cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Roxadustat for Treatment of Anemia in Participants With Lower Risk Myelodysplastic Syndrome With Low Red Blood Cell Transfusion Burden

The purpose of this study is to determine whether FG-4592 is safe and effective in the treatment of anemia in participants with lower risk MDS and low red blood cell transfusion burden.

This study includes an Open-Label Lead in, a Double-Blind component, and an Open-Label High Erythropoietin component. There is a screening period of up to 42 days followed by a treatment period of 52 weeks and a 4-week end of treatment assessment.

Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of primary MDS classified by the International Prognostic Scoring System - Revised (IPSS-R) as very low, low or intermediate risk with \<5% bone marrow blasts. There is no minimum time from diagnosis to registration/randomization except to allow for proper IPSS-R classification to be made (within 16 weeks prior to randomization), and to show transfusion dependence for participants in both portions of the study.
* RBC transfusion of either 2-4 pRBC units during the 8 weeks prior to registration/randomization or 1 pRBC in two consecutive periods of 8 weeks within the 16 weeks prior to registration/randomization. Open-Label Lead-in participants only, the requirement to demonstrate transfusion dependence can also be met by a Principal Investigator starting this particular participant on pRBC transfusion during the screening period.
* No restriction on prior use of recombinant erythropoietins or analogues (erythropoiesis-stimulating agents \[ESAs\]), except no ESA use within 8 weeks prior to Day 1 registration/randomization.
* Hemoglobin (Hb) ≤10.0 grams/deciliter (g/dL) during screening
* Eastern Cooperative Oncology Group (ECOG) of 0-2 at screening

Key Exclusion Criteria:

* Diagnosis of secondary MDS associated with prior chemotherapy, extensive radiation therapy (\>25% of bone marrow reserve), and or/other significant chemical or radiation exposure
* Significant myelofibrosis (\>2+ fibrosis)
* MDS associated with 5q(del) cytogenetic abnormality
* Screen serum erythropoietin level \> 400 milli-international units (mIU)/milliliter (mL) • Clinically significant anemia, as determined by the investigator, due to non-MDS etiologies such as iron deficiency, vitamin B12 or folate deficiency, autoimmune or hereditary hemolysis or anemia or hemorrhage or hereditary anemia such as sickle cell anemia or thalassemia.
Biomarkers of Sleep-wake Cycle in Prodromal Alzheimer's Disease: Role in Cognitive Decline?

Alzheimer's disease (AD) is characterised by a progressive loss of memory and cognitive function. In the early stages of AD, there is a progressive accumulation of molecules: β-amyloid peptides (Aβ) in the brain. There is a link between the accumulation of Aβ peptides and the deterioration of sleep, but current knowledge does not confirmed this link. The objective of this study is to define whether there is a link between cognitive decline and sleep disorders. If a correlation is found, this could allow earlier treatment of sleep disorders in the longer term in order to slow the development of AD.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of mild Alzheimer's disease with a Mini Mental State (MMS) between 21-30
* The presence of a family carer to complete neuropsychological scales, questionnaires and sleep diaries
* Having a neurological assessment and/or follow-up requiring blood and cerebrospinal fluid (CSF) sampling with biomarkers for diagnostic purposes
* Patient who had a lumbar puncture less than one year ago or patient with a scheduled lumbar puncture as part of care
* Signed informed consent
* Able to carry out all visits and follow study procedures
* Affiliation to the French social security system

Exclusion Criteria:

* Genetic form of alzheimer's disease
* Insufficient clinical and paraclinical information for the diagnosis of AD
* Anticholinesterase and/or memantine treatment or on stable doses for at least 3 months
* Use of antidepressants, anxiolytics, hypnotics, neuroleptics, 15 days before inclusion
* Patient living in a nursing home
* Illiteracy or inability to perform psycho-behavioural tests
* Major physical or neurosensory problems that may interfere with the tests
* Initial contraindication to diagnostic lumbar puncture (LP) (spinal surgery, skin infection, haemostasis abnormality, intracranial hypertension, severe coagulation disorders, curative anticoagulant therapy, severe liver failure)
* Refusal to perform a diagnostic lumbar puncture
* Contraindication to the use of E-Celsius: people weighing less than 40 kg, with intestinal disorders, with known swallowing disorders
* Patient deprived of liberty, by judicial or administrative decision;
* Major protected by law;
* Patient in a period of relative exclusion from another protocol or for whom the maximum annual compensation of €4500 has been reached;
* Refusal to participate in the protocol.
Virtual Observed Therapy for Patients With Tuberculosis

Using modern technology, investigators will observe participants taking their TB tablets three times per week using a mobile phone, iPod or computer with camera facilities in the participants home environment.

