cyrilzakka/clinical-trials huggingface dataset:
RetinaVue Diabetic Screening

the purpose of this study is to examine whether the deployment of a non-mydriatic color fundus camera in a rural prime care setting is feasible and improves the detection rate of diabetic retinopathy in patients where adherence rates with recommended ophthalmology screening is low.

The Centers for Disease Control and Prevention (CDC) have estimated that 25.6 million Americans aged 20 years or older have either been diagnosed or undiagnosed with diabetes mellitus. As such, it is crucial for patients to receive routine eye exams during their annual health assessment or diabetes follow-up visit with their primary care physician to check for diabetic retinopathy (DR). Of those Type 2 patients with a known duration of diabetes of less than 5 years, DR was diagnosed in 40% of patients taking insulin and 24% of patients not taking insulin. These percentages are especially concerning since data presented by Schoenfeld and colleagues indicates that approximately 35% of Americans with diabetes mellitus do not receive timely and recommended eye care to detect and treat their DR.10 Reasons for noncompliance include transfer to a retinal specialist, limited personal mobility, and insurance. In addition, patients regularly fail to follow-up with their ophthalmologist or optometrist due to the lack of visual symptoms-the lack of symptoms does not exclude the possibility of early diabetic retinopathy. Per the American Diabetes Association (ADA) guidelines, it is recommended that all Type 2 patients receive annual dilated eye exams. These eye exams must be completed by a knowledgeable and experienced eye care professional (i.e. ophthalmologist or optometrist). Early detection of DR and the preventative effects of therapy is an important aspect for long term vision outcomes.

The long-term goal is to improve the detection of diabetic retinopathy through better-quality measures of patient compliance and screening protocols in the prime care clinic. It is hypothesized that in type II diabetic patients without documented retinal pathology, a hand-held non-mydriatic fundus camera is superior to a referred dilated eye exams for the screening and detection of DR.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Type II diabetes without documented diabetic retinopathy

Exclusion Criteria:

1. Documented ocular pathology that may interfere with image acquisition (i.e. high grade cataract)
2. Macular pathology (i.e. macular degeneration, cystoid macular edema, central serous retinopathy)
3. Inability to attain analyzable RetinaVue image due to ocular pathology or other conditions (such as tremors limiting ability to maintain stable head for image)
4. Acute or emergent ocular pathology that requires urgent assessment by an eye care professional as identified by the RetinaVue camera interpretation report
5. Seen within the last 11 months for a diabetic eye exam.
A Study to Test Long-term Safety of Iclepertin in People With Schizophrenia Who Took Part in a Previous CONNEX Study

This study is open to adults with schizophrenia who took part in a previous CONNEX study (study 1346-0011, 1346-0012, or 1346-0013). The purpose of this study is to find out how well people with schizophrenia can tolerate a medicine called Iclepertin in the long term.

Participants take Iclepertin as tablets once a day for 1 year. In addition, all participants take their normal medication for schizophrenia.

Participants are in the study for a little more than 1 year. During this time, they visit the study site about 13 times and get about 9 phone calls from the study team.

The doctors collect information on any health problems of the participants. Doctors also regularly check the participants' symptoms of schizophrenia.


Eligibility Criteria:
Inclusion criteria:

* Signed and dated written informed consent.
* Clinically stable outpatients who have been diagnosed with schizophrenia (as per Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5)).
* Patients, who completed participation in the parent trial.
* Women of childbearing potential must use highly effective methods of birth control.
* Have a study partner who interacts with the patient on a regular basis. Further inclusion criteria apply.

Exclusion criteria:

* Participant who developed DSM-5 diagnosis other than Schizophrenia or any condition that would prevent the patient from participating in the extension trial since enrolment into the parent phase III trial.
* Any suicidal behavior and/or suicidal ideation of type 5 based on the Columbia Suicidality Severity Rating Scale (C-SSRS) in parent trial and up to and including Visit 1 of this study.
* Positive urine drug screen ≥ 3 times during the treatment period of parent trial.
* Patients who are currently or wish to participate in another investigational drug trial.
* Any clinically significant finding or condition in the judgment of the investigator that would jeopardize the patient´s safety while participating in the trial or their capability to participate in the trial.

