cyrilzakka/clinical-trials huggingface dataset:
Collaborative Assessment of Pediatric Transverse Myelitis: Understand, Reveal, Educate or CAPTURE Study

Patients and families are invited to participate in an online registry and data repository specifically for patients with transverse myelitis (TM) or acute flaccid myelitis (AFM). The data generated in this study will come from surveys, interviews, review of medical records.

Data from this study will be utilized to guide future clinical trials for children with an acute case of TM or AFM. Parents and school aged children will complete an online survey 7 banks of questions. Each bundle of survey topics have 7-10 questions. We will have both the parent and child complete a outcomes based survey within 6 months of diagnosis and invite to participate every 4 months until study end in 2024.

Both parent and child will participate in the online questionnaires. The validated questionnaires, PROMIS or Patient-Reported Outcomes Measurement Information System, are blocks of 8-10 questions. 7 blocks of questions for the parent and 7 similar blocks for the child: anxiety, depressive symptoms, fatigue, mobility, pain interference, peer relationships, upper extremity function.

Participation via the Internet: When a child or family enters the Transverse Myelitis Association (TMA) website, they will be directed to information about the CAPTURE study. If the family is interested in participation, the TMA will give them the UT southwestern in Dallas, TX research coordinator information. It is up to the parent/guardian to contact the study staff from University Texas Southwestern. Once initial contact is complete, at the family's request, study staff will send the consent form to the interested family. The family will need to email or mail the consent back. Once the signed consent form is in hand, we will send the research survey to the email the parent provides. One survey for the parent, a separate but similar survey for a school aged child.

We will invite parents of school aged children to complete a school survey. This is a one time only questionnaire. Ideally, the parents will complete this either 6 months or 1 year into their child's recovery of TM/AFM.

We invite families living outside of North America to participate in the online survey. They need to be fluent in English, same as the North American cohort.

Eligibility Criteria:
Inclusion Criteria for the registry:

* Diagnosis of transverse myelitis (TM) or acute flaccid myelitis (AFM)
* Patient is within 6 months of symptom onset
* Ability of patent or legal guardian is able to provide informed consent
* Ability of a child 10 or older able to provide assent
* Access to the internet

Exclusion Criteria for the registry:

* Inability to provide appropriate consent or assent
* Diagnosis of multiple sclerosis, neuromyelitis optica, or neuromyelitis optica spectrum disorder
Vibrotactile Stimulation With Saphenus Device

To determine the benefit of the vvibrotactile sensory feedback device.

In the United States, approximately 150.000 patients undergo a lower extremity amputation annually. With a high change of developing neuropathic pain, decreased mobility due to the missing limb and therefore depressed mental wellbeing, lower extremity amputations are debilitating the patient on multiple facets. From the usage of non-mechanical prosthetic wear, meaningful improvements have been made in surgical amputee care in the recent decades. Osseointegration, and later regenerative nerve surgical techniques like targeted muscle reinnervation (TMR) and regenerative peripheral nerve interface (RPNI) have led to major improvements in the mobility of lower limb amputees, by introducing myoeletric prosthetics. Although technological advances have let to improved motoric function and motor control over artificial limbs, sensory feedback is still a very complex aspect of regaining full control over the missing limb. Recently, introduced as a technical variation on TMR, Targeted Sensory Reinnervation is based on reinnervation of a defined skin area by another sensory nerve. Recently, application of vibrotactile feedback, connected to the lower extremity prosthetic socket, has shown promising results in regaining proprioception in the missing limb, resulting in improved walking ability and pain. However, Targeted Sensory Reinnervation (TSR) is a novel surgical technique which is not always possible to perform and not available to every lower extremity amputee. Therefore, this study aims to investigate whether this vibrotactile sensory feedback device improves gait and pain in major lower limb amputee population regardless of whether TSR has been conducted.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* Major lower limb amputee
* Willing and able to participate

Exclusion Criteria:

* Age under 18
Long-Term Safety Of PF-00547659 In Ulcerative Colitis

Subjects with Ulcerative Colitis who have completed an induction study with PF-00547659 will receive an additional 144 weeks of open-label treatment to evaluate the long-term safety of the drug.


