cyrilzakka/clinical-trials huggingface dataset:
CoreValve Evolut Pro Prospective Registry

The primary objective of this study is to evaluate the real-world performance of the CoreValve Evolut PRO transcatheter aortic valve, including leaflet function, in a prospective observational registry.

The CoreValve Evolut PRO transcatheter aortic valve was approved by the FDA in March 2017 to treat patients with symptomatic severe aortic stenosis at high or extreme risk for open heart surgery, and in July 2017 for intermediate risk patients. This latest generation device features an outer wrap to improve annular sealing and reduce paravalvular leak.

In this observational study, baseline demographic and imaging characteristics, procedural details and clinical outcomes of patients undergoing transcatheter aortic valve replacement with the CoreValve Evolut PRO will be prospectively collected into a registry database. The institutional Heart Team will select patients according to standard practice.

Eligibility Criteria:
Inclusion Criteria:

1. Symptomatic severe aortic stenosis
2. Intermediate, high or extreme surgical risk
3. The institutional Heart Team determines that transcatheter aortic valve replacement with an Evolut Pro device is appropriate

Exclusion Criteria:

1. Subject unable or unwilling to give informed consent
2. For subjects in the CT arm only, renal function precluding the administration of iodinated contrast for cardiac CT (eGFR \< 30 ml/min/1.73m2). An exception to this exclusion criterion is made if the subject is established on renal replacement therapy and is therefore able to receive intravenous iodinated contrast media.
3. Pregnancy or intent to become pregnant prior to completion of all protocol follow-up procedures
Effects of FDA Authorized Smokeless Tobacco Claims Among US Adults Who Smoke Cigarettes

This study will be an online survey experiment conducted with adults who smoke cigarettes (ages 21+) to examine their reactions to modified risk advertising claims authorized by the Food \& Drug Administration (FDA) for two smokeless tobacco brands (General Snus and Copenhagen), which describe the lower risks of these products compared to cigarette smoking. The study will compare effects of ads with different two different claim types (i.e. claims about reduced lung cancer risk and claims about reduced risks for multiple disease) versus ads with no reduced-risk claims, and examine effects on message and product perceptions, and interest in using the smokeless tobacco products. We will also examine how smokers' reactions/interest may vary based on the product brand, and asses prior awareness/exposure to the authorized claims.


Eligibility Criteria:
Inclusion Criteria:

* Adults (age 21 and over) who are current established cigarettes smokers (i.e., smoked 100 cigarettes in their lifetime and now smoke every day or somedays), based in the US, members of Ipsos' KnowledgePanel, and have chosen to complete their research panel surveys in English

Exclusion Criteria:

* Panel participants who do not meet the criteria outlined above will be excluded.
Real-time Cancer Pain Assessment and Intervention

This study aim at the advanced malignant tumor patients who suffer from cancer pain, investigate the current status of cancer pain treatment, and study the effects in pain control and quality of life improvement using the method of real-time monitoring and treatment instruction of cancer pain. This study is a randomized, controlled, single center clinical study. After recruitment, the subjects will randomly assign to standard cancer pain treatment group and standard cancer pain treatment plus real-time dynamic monitoring and treatment intervention of cancer pain using the cloud computing concept system. And then, assess the alleviation of cancer pain and quality of live. The assumption is the system will alleviate the cancer pain efficiently.

1. Cancer pain is a common symptom exists in malignant tumor patients, which bother the patients and decrease the quality of life.
2. The goal of the study is that using the real-time monitoring and intervention system will alleviate cancer pain better than the standard cancer pain treatment.
3. The cloud computing concept is developed by Sun Yat-sen University cancer center, and accord with clinical practice.
4. The subjects receive the real-time monitoring and intervention system will install the software and report in the contents of cancer pain in the software correspondingly to the doctors, and advices will be given by the software as well.
5. The quality of life and overall survival follow-up is also required.

Eligibility Criteria:
Inclusion Criteria:

* Solid tumors confirmed by pathology or cytology
* Eastern Cooperative Oncology Group Performance Status: 0-2
* sign the informed consent form
* good compliance, willing to comply with the requirements of the study
* anticipate survival time more than 3 months
* pain intensity is greater than 2 points according to numerical rating scale on enrollment; have indication of opioid analgesic drugs.
* can express subjective feelings of pain intensity clearly.
* own a smartphone or tablet device which can install and use the application program software, and can operate the software proficiently.

