cyrilzakka/clinical-trials huggingface dataset:
The Efficacy and Safety of IBI-10090 for the Treatment of Inflammation Associated With Cataract Surgery

The purpose of this study is to determine whether IBI-10090 injection is effective in the treatment of inflammation associated with cataract surgery.

A double blinded randomized trial to assess the efficacy and safety of IBI-10090, in two separate doses as compared to placebo (ATEC carrier only sans dexamethasone)

Eligibility Criteria:
Inclusion Criteria:

1. The patient must provide written informed consent by signing the Informed Consent approved by the Institutional Review Board (IRB).
2. Male or female patients at least 40 years of age scheduled for unilateral cataract surgery by phacoemulsification with posterior chamber intraocular lens implantation.
3. The patient must demonstrate best corrected visual acuity (BCVA) of 20/30-20/200 (with glare testing, if necessary) in the study eye and better than 20/200 in the fellow eye.
4. The patient must be considered by the Investigator to have visual acuity potential greater than 20/30 in the study eye.
5. The patient must have a corneal endothelial cell count by specular microscopy in the study eye of at least 2000 cells/mm2 with normal cell morphology.
6. A female patient of childbearing potential (premenopausal by medical history) must have a negative pregnancy test on Day 0 and be using an effective method of birth control (although no birth control method is 100% effective, the following are considered effective means of contraception: surgical sterilization, use of oral contraceptives, barrier contraception using either a condom or diaphragm with spermicidal gel, an intrauterine device, or contraceptive hormone implant or patch) from Screening for the duration of the study.
7. The patient must be willing and able to understand and comply with the study procedures and to communicate meaningfully with study personnel.

Key Exclusion Criteria:

1. Patients who have used any ocular, topical or oral corticosteroids within 7 days prior to Day 0.
2. Patients who have received a periocular corticosteroid injection in the study eye in the 3 months prior to screening.
3. Patients who have received any intravitreal corticosteroid delivery vehicle (e.g., Retisert, Ozurdex, Iluvien) in the study eye at any time.
4. Patients who anticipate requiring treatment with any corticosteroids by any route, except inhalation, during the study.
5. Patients with an allergy or hypersensitivity to dexamethasone.
6. Patients who are known steroid responders (corticosteroid-related intraocular pressure elevation in either eye).
7. Patients who have used topical ocular NSAIDs in the study eye within 15 days prior to Day 0.
8. Patients who have undergone prior intraocular (non-laser) surgery in the study eye within 6 months prior to screening.
9. Patients who have undergone prior intraocular laser surgery in the study eye within 3 months prior to screening.
10. Patients with planned intraocular or laser surgery in the study eye for the duration of the study.
The Effect of EX1 Training in Normal Adults

In this study, when performing aerobic and anaerobic exercise with EX1 applied to normal adults between the ages of 19 and 65. The purpose of this study was to determine the effect on the muscle activity of the trunk and lower extremities compared with and without EX1.

In this study, aerobic exercise and anaerobic exercise for normal adults were divided into two visits for a total. For aerobic exercise, the investigators compared the aerobic treadmill walking program without EX1 \[30 minutes of moderate (64-76% HRmax, 12-14 of RPE) aerobic treadmill walking, 40 minutes including warm-up and cool-down times\], the aerobic treadmill walking program with EX1 \[30 minutes of moderate (64-76% HRmax, 12-14 of RPE) aerobic treadmill walking, 40 minutes including warm-up and cool-down times\] , and the high-intensity interval exercise (HIIT) program with EX1 \[High-intensity-low-intensity interval walking exercise was performed at treadmill speed (High: 90-95% HRmax, 15-17 of RPE/Low: 60-70% HRmax, 9-11 of RPE) and EX1 resistance strength (High: resistance intensity 7- 9/Low: Resistance strength 0-2)\] to check the effect on muscle activity, heart rate, and respiratory metabolic energy consumption rate.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged 19 to 65 years without a history of central nervous system disease

Exclusion Criteria:

