cyrilzakka/clinical-trials huggingface dataset:
A Study of Intravitreal ILUVIEN® Implant as Baseline Therapy in Patients With Early Diabetic Macular Edema (DME)

This is a randomized, masked, active-controlled, parallel-group, multi-center study that will assess the efficacy of ILUVIEN as a baseline therapy in the treatment of Center Involving DME (CI-DME). The study will enroll patients who are either treatment naïve or have not received any DME treatments for the preceding 12 months as documented in medical records. Patients who received DME treatment \>12 months before screening, must not have received \>4 intravitreal injections. The study will compare 2 treatment regimens: ILUVIEN intravitreal implant (0.19 mg) followed by supplemental aflibercept as needed per protocol criteria (2 mg/0.05 mL), compared to intravitreal aflibercept loading dose (2 mg administered by intravitreal injection every 4 weeks for 5 consecutive doses) followed by supplemental aflibercept as needed per protocol criteria (2 mg/0.05 mL).


Eligibility Criteria:
Major Inclusion Criteria:

1. Male or female subjects ≥18 years of age at the time of consent.
2. Must have CI-DME confirmed by Spectral Domain Ocular Coherence Tomography (SD-OCT) and Center Subfield Thickness (CST) of: ≥350 µm in the study eye.
3. Best Corrected Visual Acuity (BCVA) of ≤80 ETDRS Letters and ≥35 ETDRS letters in the study eye at Screening Visit.

Major Exclusion Criteria:

1. Patients with Proliferative Diabetic Retinopathy (PDR); high risk proliferative diabetic retinopathy in the study eye and related complications.
2. History or current diagnosis of glaucoma or ocular hypertension (OHT) or a cup to disc ratio \>0.8; History of uncontrolled intraocular pressure (defined as IOP ≥25 mmHg with maximum topical and systemic medical hypotensive treatment) or previous filtration surgery in the study eye at Screening Visit.
3. Other conditions that can cause macular edema.
4. Patients who received prior LASER photocoagulation therapy including macular grid or pan retina photocoagulation (PRP) at any time in the study eye. Prior focal LASER photocoagulation therapy outside the macula is allowed.
5. Patients who received the following therapies in the study eye:

   1. Intravitreal or periocular steroids;
   2. Intravitreal injection of aflibercept, brolucizumab, or conbercept ≤12 months prior to Screening Visit
6. Patients who received \>1 intravitreal injection of ranibizumab or bevacizumab in the last 12 months; or have received ranibizumab or bevacizumab ≤6 weeks prior to Screening Visit
7. Patients who have lens opacities due to cataract or other etiologies that would make it difficult to examine the fundus or that affect the patients Activities of Daily Living (ADL).
8. Steroid Challenge Exclusion Criterion- At the Baseline Visit, patients who are determined to have an IOP ≥25 mmHg or an increase ≥8 mmHg from Screening will be excluded from the study.
Natural Killer Cells Function in Patients With Chronic Lymphocytic Leukemia

Purpose:

The involvement of Natural Killer cells (NK) in the efficiency of the treatment in lymphoma and the beginning of new therapies based on function and activation of NK, justify an improvement of knowledge about the status of the population of NK (number, function, genic expression) in Chronic Lymphocytic Leukemia (CLL).

Method: prospective, monocentric, descriptive study

Primary objective:

Evaluation of the expression and function of receptors activator of NK cell (KIRs) in patients with CLL at stage A with therapeutic abstention, or stage B or C which require a treatment.

Secondary objectives:

Measure of the evolution of cytotoxic function of NK cells and theirs biomarkers of activation when the patient receives an immunochemotherapy with Rituximab/ Fludarabine/ Cyclophosphamide (RCF).

