cyrilzakka/clinical-trials huggingface dataset:
The Validity and Reliability of the Turkish Version of the Heart Failure Somatic Perception Scale

The aim of this study is to evaluate The Validity and Reliability of the Turkish Version of the Heart Failure Somatic Perception Scale in patients with heart failure.

Heart failure is a global health issue that serves as the endpoint for many cardiovascular conditions, particularly coronary heart disease and hypertension. Common symptoms of heart failure include fatigue, dyspnea, edema, cough, lack of energy, orthopnea, paroxysmal nocturnal dyspnea, palpitations, and dizziness. These symptoms significantly affect the health-related quality of life of individuals with heart failure, especially in the palliative phase of the disease. Additionally, heart failure patients often experience physical limitations, reduced quality of life, and an increased rate of hospital admissions due to symptoms such as breathlessness and fatigue. The Heart Failure Somatic Perception Scale assesses the presence and severity of 18 common physical signs and symptoms of heart failure (e.g. chest pain), as well as dyspnea and its impact on daily activities through six items. Robust and rigorous measures are needed to assess the complexity of heart failure symptoms, and evidence suggests that evaluating a broad range of heart failure symptoms can be beneficial in guiding rehabilitation approaches, clinical decision-making, and survival prediction.

Eligibility Criteria:
Inclusion Criteria:

A diagnosis of heart failure. Use of optimal pharmacological treatment according to current guidelines for at least 3 months.

Functional capacity classified as New York Heart Association (NYHA) Class I-IV (ambulatory).

Age 18 or older. Ability to cooperate with measurements.

Exclusion Criteria:

Known cognitive impairment. Having undergone acute coronary syndrome, percutaneous coronary intervention, or heart surgery within the past three months.
Safety, Efficacy, and Pharmacokinetics of CSL889 in Adults and Adolescents With Sickle Cell Disease During Vaso-Occlusive Crisis

This study consists of two parts: phase 2 (Part A) and phase 3 (Part B). It is a multicenter study designed to evaluate the safety, effectiveness, and pharmacokinetics (PK) of CSL889 (human hemopexin) when given intravenously (IV) to adults and adolescents with sickle cell disease (SCD) experiencing vaso-occlusive crises (VOC). The main objectives of the study are to assess how CSL889 affects the time it takes for VOC to resolve in participants with SCD, and to evaluate the safety and tolerability of CSL889 in study participants.


Eligibility Criteria:
Inclusion Criteria:

•At the time of informed consent: \>= 18 years of age (adults); or \>= 12 to less than (\<) 18 years of age (adolescents, where approved and when enrollment for adolescents has been opened by the sponsor, with the endorsement of the Independent Data Monitoring Committee \[IDMC\]).

* Diagnosed with SCD (any genotype).
* Presented at the study site with a new acute VOC necessitating treatment with parenteral opioids.

Exclusion Criteria:

* VOC pain onset greater than or equal to (\>=) 72 hours before administration of first parenteral opioid (Part A; may be adjusted for Part B based on prespecified analysis).
* Must not have a history of greater than (\>) 5 VOCs requiring hospital admission in the past 6 months; or signs and / or symptoms of ACS; or new neurological symptoms suggestive of acute stroke or transient ischemic attack; or any stage (acute kidney injury) AKI; or been discharged from inpatient hospital admission for VOC or other vaso-occlusive event within 14 days before the current presentation.
* Serum hemoglobin \< 6 g/dL, serum ferritin \>= 2000 ng/mL, receiving an approved medication for SCD that has not been on a stable, well-tolerated regimen, currently taking methadone or buprenorphine.
Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity Study in VLBW Neonates of BSYX-A110

The purpose of this study is to evaluate the safety (including tolerability), pharmacokinetics, pharmacodynamics and clinical activity of BSYX-A110 administered in a 3-dose regimen on Study Days 0, 7, and 14.