Using modern technology, the investigators will observe participants taking their TB tablets three times per week using a mobile phone, iPod or computer with camera facilities in the participants home environment.

Investigators will connect to the participants mobile phone, iPod or computer at a mutually convenient time three times per week who will observe participants taking their TB medication.

The Virtual Observed Therapy will be carried out using NHS Lothian approved software (mobile app called POLYCOM) three times per week. This is software similar to Skype but POLYCOM is the approved software we use in NHS Lothian.

Eligibility Criteria:
Inclusion Criteria:

Any patient requiring Tuberculosis treatment

Exclusion Criteria:

Those refusing consent; the healthcare professional deems the patient that will not be able to comply with VOT
Telehealth in Improving Quality of Life in Patients During Post Radiation Therapy Visits

This pilot clinical trial studies how well telehealth works in patients during post radiation therapy visits. A telehealth virtual office visit can be performed from the patient's home or workplace, decreasing time spent traveling to visit site, time spent in waiting room, and cost to patient. Studying telehealth may improve quality of life in patients during post radiation therapy visit.

PRIMARY OBJECTIVES:

I. To examine feasibility of conducting a trial comparing a telehealth visit and an in person office visit.

SECONDARY OBJECTIVES:

I. To examine patient satisfaction, patient assessment of physician communication during a telehealth visit.

II. To examine patient distrust in the healthcare system following a telehealth visit.

III. To examine physician ability to perform a patient assessment during a telehealth visit.

IV. To examine physician perceptions of telehealth visits. V. To examine monetary and time cost to patients for telehealth visit. VI. To calculate clinic savings derived from telehealth visits.

OUTLINE:

Patients undergo their first post-treatment visit as a virtual telehealth visit using the JeffConnect application.

Eligibility Criteria:
Inclusion Criteria:

* Patients currently undergoing or planned to start radiation treatment with curative, adjuvant or palliative intent
* Karnofsky performance status (KPS) score \>= 60
* Patients must be capable to read and speak English and provide study specific informed consent prior to study entry
* Patients must have access to a computer or smartphone and internet connection at home on which they would be willing to do a telehealth study
* Pennsylvania or New Jersey residents \*Telehealth visits for New Jersey residents will only be performed by physicians with a current medical license issued by the state of New Jersey.

Exclusion Criteria:

* KPS \< 60%
* No access to a computer, smartphone or internet
* Unable to read and/or speak English
* Decisionally impaired patients
* Patients not residing in Pennsylvania or New Jersey
CORE-OLE: A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants With Severe Hypertriglyceridemia (SHTG)

The purpose of this study is to evaluate the safety and tolerability of olezarsen in participants with SHTG.

This is a multi-center, open-label extension (OLE) study of approximately 800 participants with SHTG who would be rolled over from studies ISIS 678354-CS5 (NCT05079919) or ISIS 678354-CS6 (NCT05552326). Day 1 of this study may be same as the Week 53 visit of either ISIS 678354-CS5 or ISIS 678354-CS6, as applicable. Participants will receive olezarsen during the 157-week treatment period. The study will include a 31-day qualification Period, a 157-week treatment period, and a 13-week post-treatment period.

Eligibility Criteria:
Key Inclusion Criteria:

* Satisfactory completion of either ISIS 678354-CS5 or ISIS 678354-CS6 with an acceptable safety profile, per Investigator judgment. Satisfactory completion requires that the patient did not terminate early from treatment.
* Participants must be on a stable regimen of lipid-lowering therapy that should adhere to standard of care (SOC) per local guidelines. A patient may be eligible if their regimen of lipid-lowering therapy has been changed recently, provided that lipid lowering medications are optimized and stabilized for at least 4 weeks prior to the end of the Qualification Period of this OLE study; ideally, such changes are initiated after Week 53 of the index study (ISIS 678354-CS5 or CS6).
* A patient may re-enroll in the study after having completed the study when the Treatment Period was 53 weeks, if the patient satisfactorily completed the study with an acceptable safety profile, per Investigator judgment. In the case of re-enrollment, there is no limit on the time gap between completion of treatment under the previous protocol and dosing upon re-enrollment (i.e., may exceed 17 weeks between doses).

