cyrilzakka/clinical-trials huggingface dataset:
Ketorolac vs. Steroid in the Prevention of CME

Evaluate if the incidence of sub clinical CME can be significantly reduced by use of peri-operative Acular LS plus Pred Forte when compared with Pred Forte alone in normal cataract patients.


Eligibility Criteria:
Inclusion Criteria:

* · Male or female \> 18 years of age scheduled to undergo cataract surgery with surgeon expectation of 20/20 BCVA postoperatively

  * Must be in good general health. Patients with systemic diseases will be enrolled only if there are no ocular manifestations of their disease (ie diabetics with normal retinal exams)
  * Ability to provide informed consent and likely to complete all study visits

Exclusion Criteria:

* · Known contraindication to any study medication or any of their components

  * Uncontrolled systemic disease
  * Required use of ocular medications other than the study medications during the study
  * Abnormal pre-operative OCTs if obtainable
  * Diabetic patients with a history of macular edema or diabetic retinopathy
  * AMD patients with less than a 20/20 surgical outcome expectation, epi-retinal membranes, retinal vein occlusion, or any pre-existing macular disease
Dosage Calculation for Vitamin D Treatment

Severe vitamin D deficiency can be treated with oral loading doses of cholecalciferol. Our objective was to determine how to calculate the quantity of cholecalciferol needed for supplementation by single algorithm, usable on a patient-to-patient basis.

We've conducted two studies. Study 1 was done retroactively and included 88 patients treated for low vitamin D, 60 of those with a loading dose. The second study included 29 patients and aimed to test the validity of an algorithm based on data from study 1, which included patient BMI. Both studies used oral loading doses and daily supplementation of cholecalciferol.


Eligibility Criteria:
Inclusion Criteria:

* severe hypovitaminosis D (25OH-vit.D \<25 nmol/L)

Exclusion Criteria:

* Malabsorption
* Renal disease
* Other treatment with vitamin D related products
* Patients with a recent travel history with suspected increased sun exposure
A Diagnostic Prediction Model for Prostate Cancer in Patients With PI-RADS Score 3

The goal of this observational study is to construct a predictive model for improving the diagnostic accuracy in patients with PI-RADS score of 3. The main aims of this study are:

* Construct a diagnostic model of patients with PI-RADS of score.
* Internal and external validation of the model.
* Decision curve analysis. The data of participants was collected retrospectively.

For patients with a PI-RADS score of 3, the diagnosis of prostate cancer is still use prostate biopsy, but the detection rates of prostate cancer and clinically significant prostate cancer are approximately 30% and 15%. It can be seen that most patients with PI-RADS 3 undergo unnecessary prostate biopsy and bear the risk of complications such as urinary tract infection. This makes most patients with PI-RADS 3 choose to refuse invasive prostate biopsy. Although researchers are committed to exploring biomarkers with high sensitivity and specificity, the application of biomarkers alone often cannot achieve the expected results. At present, the guidelines have recommended the use of diagnostic prediction models to assess patients' prostate cancer risk. Doctors and patients use diagnostic models to assess the risk of prostate cancer before prostate biopsy. For patients with a low probability of cancer, biopsy can be temporarily avoided, which to a certain extent reduces the phenomenon of prostate cancer overdiagnosis. This study plans to work with multiple medical centers to conduct statistical analysis based on existing prostate cancer screening markers combined with patients' clinical data such as prostate volume, prostate-specific antigen density, apparent diffusion coefficient, PI-RADS score and postoperative Gleason score, and then construct a prostate cancer diagnostic model to improve the diagnostic accuracy of prostate cancer for patients with PI-RADS score of 3. This will be of great significance for improving the early diagnosis of patients with PI-RADS 3 and reducing unnecessary prostate puncture biopsies.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with clinically suspected prostate cancer (abnormal PSA level or DRE);
2. All patients have undergone mpMRI and have complete imaging data;
3. The PI-RADS score of patients was 3;
4. Prostate biopsy was performed and has clear pathological results.

Exclusion Criteria:

1. The patient's serum tPSA is \<4ng/ml or \>100ng/ml;
2. Repeated prostate biopsy;
3. The patient's clinical, imaging, or pathological data are incomplete.
Optimal Dosage of Acetazolamide for OSA Treatment

Acetazolamide, a carbonic anhydrase inhibitor, has received some attention as potential treatment for obstructive sleep apnea (OSA). It produces a metabolic acidosis by excreting bicarbonate, thereby stimulating baseline ventilation. Evidence suggests that acetazolamide primarily improves ventilatory control instability (expressed as loop gain), which is an important contributor to the pathophysiology of OSA.