Verification, by analysis, of functions and biomarkers of the adaptive and innate immunity

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CLL (Score of Matutes \>=4) with no history of treatment: Stade A of Binet, Or Stade B or C before the beginning of the treatment with RFC
* Patients who can undergo blood collection
* Patient aged 18 years and older
* Signed consent

Non inclusion Criteria:

* Patient with anemia: haemoglobin \< 9 g/dl
* Pregnancy, breast feeding
* Patient in an urgent situation, or unable to give a consent
The Effect of Web-Based Deep Relaxation Exercises in Pregnant Women

Pregnancy is a natural but complex period in a woman's life that requires a process of adaptation to physiological, psychological and social changes. The woman first goes through a process of adaptation to pregnancy and then to motherhood. Deep Relaxation exercises, which is a low-cost and non-pharmacological method, can be effective in supporting maternal-fetal attachment and improving the perception of pregnancy. A total of 80 pregnant women (40 deep relaxation excercises and 40 control) are planned to be included in the study. Data will be collected with the 'Personel Description Form', 'Maternal Antenatal Attachment Scale (MAAS)' and 'the Pregnancy Self Perception Scale'.

Pregnancy is a natural but complex period in a woman's life that requires a process of adaptation to physiological, psychological and social changes. The woman first goes through a process of adaptation to pregnancy and then to motherhood. Deep Relaxation exercises, which is a low-cost and non-pharmacological method, can be effective in supporting maternal-fetal attachment and improving the perception of pregnancy. In this study, it was aimed to determine the effect of web-based deep relaxation exercise applied to pregnant women on maternal-fetal attachment and pregnancy perception. A total of 80 pregnant women (40 deep relaxation excercises and 40 control) are planned to be included in the study. Data will be collected with the 'Personel Description Form', 'Maternal Antenatal Attachment Scale (MAAS)' and 'the Pregnancy Self Perception Scale'. A total of 80 pregnant women (40 deep relaxation excercises and 40 control) are planned to be included in the study. Data will be collected with the 'Personel Description Form', 'Maternal Antenatal Attachment Scale (MAAS)' and 'the Pregnancy Self Perception Scale'. deep relaxation excercises wiil be appliedby midwives who are experts in their fields who are certified in these fields.

Eligibility Criteria:
Inclusion Criteria:

* Having internet access,
* 24 weeks or more of pregnancy,
* There is no risk factor in pregnancy

Exclusion Criteria:

* Mental disabilities
Does Biological Sex Influence Insulin Sensitivity and Muscle Metabolism Following High-intensity Interval Exercise?

High-intensity interval exercise (HIIE) is a type of exercise that involves alternating periods of intense exercise with periods of rest. HIIE has been shown to improve many aspects of cardiovascular and metabolic health in a time-efficient manner (e.g., only 20 minutes per exercise session). An important health benefit of exercise is improved blood sugar control, which can help reduce the risk of metabolic diseases like type 2 diabetes. A single session of HIIE has been shown to improve blood sugar in males, but it is unknown if females achieve the same health benefit. It is also not fully understood how exercise improves blood sugar in males and females. Therefore, the purpose of this project is 1) to determine if a single session of HIIE improves blood sugar control in males and females, and 2) to evaluate if changes in skeletal muscle can explain the beneficial effects of HIIE on blood sugar.

The primary purpose of this study is to determine if biological sex influences the effects of high-intensity interval exercise (HIIE) on insulin sensitivity and muscle mechanisms. The investigators will measure insulin sensitivity and muscle outcomes of participants on two separate occasions: 1) Following 30 minutes of sitting in the lab; and 2) Following a single session of HIIE on a stationary bike. Insulin sensitivity will be measured by taking blood samples after participants consume a sugary drink. Muscle outcomes will be measured by taking a small amount of muscle from the vastus lateralis (thigh) muscle. Groups of male and female participants will be recruited and tested using best practice guidelines for sex-based comparisons of exercise responses.

The study will advance knowledge regarding the potential for biological sex to influence the metabolic responses high-intensity exercise.

