cyrilzakka/clinical-trials huggingface dataset:
A Comparison of Aspheric Toric Intraocular Lens (IOL) Implantation Versus Aspheric Non-Toric Lens Implantation

The purpose of this study was to evaluate and compare uncorrected distance visual acuity measurement in pseudophakic subjects with bilateral implantation of an AcrySof IQ Toric Intraocular Lens (IOL) versus bilateral implantation of an AcrySof IQ IOL.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to understand and sign an informed consent;
* Willing and able to attend post-operative examinations per protocol schedule;
* In good ocular health, with the exception of cataracts;
* Age-related cataracts in both eyes that require extraction followed by implantation of an intraocular lens;
* Pre-operative corneal cylinder of greater than or equal to 0.75 diopter as determined by auto keratometry;
* In good ocular health, with the exception of cataracts;
* Free of diseases/conditions listed in the precautions of the AcrySof® Toric and AcrySof® IQ package inserts;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Previous corneal surgery;
* Corneal abnormality that would prevent stable and reliable visual acuity and refractive measures;
* Planned multiple procedures during cataract/IOL implantation surgery;
* Ocular disease and/or condition that may compromise study results;
* Ocular trauma, infections or nasolacrimal drainage system malfunction within 3 months of enrolment;
* Pregnant or planning pregnancy during course of study;
* Participation in any other investigational study within 30 days prior to enrolment;
* Other protocol-defined exclusion criteria may apply.
Study of Icotinib Hydrochloride in Treating Patients With Recurrent or Metastatic Esophageal Cancer After Failure of Conventional Chemotherapy

Phase II Study of Icotinib Hydrochloride in Treating Patients With Recurrent or Metastatic Esophageal Squamous Carcinoma After Failure of Conventional Chemotherapy.

Currently,there is no standard second-line therapy for esophageal squamous cell carcinoma.More effective therapy for patients with this disease who developed disease progression after first line therapy is needed.Although Erlotinib is recommended in NCCN Guideline Version 2.2013,there is still insufficient evidence on EGFR-TKI as second-line therapy for esophageal squamous carcinoma.Therefore,further research is necessary.In this phase II study,we evaluate the efficacy and safety of Icotinib Hydrochloride as treatment for patients with recurrent or metastasis esophageal squamous carcinoma after failure of conventional chemotherapy,and analyse the value of biomarkers of these patient to identify who benefit.

Eligibility Criteria:
Inclusion Criteria:

* Patients have provided a signed Informed Consent Form
* Age: 18-75 years old
* Histologically confirmed diagnosis of esophageal squamous cell carcinoma
* Patients have Received and progressed on 1 line of prior Fluoropyrimidine, platinum or taxane based palliative chemotherapy
* Measurable disease in at least 1 diameter by CT scan or MRI as per RECIST 1.1 criteria
* Life expectancy ≥ 3 months
* Karnofsky score ≥70
* Patient has adequate bone marrow and organ function

  * Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L
  * Platelets ≥ 75 x 109/L
  * Hemoglobin ≥ 9.0 g/dL
* Patient has adequate liver function

  * AST and ALT not more than 2.5 times ULN (not more than 5.0 times ULN if there is liver metastasis)
  * Serum bilirubin ≤ 2 x ULN
* Creatinine ≤ 1.5 times ULN
* No malabsorption or other gastrointestinal disorders affecting drug absorption.
* No serious complications such as active gastrointestinal hemorrhage, perforation, jaundice, gastrointestinal obstruction, non cancerous fever \> 38 ℃.
* Expect good compliance

Exclusion Criteria:

* Patient has received previous treatment with EGFR inhibitors
* Patient is currently receiving Phenytoin, rifampin, barbiturates, C Masi Bing
* Known severe hypersensitivity to Icotinib or any of the excipients of this product
* CNS metastases without radiotherapy and/or surgery
* Patients with treated CNS metastases may participate in this trial,except for those who must receive hormone therapy and those whose prior hormone therapy for CNS metastases is less than 4 weeks
* Evidence of clinically active Interstitial Lung Diseases
* Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases
* Patient has a concurrent malignancy or has a malignancy within 5 years of study enrollment, (with the exception of nonmelanoma skin cancer or cervical carcinoma in situ
* psychiatric illness that would prevent the patient from giving informed consent
* Patient is concurrently using other approved or investigational antineoplastic agent
* Pregnant or lactating women
Ultrasound Guided Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) Versus Quadratus Lumborum Block for Postoperative Analgesia in Laparoscopic Cholecystectomy

