cyrilzakka/clinical-trials huggingface dataset:
Predicting Diabetic Retinopathy From Risk Factor Data and Digital Retinal Images

The objective of this study is to compare the results of a deep learning approach to diabetic retinopathy assessment with results from (1) an in-person examination with an ophthalmologist, and (2) the assessments of optometrists involved in a teleretinal screening program.

This study represents the third aim of a grant with five aims. The study will compare and evaluate the predictive accuracy of: (a) machine learning models developed to grade diabetic retinopathy and assess the presence or absence of diabetic macular edema and (b) the assessments of optometrist readers, both from digital retinal images, against standard of care dilated retinal examinations by board-certified ophthalmologists and/or retinal-specialty fellows for 300 diabetic patients utilizing a Los Angeles County reading center.

For the study, the investigators will recruit 300-500 eligible diabetic patients for in-person eye examinations performed by board certified ophthalmologists and/or retinal-specialty fellows at Los Angeles County reading centers. The study will take place over the course of two visits: a teleretinal screening and an in-person eye examination.

The in-person dilated eye examinations that the study participants will participate in and be compensated for follow the usual standard of care that patients receive in a setting that does not utilize teleretinal screening. Yearly dilated eye examinations are standard of care for all persons with diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Type I or Type II Diabetes
* Patients who are over the age of 18 years
* Patients who have not previously been seen in the current year by the LACDHS Teleretinal Diabetic Retinopathy Screening Program and Reading Center
* Patients whose teleretinal screening exam images yield readable results

Exclusion Criteria:

* Patients under the age of 18 years
* Patients with gestational diabetes
* Patients who have previously been seen in the current year by LACDHS's Teleretinal Diabetic Retinopathy Screening Program and Reading Center
* Patients whose teleretinal screening exam images do not yield readable results, as gradable images are needed for later comparison against ophthalmologist reads.
* Previously eligible patients who do not return for an in-person eye exam within 3 months of receiving a teleretinal screening (In order for the results of the teleretinal screening and in-person eye examinations to yield similar information, patients who do not return for their in-person eye exam within 3 months of their teleretinal screening will not be able to remain in the study. This is because significant eye changes not documented by the teleretinal screening may occur after a 3-month period).
AML Patients Bearing FLT3 Mutations Based on Peripheral Blast Clearance

Prospective, multi-center, interventional, randomized, open clinical trial for the treatment of acute myeloid leukemia with FLT3 mutations customized upon the prognostic parameter PBC


Eligibility Criteria:
Inclusion Criteria:

1. Patients with de novo AML, untreated, newly diagnosed, according to WHO 2016 criteria
2. Presence of a mutation of FLT3 gene, either ITD and/or TKD
3. Adequate availability of diagnostic biologic material for full cytological, cytogenetic, genetic and immunophenotypic disease characterization according to ELN criteria.
4. Presence of morphologically identifiable blasts on peripheral blood at diagnosis
5. Presence of a Leukemia-associated aberrant immune-phenotype (LAIP) as assessed by MFC (multiparametric flow cytometry) at diagnosis
6. Age between 18 and 65 years, included
7. ECOG performance status 0-2 or disease-related reversible ECOG 3 score following adequate supportive care.
8. Signed written informed consent according to ICH/EU/GCP and national local laws

Exclusion Criteria:

1. Diagnosis of acute promyelocytic leukemia
2. Diagnosis of AML with t(8;21)(q22:q22)/RUNX1-RUNX1T1 and t(16;16)(p13:q22) or inversion of chromosome 16 (16)(p13q22)/CBFB-MYH11; in case of suspicion of CBF-related AML due to morphological and/or immunophenotypic features, specific FISH or molecular testing is strongly recommended in accordance with WHO criteria3,157
3. Patients with LVEF less than 45% (by echocardiogram or MUGA)
4. Pre-existing, uncontrolled pathology such as heart failure (congestive/ischaemic, acute myocardial infarction within the post 3 months, untreatable arrhythmias, NYHA classes III and IV), sever liver disease with total bilirubin ≥2,5 x ULN and/or ALT\>3 ULN (unless attributable to AML), acute or chronic pancreatitis, kidney function impairment with serum creatinine ≥2,5 (unless attributable to AML) and severe neuropsychiatric disorder that impairs the patient's ability to understand and sign the informed consent or to cope with the intended treatment plan. For altered liver, pancreas and kidney function tests, eligibility criteria can be reassessed at 24-96 hours, following the institution of adequate supportive measures.
5. Uncontrolled bacterial or fungal infections
6. QTc \>470 msec on screening ECG (Fridericia's formula)
7. A history of cancer that is not in remission phase following surgery and/or chemotherapy and/or radiotherapy with life expectancy \< 1 year.
8. Pregnancy declared by the patient herself. A pregnancy test is performed at diagnosis and, if applicable, before allogeneic HSCT . Female and male patients who are fertile must agree to use an effective form of contraception with their sexual partners from enrollment through 4 months after the end of treatment.
Sensory Evidence and Expectations in Pain Processing

Pain is a highly complex and subjective phenomenon which is not only rooted in sensory information but also shaped by cognitive processes such as expectation. However, the interaction of brain activity cording sensory information and expectation in pain processing are not completely understood. Predictive coding models postulate specific hypothesis about the interplay between bottom-up sensory information and top-down expectations in terms of prediction errors and predictions, respectively. They further implicate brain oscillations at different frequencies, which play a crucial role in processing prediction errors and predictions. More specifically, recent evidence in visual and auditory modalities suggests that predictions are reflected by alpha (8-13 Hz) and beta oscillations (14-30 Hz) and prediction errors by gamma oscillations (60-100 Hz). However, for the processing of pain, these frequency-specific relationships have not been addressed so far. The current project aims to investigate brain activity which reflects predictions, prediction errors and sensory evidence in pain processing using a cueing paradigm. To this end, we will apply painful stimuli with low and high intensity to the dorsum of the left hand in 50 healthy subjects. A visual cue, preceding to each painful stimulus, will predict the intensity of the consecutive painful stimulus (low vs. high) with a probability of 75%. After each painful stimulus, participants will be asked to rate the perceived pain intensity. Electroencephalography (EEG) and skin conductance will be recorded continuously during anticipation and stimulation intervals. This paradigm enables us to compare pain-associated brain responses of validly and invalidly cued trials, i.e. the representation of the prediction error, on the one hand. On the other hand, brain activity related to predictions can be investigated in the anticipation interval preceding to the painful stimulus by comparing trials with low and high intensity cues. Further, we will compare models including predictions, prediction error and sensory evidence to ascertain the involvement of each brain response in processing sensory information and expectation. Results of the study promise to elucidate the interplay of predictions, predictions errors and sensory evidence in pain processing and how they differentially relate to neural oscillations at different frequency bands and pain-evoked responses.

Not needed

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years
* Right-handedness
* Written informed consent

Exclusion Criteria:

* Pregnancy
* Neurological or psychiatric diseases (e.g. epilepsy, stroke, depression, anxiety disorders)
* Severe general illnesses (e.g. tumors, diabetes)
* Skin diseases (e.g. dermatitis, psoriasis or eczema)
* Current or recurrent pain
* Regular intake of medication
* Surgical procedures involving the head or spinal cord
* Metal (except titanium) or electronic implants
* Side-effects following previous thermal stimulation
SYMBICORT® in the Treatment of COPD

A Scientific Research Program to evaluate the efficacy of SYMBICORT® 320/9μg in the treatment of COPD in real life environment by General Practitioners


Eligibility Criteria:
Inclusion Criteria:

* patients (m/f) with COPD (GOLD stadium III and IV)

Exclusion Criteria:

* patients who recently quit smoking (\<3months)
Oxygenation Changes After 2-month Exercise in Sedentary Older Adults With Diabetes

The aim of the study is to determine the physiological evidence of how muscular and cerebral oxygenation changes link to fatigue, physical, and cognitive performance after moderate-intensity exercise in sedentary older adults with type 2 diabetes.

