cyrilzakka/clinical-trials huggingface dataset:
Glaucoma Screening With Artificial Intelligence

This randomized clinical trial aims to compare the diagnostic performance of two AI-enabled screening strategies - ROTA (RNFL optical texture analysis) assessment versus optic disc photography - in detecting glaucoma within a population-based sample. Secondary objectives are to (1) compare the diagnostic performance of ROTA AI assessment versus OCT RNFL thickness assessment by AI, and ROTA AI assessment versus OCT RNFL thickness assessment by trained graders, (2) investigate the cost-effectiveness of AI ROTA assessment for glaucoma screening, and (3) estimate the prevalence of glaucoma in Hong Kong.

Glaucoma is the leading cause of irreversible blindness affecting 76 million patients worldwide in 2020. Characterized by progressive degeneration of the optic nerve, early detection of disease deterioration with timely intervention is critical to prevent progressive loss in vision. In the 5th World Glaucoma Association Consensus Meeting, a diverse and representative group of glaucoma clinicians and scientists deliberated on the value and methods of glaucoma screening. Whereas it has been recognized that early detection of glaucoma for treatment is beneficial to preserve the quality of vision and quality of life as glaucoma treatments are often effective, easy to use and well tolerated, the optimal screening strategy for glaucoma has not yet been determined.

ROTA (Retinal Nerve Fiber Layer Optical Texture Analysis) is a patented algorithm designed to detect axonal fiber bundle loss in glaucoma. Unlike conventional Optical Coherence Tomography (OCT) analysis, ROTA uses non-linear transformation to reveal the optical textures and trajectories of axonal fiber bundles, allowing for intuitive and reliable recognition of RNFL abnormalities without the need for normative databases. It can be applied across different OCT models and is particularly effective at detecting focal RNFL defects in early glaucoma and varying degrees of RNFL damage in end-stage glaucoma. The proposed study will address whether the application AI on ROTA is feasible and cost-effective in the setting of glaucoma screening, and whether ROTA would outperform optic disc photography and OCT RNFL thickness assessment.

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 50 years or above

Exclusion Criteria:

* Physically incapacitated
* Not able to cooperate for clinical examination or optical coherence tomography (OCT) investigation will be excluded
Phase 1/1b Study of TRU-016 in Patients With Previously Treated CLL or Select Subtypes of Non-Hodgkin's Lymphoma

The purpose of this study is to evaluate the safety and tolerability of TRU-016 in patients with previously treated chronic lymphocytic leukemia, and to obtain an estimate of clinical activity in patients with CLL and non-Hodgkin's lymphoma.

This Phase 1/1b open-label study consists of two parts. The initial portion is a Phase 1 dose-escalation study evaluating the safety and tolerability of TRU-016 administered over a 4-week period to patients with relapsed chronic lymphocytic leukemia (CLL). It will identify the MTD and evaluate the pharmacokinetics and immunogenicity of TRU-016. Upon demonstrating satisfactory safety and tolerability in the Phase 1 portion, a Phase 1b expansion cohort will be enrolled to further characterize the safety of the selected dose from the first stage of the study and safety and to estimate the clinical activity of TRU-016 in patients with treatment-naive CLL, relapsed CLL and non-Hodgkin's lymphoma.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic lymphocytic lymphoma or small lymphocytic lymphoma (Phase 1) or relapsed/refractory NHL (Phase 1b)
* Previous treatment with at least one fludarabine-containing regimen
* Demonstrate at least one of the following criteria for active disease requiring treatment:

  * a)progressive splenomegaly and/or lymphadenopathy;
  * b)anemia or thrombocytopenia due to bone marrow involvement;
  * c)unintentional weight loss \>10% over preceding 6-month period;
  * d) NCI Grade 2 or 3 fatigue;
  * e) fevers \>100.5 F or night sweats for \> 2 weeks without infection;
  * f) progressive lymphocytosis with increase of \>50% over a 2-month period or anticipated doubling time of \< 6 months.
* ECOG performance status \</= 2
* SGOT, SGPT \</= 2.0 x upper limit of normal
* ANC \>/= 500/uL
* Platelets \>/= 30,000/uL
* Discontinued previous anticancer or investigational therapy for at least 30 days

Exclusion Criteria:

* Treatment with rituximab within 30 days or alemtuzumab(Campath)or radioimmune therapy within 12 weeks
* ANC \</= 500/uL
* Platelets \</= 30,000/mm3
* Previous or concurrent additional malignancy
* Significant concurrent medical diseases or conditions
* Hepatitis B surface antigen or hepatitis B core antibody positive
* Pregnant or breastfeeding
Treatment of Women After Severe Postpartum Haemorrhage

The primary purpose of this study is to get explorative information about IV high single dose infusion of iron isomaltoside 1000 compared to RBC transfusion in the treatment of severe PP-IDA evaluated as physical fatigue


Eligibility Criteria:
Inclusion Criteria:

1. PPH \> 1000 mL
2. Hb ≥ 5.5 and ≤ 8.0 g/dL (≥ 3.5 and ≤ 5.0 mmol/L)
3. Willingness to participate and signed the informed consent form

Exclusion Criteria:

1. Women aged \< 18 years
2. Multiple births
3. Peripartum RBC transfusion
4. Known iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis)
5. Known hypersensitivity to parenteral iron or any excipients in the investigational drug products
6. Women with a history of active asthma within the last 5 years or a history of multiple allergies
7. Known decompensated liver cirrhosis and active hepatitis
8. Women with HELLP (Haemolysis Elevated Liver enzymes Low Platelet count) syndrome (defined according to "Dansk Selskab for Obstetrik og Gynækologi guidelines")
9. Active acute infection assessed by clinical judgement
10. Rheumatoid arthritis with symptoms or signs of active joint inflammation
11. History of anaemia caused by e. g. thalassemia, hypersplenism or haemolytic anaemia (known haematologic disorder other than iron deficiency)
12. Not able to read, speak and understand the Danish language
13. Participation in any other clinical study where the study drug has not passed 5 half-lives prior to the baseline
14. Any other medical condition that, in the opinion of Investigator, may cause the patient to be unsuitable for completion of the study or place the patient at potential risk from being in the study. For example, a malignancy, uncontrolled hypertension, unstable ischaemic heart disease or uncontrolled diabetes mellitus
Effect of Whole-body Photobiomodulation on Muscular Performance Enhancement.

Introduction: Photobiomodulation therapy (PBMT) is based on the emission of light ranging from red to near-infrared spectra by different devices based on diode lasers or light-emitting diodes. These devices emitting different wavelengths can increase mitochondrial activity and energy synthesis (ATP - adenosine triphosphate) that in turn can help to prevent muscle damage, decrease muscle fatigue and enhance muscle performance. Thus, PBMT can be a promising therapeutic resource in the sports field. Objectives: The aim of this study is to verify the effect of PBMT on the muscle performance and prevention of muscle damage and delayed onset muscle soreness (DOMS) in professional soccer players submitted to a muscle damage protocol. Methodology: The present study is a randomized sham-controlled clinical trial following the SPIRIT guidelines.

Participants will be allocated into 3 balanced randomized groups, as follows: 1) PBMT post muscle damage protocol (PBMT-post); 2) PBMT pre (PBMT-pre) and 3) PBMT placebo (PBMT-sham). All groups will be submitted to a) anamnesis; b) measurement of blood levels of creatine phosphokinase (CK); c) delayed onset muscle soreness (DOMS); d) muscle performance tests (Squat Jump test (SJ) and Counter Movement Jump (CMJ)); e) dynamometry of the knee extensor muscles. Whole body PBMT will be applied according to the groups, during 10 min (sham or effective), with an effective dose of 13.85 J/cm2 and irradiance of 46.17 mW/cm2. Muscle damage protocol will consist of 8 exercises for lower limb muscles, with 3 sets of 10 repetitions each, 1 minute of rest between sets, and 2 minutes of rest between exercises. Next, participants will be evaluated for levels of CK, DOMS and muscle performance (SJ, CMJ, dynamometry) at 24, 48 and 72 hours after muscle damage protocol. Data will be analyzed and compared between groups with a significance level of 5%.

Eligibility Criteria:
Inclusion Criteria:

* Male individuals aged between 18 and 35 years, professional soccer players who engage in training at least 5 times a week, will be selected.

Data collection will be conducted at the Desportivo Brasil Football Club, located in Porto Feliz, São Paulo. The sample will consist of team members, with a total of 36 athletes established to compose the sample. All data collection will take place in the same location.