This study aims to compare the efficacy of using Ultrasound guided modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) versus quadratus lumborum block for postoperative analgesia in laparoscopic cholecystectomy under general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients aging ≥ 21 years to ≤ 70 of both sexes.
* Patients undergoing Laparoscopic cholecystectomy surgeries.
* ASA physical status classes I - II.

Exclusion Criteria:

* Patient's refusal of procedure or participation in the study.
* ASA classes III or above.
* Coagulopathy and bleeding disorders.
* Evidence of Local skin infections at site of injection.
* Body mass index \>40kg/m2
* A history of relevant local anesthetic allergy.
CMAC® Versus Airtraq® and Macintosh Laryngoscope in Difficult Tracheal Intubation.

It is essential that anaesthetists successfully perform orotracheal intubation in scenarios in which intubation is potentially more difficult, such as where anatomical characteristics predictive of difficult intubation are present.

The CMAC® Laryngoscope is a new intubating device. It is designed to provide a view of the glottis without alignment of the oral, pharyngeal and tracheal axes.

The CMAC may be especially effective in situations where intubation of the trachea is potentially difficult.

The efficacy of this device in comparison to the traditional Macintosh laryngoscope and other novel laryngoscopes is not known.

We aim to compare its performance to that of the Macintosh laryngoscope, the gold standard device, in patients with one or more anatomical characteristics predictive of difficult intubation.

The investigators further aim to compare it to the Airtraq® device a device which has been shown to be superior to the Macintosh laryngoscope in previous trials.

The investigators primary hypothesis is that, in the hands of experienced anaesthetists, time to intubation would be shorter using the CMAC than using the Macintosh laryngoscope in patients with two or more anatomical characteristics predictive of difficult intubation.

The investigators further hypothesize that the Airtraq® will be superior the CMAC® with one or more anatomical characteristics predictive of difficult intubation.


Eligibility Criteria:
Inclusion Criteria:

* ASA 1-3 patients undergoing surgical procedures requiring orotracheal intubation.
* Written informed Consent
* No relevant drug allergies
* Patients with 2 or more of the following predictors of difficult intubation:

  * Mallampatti II - IV
  * Thyromental distance \< 6cm
  * Mouth opening \< 3.5 cm
  * Cervical spine disease
  * Anteriorly protruding incisors
  * Presence of Caps or Crowns

Exclusion Criteria:

* Patients with history of or risk factors for gastric regurgitation
* Patients unable to consent for the trial
Cholestasis in Extreme Low Birth Weight Infants (ELBW)

Parenteral nutrition associated liver disease (PNALD) in preterm neonates is characterized by early occurrence of intrahepatic cholestasis (parenteral nutrition associated cholestasis (PNAC).

Extreme low birth weight infants (ELBW, birth weight \< 1000 g) are at increased risk for development of PNAC.

Important factors implicated in the aetiology of PNAC are high caloric parenteral nutrition using amino acids or dextrose, but also intravenous lipids and infections in particular necrotizing enterocolitis (NEC).

Due to a change of paradigm a more aggressive nutrition with early use of parenteral amino acids/lipids and early fortification of mothers milk or alternatively high caloric preterm formula is warranted. Accordingly - in line with the existing expert opinion and evidence - the feeding policy at the neonatal care units of our hospital was adapted.

Evidence exists that PNAC might be caused by the use of high concentrations of amino acids and lipids in parenteral nutrition. Furthermore NEC is associated with high osmotic feeds. Therefore the incidence of PNAC might be increased directly and indirectly after introducing the new feeding policy.

The investigators therefore aim at retrospectively investigating the incidence of PNAC before and after introduction of a feeding policy of "aggressive nutrition" for ELBW infants.