* Those who have difficulty walking independently due to problems such as visual field defects or fractures
* Those who have difficulty understanding the exercise program due to severe cognitive decline (Korean-Mini-Mental State Examination, K-MMSE≤10)
* Those who have difficulty participating in exercise programs due to adult diseases such as uncontrolled hypertension and diabetes
* Those who are at risk of falling while walking due to severe dizziness
* Those who are less than 140 cm or more than 185 cm in height that is not suitable size for the wearing of the walking assistance robot
* Those who are overweight based on body mass index (BMI) 35 or higher
The Effect of Macronutrients on Satiety and Gut Hormone Responses

This study is part of a research theme aiming at elucidating the physiological mechanisms of action of weight loss after gastric bypass surgery. The Roux-en-Y Gastric Bypass procedure induces pronounced and sustained weight loss, but the physiological mechanisms of action are not completely clear. Neither mechanical restriction of food intake nor malabsorption, are the main contributing factors. The enhanced postprandial responses of gut hormones (e.g. GLP-1 and PYY) which increase satiety as well as energy expenditure after surgery suggest a changed physiological set point for appetite and metabolism.

Our hypothesis is that the intake of high quantity of protein in a microcapsule form would be able to reach the distal parts of the intestinal mucosa and stimulate maximum stimulation of the anorectic gut hormones. The higher functions of the brain will respond to these strong neuroendocrine signals by ensuing satiety and fullness.

Ten healthy volunteers, aged 18 to 65 years will be recruited. Each subject will be studied on six occasions one week apart. On each visit, a baseline serum sample will be drawn from each subject. In a randomized way all subjects will receive the following meals in their successive weekly visits: Option 1 High protein mixed meal in capsules that break down in the stomach, Option 2 High protein mixed meal in capsules that break down in the distal small bowel, Option 3 High fat mixed meal in capsules that break down in the stomach, Option 4 High fat mixed meal in capsules that break down in the distal small bowel, Option 5 High CHD mixed meal in capsules that break down in the stomach, Option 6 High CHD mixed meal in capsules that break down in the distal small bowel. On the same day, all subjects will be offered standard ad libitum meal to measure their food consumption. After 3 hours (i.e. at 12:00) another blood sample will be drawn. All subjects will be asked to rate their appetite on a Visual Analogue Scale (VAS). Upon VAS completion the subjects will be allowed to go home.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years
* Normal fasting glucose
* Stable body weight for at least last three months
* BMI \< 30 Kg/m2
* Capacity to consent to participate
* Independently mobile

Exclusion Criteria:

* Patients who meet any of the following criteria will be excluded:
* Pre-diabetes Diabetes
* Obesity
* Smoking
* Substance abuse
* Pregnancy
* Use of medications (except for oral contraceptives)
* Chronic medical or psychiatric illness
* Any significant abnormalities detected on physical examination, electrocardiography, or screening blood tests (measurement of complete blood count, electrolytes, fasting glucose, and liver function)
the Effect of Mixture of Natural Products As Salivary Substitutes in Treatment Of Xerostomia

evaluate the efficacy of natural herbal mixture of aloe vera gel, coconut oil and peppermint in comparison to the carboxy methyl cellulose on xerostomia in a sample of patients with Sjogren's syndrome.

The study will be held in the Rheumatology clinic at El Kasr Al-Ainy Cairo University Hospital in patients with Sjogren's syndrome. Population: A random sample of adult patients diagnosed with primary or secondary Sjogren's syndrome attending at the Rheumatology clinic in El Kasr Al-Ainy, Cairo University Hospital will be enrolled in the study in a consecutive order.

The interventions will be in the form of gel to be maintained for long period in the oral cavity. The intervention is a moisturizing gel containing 10% aloe vera jelly, 10% coconut oil, 3% peppermint essential oil, 3% carboxy methyl cellulose, 10% propylene glycol, and 0.1% potassium sorbate and water up to 100%. The control is also a moisturizing gel contained 3%carboxy methyl cellulose, 3% peppermint essential oil, 10% propylene glycol, 0.1% potassium sorbate, and water up to 100%.

