cyrilzakka/clinical-trials huggingface dataset:
Dexamethasone (Sterodex) Versus Loteprendol (Lotemax) Eye Drops Following Strabismus Surgery

The purpose of this study is to compare the efficacy and side effects of topical Loteprendol etabonate 0.5% (Lotemax) versus Dexamethasone 0.1% (Sterodex) following strabismus surgery.

This is a randomized prospective study that will involve 100 patients (males and females) undergoing strabismus surgery. All patients will be randomly assigned to receive one of the study drugs (Loteprendol etabonate 0.5% (Lotemax) drops or Dexamethasone 0.1% (Sterodex) drops) after undergoing strabismus surgery. In addition to the study drug all patients (in both groups) will receive topical Ofloxacin 0.3% (Oflox) eye drops. All patients will undergo a complete ophthalmological evaluation before surgery including orthoptic assessment of their strabismus and measurement of intraocular pressure (IOP). Topical treatment with the study drug and topical Ofloxacin 0.3% (Oflox) eye drops will begin on the evening of the surgery, following a schedule that will be the same for both groups: 4 times daily during the first week, 3 times daily for the second group, twice daily for the third week, and as needed for the fourth week. All patients will be examined at 1 day, 1 week, 2 weeks and 4 weeks after surgery by a masked investigator (not the strabismus surgeon).

The parameters to be checked will include:

1. Patient pain and discomfort
2. Conjunctival chemosis
3. Conjunctival hyperaemia
4. Conjunctival discharge
5. Conjunctival gap
6. Intraocular pressure (IOP)
7. Number of pain control medications taken

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing recession strabismus surgery through a fornix approach of one of the horizontal recti muscles (either medial rectus or lateral rectus) or of the inferior oblique muscle
* Must be able to comply with topical treatment
* Must be able to comply with post-operative appointment schedule.

Exclusion criteria:

* Previous ocular surgery (including previous strabismus surgery)
* Ocular pathology
* Family history of glaucoma
* Personal history of allergic drug reaction or allergic conjunctivitis
* More than one muscle operated on
* Adjustable sutures technique
* Patients in whom it is impossible to measure IOP before surgery
Ferumoxytol Versus Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease Patients

The study will evaluate the safety and efficacy of a new intravenously administered iron drug to treat anemia in patients with chronic kidney disease who are not on dialysis.

This study will evaluate the efficacy and safety of intravenous (IV) ferumoxytol as compared to oral iron in the treatment of anemia in non-dialysis dependent CKD patients. Patients are randomized to receive either two doses of 510 mg of ferumoxytol within one week or 200 mg oral elemental iron daily for three weeks.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients ≥ 18 years.
* Have chronic kidney disease per K/DOQI guidelines.
* No change in EPO status during study.
* Baseline hemoglobin of ≤ 11.0 g/dl.

Exclusion Criteria:

* Women who are pregnant or lactating.
* Received another investigational drug or device within 30 days.
* Recent parenteral or oral iron therapy.
* Patients with active GI bleeding or acute bleeding within 4 weeks.
* Patients that have other causes of anemia.
* Major surgery within 30 days or anticipated or planned major surgery during the study.
* Patients whose EPO status changes while on study.
* Patients with active infections.
* Recent blood transfusions.
* Patients with any known allergies to iron products.
Glulisine + Lantus in Type I Patients

To evaluate the efficacy (in terms of change HbA1c from baseline to endpoint) and safety (in terms of adverse events, clinical chemistry, lipids, hematology) of insulin glulisine (HMR 1964) in subjects with type I diabetes mellitus To evaluate the change in HbA1c at week 26, blood/glucose parameters, hypoglycemia, insulin dose in subjects with type I diabetes mellitus receiving HMR 1964 and insulin glargine.


Eligibility Criteria:
Inclusion Criteria:

* Adult men and women (\>18 years) with type I diabetes mellitus (onset of diabetes under the age of 40)
* An HbA1c range of \>6.5 - \<11%
* And on multiple injection regimen (more than 1 year of continuous insulin treatment)
* Body mass index \<35.