Eligibility Criteria:
Inclusion Criteria:

* ELBW infants below 1000 Gram birth weight
* Born in house between January 2005 - December 2006 ("before") and July 2007- June 2009 ("after")

Exclusion Criteria:

* signs of cholestasis at birth
* Death or transfer before 28 Days of life
* Diseases associated with Cholestasis
Safety and Tolerability of Levetiracetam Intravenous 15 Minute Infusion in Subjects Suffering From Partial Onset Seizures

Subjects receiving LEV as adjunctive therapy to 1 or 2 other AEDs for partial onset seizures and subjects who are temporarily unable to take oral LEV, may require alternative routes of administration. The purpose of this trial was to evaluate the safety and tolerability of 1000 to 3000 mg/day LEV administered as a 15-min IV infusion b.i.d. after switching from the same oral dose.


Eligibility Criteria:
Inclusion Criteria:

* Adult
* in- or out-subjects suffering from partial onset seizures according to the ILAE classification of Epileptic Seizures;
* intake of levetiracetam as an adjunctive antiepileptic oral treatment in addition to one or two antiepileptic drugs (AED).

Exclusion Criteria:

* Had problems of venous accessibility;
* showed safety issues related to the administration of one of the concomitant AEDs requiring medical intervention;
* clinically significant ECG/lab abnormalities;
* administered vigabatrine;
* administered felbamate for less than 18 months;
* had contraindication to any component of the study medication treatment as IV formulation or known allergic reaction to or intolerance of pyrrolidone derivatives.
Anlotinib for Esophageal Cancer (AFEC)

The purpose of this study is to observe and explore the effect of single or combined treatment of arotinib on the survival and prognosis of patients with advanced esophageal cancer in the real world, and to summarize the treatment experience of a wide range of people.


Eligibility Criteria:
Inclusion Criteria:

1. Age: ≥ 18 years old, male or female;
2. Patients with esophageal cancer were diagnosed;
3. Patients assessed by doctors to benefit from single or combined treatment of arotinib;
4. Patients volunteered to join the project.

Exclusion Criteria:

None
Efficacy and Safety of 3 Different Dosage Regimens of Hyaluronic Acid in Patients With Knee Osteoarthritis (OA)

The main objective is the comparison of three different dosage regimens of hyaluronic acid in the treatment of osteoarthritis of the knee.


Eligibility Criteria:
Inclusion Criteria:

* Outpatient\>45 years of age diagnosed with primary osteoarthritis according to ACR and Kellgren criteria
* Knee pain ≥ 55 mm and ≤90 mm measured by Visual Analogue Scale (VAS) 100 mm
* Ability to understand and follow study procedures
* Written informed consent

Exclusion Criteria:

* Patients with secondary osteoarthritis of the knee according to ACR criteria.
* Severe inflammation of the knee diagnosed by physical examination or a sedimentation speed rate \< 40 mm/h and serum rheumatoid factor titre \< 1:40
* Patients having previously received surgery, including arthroscopy
* Patients with joint inflammatory disease (spondilitis, systemic rheumatoid arthritis), microcrystalline arthropathies (chondrocalcinosis, gout, fibromyalgia) and significant osteoarthritis symptoms in other joints apart from the knee, and which require pharmacological treatment
* Previous administration of any of the following treatments: hyaluronic acid ia (last year); steroids i.a. or joint lavage (last 3 months), glucosamine sulfate, chondroitin sulfate or diacerein (last 3 months), NSAIDs (last 14 days), any investigational drug (last month) or its administration during this study
Middle Term Effect of Red Yeast Rice on Plasma Lipids and Proteoma in Individuals With Suboptimal Cholesterolemia

