cyrilzakka/clinical-trials huggingface dataset:
Cyclosporine 0.05% Eye Drops for Vernal Keratoconjunctivitis Trial

To observe and compare the clinical efficacy of cyclosporine 0.05% eye drops with Loteprednol Etabonate 0.5% and Tobramycin Eye Drops 0.3% in the treatment of Vernal Keratoconjunctivitis in developing regions of China.

Vernal keratoconjunctivitis (VKC) is an allergic disease that severely affects the eyesight of adolescents. Vernal keratoconjunctivitis (VKC) usually occurs in temperate regions such as the Mediterranean region, the Middle East, Africa, Central America, and the Indian subcontinent. In the EU an estimated 3.2 per 10,000 inhabitants (0.03%). It occurs repeatedly and mainly involves type I and type IV hypersensitivity. long-term standardized treatment is necessary. Therefore, this research aims to compare the readily available cyclosporine 0.05% eye drops and Loteprednol Etabonate 0.5% and Tobramycin Eye Drops 0.3% in developing regions of Asia (China, Jiangxi Province) for long-term drug use in VKC patients in developing countries provide evidence.

Eligibility Criteria:
Inclusion criteria

* patients had a noticeable seasonal, and recurrent Itching, Discomfort(burning, stinging, and foreign body sensation), Photophobia and tears, Viscous discharge;
* Slit-lamp microscopy showed Conjunctival Hyperemia, Tarsal papillary, Limbal hypertrophy, Horner-Trantas dots, Keratitis in some patients;
* No other medication history in recent 2 weeks;
* Patients have high compliance and are willing to take drugs on time and return to the clinic in time

Exclusion criteria:

* with other related immune diseases or other drug use history in recent 2 weeks;
* Patients with evident and severe organic diseases or mental diseases;
* Low compliance, unable to take drugs on time or fail to return to the clinic on time.
Phase 2A Open Label Safety Study of Fovista® (Anti-PDGF BB) Regimen Administered in Combination With Anti-VEGF Therapy to Study Sub-Retinal Fibrosis in Neovascular AMD

The objective is to evaluate the safety of intravitreal Fovista® (anti-PDGF BB) administered in combination with anti-VEGF therapy.

The objective is to evaluate the safety of intravitreal Fovista® (anti-PDGF BB) administered in combination with anti-VEGF therapy in either a "Simultaneous" Regimen (Fovista® administered with anti-VEGF same day) or "Pre-Treatment" Regimen (monotherapy Fovista® Day 0 followed by Fovista® administered in combination with anti-VEGF Day 2).

Eligibility Criteria:
Inclusion Criteria:

* Subjects of either gender aged ≥ 50 years
* All fluorescein angiographic subtypes with presence of active choroidal neovascularization

Exclusion Criteria:

* Any intraocular surgery or thermal laser within three (3) months of trial entry. Any prior thermal laser in the macular region, regardless of indication
* Subjects with subfoveal scar or subfoveal atrophy
* Any ocular or periocular infection in the past twelve (12) weeks
* History of any of the following conditions or procedures in the study eye: Rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery (e.g. trabeculectomy), glaucoma drainage device, corneal transplant
First-in-Human Single Ascending Dose of SHR0302

The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) oral doses of SHR0302 compared to placebo. Also, pharmacokinetics (PK) and pharmacodynamics (PD) of SHR0302 after single oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects, age 18-45 years (inclusive);
* The weight of the subject should be more than 50 kg, body mass index (BMI = weight/height squared (kg/m2)) within the range of 19 to 24.

Exclusion Criteria:

* Any condition that might interfere with the procedures or tests in the study
* History of heart failure or renal insufficiency
* Smoking; Drug or alcohol abuse
Glucose Response From Antioxidant Rich Potato Chips

Assess impact of potato phytochemical on post-prandial gastric emptying and glucose release from products in a pilot human study.