This is an experimental design. One intervention group will do exercise for 2 months and be measured twice, at baseline, and after 2 months. The other 2 control groups will be assessed just once without exercise intervention. Our primary objective is to clarify physiological evidence of how muscular and cerebral oxygenation changes in sedentary older adults with diabetes after low-to-moderate intensity exercise. The secondary objective is to determine fatigue, physical, cognitive performance changes, blood glucose level among sedentary older adults with diabetes after low-to-moderate intensity exercise.

Eligibility Criteria:
Inclusion Criteria:

* For the intervention group, the inclusion criteria are

  * sedentary older adults 60 years or older who are living in their homes in the community
  * diagnosed type 2 diabetes
  * ambulatory with or without mobility devices such as a cane and/or walker
  * Be able to follow simple exercise instructions without assistance.
* For the comparison group, the inclusion criteria are

  * individuals aged 60 years or older who are living in their homes, in the community;
  * ambulatory with or without devices;
  * able to follow simple exercise instructions without assistance
  * able to walk six minutes as quickly as possible without any adverse symptoms including extreme pain on feet or joints, dizziness, vertigo, or nausea.

Exclusion Criteria:

* For the intervention group, the exclusion criteria are

  * foot deformities, cuts, blisters, or amputation, Achilles tendonitis, joint replacements within the past three months, Parkinson's disease, retinopathy such as severe glaucoma, current or uncontrolled vestibular disorders
  * current smoking or smoking within the last 12 months
  * current cardiopulmonary diseases, vascular disease, or stroke
  * dementia indicating the inability to follow exercise instructions independently
  * those who are currently or plan to receive physical therapy in the following three months
  * individuals without English proficiency will be excluded
  * If the individuals with blood glucose level are over 400 mg/dL or HbA1C \> 8.0%, and
  * type 1 diabetes.

For the comparison group, the exclusion criteria are

* individuals who have prediabetes, diabetes, or current cardiopulmonary diseases and stroke
* current smoking or smoking within the last 12 months
* individuals with foot deformities, cuts, blisters, or amputation, Achilles tendonitis, joint replacements within the past three months, Parkinson's disease, retinopathy such as severe glaucoma, current or uncontrolled vestibular disorders, and dementia.
Comparison of Nocturnal Hemodialysis (NHD) and Short Daily Hemodialysis (DHD) With the NxStage® System One™

The purpose of this study is to determine whether or not nocturnal hemodialysis is equivalent to short daily hemodialysis on a per treatment basis, using the NxStage System One in the home setting.

End Stage Renal Disease (ESRD) continues to be a devastating clinical condition. The number of patients in 2004 affected by ESRD in the United States rose to 472,000. More than 104,000 new patients began therapy for ESRD in 2004 (1.5% greater than in 2003), while the prevalent dialysis population reached nearly 336,000 (3.4% higher). Total Medicare costs for ESRD in 2004 rose to $20.1 billion while non-Medicare costs rose to $12.4 Billion(1).

Treatment options for ESRD patients are currently limited to either transplantation or dialysis. As daily hemodialysis (DHD) continues to gain widespread acceptance in the dialysis community, there is also renewed interest in nocturnal hemodialysis (NHD) therapy.

NHD has the potential to provide certain advantages over both DHD and conventional thrice-weekly in-center HD. NHD typically consists of 6 - 10 hour treatments while the patient sleeps, providing more gentle fluid removal, more time for equilibration, improved hemodynamic stability and superior clearance of larger solutes(2).

The proposed study plans to explore whether or not NHD is equivalent to DHD on a per treatment basis, using the NxStage System One in the home setting.

1. United States Renal Data System 2006 Annual Data Report: Atlas of End-Stage Renal Disease in the United States, NIH, NIDDK, Bethesda, MD, 2006
2. Lacson E, Diaz-Buxo J: Daily and Nocturnal Hemodialysis: How do they stack up? American Journal Kidney Disease, Vol 38(2) Aug 2001: 225-239.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have a stable prescription in the short daily home environment using the NxStage System One prior to enrollment.

