cyrilzakka/clinical-trials huggingface dataset:
Dupilumab in the Treatment of Severe Uncontrolled CRSwNP: a Multicentre Observational Real-life Study (DUPIREAL)

Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) is a sino-nasal chronic inflammatory disease that strongly affects patients' quality of life, especially in difficult-to-treat cases. In severe uncontrolled CRSwNP, the inflammation is mostly driven by a type 2 inflammatory pathway and its management has been rapidly changing during the last 2 years due to Dupilumab approval. It is a fully human monoclonal antibody that binds the alpha subunit of IL-4 receptors (IL-4Rα type 1 and type 2) to inhibit IL-4 and IL-13 signaling.

So far, randomized clinical trials have assessed efficacy and safety of Dupilumab in a large number of patients, whereas evidences in real life clinical practice are limited to few monocentric series.

Herewith, the investigators present a multicenter, observational nationwide retrospective real-life study with the aim to confirm the effectiveness and the safety of Dupilumab over the first year of treatment in a real life setting.

The primary objective is to evaluate the volumetric reduction of polyps by measuring the variation of total Nasal Polyp Endoscopic Score (NPS).

The secondary objectives are:

* the evaluation of changes in nasal symptoms, olfactory function and nasal obstruction
* the assessment of the patients' quality of life
* the recording of major and minor complications
* the evaluation of the response to the therapy, according to EPOS2020 criteria and EUFOREA2021
* the assessment of efficacy based on concomitant disease (Asthma and ASA triad)
* the evaluation of potential predictors of clinical response to the therapy


Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis of diffuse CRSwNP by endoscopy and CT scan performed at least 6 months prior of the therapy;
* severe disease stage defined by NPS ≥5 or SNOT-22 ≥50;
* inadequate symptom control with INCS therapy;
* failure or intolerance of previous medical treatments (at least 2 cycles of systemic corticosteroid in the last year), and/or failure of previous surgical treatment through nasal endoscopic surgery (ESS), with postoperative complications or no clinical benefit

Exclusion Criteria:

* pregnant women;
* immunosuppressive therapy;
* patients undergoing radio-chemotherapy treatments for cancer in the 12 months before the starting of therapy;
* concomitant long-term corticosteroid therapy for chronic autoimmune disorders
Evaluation of a Lifestyle Medicine Practice

This project will evaluate the success of the PI's lifestyle medicine practice.

The main objective of the study is to evaluate the effectiveness of the PI's lifestyle medicine practice over time.

Sub-objectives are:

1. Understand variables that affect success in application of lifestyle medicine to lead to improved patient outcomes.
2. Develop a model for practice evaluation that can be utilized for board certification of providers and practices that utilize lifestyle medicine.
3. Evaluate the reimbursement success of lifestyle medicine services as a factor of billing codes and insurance providers.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients who are seen by the PI in his lifestyle medicine practice at Muntean Health Care.

Exclusion Criteria:

* none
Collateral Effects of Pandemics - Care for Informal Caregivers

The study is a workpackage in the German research consortium COLLPAN. The study will map collateral effects in terms of psychosocial and spiritual burden of informal caregivers during after the pandemic and identification/mapping of risk factors.It will also map available therapeutic and preventive interventions and relief of this burden for the present situation and for future pandemics.

a scoping literature review will compile evidence on informal caregiver burden during and after the pandemic (PubMed, PsychInfo, Cochrane Database). The aim of the review is to gain knowledge on frequency, severity, source and circumstances of care givers' burden and to identify research and supportive gaps.

The study will recruit family members and care givers of patients with COVID-19 or long-COVID as well as bereaved family members and care givers of patients who have died during the pandemic in order to assess severity of burden. Recruitment will be done in collaboration with the German Association of Undertakers and the Federal Association for Bereavement Care. Family members and caregivers will be asked to complete a survey with instruments on bereavement burden (PG- 13), distress (PHQ-9; GAD-7) and care giver symptoms (IPOS; MIDOS-2). The survey will be available online (using SoSciSurvey platform) or as a paper and pencil version. Survey participants will be invited to in-depth interviews.

Recruitment of 200 participants each for caregiving of COVID-19 patients and bereaved family members will be targeted. Interviews are planned with 30 participants in each group or until saturation is reached.

Based on findings, recommendations on interventions to support family care givers will be developed

Eligibility Criteria:
Inclusion Criteria:

* having cared for a patient with COVID-19 in the first year of the pandemic (March to December 2021)

Exclusion Criteria:

* not fluent in German
Remote Ischaemic Postconditioning in the Clinical Setting of NSTEACS and Urgent PCI

This study investigates the cardioprotective effect of remote ischaemic pre-/postconditioning in patients presenting with a NSTEMI/Unstable angina undergoing PCI.

