cyrilzakka/clinical-trials huggingface dataset:
A Study of the Cypher Sirolimus-Eluting Stent to Treat Bifurcation Lesions.

The objective of this study is to assess the feasibility and safety of the sirolimus-coated Bx VELOCITY Balloon-Expandable Stent in treating patients with true bifurcation lesions.

This is a prospective, randomized study that will be conducted at up to 5 centers in Europe and the US. All patients who meet the eligibility criteria will be treated with the sirolimus-coated Bx VELOCITY Balloon-Expandable Stent and Stent Delivery System (SDS). As a secondary objective, patients will be randomized in a 1:1 ratio to receive one stent in the main branch with balloon angioplasty by a kissing balloon technique in the side branch (stent/PTCA group), or to receive stents in both the main and side branches (stent/stent group). It is anticipated that up to 70% of the patients enrolled in the stent/PTCA group will be considered treatment failures and require a stent in the side branch. These patients will have a sirolimus-coated stent placed in the side branch and will be followed per the protocol, but will be analyzed separately. Therefore, it is anticipated that up to 75 patients will be enrolled in the trial. All patients will have repeat angiography at six months, with clinical follow-up to 5 years.

Eligibility Criteria:
Inclusion Criteria:

1. Has a diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B\&C, I-II) OR has documented silent ischemia;
2. Involves a single treatment of a de novo bifurcation lesion in native coronary arteries of patients with single or multivessel disease; patients with multiple lesions can be included only if other lesions treated during the index procedure are successfully treated prior to the treatment of the bifurcation lesion;
3. Has a true bifurcation lesion defined as stenosis \> 50% in both the main branch and the ostium of the side branch;
4. Has a main branch vessel that is \<=2.5 mm and \<=3.5 mm in diameter by on-line QCA proximal to the bifurcation;
5. Has a side branch vessel that is \<=2.5 mm and \<=3.5 mm in diameter by on-line QCA.

Exclusion Criteria:

1. Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented elevation of CK levels \> 2 times normal or CK-MB levels \> 3 times normal within the preceding 24 hours and/or the CK and CK-MB enzymes remain above normal at the time of treatment;
2. Has unstable angina classified as Braunwald A I-III, or III B or C, or is having a peri infarction;
3. Has a bifurcation lesion in a non protected left main;
4. Has an ejection fraction \<=35%;
5. There is presence of thrombus in the bifurcation lesion;
6. Has a totally occluded vessel.
AQUApay (AQUA Predictive Ability in Youths): Study on the Predictive Ability of the Questionnaire AQUA© in Children and Adolescents

Allergic diseases like asthma, rhinitis, conjunctivitis and dermatitis are very frequent in athletes, even if those complaining allergic symptoms do not always receive a medical diagnosis. Many athletes already start competitive sport activities in pediatric age, but allergy screening tests are usually not performed when assessing eligibility to sport practice. Therefore, the objective of the present study is assessing the predictive ability of the Allergy Questionnaire for Athletes (AQUA©), pediatric version, to predict the atopic status in young athletes.


Eligibility Criteria:
Inclusion Criteria:

- Athletes, males or females, 7 to 14 years old

Exclusion Criteria:

* Use of systemic antihistamines or long term or high dose corticosteroids in the last two weeks;
* Poor understanding of written or spoken Italian;
* Lack of written informed consent.
Treatment of CNV With Aflibercept Combined With Pranoprofen Eye Drops or Nutraceutical Support With Omega-3

To determine whether a combination of intravitreal aflibercept and pranoprofen eyedrops or nutraceutical support provides additional benefit over IVA monotherapy for the treatment of choroidal neovascularization in age-related macular degeneration.


Eligibility Criteria:
Inclusion Criteria:

* provision of written informed consent and compliance with study assessments for the full duration of the study
* age \> 40 years
* presence of treatment-naïve neovascular AMD.

Exclusion Criteria:

* any previous intravitreal treatment
* previous laser treatment in the study eye
* myopia \> 7 diopters in the study eye
* concurrent eye disease in the study eye that could compromise visual acuity (e.g., diabetic retinopathy and advanced glaucoma)
* concurrent corneal epithelial disruption or any condition that would affect the ability of the cornea to heal
* known sensitivity to any component of the formulations being investigated.
A Study of KRN125 in Patients With Multiple Myeloma and Malignant Lymphoma

To determine if KRN125 is non-inferior to filgrastim for the mobilization of hematopoietic stem cells into the peripheral blood in patients with multiple myeloma.