Further exclusion criteria apply.
Effect Study of Parecoxib to Treat Emergence Delirium and Postoperative Pain

This prospective, double blind, placebo-controlled, parallel group study will be conducted in three study centers in Guangzhou, China. Patients aged older than 65 (ASA I-III) undergoing primary elective abdominal surgery with general anesthesia will be involved in this study. According to previous studies and our pilot trial, the sample size was estimated to be 900 subjects (each center recruiting 300 patients). All eligible patients will be randomly assigned to one of two groups: study group receiving parecoxib and control group receiving normal saline. All patients will be managed with by a standard clinical anesthesia protocol with a sevoflurane-based general anesthesia with continuous intravenous remifentanil, followed by a postoperative PCA with morphine. The emergence delirium will be evaluated by two persons blinding to medication and grouping using Riker sedation-agitation scale immediately since tracheal extubation and at specific time points until patients being discharged from PACU. Pain intensity assessments and pain relief assessments will also be conducted by the patients at given time points in 2 days postoperatively. The morphine-sparing effect, tolerability and safety of parecoxib will be investigated as well.

The inclusion criteria of this study includes:

* Aged older than 65;
* Primary elective abdominal surgery under general anesthesia;
* Ability to understand how to use pain assessment scales and PCA device.

The outcome measures of this study includes:

* Emergence Delirium Assessment;
* Pain intensity and pain relief efficacy endpoints;
* Tolerability and Safety Assessments

Eligibility Criteria:
Inclusion Criteria:

* Aged older than 65;
* Body weight of at least 50 kg;
* Primary elective abdominal surgery under general anesthesia;
* Preoperative health graded as class ASA I-III, based on medical history and physical examination;
* Ability to understand how to use pain assessment scales and PCA device

Exclusion Criteria:

* Emergency or revised abdominal surgery;
* History of known use of analgesics or any other agent that could interfere with analgesic responses during the up to 24 h before receipt of the study medication which including NSAIDs, tricyclic antidepressants, neuroleptic or antipsychotic agents, or corticosteroids (except routine preoperative medication);
* History of known or suspected drug abuse;
* Known allergy, sensitivity, or contraindication to opioid and non-opioid analgesic drugs;
* History of bleeding disorders, peptic ulceration, or anticoagulant use within the past month;
* History of asthma or bronchospasm;
* History of inflammatory bowel disease, a chronic or acute renal or hepatic disorder, coronary heart disease;
* History of dementia and psychological disorder;
* Contraindication to parecoxib.
A Randomized Controlled Trial of Three Non-pharmacologic Analgesic Techniques for Casting of Clubfoot Infants

While it has been shown that sucrose or milk ingestion decreases pain responses in heel sticks, no study up to this point has determined the best intervention for decreasing the pain response during casting for clubfoot deformity.

The goal of this study is to investigate the effect of three different non-pharmacologic interventions (sucrose, milk, water) on pain response during clubfoot casting.

This study will allow us to discern the best non-pharmacologic intervention for pain control during clubfoot casting and to provide a more pleasant, comfortable experience for patients and families.

Clubfoot deformity in newborns is common, occurring in 1-2/1000 births. Treatment of this deformity has shifted from surgical to non-surgical management. The non-surgical management includes utilizing the Ponseti technique of manipulation and casting, followed by Achilles tenotomy and brace application. The newborn undergoes, on average, 4-6 casts before the foot deformity is corrected. During this manipulation and casting, the infants can become fussy and irritable. This irritability is likely due to discomfort felt from the manipulative process and subsequent casting.

Studies that have focused on decreasing the pain response to heel sticks for laboratory testing in the neonatal intensive care units used sucrose or milk ingestion and swaddling in newborns to decrease pain responses. Both sucrose and milk have been shown to decrease the pain response as measured by the Premature Infant Pain Profile (PIPP) or the Bernese Pain Scale for Neonates. In addition, other pain scales have been used in newborn babies including the CRIES, CHIPPS, NIPS, and COMFORT scales to evaluate the effectiveness of pain relieving interventions. These scales were used alongside objective physiologic measurements such as heart rate, heart rate variability (HRV), respiratory rate, and oxygen saturation.