Both gels had similar appearance, color, smell, and weight. They will be produced by professional pharmacist in faculty of pharmacy, Al Azher university, Cairo, Egypt.it was taken from previous study with modification in percentage of aloe vera and adding coconut oil. Both gels will be applied topically in all surfaces of oral mucosa 4 times daily after eating and before sleep . The same individuals will deliver the trial interventions in all study groups, both gels will be used for 2 weeks then washout period for 7 days then cross over them. Modification of life style will be promoted as daily tooth brushing, hydration with sufficient amounts of water, eating fibrous food as fruits and vegetables, avoid any alcohol mouth wash or any other topical oral products. The medication will be withdrawn if any allergic reaction occurs.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients
2. Patients physically able to participate in the clinical trial.
3. Patients diagnosed with Sjogren's syndrome using 2016 ACR/EULAR classification criteria (Shiboski et al., 2017).
4. Secondary sjogren patients with rheumatoid arthritis.
5. Patients with clinical oral dryness positive scores.

Exclusion Criteria:

1. Patients with previous radiotherapy.
2. Patients not approved to participate in the clinical trial.
3. Patients didn't complain from xerostomia.
4. Patients with diabetes mellitus.
5. Patients taking drugs caused xerostomia as antidepressants, anticholinergics, antihistamines, and anxiolytics and antihypertensives (Campos et al., 2019).
6. Patients with symptomatic oral lesions
Pemetrexed in Patients With Advanced Neuroendocrine Tumors

The purpose of this study is to find out what effects (good and bad) pemetrexed has on patients with advanced neuroendocrine tumors.

* 1 cycle is equal to 21 days. Every 21 days the following will be performed: a review of the patients symptoms and medications; physical exam; blood tests; vital signs; and pemetrexed infusion.
* Every 3 cycles (9 weeks) an assessment of disease extent by CT scan and a 24 hour urine collection (if applicable) will be performed.
* Before patients start receiving pemetrexed, they will be given folic acid, vitamin B12 and dexamethasone to help reduce the chance of significant side effects. Dexamethasone will be taken the evening before, the morning before and the evening after receiving pemetrexed. Folic acid should be taken daily beginning 5-7 days before the first dose of pemetrexed and should be continued for three weeks after the last dose of pemetrexed. Vitamin B12 will be given as an injection 1-2 weeks before the first dose of pemetrexed and once every 9 weeks until 3 weeks after the last dose of pemetrexed.
* Patients can continue to receive treatment with pemetrexed unless there is evidence that their tumor has grown or they are experiencing serious side effects.
* Immediately after the patient has completed the study, they will be given a physical exam, including vital signs, a CT scan, and blood tets. The study staff will continue to monitor the patients health either by clinic visits or phone calls every three months for the remainder of your life.

Eligibility Criteria:
Inclusion Criteria:

* Metastatic or locally unresectable neuroendocrine tumor, excluding small cell carcinoma
* Measurable tumor
* 18 year of age or older
* ECOG performance status of 0,1 or 2
* Life expectancy of greater than 12 weeks
* WBC: \> 3.0/mm3
* Plts: \> 100,000/mm3
* Bilirubin: \< 2.0 mg/dl
* AST \< 3 x ULN (except in patients with known hepatic metastases wherein SST may be \< 5 x ULN)
* Neutrophils \> 1000/mm3
* Creatinine Clearance \> 45 ml/min. Should be measured using the standard Cockroft-Gault formula

Exclusion Criteria:

* Prior treatment with pemetrexed
* Clinically apparent central nervous system metastases or carcinomatous meningitis
* Myocardial infarction in the past 6 months
* Major surgery in the past two weeks
* Uncontrolled serious medical or psychiatric illness
* Pregnant or lactating women
Real World Study of Lapatinib Among Metastatic Breast Cancer Patients

A multicenter, retrospective, real world study of Lapatinib among Metastatic Breast Cancer (MBC) Patients in Clinical Practice.

This study collected patients used Lapatinib-base therapy among MBC, and tried to figure out if there was difference between single anti-Her2 treatment and dual anti-Her2 treatment. Furthermore, this study investigated the treatment after Lapatinib.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were treated with Lapatinib between June 2014 to June 2018.
* Patients experienced progression on prior trastuzumab-containing regimens and a taxane.
* Complete medical history was available.