Eligibility Criteria:
Inclusion Criteria:

Criteria for the multiple myeloma cohort

* Patients with histologically or pathologically diagnosed multiple myeloma
* Patients who achieved CR, sCR, VGPR, and PR with induction therapy Criteria for the malignant lymphoma cohort
* Patients with histologically or pathologically diagnosed malignant lymphoma
* First or second CR or PR Multiple myeloma cohort, malignant lymphoma cohort common criteria
* Patients aged 20 to 75 years or younger at the time of informed consent

Exclusion Criteria:

* Those who received allogeneic hematopoietic stem cell transplantation (Allo-SCT), autologous hematopoietic stem cell transplantation (ASCT), or CAR-T therapy
* Patients who have developed adverse events leading to discontinuation of hematopoietic stem-cell collection due to administration of granulocyte colony-stimulating factor (G-CSF) or apheresis
* Patients who have not been able to collect adequate amounts of hematopoietic stem cells with G-CSF or plerixafor administration
* Patients with hypersensitivity to G-CSF or plerixafor
* Patients with ECOG Performance status (PSs) of 2 or greater.
* Patients whose cardiac or pulmonary conditions were judged to be inappropriate for apheresis or ASCT.
* Pregnant or breastfeeding female patients
Alirocumab and Reverse Cholesterol Transport

Alirocumab is an injectable treatment for elevated blood cholesterol. The hypothesis of this study is that it also increases cholesterol excretion from the body into the stool, a process sometimes called reverse cholesterol transport. A cholesterol metabolic study will be done before and after 6 weeks of alirocumab treatment. If alirocumab increases reverse cholesterol transport, it is possible that this action provides additional protection from cardiovascular disease.

This study is a single-site, randomized, placebo-controlled clinical trial in which about 24 subjects are expected to complete an 8-week study period. The performance site is Washington University School of Medicine. Even though alirocumab is an approved drug, the investigators consider this to be a phase I trial because it is a physiological study in which the primary endpoint is change in fecal cholesterol excretion and measures of reverse cholesterol transport. It is not a treatment protocol and uses healthy subjects.

Subjects with greater than ideal cholesterol but not taking cholesterol lowering drugs will be studied. All receive whole body cholesterol metabolism tests before and after treatment for 6 weeks with either alirocumab or placebo. Each test takes 2 weeks. On the first day the subjects receive about 35 mg cholesterol-d7 intravenously and blood samples are obtained in order to measure cholesterol turnover rate, pool size, esterification rate, transfer from HDL to LDL and removal from the plasma compartment. Fecal cholesterol excretion and related parameters are measured on days 13 and 14 after a relative steady-state is obtained. During this time the subjects consume a metabolic kitchen diet controlled in cholesterol and phytosterol content and consume oral tracer capsules consisting of cholesterol-d5 and sitostanol-d4. Plasma and stool samples are analyzed by gas chromatography/tandem mass spectrometry to determine daily percent cholesterol excretion from rapidly-mixing body cholesterol pools, fecal cholesterol mass and percent cholesterol absorption. The cholesterol metabolic test is repeated on day 43 and final measurements are made on day 57. Treatment effect, defined as the difference between active and placebo treatments is then calculated. Based on animal data it is expected that alirocumab will increase the efficiency of cholesterol excretion from body pools and the rate of removal of cholesterol ester from plasma.

Eligibility Criteria:
Inclusion Criteria:

* Healthy or with stable medical or surgical illnesses
* LDL\>100 mg/dl.

Exclusion Criteria:

* Triglycerides\>250
* Taking drugs affecting lipid metabolism
* Elevated liver function tests
* Diabetes mellitus
* A1c 6.5% or greater
* Pregnant
* Breastfeeding
* Desire for conception in either sex.
Study to Evaluate the Effects of AT-527 in Non-Hospitalized Adult Patients With Mild or Moderate COVID-19

This randomized study evaluates the antiviral activity, safety, efficacy and pharmacokinetics of AT-527 versus a placebo in participants with mild or moderate coronavirus disease (COVID-19) who are not hospitalized.


Eligibility Criteria:
Inclusion Criteria:

* Positive SARS-CoV-2 diagnostic test (RT-PCR or rapid antigen test)at screening
* Has symptoms consistent with mild or moderate COVID-19, as determined by the investigator, with onset ≤5 days prior to randomization

Exclusion Criteria:

