cyrilzakka/clinical-trials huggingface dataset:
"Clinical and Epidemiological Characteristics of Inflammatory Rhinitis in Patients on Biotherapies"

Inflammatory rhinitis is a side effect observed in patients treated with biotherapies in the context of chronic bowel disease (IBD) or spondylartrhopathy (SPA). This damage is still poorly described in the literature. I The objective of this study is to study the associated characteristics of crustal rhinitis in a cohort of patients treated with biotherapy for chronic inflammatory disease (IBD, SPA, psoriasis).

Inflammatory rhinitis is a side effect observed in patients treated with biotherapies in the context of chronic bowel disease (IBD) or spondylartrhopathy (SPA). This damage is still poorly described in the literature. It can occur in isolation or in association with a fold pustulose table, which differs from the classic fold pustulose described by Cribier et al in autoimmune diseases by the presence of staphylococcus aureus in the pustules. Some authors also describe associated paradoxical psoriasiform reactions or an impetigo. In our experience, this condition is more frequently found in patients treated for IBD or SPA and has a clinically characteristic fissure appearance. Thus, the semiology but also the epidemiology of this crusty rhinitis is still poorly described.

The objective of this study is to study the associated characteristics of crustal rhinitis in a cohort of patients treated with biotherapy for chronic inflammatory disease (IBD, SPA, psoriasis).

Patient recruitment will take place over a one-year period, in a multi-centre manner (Angers and Nantes University Hospital) with prospective data collection in the form of a questionnaire and clinical evaluation during a dermatology consultation planned in the traditional care pathway for the follow-up of patients with skin manifestations during biotherapy treatment.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient (\> 18 years of age),
* Biotherapy treatment: anti TNF, ustekinumab, secukinumab, ixekizumab, Rituximab, vedolizumab, abatacept, inhibitor jak kinase, anti Il1, Anti Il6,
* Biotherapy treatment \> 3 months,
* Chronic inflammatory disease: psoriasis, ankylosing spondylitis (SPA), rheumatoid arthritis (RA), Crohn's disease (CD), bleeding rectocolitis (HRC)
* No opposition to the study

Exclusion Criteria:

* Patient under legal protection measure,
* Refusal of the subject to participate in the study,
Use of a Mobile-based App for SCD Patients

The study will seek to enroll 100 sickle cell or thalassemia patients who are age 12 or older who have access to a smartphone or tablet with Internet access daily.

The study will evaluate patient-reported comfort level with using a mobile device to record their pain levels, as well as adherence to recording these levels daily.

The study will track patients' assessment of their pain, actions taken, and outcomes related to pain management and provider involvement.

This study will attempt to collect information about differences in the use of two traditional pain assessment modes (verbal scale and paper) versus the use of a pain assessment tool on a mobile device in the form of a smartphone, tablet, or iPad with an Android or iOS operating system.

The study will evaluate patient-reported comfort level with using a mobile device to record their pain levels, as well as adherence to recording these levels daily. The study will track patients' assessment of their pain, actions taken, and outcomes related to pain management and provider involvement. This study will attempt to collect information about differences in the use of two traditional pain assessment modes (verbal scale and paper) versus the use of a pain assessment tool on a mobile device in the form of a smartphone, tablet, or iPad with an Android or iOS operating system. The study will seek to enroll 100 sickle cell or thalassemia patients who are age 12 or older who have access to a smartphone or tablet with Internet access daily. Patients enrolled in this study will be ask to use a mobile device such as a smartphone or a tablet with Android or iOS operating system to record daily pain level and related information once daily or more frequently for a period of forty-two days. A 1:1 randomization assignment will be made to have patients receive automated "canned" provider feedback or not.

