cyrilzakka/clinical-trials huggingface dataset:
AI Classifies Multi-Retinal Diseases

The objective of this study is to establish deep learning (DL) algorithm to automatically classify multi-diseases from fundus photography and differentiate major vision-threatening conditions and other retinal abnormalities. The effectiveness and accuracy of the established algorithm will be evaluated in community derived dataset.

Retinal diseases seriously threaten vision and quality of life, but they often develop insidiously. To date, deep learning (DL) algorithms have shown high prospects in biomedical science, particularly in the diagnosis of ocular diseases, such as diabetic retinopathy, age-related macular degeneration, retinopathy of prematurity, glaucoma, and papilledema. However, there is still a lack of a single algorithm that can classify multi-diseases from fundus photography.

This cross-sectional study will establish a DL algorithm to automatically classify multi-diseases from fundus photography and differentiate major vision-threatening conditions and other retinal abnormalities. We will use the receiver operating characteristic (ROC) curve to examine the ability of recognition and classification of diseases. Taken the results of the expert panel as the gold standard, we will use the evaluation indexes, such as sensitivity, specificity, accuracy, positive predictive value, negative predictive value, etc, to compare the diagnostic capacity between the AI recognition system and human ophthalmologist.

Eligibility Criteria:
Inclusion Criteria:

* fundus photography around 45° field which covers optic disc and macula
* complete patient identification information;

Exclusion Criteria:

* incomplete patient identification information
A Comparative Study Between Ultrasound Guided Thoracic Paravertebral Block VS Serrartus Anterior Muscle Block in VATS as Regard Their Effectiveness in Post-operative Analgesia

A comparative study between ultrasound guided thoracic paravertebral block VS ultrasound guided serrartus anterior muscle block in video-assisted thoracoscopic surgeries as regard their effectiveness in post-operative analgesia

The use of loco-regional analgesia is recommended to control postoperative pain after VATS as it allows opioid sparing and facilitates early postoperative rehabilitation. Different loco-regional analgesic techniques could be used to control pain after thoracic surgery such as a paravertebral block, an intercostal block and serratus plane block. In this study, Thoracic paravertebral nerve block will be compared to Serratus anterior nerve block, both will be done Ultrasound guided (USG) using bupivacaine (0.25%) for postoperative analgesia.

Eligibility Criteria:
Inclusion Criteria:

* Patients American Society of Anesthesiologists physical status (ASA) I to II
* Both sexes.
* Aged ≥ 20 to ≤ 65years.
* Scheduled for VATS under general anesthesia.

Exclusion Criteria:

* Patient's refusal.
* Patients American Society of Anesthesiologists physical status (ASA) III to IV
* Patients with major spine deformities.
* Disruption of the local anatomy, secondary, for instance, to the presence of chest drains or surgical emphysema, resulting in difficulty in ultrasound interpretation and distortion of tissue planes.
* Patients with bleeding disorders and coagulopathy.
* Infection at the injection site.
* Known allergy to local anesthetics.
* Patients with pre-existing myopathy or neuropathy.
* Ipsilateral diaphragmatic paresis.
* Tumors in the paravertebral space at the level of injection.
Effectiveness of Exergames on Cognitive, Social Functionamong Chronic Schizophrenia

An experimental study with random assignment will be adopted. The participants from 2 hospitals will be assigned to two groups: experimental group (n=77), and control group (n=77). Experimental group, in addition to scheduled activities, will be provided with the "individual brain training exergames (a program for improving cognitive function and eye-hand coordination)" three times a week and 30 minutes each time. The control group will be maintained with their scheduled activities in daycare as usual. Behavioral intentions, cognitive function, social function, and hand-eye coordination will be measured at 0, 3, 6, 9, 12 weeks.

In the first year, an experimental study with random assignment will be adopted. The participants from 2 hospitals will be assigned to two groups: experimental group (n=77), and control group (n=77). Experimental group, in addition to scheduled activities, will be provided with the "individual brain training exergames (a program for improving cognitive function and eye-hand coordination)" three times a week and 30 minutes each time. The control group will be maintained with their scheduled activities in daycare as usual. Behavioral intentions, cognitive function and hand-eye coordination will be measured at 0, 3, 6, 9, 12 weeks.