Few studies have assessed the efficacy of acetazolamide in patients with OSA. Since most of them had a small sample size and used different therapeutic dosages, clinical applications are currently limited. Therefore, this study aims to compare the effect of two acetazolamide dosages on the severity and pathophysiology of OSA.

In this double-blind, parallel-group, controlled trial, eligible patients will be randomized into one of the following treatment arms: (1) placebo, (2) 250 mg of acetazolamide, or (3) 500 mg of acetazolamide. After 4 weeks, treatment outcome will be assessed by in-laboratory polysomnography. Additionally, arterial blood gas analysis and lung function tests will be performed before and during treatment.

Eligibility Criteria:
Inclusion Criteria:

* AHI between 15 and 65 events/hour
* BMI \< 35 kg/m²

Exclusion Criteria:

* Craniofacial anomalies
* Central sleep apnea (defined as central AHI \> 25% of total AHI)
* Contra-indications related to acetazolamide treatment

  * Hypersensitivity to sulphonamides or acetazolamide
  * Renal impairment, electrolyte imbalances, and/or adrenocortical insufficiency
  * Clinically significant metabolic, hepatic, and/or hematological disease
  * Chronic obstructive pulmonary disease
  * Closed-angle glaucoma
* Conditions likely to affect OSA physiology: neuromuscular disease or other major neurological disorders, heart failure, or any other unstable major medical condition.
* Intake of drugs that substantially stimulate or depress respiration, including benzodiazepines, opioids, theophylline, and pseudoephedrine
* Inadequately treated sleep disorders other than OSA that would confound functional sleep assessment
* Inability of the patient to understand and/or comply to the study procedures
* Active psychiatric disease (psychotic illness, major depression, anxiety attacks, alcohol or drug abuse)
* Pregnancy
Trial of BIBF1120 (Nintedanib) in Patients With Recurrent or Metastatic Salivary Gland Cancer of the Head and Neck

Recently, sorafenib which can target VEGFR and PDGFR demonstrated 13-16% of response rate in patients with recurrent/metastatic salivary gland cancers, suggesting that VEGFR and PDGFR might be important role in salivary gland cancers. Accordingly, several trials with various anti-angiogenic molecular targeted agents such as dasatinib, dovitinib, or sunitinib in salivary gland cancer are ongoing.

Nintedanib (BIBF1120) is a potent small molecule triple receptor tyrosine kinase inhibitor (PDGFR/ FGFR1-2 and VEGFR1-3). VEGFR-2 is considered to be the crucial receptor involved in initiation of the formation as well as the maintenance of tumor vasculature. In vitro, the target receptors are all inhibited by nintedanib in low nanomolar concentrations. In in vivo nude mouse models, nintedanib showed good anti-tumor efficacy at doses of 50-100mg/kg, leading to a substantial delay of tumor growth or even complete tumor stasis in xenografts of a broad range of differing human tumors.

Based on this background, in this study, the investigators would like to conduct a phase II study of Nintedanib (BIBF 1120) in patients with recurrent or metastatic salivary gland cancer of the head and neck to evaluate efficacy and safety.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven salivary gland cancer of the head and neck (According to WHO classification, mucoepidermoid cancer, adenoid cystic carcinoma, or adenocarcinoma/salivary duct cancer are eligible)
* Recurrent or metastatic salivary gland cancer of the head and neck patients who failed one line of systemic chemotherapy
* age ≥ 18 years
* At least one measurable tumor lesion according to RECIST 1.1
* ECOG performance status 0-2
* Adequate hematologic function (absolute neutrophil count \> 1,500/m/, platelets \> 100,000/ml, haemoglobin \> 9.0 g/dl), hepatic function (alanine transaminase/aspartate transaminase \< 5 x ULN, total bilirubin \< 1.5 x ULN), renal function (creatinine clearance \> 45 ml/min)
* Written informed consent

Exclusion Criteria:

* Uncontrolled systemic illness such as DM, CHF, unstable angina, hypertension, history or myocardial infarction in the 12 months prior to the start of the treatment, or arrhythmia
* Hemorrhagic or thromboembolic events in the past 6 months
* Major injuries in the 10 days prior to start of the study
* Patients with post-obstructive pneumonia or uncontrolled serious infection
* Pregnant or nursing women
* Uncontrolled symptomatic brain metastasis
* Prior history of malignancy within 5 years from study entry except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, and well treated thyroid cancer
The Prevalence of Lung Cancer in Patients With Interstitial Lung Disease

The investigators will evaluate the prevalence of lung cancer associated with interstitial lung disease (ILD) and idiopathic pulmonary fibrosis (IPF) utilizing the Korean Health Insurance Review and Assessment Service (HIRA) database, spanning the period from January 2011 to December 2011. The database (HIRA-NPS-2011-0001) was based on random sampling of outpatients from whole population. Patients with ILDs, IPF, connective tissue disorder (CTD), and COPD were identified based on the International Classification of Disease-10 (ICD-10) diagnostic codes.

The epidemiology of lung cancer related to interstitial lung disease (ILD) with or without with connective tissue disease (CTD) as well as idiopathic pulmonary fibrosis (IPF) has not been well established yet. Interstitial lung disease has a potential to develop lung cancer in the name of scar cancer. The investigators aimed to explore prevalence of lung cancer in patients with ILD with or without CTD and IPF in comparison with chronic obstructive pulmonary disorder (COPD).

The investigators will evaluate the prevalence of lung cancer associated with ILD and IPF utilizing the Korean Health Insurance Review and Assessment Service (HIRA) database, spanning the period from January 2011 to December 2011. The database (HIRA-NPS-2011-0001) was based on random sampling of outpatients from whole population. The sample cases are total 1,375,842. Among them 670,258 cases (age \> 40) were evaluated. Patients with ILDs, IPF, CTD, and COPD will be identified based on the International Classification of Disease-10 (ICD-10) diagnostic codes.

Eligibility Criteria:
Inclusion Criteria:

* equal to above 40 years old

Exclusion Criteria:

* none
Snore Positive Airway Pressure Trial

This study will aim to assess the acceptance of the Snore PAP system as a treatment concept for snore. The study will subjectively assess participant and bed partner acceptability and usability of the Snore PAP system and objectively assess participant compliance with the Snore PAP system.


Eligibility Criteria:
Inclusion Criteria

* Participants willing to provide written informed consent
* Participants who can read and comprehend written and spoken English
* Participants who are ≥ 18 years of age
* Participants are CPAP naïve
* Participants who are self/ partner reported snorers
* Participants whose ApneaLink study results demonstrate snore
* Participants who are willing to use Nice system in place of current non prescribed methods for alleviating snore
* Participants have a bed partner
* Participant's bed partner willing to answer assessment questionnaire

Exclusion Criteria

* Participants previously diagnosed with obstructive or central sleep apnoea
* Participants whose ApneaLink home study indicates AHI ≥6
* Participants who are pregnant or breastfeeding
* Participants who have a pre-existing lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (\< 2years) case of pneumonia or lung infection; lung injury)
* Participants with severe bullous lung disease, history of pneumothorax, pathologically low blood pressure, dehydration, cerebrospinal fluid leak, recent cranial surgery or trauma.
* Participants who cannot participate for the duration of the trial
* Participants who are established on bi-level support therapy
* Participants currently using a prescribed medication/ device to alleviate snore
* Participants who are physically unable to comply with the protocol- no access to internet to conduct online visits with researcher or unable to attend clinic for visit
Influence of NEP Inhibition on Vascular Leak and Inflammation (NEPi-INFLAMMATION)

Acute Respiratory Distress Syndrome (ARDS) is a severe type of lung injury that affects 10% of patients admitted to Intensive Care Units worldwide, with an unacceptably high mortality of up to 48% in those with the most severe form of the condition. It is a complex and poorly understood syndrome that results in progressive failure of the lungs. Crucially, the inflamed lungs allow fluid to leak from the circulation into the airspace, so that patients' lungs fill with fluid - "drowning from the inside". As this condition progresses, the patient typically requires increasing amounts of oxygen and eventually, support from a ventilator. To date, there are no effective treatments for ARDS that can limit, stop or repair this process.