While it has been shown that sucrose or milk ingestion decreases pain responses in heel sticks, no study up to this point has determined the best intervention for decreasing the pain response during casting for clubfoot deformity. The goal of this study is to investigate the effect of three different non-pharmacologic interventions (sucrose, milk, water) on pain response during clubfoot casting, allowing us to discern the best non-pharmacologic intervention for pain control during clubfoot casting and to provide a more pleasant, comfortable experience for patients and families. A secondary objective is to investigate whether or not family environment or the level of anxiety felt by the parents impacts the pain felt by the infant during the casting process.

Eligibility Criteria:
Inclusion Criteria:

* idiopathic clubfoot deformity
* undergoing clubfoot casting for correction

Exclusion Criteria:

* cannot use a bottle for feeding
* on solid food
* have had surgery
* have been given an analgesic within three hours prior to data collection
IS There a Correlation Between Sypmtoms of Gastroparesis and the Duration of Video Caspule Retention in the Stomach

Gastroparesis is a syndrome characterized by delayed gastric emptying in absence of mechanical obstruction of the stomach. The cardinal symptoms include postprandial fullness (early satiety), nausea, vomiting, and bloating.Capsule endoscopy (CE) has evolved to become a first-line, noninvasive diagnostic technique for the small bowel. CE is now being utilized to assess patients for obscure gastrointestinal bleeding, possible Crohn's disease, celiac disease and small bowel tumors. Capsule endoscopy is preformed in a fasting state, and usually past the pylorus of the stomach into the duodenum after up to 30-40 minutes. The aim of the study is to determine the correlation between gasytoparesis symptoms to duration of capsule retention in the stomach


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Undergoing video capsule endoscopy for any indication

Exclusion Criteria:

-Endoscopic intraduodenal insertion of the capsule -
Penn State TXT2Quit Study

This study is evaluating the feasibility and short term smoking cessation outcomes of an automated smoking cessation intervention delivered via mobile phone text messaging as an adjunct to Varenicline in a primary care setting.


Eligibility Criteria:
Inclusion Criteria:

* Smoke \>4 cigarettes/day for at least 6 months
* Age 21+
* Want to quit and ready to try in next 30 days
* Willing to quit all forms of tobacco (including e-cigs)
* Willing to use Chantix to try to quit
* Have a cell phone able to receive text messages
* Willing to attend 3 visits and use varenicline for smoking cessation
* Plan to live in local area for next 6 months
* Read and write in English
* Women not pregnant and taking steps to avoid
* Able to understand and willing to sign consent

Exclusion Criteria:

* History of allergic reaction or other adverse event while using varenicline
* Used a smoking cessation aid/medicine in past 1 month (including e-cigs)
* Currently pregnant or nursing
* Does not have a mobile phone that can send and receive text messages or unwilling to receive study texts
* Uncontrolled serious mental illness or substance abuse or inpatient treatment for these in the past 6 months
* Uses non-cigarette tobacco products and does not plan to quit all tobacco.
* Has a history of kidney problems or receives dialysis
* Had any thoughts that they would be better off dead or of deliberate self-harm in the prior 4 weeks
* Had a heart attack in the past 4 weeks
* Mental conditions that would prohibit the participant from completing the protocol
Oxygen Reserve Index in Different Fresh Gas Flow

Our primary objective is to determine whether oxygen reserve index ORI can be a reliable and sensitive indicator of hypoxia and hyperoxia in low-flow anesthesia settings. Our secondary objective is to investigate the ORI changes during preoxygenation stage.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-III patients
* 18-75 years old
* underwent general anesthesia
* elective ear, nose and throat surgery, lasting longer than 60 minutes

Exclusion Criteria:

* who did not consent to participate,
* those with finger deformities
* unregulated diabetes mellitus, severe heart, kidney, or liver failure, sensitivities to local anesthetics or opioids, those who were morbidly obese (BMI \&amp;gt;40 kg/m²), and breastfeeding women.
Comparison of Therapeutic Effects of Greater Occipital Nerve Block, Topiramate, and Flunarizine on Episodic Migraine

Background: Preventive drug therapy in migraine aims to reduce the attack frequency, severity and duration of headache. Flunarizine and topiramate are widely used in the prevention of migraine attacks. Greater occipital nerve block (GONB) is an alternative treatment option for the prophylactic treatment of migraine. In this study, investigators compared the effectiveness of GONB, topiramate, and flunarizine in terms of reduction in post-treatment VAS scores and attack frequencies in patients with episodic migraine in a four-week period.

Material and Methods: At least one hundred and twenty migraine patients are aimed to be randomly divided into three treatment groups, namely flunarizine (n=40, estimated), topiramate (n=40, estimated) and GONB (n=40, estimated). The patients will be followed up for four weeks and the attack frequencies and VAS scores will be recorded weekly. At the end of the fourth week, the response rates based on 50% and 75% or more reduction in the VAS scores and attack frequencies will be calculated. Group-wise comparisons will be assessed statistically.


Eligibility Criteria:
Inclusion Criteria:

1. Migraine diagnosis according to ICHD-2
2. Ages between 15 -45 Volunteering
3. Monthly attack number between 5-14
4. BMI between 18-30
5. w/o history of nephrolithiasis
6. w/o history of DM, peripheral vascular disease
7. w/o history of chronic systemic diseases (lung, heart,liver, kidney)
8. w/o any detected CNS disease (including MS, movement disorders, CVD, primary or secondary tumors)
9. w/o history of acute or chronic psychiatric disease
10. w/o history of antiplatelet and anticoagulant medication
11. w/o any combination of medication overuse headache or other primary headaches
12. w/o previous medication of flunarizine and topiramate
13. w/o previous application of GONB

Exclusion Criteria:

1. Pregnancy
2. Lost to follow up

   * exited with his/her own will
   * detected primary headache during follow up
   * cessation due to adverse effects of topiramate
   * cessation due to adverse effects of flunarizine
Restenosis Treatment With Rapamycin Eluting Stent or Paclitaxel Eluting Balloon Catheter (RESTENOZA)

The aim of the study is to compare rapamycin eluting stent and paclitaxel eluting balloon catheter in the treatment of restenosis in bare metal stent.

Study aims:

* Clinical efficacy evaluation of different treatment's strategies, including periprocedural and long-term endpoints defined as: death, myocardial infarction, brain stroke, necessity of repeated revascularization
* Evaluation of intravascular ultrasound (IVUS) as an optimisation method for direct and long-term revascularization effects
* Evaluation of optical coherence tomography as an optimisation method for direct and long-term revascularization effects
* Evaluation of late lumen loss and neointimal hyperplasia in stent in long-term follow-up
* Analysis of direct and indirect medical costs of alternative treatment strategies

Study group:

200 patients with symptomatic restenosis evidenced angiographically in bare metal stent implanted in native coronary artery. Patients will be randomised to 2 therapeutic groups:

* Patients treated with rapamycin eluting stent (n=100)
* Patients treated with paclitaxel eluting balloon catheter (n=100)

Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age
* symptomatic restenosis in bare metal stent implanted in native coronary artery
* angina pectoris
* ischemia evidenced by non-invasive diagnostic tests
* angiographically evidenced in-stent restenosis \> 50% assessed by quantitative coronary angiography (QCA)
* vessel diameter \> 2,5 mm

Clinical exclusion criteria:

* myocardial infarction within less than past 72 hours
* heart failure with left ventricular ejection fraction (LVEF) \< 30%
* chronic renal failure with significant impairment of glomerular filtration (creatinine \> 2 mg/dl)
* hypersensitivity or contraindication to acetylsalicylic acid, clopidogrel, heparin, abciximab, rapamycin, paclitaxel
* hypersensitivity to contrast
* other diseases that may cause significant deterioration in long-term prognosis
* acute or chronic inflammatory diseases
* patients who are unwilling to consent for participation in the study