Exclusion Criteria:

* Active proliferative diabetic retinopathy
* Diabetes other than type I diabetes mellitus
* Pancreatectomised subjects
* Subjects who have undergone pancreas and or islet cell transplantats, requiring treatment with not permited drugs during the study, previous treatment (in the period not less than 1 month before the beginning of the trial) with insulin glargine
* Hypersensitivity to insulin
* Major systemic diseases
* Impaired hepatic or renal function

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Effects of Hypocaloric Diets With Different Glycemic Loads on Pulse Wave Velocity

Worldwide, in terms of attributable deaths, the main intermediate risk factor for the development of cardiovascular diseases is systemic arterial hypertension, followed by overweight and sustained hyperglycemia. These factors have positively influenced public and private spending on health. The more robust studies showed that age is one of the main determinants of arterial stiffness. However, there is a possibility that other variables, such as elevated glucose levels, obesity, and systemic inflammation itself, as well as insulin resistance are important factors in this scenario. On the other hand, the measurement of the pulse wave velocity is widely acceptable for the evaluation of the arterial stiffness, inferring the cardiovascular risk in different populations. Since arterial stiffness is influenced by hemodynamic forces and inflammatory mediators, which may be related to sodium and glucose balance, it is necessary to evaluate whether a hypocaloric and low glycemic load diet, in a thesis that decreases lipid and inflammatory levels, may have favorable effects on pulse wave velocity in overweight adults.

The diets will be calculated in Microsoft Excel 2018 software, using tables of nutritional composition, glycemic index and glycemic load, which have foods with high glycemic index or glycemic load (white rice, white bread, corn flakes, mashed potatoes, orange juice (brown rice, whole wheat bread, whole noodles, oat bran, yogurt, milk, apple, pear, peach). The methodology for calculating GC estimates will be based on the FAO / WHO Protocol. The diets will be designed in 1200, 1400, 1600, 1800 and 2000 kcal / day. All participants will be categorized according to one of the five levels of the diet's energy content. In addition, all patients will receive a leaflet with nutritional guidelines according to their diet.

During the study, participants will be required to maintain their medication consumption, if any, as prescribed by a physician. To assess adherence to the diet, participants will consult with a nutritionist on a weekly basis and complete the 24-hour food recall.

It will be measured the pulse wave velocity.This outcome will be evaluated before the beginning of the diets and 6 weeks after the beginning of the diets.

Eligibility Criteria:
Inclusion Criteria:

* Both sex
* Between 20 and 59 years old
* Body mass index ≥ 25.0 kg/m²
* Physically inactive (physical activity \<150 min/week)

Exclusion Criteria:

* Pregnant women
* Vegetarians
* Vegans
* Users of dietary supplements
* Smokers
* Alcohol abusers (men: more than 4 doses in a single day or more than 14 doses per week; women: more than 3 doses in a single day or more than 7 doses per week)
* Individuals with a previous diagnosis of hypertension
* Chronic kidney disease
* Type 1 or 2 diabetes mellitus
* Hypothyroidism
* Hyperthyroidism
* Events in the last 6 months (coronary artery disease, acute myocardial infarction, cerebral vascular disease, peripheral arterial disease, or heart failure)
Randomized Anastrozole Exercise Trial

This is a randomized, phase III trial of a 12 week exercise program, followed by a 36 week voluntary, self-directed exercise program (total 48 weeks) compared to standard supportive care. The purpose of the trial is to determine whether the exercise program is better than standard supportive care to decrease the muscle and joint aches (musculoskeletal symptoms) that result from aromatase inhibitors.

Hypothesis An exercise program that includes stretching, strengthening and aerobic components may improve physical quality of life among women with musculoskeletal symptoms who are taking aromatase inhibitors.


Eligibility Criteria:
Inclusion Criteria:

* Women who have been on an adjuvant AI for at least 6 weeks.
* The presence of some musculoskeletal symptoms.
* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1
* ER and or PgR positive early breast cancer, stages I, II or III
* Completion of any adjuvant chemotherapy (if given) and primary breast cancer surgery.
* Be willing to switch to Anastrozole if on another AI
* Signed written informed consent

Exclusion Criteria:

* Metastatic disease (no imaging or labs required in absence of clinical suspicion of metastases)
* Evidence or history of inflammatory arthropathy (for example, rheumatoid arthritis)
* Any medical condition (for example, significant heart disease) that would prevent a subject from completing an exercise program.
* Unable to take Aromatase Inhibitor (AI)
* Planned secondary reconstruction procedures during the 48 week study period
* Any medical, physical, geographic, emotional, or economic condition that in the judgement of the clinician/study doctor, would make an individual unable or unlikely to be able to exercise three times a week for 12 weeks.
* Unable to complete a study log book and questionnaires (unable to read and write English and no one at home who can adequately do so).
* The use of any exogeneous estrogen and/or progesterone except Estring and natural plant estrogens
Hypophosphatemia Deleteriously Affects Outcome of Septic Shock Patients Admitted to ICU

Patients with severe sepsis/septic shock complicated by hypophosphatemia are at high risk of developing morbidities other than that underlying sepsis and more vulnerable to higher mortality rate. Thus, the current study hypothesized that diagnosis and management of hypophosphatemia may be advantageous for reduction of morbidity and mortality rates of septic patients admitted to ICU

The current study was started since June 2018 till Jan 2020 after approval of the study protocol by the Local Ethical Committee. The study intended to include all patients admitted to ICU with or developed severe sepsis or septic shock within 24-hr after admission to ICU.