This research study is aiming to look at a naturally occurring substance produced by blood vessels, C-type natriuretic peptide (CNP). The investigators have evidence suggesting that CNP plays a role in maintaining the barrier provided by blood vessels that stops fluid leaking out into tissues. This is based on various studies done on CNP by the investigators research group that have established its widespread role in maintaining cells that line blood vessels and play a vital role in lungs' barrier function: the endothelium.

CNP is broken down in part by an enzyme called Neutral endopeptidase and therefore, drugs that inhibit this enzyme would result in increased CNP concentration and activity. If CNP does in fact strengthen the lungs' endothelial barrier, then this class of drug may benefit patients with ARDS. The aim of this experimental medicine study is to assess the effect of using the licensed NEP inhibitor Racecadotril, in a well-established, safe model of inflammation-induced skin blisters in healthy human volunteers to determine primarily whether the fluid accumulation i.e. leak, in these blisters is reduced by treatment with this drug.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male and female volunteers
2. BMI of 18-40 kg/m2
3. Aged 18-45
4. Volunteers who are willing to sign the consent form

Exclusion Criteria:

1. Healthy subjects unwilling to consent
2. Smokers
3. Known sensitivity to Racecadotril
4. History of any serious illnesses, including recent infections or trauma
5. A personal history of keloid scarring, or a family history of keloid scarring in a first degree relative with similar skin pigmentation
6. Subjects taking systemic medication (other than the oral contraceptive pill)
7. Subjects who are pregnant or any possibility that a subject may be pregnant, unless in the latter case a pregnancy test is performed with a negative result
8. Women who are breastfeeding
9. Subjects with recent or current antibiotic use
10. Subjects with a history of skins conditions.
11. Subjects with a history of allergic reaction to any topical application or history of angioedema
12. Subjects with any history of a blood-borne infectious disease such Hepatitis B or C virus, or HIV.
Methylated Biomarkers Predictive of Endometrial Cancer Risk

The goal of this observational study is to identify endometrial cancer risk predictive biomarkers and to optimise the methodology for their detection and quantification in non-invasive samples.


Eligibility Criteria:
Inclusion Criteria:

1. Women aged 45-70 years
2. Attending St Mary's Hospital, Manchester for an elective hysterectomy by any route for either the treatment of endometrial cancer or a benign gynaecological condition
3. Able to consent to participation in the study

Exclusion Criteria:

1. Presence of malignancy asides from endometrial cancer
2. Undergoing elective hysterectomy for suspected ovarian cancer
Blood, Hair and Lung Concentrations of Metals and Metalloids in Patients With Lung Cancer or Chronic Obstructive Pulmonary Disease

Prospective research to study the relationship between concentrations of metals/metalloids in blood, hair and lung tissue with the occurence of lung cancer or chronic obstructive pulmonary disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients of 18 to 75 years of age.
* Patients admitted for lung resection (either cancerous or non-cancerous) or lung transplant

Exclusion Criteria:

* Patients with mental or physical conditions that prevent them giving their agreement for the study
Metformin and Pioglitazone Effects on Fetuin-A and Osteoprotegrin Concentrations in Type 2 Diabetes Patients

Oral hypoglycemic agents, along with dietary modification and exercise encompass the mainstay of treatment in early stages of T2DM. Biguanides and thiazolidinediones are two major groups of hypoglycemic medications that while function via different pathways, mare both effective in short- and long-term glucose control. These medications diminish or delay long term micro- and macrovascular complications associated with T2DM although at different rates. Excessive insulin resistance accounts for a sustained increase in cardiovascular incidents in T2DM subjects. Given the shared pathway of insulin resistance/fetuin-A/OPG in atherosclerosis formation, it is conceivable that insulin sensitizing anti-diabetes medications are able to modify successive CAD risk via direct and indirect amelioration of insulin resistance/fetuin-A/OPG. The present study is therefore designed to investigate the effects of metformin and pioglitazone monotherapy on serum concentrations of fetuin-A and OPG in a group of Iranian adults with newly diagnosed T2DM.


Eligibility Criteria:
Inclusion Criteria:

Newly diagnosed type 2 diabetes patients based on American Diabetes Association criteria (2011) for diagnosis of diabetes

Exclusion Criteria:

Previous intake of oral hypoglycemic agents for treatment of diabetes or other hyperglycemia associated conditions Intake of glucocorticoids in the past one year Major illnesses of heart, lung, kidney, and liver.
A Clinical Study of the Paradise™ Renal Denervation System in Patients with Hypertension (RADIANCE-HTN DUO)

To compare the antihypertensive effect of renal denervation with the Paradise™ system with that of a sham procedure in hypertensive patients receiving two antihypertensive drugs at the time of consent, and treated with a duo combination antihypertensive pill.