Eligibility Criteria:
Inclusion Criteria:

* Subjects between 18 and 66 years of age.
* Subjects previously enrolled in study A7281009 (NCT01620255) who have completed the 84 day (12 week) induction period.

Exclusion Criteria:

* Subjects that have completed Day 84 (Week 12) of study A7281009 but have experienced serious event(s) related to the investigational product, an unstable medical condition, or any other reason, in the opinion of the investigator, would preclude entry or participation in this study.
* Subjects who are taking any dose of Azathioprine (AZA), 6-mercaptopurine(6 MP) or Methotrexate (MTX).
Effect of Urtica Dioica on Glycemic Control in Patients With Type 2 Diabetes Mellitus

Diabetes mellitus is the most common metabolic disorder worldwide. Some herbs are traditionally used in treatment of type 2 diabetes mellitus (T2DM). Urtica Dioica (UD) or stinging nettle is traditionally used in Morocco, Turkey, Brasil, Jordan and with much frequency in northern Iran.

Studies on animal models along with in vitro studies has shown hypoglycemic effect for aqueous extract of UD.

This study aimed to investigate hypoglycemic effects of UD tea bags in patients with T2DM on glycemic control, insulin sensitivity, along with its effects on lipid profile (LP), blood pressure (BP), liver, and kidney function.

The study will be performed under randomized, double-blind, placebo controlled, and case-control design. The object of this study is patients with T2DM. Patients are randomly assigned to start with placebo tea bags (3 tea bags as 2-gram tea bag steamed in boiling water for 20 minutes: mixture of bran powder which is already boiled in water twice plus spinach powder) in control groups and UD tea bags (3 tea bags as 2-gram tea bag steamed in boiling water for 20 minutes) in patients with T2DM for two months. Every two weeks, fasting glucose, postprandial glucose after a standard breakfast, serum insulin, lipids, alanine amino transferase (ALT), aspartate amino transferase (AST), creatinine (to calculate GFR), along with blood pressure will be measured.

To the best of our knowledge, this is the first Randomized Clinical Trial.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of T2DM
* Must be able to drink UD or Placebo tea bags 3 times every day

Exclusion Criteria:

* Insulin dependent diabetes
* History of congestive heart failure within last 5 years (NYHA Class III-IV)
* History of significant pulmonary disease, myocardial infarction, cerebrovascular accident, or nephrotic syndrome within last 1 year
* Thyroid disease
* Known renal or hepatic insufficiency
* Gastric problem
* History of UD or and other herb use in past 6 months
* Pregnancy or lactation
* Use of any herbal or supplement within past 6 months
* Use of an investigational drug (within 30 days prior to enrollment)
* Known maternal allergies
* Dumping syndrome
ECHANGE: EHealth Design to Facilitate Weight Maintenance Following Initial Weight Loss

The aim of this study is to evaluate an eHealth intervention facilitating weight maintenance following initial weight loss during a 3-month trial (pilot test)

Obesity rates are rapidly increasing and even with diets and interventions aiding weight loss, an alarmingly large percentage of people struggle to maintain the lost weight. In the face of obesity, weight maintenance is therefore arising as a major obstacle and new innovative approaches are called for. Despite the fact that a substantial number of web-based diets, health and fitness focused interventions or "apps" already exist, few focus on weight maintenance, are research based or available post study. In addition, most have yet to show short- or long-term effect and few, if any, are developed together with users (e.g., patients, health care professionals). eHealth solutions may therefore be a "missing link" in supporting self-regulation and motivation for sustainable health behavior change and weight loss maintenance. The aim of this study is to evaluate a person-centered, evidence based interactive eHealth intervention facilitating weight maintenance following initial weight loss during a 3- month feasibility pilot trial.

Eligibility Criteria:
Inclusion Criteria:

* BMI 30 or more before weight loss
* 8% weight reduction or more through conservative methods
* Aim to maintain weight after weight loss or prevent weight gain
* Understand and read the Norwegian languague
* Can access the internet and own a smartphone

Exclusion Criteria:

* Weight loss through surgery or medication
* Medication to support weight loss or maintenance
Psilocybin for Major Depressive Disorder

The goal of this study is to assess the effectiveness of psilocybin for the treatment of Major Depressive Disorder and potential therapeutic mechanisms. Enrolled participants will receive a single active dose of psilocybin, or a dose considered high enough to treat depression, administered orally with accompanying psychological support.