All patients admitted to ICU were eligible to evaluation for demographic and clinical data including hemodynamic data. Disease severity and its impact on body organs were evaluated using acute physiology and chronic health evaluation II score (APACHE II) (20) and SOFA (18) scores. Exclusion criteria included maintenance on immunodepressent therapy for any indication, severe hemorrhagic shock, pregnancy and refusal of nearest relative to sign the written concept for study participation. Children and adulthoods younger than 18 years and patients who were expected to die were also excluded from the study.

Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to ICU were eligible to evaluation for demographic and clinical data including hemodynamic data.
* Disease severity and its impact on body organs were evaluated using acute physiology and chronic health evaluation II score (APACHE II) (20) and SOFA (18) scores.

Exclusion Criteria:

* Maintenance on immunodepressent therapy.
* Severe hemorrhagic shock.
* Pregnancy
* Refusal of nearest relative to sign the written concept for study participation.
Predictive Value of PS Application in Premature Infants With RDS

A multicenter prospective study was conducted to compare the predictive value of 6-zone, 10-zone, and 12-zone LUS scores for PS application in early and late preterm infants.


Eligibility Criteria:
Inclusion Criteria:

1. Hospital admission within 2 hours after birth;
2. The diagnosis was RDS;
3. Parents agree to attend

Exclusion Criteria:

1. chromosomal abnormalities or complex congenital malformations;
2. congenital pulmonary disease;
3. severe sepsis, disseminated intravascular coagulation, septic shock and other critical conditions;
4. LUS and blood gas analysis have been examined before the application of alveolar surfactant.
Effect of Adalimumab Therapy on Psoriasis Patient

to evaluate the impact of adalimumab therapy on quality of life in patient with severe psoriasis.

to evaluate the impact of adalimumab therapy against methotrexate therapy on quality of life in patient with severe psoriasis and follow up after 24 week by A- Medical history age, sex, marital state, occupation, educational level and family history. dermatologic history: onset, course, duration. B- Complete dermatologic examination

C- Psoriasis Area and Severity Index (PASI) score:

The scoring involves rating the symptoms of psoriasis from none to very severe and estimating the percentage of the body that they affect.The range of absolute PASI scores is 0-72, with higher scores indicating a greater severity of psoriasis. A score of 0 indicates no psoriasis, while a score higher than 10 suggests severe psoriasis. The scoring system includes a section for intensity and another for body coverage .The score will be evaluated before treatment, at week 12 and at week 24.

D- Dermatology Life Quality Index (DLQI):

It is self-reported questionnaire . It has been translated to \>110 languages. Measurement properties of the DLQI, such as validity, reliability, and responsiveness to change were reported. It is widely used in both clinical practice and research settings, including randomized controlled trials, patient registries, and national treatment and reimbursement guidelines . The study will depend on the Arabic Tunisian version of the DLQI questionnaire . DLQI consists of 10 questions related to symptoms, feelings, daily activities, leisure, work, personal relationships and the effects of treatment on daily life within the past week. Scores can range from 0 to 30, with higher scores representing worse quality of life . The questionnaire will be answered by all participant before initiation of treatment, at week 12 and at week 24 of treatment.

Eligibility Criteria:
Inclusion Criteria:

.Adult patients (\> 18 years) with severe psoriasis who will start treatment with either adalimumab or methotrexate.

Exclusion Criteria:

.Pregnancy or lactation. .Chronic liver or renal disease. .History of tuberculosis. .Cancer and blood disorder.
Comparison of MTX+Anti-TNF to MTX+Conventional DMARDs in Patients With Early Rheumatoid Arthritis (RA) Who Failed MTX Alone (SWEFOT)

The Swefot trial was designed to compare two treatment strategies for patients with early rheumatoid arthritis (less than 1 year symptom duration): the use of a combination of traditional antirheumatic medications (DMARDs), versus a combination including a newer "biological" anti-TNF medication. In order to make this trial consistent with current practices in rheumatology, all patients were first given the most commonly used antirheumatic medication, methotrexate (MTX). After 3-4 months those patients who had not responded adequately to this treatment were randomized to receive either MTX plus sulfasalazine plus hydroxychloroquine, or MTX plus infliximab. Again, to be truly life-like, the trial allowed patients who could not tolerate one of the added medications to switch in treatment - but keeping with the same strategy - so that sulfasalazine plus hydroxychloroquine could be replaced by cyclosporin A, and infliximab by etanercept. The primary outcome in this trial was the percentage of patients who, after one year of treatment, achieved a "good response" as defined by Eular.