The primary purpose of our research will be to evaluate if, in healthy subjects with a low- moderate cardiovascular risk (CV risk\>1% but \< 5%) evidenced by sub-optimal cholesterol levels as per ESC/EAS guidelines (LDL cholesterol \>115 mg/dL, \< 190 mg/dL) supplementation with a red yeast rice food supplement containing less than 3 mg total monacolins per daily dose is able to significantly influence plasma lipid levels. Furthermore, liver and muscle proteomic pattern and vascular response to dietary supplementation will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged ≥ 30 years and ≤ 70 years old.
* Body Mass Index included between 18 Kg/m2 and 35 Kg/m2
* Total cholesterolemia between 200 and 280 mg/dL and/or LDL-Cholesterol between 130 mg/dL and 190 mg/dL.
* TG\<400 mg/dL.
* Subjects who, according to the SCORE charts, have a low or moderate cardiovascular risk (defined as a total cardiovascular risk \< 5%) and for whom, according to ESC/EAS guidelines 2012, the intervention strategy does not require a pharmacological lipid-lowering intervention.
* Subjects who have the capability to communicate, to make themselves understood, and to comply with the study's requirements.
* Subjects agree to participate in the study and having dated and signed the informed consent form.

Exclusion Criteria:

* Assumption of lipid lowering drugs or dietary supplements, or drugs potentially affecting the lipid metabolism;
* Assumption of any kind of drug treatment non-stabilized for at least 3 months;
* Known current thyroid, gastrointestinal or hepatobiliary diseases (including liver transaminases ≥3ULN), as well as any muscular disorders (even subclinical, including serum CPK ≥3ULN);
* Current or previous alcohol abuse;
* Pregnancy and Breastfeeding
* Known previous intolerance to red yeast rice
* History or clinical evidence of any significant concomitant disease that could compromise the safety of the subject or the possibility of completing the study;
* Any medical or surgical condition that would limit the patient adhesion to the study protocol.
CARESTREAM Vue PACS v12.1.5 CT Perfusion Clinical Protocol

The purpose of this clinical study is to evaluate the CARESTREAM Vue PACS 12.1.5 Computed Tomography (CT) Perfusion ("investigational device") imaging performance. Evaluation of CT Perfusion (CTP) imaging will compare CTP with the predicate device, the Olea Sphere PACS with CT Perfusion Module.

This study will demonstrate the imaging performance CTP by an assessment of 30 CTP de-identified patient cases collected retrospectively. The purpose of the study is to demonstrate equivalent clinical quality between the investigational and predicate devices using a radiologist evaluation of key metrics which are applicable to CTP images.

The maps include the following:

* Mean Transfer Time (MTT) - the time that the contrast material stays in the tissue
* Cerebral Blood Volume (CBV) - the volume of blood that is in a known volume of the tissue based on the concentration of contrast material that is in the tissue over the time
* Cerebral Blood Flow (CBF) - describes the flow of the blood to the affected tissue
* Time To Peak (TTP) - the time that maximum enhancement is achieved at each volume of the tissue
* Time to maximum of impulse response function (TMAX)

The retrospective data collected for each patient will include a non-contrast head CT exam completed on the same day as CTP image, and a follow-up head CT at least 1-2 days after the initial imaging study (initial non-contrast head CT) if available.

Similar performance between the investigational and predicate devices was demonstrated by the following criteria.

i. Substantial equivalence of the perfusion maps between devices ii. Substantial equivalence of the core and penumbra tissues resulting from thresholds on the perfusion maps between devices iii. The clinical decision based on the exclusion or inclusion criteria for treatment is equivalent between devices

Eligibility Criteria:
Inclusion Criteria:

* Retrospective patient CTP cases with case maps that include the following information: MTT, CBV, CBF, TTP, and TMAX.
* Initial CT exam and CT exam 1-2 days after the initial exam if available, and
* Retrospective CTP case with subject/patient 18 years of age or older

Exclusion Criteria:

* Low quality images, or images that are not clinically acceptable for clinical diagnostic reading as determined by the Principal Investigator,
* Subject less than 18 years of age
Assessment of "Gut Feelings" Accuracy Regarding the Effect of Professional Experience in General Practitioners in Clinical Decision Making

Knowledge, experience and professional development limit the risk of diagnostic error for the clinician in daily practice. However, research has shown that other non-analytical factors are involved in clinical decision making. Intuition (or "gut feelings") is a subjective element involved in medical decision-making, and its place and relevance are being explored. The concept of "gut feelings" comes from General Practitioners (GPs) themselves and their description of their own practice. Several studies have shown its place in medical decision-making models, particularly in the face of diagnostic uncertainty.