This Phase II study will be a randomized, double blind, placebo controlled study of BSYX-A110 in very low birth weight neonates. A total of 80 infants will be dosed in this study. Participants will receive either BSYX-A110 or placebo, at 60 mg/kg or 90 mg/kg. The Study Drug will be administered at 48-120 hours of life, 7 days after the initial dose, and 14 days after the initial dose for all dose groups.

Eligibility Criteria:
Inclusion Criteria:

Patients must meet all of the following criteria at the time of first infusion (Day 0):

1. 48-120 hours of age, inclusive
2. Birth weight of 700-1300 grams
3. Inpatient in a Neonatal Intensive Care Unit
4. Written informed consent obtained from the parent(s) or legal guardian

Multiple gestations:

1. Siblings from multiple gestations may be enrolled if they each meet the entry criteria
2. No more than 4 subjects in any birth weight cohort may be siblings

Exclusion Criteria:

Patients may have none of the following at the first dose:

1. Survival not expected for at least 1 week after infusion
2. Clinically overt systemic infection, as determined by history, physical examination, and positive culture from a normally sterile site. (Infuse only when infant clinically stable and cultures negative for 48 hours. If being evaluated for sepsis, decision to infuse may be deferred as allowed by protocol infusion window. Infusions outside of protocol window must be approved by Sponsor.)
3. Severe congenital anomalies or genetic disorders that are likely to be fatal or that may interfere with drug distribution or metabolism, as determined by history and/or physical examination, and including but not limited to:

   i. Trisomy 13 ii. Trisomy 18 iii. Hypoplastic Left Heart Syndrome iv. Omphalocele v. Gastroschesis vi. Holoprosencephaly
4. Known or suspected hepatic or renal insufficiency
5. Clinically uncontrolled seizures
6. Immunodeficiency other than due to prematurity
7. A history of standard immune globulin administration prior to first study drug infusion (excluding Hepatitis B Immune Globulin, HBIG)
8. Any history, in the infant subject or its mother, of a hypersensitivity or severe vasomotor reaction to immunoglobulin G, or blood products
9. Currently receiving, recently received, or planned to receive other investigational agents that could interfere with conduct or results of this study; including enrollment in another investigational study for a product under an IRB-approved protocol
10. Expectation that the patient will not be able to be followed for the duration of the study
11. Mother with serology positive for hepatitis B surface antigen
Prevalence of Auditory Dysfunction and ICU-acquired Delirium Following Cardiac Surgery With Cardiopulmonary Bypass: a Prospective Observational Study

AUDICS-ICU is a prospective observational aiming to evaluate the prevalence of auditive dysfunction following cardiac surgery. Participants will undergo audiometric testings before and 3 months after cardiac surgery with cardiopulmonary bypass. Furthermore, the study evaluates hearing loss-associated ICU-acquired delirium after cardiac surgery with cardiopulmonary bypass.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* Undergoing non urgent cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

* Pregnant
* History of ear surgery
* Ear disease
* Inadequate understanding of the protocol
Scorpio Posterior Stabilised (PS) vs Scorpio NRG ("Energize") PS - Total Knee Arthroplasty

Single-centre, prospective, randomized comparative study to compare the maximum flexion and Chair Raise achievement ratios of the Scorpio PS and and the Scorpio NRG PS. Documentation of all complications.

Surveillance design: Single-centre, prospective, randomized comparative study. Objectives: To compare the maximum flexion (active and passive) and Chair Raise achievement ratios. All complications will be documented.

Number of subjects to be enrolled: All consecutive Scorpio patients are included until a group size of 88 is reached.

Clinical evaluations: Chair raise test, Stair climb test, Western Ontario McMaster Osteoarthritis Index (WOMAC) patient self evaluation, EuroQuol - 5 dimension (EQ-5D) patient questionnaire. Standard clinical, functional and pain parameters (Knee Society Score), pre-operatively and post-operatively. All per- and post-op complications.