Exclusion Criteria:

* Patients are not eligible if:

  * they are currently enrolled in another drug or device study which could impact the successful completion of this study
  * they are currently on NHD, or less than 3 months since discontinuing NHD
  * if they were previously enrolled in this study.
Repair of Ischemic Mitral Regurgitation: Comparison Between Flexible and Rigid Annuloplasty Rings

Mitral valve repair for ischemic mitral regurgitation is performed primarily by annuloplasty. There is some degree of late failure, which may be due in part to the type of ring employed. We want to compare late results with mitral valve annuloplasty using flexible vs rigid annuloplasty rings.


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing CABG with Mitral valve repair for ischemic MR

Exclusion Criteria:

* Other valve procedures
Molecular Mediators of Nerve Injury Signaling

Specific proteins and other signaling molecules are increased and decreased following nerve injury. Some of these are important in producing pain or explaining why pain persists after traumatic nerve injuries or in disease states such as diabetes. In this study, the investigators hypothesize that it is possible to detect changes in specific signaling molecules and that these will provide insights into novel treatment strategies. The patients to be included are those who are undergoing the removal of tissue during surgery. The tissues that would otherwise be discarded will be included in the study as appropriate.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing surgery where tissue removal is anticipated

Exclusion Criteria:

* age younger than 18
AT GOAL: Adopting Technology for Glucose Optimization and Lifestyle in Pregnancy

This study will assess differences in patient preferences and glucose control between continuous glucose monitoring and standard glucose checks in pregnant patients with Type 2 Diabetes. 40 participants will be on study for approximately 182 days (26 weeks).

This pilot single site randomized control trial will compare the blood glucose control and participant satisfaction scores of continuous glucose monitoring vs standard glucose checks in pregnant women with a prior diagnosis of Type 2 diabetes.

The study population will consist of 40 women who are less than 20 weeks pregnant at time of enrollment who have a pre-pregnancy diagnosis of Type 2 diabetes. Participants will be randomized to one of two treatment arms.

* Arm 1: Placement of Dexcom G6 continuous glucose monitor for glucose monitoring for duration of pregnancy
* Arm 2: Continuation of standard glucose finger sticks with placement of a blinded Dexcom Pro G6 continuous glucose sensor for two ten day periods (at enrollment and again at 28-32 weeks gestation)

Participant accrual will occur over 18 months at 1 site. Participants will complete 3 study visits, all of which will be in conjunction with previously scheduled prenatal or diabetes visits: at the time of consent (less than 20 weeks gestation), 28-32 weeks gestation, and 2-6 weeks postpartum.. Surveys will be administered at each time point. At the final visit, patients will be asked for participate in a 2-5 minute directed interview as well.

* Primary Objective

  * To examine the feasibility of completing a study to assess for differences in patient preferences and glucose control between continuous glucose monitoring and standard glucose checks in pregnant patients with Type 2 Diabetes.
* Secondary Objectives

  * To estimate the effect of continuous glucose monitoring devices placed prior to 20 weeks in pregnancy in patients with Type 2 diabetes on time in range, as measured between 28-32 weeks of pregnancy.
  * To assess patient satisfaction to continuous glucose monitoring during pregnancy
  * To estimate the effect of continuous glucose monitoring on the incidence of neonatal morbidity and mortality.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years of age at enrollment
* Ability to consent in English
* Gestational age less than or equal to 19 weeks 6 days at enrollment
* Appropriate dating by certain LMP or ultrasound performed less than or equal to 19 weeks 6 day
* Diagnosis of Type 2 Diabetes less than or equal to 19 weeks 6 days
* Singleton gestation

Exclusion Criteria:

* Age less than 18 years of age at enrollment
* Lack of appropriate dating
* Multiple gestations
* Use of concentrated insulin at enrollment (ie U500)
* Preexisting CGM in place
* Chronic use of medications known to cause hyperglycemia, such as HIV antiretrovirals and inhaled, injectable and oral corticosteroids
* Be unwilling or unable to present to Center for Perinatal Care for visits
The Effect of Periodontal Health on Smile

Anamnesis was taken from 108 patients aged 18-33 who applied to the clinic and met the inclusion criteria. Photographs of the patients' smiles were taken without any measurement. Plaque , gingival index , bleeding on probing, pocket depth measurements, clinical attachment, and gingival recession levels were measured, respectively. Patients were divided into two groups: peri-implant health and gingivitis. Gingival thickness and keratinized gingival width were also measured. In addition, the smile aesthetic index, style, type, and stage were also determined using the smile classification system. Gingival visibility was measured in mm from the photographs taken.