Preclinical data obtained using an Caco-2 intestinal cell model and enzyme assays suggest phenolic-rich potato extracts decrease intestinal glucose transport. The aim is to determine if these effects extend to the the an in vivo situation. Specifically, the glycemic response following consumption of phenolic rich pigmented potatoes compared to white potatoes with lower phenolic content will be measured. Gastric emptying will also be measured to show the effects are in fact due to rate of carbohydrate digestion and intestinal glucose transport and not gastric emptying rate.

Eligibility Criteria:
Inclusion Criteria:

* BMI 18-25 non-smoker

Exclusion Criteria:

* BMI outside 18-25 smoker previous gastrointestinal disease or other disease
Improving Cancer Outcomes Through Personalized Care Planning and Symptom Management.

This Study is a case control Study conducted with 100 patients with a solid tumor cancer diagnosis (lung, breast, or gynecologic cancer). Records of 50 patients who received treatment plans as standard of care will be abstracted for control data. 50 patients undergoing cancer treatment will receive a treatment plan and report symptoms using Carevive PROmPT™.


Eligibility Criteria:
Inclusion Criteria:

* All participants must be 18 years of age or older.
* Subject participants must have a diagnosis of a breast, lung, or gynecologic cancer.
* Patients must have completed their navigation visit and received a Treatment Care Plan.
* Subjects must be able to complete on-line surveys using a cell phone, tablet, or computer.
* Subjects must be starting or receiving treatment.
* All participants must be able to understand English.

Exclusion Criteria:

* Any patient who cannot understand written or spoken English.
* Any patient without the ability to complete on-line surveys using a cell phone, tablet, or computer.
* Any prisoner and/or other vulnerable persons as defined by NIH (45 CFR 46, Subpart B, C and D).
Right Ventricular Involvement in Inferior Myocardial Infarction Patients Using 2 Dimensional Speckle Tracking Echocardiography

Right ventricular infarction usually occurs in association with inferior myocardial infarction in about 10-50% of the cases. Currently the presence of elevation in right pericordial leads is the most powerful indicator of right ventricular infarction.

The incidence of right ventricular infarction is more in postmortem studies,meaning that Right ventricular infarction is underestimated, possible explanation for this difference could be explained that electrocardiographic sign of Right ventricular infarction disappear early or patients presented late.

The incidence of right ventricular infarction is more in postmortem studies,meaning that Right ventricular infarction is underestimated, possible explanation for this difference could be explained that electrocardiographic sign of Right ventricular infarction disappear early or patients presented late

The role of Right ventricular systolic function in inferior myocardial infarction patients with or without Right ventricular infarction Had been studied. In our study we will Assess Right Ventricular infarction in patients of acute inferior myocardial infarction undergoing primary percutaneous coronary intervention by correlating electrocardiogram, Right ventricular systolic function by echocardiography with the angiographic finding.

Eligibility Criteria:
Inclusion Criteria:

1. Patients of recent acute inferior myocardial infarction.
2. Patients managed by Primary percutaneous coronary intervention.

Exclusion Criteria:

1. Pervious inferior Myocardial Infarction.
2. Inferior Myocardial Infarction treated by thrombolytic therapy.
3. Chronic pulmonary disease.
4. estimatedPulmonary Artery Systolic Pressure ≥35 mmHg by Echocardiography.
5. Valvular heart disease. 6- Dilated cardio-myopathy patients.
Soy as an Innovative Dietary Component in Abdominal Obesity Management Amongst Peri- and Early Menopausal Women

This is a pilot study examining the effect of dietary supplements that contain soy products. The purpose of this study to find out if soy supplementation can help to reduce the storage of a certain kind of fat on the body, visceral fat. Visceral fat is fat found deep in the abdomen; it has the potential to increase the risk of certain health problems.