Eligibility Criteria:
Inclusion Criteria:

* SCD, thalassemia, or history of experiencing pain

Exclusion Criteria:

* none
Smartphone Application for Initiation of Protective Ventilation. Clinical Impact of Instrumental Dead Space Reduction

Clinical evaluation of a new educative tools (Smartphone application) based on impact of instrumental dead space reduction after initiation of protective ventilation during mechanical ventilation.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Mechanical ventilation (control,assist control or SIMV mode)
* haemodynamic stability (vasopressor \< 0.2 ug/kg/min)
* no prone position schedule in the next 2 hours following procedure inclusion
* presence of an Arterial catheter

Exclusion Criteria:

* ECMO or anticipate ECMO
* body temperature \< 36.0 for post operative patient (cardiac surgery)
A 12-Week Safety and Pharmacodynamic Study of AT1001 (Migalastat Hydrochloride) in Participants With Fabry Disease

Study to evaluate the safety, tolerability, and pharmacodynamics of migalastat hydrochloride (HCl) (migalastat) and how migalastat works in participants with Fabry disease.

This was a Phase 2, open-label study in male participants with Fabry disease. The study consisted of a 4-week screening period during which participants' genotype was assessed for α-galactosidase A (α-Gal A) activity in response to migalastat via an in vitro assay. Participants were required to have α-Gal A activity responsive to migalastat. The study consisted of a 12-week treatment period, followed by an optional 36-week extension period. Participants received migalastat 150 milligrams (mg) once every other day (QOD) for 12 weeks during the treatment period. Participants could then opt to participate in the extension period.

Eligibility Criteria:
Inclusion Criteria:

* Males between 18 and 65 years of age (inclusive)
* Hemizygous for Fabry disease
* Had a confirmed diagnosis of Fabry disease with a documented missense gene mutation (individual or familial)
* Had enhanceable enzyme activity based on in vitro tests
* Had documented evidence of cardiac and/or renal dysfunction (for example, abnormal electrocardiogram (ECG), left ventricular hypertrophy, renal insufficiency) and/or cerebral tissue dysfunction documented by evidence of stroke and/or peripheral nervous tissue dysfunction (for example, intolerance to heat/cold, decrease of perspiration)
* Must have been previously untreated by enzyme replacement therapy (ERT) or substrate depletion for Fabry disease or were able to stop ERT for at least 18 weeks or up to three months, and be willing to undergo two kidney and three skin biopsies
* Agreed to be sexually abstinent or use a condom with spermicide when engaging in sexual activity during the course of the study and for a period of 30 days following their completion of the study
* Were willing and able to sign an informed consent form

Exclusion Criteria:

* History of significant disease other than Fabry disease
* History of organ transplant
* Serum creatinine \>2 mg per deciliter on Day -2
* Screening 12-lead ECG demonstrating corrected QT interval \>450 milliseconds prior to dosing
* Pacemaker or other contraindication for magnetic resonance imaging (MRI) scanning
* Took any of the following prohibited medications: Fabrazyme® (agalsidase beta), Replagal™ (agalsidase alfa), Glyset® (miglitol), Zavesca® (miglustat), or any experimental therapy for any indication
* Participated in a previous clinical trial in the last 30 days
* Any other condition, which, in the opinion of the investigator, would jeopardize the safety of the participant or impact the validity of the study results
VR-Based Video Modeling for Novice Swimmers

Understanding the complex dynamics of motor skill acquisition in swimming is critical for developing effective training programs. Advances in technology, such as virtual and augmented reality, offer new opportunities to enhance learning and performance in this field. This study investigated the impact of virtual reality (VR)-supported video modeling (VM) swimming exercise programs compared with traditional approaches on the swimming performance of beginners.

Fifty-five university students participated in the study. They were divided into two groups: the VR-supported VM group (VRVM) (n=28) and the traditional swimming group (TSG) (n=27). The VRVM group engaged in VR-supported VM practice in addition to traditional swimming training, whereas the TSG group only participated in traditional swimming training. The performance variables measured included swimming stroke (SS), crawling kick (CK), swimming duration (SD), heart rate (HR), and rate of perceived excretion (RPE).


Eligibility Criteria:
Inclusion Criteria:

Never having taken a swimming course before. Not having any health problems. Not having water phobia.

