cyrilzakka/clinical-trials huggingface dataset:
Effect of SIMBRINZA® Suspension as an Added Therapy to TRAVATAN Z®

The purpose of this study is to demonstrate the additive effect of brinzolamide 1%/brimonidine 0.2% (SIMBRINZA® suspension) in subjects with either open angle glaucoma or ocular hypertension who are currently on a prostaglandin analogue (PGA) monotherapy (TRAVATAN Z®).

This study was divided into 2 sequential phases. The Screening/Eligibility Phase included one Screening Visit and two Eligibility Visits, during which subjects washed out of all other intraocular pressure (IOP)-lowering medications and dosed with TRAVATAN Z®, 1 drop instilled in each eye once daily for 28 days. Subjects who met all inclusion/exclusion criteria were randomized at the second Eligibility Visit. The Treatment Phase consisted of two on-therapy visits (Week 2 and Week 6).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of open angle glaucoma or ocular hypertension;
* Mean IOP measurements in at least 1 eye (study eye) of ≥ 21 mmHg and \<32 mmHg at 8 AM while on travoprost monotherapy at 2 consecutive visits (Eligibility 1 and Eligibility 2);
* Able to understand and sign Informed Consent form;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Women of childbearing potential who are pregnant, breastfeeding, or do not agree to use an adequate birth control method throughout the study;
* Any form of glaucoma other than open angle glaucoma or ocular hypertension;
* Severe central visual field loss;
* Chronic, recurrent, or severe inflammatory eye disease;
* Ocular trauma within the past 6 months;
* Ocular infection or ocular inflammation within the past 3 months;
* Best-corrected visual acuity score worse than approximately 20/80 Snellen;
* Eye surgery within the past 6 months;
* Any condition, including severe illness, which would make the subject unsuitable for the study in the opinion of the Investigator;
* Use of any additional topical or systemic ocular hypertensive medication during the study;
* Patients who, in the opinion of the Investigator, cannot discontinue all IOP-lowering ocular medication(s) per the appropriate washout schedule prior to Eligibility 1 Visit;
* Other protocol-defined exclusion criteria may apply.
Study Evaluating of Calcineurin Inhibitor and Sirolimus (Rapamune) Treatment in Liver Transplant Recipients

The purpose of this study is to evaluate the sirolimus conversion regimen as compared with the calcineurin inhibitor continuation regimen with regards to renal function in stable liver transplant subjects.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than 13 years (age greater than 18 years as required by some local regulations).
* Receiving immunosuppressive therapy with calcineurin inhibitors (CI) +/- corticosteroids +/- antimetabolite.
* 6 to 144 months after orthotopic liver transplantation.
* Cockcroft-Gault GFR values ≥40 mL/min and ≤90mL/min at screening

Exclusion Criteria:

* History of nonhepatic transplantation
* Evidence of systemic infection (sepsis, bacteremia, pneumonia etc).
* Known or suspected malignancy \< 5 years before random assignment.
Pilot Trial: Comparison of Flow Patterns

The purpose of this study is to determine why sutureless aortic bioprostheses apparently offer better haemodynamic properties compared to sewed-in aortic bioprostheses in patients who underwent aortic valve replacement.

Our approach to address this question is the combination of clinical data with the application of specifically validated experimental and computer based analyses to compare the performance of these valves under patient-specific conditions.


Eligibility Criteria:
Inclusion Criteria:

* Patient underwent open aortic valve replacement with either an Edwards Magna Ease or an Edwards Intuity valve
* Implanted valve size 23mm
* Surgical access via full sternotomy or hemisternotomy
* Intuity Valve System implanted by one of the clinical investigators of the TRITON trial (http://clinicaltrials.gov/show/NCT01445171) at the Medical University of Vienna
* Post-operative ejection fraction ≥50%
* Sinus-Rhythm
* Ability to understand and comply with study procedures
* Signed informed consent

Exclusion Criteria:

* Under 18 years of age
* Emergency surgery
* Pregnancy
* Previous aortic root replacement
* Previous aortic valve replacement
* Previous or concomitant root enlargement
* Previous or concomitant repair of the ascending aorta
* Paravalvular leakage
* Ectasia of the ascending aorta
* Previous or concomitant myomectomy
* Concomitant replacement or repair of valves other than aortic
* Usage of more than 3 sutures for implantation of the Intuity Valve System
* Heavily calcified aortic root
* Glomerular filtration rate (GFR) \< 30 ml/min
* Inability to understand or comply with study procedures
* Known allergic reaction to iodinated, non-ionic contrast agents
Biomarkers in Exhaled Breath of Glucose Fluctuation in Type 1 Diabetes

The investigators are investigating the "biochemical fingerprint" of hypoglycemia (low blood sugar) in the breath of people with type 1 diabetes.

The investigators aim through the use of proton-transfer-reaction mass spectrometry to perform comprehensive breath analysis to identify compounds of interest associated with glucose fluctuations. More than 500 different volatile organic compounds can be detected in human breath. Compounds such as ethane, pentane and isoprene (hydrocarbons), as well as acetone, acetaldehyde, methanol, ethanol, 2-propanol (oxygen-containing compounds), are most likely to be relevant and measurable in our study population. Hydrocarbons are stable end-products of lipid peroxidation and show only low solubility in blood and therefor are excreted into breath within minutes of their formation in tissues. There is evidence for increased hydrocarbon production in states of oxidative stress. Oxygen-containing compounds such as acetone/acetaldehyde (ketones) are also clinically relevant in the measurement of insulin deficient states of catabolism in patients with diabetes. A previous study of exhaled isoprene was found to be elevated during hypoglycemia. This study aims to expand on this to characterize the full range of changes in concentrations of volatile organic compounds in human breath during glucose fluctuations.

Characterizing this "biochemical fingerprint" of hypoglycemia may provide clues about what so-called diabetes alert dogs are detecting as well as improve our understanding of hypoglycemia, the physiology behind hypoglycemia unawareness, and potentially identify a novel non-invasive measure of blood glucose.

Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of type 1 diabetes
* No current or planned tobacco/nicotine use including vaping during the study
* Are not pregnant or planning to become pregnant during the study timeframe

Exclusion Criteria:

-
The Effect of Deep Inhalation on Mannitol Responsiveness

The study will assess how the inhalation technique used (deep inhalations versus tidal breathing) influences the results of a mannitol challenge test and a methacholine challenge test, if at all.

This study will look at airway responsiveness to inhaled methacholine and mannitol administered with and without deep inhalation. This study will also investigate the role of airway inflammation on these responses, using sputum differential cell counts and fractional exhaled nitric oxide.

This is a single center, open label, randomized study. Individuals with stable asthma will be eligible for enrollment. The study will consist of two parts, screening and testing.

Part 1: Screening

Participants will undergo consent procedures and assessments of fractional exhaled nitric oxide levels, airway responsiveness to methacholine and sputum induction. If participants show airway responsiveness to methacholine (i.e. methacholine PC20 16mg/mL), they will be scheduled to undergo the testing part of the study.

Part 2: Testing

Participants will be randomized to undergo two methacholine or two mannitol challenges. Further randomization will occur with respect to whether the standard challenge method or the modified challenge method is performed first.

Eligibility Criteria:
Inclusion Criteria:

* signed informed consent
* men and women between 18 and 75 years of age
* FEV1 at first measurement of greater than or equal to 65% predicted
* methacholine provocative concentration causing a 20% in FEV1 at screening that is less than or equal to 16mg/ml
* generally good health
* stable asthma

Exclusion Criteria:

* respiratory infection within 4 weeks of screening visit
* worsening of asthma within 4 weeks of screening visit
* lung disease other than asthma
* significant medical comorbidity
* current smoker or ex-smoker with significant smoking history
* currently pregnant or breastfeeding
Encapsulated Flavour Effects on Satiety

The purpose of this study is to evaluate the satiating effects of different gummies with encapsulated flavour on overweight subjects (BMI ≥25 and \<30 kg / m2). Some studies have shown that the contribution of different flavours could reduce food intake. This have made grown the interest of food industry in incorporate these compounds in food and to being able to develop new functional foods into the control of body weight, as well as variables of glucose metabolism and lipid profile, which can contribute to te prevention of cardiovascular diseases.