Eligibility Criteria:
Inclusion Criteria:

* Patients requiring a primary total knee arthroplasty (TKA)
* Male and nonpregnant female patients
* Between 18 and 80 years of age at time of surgery
* Patients with a diagnosis of osteoarthritis (OA), avascular necrosis (AVN), and not severe posttraumatic arthritis
* No previous osteosynthesis of the involved knee during the last 12 months
* Patients who understand the conditions of the study and are wiling to participate for the length of the described follow up
* Patients who are capable of, and have given, informed consent for participation in the study

Exclusion Criteria:

* Patients requiring revision surgery of a previous implanted total knee system
* Patients with a diagnosis of severe posttraumatic arthritis (TA) and rheumatoid arthritis (RA)
* Patients with active infection
* Patients with malignancy
* Patients with an immobile hip or ankle arthrodesis
* Severe obese patients (BMI \> 35)
* Patients with a neurological deficit
* Previous history of unicompartmental knee arthroplasty or patellar prosthesis
* Patients with concurrent illnesses which are likely to affect their outcome
Homeostatic Roles of Eosinophils in Asthma

The HOMEOS study is an exploratory, observational, and monocentric research. It focuses on characterizing the homeostatic roles of eosinophils in severe asthma. The primary objective is to identify eosinophil subpopulations among different groups of severe asthmatic patients using flow cytometry. The study aims to advance understanding of eosinophil diversity, which could guide new therapeutic approaches .


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with mild asthma with severe asthma (Biologic-naïve, responders to anti-eosinophil biologic therapies and resistant to anti-eosinophil biologic therapies), control subjects without asthma
* Signature of informed consent
* Affiliation with the French social security system

Exclusion Criteria:

* Non-eosinophilic asthma
* Coexistence of a chronic eosinophilic inflammatory condition other than asthma
* Other respiratory conditions (cystic fibrosis, COPD, allergic bronchopulmonary aspergillosis, etc.)
* Treatment with corticosteroids within 10 days prior to inclusion
* Active smoking or a smoking history of more than 20 pack-years
* Pregnant women
* Legal incapacity or limited legal capacity
* Subject unlikely to cooperate with the study and/or with anticipated low cooperation as assessed by the investigator
* Subject without health insurance
* Subject currently in an exclusion period of another study or as indicated by the "national registry of volunteers."
Acupuncture for the Treatment of Medication-Dependent Hypotension in Heart Failure

Acupuncture is believed to increase blood pressure in people who struggle with low blood pressure. This is a common problem facing people with heart failure, and sometimes these people need to take medications to artificially increase their blood pressure. This study is designed to determine if using acupuncture in people with heart failure can improve their blood pressure enough to not require medications to artificially increase blood pressure.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years old
* Chronic congestive heart failure (systolic or diastolic)
* Medication list includes midodrine or fludrocortisone, either taking as scheduled or as needed

Exclusion Criteria:

* History of acupuncture of any kind in the last 3 months
* Acute decompensated heart failure, as indicated by clinical picture at time of enrollment
* Currently on a mechanical device (LVAD, TAH, ECMO)
* History of hepatorenal syndrome, adrenal insufficiency, for which midodrine and fludrocortisone respectively is specifically being used to treat that condition
* Lack of suitable locations for which to place acupuncture seeds
Effect of Child Delivery on Intraocular Pressure

The purpose of this study is to evaluate the effect of child delivery on the intraocular pressure in healthy women.

Little is known about the changes in intraocular pressure (IOP) during child delivery. During labor there are several stages which are accompanied by many physiological changes and pharmacological interventions that may potentially influence the IOP. Among these are delivery position (lying versus sitting or kneeling), vascular changes and pharmacological effects (anesthetic agents, oxytocin and other drugs). The purpose of this study is to evaluate the effect of child delivery on the intraocular pressure (IOP) in healthy women. This will expend our understanding of the physiology of labor and its effect on the eye and it may serve as basis to determine the management of labor.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Pregnant women admitted to the labor room.
* Healthy women that do not take any systemic medications.
* No known ocular condition, except for refraction errors, strabismus or amblyopia.
* Eligible women who are able to sign an informed consent form.

