cyrilzakka/clinical-trials huggingface dataset:
Pupil Centroid Shift Compensation in Photorefractive Keratectomy Candidates

patients who are candidates of PRK will be recruited in this intrasubject randomized clinical trial. Inclusion criteria are myopia or myopic astigmatism with refractive cylinder. Exclusion criteria were unstable refractive error, age less than 21 years old, corneal opacity, keratoconus, keratoconus suspects, residual corneal stromal thickness less than 350 µm, moderate or severe dry eye disease and any other ocular pathology other than refractive error. Complete eye exam will be performed preoperatively including: uncorrected distance visual acuity (UDVA), best spectacle corrected distance visual acuity (CDVA), cyclorefraction, slit lamp biomicroscopy, Goldmann applannation tonometry, dual scheimpflug tomography (Ziemmer), topography in mesopic condition accompanied by pupilometry and iris registration (Topolyzer Vario, Alcon Laboratories, Inc., Fort Worth, TX), and funduscopy with dilated pupil.

Surgical Technique The same surgeon (A.F.) will perform all surgeries. After installation of Tetracaine 1%, periorbital skin will be prepared with povidone iodine 5%. Iris registration will be performed in all eyes before epithelial removal. Ethylalcohol 20.0% into a 9.0 mm well for 20 seconds will be applied on the central cornea, and then the epithelium of the central 9.0 mm area will be removed by hockey knife. In the right eye of each patient PCS compensation will be turned on (PCS-On group) and in the left eye it will be turned off (PCS-Off group). Excimer laser ablation will be performed by Wavelight Allegretto EX500 (Alcon, Fort Worth, TX, USA). Selection of which eye to be first ablated will be done randomly. Randomization will be performed based on a computer software by a Biostatistician which produced the first eye to be operated. Static cyclotorsion compensation will be active in all eyes. The ablation profile will be wavefront-optimized in all cases.

Postoperative Course Postoperatively, chloramphenicol 0.5% eye drops and betamethasone 0.1% eye drops will be prescribed every 6 hours for 10 days. Thereafter, Fluorometholone 0.1% eye drops every 6 hours for 1 month and every 8 hours for the next month will be given. Follow-up examinations were scheduled at 1, 2, 3, 4, 7 and 15 days and 1, 2, 3, and 6 months postoperatively. After contact lens removal each follow-up examination includes the UDVA, manifest refraction, and IOP measurements as well as a slit lamp biomicroscopy. Corneal imaging with Galilei tomography, CDVA and cyclorefraction will be performed at the final follow-up examination 6 months postoperatively.


Eligibility Criteria:
Inclusion Criteria:

* myopia
* myopic astigmatism

Exclusion Criteria:

* unstable refractive error, age less than 21 years old
* corneal opacity
* keratoconus, keratoconus suspects
* residual corneal stromal thickness less than 350 µm
* moderate or severe dry eye disease
* any other ocular pathology other than refractive error
Parallel Comparison of 18 Gene Classifiers and Oncotype DX (Nanostring)

A recurrence index for distant recurrence (RI-DR), an 18-gene-based clinical-genomic model, has been developed for early-stage breast cancer (EBC). In this study, Investigators compared the prognostic performance of the RI-DR with the Oncotype DX (ODx) recurrence score (RS) for any recurrence risk type.

With improved diagnosis, breast cancer can now be detected at early stages, thus improving survival rates. However, overtreatment is common; considering that the risk of recurrence is low, patients may suffer from side effects without receiving the full benefits of adjuvant therapies.

To overcome the imprecision of prognosis based on clinicopathologic factors, genomic tests for breast cancer prognosis, such as the Oncotype DX® (ODx), MammaPrint®, and EndoPredict® assay kits, are frequently utilized. These multigene panels were development based on Caucasian populations, and may not suitable to Asian population due to the differences in the incidence and lifestyle of breast cancer patients from different ethic backgrounds. To fiil this gap, an 18-gene classifier (18-GC) based on the gene-expression profiling of Chinese breast cancer patients was developed

In the current study, investigators combined clinical variables and genetic information to generate a clinical-genomic model: RI-DR, a recurrence index for distant recurrence (based on a genomic model and 6 clinical variables: age, tumor size, lymph node status, estrogen receptor status, lymphovascular invasion, tumor grading).