Obesity is a leading risk factor for many chronic diseases in the USA. Abdominal fat, specifically visceral fat is metabolically active and can be detrimental to health. Abdominal obesity is especially high in postmenopausal women (prevalence rates 50- 70%) in whom estrogen deficiency may lead to accumulation of excess visceral fat. Although estrogen replacement therapy is effective in preventing visceral fat accumulation, its adverse effects warrant a search for a safer phytochemical that exerts estrogenic properties. Soy, containing isoflavones (estrogen-like compounds), is a promising dietary component in reducing abdominal obesity in menopausal women. The favorable effects of isoflavones were already demonstrated in animal studies.The effects of soy compounds as a dietary component in preventing and reducing abdominal obesity and its associated metabolic abnormalities will be examined among menopausal Women. We will use quantitative magnetic resonance spectroscopy/imaging (qMRS/I) to determine dose and effects of soy supplementation for preventing and treating abdominal adiposity. The results from this study will shed light on the application of soy as a novel dietary approach in preventing and managing abdominal obesity among peri- and early menopausal women.

Eligibility Criteria:
Inclusion Criteria:

1. Between the ages of 45 and 60
2. experiencing irregular menses along with one or more other symptoms of menopause including: vaginal dryness, difficulty sleeping, hot flashes, mood changes, increased abdominal/belly fat, or with cessation of menstrual cycle for no more than three years
3. having a BMI greater than 25
4. Waist circumference greater than 88 cm
5. having the ability to understand study procedures and to comply with them for the entire length of the study.

Exclusion Criteria:

1. Have ever been diagnosed with cancer
2. Have tumors in the reproductive system
3. Allergies to soy or milk protein
4. Have known metabolic disorders that may affect body weight and body composition (e.g., hypercortisolism and hypothyroidism, non-alcoholic fatty liver disease)
5. Are receiving hormone replacement therapy or estrogen-like remedy
6. Are taking medications (e.g., thyroid, cortisol/cortisone, ephedra, thermogenics, etc) within 30 days prior to the start of the study.
7. Are emotional or uncontrolled eaters as measured by a brief screening tool Three-Factor Eating Questionnaire (TFEQ), i.e., 3 "yes" to the three emotional eating questions or 2 "yes" to the 2 uncontrolled eating questions.
Near-infrared Software Performance Study

This study will look at the performance capabilities of software for VeinViewer.

This study will look at the performance capabilities of future software for VeinViewer.

Eligibility Criteria:
Inclusion Criteria:

1. Must be 18 years of age or older
2. Must be considered to be in overall good health by investigator
3. Must pass all prescreening questions
4. Must be able to read and understand English

Exclusion Criteria:

1. Presence of tattoos, scarring, and/or extensive hair in the areas to be assessed for cannulation.
2. IV cannulation in the arms or hands in the previous 4 weeks.
Immunodysregulation As an Expression of Underlying Inborn Errors of Immunity: Implementation of Diagnostics and Management of Pediatric and Adult Patients with Immune System Disorders

This is an observational, retro-prospective, moncentric study focused on Inborn Errors of Immunity, an heterogeneous group of inherited diseases due to defects in the differentiation and/or function of the immune system. The primary aim of this study is to obtain a clinical-immunological, functional and molecular characterisation of paediatric and adult patients with confirmed or suspected Inborn Errors of Immunity, particularly of patients with manifestations of immunedysregulation, focusing on clinical course, immunophenotypic laboratory and functional abnormalities, genetic background.

Due to the observational nature of the study, patients were and will be treated according to normal clinical practice and in accordance with medical judgement. The following evaluations were performed in the retrospective cohort and will be performed in the prospective cohort:

* Standard haematochemical examinations;
* Extended lymphocyte typing;
* Plasma dosage of immunoglobulins;
* Evaluation of early and late responses to Measles-Parotitis-Rosolia and Diphtheria-Tetanus-Pertussis vaccinations;
* Evaluation of antibody responses to vaccines against Haemophilus Influenzae, Neisseria Meningitidis and Pneumococcus;
* Detection of auto-antibodies on HEp-2 cells, and of auto-antibodies directed against haemopoietic cells and proteins of innate and adaptive immunity;
* Plasma dosage of complement factors (C3, C4);
* Radiological assessment;
* Functional immunological assay;
* Molecular-genetic investigations of targeted gene panels involved in immunodysregulation and Inborn Errors of Immunity.