Key Exclusion Criteria:

• Have any new condition or worsening of existing condition which in the opinion of the Investigator would make the participant unsuitable for enrollment, or could interfere with the participant participating in or completing the study, including need for treatment with disallowed medications, or need to change the required stable regimen as per either ISIS 678354-CS5 or ISIS 678354-CS6 study entry criteria. It is acceptable to adjust a regimen of lipid-lowering therapy as described in the second Key Inclusion Criterion above, and it is acceptable to adjust or stop lipid-lowering therapy at or after Week 13 per Investigator judgment.

NOTE: Other Inclusion/Exclusion criteria may apply.
Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease (K-ELUVIA Registry)

* Prospective, multi-center single-arm observational study
* A total of 100 subjects with femoropopliteal artery disease who meet all inclusion and exclusion criteria will be included.
* Patients will be followed clinically for 12 months after the procedure.
* An imaging study (duplex ultrasound, CT or catheter-based angiography) follow-up according to participating hospital's protocol will be performed at 12 months.
* Ankle-brachial index, symptom status and presence of stent fracture will be evaluated at 12 months.

Enrollment (day 0):

1) Written consent

Post PTA (Day 1 \~3):

1. Symptom: Rutherford class
2. Adverse event
3. Ankle-brachial index
4. Laboratory test: - eGFR, Cr, ALT, AST

   * Hb, WBC, platelet
5. Concomitant medication

Regular Follow-up Visits

Visit 1 (post-PTA 30±14 days):

1. Symptom: Rutherford class
2. Physical examination
3. Concomitant medication
4. Adverse event
5. Laboratory test:

   * AC glucose, eGFR, Cr, ALT, AST
   * Hb, WBC, platelet
   * Lipid level (total cholesterol, LDL-C, triglyceride, HDL-C)
   * HbA1c in case of DM
   * hsCRP

Visit 2 (post-PTA 6 months ± 30 days):

1. Symptoms: Rutherford class
2. Physical examination
3. Ankle-brachial index
4. Concomitant medication
5. Adverse event

Visit 3 (post-PTA 12 months ± 30 days): (Mandatory)

1. Symptoms: Rutherford class
2. Physical examination
3. Ankle-brachial index
4. Duplex ultrasound, CT, or catheter angiography
5. Concomitant medication
6. Adverse event 7) Biplane radiograph of femur for evaluation of stent fracture 8) Laboratory test: - AC glucose, eGFR, Cr, ALT, AST

   * Hb, WBC, platelet
   * Lipid level (total cholesterol, LDL-C,triglyceride, HDL-C)
   * HbA1c in case of DM
   * hsCRP

Eligibility Criteria:
Inclusion Criteria:

* Age 19 years of older
* Symptomatic peripheral artery disease: Moderate or severe claudication (Rutherford category 2 or 3) and Critical limb ischemia (Rutherford category 4-5)
* Femoropopliteal artery lesions with stenosis \> 50%
* ABI \< 0.9 before treatment
* Patents treated with ELUVIA stent for femoropopliteal artery disease
* Patients with signed informed consent

Exclusion Criteria:

* Acute critical limb ischemia
* Severe critical limb ischemia (Rutherford category 6)
* Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, cilostazol, or contrast agents
* In-stent restenosis lesions (Restenosis lesions without previously implanted stents are eligible to the enrollment)
* Bypass graft lesions
* Age \> 85 years
* Severe hepatic dysfunction (\> 3 times normal reference values)
* Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
* LVEF \< 40% or clinically overt congestive heart failure
* Pregnant women or women with potential childbearing
* Life expectancy \<1 year due to comorbidity
* Untreated proximal inflow disease of the ipsilateral iliac arteries (more than 50% stenosis or occlusion)
Addiction Remission and Addiction Transfer After Bariatric Surgery

To evaluate addiction remission and addiction transfer after bariatric surgery.