* Clinical signs indicative of COVID-19 illness requiring hospitalization, defined as any of the following: shortness of breath at rest, respiratory rate ≥30, heart rate ≥125, peripheral capillary oxygen saturation ≤93% on room air
* Treatment with a therapeutic agent against SARS-CoV-2 including, but not limited to, other direct acting antivirals, convalescent plasma, monoclonal antibodies against SARS CoV-2, or intravenous immunoglobulin within 3 months or less than 5 drug elimination half-lives (whichever is longer) prior to screening
* Requirement, in the opinion of the investigator, for any of the prohibited medications during the study
* Use of hydroxychloroquine or amiodarone within 3 months of screening
* Pregnant or breastfeeding, or intending to become pregnant during the study or within 30 days after the final dose of AT-527. Women of childbearing potential must have a negative urine pregnancy test result at screening
* Abnormal laboratory test results at screening
* Clinically significant abnormal ECG, as determined by the Investigator, at screening
* Planned procedure or surgery during the study
* Known allergy or hypersensitivity to study drug or drug product excipients
* Substance abuse, as determined by the investigator, within 12 months prior to screening
* Poor peripheral venous access
* Malabsorption syndrome or other condition that would interfere with enteral absorption
* Any clinically significant history of epistaxis within the last 3 months and/or history of being hospitalized due to epistaxis of any previous occasion
* History of anaphylaxis
* Any uncontrolled serious medical condition or other clinically significant abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
Influence of Body Positioning on the Identification of Tuffier's Line Using the Palpation Method: An Ultrasound Study

The study aims to ascertain whether being placed in a sitting or lateral decubitus position, influences identification of the midpoint of the L4/L5 intervertebral space, using manual demarcation of Tuffier's line. Participants will be randomly assigned to a sitting or lateral decubitus position. The mid-point of the L4/L5 intervertebral space will be identified using anatomical palpation and compared to the "true" mid-point measured by ultrasound. The procedure will be repeated in both positions on the same participant.The study will be a prospective, randomized, double blinded, crossover trial

Anaesthetists insert epidurals or spinal anaesthetics (collectively called central neuraxial blocks) to patients during childbirth to provide pain relief and anaesthesia. A spinal anaesthetic involves the injection of pain relieving medicines directly into the sac of fluid that surrounds the spinal cord. An epidural uses a different technique to place a thin plastic tube into the fatty tissues that surround this sac. Spinal anaesthesia must be placed below where the spinal cord ends to avoid nerve trauma. Doctors have traditionally been taught to identify a safe level, by feeling the top of a patients hips and drawing an imaginary line between these two points across the patients back known as Tuffier's line. This identifies L4/5 interspace, below which anaesthetists avoids the termination of the spinal cord. The same blind "anatomical rule" is used throughout anaesthetics, whether the patient is male or female, young or old, pregnant or non-pregnant, supine or lateral, an approach that is clearly far from robust. The physiological changes of pregnancy such as fluid retention and weight gain can further make identification of the standard landmarks challenging. Advances in ultrasound technology have allowed direct visualisation of the bones in the back. Studies have shown that the conventional anatomical based method for locating the point of needle insertion is unreliable even amongst experienced anaesthetists.

Spinal or epidural anaesthesia can be performed with the patient either sitting or lying on their side. The investigators aim to determine whether a difference exists between the perceived mid-point of the L4/L5 intervertebral space, identified using manual demarcation of Tuffier's line, in these two positions. Ultrasound will then be used to ascertain the distance from the "true" midpoint.

Eligibility Criteria:
Inclusion Criteria:

* \>37 weeks gestation
* BMI\<40
* Singleton pregnancy
* Aged 16 to 65 years old.
* Latent phase of labour (\<4cm cervix dilatation).

Exclusion Criteria:

* Previous spinal surgery
* Scoliosis
* Age\<16
* Patient unable to tolerate positions
* Degenerative disease of the spine
* Patient refusal or inability to provide informed consent
* Patient in established labour (i.e. \>4cm cervical dilatation)
Terazosin and Parkinson's Disease Extension Study

The purpose of this study is to investigate the long-term effects of treatment with the selective post-synaptic a1-adrenergic blocker terazosin on serial in a population of subjects with defined pre-motor Parkinson's disease (PD) risks and abnormal imaging exams. Imaging changes will be correlated to the presence and severity of motor and non-motor symptoms of PD, measured by validated clinical scales and cardiac autonomic function tests.

The purpose of this study is to investigate the long-term effects of treatment with the selective post-synaptic a1-adrenergic blocker terazosin on serial 123 Ioflupane Dopamine Transporter single-photon emission-computed tomography (123I-FP DAT-SPECT) in a population of subjects with defined pre-motor PD risks (i.e., RBD and at least one among hyposmia, constipation, depression and color vision abnormality) and abnormal Iodine-123 meta-iodobenzylguanidine (123I-MIBG) uptake. Imaging changes will be correlated to the presence and severity of motor and non-motor symptoms of PD, measured by validated clinical scales and cardiac autonomic function tests. The rate of RBD clinical conversion to PD will be estimated and compared to available data in the literature.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in the study "The Effect of alpha1- adrenergic receptor antagonist Therapy on Cardiac and Striatal Transporter Uptake in Pre-Motor and Symptomatic Parkinson's Disease" (STUDY #000540)
* Capacity to give informed consent

Exclusion Criteria:

* Secondary Parkinsonism, including tardive
* Concurrent dementia defined by a score lower than 22 on The Montreal Cognitive Assessment (MoCA)
* Concurrent severe depression defined by a Beck Depression Inventory-Fast Screen (BDI fast screen) score greater than 13
* Comorbidities related to sympathetic nervous system (SNS) hyperactivity
* Heart failure (LVEF \<45%)
* Recent myocardial revascularization (\<12 weeks)
* Hypertension (systolic blood pressure SBP\>150mmHg (millimeters of mercury) or diastolic blood pressure DBP\>100mmHg)
* Chronic Atrial fibrillation
* Concurrent Use of Beta-adrenergic antagonist
* Diabetes mellitus
* Chronic Obstructive Pulmonary Disease (COPD)
* Untreated Sever Sleep Apnea; Apnea-Hypopnea Index (AHI) \> 30/h.
* Severely reduced kidney function (Glomerular Filtration Rate\<30ml/min)
* Contraindications to the use of terazosin
* Recent myocardial infarction (\<48 h)
* Ongoing angina pectoris
* Cardiogenic shock or prolonged hypotension
* Breast-feeding
* Current use of phosphodiesterase type 5 inhibitors: sildenafil (ViagraTM), tadalafil (CialisTM), or vardenafil (LevitraTM)
* History of priapism (persistent and painful erection)
* Neurogenic orthostatic hypotension defined as symptomatic decrease in BP \> 20mmHg systolic or \> 10mmHg diastolic and HR increase \< 20bpm on supine to sitting or standing.
* Blood pressure less than 110 mm Hg systolic at screening or baseline visit
* Use of investigational drugs within 30 days before screening
* For female participant, pregnancy, or plans for child-bearing during study period
* Allergy/hypersensitivity to iodine or study medication
Clinical Evaluation of Two Toric Soft Contact Lenses

The aim of this study is to compare the short-term clinical performance of two toric contact lenses.

The aim of this study is to evaluate the short-term clinical performance of two toric contact lenses when compared to each other after 15 minutes of daily wear each

Eligibility Criteria:
Inclusion Criteria:

* Is between 18 and 40 years of age (inclusive)
* Has had a self-reported visual exam in the last two years.
* Is an adapted soft contact lens wearer.
* Is not a habitual wearer of either study lens.
* Has a contact lens spherical prescription between +5.00 to -9.00 (inclusive) best corrected visual acuity of 20/30 or better in either eye.
* Have contact lens prescription of no less than -0.75D of astigmatism and no more than -2.25D in both eyes.
* Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
* Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
* Has clear corneas and no active ocular disease.
* Has read, understood and signed the informed consent letter.
* Patient contact lens refraction should fit within the available parameters of the study lenses.
* Is willing to comply with the wear schedule (at least 5 days per week, \>8 hours/day assuming there are no contraindications for doing so).
* Is willing to comply with the visit schedule.

Exclusion Criteria:

* Has a CL prescription outside the range of the available parameters of the study lenses.
* Has a spectacle cylinder less than -0.75D or more than -2.50D of cylinder in either eye.
* Slit lamp findings that would contraindicate contact lens wear such as:

  1. Pathological dry eye or associated findings
  2. Pterygium, pinguecula, or corneal scars within the visual axis
  3. Neovascularization \> 0.75 mm in form of the limbus
  4. Giant papillary conjuctivitis (GCP) worse than grade 1
  5. Anterior uveitis or iritis (past or present)
  6. Seborrheic eczema, seborrheic conjunctivitis
  7. History of corneal ulcers or fungal infections
  8. Poor personal hygiene
  9. Has a know history of corneal hypoesthesia (reduced corneal sensitivity)
  10. Has aphakia, kertaoconus or a highly irregular cornea.
  11. Has Presbyopia or has dependence on spectacles for near work over the contact lenses.
  12. Has undergone corneal refractive surgery.
  13. Is participating in any other type of eye related clinical or research study.
A Retrospective Pharmacoeconomic Study of Lung Cancer

Lung cancer is the No. cause of cancer death in Taiwan. Yet most of lung cancer are diagnosed at late stage, not amenable to surgical resection. With the introduction of new targeted agents, such as EGFR tyrosine kinase inhibitors and the identification of EGFR mutations, lung cancer management has markedly changed in recent years. However, these new agents are costly and their payment is restricted in certain situations defined National Insurance Agency. Therefore, using databases from National Insurance Agency might not be able to reflect the exact impact on pharmacoeconomics. In this study, the investigators will analyze the data from a tertiary medical center, where all the costs including insurance reimbursement, co-payment, and payment not covered by insurance. The investigators will also compare with the investigators results with national database to analyze the cost benefit of these new agents on lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* lung cancer patients in WanFang Hospital

Exclusion Criteria:

* non