Eligibility Criteria:
Inclusion Criteria:

* patients with confirmed or suspected Inborn Errors of Immunity;
* age \< 50 years at onset of clinical features suspected for Inborn Errors of Immunity;
* obtaining informed consent from patients or parents/legal guardian of pediatric patients.

Exclusion Criteria:

• patients in whom infectious susceptibility and immunodysregulation can only be attributed to known non-immunological causes: acquired immunodeficiency secondary to chronic infections (HIV), and acquired immunodeficiency secondary to immunosuppressive treatment.
Systematic Chart Review of Carotidynia Patients

Systematic retrospective study of medical charts and medical imaging files, of patients consulting for acute neck pain and presenting unclassified abnormalities on dedicated vessel imaging.


Eligibility Criteria:
Inclusion Criteria:

* acute cervical tenderness or neck pain fulfilling the characteristics of an idiopathic neck pain syndrome as defined by the International Headache Society in 1988
* the performing of a diagnostic imaging like MRI, CT or US of the cervical area with a dedicated vessel analysis
* unilateral or bilateral abnormalities of common carotid, carotid bifurcation or internal carotid arteries on dedicated vessel imaging.

Exclusion Criteria:

* patients without imaging, or without dedicated vessel analysis
* patients presenting with pain caused by a clearly identified vascular disease on dedicated vessel analysis imaging such as carotid occlusion, carotid dissection, vasculitis like giant cell arteritis.
* patients with no abnormality on cervical or vessel imaging
Helping Employees Lose Pounds

This study will evaluate the effectiveness of financial incentives and messaging tailored to individual goals and aspirations to promote and sustain weight loss. This is a 2-arm randomized controlled trial that will recruit eligible employees at a large university to participate in a 3-month weight loss program, followed by a 3-month follow-up period. The primary outcome will be change in autonomous motivation for weight loss.

The study hypothesis is that intervention group participants will have a greater increase in autonomous motivation for weight loss than participants in the control group at 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Interested in losing weight
* Body Mass Index between 30 and 40 kg/m2
* Have wireless internet at home
* Have Android or iOS smart device
* Willing to record themselves weighing in on a scale or let a family member record them weighing in on a scale

Exclusion Criteria:

* Pregnant or lactating, or intending to become pregnant in the next 6 months
* Taking medication (other than metformin) for diabetes to control blood sugar
* Having a serious psychiatric diagnosis, unstable medical conditions or experienced a heart attack or stroke in the past 6 months
* Having a history of drug or alcohol abuse or addiction to prescription medications
Comparison of Rice-richen and Wheaten-richen Meal on Glucose Control Among Chinese Women With Gestational Diabetes Melitus (GDM)

Since the prevalence of gestational diabetes melitus (GDM) increased by ..., as an important part of medical treatment, nutrition therapy is highly required to help patients achieve normoglycemia. Carbohydrate intake is the primary nutrient affecting postprandial glucose levels,therefore the total amount and type of carbohydrate should be manipulated to blunt postprandial hyperglycemia. However,the type of carbohydrate has not yet been established. Rice and wheaten food have similar Glycemic Index (GI),but some researches found the glucose response to them is different. A case-control study is designed to compare the glucose control status between rice-richen meal and wheaten-richen meal, and all other macronutrients and micronutrients are all calculated and same between two groups, which may provide more clues for type of carbohydrate recommendation for Chinese women with GDM.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women who undergo health examination in obstetric department in Peking Union Medical College Hospital.
* 20-45 years old.
* Pregnant women who are diagnosed with GDM according to the American College of Obstetricians and Gynecologists (ACOG) diagnostic criteria during 24-28 weeks.
* Be ability to use mobile medical equipment, conditional follow-up of the mother and child.
* Voluntary participation in this study.