By using tissues that have been tested with ODx, in this study, investigators evaluated the performance of the RI-DR model with that of the ODx assay in the prognosis assessment of a cohort of patients from Taiwan.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who have performed (Oncotype Dx) genetic testing methods before June 30, 2017.
2. Surgery (mastectomy or breast preservation) as the first treatment.
3. ER or PR IHC positive
4. HER2 negative
5. N0-N1 patient
6. Available with FFPE tumor tissue

Exclusion Criteria:

1. T3-T4 or N2-N3
2. With distant metastasis before surgery
3. Preoperative chemotherapy / radiotherapy
4. Insufficient FFPE tumor samples
The Efficacy of Adductor-Canal-Blockade on Pain and Morphine Consumption After Revision Knee Arthroplasty

The purpose of this study is to determine whether Adductor-Canal-Blockade is effective at reducing pain and morphine consumption after revision knee arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* Revision Knee Arthroplasty in general anaesthesia
* American society of anesthesiologists (ASA) 1-3
* BMI 18-40
* Written informed consent

Exclusion Criteria:

* Can not cooperate to the exam
* Do not speak or understand Danish
* Drug allergy
* Alcohol or drug abuse
The Effects of Diesel Exhaust Inhalation on Vascular Function - the Role of Endothelin

The purpose of this study is to identify the role of endothelin 1 (a natural vasoconstrictor) in the adverse vascular effects demonstrated after exposure to air pollution

Air pollution is a major problem, and can be linked to around 5% of all deaths worldwide each year. There are strong associations between air pollution exposure and heart disease but we do not yet understand how these harmful effects are mediated. Understanding this mechanism is likely to have a major impact on the way we treat patients with heart disease and have the potential to shape future environmental health policy. The upregulation of Endothelin-1 provides a plausible mechanism for these harmful effects, and we plan to investigate this in more depth in the human forearm following exposure to diesel exhaust.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers

Exclusion Criteria:

* Use of regular medication
* Cigarette smoking
* Significant occupational exposure to air pollution
* Intercurrent illness
Psycho-emotional Impact of Preoperative Counselling in Cervico-carcinoma Screening Programs

The communication of an altered Pap smear or positive HPV test has a strong impact on patients on a psychological level. HPV positive women are more likely to have higher level of stress, anxiety, depression and impaired sexual life.

The examiner want to establish this impact through different surveys (DASS-21 (Depression Anxiety Stress Scales); PCL-5 (Posttraumatic Stress Disorder Checklist); DTS (Dyadic Trust Scale), CDDQ (Cervical Dysplasia Distress Questionnaire) and MPI (Match Patient Inventory) from the moment the patient receives the news until after completing treatment for her intraepithelial neoplasia.


Eligibility Criteria:
Inclusion Criteria:

* patients accessing our Colposcopy service from Prevenzione Serena program with an altered pap smear or a two-times positive HPV test
* patients with biopsy result of HSIL
* ability to fill in surveys via e-mail

Exclusion Criteria:

* previous access in our Colposcopy service
* patients not enrolled in Prevenzione Serena
* pregnant patients
* inability to fill in surveys via email
* partial or total language barrier
* denied consent to participate
Evaluation of Ecallantide for the Acute Treatment of Angiotensin Converting Enzyme Inhibitor Induced Angioedema

The investigators will conduct a double-blind, randomized controlled trial comparing the safety and effectiveness of ecallantide to conventional therapy. A rescue cross-over design will be used such that patients failing to improve on standard therapy will additionally be treated with ecallantide. Therefore, a historical control cohort will be enrolled for analysis of secondary endpoints. In addition, since some patients treated with conventional therapy may improve rapidly and therefore not be eligible for inclusion in the study, the investigators will enroll these patients as an observational arm to enable the conduct of sensitivity analysis.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females of any race or ethnicity 18 or older. The locations of the study will permit all racial and ethnic distribution in the study
2. Must currently be on an ACE inhibitor
3. Presenting with ACE induced angioedema within 12 hours after onset. This is to be documented in the source document and CRF
4. All females of childbearing age must have a negative pregnancy test prior to administration of the study drug.