The Swefot trial was designed to compare two treatment strategies for patients with early rheumatoid arthritis (less than 1 year symptom duration): the use of a combination of traditional antirheumatic medications (DMARDs), versus a combination including a newer "biological" anti-TNF medication. In order to make this trial consistent with current practices in rheumatology, all patients were first given the most commonly used antirheumatic medication, methotrexate (MTX). After 3-4 months those patients who had not responded adequately to this treatment were randomized to receive either MTX plus sulfasalazine plus hydroxychloroquine, or MTX plus infliximab. Again, to be truly life-like, the trial allowed patients who could not tolerate one of the added medications to switch in treatment - but keeping with the same strategy - so that sulfasalazine plus hydroxychloroquine could be replaced by cyclosporin A, and infliximab by etanercept. The primary outcome in this trial was the percentage of patients who, after one year of treatment, achieved a "good response" as defined by Eular. Secondary outcomes include Eular and ACR responses, HAQ and other QOL assessments, radiographic outcomes, and health-economic outcomes including EQ5D.

Eligibility Criteria:
Inclusion Criteria:

* RA, symptom duration \< 12 months

Exclusion Criteria:

* Contraindication to any of the trial medications
Study of S-1 Plus DC-CIK for Patients With Unresectable Locally Advanced Pancreatic Cancer

The purpose of this study is to evaluate the antitumor effect and safety of clinical effectiveness S-1 plus dendritic cell activated Cytokine induced killer treatment (DC-CIK) for unresectable locally advanced pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed locally advanced, unresectable or metastatic adenocarcinoma of the pancreas not amenable to curative radiotherapy or surgery.
* Capable of oral intake
* Between 18 and 80 years old
* Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
* Karnofsky Performance Status (KPS) ≥ 70%
* Normal functions of heart, lung and bone marrow
* Adequate hematological profile： Hemoglobin ≥ 9.0 g/dL Absolute granulocyte count ≥ 1,500/mm3 Platelet count ≥ 100,000/mm3
* Adequate hepatic function Total bilirubin level≤ 3.0 times the upper limit of normal (ULN) Transaminases AST (SGOT) and ALT (SGPT) ≤ 2.5 times ULN
* Adequate renal function(normal serum creatinine level)
* A life expectancy≥ 2 months
* Informed consent signed

Exclusion Criteria:

* Current enrollment in another clinical study with an investigational agent. Patients participating in surveys or observational studies are eligible to participate in this study
* Any radiotherapy or surgery within the previous 3 weeks
* Symptomatic brain metastasis not controlled by corticosteroids
* Bone marrow metastasis
* Active infection
* Serious complications
* Receiving a concomitant treatment with drugs interacting with S-1. The following drugs are prohibited because there may be an interaction with S-1: phenytoin, potassium warfarin , flucytosine, cimetidine and folinic acid.
* Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy
Implementing Peri-operative Mobile Application for Contactless Vital Signs

The huge impact of the COVID-19 pandemic on global healthcare systems has prompted search for novel tools to stem the tide. New digital health tools can provide possible health solutions in this time of unprecedented medical crisis to mitigate the impact of this pandemic. This proof of concept study will determine the feasibility and effectiveness of implementing a mobile application for contactless measurement of vital signs (MAC-VITAL) such as blood pressure (BP), heart rate (HR), respiratory rate (RR) and oxyhemoglobin saturation (SpO2) from surgical patients peri-operatively. Contactless measurement of vital signs will bridge the current gap between virtual care and in-person medical assessments. This study aims to determine whether a mobile app can effectively measure vital signs without any person to person contact and how this technology can be implemented in a peri-operative setting during COVID-19.

This study is a prospective proof of concept study to be conducted at Toronto Western Hospital,Toronto General Hospital, Hamilton General Hospital (Hamilton, Ontario), Juravinski Hospital (Hamilton, Ontario) and Trillium Health Partners, Mississauga, Ontario. This proof of concept study will determine the feasibility and effectiveness of implementing a contactless mobile application to obtain vital signs from patients in the peri-operative setting. Informed consent to participate in the study will be obtained.

Vital signs measurement will be obtained by the research staff using hospital standard medical devices and the Anura Research App will also be used to measure vital signs. Measurement will take place before surgery and post surgery (1 ±2hrs and 2 ±4hrs after surgery).

Eligibility Criteria:
Inclusion Criteria

* Patients scheduled to undergoing elective inpatient surgery under general and/or regional anesthesia
* 18 years or older

Exclusion Criteria

* Refusal to consent for the study
* Non-English speaking.