Exclusion Criteria:

To be able to progress by stroking on the water without any support from anywhere.
Outcomes Comparison of Chronic Immune Thrombocytopenic Purpura (ITP) Patients Switched to Eltrombopag and Romiplostim

Chronic immune thrombocytopenic purpura (ITP) is characterized by low platelet counts and the risk of severe bleeding complications. The two recently introduced TPO-RA drugs, namely, eltrombopag and romiplostim, have shown efficacious sustained response with continuous administration. Both drugs are indicated for the treatment of thrombocytopia in patients with chronic ITP who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. While these trials address important clinical questions they were not intended to evaluate what happens in the real-world settings with actual patient living daily lives. The purpose of this health outcomes study is to understand how the two TPO receptor agonists (TPO-RA) currently available in the US are being used in clinical practice and how their use impacts chronic ITP patients' daily lives. The study hypothesis is that patients who switched to eltrombopag report a better health-related quality of life than those who switched to romiplostim. This study utilized a hybrid design of retrospective chart review study and cross-sectional patient survey. A customized Patient Case Report Form (CRF) will be used to retrospectively collect clinical data from patient medical charts where the primary cohorts consist of patients who have switched from other ITP medication to eltrombopag or romiplostim. A cross-sectional survey will be employed to collect patient reported outcomes (PRO) data, including health-related quality of life and treatment satisfaction, using a compository questionnaire. Analyses of cross-sectional survey data and retrospective medical chart review data in patients who switch to either eltrombopag or romiplostim from their prior primary therapy will be conducted.


Eligibility Criteria:
Inclusion criteria

* Adults 18 years and older diagnosed with chronic ITP
* Switched to eltrombopag or romiplostim a minimum of 4 weeks prior to index date
* Received corticosteroids, rituximab, or one TPO-receptor agonist as prior primary therapy before switching to eltrombopag or romiplostim
* Medical history must be available from chronic ITP diagnosis through to most recent office visit
* Patients who complete the self-administered questionnaire were the same patients whose medical charts were reviewed

Exclusion criteria

* Age less than 18 years old
Reduction of Right Ventricular Pacing Using the Feature Ventricular Intrinsic Preference (VIP)

The purpose of this study is to evaluate the efficacy of the VIP™ feature (available in dual chamber Victory® devices) to reduce unnecessary RV pacing, and to determine if patients with implanted SJM pacemakers will benefit by using VIP™ rather than only a programmed AV/PV delay.


Eligibility Criteria:
Inclusion Criteria:

* Patient has been implanted with dual chamber SJM Victory® device with VIP™ for 1 month (± 2 weeks).
* At the time of pacemaker implant, VIP™ is programmed "OFF".
* At the time of enrollment, patient is paced in the RV ≤ 60% of the time.
* Patient is medically stable.

Exclusion Criteria:

* Patient has evidence of complete AV block, such that ventricular pacing would be required as part of the patient's routine management.
* Patient is indicated for AF Suppression.
* Patient has persistent or chronic atrial fibrillation.
* Patient is unable to comply with the follow-up visits due to geographical, psychological, or any other reasons.
* Patient is currently participating in another device research study.
* Patient is younger than 18 years of age.
* Patient is pregnant.
* Patients life expectancy is less than 12 months.
Pathogenic Metagenomic Next-generation Sequencing to Optimize the Diagnosis of Decompensated Cirrhosis Infection

The goal of this observational study is to learn about clinical application of pathogenic metagenomic next-generation sequencing to optimize the diagnosis of infection in decompensated cirrhotic patients. The main questions it aims to answer are:

1. mNGS testing in optimizing anti-infective drug use in patients with acute decompensation, including response to empiric antibiotic therapy.
2. Proportion of patients with re-compensation.
3. The positive rate of mNGS in patients with acute decompensated cirrhosis and the characteristics of pathogen.
4. The incidence, risk factors and clinical correlation of CMV reactivation.

Metagenomic next-generation sequencing (mNGS) is emerging as an important culture-independent technique that can detect nearly all known pathogens simultaneously from a clinical sample.Sequencing of microbial cell-free DNA (cfDNA) has recently been shown to enable diagnosis of several infection. Relevant studies on the clinical application of mNGS in cirrhosis patients are rare. The primary aim of this study was to comprehensively evaluate the fragments of genomic DNA from circulating microorganisms in acutely decompensated cirrhosis patients by sequencing the microbial cfDNA and relate this to clinical outcomes. The secondary aim was to validate the potential role of CMV reactivation, a known NHV with available antiviral medicines, in determining the prognosis of decompensated cirrhosis patients.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old.
* Diagnosis of cirrhosis, previously known or not, of any etiology, histologically proven or not.
* Acute decompensation: ascites, digestive hemorrhage or hepatic encephalopathy.