Exclusion Criteria:

1. Participation in another investigational study within 30 days prior to enrollment
2. Patients who improve on conventional (standard of care) therapy
3. Patients previously treated with ecallantide
4. Hypersensitivity to ecallantide
5. Pregnancy or breast feeding
6. Other definable causes of angioedema (i.e., hereditary or acquired angioedema)
7. Patients receiving C-1 inhibitor as prophylaxis
8. Treatment requiring tranexamic acid, and epsilon-aminocaproic acid
9. Receiving fresh frozen plasma within 3 days prior to enrollment
Dexmedetomidine vs Control on Attenuation Hemodynamic Response to Noxious Stimuli in CABG Surgical Patients

Aim to study efficacy of dexmedetomidine to attenuate hemodynamic response to intubation, skin incision, sternotomy and aortic cannulation

A randomized controlled trial was conduct between January2024 and March2024 at Sawanpracharak hospital, Thailand. Of 60 patients undergoing elective coronary artery bypass graft, 30 were assigned to group dexmedetomidine and 30 to group control. Dexmedetomidine prepared by anesthetist nurse in concentration 0.1 microgram/kg/ml total volume 50 ml. loading dose 60 ml/hour for 10 minutes before induction of anesthesia then 5ml/hour until the patient on cardiopulmonary bypass (loading dose 1 microgram/kg for 10 minutes then 0.5 microgram/kg/hour). Group control receive normal saline 60ml/hour for 10minutes then 5 ml/hour

Eligibility Criteria:
Inclusion Criteria:

* patients schedule for CABG
* American Society of Anesthesiologist (ASA) class II-III

Exclusion Criteria:

* anticipated difficult intubation
* body mass index\&gt; 30 kg/m2
* Ejection Fraction \&lt; 40%
* left main coronary artery occlusion \&gt;50%
* left bundle branch block
* severe valvular heart disease
* severe pulmonary, renal, hepatic disease
* neurologic disease
* preoperative medication with methyldopa or clonidine
Predictive Value of Dynamic Combination of BNP and NGAL for the Prognosis of Patients With Sepsis

Objective: to clarify the predictive value of brain natriuretic peptide (BNP) in combination with neutrophil gelatinase associated lipocalin (NGAL) for the prognosis of patients with sepsis.


Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years and \<85 years;
* presence of severe sepsis according to Survival Sepsis Campaign 10;
* all patients voluntarily joined this study with informed consents.

Exclusion Criteria:

* participated in other trials within 30 days before the criteria for this trial were met;
* expected to die within 24 hours;
* pregnant;
* advanced malignancy with life expectancy \<6 months;
* history of congestive heart failure;
* chronic renal dysfunction (baseline creatinine \>176.8μmol/L); and
* relatives were unwilling to agree to the use of full life support.
Upper GI Serial Tumour Biopsies

This is a prospective translational research study in which tumour samples, blood samples and other biospecimens will be requested from patients with locally advanced or metastatic malignant oesophageal and gastric carcinoma. There are two parts to the study:

* Part A - evaluation of serial tumour biopsies
* Part B - evaluation of circulating biomarkers and other biospecimens

This is a prospective, non-randomised, non-interventional, translational research study in which patients with locally advanced or metastatic oesophageal and gastric carcinoma will be asked to donate tissue, blood and other available biospecimens for translational and biomarker research. This is an exploratory biomarker study to generate preliminary data for future research projects incorporating identified aberrations.

The overall aims of the study are to employ serial tumour biopsies, blood borne biomarkers and other biospecimens to investigate mechanisms of resistance to systemic therapy and develop predictive biomarkers of this resistance in patients with locally advanced and metastatic malignant oesophageal and gastric carcinoma. Blood biomarkers will include enumeration and characterisation of circulating blood cell subtypes, as well as the evaluation of circulating cell-free proteins and nucleic acids. Other biospecimens include urine, stool and hair follicle samples that the patient is willing to donate for research purposes, and ascitic, pleural, pericardial or cerebral spinal fluid, available to collect as part of clinically indicated procedures (standard care) and surplus to routine clinical requirements. These other biospecimens would be stored at the Biobank.