In the second year, the investigators continue first year study, the experimental group will be provided with the "team cooperation training exergames (a new program for improving sugar control, cognitive and social function)" three times a week and 30 minutes each time. The control group will still be maintained with their scheduled activities in daycare as usual. Cognitive and social function and related physiological indices (muscle mass, fasting blood sugar, glycosylated hemoglobin (HbA1c) and reduction body fat will be measured before intervention and at 0, 3, 6, 9, 12 weeks.

In the third year, in the first three months, the investigators will use the concept of "empowerment" to design a seed program for training 2-3 patients to be "exergame instructors". Experimental group A will be provided with the "team cooperation exergames" three times a week and 30 minutes each time by research team. Experimental group B will be provided with the "team cooperation exergames (teamwork and exercise)" three times a week and 30 minutes each time by "exergame seed ". The control group will be maintained with their scheduled activities in daycare as usual. Cognitive and social function, and related physiological indices will be measured at 0 3, 6, 9, 12 weeks.

The investigators expect this research project can improve the cognitive, social function and sugar control among chronic schizophrenia patients with diabetes mellitus, and the "exergames" can be extended.

Eligibility Criteria:
Inclusion Criteria:

* schizophrenia
* aged 20-65 years

Exclusion Criteria:

* Violence or suicidal behavior
* Dementia
Feeding the Patient at Nutritional Risk: Does the Clinical Outcome Improve?

The aim of the present study is to take stronger action in solving the problems of malnutrition in the hospital setting and in the first two months after patient's discharge. The main objective is to evaluate the clinical benefit (eg. QoL, body composition and body function) of nutritional intervention (nutritional therapy) in a sample of patients at nutritional risk according to the NRS 2002.


Eligibility Criteria:
Inclusion Criteria:

* all patients coming on station

Exclusion Criteria:

* patients with a screening total score \<3 according to the NRS-2002 system
* less than 18 years of age, expected hospital stay less than 4 days
* expected survival less than 1 month
* pregnant or lactating women
* patients with psychiatric disorders
* patients with cardiac failure as defined by the Goldmann classification class \>II (recent rest pain, unstable angina pectoris)
* patients with respiratory failure (Peak Flow Rate: PEFR \<50%)
* patients with hepatic dysfunction (Child \>A)
* patients suffering from an intestinal obstruction or ileus
* patients with renal failure (creatinine \>250 μmol/l) or receiving haemodialysis
* patients that are already receiving, or are planned to receive parenteral nutrition
* patients unable to understand the German language
Phase I Study of GW572016 With Topotecan to Treat Advanced Solid Malignancies

Participants will take GW572016 by mouth daily each cycle (cycles 28 days in length) and will be given Topotecan intravenously on Days 1, 8 and 15.

Participants will take GW572016 by mouth daily each cycle (cycles 28 days in length) and will be given Topotecan intravenously on Days 1, 8 and 15. During Cycle 1 participants will be required to spend the evening before Day 1 in the General Clinical Research Center and frequent blood samples will be drawn on Day 1; this schedule will be repeated the evening of Day 6 with the blood samples drawn on Day 7. Participants will have weekly CBCs.

Eligibility Criteria:
Age 18 and older Histologic proof of cancer that is unresectable ANC greater than 1500 u/L PLC greater than 100,000 u/L Total bilirubin less then or equal to ULN AST less than 3 x ULN or AST less than 5 x ULN if liver involvement Creatinine less than 1.5 x ULN Hemoglobin greater than 9 g/dL Echocardiogram with ejection fraction great than 40% Life expectancy of more than 12 weeks
Effectiveness of Carbon Filters to Reduce the Anesthetic Gas Concentration in an Anesthetized Patient