Eligibility Criteria:
Inclusion Criteria:

* Currently meeting DSM-V Criteria for a Major Depressive Episode of at least mild-moderate severity
* Aged 18-85
* Ability and willingness to attend study visits and complete study assessments

Exclusion Criteria:

* Presence of medical conditions at screening that may affect the safe administration of psilocybin (including, but not limited to: AST/ALT \> 150, QTc \> 450ms, MELD \> 9)
* Depression deemed secondary to a severe medical condition
* Recent use of any classical psychedelic drug or MDMA
* Recent use of any interventional psychiatric treatment (including: ECT, ketamine, esketamine, TMS)
* Intention to begin any new treatment for depression prior to primary outcome determination
* Use of any excluded medication
* Active substance use disorder
* Presence of any psychiatric condition that may interfere with the safe administration of psilocybin
* Active suicidal ideation
Active and Placebo Controlled Study to Test the Efficacy and Safety of an Aspirin-Lidocaine Lozenge in the Symptomatic Treatment of Sore Throat Associated With a Common Cold

The purpose of this study is to investigate the analgesic efficacy of a single dose of a fixed combination of 500 mg Aspirin (Acetylsalicylic Acid) and 4 mg Lidocaine in adult patients with sore throat associated with a common cold in comparison to a single treatment with 500 mg Aspirin or 4 mg Lidocaine alone as well a Placebo (treatment without any active ingredient). The combination of Aspirin and Lidocaine in a single lozenge is expected to provide relief from sore throat pain by sequential action. A very fast inset of action will be achieved by the locally acting Lidocaine and a long duration of action will be achieved by the systemically acting Aspirin.


Eligibility Criteria:
Inclusion Criteria:

* Males and females of at least 18 years of age
* Onset of common cold within the last 3 days (12 to 72 hours)
* History of at least 4 symptoms associated with URTI in the last 24 hours out of runny nose, stuffy nose, sneezing, wet cough, dry cough, sweating, earache, ear fullness, sinus pressure/pain, head heaviness, muscle aches and pains, feverish discomfort, chills, hoarseness, sore throat, scratchy throat and headache as documented in the history of URTI
* Current sore throat confirmed by a score ≥ 6 on a 11-category vertical ordinal scale for sore throat pain
* Findings that confirmed the presence of tonsillopharyngitis

Exclusion Criteria:

* Pregnancy (i.e. positive pregnancy test at baseline)
* Breastfeeding
* History of hypersensitivity (allergic reaction) to ASA or any other NSAID
* History of hypersensitivity (allergic reaction) to lidocaine
* History or acute state of peptic ulceration or gastrointestinal bleeding
* History of bleeding tendency
* History of asthma
* Clinical diagnosis of chickenpox or influenza
* History or presence of severe liver or kidney disease
* Intake of short-acting analgesics (e.g. ASA, paracetamol, ibuprofen, diclofenac) either as a single ingredient or as part of a combination cold product in the last 6 hours, or intake of long-acting analgesics (e.g. naproxen) in the last 12 hours, or intake of any other NSAID in the last 24 hours
* Use of any local or systemic short-acting cough and cold preparation (e.g. decongestant or antihistaminic drug) in the last 12 hours
* Use of any cough or sore throat lozenges/candies or any menthol-containing product (including mentholated tissues) in the last 6 hours
* Current intake or requirement of any prescription medication for the current treatment of acute respiratory tract illness
* Administration of anticoagulants in the last 7 days
* Inability to breathe through the nose or a history of chronic mouth breathing
* Presence of any severe concomitant disease or condition which, in the opinion of the investigator, is a reason for exclusion, e.g. serious cardiovascular diseases (in particular arrhythmias), treatment with antiarrhythmics or methotrexate
Biomarker in Tumor Tissue Samples From Patients With Rhabdomyosarcoma

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research trial studies biomarkers in tumor tissue samples from patients with rhabdomyosarcoma.