Eligibility Criteria:
Inclusion Criteria:

1. Age of 18 years or more.
2. Patients must have given written informed consent.
3. Evidence of locally advanced or metastatic oesophageal and gastric carcinoma, i.e. stage III or IV disease.
4. Accessible tumour that can be safely biopsied using radiological or surgical techniques (if consenting to part A).
5. Full blood count and coagulation tests within acceptable parameters (if consenting to part A).

Exclusion Criteria:

1. Inability to provide informed consent.
2. History of significant bleeding disorder (patients on anticoagulation are eligible if the anticoagulation can be safely managed to allow fresh tumour biopsies and blood sampling).
3. History of HIV, Hepatitis B/C or other transmissible human disease.
4. Any conditions where research biopsies or blood sampling may increase risk of complications for the patient and/or investigator, including high risk groups such as intravenous drug users.
High Dose Versus Standard Dose Proton Pump Inhibitor (PPI) in High-risk Bleeding Peptic Ulcers After Combined Endoscopic Treatment

The study was designed to evaluate the efficacy an adjuvant use of standard dose or high dose of proton pump inhibitor after combined endoscopic hemostasis therapy.

Acute peptic ulcer bleeding remains the most common cause of acute upper gastrointestinal bleeding. Endoscopy serves as a tool for initial diagnosis and triage and also a tool for immediate hemostasis, especially for high-risk lesions. High-risk lesions include peptic ulcers with active spurting vessel, oozing vessel, or NBVV, nonbleeding visible vessel. Current modalities of endoscopic hemostasis include epinephrine injection, endoscopic coaptive thermocoagulation, hemoclipping. Endoscopic hemostasis has been documented by a number of clinical studies to be effective in decreasing rebleeding, need for emergency surgery, decreasing hospitalization days. Current evidence also shows that combination therapy with epinephrine injection and heater probe thermocoagulation/hemo-clip hemostasis is more effective than epinephrine injection alone or than heater probe thermocoagulation alone, or than hemoclip hemostasis alone. Studies showed a high dose intravenous proton pump inhibitor infusion after initial endoscopic hemostasis reduced recurrent ulcer bleeding. However, it was still controversial whether an adjuvant use of standard-dose proton pump inhibitor therapy to endoscopic therapy had similar benefit. We hypothesized that an adjuvant use of standard dose of proton pump inhibitor after combined endoscopic hemostasis therapy offer similar benefit as high dose proton pump inhibitor did.

Eligibility Criteria:
Inclusion Criteria:

* adults aged above 16 years old with acute nonvariceal upper gastrointestinal bleeding
* read, agree to attend the study, and signed informed consent indicated to receive esophagogastroduodenoscopy(EGD)
* peptic ulcers with high risk lesions (active bleeding: spurting, oozing peptic ulcers. Ulcers with NBVV: nonbleeding visible vessel)

Exclusion Criteria:

* unable to receive EGD (unable to open mouth, upper gastrointestinal obstruction)
* bleeding tendency (platelet \< 50x109/L, prothrombin time INR \>2, ongoing use of heparin or coumadin)
* gastric malignancy
* myocardial infarction within recent one week
* recent cerebrovascular event within recent one week
* pregnancy
* refuse to attend the study
* known allergy history to epinephrine or pantoprazole
Drug-drug Interaction Study(Lobeglitazone, Warfarin)

The purpose of this study is to evaluate a pharmacokinetic drug interaction between lobeglitazone and warfarin in healthy subjects.

From day 1 to day 12, lobeglitazone 0.5mg is administered daily to Group 1 subjects during period 1. Then on day 5,warfarin 25mg is co-administered Group 1 subjects at period 1. After 10 day-break, warfarin 25mg is administered Group 1 subjects at period 2. On period 2, lobeglitazone is not administered.

Group 2 is administered in reverse order.