Exclusion Criteria:

* Family history of glaucoma (first degree relatives).
* Known allergic reaction to local anesthesia (oxybuprocaine hydrochloride).
* Women who are unable to sign an informed consent form.
Polyacrylamide Hydrogel Injection Treatment for Anal Incontinence

A randomized study to evaluate the safety and effects of transanal submucosal polyacrylamide hydrogel injection therapy for anal incontinence.

A prospective randomized study to assess the use of Bulkamid for anal incontinence using three different transanal injection techniques .

Patients with anal incontinence severity Wexner score \>7. Standardised injection treatment at baseline. Clinical status and subjective symptom evaluation (Wexner score and FIQL) at baseline, 2 months, 6 months and 1 year.

Eligibility Criteria:
Inclusion Criteria:

* informed consent, anal incontinence with Wexner score \>10

Exclusion Criteria:

* ino additional pregnancies, schedule for pelvic organ surgery within 1 year of treatment, current or previous pelvic organ cancer, insulin treated diabetes, inflammatory bowel disease
Use of Hyaluronic Acid Injection in Lateral Patellar Compression With Femoral Condylar Degenerative Changes After Arthroscopic Release

Ninety patients are involved in this study, who underwent arthroscopic lateral patellar release for lateral patellar compression syndrome and they had patellofemoral degenerative lesion, which diagnoses by MRI preoperatively and proved by arthroscopic examination to be early stages of degenerative changes with no loss of articular surface. The patients were divided in to two groups (A and B). Group A (45 patients) were treated by local injection of Hyaluronic acid intraarticularly, and Group B (45 patients) were no injection intraarticular.

This study was done by one orthopedic surgeon in two hospitals. Ninety patients are involved in this study, who underwent arthroscopic lateral patellar release for lateral patellar compression syndrome and they had patellofemoral degenerative lesion, which diagnoses by MRI preoperatively and proved by arthroscopic examination to be early stages of degenerative changes with no loss of articular surface. The patients were divided in to two matched groups (A and B) regarding the age and gender; Group A (45 patients) were treated by local injection of Hyaluronic acid intraarticularly, 2 weeks after arthroscopy and were followed by VAS of knee pain for one year at (3) months, (6) months and (12) months, and Group B (45 patients) were no injection intraarticular. The study started on June (2017) and ends on March (2020). injection of Hyaluronic acid was used and followed in the same way. All patients presented with anterior knee pain which failed to respond to conservative treatment for 6 weeks or recurrent of symptoms after stopping of conservative treatment which involved changes of life style and NSAID. MRI done for all patients before operation.

Eligibility Criteria:
Inclusion Criteria:

* Lateral patellar compression syndrome

Exclusion Criteria:

* Patellar instability.
* Smoking.
* Diabetes Mellitus.
* Previous knee surgery.
Silicone Earplugs for VLBW Newborns in Intensive Care

The purpose of this study was to determine the effects of individual noise reduction using silicone earplugs for very low birthweight newborns in neonatal intensive care on growth and development. The study hypothesis was that newborns who were randomized to the earplug group would be heavier than controls at 34 weeks post-menstrual age.


Eligibility Criteria:
Inclusion Criteria:

* birthweight between 401 and 1500 grams
* less than 1 week of age
* parental informed consent
* availability of research personnel

Exclusion Criteria:

* terminal illness
* congenital anomalies
* syndromes associated with hearing loss
The Effect of Schumann Resonance on Preterm Newborns

Body weight gain is crucial for preterm newborns, especially those with a low birth weight. Owing to their noninvasive, noncontact, and non-pharmaceutical properties, extremely low frequency electromagnetic fields (ELF-EMFs) are a promising medium of alternative and complementary therapy.

Sixty-one preterm newborns of 32-35 weeks' gestational age were recruited from the neonatal intensive care unit of the Chung Shan Medical University Hospital and randomly assigned to one of two groups: the experimental group (n = 31) or the control group (n = 30). Both groups received the same medical care, but the experimental group was exposed to ELF-EMFs until discharge.