OBJECTIVES:

* To determine and quantify the degree of surface insulin-like growth factor I receptor (IGF-IR) expression in rhabdomyosarcoma (RMS) tumor tissue.
* To assess the feasibility and validity of a mass spectrometry assay for IGF-IR expression on paraffin-embedded tumor tissue.

OUTLINE: Paraffin-embedded tumor tissue slides are analyzed for insulin-like growth factor I receptor (IGF-1R) expression by mass spectrometry and correlated with the results obtained by IHC assay.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of rhabdomyosarcoma

  * Alveolar or embryonal rhabdomyosarcoma
* Available samples from the Cooperative Human Tissue Network (CHTN) bank

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Combining tsDCS and Exoskeleton Gait Training on Spinal Excitability in SCI

The purpose of the study is to determine whether transcutaneous spinal direct current stimulation (tsDCS) is safe for individuals with spinal cord injury (SCI). tsDCS is an electrical current applied to the skin. The plan is to also study the potential neurophysiological changes (changes in speed and excitability of the nerves) and functional improvements in gait (for example, gait quality, speed and walking distance) for individuals with SCI after combined application of tsDCS and exoskeleton assisted gait training.

Subjects will participate in two baseline visits, 4 days apart. Each baseline visit will last 1 hour and will include assessment of soleus H-Reflex and 10 meter walk test on arrival and 40 minutes after the initial assessment. Subjects will be asked to minimize their activity between assessments by either sitting in a chair or lying on a mat.

Each training visit will involve either an exoskeleton intervention or a combined exoskeleton and tsDCS intervention. Each training visit will include assessment of soleus H-Reflex and 10 meter walk test before and after the exoskeleton intervention or before and after the combined exoskeleton and tsDCS intervention.

Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant female
* ≥18 years of age
* Able to achieve adequate fit within exoskeleton
* Diagnosis of spinal cord injury (SCI), T10 level and above (T11 and 12 may participate if no clinical signs of lower motor neuron lesion present)
* Minimum of 6 months post injury
* Sufficient range of motion to attain normal, reciprocal gait pattern, and transition from normal sit to stand or stand to sit
* Weight \<220 pounds
* Intact skin on all surfaces in contact with device and load bearing surfaces
* Ability to perform informed consent

Exclusion Criteria:

* Pregnancy
* Spinal instability
* Unhealed limb or pelvic fractures or any condition restricting weight bearing in limbs
* Presence of peripheral neuropathy or any pathology that could influence reflex excitability
* Diagnosis of other neurological injury other than SCI such as stroke/cerebrovascular accident (CVA), multiple sclerosis (MS), acquired brain injury (ABI), cerebral palsy (CP)
* Uncontrolled spasticity (≥3 on Modified Ashworth Scale)
* Colostomy
* Decreased range of motion or contractures in legs (\>10° at hips, knees or ankles)
* Uncontrolled autonomic dysreflexia
* Unresolved deep vein thrombosis
* Inability to tolerate standing due to cardiovascular issues or orthostatic hypotension
* Severe comorbidities: active infections, heart, lung, or circulatory conditions
* Pressure sores, impaired skin integrity
* Use of mechanical ventilation for respiratory support
* Presence of any of the following contraindications to electrical stimulation: cardiac pacemaker, deep brain stimulator, or evidence of cancerous (malignant) tissue
* Presence of metal in thoracic spine or region of electrode placement
QUALITATIVE SURVEY ABOUT NURSES FIRST WORK EXPERIENCE DURING COVID-19 PANDEMIC

During covid-19 pandemic an huge reorganization of all PiacenzaHospital was done to manage the increasing requests for hosptitalization.

New nurses had to face first work experience in full pandemic Emergency. Altough even before the pandemic, being a newly graduated nurses was described as a stressful and isolating experience , we can't find studies in the literatureconcerning newly graduated and newly hired nurses during the pandemic pediod.

The study purpose is to describe and analyze, trough a phenomenological research, the experience of these nurses.