Angiographic exclusion criteria:

* significant stenosis in left main coronary artery (LM)
* multivessel disease qualifying for coronary artery bypass grafting (CABG)
* anatomical localization and morphology that preclude optimal percutaneous intervention intervention's (PCI) result or intravascular ultrasound (IVUS) or optical coherence tomography performance
* vessel diameter \< 2,5 mm
* restenotic lesion length \> 30 mm
Effect of a New Combination Bronchodilator on Exercise in GOLD Stage II Moderate COPD

Preliminary information from our laboratory indicated that even patients with milder chronic obstructive pulmonary disease (COPD) can have significant physiological derangements which become more pronounced during exercise, leading to intolerable dyspnea at lower levels of ventilation than in health. This study will explore pathophysiological mechanisms of dyspnea and activity limitation in GOLD stage II COPD and will determine if there is a sound physiological rationale for the use of dual long-acting beta2-agonist (LABA)/long-acting muscarinic antagonist (LAMA) therapy (GSK573719/ GW642444 Inhalation Powder) versus LAMA alone (GSK573719) as treatment for dyspnea and exercise intolerance in this subpopulation. Objectives of this study are to determine if: 1) neuromechanical uncoupling of the respiratory system contributes to exertional dyspnea in milder COPD, and 2) treatment with LABA/LAMA improves dyspnea and exercise endurance compared with LAMA by improving neuromechanical coupling. The investigators hypothesize that: 1) dyspnea is related to excessive dynamic lung hyperinflation, tidal volume restriction and increased ratio of central respiratory neural drive to tidal volume displacement, a measure of neuromechanical uncoupling of the respiratory system, and 2) LABA/LAMA will improve dyspnea and exercise endurance, which will be explained by partial reversal of the above mechanical abnormalities. The investigators will conduct a randomized, double-blind crossover study and compare the effects of once-daily LABA/LAMA over 4-weeks with LAMA on dyspnea, exercise endurance and ventilatory mechanics in GOLD stage II COPD.


Eligibility Criteria:
Inclusion Criteria:

* Stable moderate COPD
* Post-bronchodilator FEV1/FVC\<0.7 and 50%≤FEV1\<80% predicted
* Baseline Dyspnea Index ≤ 9 and MRC dyspnea scale \>2
* Cigarette smoking history at least 20 pack-years

Exclusion Criteria:

* Presence of a significant disease other than COPD that could contribute to dyspnea and exercise limitation
* Important contraindications to clinical exercise testing
* Use of daytime oxygen
* History of asthma
A Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Hematologic Malignancy

This is a phase I study evaluating the safety, tolerability and preliminary efficacy of IBI322 in subjects with hematologic malignancies who have failed standard treatment.

This Phase 1a/1b study will be conducted to evaluate the safety, tolerability, PK, PD, immunogenicity, and preliminary antitumor activity of IBI322 in China. Phase 1a is a dose escalation and plans to enroll approximately 39-102 subjects with hematologic malignancies who have failed standard treatments. Phase 1b is a dose expansion and plans to enroll approximately 80 subjects with hematologic malignancies.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically/cytologically confirmed hematologic malignancy who failed the standard treatment
2. At least one evaluable lesion
3. Male or female 18 to 75 years old
4. Eastern Cooperative Oncology Group Performance Status Performance Status (ECOG PS) 0-2
5. Must have adequate organ function

Exclusion Criteria:

1. Previous exposure to any anti-CD47 monoclonal antibody, SIRPα antibody, or CD47/SIRPα recombinant protein
2. Previous exposure to chimeric antigen receptor T cell immunotherapy (CAR-T)
3. Subjects participating in another interventional clinical study, except for: observational (non-interventional) clinical studies or survival follow-up phase of interventional studies
4. Use of anticoagulants and/or aspirin, or other non-steroidal anti-inflammatory drugs within 2 weeks prior to study start
5. A history of blood transfusion within 2 weeks prior to study start