Eligibility Criteria:
Inclusion Criteria:

* 18-35 yrs
* VO2peak considered recreationally active as defined as 'fair' or 'good' (males: 41.6- 50.5ml/kg/min; females: 35-41.9 ml/kg/min) based on Canadian Society for Exercise Physiology (CSEP) normative fitness values.
* BMI between 18-27 kg/m2
* 1-3 structured exercise sessions/week, and not training for any specific sport
* Weight stable (within ± 2kg for at least 6 months)
* Eumenorrheic (female only), defined as menstrual cycle lengths ≥ 21 days and ≤ 35 days resulting in 9 or more consecutive periods per year)
* Non-smoker

Exclusion Criteria:

* Diagnosed with cardiovascular or metabolic disease, hyper- or hypogonadism, and/or polycystic ovarian syndrome (PCOS)
* The use of medication for managing blood glucose or lipid metabolism
* Current use of oral contraceptives or use within the last 3 months
* Irregular menstrual cycles (\<21 days or \>35 days)
* Pregnant, lactating, or menopausal
* Recreational smoking of any kind
* Inability to perform the study exercise protocols or follow the pre-trial dietary or physical activity controls
* Taking medications affecting substrate metabolism (corticosteroids or nSAIDs)
* Actively engaging in a low-carbohydrate diet (e.g., ketogenic, Atkins)
Comparing Eye Pressure Using Maximal Tolerated Local Therapy or Systemic Acetazolamide

Local therapy for glaucoma is known to induce a conjunctival inflammation. Because of this, trabeculectomy is more likely to fail. The investigators exchange the local therapy by systemic therapy using acetazolamide and measure the eye pressure using local therapy and systemic therapy using acetazolamide. The investigators suspect an elevated eye pressure using acetazolamide compared to local therapy. In summary acetazolamide could be a better choice in reference to conjunctival inflammation, but a worse choice in reference to controlling eye pressure.


Eligibility Criteria:
Inclusion Criteria:

* Patients with uncontrolled intraocular eye pressure
* Patients with planed trabeculectomy in 3 to 4 weeks

Exclusion Criteria:

* Patients not meeting the inclusion criteria
* Patients with known intolerance to acetazolamide
Long-term Evaluation of Direct Pulp Capping

Calcium hydroxide and mineral trioxide aggregate have been used in vital pulp therapy with variable outcomes recorded by different study. They will be compared when used for direct pulp capping in cariously exposed mature permanent teeth.

Vital pulp therapy has the benefit of providing patients with a conservative treatment option with relatively low cost when compared to conventional root canal treatment and spares them possible post-treatment consequences that might occur. Vital pulp treatment in trauma cases is associated with high success rate but controversy still exists regarding vital pulp treatment in carious-exposed pulp.

The purpose of this study is to evaluate the success rate of direct pulp capping performed with MTA-Angelus® or calcium hydroxide in mechanical-exposed or carious-exposed mature permanent human teeth. Patients included in this study will be recruited from routine dental patients attending conservative clinics in JUST Dental Teaching Centre. Adult patients scheduled for routine conservative treatment involving caries removal and restoration with mechanical or carious pulp exposure will be invited to participate in this study.

A total of 80 carious human teeth with carious pulp exposure will be included in this randomized clinical study. Patients are among those scheduled for conservative dental treatment and end with pulp exposure. The patients and/or their parents will be asked to sign a consent form after receiving a detailed explanation about the study rationale, clinical procedures, and possible risks. The exposed teeth will be divided randomly into two experimental groups (n=40) according to the dressing materials; MTA-Angelus® or calcium hydroxide, then teeth will be restored with permanent filling. Teeth will be reviewed recording any signs and symptoms. Patients will be reviewed in 1 week, 3 months and yearly after. MTA-Angelus and calcium hydroxide are anticipated to be biocompatible and induce hard tissue barrier. This project will reveal if tested materials are presented with promising profile upon using as direct pulp capping dressing in mechanical and carious-exposed pulp.

Eligibility Criteria:
Inclusion Criteria:

1. carious teeth that had no previous root canal treatment
2. Pulpal diagnosis of normal or reversible pulpitis

Exclusion Criteria:

1. History of irreversible pulpal pain
2. Immature teeth
3. Non restorable teeth
4. Teeth with active periodontal disease
5. History of any systemic disease
6. Concurrent medication with systemic steroids, antibiotics, analgesics, immunomodulatory drugs or cytotoxics
Efficacy And Safety Of Azithromycin SR Compared With Minocycline In Acne

The primary objective is to evaluate the clinical efficacy of azithromycin microspheres treatment in outpatients with moderate to severe inflammatory acne compared with first line treatment minocycline after 8 weeks of therapy

The study prematurely discontinued on the February 1, 2008 due to slow enrollment.It should be noted that safety concerns have not been seen in this study and have not factored into this decision.