A randomized, cross-over and double-blind pilot study with 3 study arms is being performed to evaluate the satiating properties of the encapsulated flavours in different gummies in a group of healthy overweight subjects.

The investigators included 12 participants (6 men and 6 women) between 18 and 55 years (BMI ≥25 and \<30 kg / m2). All volunteers will be randomized into 3 study groups, and participants will receive the 3 different study products in order during the 3 experimental phases.

Eligibility Criteria:
Inclusion Criteria:

* Men and women from 18 to 65 years old.
* Body Mass Index (BMI) ≥25 and \<30 kg/m2.
* Adequate cultural level and understanding for the clinical trial.
* Signed informed consent

Exclusion Criteria:

* Subjects with BMI ≥30 or \<25 kg /m2
* Subjects diagnosed with Diabetes Mellitus.
* Subjects with dyslipidemia on pharmacological treatment
* Subjects with hypertension on pharmacological treatment
* Subjects with established diagnosis of eating disorder
* Smokers or those subjects with high alcohol consumption (\> 2-3 servings/day in men and\> 1 serving/day in women (1 serving = 1 glass of wine or 1 bottle of beer)
* Subjects under pharmacological treatment (except oral contraceptives)
* Subjects with large weight fluctuations of more than 4 kg or who have undergone in six months a weight loss diet
* Subjects with sensory problems
* Subjects with gastrointestinal diseases that affect the digestion or absorption of nutrients
* Pregnant or breastfeeding women
* Women with menstrual irregularities (absence of menstrual cycle at least 2 months)
* Subjects with intense physical activity.
* Subjects with food allergies to meals included in breakfast, study product or lunch or that reject their consumption
* Subjects with a diagnosis of celiac disease or a gluten intolerance
Effect of Air-tamponade on Intraretinal Cystoid Changes After Membrane Peeling

Patients with intraretinal cystoid changes before scheduled membrane peeling for epiretinal membranes are included. Patients are randomized for balanced salt solution (BSS) or air-tamponade.

Patients with intraretinal cystoid changes before scheduled membrane peeling for epiretinal membranes are included. 23G-pars plana vitrectomy with membrane peeling is performed in all patients. Before surgery patients are randomized for BSS or air-tamponade. Optical coherence tomography (OCT) is performed 5 days after and 3 months after surgery, visual acuity is measured 3 months after surgery.

Eligibility Criteria:
Inclusion Criteria:

* epiretinal membranes and intraretinal cystoid changes

Exclusion Criteria:

* macular edema due to other reason than epiretinal membrane
* hereditary ocular disease
* pregnancy
Assessing Exclusive Breastfeeding Practice

This study was a longitudinal design. The questionnaire on exclusive breastfeeding was administered and was validated against the deuterium oxide dose-to-mother technique to assess human milk intake of babies aged 3 and 6 mo.

This study is a longitudinal design that aimed to assess exclusive breastfeeding (EBF) practices in Asian countries and to compare the agreement in EBF between maternal recall and the dose-to-mother technique (DTM) technique. The questionnaire on exclusive breastfeeding was administered and was validated against the deuterium oxide dose-to-mother technique to assess human milk intake of babies aged 3 and 6 mo. The study planned to recruit 30 mother-baby pairs from each participated country. The was carried out in 7 countries in Asia, namely, Indonesia, Malaysia, Mongolia, Pakistan, Sri Lanka, Thailand, and Vietnam.

Mothers were approached at child birth, to explain the project objective and obtain written informed consent. A screening questionnaire was administered to obtain the interest to participate in the study. Only mothers who intend to exclusive breastfeeding till 6 mo will be eligible for further information and sample collection. Isotope dosing of mothers and saliva sample collection were done when the baby is at 3 mo ± 1wk, when a questionnaire (validation questionnaire) was administered. A basal saliva sample was collected prior to dosing with deuterium oxide. The isotope dosing of the mother was given and saliva samples were collected (post-dose) on day 1,2,3,4 and days 13,14.

