cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Use of Empagliflozin in Patients with HF with PEF in a Cardiology Outpatient Department

This study aims to evaluate whether the use of a 25 mg dose of empagliflozin compared to the 10 mg dose used would bring additional benefits in the improvement outcomes of the Kansas City Cardiomyopathy Questionnaire (KCCQ SST), in the 6-minute walk test (6MWT) without causing significant side effects.

This study aims to evaluate whether the use of a 25 mg dose of empagliflozin compared to the 10 mg dose used would bring additional benefits in the improvement outcomes of the Kansas City Cardiomyopathy Questionnaire (KCCQ SST), in the 6-minute walk test (6MWT) without causing significant side effects. Patients will be randomized and will receive one of the two doses of empagliflozin. All patients in both groups will be equally evaluated by the tests, before receiving the medication, and also 8 weeks after.

Eligibility Criteria:
Inclusion Criteria:

* Patients \>18 years old.
* Echocardiogram with ejection fraction \> 50%
* Patients must present at least one of the following items to be included in the study: Patients with a previous diagnosis of Heart Failure with Reduced Ejection Fraction (HFrEF) who have improved on the echocardiogram to an ejection fraction above 50%, patients with a previous ejection fraction between 40-49% who have progressed to ejection fraction above 50%. For these groups there is no need to perform the score for heart failure with preserved ejetion fraction score (since the diagnosis of HF was already known). Patients with signs/symptoms of HFpEF, who present structural morphological changes such as left atrium enlargement or left ventricular hypertrophy (LVH).
* After recently undergoing the score for heart failure with preserved ejetion fraction score (H2FPEF), patients who present scores that place them at least at an intermediate probability of HFpEF would be eligible for entry into the study.
* Signing the consent form

Exclusion Criteria:

* Patient with type I DM
* Estimated glomerular filtration rate (eGFR), using the Chronic Kidney Disease Epidemiology (CKD EPI) equation, with a cutoff of \<20 mL/mm/1.73m2
* Patient currently using SGLT2 antagonists
* Patient with a history of allergic reaction or significant sensitivity to empagliflozin
* Female patient who is pregnant or considering becoming pregnant during the study or for 3 months after the last dose of study medication
* Patients that are breastfeeding
* Patients considered by the investigator, for any reason, to be an unsuitable candidate for the study
* Patients with a previous diagnosis of HFpEF who presents a low probability of diagnosis after being re-stratified by the previously mentioned score
* Patients unable to walk or understand/comply with the study protocol.
An Open-Label Tolerability and Exploratory Efficacy Study of Zonisamide for Dyskinesias in Parkinson's Disease

In this 12-week, open-label pilot study, the investigators will enroll 20 subjects with Parkinson's Disease to determine if two doses of Zonisamide are tolerable and demonstrate clinical benefit for Dyskinesias. The primary outcome measure is tolerability, as determined by number of subjects able to complete the study on their originally assigned dosage. Secondary outcome measures will use the Unified Dyskinesia Rating Scale (UDysRS), comprised of an Objective Section and a Historical Section, to compare baseline to 6 and 12-week measurements. Additional analysis of the effect of Zonisamide on quality of life will be measured by the Parkinson's Disease Quality of Life Questionnaire (PDQ-39).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PD
* Identified dyskinesias of the limbs or trunk as agreed upon by subject and investigator, with dyskinesias considered moderately to completely disabling (UPDRS question 33, greater or equal to 2)
* Able to provide informed consent and swallow capsules
* Stable doses of dopaminergic therapy for 2 weeks before and expected throughout the study.

Exclusion Criteria:

* Atypical parkinsonism
* Concurrent use of amantadine or active DBS where patient has some control over settings
* Prior surgery for PD
* Sulfa allergy or intolerance of zonisamide
* Significant concomitant medical illness in the opinion of the Principal Investigator (renal disease, liver disease)
* Pregnant subject or a subject who plans to become pregnant
Study to Assess GW642444 in Asthma Patients

This is a study of GW642444M, a long-acting beta 2 specific agonist. This study will examine GW642444M via the inhaled route and will assess the efficacy, safety, tolerability, pharmacodynamics and pharmacokinetics of a single administration of three inhaled doses (25, 100 and 400 µg) of GW642444M in persistent asthmatics. This study will be a single-centre, placebo-controlled, dose-ascending, five-way crossover in 30 asthmatic patients.

