cyrilzakka/clinical-trials huggingface dataset:
Neoviderm Skin Emulsion in the Prevention of Radiation Dermatitis

The purpose of this study is to determine whether NeoVIDERM is effective at preventing radiation dermatitis in patients receiving external beam radiation therapy to the head and neck or breast areas.


Eligibility Criteria:
Inclusion criteria: For patients receiving radiation to the breast

1. Patients receiving a dose of at least 50 Gy in 25 fractions with concomitant chemotherapy or treated with the McGill technique.
2. Patients able to understand and sign an informed consent form.
3. Patients that do not have active connective tissue disorders.
4. Patients 18 years or older.
5. Patients that did not receive any previous radiation.
6. Patients that do not have any known allergy to any ingredients of the NeoVIDERM cream
7. Patients need to be able to apply the creams themselves or have help with applying the creams.

Inclusion criteria: For patients receiving radiation to the head and neck

1. Patients receiving radiotherapy on fields that include both sides of the neck
2. Patients able to understand and sign an informed consent form.
3. Patients that do not have active connective tissue disorders.
4. Patients 18 years or older.
5. Patients that did not receive any previous radiation.
6. Patients that do not have any known allergy to any ingredients of the NeoVIDERM cream
7. Patients need to be able to apply the creams themselves or have help with applying the creams.

Exclusion criteria: For patients receiving radiation to the breast or the head and neck

1. Patients that have a type V or type VI skin type according to the Fitzpatrick scale (because these patients will likely have less radiodermatitis and if they do, it will be harder to evaluate it).

   The Fitzpatrick Scale:
   * Type I (scores 0-7) White; very fair; freckles. Always burns, never tans
   * Type II (scores 8-16) White; fair. Usually burns, tans with difficulty
   * Type III (scores 17-25) Beige; very common. Sometimes mild burn, gradually tans
   * Type IV (scores 25-30) Beige with a brown tint; typical Mediterranean Caucasian skin.

   Rarely burns, tans with ease
   * Type V (scores over 30) Dark brown. Very rarely burns, tans very easily
   * Type VI Black. Never burns, tans very easily
2. Allergic to any ingredient in Neoviderm cream
Early Intervention With Therapeutic Exercise in Plantar Fasciopathy

The aim of this project is to evaluate the efficacy of a therapeutic exercise programme in patients with plantar fasciitis applied early and aimed at strengthening the hip and foot musculature.

All patients will be informed about the study to be carried out and will give their prior informed consent. The programme has a first part of teaching directed to patients by physiotherapists, and a second part of application at home, with a duration of 12 weeks. An experimental study will be designed with random assignment of patients with similar characteristics to two groups. The non-experimental group will receive their usual treatment (medication and recommnendations as stretching) and the experimental group will follow their usual treatment and also participate in the therapeutic programe.

Eligibility Criteria:
Inclusion Criteria:

* Patients with referred pain in the medial plantar area of the heel, accentuated with initial steps after a period of inactivity but also worsening after prolonged body weight bearing, of at least 3 months evolution prior to inclusion in the study.
* Reproduction of the pain referred by the patient with palpation at the proximal insertion of the plantar fascia.

Exclusion Criteria:

* Pregnancy.
* Injection of corticoids in the area in the 6 months prior to recruitment.
* Previous illnesses that may alter gait (central or peripheral neurological pathology, degenerative and inflammatory arthropathies, systemic illnesses).
* Existence of concomitant foot pathology (metatarsalgia, stress fractures, neuropathies due to entrapment, tendinitis, history of foot/ankle surgery, etc.).
* People who do not have the capacity to understand and follow an exercise programme.
Pre and Post-arterial Recanalization Imaging of Central Retinal Artery Occlusions (CRAO)

Central retinal artery occlusions (CRAO) are the equivalent of an ischemic stroke at the retinal level. They share the same risk factors and common pathology. The diagnosis of a CRAO is clinically based on the sudden occurrence of a decrease in deep visual acuity with fundamentally signs of reactive ischemia.