Exclusion Criteria:

* Age \> 80 years old.
* Malignancy of liver or other organs (including leukemia).
* Receiving immunosuppressive agents for non-hepatic diseases.
* HIV infection.
Effectiveness of Enhanced External Counterpulsation for Post-acute Stroke Patients

The goal of this clinical trial is to learn if there benefits combine enhanced external counterpulsation (EECP) with the standard post-acute care (PAC) rehabilitation treatment to treat stroke patients.. The main questions it aims to answer are:

What is the feasibility of combining EECP and PAC? Does EECP combined PAC rehabilitation improve functional outcomes of post-stroke patients? Researchers will compare standard PAC rehabilitation and EECP combined PAC rehabilitation to see if EECP has benefits to treat stroke.


Eligibility Criteria:
Inclusion Criteria:

* Patients with acute cerebrovascular disease, within 1 month after acute attack.
* Stable medical condition: (1). Neurological condition: The neurological condition has not deteriorated for more than 72 hours. (2). Vital signs including blood pressure, heartbeat, and body temperature are stable or controllable for more than 72 hours. (3). No complications such as infection, blood abnormalities, gastrointestinal bleeding, or stable or controllable after treatment.
* Those whose functional status is moderate to moderately severe functional impairment (MRS 3-4) and who are judged by the medical team to have active rehabilitation potential: (1). Have basic cognition, learning ability and willingness. (2) Have sufficient physical strength: able to maintain a sitting position on a wheelchair or bed edge for at least one hour with support. (3). Be able to actively participate in rehabilitation treatment plans.
* Aged over 20 years old

Exclusion Criteria:

* Patients with atrial fibrillation/arrhythmia.
* Within 2 weeks after cardiac catheterization or arterial puncture at the femoral artery puncture site.
* Decompensated heart failure (NYHA class 3 or 4).
* Left ventricular ejection fraction (EF) \< 30%.
* Moderate or severe aortic regurgitation.
* Persistent and uncontrolled hypertension (blood pressure persistently \>160/100 mmHg).
* Bleeding tendency.
* Active phlebitis/venous disease of the lower extremities.
* Severe vascular occlusive disease of the lower extremities.
* The presence of documented aortic aneurysm/dissection requiring surgical repair.
* Pregnancy.
A Placebo-Controlled Study of the Safety of INCB054707 in Participants With Hidradenitis Suppurativa

The purpose of this study is to evaluate the safety of INCB054707 over an 8-week treatment period in men and women with moderate to severe hidradenitis suppurativa.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of HS (confirmed by a dermatologist) with a disease duration of at least 6 months before screening.
* Stable course of HS for at least 90 days before screening, as determined by the investigator.
* HS lesions present in at least 2 distinct anatomic areas, 1 of which must be Hurley Stage II or Hurley Stage III at screening.
* Total AN count of at least 3 at screening and baseline.
* Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

* Women who are currently pregnant or lactating.
* Presence of \> 20 draining fistulas at screening and baseline.
* Participants with protocol-defined concurrent conditions or history of other diseases.
* Prolonged QT interval corrected for heart rate using Fridericia's formula (QTcF), defined as ≥ 450 msec.
* Positive test result for tuberculosis from the QuantiFERON-TB Gold test, or T-SPOT.TB test at screening.
* A history of active tuberculosis (treated or untreated) or a history of untreated latent tuberculosis.
* Positive serology test results for HIV, hepatitis B surface antigen, hepatitis B virus core antibody, or hepatitis C virus (HCV antibody with positive HCV-RNA) at screening.
* Decreased blood cell counts at screening per protocol-defined criteria.
* Severely impaired liver function (Child-Pugh Class C) or alanine aminotransferase or aspartate aminotransferase levels ≥ 1.5 × upper limit of normal at screening.
* Impaired renal function with serum creatinine \> 1.5 mg/dL at screening.
* Use of protocol-prohibited medications.
* Known or suspected allergy to INCB054707 or any component of the study drug.
* Known history of clinically significant drug or alcohol abuse in the last year before baseline.
Clinical Study With Lyrica In Patients Suffering From Epilepsy

Clinical study with Lyrica (pregabalin) in patients suffering from epilepsy. This drug is used as adjunctive therapy with one or more antiepileptics. Lyrica has potential to reduce seizure frequency.