Eligibility Criteria:
Inclusion Criteria :

* Patients who have received antihypertensive treatment with two antihypertensive drugs (ARB/ACE inhibitor and Ca channel antagonist, either as a single agent or as a combination) for at least 4 weeks prior to obtaining consent, with no change in the type or dosage.
* Patients with a mean seated office blood pressure of between 140 mmHg and 180 mmHg systolic and between 90 mmHg and 110 mmHg diastolic at screening visit.
* Patients with a mean 24-hour ABPM (ambulatory blood pressure measurement) of between 130 mmHg and 170 mmHg systolic and between 80 mmHg and 105 mmHg diastolic at baseline visit

Exclusion Criteria

* Lacks appropriate renal artery anatomy for renal denervation
* Secondary hypertension other than sleep apnea
* Type 1 diabetes mellitus or uncontrolled Type 2 diabetes
* Any history of cerebrovascular event or severe cardiovascular event, within 6 months prior to consent
* Repeated hospitalization for hypertensive crisis (twice or more) within 12 months prior to obtaining consent, or any hospitalization for hypertensive crisis within 3 months prior to obtaining consent
* Patients prescribed to drugs that have antihypertensive effects for other chronic diseases, and the investigator considers that discontinuation of these drugs may pose a serious risk to health
* Patients who are taking drugs known to affect blood pressure and the investigator judges that it is not possible to discontinue these drugs during the study period
* Patients with a history of persistent or permanent atrial tachyarrhythmia
* Patients with active implantable medical devices
* Primary pulmonary hypertension
* Patients with contraindications or unacceptable anaphylactic reactions or uncontrolled allergy to contrast media
* Night shift workers
* Pregnant, nursing or planning to become pregnant
* Patients with any of the following central laboratory tests at screening

  * Plasma aldosterone/renin ratio greater than or equal to 200 and plasma aldosterone greater than or equal to 60 pg/ml
  * HbA1c greater than or equal to 8.0%
  * eGFR less than 40 mL/min/1.73m2
Comparing the Effect of Online and Conventional Oral Health Education in Egypt

This study aims to compare the results of online oral health education and conventional oral health education methods in terms of their effectiveness towards improving the knowledge and practice of oral hygiene in primary school children in Egypt.

This study is done in two schools in Egypt, in 3rd and 4th grade respectfully. The classrooms in each grade will be randomly assigned to each of the two groups (online and conventional oral health education). A questionnaire that assesses knowledge and attitude towards self oral care will be administered by the primary investigator before and after the oral health education sessions. The pre and post questionnaires will be compared in terms of results to evaluate the effectiveness of both methods.


Eligibility Criteria:
Inclusion Criteria:

* 3rd and 4th grade Egyptian students.
* Average of age 7-10 years old.
* Currently residing in Egypt.
* Both male and female students.

Exclusion Criteria:

* Those who do not consent to participate in the study.
* Those who cannot speak English or Arabic.
* Non-Egyptians
Effectiveness of Dog-Assisted Therapy on Compliance and Home Oral Hygiene Activities in Disabled Patients

Recent scientific studies have shown how interaction with an animal can alleviate particular conditions of stress and conflict, thus representing a solid support for minor patients with social behavior problems or with physical or mental disabilities. In this co-therapy, a fundamental role is played by the relationship that is established between the human being and the animal, a very particular relationship capable of bringing about positive changes, in both members, but especially in the man who, benefiting from this push for change, can improve his own situation, whatever it is, and follow with greater interest and involvement the actual therapy activities proposed by the team that is following him.


Eligibility Criteria:
Inclusion Criteria:

* Patients had to be between 5 and 16 years old;
* Patients with disability;
* Non-collaborating or with limited collaboration (Frankl Scale 1 or 2);
* Patients with a Plaque Control Record (PCR) of 40% or more;
* Patients with partial autonomy in home oral hygiene procedures.

Exclusion Criteria:

* Patients with fear of dogs;
* Patients with dog hair allergy;
* Patients with infectious disease;
* Tetraplegic and visually impaired subjects.