Malignant hyperthermia is a potentially fatal inherited disorder triggered by exposure to volatile anesthetic gases, most commonly recognized in children during anesthesia. Carbon filters have been used to scavenge various gases. A new carbon filter (Vapor Clean, Dynasthetics, LLC, Salt Lake City, Utah) with a 510(k) clearance specifically for scavenging anesthetic gases is being marketed, though the filter itself has never been studied in vivo. Bench studies conducted by the manufacturer of the product demonstrate it is extremely effective in reducing the volatile gas output from an anesthesia machine within 2 minutes. This pilot study will measure the effect on volatile gas concentration in non-malignant hyperthermia susceptible patients. Twelve (12) patients will undergo standard anesthetic induction using inhalational anesthetic (Sevoflurane®) and maintained on 3% for 30 minutes to attain steady state concentrations.1 At that time, a total intravenous anesthetic technique will be started and maintained throughout the case. Simultaneously a Vapor Clean filterset will be placed in the breathing circuit (inspiratory and expiratory limbs). Volatile gas concentration will be measured and recorded. This research will determine the feasibility of using this carbon filter to quickly reduce the breathing circuit gas concentration of volatile anesthetic in the clinical setting. This is fundamental in establishing this as a key life saving measure in eliminating the stimulus in a malignant hyperthermia event.

see above.

Eligibility Criteria:
Inclusion Criteria:

* healthy ASA PS I or II children 2 years to 16 years old
* having general anesthesia for approximately 1 hour or more

Exclusion Criteria:

* malignant hyperthermia susceptible patients (personal or family history)
* patients with known neuromuscular disorders at high risk of malignant hyperthermia (e.g., muscular dystrophy)
* egg or soy allergy
* patient or parent refusal
* pregnant patients
Survey Among Healthcare Professionals Treating Patients With Metastatic Breast Cancer in Selected European Countries to Evaluate Their Knowledge on Management of Hyperglycemia When Using Alpelisib

This is a multinational, non-interventional, cross-sectional survey conducted among HCPs based in the EU/EEA who prescribe Piqray. The survey will assess the knowledge of HCPs prescribing Piqray in relation to the management of hyperglycemia in patients treated with Piqray. The survey will endeavor to collect a minimum to 30-50 completed surveys.


Eligibility Criteria:
Inclusion Criteria:

* Has prescribed Piqray to at least 1 locally advanced or MBC patient within 6 months prior to completing the survey.
* Provides permission to share their anonymized responses in aggregate with EMA or NCAs, if requested.

Exclusion Criteria:

HCPs who are direct employees of Novartis, the EMA (or any other regulatory bodies), or ICON.
RRISC Study: Reduction of Restenosis In Saphenous Vein Grafts With Cypher Sirolimus-Eluting Stent.

Context: Sirolimus-eluting-stents have improved the benefits of percutaneous interventions in native coronary arteries reducing the occurrence of restenosis and repeated revascularization, however saphenous vein grafts have been always excluded form randomized trials.

Objective: To evaluate the angiographic and clinical impact of sirolimus-eluting-stents with respect to bare-metal-stents in degenerated vein grafts.

Design: Double-blind randomized controlled non-industry-sponsored trial.

Setting: A single-center tertiary-care referral hospital.

Patients: All patients are randomly allocated to sirolimus-eluting-stent implantation or the corresponding bare-metal-stent. All patients are followed clinically and repeated angiographic follow-up is performed in all at 6-months.

Main outcome measure: Primary end-point is 6-months angiographic in-stent late loss. Secondary end-points include: binary angiographic in-stent and in-segment restenosis, intravascular-ultrasound-measured neo-intimal hyperplasia volume and all the clinical events (death, myocardial infarction, target-lesion and target-vessel revascularization).


Eligibility Criteria:
Inclusion Criteria:

* 18 to 85 years-old
* clear signs and/or symptoms of stable or unstable angina or documented silent ischemia
* one or more de-novo target lesions (\>50% diameter stenosis by visual estimate) localized in one or more diseased SVG with a reference vessel diameter (RVD) included between 2.5 and 4.0 mm (by visual estimate)
* signed informed consent.