Key assessments: efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics will be assessed by measurement of FEV1, blood pressure, pulse rate, 12-lead ECGs, clinical laboratory safety tests, collection of adverse events and blood samples.


Eligibility Criteria:
Inclusion criteria:

* Subjects with a documented history of persistent asthma, with the exclusion of other significant pulmonary diseases
* Female subjects of non-child bearing potential (i.e. post-menopausal or surgically sterile)
* Subjects who are current non-smokers, who have not used any inhaled tobacco products (snuff is permitted) in the 12 month period preceding the screening visit and who have a pack history of less than 10 pack years.
* Subjects with clinically stable persistent asthma within the 4 weeks preceding the screening visit and with a screening pre-bronchodilator FEV1 between 60 and 90% predicted (having abstained from bronchodilators for the required period). Predicted values are based on the ECCS 1993 normal ranges
* During the screening visit, subjects must demonstrate the presence of reversible airway disease, defined as an increase in FEV1 of greater than 12.0% over baseline and an absolute change of greater than 300 mL within 30 minutes following a single 400 mcg salbutamol dose.
* Subjects who are currently taking ICS at a total daily dose of 200 to 500 mcg of FP or equivalent ICS

Exclusion criteria:

* Subjects who have a past or present disease, which as judged by the Investigator and the Medical Monitor, which may affect the safety of the subject or outcome of this study
* A screening Holter ECG tracing that reveals clinically concerning arrhythmias (including, but not limited to, ventricular ectopic runs of 4 beats, R on T phenomena, bigeminy, trigeminy).
* A mean QTc(B) value at screening \>430 msec (male) / \>450 msec (female) or an ECG that is not suitable for QT measurements (e.g. poorly defined termination of the T wave).
* Any adverse reaction including immediate or delayed hypersensitivity to any ß2 agonist or sympathomimetic drug, or known or suspected sensitivity to the constituents of GW642444 inhalation powder (e.g., lactose or COA).
* Subjects weighing \< 50 kg
* Subjects who have participated in any GSK study involving administration of COA.
A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986337 When Taken by Mouth by Healthy Participants

The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-986337 in healthy participants and in healthy Japanese participants.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations
* For Japanese cohorts in Part C, must be first-generation Japanese (born in Japan, not living outside of Japan for more than 10 years, and both parents are ethnically Japanese)
* Body mass index (BMI) of 18.0 kg/m\^2 to 30.0 kg/m\^2, inclusive, at screening; BMI = weight (kg)/height (m)\^2
* Women and men must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

* Women who are of childbearing potential
* Women who are breastfeeding
* Prior exposure to BMS-986278
* Positive nasopharyngeal reverse transcriptase polymerase chain reaction (RT-PCR) test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on Day -2

Other protocol-defined inclusion/exclusion criteria apply
The Study of Functional Magnetic Resonance Imaging in Abdominal and Pelvic Diseases

The purpose of this study is to study the diagnostic efficiency of functional magnetic resonance imaging in Abdominal and Pelvic Diseases.


Eligibility Criteria:
Inclusion Criteria:

* All patients with abdominal or pelvic diseases who provide informed consent
* Healthy Volunteers

Exclusion Criteria:

* claustrophobic
* pregnancy
Effect of Ticagrelor vs. Dipyridamole on Adenosine Uptake

The investigators are trying to determine if a single dose of Ticagrelor will increase delivery of intraarterially-infused adenosine into the forearm interstitium, consistent with adenosine reuptake blockade.

The investigators will compare adenosine interstitial levels using a parallel design study with three groups of subjects. Forearm interstitial adenosine levels will be measured at baseline and after intrabrachial infusion of adenosine at two doses. Subjects will then randomly receive Ticagrelor 180 mg, Dipyridamole 200 mg, or placebo. Two hours later the investigators will repeat the dialysate collections at baseline and after adenosine infusions.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects will be healthy volunteers, without significant pulmonary, cardiovascular gastrointestinal, hematological or renal diseases
2. Not taking any regular medications
3. Able to provide signed consent prior to study participation.