Eligibility Criteria:
Inclusion Criteria:

* No systemic disease

Exclusion Criteria:

* Active smoking,
* Ongoing or past orthodontic treatment,
* Pregnancy,
* Nursing,
* Individuals who have drug-induced gingival hyperplasia, hereditary gingival fibromatosis, permanent or removable prostheses in the upper front area, or missing teeth in the front region
Tacrolimus in Children With Henoch-Schönlein Purpura Nephritis

Henoch-Schönlein purpura (HSP) is the most common vasculitis in children, with an incidence of approximately 10:100 000 children and a slight male predominance (male-to-female ratio of 1.5:1). Henoch-Schönlein purpura nephritis (HSPN) is the principal cause of morbidity for HSP and 1%-7% of HSPN patients may progress to renal failure or end-stage renal disease.

Immunosuppressive therapy has become the standard treatment in children with HSPN, however the use of these drugs are still mainly in an off-label manner in clinical practice. Tacrolimus, a calcineurin inhibitor, has been recently suggested in the treatment of HSPN in children. However, the evidence-based clinical data are still limited.

Given the potential benefits and unmet need in clinical practice, the purposes of this pilot study were to assess effectiveness and safety of tacrolimus in HSPN children and evaluate the potential impact of CYP3A5.


Eligibility Criteria:
Inclusion Criteria:

HSPN children Aged less than 18 years; receiving tacrolimus as initial immunosuppressive therapy -

Exclusion Criteria:

Children received other immunosuppressive drug before the trial or other systemic trial drug therapy; Children had a concomitant medical condition, whose participation, in the opinion of the Investigator and/or medical advisor, may create an unacceptable additional risk.

-
Western Sydney Kidney Injury Biopsy Study

The investigators aim to develop a clinically validated, histological acute tubular injury (ATI) scoring system to help improve diagnostic precision and predict clinical outcomes following ATI.

To use an unbiased, data-driven approach, correlating pathological features (including digital pathology), key signatures using spatial technologies (transcriptomics or proteinomics) with relevant clinical outcomes. Spatial technologies (including spatial transcriptomics and spatial proteinomics) allow the use of 'precision pathology' to study the critical link between molecular characteristics to histological structure.

The study is an investigator-led, retrospective, observational cohort study. This study is intended to be in perpetuity and there will be regular reporting to the local HREC (Western Sydney Local Health District, WSLHD)

Primary aim: the investigators aim to derive a clinically validated scoring system for acute kidney injury and iteratively improve its performance through machine learning algorithms over time.

Secondary aims:

* Derive a spatially resolved transcriptomic signature of acute kidney injury (AKI)
* Derive accurate transcriptomic signatures aligned with key cell types in AKI
* Derive unique gene signatures to differentiate different causes of AKI

All participants included in the study must be age ≥ 18 years old at time of enrolment and

1. Had a kidney transplant at any time after the year 2000
2. Kidney biopsy sample sent to Westmead Hospital for clinical interpretation
3. Have information regarding kidney function available.

This will include groups with

1. Acute tubular injury (ATI) only
2. ATI concurrently diagnosed with any other pathology on biopsy
3. Biopsies with no ATI (negative control)

Collection of health related data will be through review of primary medical records to improve the diagnostic utility of kidney biopsies performed to evaluate the cause of AKI.

The investigators will also be requesting waiver of consent for access to histopathology slides and residual kidney tissue

* Histopathology slides, which were created and analysed as part of routine clinical care.
* Residual kidney tissue, either as paraffin blocks or fresh frozen tissue

Eligibility Criteria:
Inclusion Criteria:

1. Had a kidney biopsy (native kidney or transplant kidney included) after year 2000
2. Kidney biopsy sample sent to Westmead Hospital for clinical interpretation

Exclusion Criteria:

1. Patients who have never had a kidney biopsy performed
2. Biopsy sample not available at Westmead Hospital
3. No information on kidney function (serum creatinine or eGFR)