A prospective study to evaluate addiction remission and addiction transfer 6 and 24 months after primary surgery (sleeve gastrectomy, Roux-en-Y- gastric bypass and One anastomosis gastric bypass) in obese patients. A questionnaire evaluating food addiction (Yale Food Scale), alcohol addiction (Audit Scale), nicotine addiction (Fagerström Scale), exercise addiction (Exercise Addiction Inventory), internet addiction (ISS20) and drug addiction (Drug Use Questionnaire) gets completed prior to surgery and 6 and 24 months after surgery.

Eligibility Criteria:
Inclusion Criteria:

* BMI \> 35kg/m² and obesity related disease or BMI \> 40kg/m²

Exclusion Criteria:

* decline of study participation
Rhythm and Music to Rehabilitate Reading Disorders

The purpose of this study is to determine whether music training is an effective treatment of reading disorders

Introduction: Children with dyslexia show deficits in temporal processing, both in language and in music. Musical activity increases phonological awareness, word segmentation, working memory, as well as reading abilities in children with typical development, a compelling evidence for a role of music training in fostering brain plasticity. Within this theoretical framework, we investigate the hypothesis that music training, by improving temporal processing and rhythm abilities, improves phonological awareness and reading skills in children with dyslexia.

Methods: The study is a prospective, multicenter, open randomized controlled trial, consisting of test, rehabilitation and re-test

Eligibility Criteria:
Inclusion Criteria:

* Italian native language
* Reading performance (accuracy and/or speed) failed on at least two of three school grade standardized Italian tests: text, words, pseudowords (cut-offs: z-score \<-1.8 standard deviations from the mean for speed scores, a score \<5th percentile in the accuracy scores).
* Hearing and neurological examination within normal range
* Normal or corrected-to-normal visual acuity
* General IQ \>85 at Wechsler Intelligence Scale for Children III.

Exclusion Criteria:

* Presence of comorbidity involving Attentional Deficit Disorders with Hyperactivity (ADHD)
* Presence of comorbidity involving Specific Language Impairment (SLI)
* Presence of comorbidity involving Oppositional Defiant Disorder (ODD)
* Severe emotional-relational impairments
* Previous formal musical or painting education for more than one year, other on-going treatment.
* Presence of other diseases (i.e. diabetes , cystic fibrosis, asthma...) that could influence the performance in cognitive and executive functions.
Comparison of Remimazolam and Midazolam for Preventing Intraoperative Nausea and Vomiting During Cesarean Section Under Spinal Anesthesia

Spinal anesthesia is widely accepted as the anesthetic method of choice for Cesarean section. However, high-level blockage or hypotension induced by this technique may induce intraoperative nausea and vomiting (IONV), which is associated with patient discomfort and protrusion of abdominal viscera which may adversely affect patient safety. To prevent IONV, midazolam is frequently administered after delivery, but risk of hypotension and prolonged sedation due to its active metabolite also increases. On the other hand, remimazolam is known to have relatively shorter half-life and less likely induce hypotension when compared to midazolam, yet its effect on IONV has not been thoroughly evaluated. Hence, this study aimed to compare the effects of remimazolam and midazolam in preventing IONV in patients scheduled for elective Cesarean section.


Eligibility Criteria:
Inclusion Criteria:

Patients (age ≥ 20yrs and ASA Class II or III) who are scheduled for elective Cesarean section

Exclusion Criteria:

Emergency surgery Patients who are diagnosed preeclampsia or eclampsia, BMI ≥ 40kg/m2, IUP \< 36 weeks Patients with contraindications to spinal anesthesia Patients who do not want sedation during the procedure
The Evaluation of White Matter Intensities in Patients with Pediatric Epilepsy

Aim: Neuroimaging is an important tool, in combination with a detailed medical history, physical examination, and electroencephalography, in the diagnosis and classification of epilepsy. White matter hyperintensities (WMHs) are bright areas of high signal intensity seen in white matter at T2-weighted MRI. Researchers aimed to evaluate whether white matter hyperintensities are more common in children with epilepsy.