Eligibility Criteria:
Inclusion Criteria:

* male and female, \> 16 years of age, with diagnosis of acne papulo-pustular, moderate (19-30 GAGS score) to severe (31-33 GAGS score)

Exclusion Criteria:

* pregnancy, gastrointestinal and endocrinological disease, specific systemic disease, hormonal contraceptives, isotretinoin, topic drugs for acne (except detergent allowed)
Effect of Different Skin Creams on TEWL

Prospective, single center, clinical pilot study to test the hypothesis that lipid rich EpiCeram® is superior in improving skin barrier function compared to Aveeno Daily Moisturising Sheer Hydration Lotion®.

Prospective, single center, clinical pilot study to test the hypothesis that lipid rich EpiCeram® is superior in improving skin barrier function compared to Aveeno Daily Moisturising Sheer Hydration Lotion®.

Primary Objective: To compare skin barrier function, assessed by TEWL AUC, between non-lesional areas of the skin treated with EpiCeram®, Aveeno Daily Moisturising Sheer Hydration Lotion® or no emollient use for one week.

Secondary Objectives: To assess lipid and protein profiles of skin tape strips from non-lesional skin, after a week of either EpiCeram®, Aveeno Daily Moisturising Sheer Hydration Lotion® or no treatment.

Exploratory Objectives :

* To study whether the effects on TEWL on lesional and non-lesional skin persist 24 hours after cessation of therapy.
* To evaluate whether baseline food and environmental allergy sensitization (assessed via skin prick testing during screening) affects the outcomes. See protocol section 3.1 for allergen details.
* A central repository of blood samples will be stored for future use to assess plasma biomarkers to help characterize clinical outcome data.

Eligibility Criteria:
Inclusion Criteria:

1. Parent guardian must be able to understand and provide informed consent per Institutional Review Board (IRB) guidelines and regulations.
2. Male or female participants, between the ages of 0 to 40 years will be included
3. Diagnosis of moderate to severe active AD (Scoring Atopic Dermatitis (SCORAD) score \> 26) without a history or current manifestations of eczema herpeticum (EH)
4. AD affecting at least 3 different skin areas (contralateral arms and one lower extremity)

Exclusion Criteria:

1. Inability or unwillingness of a parent guardian to give written informed consent, or to comply with study protocol.
2. Participants with skin disease other than AD that might compromise the stratum corneum barriers (e.g., bullous diseases, psoriasis, cutaneous T-cell lymphoma (also called Mycosis Fungoides or Sezary syndrome\], dermatitis herpetiformis, Hailey-Hailey, or Darier's disease).
3. Known or suspected immunosuppression
4. Severe concomitant illness(es)
5. History of serious life-threatening reaction to latex, tape, or adhesives
6. Has received total body phototherapy (e.g., ultraviolet light B \[UVB\], psoralen ultraviolet light A \[PUVA\], tanning beds \[\>1 visit per week\]) within 30 days of the Enrollment Visit
7. Use of topical corticosteroids, topical immunomodulatory agents (such as calcineural inhibitors and crisaborole), or topical antibiotics on the upper or lower extremities within 7 days of the Enrollment Visit
8. Has taken a bleach bath within 7 days of the Enrollment Visit
9. Use of systemic antibiotics, antiparasitics, antivirals, or antifungals within 7 days of the Enrollment Visit.
Swiss Cohort of Health Professionals and Informal Caregivers

The healthcare system is continuously evolving to adapt to the population's needs, both in terms of healthcare practices, and in financial and organizational aspects. The current COVID-19 pandemic has added additional pressure to the healthcare system and shown its limits in terms of preparedness. It has also shown once again that both healthcare professionals (HCPs) and informal caregivers (ICs) play a central role for the functioning of the healthcare system.