Eligibility Criteria:
Inclusion Criteria:

* A healthy male volunteer between 19 and 55 years old.
* BMI between 19 and 27.
* Signed the informed consent form prior to study participation.
* Able to participate in the entire trial

Exclusion Criteria:

* Clinically significant hepatic, renal, digestive system, respiratory system, endocrine system, nervous system, hematologic, cardiovascular system, tumor or have history of tumor
* Clinically significant hemorrhagic disease
* Genetic problems such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
* Have hypersensitivity reactions history for lobeglitazone, warfarin, excipient of IP or aspirin, antibiotics
* Medication which might significantly alter the absorption, distribution, metabolism, or excretion of investigational products within 30 days prior to screening
* Participated in the other clinical trials and administrated IP within 60 days prior to screening
* Subject takes ethical drug or herbal medicine within 14 days, OTC within 7 days before screening
* Previously donate whole blood within 60 days or component blood within 30 days
* sit SBP \< 90mmHg or sit SBP ≥ 140mmHg or sit DBP \< 60mmHg or sit DBP ≥ 90mmHg
* A heavy alcohol consumer (alcohol \> 140 g/week) or cannot stop drinking
* A heavy smoker (cigarette \> 10 cigarettes per day) or cannot stop smoking
* A heavy caffeine consumer (more than 4cups per a day) or A heavy grapefruit consumer (more than 1cup per a day) or cannot stop having
* Positive for the Triage TOX drug on urine
* Positive for HIV antibody, HBsAg, HCV antibody test
* AST, ALT or Total bilirubin \> UNL \* 1.5
* Estimated GFR \< normal limit
* INR, aPTT over the normal limit
* Clinically significant laboratory test result
* Clinically significant ECG
* An impossible one who participates in clinical trial by investigator's decision including other reason
Coronary Artery Bypass and Nitrate Oral Supplementation

The purpose of this study is to determine whether oral sodium nitrate administration prior to coronary artery bypass surgery can reduce perioperative levels of troponin T. In addition, plasma and urine surrogate markers of renal, hepatic and brain injury will be monitored.

Nitric oxide (NO) is an important mediator in the cardiovascular system and has been shown to have protective properties in ischemia-reperfusion injury. Inorganic nitrate, an oxidation product from endogenous NO production and also a constituent in green leafy vegetables, can be recycled, via nitrite, back to bioactive NO in the body. Recent research has shown beneficial effects of nitrate and nitrite in animal models of myocardial ischemia-reperfusion injury. Moreover, dietary nitrate reduces blood pressure and oxygen cost during exercise in humans.

During coronary bypass surgery the heart undergoes ischemia-reperfusion injury and troponin T is most often released from the myocardium. The aim of the present study is to investigate if preoperative inorganic nitrate, in doses easily achievable from the diet, can affect troponin T release as well as other surrogate markers of injury to the liver, kidneys and the brain. In addition, plasma and urine samples will be collected for markers of oxidative stress and inflammation (sCRP and cytokines). Patients planned for bypass surgery who give their written informed consent will, the night before surgery, get a standardized, low-nitrate meal where after they receive sodium nitrate on two occasions preoperatively; the night before and in the morning before surgery. Plasma and urine samples will be collected at various time points up to 72 hours after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing coronary artery bypass surgery
* Over 18 years of age

Exclusion Criteria:

* Over 80 years of age
* Pregnancy
* Reoperation
* Intended heart valve or additional surgery
* Angina or troponin release above 45 nmol/L \< 48 hours before surgery
* Medication with organic nitrates/nitrites \< 24 hours before surgery
* Medication with glibenclamide or corticosteroids
* Significant renal, pulmonary or hepatic disease
Evaluating The Effects Of Cimetidine On The Elimination Of PD 0332334 From The Body

The purpose of this study is to estimate the effects of multiple doses of cimetidine on the pharmacokinetics of a single dose of PD 0332334 and to evaluate the safety and tolerability of PD 0332334 when co-administered with cimetidine.

Detailed Description:

Additional Study Purpose Details: Evaluate the effects of multiple doses of cimetidine on the pharmacokinetics (e.g., elimination from the body) of a single dose of PD 0332334.

On February 18th 2009, a decision to terminate further development for PD 0332334 was communicated to investigators in this study. The decision to terminate this study was not based on any safety concerns.

Eligibility Criteria:
Inclusion Criteria:

* healthy
* male or female adults

Exclusion Criteria:

* Current or history of clinically significant medical illness
* Smokers
* Illicit drug use