Exclusion Criteria:

1. History of asthma
2. Pregnancy
3. Exposure to an investigational drug in the last 2 months.
4. Known hypersensitivity to study medications
Rheumatoid Arthritis Patients on Adalimumab to Evaluate Its Effect on Synovitis Using Ultrasonography in an Egyptian Population

This Post-Marketing Observational Study (PMOS) was conducted to assess the effectiveness of adalimumab on reducing synovitis (inflammation of the synovial membrane, which lines movable synovial joints, such as shoulders, elbows, wrists, knees, and hips) in adult participants with Rheumatoid Arthritis (RA) in Egypt. B-mode ultrasonography data was collected from participants receiving adalimumab treatment who had not been treated with any other anti-tumor necrosis factor (anti-TNF) therapy in the past.

This study was a prospective, observational, single arm, multicenter study. Participants were treated with adalimumab in accordance with usual clinical care practices and local marketing authorization requirements. A total of 5 visits were planned: Baseline (Visit 1), Visits 2, 3, 4 and 5 (Week 13). The time interval between the baseline visit and the second visit was approximately 2-3 weeks, with a window of one week. Additional study objectives were to investigate the rate of RA progression via changes in the B-mode ultrasonography assessment score over time as well as changes in the number of joints with erosion over time. The study was terminated due to low enrollment.

Eligibility Criteria:
Inclusion Criteria:

A patient will be enrolled in this study if he/she fulfills ALL of the following criteria:

* Male or Female patients ≥ 18 years of age with diagnosis of RA
* Patient is eligible to start adalimumab therapy according to the local product label and prescription guidelines
* Patient is naïve to all biologics e.g. anti-cluster of differentiation 4 (anti-CD4) and anti-TNF treatments at the start of the study
* Patient has no history of inflammatory arthritis other than rheumatoid arthritis
* Patient has no history of lymphoma or leukemia or other malignancies
* Has negative result of tuberculosis (TB) screening test or is receiving TB prophylaxis as per local guidelines, Provided written Authorization to the investigator to use and/or disclose personal and/or health data, or Informed Consent if requested by the Local Regulations

Exclusion Criteria:

* Patients that are not diagnosed with rheumatoid arthritis as judged by the American College of Rheumatology criteria
* Patient is currently diagnosed with any condition other than rheumatoid arthritis that may affect radiography progression
* Susceptibility to infections including TB, as judged by the investigator
* Patient is carrier of Hepatitis B virus
* Patient is a pregnant or lactating female at the time of screening
Effect of Adding Sufentanil to Epidural Ropivacaine on Perioperative Metabolic and Stress Responses in Combined General/Epidural Anaesthesia for Geriatric Radical Retropubic Prostatectomy

The purpose of this study is to compare metabolic and stress responses in combined general/epidural anesthesia in geriatric cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* elective RRP for prostatic cancer scheduled in the morning (9-11 a.m.)
* patients aged more than 65 years
* ASA physical status I or II
* absence of contraindications to epidural approach
* absence of a history of chronic pain or opioid medication

Exclusion Criteria:

* contraindication to epidural catheterization
The Effect of Therapeutic Play Before Dressing on Anxiety and Fear in Children

The goal of this experimental study is to determine the effect of therapeutic play method applied to hospitalized children aged 7-12 before the first surgical dressing attempt, on anxiety and fear. Researcher will compare the study and control groups to see if therapeutic play has an effect on anxiety and fear.

G-Power 3.1.9.4 package program was used for sample size calculation in the study. Children will be assigned to the study and control groups using the www.randomizer.org program with a simple randomization method to ensure homogeneity between the study and control groups. Before dressing, a warm-up play will be played for 10 minutes with the study group, followed by a 20-minute therapeutic game in which the dramatization method will be used. The children in the control group will be subjected to the routine dressing procedure. The data of the research will be collected using the Child and Parent Information Form, Child Anxiety Scale-State Scale and Child Fear Scale.