Exclusion Criteria:

* Multiple pregnancy.
* Merger of serious diseases (such as hypertension, respiratory diseases, kidney disease, abnormal coagulation, immune system diseases, infectious diseases), history of adverse pregnancy (such as spontaneous abortion, habitual abortion), and history of GDM.
* Pregnant women with known diabetes before pregnancy, those requiring insulin or hormone therapy.
* Pregnant women who are deemed inappropriate to participate in this clinical study by her physician.
Evaluation of Advanced Imaging and Visualization for Clinical Deep Brain Stimulation

The objective of this project is to evaluate next generation visualization tools and surgical targeting models for clinical deep brain stimulation (DBS).

This study will evaluate the performance of HoloDBS software in comparison to the current standard (SOC) clinical planning tools to prepare for DBS surgery. The investigators hypothesize that HoloDBS will provide more detailed and anatomically useful information to the neurosurgeon and neurologist than the current clinical standard.

The study team reviews electronic medical records (EMR) from patients who are undergoing DBS surgery. There are no study visits involved in this study as only data from standard clinical care will be used. All study activities are executed by the study team and there are no interventions.


Eligibility Criteria:
Electronic medical records (EMR) from all patients undergoing preoperative DBS evaluation will be reviewed and their data will be used for this study's purposes if they fit the inclusion and exclusion criteria.

Inclusion criteria:

* age 18 years and over
* meeting qualification for deep brain stimulation for Parkinson's disease with one or more of medication refractory tremor, motor fluctuations despite medication optimization, or levodopa responsiveness but limited by medication induced adverse effects (nausea, dystonia, dyskinesia for example).

Exclusion criteria:

* consideration of alternate diagnosis to Parkinson disease
* high risk medical comorbidities which would make the patient not a candidate for surgery.
Development of Motility and Cognition in Infants

PILKE study uses wearables for assessing motor development in infants in order to define functional growth trajectories in the normal infants and infants at risk of neurological compromise. In addition, PILKE studies correlation of early motor development to later neurocognitive development.

PILKE study builds on the recent development of an infant wearable, MAIJU, a multisensor garment that can be used to quantify infants posture and movement patterns out-of-hospital. The study will recruit typically developing infants (control group) and infants with an identified or suspected risk of neurodevelopmental compromise, as well as infants undergoing orthopedic follow-up for hip issues.

Infants will be examined and treated according to clinical routine practise, while MAIJU and other novel measures are added to monitor aspects of neurodevelopment. Recordings with MAIJU will be done every 6-8 weeks from about 5 months to 18 months of age, and the neuropsychological outcome is assessed using Bayley scales at two years of age.

The study is observational by design, and the trajectories of motor performance are compared to other clinically identified measures of development.

Eligibility Criteria:
Inclusion Criteria:

* age at enrollment 5-8mos
* typically developing

Exclusion Criteria:

* all neurologically significant medical histories during pregnancy, at birth or postnatally
* suspicion of developmental delay
* suspicion or diagnosis of syndromes with neuromotor symptoms
The Risk Factors of Cardiovascular Disease in Elderly Diabetic Patients: A Prospective Cohort Study

In the previous cohort studies focused on diabetes in China, there were few studies on elderly patients with diabetes. The aim of this prospective cohort study was to investigate the prevalence, management and nutritional status of elderly diabetic patients aged ≥65 years in Shanghai and Suzhou communities, and record the occurrence of endpoint events.

This is a multicenter, observational, prospective cohort study.We plan to collect the baseline information in three years, and follow up every two years for at least 10 years. The study will enroll 5000 elderly diabetic patients aged ≥65 years and be conducted in Shanghai and Suzhou. The primary outcomes include MACE(major adverse cardiovascular events) , all-cause mortality, and chronic complications of diabetes and so on.

Eligibility Criteria:
Inclusion Criteria:

* Men or women aged 65-100 years old;
* Patients who had been diagnosed with diabetes mellitus.

Exclusion Criteria:

* Patients with psychiatric disorders or impaired cognitive function;
* Patients who cannot or reject to sign the consent form.