Exclusion Criteria:

* Myocardial Infarction within the previous 7 days
* documented left ventricular ejection fraction \<25%
* impaired renal function (creatinine \>3.0 mg/dl) at the time of treatment
* outflow obstruction of the graft due to distal anastomotic stenosis
* totally occluded Saphenous Vein Graft
* brachytherapy treatment in the index vessel before enrollment
* life expectancy less than 12 months
* known allergy to aspirin, clopidogrel bisulfate, heparin, stainless steel, contrast agent or sirolimus
* hemorrhagic diatheses
* a recent positive pregnancy test, breast-feeding, or the possibility of a future pregnancy.
Balanced (Egg) Protein During Obesity Reduction: Differential Responses of Insulin Resistance by Race

The purpose of the trial is to assess the effects of combining regular, generous intakes of high quality protein (with substantial amounts provided from whole eggs and egg whites) with calorie restriction on insulin resistance and weight loss (along with function, body composition, racial disparities, and a number of secondary outcomes) in black and white older adults with prediabetes who are participating in a 4-month intervention. The investigators will compare these effects to the same outcomes with a control group consuming a traditional control regimen of calorie restriction over the same duration.

Older (\>60 yrs) men and women (50% African American, 50% white) who are obese (BMI \>30 kg/m2) and have pre-diabetes will be randomly assigned (1:1 ratio; couples randomized together) to one to two treatment groups: 1) Weight loss intervention (WL-Control; n = 20): subjects follow a calorie-reduction diet for a weight loss of ≥10%, protein\~0.8g/g/d; and 2) High protein weight loss intervention (WL-Protein; n = 20): subjects follow a calorie-reduction diet for a weight loss of ≥10%, with a high proportion of high quality protein (\> 30g protein, 3/day, 60-70% egg protein). Primary (insulin resistance/sensitivity, weight loss) and secondary outcomes (physical function, body composition, diet adherence, cognitive function, readiness to change) will be measured at 0 and 4 months.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 60 years
* Identifies as Caucasian/white or African-American/black
* Obese body weight (\>30 kg/m2)
* Able to speak and understand spoken and written English
* Elevated fasting plasma glucose (≥95 and \<126 mg/dL)
* Age-normal Kidney function (≥ 45 mL/min/1.73 m2)

Exclusion Criteria:

* Body weight \> 224 kg (limit of the BodPod)
* Treated or untreated diabetes (prior diagnosis, treatment, or fasting blood glucose ≥126 mg/dL)
* Presence of unstable, acutely symptomatic, or life-limiting illness
* Positive screen for dementia using Mini-Cog evaluation tool
* Neurological conditions causing functional or cognitive impairments
* History of significant weight instability (defined as \> 10 pounds weight gain or loss over 6 months prior to study participation)
* Allergy or intolerance to egg products
* Unwillingness or inability to be randomized to any one of two intervention groups, submit to all study testing, or continuously participate in a randomly assigned lifestyle intervention program for four months
* Inability to walk independently
* Unable to give consent
* Unable to complete written recording forms including journals of eating and exercise behaviors.
* Current use of the following medications: monoamine oxidase inhibitors, prescription weight loss medications, insulin, metformin or any other hypoglycemic agent
* Primary Care Physician advises against participation
* Smoker
* Unusually or unstable renal function
Statins in Patients With Type 2 Diabetes Mellitus and Previous History of Acute Coronary Syndrome

The purpose of this study was to compare the efficacy and safety of high dose atorvastatin (40 mg) versus high dose rosuvastatin (20 mg) in Egyptian type II diabetic patients with previous acute coronary syndrome history. This open-labeled prospective, randomized clinical trial compared once daily atorvastatin 40mg (Ator®) versus once daily rosuvastatin 20mg (Crestor®). The primary outcome was the 50% reduction in low-density lipoprotein cholesterol levels at 12 weeks. The secondary outcome was the achievement of low-density lipoprotein cholesterol level \< 55 mg/dl.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis with type 2 diabetes.
* Previous history of acute coronary syndrome.
* Abnormal baseline lipid profile.