The mother-baby pairs were followed up for another sample collection at 6 mo ± 1 wk and all procedures were repeated, including a questionnaire administration, basal sample collection, deuterium oxide dose administration, and post-dose sample collection. Body weight and height/length of mothers and infants were measured. All saliva samples were analyzed by Isotope ratio mass spectrometer (IRMS) or Fourier Transform Infrared Spectroscopy (FTIR).

Quantity of breast milk intake, non milk oral intake (NMOI) and maternal body composition were determined using standard assumption and formulae developed by the International Atomic Energy Agency (IAEA). Children with NMOI ≥ 86.6 g/day were considered as non-EBF using stable isotopic DTM technique. The overall agreement of EBF classification between the recall and DTM techniques is presented using Kappa statistic with 95% confidence interval.

Eligibility Criteria:
Inclusion Criteria:

* Mother who practice exclusive breastfeeding
* Age of mother 18 - 40 years
* Parity: no more than 3
* Baby 3 month ± 7 days
* Nutritional status Weight-for-height Z score (WHZ) \> -2
* Full term baby (37 - 40 weeks)

Exclusion Criteria:

* Twin or more baby
* Low birth weight
* Baby with oedema
* Mother with fluid retention disease (kidney disease, heart disease, hypothyroidism)
* Smoking mother
* Drinking alcohol mother
Automated Pupillometry in Patients Underwent Cardiac Surgery to Predict Postoperative Delirium

The rate of postoperative delirium in patients who underwent cardiac surgery is very high. Different predictors and/or scores were studied for the prediction of Post Operative Delirium (POD)after heart surgery, but none of them was validated. The investigators aim to explore the role of pupillary alterations during anesthesia in open-heart surgery.

The goal of this prospective study is to evaluate if pupil alterations during cardiac surgery, evaluated by an automated pupillometer (NPi-200) ( AP), could predict postoperative delirium.

Consent was obtained during the hospitalization before the planned surgery.

On the day of surgery, before general anesthesia is started, Near-infrared spectroscopy (NIRS) sensors are applied to the patient's forehead bilaterally and the baseline value is recorded. Pupils' variables (i.e., diameter, % constriction, constriction velocity, dilation velocity, latency, NPi) are also recorded from both the right and left eye with AP (NPi-200).

From the induction of anesthesia, pupillary variables in both eyes are recorded and measured every 30' such as the concomitant NIRS values (at least one measurement per eye per operative phase). Moreover, hemodynamic and respiratory parameters concomitant with the pupillary measurements are measured.

Following surgery, the patient is transferred to the Cardiac Intensive Care Unit. There, NIRS monitoring as as well as automated pupillometry measurements will be maintained until the patient regains consciousness (defined as RASS sedation scale \>-3).

Once the patient has regained consciousness (RASS\>-3), is assessed twice a day (morning and afternoon) with the Confusion assessment method-intensive care unit (CAM-ICU) score by the nursing staff and/or medical staff. The presence or absence of POD will then be reported as well as any pharmacological and non-pharmacological treatments.

Any neurological complications and diagnostic investigations arising in the post-operative period will also be noted.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing elective open cardiac surgery (\>18 yr)
* Elective open cardiac surgery and cardiopulmonary bypass

Exclusion Criteria:

* Patients \<18 years of age
* Emergency surgeries
* Heart operations, not including extracorporeal circulation
* Surgery for aortic arch dissection with hypothermia and/or circulatory arrest
* Patients affected by psychiatric disorders undergoing with or without neuroleptic therapy
* Patients who have the refused consent
* Patients with ocular problems (acute or previous trauma to one or both eyes, blindness, ocular prosthesis)
Evaluation of Two Marketed Multifocal Contact Lenses

This is a single-masked, randomized, cross-over, dispensing, 6- visit pilot study. The purpose of this clinical study is to evaluate the performance of two marketed multifocal lenses.