A questionnaire used as a standardized measurement tool for gut feelings was created to address this issue. The Gut Feelings Questionnaire (GFQ) has been translated into French, German and Polish during a standardized linguistic validation procedure. It is currently validated and available in five languages. The QGF has been tested and validated in clinical practice by Belgian, French and Dutch physicians. Its feasibility has been evaluated in these three health systems.

The Gut Feelings Questionnaire was used in a prospective study to determine the accuracy of the sense of alarm in patients consulting their GP for chest pain and/or dyspnea. But the role of the practitioner's experience has not been studied: is the gut feeling more accurate in experienced GPs than in first semester interns in general practice?


Eligibility Criteria:
Inclusion Criteria:

- GP population: General practitioners established for more than 3 years

- Intern population: Interns in general medicine in the first year of the third cycle of the diploma of specialized studies in general medicine

Exclusion Criteria:

- For the 2 populations: Refusal to participate

- Intern population: Interns in the second and third year of the diploma of specialized studies in general medicine
Physical Training in Hospitalized Elderly

Background The Activity in GEriatric acute CARe (AGECAR) is a randomized control trial to assess the effectiveness of an intrahospital strength and walk program during short hospital stays for improving functional capacity of patients aged 75 years or older.

Objective: The main objective of this study is to assess whether an inpatient exercise program, beyond other components of interdisciplinary care, could reduce hospital associated disability (HAD) in medical patients aged 75 years and older admitted to an acute care for elders (ACE) unit.

Population: The reference population will be patients aged 75 years and older admitted to the ACE unit from the emergency department. This study will include only patients discharged alive. Exclusion criteria include patients fully dependent at baseline, unable to sign informed consent, unstable medical condition, short stay (\<3 days), end stage illness.

Interventions: Patients will be randomly assigned to a control or an intervention group. Participants allocated to the control group will receive usual care in the ACE unit with actions directed to prevent delirium and functional decline. The intervention group, in addition to the usual care, will receive an exercise program. Briefly, this program consisted of strengthening of lower limbs muscles, and walking, daily from Monday to Friday.

Eligibility Criteria:
Inclusion Criteria:

* Participants will include approximately 150 elderly people aged 75 years or older recruited from patients admitted into the Geriatrics Department of the Hospital General Universitario Gregorio Marañón (Madrid, Spain).
* Able to ambulate, with or without personal/technical assistance.
* Able to communicate.
* Informed consent: Must be capable and willing to provide consent.

Exclusion Criteria:

* Duration of hospitalization \< 72 hours
* Any factor precluding performance of the physical training program or testing procedures as determined by the attending physician. These factors include, but are not limited to the following:
* Terminal illness.
* Myocardial infarction in the past 3 months.
* Not capable of ambulation.
* Unstable cardiovascular disease or other medical condition.
* Upper or lower extremity fracture in the past 3 months.
* Severe dementia.
* Unwillingness to either complete the study requirements or to be randomised into control or intervention group.
* Presence of neuromuscular disease or drugs affecting neuromuscular function.
Assessing the Reliability of Non-invasive Blood Glucose Monitoring Device

Adequate glycemic control in patients with Diabetes Mellitus (DM) is a desired therapeutic goal that is difficult to achieve with current blood glucose monitoring technology. Home blood glucose monitoring (HBGM) technology, which requires finger pricking, is a source of severe inconvenience and hence, a lack of compliance.Thus, the need for non-invasive and easy to operate glucose monitoring in DM patients for strict glycemic control cannot be overemphasized.

The Glucometer GM-205 blood glucose readings are accurate and measure blood glucose with an acceptable mean relative error when compared to acceptable invasive blood glucose measurements.

The primary objectives of the trial are to determine:

1. Assessing the reliability of the Glucometer GM-205 in evaluating blood glucose levels compare to the standard glucose blood test
2. Creating database of glucose levels readings utilizing the Glucometer GM-205.


Eligibility Criteria:
Inclusion Criteria:

1. Diabetes Mellitus type one or type two.
2. Patients that are using Insulin.

Exclusion Criteria:

1. Vascular diseases
2. Pregnant and lactating women.
3. Exclusive use of long term Insulin.