During the evaluation of the data, the sociodemographic characteristics of the groups participating in the study will be stated as numbers and percentages, and the normal distribution of the anxiety scale and fear scale scores before the play, after the play and after the dressing process in the Intervention and control groups will be determined by looking at the skewness coefficients. The Factorial Anova Test will be used for mixed measurements in order to examine the anxiety and fear changes of the children in the Intervention and control groups before the play, after the play and after the dressing process. In addition, since this test does not measure the different changes between the groups, the Anova Test in Repeated Measurements will be used to compare the anxiety and fear scores of only the Intervention group and only the control group before the play, after the play and after the dressing process. If the data do not have a normal distribution, the Friedman Test, which is a nonparametric test, will be used.

Eligibility Criteria:
Inclusion Criteria:

* Children in the 7-12 age group
* Children who speak and understand Turkish
* Children whose first dressing will be done in the service on the second day after the operation

Exclusion Criteria:

* Children with hearing, vision and speech problems in themselves or their parents
* Children with a mental disorder in themselves or in their parents
* Children who had circumcision surgery (because the primary dressing was removed and crystallin spray was sprayed on the surgical area and the area was left open)
* Children who should not move before dressing (having hypospadias surgery)
* Children still in the intensive care unit at the time of the first surgical dressing
* Children whose dressing had to be changed before the second postoperative day (wetting, bleeding, opening, etc.)
* Children with previous play therapy experience
Mechanisms of Chronic Kidney Disease (CKD)-Induced Foam Cell Formation

There is currently little understanding of macrophage cholesterol homeostasis and foam cell formation across the spectrum of CKD. We hypothesize that an inverse relationship exist between the severity of CKD and processes underlying foam cell formation, and that the relationship becomes independent of serum lipoprotein levels as renal function declines. We propose to systematically examine scavenger receptors and cholesterol uptake as well as cholesterol transporters and efflux mechanisms in individuals with normal renal function, patients with moderate CKD. We further propose to determine if processed contributing to foam cell formation are related to the plasma lipid profile and if the relationship is modified by co-morbidities, such as diabetes, obesity, systemic inflammation which are common in this population and directly influence vascular integrity. These data will be critically important to understand when the abnormality starts and will provide crucial information.


Eligibility Criteria:
Inclusion Criteria:

Patients with moderate degree of CKD, or patients with advanced CKD or control subjects with intact kidney function

Male or female

All ethnic groups

≥ 18 years and have signed informed consent

Exclusion Criteria:

Pregnancy and current smoking

BMI \> 45

Rheumatoid arthritis and systemic lupus erythematosus

History of active or chronic hepatitis B, history of active or chronic hepatitis C, human immunodeficiency virus (HIV)

For moderate CKD subjects: nephrotic syndrome

For control subjects: nephrotic syndrome, patients with estimated GFR \< 60 mL/min/1.73 m\^2, or proteinuria
Control of Hidradenitis Suppurativa of the Underarms After Combination Deroofing and Laser

The purpose of the study is to determine whether a series of laser hair removal treatments can improve participant outcomes after deroofing procedures. A deroofing procedure is a surgery where larger hidradenitis suppurativa bumps (called nodules) and hidradenitis suppurativa tunnels (called sinus tracts) are removed and left to heal open without stitches.

Hidradenitis Suppurativa (HS) is a chronic inflammatory disorder characterized by follicular occlusion and rupture which leads to scar and sinus tract formation. Given that medical treatments for HS primarily target inflammation, a multifaceted approach to therapy incorporating procedural techniques is thought to lead to better disease control. Deroofing of nodules and sinus tracts has shown to be beneficial in the treatment of recalcitrant areas that do not respond fully to medical therapy alone. In addition, multiple studies demonstrate the efficacy of long-pulsed 1064-nm Nd:YAG laser in the treatment of HS. To date, no study has evaluated the efficacy of combining surgical deroofing and laser treatment.