- Included all adult patients with partial seizures and without contraindications according to Summary of Product Characteristics (SmPC).

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with partial seizures.

Exclusion Criteria:

* Contraindications according to Summary of Product Characteristics (SmPC).
Postoperative Analgesia in Children After Propofol Anesthesia

The investigators hypothesize that patients anesthetized with sevoflurane have more pain, postoperatively, than those anesthetized with propofol.

In a randomize, prospective, double-blind study, the subjects are 100 premedicated children, aged 3 to 6 years, who undergo one type of surgical procedure, hernia repair surgery. Anesthesia is maintains with propofol anesthesia (group P, n=50) or with sevoflurane anesthesia (group S, n=50). and fentanyl administered during surgery. Faces Pain Scale (FPS) is use to assess pain severity.

Eligibility Criteria:
Inclusion Criteria:

* Patient is 3- 6 years old
* Patient is scheduled for hernia repair surgery at University Clinical center of Kosovo Patients is ASA I/II Patient meets criteria to receive either propofol or sevoflurane anesthesia Patient's parent/guardian provides written consent

Exclusion Criteria:

* allergy to any of the drugs
* preoperative anxiety
* postoperative agitation
* ASA physical status \>II
Analgetic Effect of Nitrousoxide-oxygen Inhalation for Dental Treatment of Children

To assess the analgetic effect of nitrousoxide-oxygen inhalation on pain perception in 12-15 years old children from 1) the dental pulp; 2) the masseter muscle; 3) the skin on the upper lip

The present study is a randomized, cross-over blinded study on the analgetic effect of nitrousoxide-oxygen on sensitivity of the dental pulp, the skin and muscles.

It is conducted in healthy 12-15 year old Danish children attending public schools in the municipality of Aarhus, Denmark

Eligibility Criteria:
Inclusion Criteria:

* ASA-groups I or II
* 12-15 year of age
* sound upper central incisors

Exclusion Criteria:

* difficulties breathing through the nose
* pregnancy
* trauma to test teeth
Sublingual Sufentanil PCA Usability for Postoperative Pain (Zalviso® System)

Intravenous patient-controlled analgesia (iv-PCA) is the gold standard for the treatment of moderate to severe postoperative pain. It is used in more than 20% of cases after major surgery. Well known disadvantages of this method include the need of intravenous line (invasive, infection risk), the risk of pump programming error, possible delay for ambulation/barrier for enhanced rehabilitation programmes, and time/resource demanding (the need of preparation and installation). Sublingual sufentanil based PCA (Zalviso®) addresses cited issues. The safety and analgesia efficiency of this system is well described. However, the usability and satisfaction of Zalviso® varies depending on clinical settings. The goal of this study is to evaluate the usability and satisfaction of patients, nurses, and physical therapists using Zalviso® System during the first 72 hours in the settings of Enhanced Recovery After Surgery protocol after major interventions associated with moderate to severe postoperative pain.


Eligibility Criteria:
Inclusion Criteria:

* Adults
* 16 \<BMI \<40
* ASA I and II
* Patient with traumatic functional surgery - Knee and hip arthroplasty, shoulder surgery, tibial osteotomy / femoral osteotomy; or plastic and aesthetic surgery with volume correction of more than 30% of body surface area (bodylift), DIEP, DLA.
* Patient who should theoretically benefit of a postop self-controlled analgesia of morphine for 72 hours on average
* Patient informed of the modalities of the study with delivery of an information leaflet
* Free and informed consent collection

Exclusion Criteria:

* Patient refusing to participate in the study
* Language barrier
* Hypersensitivity to sufentanil,
* Respiratory failure
* Renal insufficiency (GFR \<30 ml / min)
* Epilepsy not controlled by treatment
* Psychic and mental illness not controlled by treatment
* Hepatocellular insufficiency (TP \<50%)
* Heart failure (LVEF \<50%)
* patients with chronic pain, treated with level 3 analgesic and / or already treated for neuropathic pain
* Drug-addicted patients
* Pregnant or lactating women