Exclusion Criteria:

* Medical history was incomplete.
Predicting Intubation of Patients Hospitalised for Acutely Attacked Asthma

Although the asthmatic treatments currently be effective in term of efficacy of inhaled medications and good clinical outcome including symptom controlled and asthma exacerbation number, the large number of worse event still have been reported. Few cases eventually have been intubated and died even though using optimal medication. In this study, we will search to identify factors that may influence intubation in hospitalised patient with asthmatic attack.


Eligibility Criteria:
Inclusion Criteria:

* Patients who had been admitted and diagnosed as asthmatic attack between year 2016-2018.
* Patients who have age \> 15 year old.

Exclusion Criteria:

* Non
Clinical Evaluation of Opti-Free III (FID 109182) Compared to Opti-Free Plus® in Japan

The purpose of this study is to compare an investigational contact lens care product (FID 109182) to a commercially available contact lens product (Opti-Free Plus®) for corneal staining when used with Acuvue® Oasys® contact lenses. The contact lenses will be pre-soaked in the products for 24-48 hours prior to a 2-hour contralateral wear period.


Eligibility Criteria:
Inclusion Criteria:

* Soft contact lenses habitual wearer, both eyes.
* Voluntarily sign Informed Consent.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Unable to tolerate the ingredients in Opti-Free® and similar contact lens care products.
* Potential use of eye drops during the study, including over-the-counter products, except for artificial tear eye drops.
* Eye infection, blepharitis, iris inflammation, or severe eye inflammation.
* Corneal staining greater than Grade 1 at baseline.
* Pregnant, lactating, or intend to become pregnant during study period.
* Other protocol-defined exclusion criteria may apply.
Long Term Effects of Heat and Moisture Exchangers (HMEs)

Assessment of long term effect of Provox Life HME use on pulmonary symptoms in laryngectomized patients.


Eligibility Criteria:
Inclusion Criteria:

* Total laryngectomy, irrespective of pharynx reconstruction method
* 18 years or older
* Longer than 3 months after total laryngectomy
* Longer than 6 weeks after postoperative radiotherapy

Exclusion Criteria:

* Current use of HMEs (within last 3 months)
* Medical problems prohibiting the use of HME
* Active recurrent or metastatic disease (medical deterioration)
* Recent pulmonary infections/unstable pulmonary condition
* Insufficient physical, cognitive, or mental ability required to attach, remove or operate the devices themselves
* Low tidal volumes
* Unable to understand the Participant Information and/or unable to give Informed Consent
Modification of the Local Abnormal Ventricular Activity Only

Local abnormal ventricular activity (LAVA) is composed of high-frequency, mainly low voltage signals that represent near-field signals from slow-conducting tissue and thus potential VT isthmuses. The identification of LAVA potentials and their modification have usually been a complimentary component of the substrate-based modification of scar related ventricular arrhtyhmias. With better identification through technical solutions and improved algorithms, LAVA modification may be feasible for treatment in therapy refractory VT.

As of 2019 we started LAVA modification only in a subset of patients with therapy refractory ventricular tachycardia. The cohort icludes 55% patient with ischemic cardiomyopathy and 45% with dilated cardiomyopathy. 80% are ICD recipients. These patients were now retrospectively analysed in depth. The endpoint is time to relapse of ventricular tachycardia or ICD shock or death due to malignant arrhythmia. We evaluated all patients we treated accordingly from March 2019 through October 2020. No patient was excluded.

Eligibility Criteria:
Inclusion Criteria:

therapy refractory ventricular arrhythmia

Exclusion Criteria:

none
Effects of Heart Imaging Radiation on DNA Double-Stranded Breaks in Blood Lymphocytes and Hair Follicle Cells

Purpose

1. To investigate the effects of cardiac imaging radiation on the induction of DNA double-strand breaks by enumerating gamma-H2AX foci in blood lymphocytes and plucked hair follicle cells.
2. To estimate whether the use of breast shields in cardiac computed tomographic angiography (CCTA) limits the effective radiation exposure of breast tissue.