Patients presenting with Non ST elevation acute coronary syndromes (NSTEACS) - NSTEMI and Unstable angina patients are enrolled in this study.

Eligible patients are approached, with patient information sheets and are consented for involvement into the study. Patients are randomised to intervention or control. Patients randomised to intervention will receive 3 x 5 minutes of forearm ischaemia (with the cuff inflated to 200 mmHg) separated by 5 minutes of reperfusion between each cuff inflation, prior coronary angiography.

This protocol of episodic forearm ischaemia/reperfusion has been demonstrated to confer remote ischaemic preconditioning-induced protection.

Prior to the intervention, a blood sample will be taken to measure serum troponin T and CK-MB (baseline level). Following PCI patients will be reviewed on the wards and their ongoing recovery will be assessed and reviewed prior to discharge from the study. Troponin T and CK-MB levels will be measured for the 24 hours after PCI, at various time points (6 hour, 12 hour, 24 hour) as a measure of the degree of myocardial damage, and levels compared between the different treatment groups.

Primary end point

Myocardial injury (Peri-procedural Myocardial Infarction and Injury) measured by cTnT and CK-MB release over 24 hours after primary PCI.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted with NSTEMI/ Unstable angina undergoing percutaneous intervention

Exclusion Criteria:

* Known renal failure
* Known liver disease
* Peripheral vascular disease involving upper limbs
* Inability to consent
A Study to Assess the Long-Term Safety of Tacrolimus Cream in the Treatment of Psoriasis

A study to assess the long-term safety of tacrolimus cream in the treatment of psoriasis

A long-term, open label, non-comparative, multi-center study to evaluate the safety of tacrolimus cream-B 0.1% in treating the signs and symptoms of psoriasis.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of plaque psoriasis

Exclusion Criteria:

* Skin disorder other than plaque psoriasis in the areas to be treated.
* Disease on only scalp
Laughter Yoga's Impact on Children's Anger and Well-Being

This study aims to evaluate the effects of laughter yoga on anger levels and mental well-being in schoolchildren. Research indicates that laughter yoga has the potential to reduce stress and improve communication skills. There have been few studies specifically targeting children with high anger levels and low mental well-being. This study focuses on children under stress or with limited social support. Laughter yoga is a fun and effective technique that can be easily integrated into children's daily lives. The study is expected to provide positive contributions to the educational environment and reduce behavioral issues.

This study is a randomized controlled trial aimed at evaluating the effects of laughter yoga on school-aged children's anger levels and mental well-being. The research encompasses a total of 2958 students from two primary schools in Mersin Akdeniz, using 396 fourth-grade students as the sample. Specifically, this research targets children exposed to stress or limited social support, as there are few studies focusing on children with high anger levels and low mental well-being. Children will be assigned to intervention and delay groups based on simple randomization of their anger scores. This process will be conducted branch-based with the assistance of another researcher, and neither participants nor statisticians will have access to group information. The research will collect data in four stages: pre-test, intervention process, post-test, and a follow-up one month later. At each stage, the Emotion Regulation Scale for Children and the Mental Well-Being Questionnaire will be used. Participants will fill in the Mental Well-Being Questionnaire every night before bed during the intervention period, allowing us to evaluate the study's effects. In the long term, it is expected that integrating laughter yoga into children's daily lives in a fun and effective way will provide positive contributions in educational settings and reduce behavioral problems. Research also indicates that laughter yoga has the potential for stress reduction and enhancing communication skills.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 8-11,
* Being a student who regularly attends the school where the study is conducted between February 3 and June 6, when research data is collected,
* Having written consent from a parent/guardian to participate in the study,
* Being willing to participate in the study, and
* Scoring above the median on the Emotion Regulation Scale for Children.

Exclusion Criteria:

* Having a diagnosed health problem that could interfere with laughter exercises (respiratory issues, heart conditions, musculoskeletal problems),
* Having undergone psychological treatment in the last 3 months,
* Currently participating in another psychological support program, and
* Scoring below the median on the Emotion Regulation Scale for Children.
* The criteria for termination of the intervention are not attending two consecutive sessions and non-compliance with the study protocol.
Evaluation of the Efficacy and Safety of Wearable ECG (AT-Patch) in Patients With Hypertrophic Cardiomyopathy Requiring 48-Hour Holter MonitoringEvaluation of the Efficacy and Safety of Wearable ECG (AT-Patch) in Patients With Hypertrophic Cardiomyopathy Requiring 48-Hour Holter Monitoring

* Validation of validity, superiority, and safety of data analysis results using AT-Patch compared to 48-hour Holter test results
* Number of subjects: 100 (including 10% dropout rate)
* Performance and safety were verified by simultaneously attaching a 48-hour Holter and a wearable Holter device (ATP-C75 or ATP-C135).