Small studies have highlighted the value of cerebral MRI (Magnetic Resonance Imaging) in CRAO with almost 25% of ischemic strokes found on diffusion sequences and the demonstration of a correlation between anomalies in diffusion sequence and the probability of a pathology with a high risk of recurrence (carotid stenosis or emboligenic cardiopathy). But there are usually few radiological signs that allow a direct positive diagnosis of CRAO, an etiologic diagnosis or a prognosis. This descriptive study will focus on CRAO at the diagnostic and post-treatment phases in the short and medium term, in order to (i) identify imaging etiologic signs of CRAO with specific sequences from a 3 Tesla MRI, (ii) identify positive diagnostic signs of CRAO with the same specific sequences, (iii) correlate these signs with the visual prognosis one month after the CRAO.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* CRAO (onset of symptoms ≤ 48 hours)
* Consent to participate in the study

Exclusion Criteria:

- Contraindications to 3 Tesla MRI
cAMP Signaling and Muscle Adaptations

The role of cAMP signaling mediated by beta2-adrenergic stimulation with agonists has been well-studied in skeletal muscles of animals. Studies in humans are scant and the scope of the present study is thus to investigate the role of cAMP signaling by beta2-adrenergic stimulation for muscle adaptations in humans.


Eligibility Criteria:
Inclusion Criteria:

* healthy young men
* 18-35 years of age
* Informed consent
* Active 2-5 hours of training pr. week
* Maximal oxygen uptake (ml/min/kg) of 40-60
* Lean body mass of 55-65 kg / Lean mass index 14-22 kg/m2

Exclusion Criteria:

* Smoker
* Allergy towards study drugs
* Chronic disease
Evaluation of Safety and Efficacy of Lumason in Pediatric Echocardiography

Safety and Efficacy Study in pediatric subjects aged 9 to 17 years of age with suboptimal LV EBD on non-contrast 2D echocardiography. Imaging modalities that are used throughout the study in pediatric subjects represented those utilized in routine clinical practice in adults.

This was a Phase III, multicenter, open-label study that was to be conducted at approximately 7-12 sites in the United States, Canada and Europe in pediatric patients with suboptimal LV EBD on non-contrast 2D transthoracic echocardiography. It was estimated that 92 patients were to be enrolled to provide 73 evaluable patients.

Three cardiologists unaffiliated with enrolling centers (blinded readers), blinded to the patient's identity and clinical profile were to independently evaluate the echocardiograms. The efficacy analysis was primarily based on the blinded reader evaluations.

Imaging modalities that are used throughout the study in pediatric subjects represented those utilized in routine clinical practice in adults.

One of the sites participating in this study was to be asked to consent a subset of patients for additional blood sampling for analysis of SF6 concentration in blood from a total of 6 patients (3 males and 3 females) in the age group 9 up to 12 years of age and 6 patients (3 males and 3 females) in the age of \>12 up to and including 17 years.

The current study was designed to assess the efficacy of Lumason-enhanced echocardiography in pediatric patients.

Eligibility Criteria:
Inclusion Criteria:

* Provide Written informed consent from parent(s) or legal guardian
* Provide assent when required according to local regulations
* Suspected of having cardiac disease or undergoing evaluation of cardiac anatomy for congenital heart disease
* Undergone a previous transthoracic echocardiogram within one month prior to enrollment resulting in suboptimal left ventricular endocardial border defined as ≥ 2 contiguous segments in any given view that cannot be visualized.

Exclusion Criteria:

* Children \< 9 years of age
* Previously enrolled in the study
* Administered any other contrast agent either intravascularly or orally within 48 hours of Lumason administration
* Known right-to-left, bidirectional or transient cardiac shunt (ruled out with agitated saline study performed before administration of Lumason)
* Known hypersensitivity to one or more of the ingredients of the investigational product
* Received an investigational compound within 30 days before enrolling into this study
* Pregnant or lactating female
* Determined by investigator to be unsuitable for the study
Near Infrared Light in Paediatric Blood Drawing Centre

Reaching a peripheral venous access or making a blood sample in a scared infant or toddler can be challenging even for experienced nurses o pediatricians. Up to 60% of children report pain and distress during venipuncture and multiple attempts can result in more difficult physical and emotional conditions for subsequent insertions so that the procedure should be performed with the less number of punctures as possible. In about one third of children, more than one attempt is required to achieve peripheral intravenous cannulation. In the last years, specific tools have been developed to enhance the success in venipuncture or incannulation. Near-infrared (NIR) technology consists on light-emitting diodes placed underneath the hand, that makes vessels visible by projecting the processed image in a green light directly on to the puncture site. According to previous studies, NIR had shown a trend in reduction of time employed for a blood sample, in children younger of 6 yr.