The primary objective of the study is to analyze blood and hair samples from patients undergoing cardiac imaging to estimate radiation exposure levels as well as their biological effects (i.e. to determine the degree of genotoxicity by measuring the amounts of DNA double-strand breaks).

The secondary objective is to investigate whether the use of in-plane breast shielding in female patients undergoing CT angiography (CCTA) limits the radiation exposure of breast tissue and subsequent DNA damage in blood lymphocytes and hair follicle cells.

Eligibility Criteria:
Inclusion Criteria:

* Adult male and female adult subjects (age greater than 18 years)
* Referred for cardiac computed tomography angiography (CCTA), myocardial perfusion scintigraphy (MPS), or diagnostic invasive coronary angiography (ICA).

Exclusion Criteria:

* Female patients that identify themselves as pregnant or have a positive pregnancy test prior to cardiac imaging.
* History (present or past) of leukemia or lymphoma.
* History of radiation therapy
* X-ray examination or scintigraphy within the last 72 hours.
* History of coronary revascularization (coronary artery bypass grafting or percutaneous coronary intervention)
* Patients undergoing percutaneous coronary intervention at completion of diagnostic left heart catheterization
A Study to Optimize Subretinal Surgical Delivery and to Evaluate Safety and Activity of Opregen in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration (GAlette)

This study will evaluate the success and safety of subretinal surgical delivery as well as the preliminary activity of OpRegen in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). All endpoints are assessed for the study eye unless otherwise indicated


Eligibility Criteria:
Inclusion Criteria:

* Ability to undergo a vitreoretinal surgical procedure under monitored anesthesia care
* Diagnosis of GA secondary to AMD
* BCVA score \>/= 29 letters and \</= 60 letters in the study eye as assessed by ETDRS
* Pseudophakic (study eye)

Exclusion Criteria:

* Pregnancy or breastfeeding
* History of cognitive impairment or dementia
* Any type of systemic disease or its treatment, in the opinion of the investigator, including any medical conditions that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical status of the participant to a significant degree or put the participant at special risk

Ocular Exclusion Criteria for Study Eye:

* Any current or history of ocular disease other than GA that may confound assessment of the macula
* History of retinal detachment
* History of vitrectomy, glaucoma-filtering surgery, or corneal transplant
* Uncontrolled glaucoma or advanced glaucoma
* Any cataract surgery or intraocular surgery within 3 months prior to subretinal surgical delivery of OpRegen
* History of other ocular or intraocular conditions that contraindicate the use of an investigational drug or may affect interpretation of the study results or may render the participant at high risk for treatment complications
* Any existing posterior segment device or implant
Open Pilot Trial of TES for Depression

This study will investigate whether using oscillating TES (random noise stimulation) or intermittent tDCS will have greater antidepressant effects in depressed subjects, compared to standard tDCS.


Eligibility Criteria:
Inclusion Criteria:

* Subject meets criteria for a DSM-IV Major Depressive episode.

Exclusion Criteria:

* Diagnosis (as defined by DSM-IV) of: any psychotic disorder (lifetime); bipolar disorder; eating disorder (current or within the past year); obsessive compulsive disorder (lifetime); post-traumatic stress disorder (current or within the past year); mental retardation.
* Subject has not responded adequately to standard tDCS or is not appropriate for trial of standard tDCS (eg depression too chronic in duration)
* Total MADRS depression score of 20 or more
* History of drug or alcohol abuse or dependence (as per DSM-IV criteria) within the last 3 months (except nicotine and caffeine).
* Inadequate response to ECT in the current episode of depression.
* Subject is on regular benzodiazepine medication which it is not clinically appropriate to discontinue.
* Subject requires a rapid clinical response due to inanition, psychosis or high suicide risk.
* Neurological disorder or insult, e.g., recent stroke (CVA), which places subject at risk of seizure or neuronal damage with TES.
* Subject has metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.
* Female subject who is pregnant. However, women of child bearing age are eligible if they have the pregnancy test but will be excluded if they are sexually active and not using reliable contraception (urine test for pregnancy will be used if appropriate).