Eligibility Criteria:
Inclusion Criteria:

* Adults
* first work experience nurses after gratuation
* not opposed to partecipate to this study

Exclusion Criteria:

* refusing to partecipate
A Study to Evaluate the Safety and Pharmacokinetics of BMS-986177 in Participants With End-stage Renal Dysfunction on Chronic Stable Hemodialysis Treatment

An oral dose of BMS-986177 administered in End-stage Renal Dysfunction (ESRD) participants before and after a hemodialysis session to evaluate safety, tolerability, and pharmacokinetics in this patient population.


Eligibility Criteria:
Inclusion Criteria:

* Classified at screening as having ESRD requiring hemodialysis at least 3 times per week for 3 months.
* Clinical, ECG, and laboratory findings consistent with renal dysfunction
* BMI of 18.0 to 38.0 kg/m2 inclusive
* Subjects must receive unfractionated heparin during dialysis treatments and are able to withstand a decrease in their established heparin dose (75% of current dose)
* Women Not of child bearing potential (WNOCBP). Sexually active fertile men with partners who are WOCBP must use non-hormonal highly effective birth control

Exclusion Criteria:

* History of uncontrolled or unstable cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening
* Evidence or history of coagulopathy, prolonged or unexplained clinically significant bleeding, or frequent unexplained bruising
* Current or recent (within 3 months of study drug administration) clinically significant gastrointestinal disease or gastrointestinal surgery that could interfere with absorption of study drug
* Any condition requiring anticoagulation such as, but not limited to, atrial fibrillation, mechanical prosthetic valve, deep venous thrombosis, or pulmonary embolism (other than heparin required during hemodialysis)
* Need for aspirin or need for P2Y12 antagonist therapy (for example clopidogrel, prasugrel, or ticagrelor)
* Other protocol defined exclusion criteria could apply
Dysmenorrhea Exploration in Teenagers, Their Parents and Caregivers

Teenagers experimenting severe dysmenorrhea also face age-specific challenges, particularly impacting their self-confidence, self-esteem, and relations. On one hand, the study team will conduct focus group interviews to better understand the experience of teenagers and their parents consulting pediatric services for severe dysmenorrhea. On the other hand, they will conduct focus group interviews with caregivers from services that usually encounter such patients (gastrologic, gynecologic and pain services). This, allowing to later propose specific tools and healthcare organization to evaluate and accompany teenagers suffering from severe dysmenorrhea.

Endometriosis is a complex disease that remains underdiagnosed (7 to 9 years delay), and incorrectly treated. While endometriosis was at first considered as a condition affecting adult women, since the early 2000s, literature has described more and more cases of adolescent patients, with frequently atypical presentations. Indirect prevalence estimates ranging from 25% to 100% in adolescents' girls with pelvic pain. Moreover, Arruda et al. indicate that adolescents girls arrive after a delay in diagnosis which has a significant impact on the progression of the disease and on their confidence in the medical listening and understanding abilities. However, the pain induced by dysmenorrhea has a profound impact on everyday life of and are frequently responsible for school missing as shown in the RESENDO survey.

By conducting a qualitative analysis based on focus groups, the main objective of the study is to describe as faithfully and extensively as possible the experience of teenage patients and their parents consulting for severe dysmenorrhea, and delineate factors potentially improving or hindering care engagement.

The study utilizes a qualitative method as a tool to have a better understanding of this population, a population increasing in pediatric gynecology services or pain management consultations. Gathering their words, their views on their symptoms and its repercussions, and their main issues, will enable to build a relationship of trust with caregivers, better address the broad problematic, and identify risk factors.

Eligibility Criteria:
INCLUSION CRITERIA :

* For " teenage" groups:

  * adolescents between 11 and 17 years old
  * consulting for severe dysmenorrhea (whether through pediatric gynecology, pain management or gastric consultation)
* For "parents" groups:

  o Parent (mother or father) of an adolescent patient consulting for severe dysmenorrhea
* For "medical staff" groups:

  * Member of a consultation receiving adolescent patients with severe dysmenorrhea
  * All type of professionals (nurses, psychologist, doctors...)

Exclusion criteria :

* For " teenage" groups:

  * suffering from an identified chronical disease
  * identified psychiatric condition
* For "parents" groups:

  o Parents whose adolescent opposes their participation in this study
* For "medical staff" groups:

  * no exclusion criteria