The aim of this trial is to investigate if the use of the VeinViewer® in a pediatric blood drawing center could decrease time spent to perform the procedure and improve the rate of first attempt success.


Eligibility Criteria:
Inclusion Criteria:

* subjects accessing the outpatient blood-drawing service

Exclusion Criteria:

* application of topical anaesthetic cream
Is the Human Microbiome Altered in Patients With Axial Spondyloarthritis?

This study aims to compare biological communities in stool samples obtained from age, diet and BMI-matched subjects in five study groups: subjects with ankylosing spondylitis (AS) never treated with tumor necrosing factor (TNF) inhibitors, subjects with ankylosing spondylitis previously or currently treated with TNF inhibitors, subjects with non-radiographic axial spondyloarthritis (nrSpA) never treated with tumor necrosing factor (TNF) inhibitors, subjects with non-radiographic axial spondyloarthritis previously or currently treated with TNF inhibitors and healthy participants.

The differences in fecal microbiota composition will be explored using shotgun metagenomic sequencing through the University of Washington. The investigators predict that this study will confirm a significant difference between the fecal microbiota composition (FMC) of both AS and nrSpA patients and controls.


Eligibility Criteria:
Inclusion Criteria:

* Able to provide informed consent
* Male or Female patients ≥18 years of age
* Additional Inclusion Criteria based on cohort

Exclusion Criteria:

* Current use of any pain-relieving medications other than NSAIDs, APAP and/or opioids
* Corticosteroid therapy or probiotic exposure within the last two weeks
* Antibiotic exposure within the past two months
* History of psoriasis or inflammatory bowel disease or reactive arthritis or any other chronic rheumatologic disease
* Active infection
* History of hepatitis B or C or HIV
* Active cancer or history of colon cancer or any form of chemotherapy or radiation within the past year
* Celiac disease
* Use of proton pump inhibitors within the prior two months
* History of clostridium difficile
* Pregnancy
* Active diarrhea (defined as a decrease in fecal consistency lasting four or more weeks)
* Additional Exclusion Criteria based on cohort
A Food Effect Study to Evaluate the Pharmacokinetics of ASP1517

The objective of this study is to evaluate the effect of food on the pharmacokinetics of a single oral dose of ASP1517 in non-elderly healthy adult male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Body weight: ≥50.0 kg and \<80.0 kg
* Body-mass index : ≥17.6 and \<26.4 kg/m2
* Subject must agree to use two of the established contraceptive methods after informed consent acquisition through 84 days after the last administration of the study drug.
* Subject must agree not to donate sperm after informed consent acquisition through 84 days after the last administration of the study drug.

Exclusion Criteria:

* Received or is scheduled to receive any investigational drugs in other clinical trials or post-marketing studies within 120 days before screening or during the period from screening to the hospital admission day of Period 1
* Received or is scheduled to receive medications (including over-the-counter \[OTC\] drugs) within 7 days before the hospital admission day of Period 1
* Received or is scheduled to receive supplements within 7 days before the hospital admission day of the Period 1
* Deviates from any of the normal range of blood pressure, pulse rate, body temperature and standard 12-lead electrocardiogram (ECG) at screening or the hospital admission day of Period 1
* Meets any of the criteria for laboratory tests at screening or the hospital admission day of Period 1. Normal ranges of each test specified at the test/assay organization will be used as the normal ranges in this study.
* Concurrent or previous drug allergies.
* Development of (an) upper gastrointestinal symptom(s) within seven days before the hospital admission day of Period 1.
* Concurrent or previous hepatic disease, heart disease, respiratory disease, gastrointestinal disease, renal disease, endocrine disease, cerebrovascular disorder, malignant tumor, retinal neovascular lesions and macular edema.
* A history of digestive tract excision.
* Previous use of hypoxia inducible factor-prolyl hydroxylase inhibitors (HIF-PHI) such as ASP1517 (FG-4592), YM311(FG-2216) or erythropoietin products.
* Excessive alcohol or smoking habit.
Financial Toxicity and Quality of Life in Patients With TGCT

