography that are associated with increased risk of infective endocarditis, justifying transesophageal echocardiography examination and (III) establish scoring algorithms to help treating physicians to assess the risk of endocarditis in severely diseased patient cohorts prior to echocardiography examinations and to avoid unnecessary echo exams.


Eligibility Criteria:
Inclusion Criteria:

* patients referred for echocardiographic assessment of suspected endocarditis

Exclusion Criteria:

* Unwillingness to participate.
Preventing Urinary Tract Infections With E. Coli Nissle:

Urinary tract infections (UTIs) account for 5-14% of pediatric emergency department visits annually. At the moment, up to one third of children suffering of acute (UTI) will have a new infection and there is a lack of effective methods for preventing secondary UTIs in young children. Majority of UTIs in children are caused by intestinal bacteria of the patient, mainly E. coli that colonizes gut of the patient. E. coli Nissle is a probiotic strain that has been used successfully for treating acute gastrointestinal infections in children. The strain has also been proved to be safe for infants and young children. E. coli Nissle could be a potential solution for preventing recurrent urinary tract infections in children as it competes with pathogenic bacteria that usually cause UTIs in children.

The aim of this study is to evaluate efficacy of E. coli Nissle strain in secondary prevention of urinary tract infections in young children.

In order to asses efficacy of E. coli Nissle strain in prevention of recurrent UTIs in children, we aim to conduct randomized, placebo controlled and double blinded clinical trial. We are going to recruit children who are suffering the first urinary tract infection of their life. The UTI will be treated by normal clinical recommendations decided by treating physician. Intervention will start on the day following the last day of the antimicrobial course.

The intervention will last for 15 days and the study participants will receive either intervention drug or placebo. Intervention drug contains 10 E8 CFU/ml of E. coli Nissle strain and will be administered as dose of 1 ml of oral suspension once daily for children aged under one year and twice daily for children aged more than one year.

The study patients will be monitored by monthly electronic surveys for six months after the intervention in order to measure proportion of the children who will have a new UTI during the follow up. We are also going to record possible adverse effects in both study groups. Also use of antimicrobial medication due to any reason will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Children who suffer of the first urinary tract infection of their life defined as pyuria, presence of symptoms (fever or focal symptom), no other explanation for infection, bacterial culture positive or culture result pending
* Written informed consent

Exclusion Criteria:

* Preterm birth, gestational age less than 35 weeks
* Signs of life-threatening infection (such as meningitis)
* Detected anomaly in urinary tract
* Primary immunodeficiency
* Detected anomaly of GE tract
* Ongoing antimicrobial prophylaxis
* Hospital-acquired infection
Managing Wounds With Allevyn Life in a Home Health Care Environment

When elderly patients need help caring for wounds, physicians may refer patients to home health care providers. The home health provider sees the patient in the patient's home and assists the patient with wound care. Working with the patient's physician, the home health provider will use the appropriate wound covering ("dressing" or "bandage") to cover the wound. The goal of the home health provider is to ensure that the wound stays clean and progresses toward closure. The home health provider will conduct in-home patient visits at appropriate intervals to assess the status of the wound.

Extensive resources are required to see patients in their own homes. If a dressing could effectively manage wounds and allow longer time between in-home visits (without affecting patient safety or progress of the wound toward closure), then resources could be saved. Thus, newer dressings are designed for longer wear times, using advanced foam pads and adhesives that help keep the dressing in place. The hypothesis of this study is that the use of Allevyn Life will decrease the number of in-home visits by home health providers without sacrificing patient safety.


Eligibility Criteria:
INCLUSION CRITERIA

1. The informed consent document must be read, signed, and dated by the subject or the subject's legally authorized representative before conducting any study procedures or exams. 2. Subjects sixty-five (65) years of age or older. Subjects may be of either sex and of any race.

3. Willing and able to allow home health clinician to conduct all required study visits.

4. The subject (or caregiver) must be able to follow instructions, including the ability to have regular contact with the home health clinician between study visits.

5. Are covered by traditional Medicare. 6. Have a wound that is suitable for treatment with a foam dressing and can be appropriately covered by a single piece of ALLEVYN Life or the comparator dressing.

7. At Screening, wound exudate must be moderate to heavy, as determined by the home health clinician.

8. Target wound may be a trauma wound, chronic wound, or post-surgical wound. 9. Wound care is the primary reason for the home health clinician visits and determines the frequency of home health visits. Subjects may have other comorbidities, but these cannot be the determining factor in scheduling the frequency of the home health visits.

EXCLUSION CRITERIA

1. Contraindications or hypersensitivity to the use of the study dressings or their components (e.g., adhesive)
2. Any wound that requires an additional covering (e.g., compression dressing, cast, etc.) over the study dressing that prevents daily visualization of the dressing under study.
3. Target wound that requires daily dressing changes due to topical wound treatment (e.g., daily applications of ointments, creams, etc.)
4. Target wound and dressing that cannot be visualized by the subject or subject's caregiver.