Eligibility Criteria:
Inclusion Criteria:

* Potential subjects must satisfy all of the following criteria to be enrolled in the study:

  1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
  2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
  3. The subject must be between at least 40 years of age and not greater than 70 years of age.
  4. The subject's distance spherical equivalent refraction must be in the range of +3.75 D to -3.75 D.
  5. The subject's refractive cylinder must be ≤ -0.75 D in each eye.
  6. The subject's ADD power must be in the range of +0.75 D to +2.50 D in each eye.
  7. The subject must have best corrected visual acuity of 20/20-3 or better in each eye.
  8. The subject must own a pair of wearable spectacles if required for their distance vision.
  9. The subject must be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 8 hours per wear day, for 1 month or more duration).
  10. The subject must either be wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire".

      Exclusion Criteria:
* Potential subjects who meet any of the following criteria will be excluded from participating in the study:

  1. Ocular or systemic allergies or disease, or use of medication which might interfere with contact lens wear.
  2. Pregnancy or lactation.
  3. Currently diagnosed with diabetes.
  4. Infectious diseases (e.g. hepatitis, tuberculosis) or an immune-suppressive disease (e.g. HIV).
  5. Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular abnormalities which would contraindicate contact lens wear.
  6. Entropion, ectropion, extrusions, chalazia, recurrent styes, dry eye, glaucoma, history of recurrent corneal erosions.
  7. Any previous, or planned, ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, lid procedures, cataract surgery, retinal surgery, etc.).
  8. A history of amblyopia, strabismus or binocular vision abnormality.
  9. Any ocular infection or inflammation.
  10. Any ocular abnormality that may interfere with contact lens wear.
  11. Use of any ocular medication, with the exception of rewetting drops.
  12. History of herpetic keratitis.
  13. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
  14. Employee of clinical site (e.g., Investigator, Coordinator, Technician)
Radiofrequency Ablation Using Combined RF Energy Delivery Mode and Octopus Electrodes for Hepatocellular Carcinoma

The purpose of this study is to evaluate, through a prospective multicenter trial, the procedural time, safety, technical success rate for achieving a safety margin of at least 5 mm around the tumor, and the clinical efficacy (local and remote recurrence rates: estimated local recurrence rate at 12 months) of radiofrequency ablation using the "No-touch" technique. This approach employs Octopus electrodes and combined radiofrequency energy delivery (dual switching monopolar and bipolar mode) for the treatment of hepatocellular carcinoma.


Eligibility Criteria:
\*\*Inclusion Criteria\*\*

1. Agreement to the protocol requirements and provision of informed consent.
2. Age between 20 and 85 years.
3. Child-Pugh Class A or B7.
4. Patients with liver cirrhosis who are candidates for radiofrequency ablation (RFA) based on multi-detector computed tomography (MDCT) or multi-detector computed tomography (MRI) within 60 days, with a suspected hepatocellular carcinoma (HCC) lesion of 1-3 cm.

   * \*\*HCC Diagnostic Criteria:\*\* A. Presence of risk factors (e.g., hepatitis B virus (HBV) positive, hepatitis C virus (HCV) positive, liver cirrhosis).

   B. Findings consistent with HCC on at least one imaging modality (MDCT, dynamic MRI, or Primovist MRI) according to the Korean Liver Cancer Association (KLCA) criteria.

   C. Histological diagnosis of HCC.
5. No prior history of HCC treatment, or if previously treated, no recurrence confirmed for at least two years.

\*\*Exclusion Criteria\*\*

1. Presence of three or more malignant liver tumors.
2. Diffuse infiltrative type tumors with unclear boundaries.
3. Recurrent HCC within two years of previous treatment.
4. Tumors adhered to major hepatic vessels or bile ducts by more than 5 mm.
5. Poor tumor visibility even with contrast-enhanced ultrasound (CEUS)-fusion image guidance.
6. Vascular invasion by malignant liver tumors.
7. Severe coagulopathy (platelets \<50,000/mm³ or International Normalized Ratio (INR) \>50% prolongation).
8. Presence of extrahepatic metastasis.
9. Situations where obtaining appropriate data for the study is unlikely.