This is a cross-sectional, observational study employing validated questionnaires to investigate financial toxicity in subjects with testicular germ cell tumors (TGCT). As background, TGCTs are the most common malignancies among men from age 15-35. Treatment is highly curative, but often consists of intensive multi-cycle chemotherapy with significant potential for physical toxicity. The treatment course itself is disruptive and long term physical and mental health consequences can increase risk for financial toxicity. Thus, we aim to study financial toxicity in both patients with TGCT actively receiving treatment and in TGCT survivors. There will be two separate cohorts: Cohort 1 will consist of subjects with recently diagnosed TGCT who will undergo multi-agent, multi-cycle chemotherapy and Cohort 2 will consist of subjects who have completed chemotherapy and are long-term survivors.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years of age
* Patients with histologically or clinically confirmed germ cell tumor.
* Completed treatment for germ cell tumor with multicycle (\> 2 cycles) / multiagent chemotherapy.
* Within years 1-5 of surveillance since Day 1 of last cycle of chemotherapy
* Signed informed consent

Exclusion Criteria:

* Long-term survivors

  * Patients undergoing active chemotherapy
  * Patients who did not complete 1st line chemotherapy.
A Randomised, Single Centre, Double-blind, Two-period, Cross-over Trial in Healthy Subjects Investigating the Bioequivalence Between Subcutaneous Injections of Semaglutide Produced by Two Manufacturing Processes

This trial is conducted in Europe. The aim of the trial is to investigate the bioequivalence (assessment of the expected biological equivalence of two pharmaceutical drug products with identical active ingredient) between subcutaneous injections of semaglutide produced by two manufacturing processes.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects
* Body mass index (BMI) of 18.5-30 kg/m\^2 (both incl.)

Exclusion Criteria:

* History of or presence of cancer, diabetes, pancreatitis or any clinically relevant cardiovascular diseases or other major disorders
* Use of prescription or non-prescription medicinal products (except routine vitamins, acetylsalicylic acid and paracetamol) within 3 weeks (or within 5 half-lives of the medicinal product, whichever is longest) prior to the first dosing of semaglutide
* Smoking, drug or alcohol abuse
* Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or not using adequate contraceptive methods for the duration of the trial and for 3 months following the last dose of semaglutide
Teta Burst Versus 10 Hz Repetitive Transcranial Magnetic Stimulation İn Neuropathic Pain: A Sham Controlled Comparison

Neuropathic pain is a common complication after spinal cord injury (SCI), which significantly affects the patient's quality of life and may be resistant to pharmacological treatment. In our study, we aimed to evaluate the efficacies of intermittent theta burst (iTBS) and high frequency (10 Hz) repetitive transcranial magnetic stimulation (rTMS) by comparing them with each other and with sham stimulation, in the treatment of neuropathic pain resistant to pharmacological treatment in patients with SCI.

Question 1: İs rTMS anda iTBS treatment, useful for pain severity and the effect of pain on daily functions, in the treatment of neuropathic pain in SCI Question 2: Are rTMS and iTBS treatments effective in depression in patients with neuropathic pain after spinal cord injury?