An increasing number of studies are alerting on HCPs' situation, regarding their physical and mental health (e.g. emotional exhaustion, professional well-being) on the one hand, and the functioning of the healthcare system (e.g. absenteeism, turnover, career change) on the other hand.

Besides healthcare professionals, ICs, defined as individuals providing non-professional care on a regular basis to people in need of care, play an important role in fulfilling the daily needs of the most vulnerable individuals. While doing the latter, caring for others has shown to have negative impact on the ICs' life, in terms of health-related implications, psychological burden, quality of life, etc. Despite being increasingly recognized as having a key role in the provision of care, they have only been limitedly considered in studies on healthcare professionals.

In that context, the investigators develop SCOHPICA project, the Swiss cohort of healthcare professionals and informal caregivers, which is an open prospective national cohort using a concurrent embedded mixed method design. This project targets all types of HCPs and ICs, and will investigate determinants of intent to stay and well-being according to participants' trajectories.

As the ICs' study launch is planned in 2024, in depth details of this part of the project will be added to the registration once this part of the study will be definitely planned.


Eligibility Criteria:
Inclusion Criteria (HCPs):

* Working as HCP, in any profession
* Taking care of patients currently and actively
* Working in any health work setting
* Working as an independent or a salaried
* Working in Switzerland

Exclusion Criteria (HCPs):

* Being retired at baseline
* Unable to read or speak in one of the national languages: German, French, Italian

Inclusion and exclusion criteria for ICs will be defined later on.
Metabolic Remodeling in Fontan Patients

Assessment of metabolic alterations in adult Fontan patients with a dominant left ventricle with the help of serum examinations (Metabolomics). The aim is to find a tool for the completion of the (semi-)invasive monitoring of Fontan hemodynamics.

Patients who are born with just one single heart chamber need to undergo surgical therapy allowing the single heart chamber to pump the blood into the systemic circulation and allowing the blood to flow passively to the lungs (Fontan circulation). Regular ultrasound, cardiopulmonary exercise testing, and invasive diagnostic tools (catheterization, general anaesthesia needed) are necessary to early find out cardiac, vascular, or circulatory impairment. It is still very difficult to diagnose and therapy failure of this Fontan system early enough.

It is reported that in patients with a failing two-chambered heart, the energy source for the heart and the body in general switches from the use of lipids to the use of sugar and ketone bodies. First studies show decreased concentrations of membrane lipids in Fontan patients with a left dominant ventricle, and the energy metabolism has not been focused yet in those patients.

The investigators hypothesize that there are differences in the pattern of the structural metabolism in adult Fontan patients with a left-dominant vs. a right-dominant ventricle. Furthermore the investigators hypothesize that there are alterations in the energy metabolism in adult Fontan patients in comparison to healthy two-chambered controls, and that those alterations correlate with the grade of impairment of cardiopulmonary function.

With the help of a special biochemical examination (mass spectrometry-based Metabolomics study) blood of Fontan patients will be analyzed, and the results will be correlated with the results of ultrasound and cardiopulmonary exercise testing. The aim of this study is to establish sensitive blood markers indicating cardiac, vascular, circulatory or further organ dysfunction in Fontan patients. This should allow optimal Fontan system monitoring with an optimal timing of an additional invasive diagnostic catheterization and of nutritional, medical or interventional therapy.

Eligibility Criteria:
Inclusion Criteria:

* Fontan circulation (right systemic ventricle), biventricular heart with heart failure resp.
* ≥ 18 years
* Written informed consent of patients
* 8 hours fasting period before blood sample

Exclusion Criteria:

Intake of medication directly affecting metabolic (e.g. metabolism of lipids (statine)) or hemodynamic state (e.g. beta-blockers, sildenafil) (other than angiotensin converting enzyme (ACE)-inhibitors and anticoagulation therapy)

* Cachectic disease
* Non-congestive hepatic or renal dysfunction
* (Inherited) metabolic disorders