Exclusion Criteria:

* Individuals with any impediment to physical activity or those presenting dysfunctions that may impair the neuromuscular system will be excluded.
Short-term Structured Exercise Training Program Plus Diet Intervention in Patients With Polycystic Ovary Syndrome (PCOS)

Clomiphene citrate (CC) is the first-line therapy for infertile women with polycystic ovary syndrome (PCOS). Unfortunately, at least 20% of PCOS results are not responsive to CC. Structured exercise training (SET) and diet has been successfully employed to restore ovarian function and to improve reproductive outcomes in obese and overweight women with PCOS. The current study was aimed to test the hypothesis that a short-term SET program plus diet intervention can improve the ovarian response to CC in CC-resistant PCOS patients.

Ninety-six PCOS patients considered CC-resistant because not responsive to 150 mg daily of CC were randomized in three arms (group A, B, and C). Group A underwent SET program plus hypocaloric diet for two months, group B had one month of observation followed by one-cycle of CC therapy, and group C underwent SET program plus hypocaloric diet for two months and received one-cycle of CC for one cycle. CC was always given at the maximal dose previously used. Clinical, hormonal and metabolic data were assessed at baseline and after intervention. Ovulation was monitored by ultrasound and confirmed by plasma progesterone assay.

Eligibility Criteria:
Inclusion Criteria:

* PCOS
* Anovulation

Exclusion Criteria:

* Major Medical Condition
* Severe Obesity
Aripiprazole for the Augmentation of Antidepressant Therapy

The study aims to evaluate effectiveness and tolerability of aripiprazole augmentation in outpatients with major depressive disorder who have had inadequate response to antidepressants in Taiwan clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients, either gender, 20-65 years of age
* Patients diagnosed with major depressive disorder as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), who fulfill both the following criteria:

  * Having at least one and no more than three inadequate responses of antidepressants
  * HAM-D17 score ≥ 14
* Willing and able to comply with the study procedure and sign a written informed consent

Exclusion Criteria:

* Females who are pregnant/lactating or planning to be pregnant
* Presence of personality disorder cluster B (dramatic, emotional or erratic disorders) or any psychotic symptomatology in the current depressive episode based on Investigators judgment
* History of organic mental disorder within 1 year prior to the screening visit
* Acute risk of suicide attempts within 3 months prior to the initiation of study treatment (HAM D-17 score item 3 ≥ 3)
* Electroconvulsive therapy (ECT) for current episode
* Past exposure to aripiprazole treatment or any investigational product (including drug and invasive medical device) within 4 weeks prior to the initiation of study treatment
* History of substance / alcohol abuse within 1 year prior to the screening visit
* Patient with any medical or psychotic feature, including the presence of significant abnormal laboratory values, which is considered not suitable for this study by Investigator
Aquaresis Utility for Hyponatremic Acute Heart Failure Study

Hyponatremia is a common finding in acute heart failure (HF) patients and is associated with worse prognosis. In addition to its prognostic value, hyponatremia may have importance during the acute management of HF. We've recently shown that acute or chronic hyponatremia, especially \<130 mEq/L, was associated with higher loop diuretic dose requirements and more frequent need for escalation of the diuretic regimen to achieve the same level of diuresis as normonatremic HF patients. Aquaresis with tolvaptan represents a potentially advantageous approach to the management of volume overload in HF, especially in patients presenting with concomitant hyponatremia. The purpose of the current study is to prospectively evaluate the comparative efficacy and safety of a tolvaptan-based diuretic regimen compared to conventional diuresis with a furosemide-based regimen on short-term clinical and treatment outcomes in hyponatremic acute HF patients.

This will be a prospective, open-label, parallel-group, randomized study comparing a tolvaptan-based aquaretic regimen to a conventional continuous infusion loop diuretic-based regimen of furosemide. Up to 55 (target sample size of 50) adult subjects admitted with acute HF and signs of volume overload, and serum sodium less than 135 mEq/L will be randomized to tolvaptan or furosemide treatment arms. The initial 24 hours of study treatment will compare tolvaptan monotherapy to furosemide monotherapy. After the initial 24 hours, treatment regimens may be altered to achieve desired clinical goals. Patients will be followed for up to 96 hours and at discharge for study purposes.