Pharmacological treatments may be insufficient to limit neuropathic pain. Therefore, research continues for safe and effective new treatments. Transcranial magnetic stimulation (TMS) is a non-invasive brain stimulation method that modulates the cortical excitability of the motor area to which it is applied. Theta Burst stimulation (TBS) is a new rTMS method consisting of stimulation sequences in a special pattern. It stands out with its ability to deliver high pulses in a short time and its high capacity to induce cortical plasticity. Intermittent TBS (iTBS) and high frequency rTMS facilitate excitability in the motor area where it is applied, and this effect is used in pain treatment. Pain modulation with these methods has been tried in some studies. Therefore, repetitive magnetic stimulation of the motor cortex by these two methods may be good options for the treatment of neuropathic pain resistant to pharmacological treatment in patients with SCI.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18-65,
* Traumatic/Non-traumatic spinal cord injury (\>4 months),
* For \>3 months, despite pharmacological treatment (no dose or medication changes have been made for at least 1 month), Brief Pain Inventory (BPI)-Part 1 average pain score is ≥4/10, neuropathic pain at the injury level and/or below (DN4 ≥4 /10) patients

Exclusion Criteria:

* Pain attributed to causes other than neuropathic pain (e.g. musculoskeletal pain, pain resulting from diabetic polyneuropathy), Having a history of epilepsy, dementia, cognitive impairment, neurodegenerative disease,
* Having a history of psychiatric illness (except reactive depression),
* Having a lesion in the brain due to vascular, traumatic, tumoral or infectious reasons,
* Having a history of alcoholism,
* Having an intracranial metallic implant,
* Having a cardiac pacemaker,
* Pregnant patients
Delirium Detection During Routine Patient Care

Despite the presence of validated tests, there are still drawbacks to implementing delirium diagnosis tests in hospital wards. We developed a new, simple, easy to implement user friendly delirium diagnostic test that is likely to facilitate implementation in many departments. The present study will compare the new test to a well validated older test - 4AT.

Delirium is characterized by an acute onset altered mental status and/or a confusional state. Although delirium has been known since ancient times, the condition is often not diagnosed, documented, evaluated, and managed. Early detection of delirium in hospitalized patients may be critical, particularly on internal medicine wards, as mental deterioration in the elderly can be the first sign of preventable diseases and disorders that precipitate delirium. Nevertheless only 15%-35% of cases of delirium in hospitalized patients are identified by the treating staff and documented in the medical records. The main reasons for this shortcoming are insufficient awareness to emerging delirium, and excessive work load.

We have recently developed and implemented in our Department of Internal Medicine a new diagnostic tool for delirium. This test, designated R\&M, is based on a combination of RADAR (Recognizing Acute Delirium As part of your Routine), performed by the nurses during medication dispensing, and MOYB (Months Of the Year Backwards), performed by residents during the routine rounds in patients with positive RADAR. Both tests are online and saved in the patients' electronic records.

The purpose of this study is to demonstrate non-inferiority of R\&M compared to 4AT (Attention, Abbreviated mental test, Alertness, Acute onset Test), an old and well validated delirium recognition test. The sample size required for a sensitivity of 95% and a 95% confidence interval was calculated to be n=365, assuming delirium prevalence of \>20% in elderly patients hospitalized in internal medicine wards.

Eligibility Criteria:
Inclusion Criteria:

- patients \>70 yrs old, hospitalized in the department of internal medicine

Exclusion Criteria:

* severe dementia
Disruption of Memory Reconsolidating as a Treatment for Panic Disorder

Animal and human fear conditioning studies have repeatedly shown that administering propranolol before or after retrieval of a previously acquired fear results in an elimination of the fear expression. This approach, known as disruption of fear memory reconsolidation, is a promising new avenue for treating anxiety disorders. The present study aims to test its efficacy in patients with panic disorder.


Eligibility Criteria:
Inclusion Criteria:

* a primary diagnosis of panic disorder according to DSM-V
* written approval of an independent physician for participation

Exclusion Criteria:

* other relevant treatment for panic disorder at the time of study - e.g., Cognitive Behavioral Therapy (CBT)
* diagnosis of depression
* diagnosis of psychosis
* use of psychotropic medication
* history of pulmonary diseases
* metabolic acidosis
* history of cardiovascular diseases
* heart problems among first-degree relatives
* heart rate (HR) \< 60
* blood pressure (BP) \< 90-60 or BP \> 170-100
* history of black-outs or fainting
* diabetes
* liver or kidney diseases
* hyperactive production of thyroid hormones
* epilepsy
* any medication contra-indicative of the use of propranolol
* pregnancy