Material-method: Patients who underwent cranial MRI with diagnoses of epilepsy based on International League Against Epilepsy (ILAE) criteria at the Balıkesir University Medical Faculty Pediatric neurology clinic, Türkiye, between 01.08.2019 and 01.03.2024 and patients who underwent cranial MRI during the same period due to indications other than epilepsy, such as headache, syncope, and vertigo, were included in the study. Written informed consent was received from all patients.

Aim: Neuroimaging is an important tool, in combination with a detailed medical history, physical examination, and electroencephalography, in the diagnosis and classification of epilepsy. White matter hyperintensities (WMHs) are bright areas of high signal intensity seen in white matter at T2-weighted MRI. Researchers aimed to evaluate whether white matter hyperintensities are more common in children with epilepsy.

Material-method: Patients who underwent cranial MRI with diagnoses of epilepsy based on International League Against Epilepsy (ILAE) criteria at the Balıkesir University Medical Faculty Pediatric neurology clinic, Türkiye, between 01.08.2019 and 01.03.2024 and patients who underwent cranial MRI during the same period due to indications other than epilepsy, such as headache, syncope, and vertigo, were included in the study. Written informed consent was received from all patients.

Eligibility Criteria:
Inclusion Criteria:

Cranial MRI during the same period due to indications other than epilepsy;

* headache
* syncope and
* vertigo

Exclusion Criteria:

Patients with neuropsychiatric disorders;

* depression,
* psychotic disorders,
* autism spectrum disorder History of medication use for any chronic disease other than seizure medication, History of vascular disease ;
* Collagen tissue diseases;
* lupus,
* juvenile rheumatoid arthritis,
* polyarteritis nodosa,
* Kawasaki disease Demyelinating disease
* acute demyelinating disease (ADEM),
* Multiple sclerosis Acute symptomatic seizure or a single unprovoked seizure, İncomplete file data, or MRI performed at a location other than our hospital
Red Cell Rejuvenation for the Attenuation of Transfusion Associated Organ Injury in Cardiac Surgery

The REDJUVENATE Trial proposes to test the hypothesis that postoperative organ injury and inflammation will be less if patients undergoing cardiac surgery who are at risk of large volume blood transfusion (defined as the administration of ≥4 units of red cells) receive rejuvenated washed cells compared to standard care (unwashed aged stored cells).

In the REDJUVENATE trial, we propose to establish whether the administration of rejuvenated red cells will reduce inflammation and organ injury in cardiac surgery patients at risk of large volume blood transfusion when compared to standard care. Organ injury and sepsis accounts for the majority of all deaths following cardiac surgery. Once organ injury is established care is primarily supportive and there are no effective treatments. Prevention is therefore a key clinical strategy to prevent death, morbidity and high healthcare costs attributable to these complications. Sepsis and inflammatory organ injury are also the principal causes of death following paediatric cardiac surgery, trauma, non-cardiac complex surgical procedures and in critical care; clinical settings that are also among the principal consumers of blood components. National and international blood management strategies are focused on these patients. Evidence of a clinical benefit attributable to the use of rejuvenated red cells in cardiac surgery patients is therefore likely to translate into more widespread benefits to patients and the National Health Service (NHS).

Eligibility Criteria:
Inclusion Criteria:

1. Adult cardiac surgery patients (≥18 years) undergoing cardiac surgery with cardiopulmonary bypass.
2. Identified as representing a high risk group for massive blood transfusion using a modified risk score. A large volume blood transfusion (LVBT) score of \>23 indicates predicted risk of receiving ≥4 units of allogeneic red cells equal to or greater than 55 per cent.

Exclusion Criteria:

1. Emergency or salvage procedure
2. Patients with end stage renal failure defined as an estimated Glomerular Filtration rate (eGFR) \<15 mL/min/1.72 m2 calculated from the Modification of Diet in Renal Disease equation, or patients who are on long-term haemodialysis or have undergone renal transplantation.
3. Patients who are prevented from having blood and blood products according to a system of beliefs (e.g. Jehovah's Witnesses).
4. Patients with a pre-existing sepsis or organ injury defined as documented sepsis, acute kidney injury, acute lung injury, myocardial infarction, low cardiac output, liver injury, stroke or pancreatitis within 5 days of surgery.
5. Pregnancy.
6. Patients who are participating in another interventional clinical study.
7. Patients requiring irradiated blood.
8. Sickle cell anaemia.