Eligibility Criteria:
Inclusion Criteria:

* Acute HF with signs or symptoms of volume overload \[i.e. elevated jugular venous pulsation (JVP), rales, edema\]
* Serum sodium \< 135 mEq/L at time of or within first 48 hours of hospitalization
* Randomized within 48 hours of presentation to hospital
* ≥ 18 years of age
* Informed consent

Exclusion Criteria:

* Severe symptomatic hyponatremia requiring acute treatment
* Severe renal impairment upon admission (creatinine clearance \< 20 mL/min)
* Renal replacement therapy dependent, or requiring upon admission
* Acute coronary syndrome on admission
* Requires or has a mechanical circulatory support device
* Evidence of cardiogenic shock requiring intravenous vasopressors
* Pregnancy
* Patient requiring concomitant use of strong CYP3A4 inhibitors (clarithromycin, ketoconazole, itraconazole, ritonavir, indinavir, nelfinavir, saquinavir, nefazodone, and telithromycin)
Assessment of HyperQ Signal for Detecting Ischemia During Dobutamine Stress ECG

The purpose of the study is to verify the ability of the HyperQ signal to detect Dobutamine induced Ischemia. The gold standard for ischemia will be the results of Angiography if performed, or Echocardiographic imaging, which was performed during the test.

Subjects referred for Dobutamine Stress Echocardiography who will sign an Informed consent form will go through the test. High resolution ECG from 12 leads will be recorded using BSP's HyperQ system before, during and following the Echo testing. This wil be done without interfering or affecting any aspect of the normal procedure. Standard Protocol will be used with standard test termination indications.

The Diagnostic stage will include analysis of the hyperQ signal, aiming to classify results as ischemic or non-ischemic.

The HyperQ data will be compared to DSE results which will be used as the "gold standard" for this study unless Angiography results are obtained.

An additional comparison evaluation will be performed to assess the advantage of the HyperQ results on the ST-changes results obtained from conventional ECG.In addition all recruited subjects will be followed for up to 12 months.During this period a phone call will be performed every 3 months to evaluate cardiac status, hospitalization and especially Angiography procedures.

Eligibility Criteria:
Inclusion Criteria:

* Subject referred to dobutamine stress Echocardiography
* Subject signed informed consent

Exclusion Criteria:

* Subjects with implantable Pacemakers or Defibrillators
* Subjects with Wolff-Parkinson-White Syndrome
Influence of Depressive Mood on Rehab Outcome

The purpose of this study is to determine the effects of depressive mood on outcomes of an in-house rehabilitation program.


Eligibility Criteria:
Inclusion Criteria:

* 2-week in-house-rehab at an acute geriatric unit
* ability to take part in assessments
* understanding German language
* Informed Consent

Exclusion Criteria:

* anti-depressive medication shorter than 4 weeks before enrollment
* In-house rehab \< 14 days
* advanced stage of dementia
Vitamin D and Critically Ill Patients

The higher rate of vitamin D deficiency is spotted among patients being hospitalized or in critical condition. Especially, vitamin D level below normal prolongs hospital stay and increases incidence of adverse prognosis and pushing up mortality of a number of diseases. However, it is remain unclear the relationship between vitamin D levels and critically ill, especially infection or sepsis. In this study, the investigators evaluate the significance of vitamin D for diagnosis and other relevant assessments of ICU cases, including vitamin D's relevance to sepsis, as well as its value in severity and prognosis assessment, high-performance liquid chromatography and tandem mass spectrometry was used to detect the quantification of the total 25(OH)D in serum of critically ill patients. The investigators speculate that measurement of vitamin D could be taken as an indicator for diagnosis and assessment in critically ill patients.


Eligibility Criteria:
Inclusion Criteria:

* Male and female aged 18 years old and over;
* Entered ICU;
* Fulfilled at least two criteria of systemic inflammatory response syndrome

  * core temperature higher than 38 °C or lower than 36 °C
  * respiratory rate above 20/min, or PCO2 below 32 mmHg
  * pulse rate above 90/min, and
  * white blood cell count greater than 12,000/μl or lower than \< 4,000/μl or less than 10% of bands.

Exclusion Criteria:

* patients or their relatives refused
Effect of HMOs as Nutritional Support for Normal Bowel Movements in IBS Patients

This is an open labeled, one-armed real-world study in IBS-patients. All participants will receive active treatment for 12 weeks.

The primary objective of the study is to assess the effect of Human Milk Oligosaccharides (HMOs) on bowel function in adults with IBS. Secondary objectives are to evaluate HMOs' tolerability, effect on participant reported satisfaction with bowel habits, interference with life in general, quality of life, somatic symptoms, and anxiety and depression in all patients and subgroups of patients.