Prospective, sequential, superiority test Patients diagnosed with hypertrophic cardiomyopathy who require 48-hour Holter monitoring.

* 48-hour Holter vs ATP-C75 (48-hour comparison/total time comparison)
* 48-hour Holter vs ATP-C135 (48-hour comparison/total time comparison)
* Comparison between IDs

Eligibility Criteria:
Inclusion Criteria:

1. Male and female subjects aged 19 years or older
2. Subjects diagnosed with hypertrophic cardiomyopathy who require 48-hour Holter examination

Exclusion Criteria:

1. Those judged by the investigator to be unsuitable for this clinical trial or those who may increase the risk due to participation in the clinical trial
2. Those with sensitive or allergic skin, skin diseases such as skin cancer or rashes
3. Those with pacemakers, implantable cardioverter-defibrillators, or other implantable electrical devices
4. Pregnant women
LEMURS SSI: Evaluation of Behavioral Incentives

The goal of this substudy is to determine if a brief single-session-intervention (SSI) coupled with different incentive strategies to support engaging in wellness-related activities.

The goal of this substudy is to determine if a brief single-session-intervention (SSI) coupled with different incentive strategies to support engaging in wellness-related activities. Participants will be given a brief SSI that will provide education and strategies to improve a wellness related goal (e.g., improve sleep, improve physical activity, improve mental health). They will then be asked to select a series of wellness related-behaviors in support of that goal to complete each day (e.g., going for a 20 minute walk, going to bed at a specific time). Participants will be randomized to one of four incentive conditions and receive rewards based on their completion of such activities. The aim of the study is to determine which incentive strategy may prove most effective in promoting wellness behaviors. There are two main factors (Recipient x Restoration) that will create four distinct groups. Recipient refers to who will receive the incentive - either an individual or a charity. Restoration refers to what happens when a participant misses a day of completing their goal - they are given a restorative (additional) incentive to participants on the following day or not given such an incentive. The primary hypothesis is that individuals receiving the incentive with a restorative element will result in significantly more activities completed. Additional hypotheses regarding differences among the other groups are not made given the lack of prior work on these strategies in this area.

Eligibility Criteria:
Inclusion Criteria:

Current undergraduate student in their first year of school own a mobile device

Exclusion Criteria:

None
Evaluating the Safety of Long Term Dosing of Romiplostim (Formerly AMG 531) in Thrombocytopenic Subjects With Myelodysplastic Syndromes (MDS)

This is an open label extension study of romiplostim for treatment of thrombocytopenia (platelet count ≤ 50 x 10\^9/L) in MDS subjects. The study is designed to assess the long-term safety of treatment with romiplostim, as measured by incidence of overall adverse events, the incidence of bleeding events, the utilization of platelet transfusions, and the duration of platelet response. The study will further describe the time to disease progression to acute myeloid leukemia (AML) and survival.


Eligibility Criteria:
Inclusion Criteria

* Subject completed a romiplostim study for the treatment of thrombocytopenia in subjects with MDS
* Subject has an Eastern Cooperative Oncology (ECOG) performance status of 0 to 2
* Subject had a platelet count ≤ 50 x 10\^9/L since the final dose of investigational product in the parent study
* Subject or his/her legally acceptable representative provided written informed consent before any study-specific procedures were initiated

Exclusion Criteria

* Subject has been diagnosed with AML or has a blast count ≥ 10% by peripheral blood or bone marrow biopsy
* Subject has a prior history of leukemia
* Subject has a prior history of bone marrow or stem cell transplantation
* Subject has a prior malignancy (other than in situ cervical cancer, controlled prostate cancer, or basal cell cancer of the skin) unless treated with curative intent and without evidence of disease for ≥ 3 years before randomization
* Subject has active or uncontrolled infections
* Subject has unstable angina, congestive heart failure \[New York Heart Association (NYHA) \> class II\], uncontrolled hypertension (diastolic \> 100 mmHg), uncontrolled cardiac arrhythmia, or recent (within 1 year) myocardial infarction
* Subject has a history of arterial thrombosis (eg, stroke or transient ischemic attack) in the past year
* Subject has a history of venous thrombosis that currently requires anti-coagulation therapy
* Subject received interleukin (IL)-11 within 4 weeks of screening
* Subject previously received a thrombopoietic growth factor (other than romiplostim)
* Subject has a known hypersensitivity to any recombinant E coli-derived product (eg, Infergen®, Neupogen®, Somatropin, Actimmune)
* Subject is currently enrolled in investigational device or drug study(ies), has not yet completed at least 4 weeks since ending investigational device or drug study(ies) (other than parent romiplostim study), or subject is receiving other investigational agent(s)/device(s)
* Subject is of child-bearing potential and is evidently pregnant (eg, positive human chorionic gonadotropin \[HCG\] test) or is breast feeding
* Subject is not using adequate contraceptive precautions
* Subject has any kind of disorder that compromises his/her ability to give written informed consent (and does not have a legally acceptable representative) or is unable to comply with study procedures
A Study of the Use of Methotrexate in the Treatment of Chronic Idiopathic Urticaria