Eligibility Criteria:
Inclusion Criteria:

* gestational age (GA) between 32 and 35 weeks
* Neonatal Therapeutic Intervention Scoring System (NTISS) score \<9

Exclusion Criteria:

* (1) a diagnosis of congenital anomaly, intrauterine growth retardation, cerebral palsy, or hydrocephalus; (2) an NTISS score\>9
Silymarin in NAFLD

This study evaluates the influence of Silymarin in reducing laboratory, ultrasonographic (Fibroscan) and metabolic components of NAFLD. Half of the patients will receive Silymarin (Verum) while the other half will receive placebo

In this study will participate patients who come to the regular ambulatory examinations (referred by gastroenterologists, nephrologists or family physicians in the Department of Gastroenterology and Department of Nephrology, dialysis and kidney transplantation KBC Rijeka) and have one or more components of the metabolic syndrome (hypertension, diabetes, obesity, dyslipidemia).Nonalcoholic fatty liver disease will be defined by transient elastography (FibroScan, Echosens, Paris); Controlled Attenuation Parameter (CAP) for assesment of liver steatosis and Liver Stiffness Measurements (LSM) for liver fibrosis. In all patients other causes of chronic liver disease will be excluded; chronic viral hepatitis, autoimmune diseases and other metabolic liver diseases as well as use of drugs than can cause liver steatosis and fibrosis and alcoholic liver disease.

This study will include 350 patients. Taking into account the possible drop-out rate around 15% of the patients during the study period, a total of 400 patients will be randomized. Patients will be randomized into two groups. The first group will be consisted of the patients with NAFLD who will be receiving Verum therapy during the 6 month period. The second group will be consisted of the patients with NAFLD who will be receiving placebo during the 6 months period, which will be identical to the Verum preparation in its packaging and form.

After the 6 months of therapy in all patients will be evaluated: liver enzymes and metabolic laboratory parameters of NAFLD (insulin resistance, lipidogram and serum glucose), as well as the TE-CAP in order to evaluate the efficiency of Silymarin for the treatment of NAFLD.

Eligibility Criteria:
Inclusion Criteria:

* NAFLD patients
* signed informed consent
* possibility to follow instruction and the protocol

Exclusion Criteria:

* chronic B or C hepatitis
* usage of hepatotoxic drugs in the period of 6 months before inclusion
* chronic kidney insufficiency (grade 4 and 5), hemodialysis
* any other chronic liver disease
* opioid dependancy
* any malignancy
* HIV seropositivity
* alcohol abuse
* pregnancy
* inability to follow the protocol
Erector Spinae Plane Block Versus Classic Epidural Analgesia in Labor

Prosepective,Randomized, controlled study enrolling full termed parturients admitted for vaginal delivery.

At the sencond stage of labor: 3cm of cervix dilatation, patients will be randomized in 2 groups:

* ESP group: patients will receive ultrasound guided, bilateral ESP Block performed at the level of the 3 rd Lumbar transverse process.
* Epidural Analgesia Group: Patients will have a classic lumbar continuous epidural analgesia.

Prosepective,Randomized, controlled study enrolling full termed parturients admitted for vaginal delivery.

At the sencond stage of labor: 3cm of cervix dilatation, patients will be randomized in 2 groups:

* ESP group: patients will receive ultrasound guided, bilateral ESP Block performed at the level of the 3 rd Lumbar transverse process.
* Epidural Analgesia Group: Patients will have a classic lumbar continuous epidural analgesia.

For the first group: 20 ml of 0,375% isobaric Bupivacain solution will be injected bilaterally under ultrasound direct vision.

Concerning the second group, patients will have a continuous injection of 0,125% Bupivacain solution associated to 0,25 mcg of Sufentanil/ml through an epidural catheter in the L3-L4 or L4-L5 intervertebral space.

For the 2 groups, analgesia will be assessed during all the labor period hourly using the Visual Analog pain Score (VAS).

Eligibility Criteria:
Inclusion Criteria:

* Full termed parturients admitted for vaginal delivery
* singleton pregnancy
* No contraindications to perimedullar analgesia techniques

Exclusion Criteria:

* Indication to Cesarean section during labor period