In this study, participants with Hurley stage II disease of bilateral axillae who meet the study criteria will be treated. Deroofing will be performed to all nodules and sinus tracts in a randomly selected axilla of each participant. Immediately prior to deroofing, participants will have their initial Nd:YAG laser treatment to the selected axilla. Participants will then be treated every four weeks with a series of additional laser treatments. The opposite (untreated) axilla will serve as a control for monitoring baseline disease activity.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Diagnosis of hidradenitis suppurativa Hurley stage II with bilateral axillary involvement
* Must be under the care of a board certified dermatologist and planning to undergo a deroofing procedure of one axilla for the treatment of their HS
* Disease must be active in the bilateral axillae

  * Activity to be defined as having had at least one flare in the last six months
  * Flare to be defined as patient reported worsening of disease beyond baseline or clinical evidence of active inflammation (i.e. erythema, edema, drainage, tenderness)

Exclusion Criteria:

* Pregnancy
* Clinical evidence of active superinfection
* Previous deroofing surgery in any axilla
* Previous laser therapy in any axilla
* Patients on the following medical therapies:

  * Any systemic immunomodulating agent that has been started within 3 months of initial deroofing and laser treatment

    * Patients on immunomodulators \>3 months with no change in therapy are eligible for participation
  * Use of topical antibiotics, antiseptics, oral antibiotics, oral steroids, intralesional steroids

    * Patients must have stopped all of these agents at least 2 weeks prior to surgical deroofing
  * Use of intramuscular steroids

    * It must be at least 4 weeks since administration of intramuscular steroids before deroofing for a patient to be eligible for participation
ESAN II - Energy Sensing in Depression

The purpose of this study is to assess the effects of polyphenols from natural aronia juice on the immune system.

Therefore, the study aims to distinguish the effects of natural juices that are rich in phytonutrients such as polyphenols and carotenoids in healthy and depressive subjects in order to use the known positive effects of these food sources in the therapeutic setting.

The consumption of natural fruit juices that are rich in polyphenols and carotenoids mirror a model of vegetarian diet due to the increased micronutrient density derived from plant food. Results obtained here can be seen as preliminary explanation models for the beneficial effects of vegetarian diet.

It is hypothesized, that the consumption of naturally polyphenol rich aronia juice changes the expression of regulatory T cells, specific cells of the immune system that contribute to immunomodulation. Furthermore, beneficial changes in the gut microbiome, the metabolome and the nutritional status are expected in the studied groups.

The study was registered retrospectively (after start of recruitment) on Clinicaltrials.gov.


Eligibility Criteria:
Inclusion Criteria:

1. Socio-demographic criteria:

   1. Gender: female
   2. Age: 18-40 years
2. Confirmation of the study settings

   1. receives of information on

      * the aims,
      * methods,
      * anticipated benefits,
      * potential risks, and
      * entailed discomforts of the study
   2. signed declaration of consent
3. Subgroup of depressive patients:

   1. diagnosis of depression according to the ICD-10 criteria for depression
   2. diagnosed by an experienced psychiatrist

      * a structured diagnostic interview
      * voluntarily agreement to participate
      * signed informed consent
4. Subgroup of normal weight participants:

   * WHO criteria for normal weight (body mass index (BMI) 18.5-24.99 kg/m2)
5. Subgroup of obese participants

   * WHO criteria for obesity (BMI \< 30.0 kg/m2)

Exclusion Criteria:

1. Formal criteria:

   * lack of informed consent
2. Health criteria

   1. alcohol- or drug abuse
   2. major cognitive deficits (which do not allow adequate testing)

      * according to Mini Mental Status Examination (MMSE) \<20
   3. patients which are currently in the locked ward of the clinic
   4. acute or chronic diseases or infections within the previous two months

      * upper respiratory tract infections
      * fever
      * chronic inflammatory disorders
      * autoimmune-disorders
      * blood diseases
      * mitochondrial diseases
3. Digestive disorders

   1. fructose intolerance
   2. history of digestive diseases such as

      * inflammatory bowel disease
      * irritable bowel syndrome
   3. treatment that may has influenced the microbiome

      * antibiotic or antifungal treatment within the previous two months
      * daily or irregular intake of prebiotics or probiotics within the previous two months (the intake of yoghurt and dairy products are permitted)
   4. history of gastrointestinal surgery (other than appendectomy)
4. Pregnancy and period of breastfeeding