The purpose of this study is to determine whether methotrexate produces significant improvement in chronic idiopathic urticaria, compared with placebo

Chronic idiopathic urticaria is thought to affect approximately 0.1% of the population. It can be very disabling and difficult to treat. Antihistamines are the only drugs licensed for treatment of urticaria, however there is a group of severely affected patients with chronic idiopathic urticaria who fail to respond. Previous trials have shown ciclosporin to be beneficial, and small studies support the use of intravenous immunoglobulins and plasmapheresis. However, not only are these options expensive, but since chronic idiopathic urticaria may persist for years, their prolonged use may be limited by adverse effects. We have previously published a report of 2 patients who responded to methotrexate, and wish to properly evaluate the efficacy of methotrexate in the treatment of CIU.

In the first part of the study patients will be given either placebo or methotrexate for 8 weeks and in the second part of the study, non-responders will be offered open labelled methotrexate for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* severe unremitting chronic idiopathic urticaria
* disease resistant to treatment with antihistamines
* aged 18 years or more

Exclusion Criteria:

* predominant physical urticaria
* urticarial vasculitis
* any contraindication to the use of methotrexate, eg. pregnancy / breast feeding, women wanting to conceive or man wanting to father a child within 12 months of entry, use of drugs which interact, underlying medical conditions
* use of immunosuppressant within 4 weeks of entry
A Study of AZD4205 in Healthy Adult Subjects

This study is to assess the safety, tolerability, pharmacokinetics of AZD4205 following single and multiple ascending dose in healthy adult subjects, and to assess the effect of food on the pharmacokinetics of AZD4205.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must be able to understand the nature of the trial and provide a signed and dated, written informed consent form prior to any study specific procedures, sampling and analyses.
2. Female and/or male aged ≥18 \~ ≤ 45 years, with BMI ≥18\~≤ 28kg/m2.
3. Female subjects must have negative pregnancy tests at screening and check-in AND: have been surgically sterile OR post-menopausal OR, if of child-bearing potential, must be using an acceptable method of contraception.
4. Male subjects must be surgically sterile or using an acceptable method of contraception during the study and for 6 months after the last dose of AZD4205 or matching placebo to prevent pregnancy with a partner.

Exclusion Criteria:

1. Evidence or reported history of clinically significant hematological (absolute neutrophil count \< 1.5 x 10\^3/μL; platelet count \< 100 x 10\^3/μL; hemoglobin \< 9 g/dL, INR \> 1.5), renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease determined by the investigator.
2. Infections
3. Received a live vaccine within 3 months before first dose of IP.
Evaluation of the Efficacy of Citrulline Supplementation on the Delay of Delivery for Women Hospitalized for Pre-eclampsia (CITRUPE)

Pre-eclampsia (PE) complicates 2-8 % of pregnancies and is associated with high maternal and fetal morbidity and mortality. The early clinical manifestations are the occurrence of a maternal blood pressure and proteinuria. Placental dysfunction impairs the nutrient supply to the fetus, and may be the cause of an intrauterine growth retardation (IUGR). This is a disease that causes prematurity and currently the only known cure is delivery of the placenta. Nitrogen monoxide (NO) regulates the placental blood flow. However, pre-eclampsia is directly related to a failure of placental NO production. In this context, several clinical trials have tested the effect of NO donors such as L- arginine. However, supplementation with L -Arginine in a randomized trial in Nantes, has proved to be ineffective in severe vascular IUGR.

Citrulline is a natural aminoacid precursor to arginine and in contrast to L-arginine escapes uptake in the liver and appears directly in the peripheral blood converted by the kidney in arginine, released into the systemic circulation, Citrulline may therefore be more effective in the treatment of pre-eclampsia.

This prospective, randomized, comparative and double-blinded study aims to prolong pregnancy for patients with pre-eclampsia before 36 weeks.


Eligibility Criteria:
Inclusion Criteria:

* age \>= 18 years old
* pregnant woman
* singleton pregnancy
* woman with pre-eclampsia (\<36 weeks) without indication of forthcoming extraction
* subjects affiliated with an appropriate social security system
* subjects out of context of guardianship
* written signed informed consent form

Exclusion Criteria:

* age \< 18 years old
* isolated hypertension or isolated proteinuria
* severe pre-eclampsia with indication of forthcoming extraction in emergency
* term pregnancy \>= 36 Weeks when diagnosis is done
* multiple pregnancy
* lactose intolerance
* context of guardianship