Exclusion Criteria:

* Patients taking concurrent lipid lowering agents such as bile acid sequestrants (cholestyramine, colesevelam), niacin, ezetimibe, fenofibrate and/or omega3.
* Patients taking concurrent interacting medications such as ciclosporin, gemfibrozil, clarithromycin and/or itraconazole.
* Patients with active liver disease, bile duct problems, or ALT \> 3 × upper limit of normal (ULN).
* Patients with serum creatinine \> 2 mg/dl.
* Patients have incidence or history of hypersensitivity reaction to any of the statin used.
* Women who were pregnant, breast-feeding or of child-bearing potential and not using a reliable form of contraception at the time of recruitment
Effects of Natural Sounds on Attention Restoration in Virtual Reality

This study aims to examine whether listening to natural sounds in a noisy virtual reality environment compared to no natural sounds influences physiological markers.

The investigators hypothesize that listening to natural sounds has restorative effects on attention by supporting greater use of involuntary attention. This generates the prediction that exposure to natural sounds in the context of a noisy environment will have greater restorative effects on attention (i.e., physiological) as compared to the control group (exposed to noise only). Individual differences (i.e., age, gender, caffeine and food intake, body mass index, skin temperature, noise sensitivity, sleep quality, baseline physiology and behavioural performance) will be examined and accounted for.

Eligibility Criteria:
Inclusion Criteria:

* Singapore-based
* Non-clinical
* 18-35years

Exclusion Criteria:

* Individuals with hearing difficulties or failing to meet the minimal threshold for normal hearing
* Individuals with a history of ear, developmental, neurological, or psychiatric disorder
Reducing Preterm Births in Underserved Pregnant Women

Timely screening and management of modifiable conditions can reduce preterm births, yet providing effective prenatal risk management systems to meet the unique needs of medically underserved populations is complex. If the proposed system proves to be effective in reducing preterm births it can improve maternal and child quality of life as well as reduce the economic burden of preterm births in the U.S.

The primary aim of this proposal is to test the efficacy of a clinic-based, computer-assisted intervention system to significantly reduce preterm births in high-risk populations. This system will: (1) assess a pregnant woman's unique risks in six modifiable areas associated with increased risks of preterm birth including smoking cessation, poor nutrition, domestic violence, maternal depression and stress, urinary and reproductive tract infections and substance use; (2) provide her with tailored advice and action planning tools on reducing her risks; (3) provide her certified nurse midwife or physician with information related to her assessed risks and counseling suggestions tailored for her needs, and \[(4) promote effective referrals to, and successful linkages with community-based support organizations.\] Because preterm birth rates are much higher for underserved African American women, we are proposing to focus the intervention with this population.

Eligibility Criteria:
Inclusion Criteria: Study inclusion criteria include:

1. age 16-48 years,
2. 1st trimester of pregnancy,
3. race/ethnicity (non-Hispanic Black, or English-speaking Hispanic Black), and 4) a self-reported completion of grade 6 or higher.

Exclusion Criteria: Exclusion criteria include:

1. a medical condition or risk to the pregnancy that the physician or nurse midwife determines serious and a reason for exclusion, and
2. a literacy level of \< grade 6. No prior experience using a computer is needed. -
Efficacy and Safety Study of OPC-1085EL Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension

The purpose of this study is to determine the efficacy and safety of OPC-1085EL ophthalmic solution in comparison with latanoprost ophthalmic solution in subjects who are insufficiently responsive to latanoprost ophthalmic solution.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with diagnosis of bilateral primary open-angle glaucoma or ocular hypertension

Exclusion Criteria:

* Subjects with ocular conditions as defined by the protocol
Optimisation of Cardiac Resynchronisation Therapy by Non-invasive Cardiac Output - The CHOICE2 Study

An evaluation of the role of resting and exercise cardiac output measurement, by the inert gas rebreathing method, in optimisation of patients with cardiac resynchronisation pacemakers.


Eligibility Criteria:
Inclusion Criteria:

* Cardiac Resynchronization Device in situ for Heart Failure

Exclusion Criteria:

* Unable to cope with mouthpiece
* Estimated life expectancy \< 6 months