In this trial, a total of 300 adults (at least 18 years of age) diagnosed with irritable bowel syndrome (IBS) in accordance with the Rome IV criteria will be included. Patients will be recruited from gastroenterologists and primary care clinics across the USA. The study product, Fuco-N-Tetraose, will be taken daily throughout the course of the trial. All data will be collected through 4 web based surveys, and the participants will complete those at baseline before the intervention starts, and after 4, 8 and 12 weeks of intake of the study product.

The primary outcome of the study will be assessed by the Patients' Global Impression of Change (PGIC) scale. Other questionnaires used in the study includes the IBS specific Gastrointestinal Symptom Rating Scale (GSRS-IBS), the IBS Quality of Life Scale (IBS-QoL), the Participant Health Questionnaire-4 (PHQ-4), the Participant Health Questionnaire-12 (PHQ-12), and the Bristol Stool Form Scale (BSFS). All outcomes will be evaluated in all patients and in sub-groups of patients. i.e. subtypes by predominant bowel habit (diarrhea-predominant, constipation-predominant, or altered/mixed pattern), and lactose intolerant patients.

Eligibility Criteria:
Inclusion Criteria:

1. Ability to give oral and written informed consent
2. Age minimum 18 years at enrolment
3. Current clinical diagnosis of IBS from a healthcare provider, and meeting Rome IV IBS diagnostic criteria
4. Ability and willingness to understand and comply with the study procedures
5. Ability to read, speak and understand English
6. Free access to the internet via computer, tablet or smartphone to complete study surveys and also to allow for study team follow-up as needed.

Exclusion Criteria:

1. Participation in a clinical intervention study one month prior to screening visit and throughout the study.
2. Medically diagnosed with celiac disease, Crohn's disease, ulcerative colitis, diverticulitis, inflammatory bowel disease, or clostridium difficile infection by a doctor
3. Pregnant or lactating or wish to become pregnant during the period of the study.
4. Lack of suitability for participation in the study for any reason as judged by the site investigator or Principal Investigator.
Thrombophilia In Beta Thalassemia

β-thalassemia disease is one of the most common congenital hemolytic anemia commonly found in the malarial belt areas including the Mediterranean, the Middle East, Africa, Southeast Asian countries, and China.

β-thalassemia represents a major public health problem in Egypt, it is estimated that there are 1000/1.5 million per year live births born with β-thalassemia. The average life expectancy of patients with β-thalassemia has improved over the last few years as compared to that of in the previous millennium. This has led to the discovery of new set of problems such as increased hypercoagulable state in β-thalassemia like micro infarcts in spleen and lung indicating an activated coagulation pathway. The, incidence of thromboembolism in patients with thalassemia disease is approximately 10 times higher than normal population, it accounts between 1.7 and 9.2%. On the other hand, a study conducted by Chaudhary and Ahmad, 2012 showed decreased aggregation in majority of β-thalassemia patients. Another study conducted by Ibrahim, 1999 had noticed few patients to have bleeding manifestations in the form of epistaxis. Mussumeci et al., 1987 noted that both thrombophilic and anti-thrombophilic proteins were reduced as a consequence of liver damage. The net clinical outcome depends on the fine balance between the prothrombotic and antithrombotic pathways.

Eligibility Criteria:
Inclusion Criteria:

1. All blood samples from thalassemia patients before blood transfusion.
2. In splenectomized patients taking Aspirin, the tests will be performed 7 days after discontinuation of the drug.

Exclusion Criteria:

1. Patients with other hemoglobinopathies other than beta-thalassemia.
2. Patients suffering from hepatic or cardiac dysfunctions of another aetiology.
3. Patients with history of familial thrombophilia or use of anticoagulant therapy.
Effects of Early Postoperative Showering After Coronary Artery Bypass Grafting Using Bilateral Internal Thoracic Artery

The study to evaluate effects of early postoperative showering after coronary artery bypass grafting using bilateral internal thoracic artery


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* Patients who underwent coronary bypass grafting with bilateral internal thoracic artery through median sternotomy
* Patients whose all drains or pacing wires are removed

Exclusion Criteria:

* Concomitant operation
* Redo-surgery
* prolonged intensive care unit stay (more than 4 days) due to serious complications after surgery
* open wounds
* active infection
* prolonged drains