Exclusion Criteria:

* poor compliance, refuse to sign the informed consent form, or difficult to comply with the requirement of the study.
* slight pain or no pain, no indication of opioid analgesic drugs.
* contraindication of opioid analgesic drugs
* no other medical workers give instructions during the study.
Clareon Intraocular Lens Stability in Vitrectomy Patients: CLOVE Study

This prospective randomized controlled trial will be conducted to investigate Clareon intraocular lens (IOL) stability in vitrectomy patients. The investigator plans to target the patients undergoing cataract surgery. A randomized study will be conducted with 2 arms, one with Clareon IOL versus a second arm using the Tecnis 1 In this non-inferiority study, the investigator will compare Clareon IOL from Alcon with the existing Tecnis 1 IOL from Precision Lens which is the commonly used intraocular lens in combined vitrectomy cases in Hong Kong.

All patients will undergo standard phacoemulsification cataract extraction with Clareon IOL or Tecnis 1 IOL by an experienced cataract surgeon. Followed by vitrectomy to treat either, epiretinal membrane or vitreous hemorrhage.

All patients returned for follow-up visits at 1 week, 1 month, and 6 months after surgery for ophthalmic assessments including:

* Visual acuity measured by Early Treatment of Diabetic Retinopathy Study (ETDRS) chart
* Refraction
* Axial movement and tilt measured by Pentacam (OCULUS Optikgeräte GmbH, Germany) using the Sasaki method. The Scheimpflug image of the horizontal cross-section and the vertical cross-section of the IOL will be selected for measurement. Central ACD will be measured as the distance between the central corneal posterior endothelium to the anterior surface of IOL. The subtraction in ACD between two visits indicated forward or backward axial movement of the IOL.
* Decentration will be measured from the center of the IOL anterior surface to the pupillary axis, which will be perpendicular to the line between the two anterior chamber angles and through the midpoint of the line.
* Tilt will be measured as the angle between the IOL axis and the perpendicular visual axis.
* Any surgical complications and post-op complications will be documented.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of senile cataracts and epiretinal membranes or vitreous hemorrhage
* Age between 50 and 80 years.

Exclusion Criteria:

* Diagnosis of vision-impairing diseases including uveitis, glaucoma and corneal pathologies resulting in high astigmatism, severe refractive error (preoperative spherical equivalent of either eye \>-6.00D or +5.00D);
* Diagnosis of possible lenses instability including History of ocular trauma, Pseudoexfoliation syndrome; past refractive surgery or other ophthalmic surgery;
* Known Capsular or zonular disorders that might affect the post-operative centration of IOLs, e.g., pseudo-exfoliation syndrome or Marfan syndrome;
* Surgical complications including severe hyphema, iris injury, repeated IOL implantation during surgery, failure to achieve in-the-bag IOL implantation, posterior capsular rupture, usage of tamponade (gas or oil) and corneal sutures.
* Difficulty in obtaining IOL measurements (eg. Small pupil, corneal opacities, patient cooperation)
Comparison of Three Different Pain and Anxiety Reducing Methods in Adult Patients Undergoing Bone Marrow Puncture

The purpose of this study is to investigate and compare the effects of three different methods for reducing pain and anxiety in adult patients undergoing puncture of the bone marrow. The investigated methods are: cognitive behavioural technique, administration of a sedative drug(Midazolam) and administration of an analgetic drug (Piritramid)prior to the procedure. Additionally, there are two comparison groups in which the patients receive either placebo treatment or no treatment at all.

The puncture of the bone marrow is a routine medical procedure which is often performed in the field of hematology/oncology. When carefully and appropriately performed, the puncture of the bone marrow has a very low rate of complications and is generally safe for the patient. However, it is an invasive and painful procedure associated with anxiety, especially in patients undergoing repeated punctures. Therefore an appropriate preparation of the patient for the puncture is essential in order to minimize the stress experienced during the procedure. In this regard, there are numbers of both pharmacological and non-pharmacological interventions in pedriatric patients aimed at reducing the punction related pain and anxiety in this patients. Nevertheless an evidence based approach for the pretreatment of the patients is yet to be established. The aim of this study is to investigate three different methods for reducing the pain and anxiety associated with the puncture of the bone marrow in adult patients. Two of the of the investigated methods involve pretreatment of the patients with pharmacological agents (sedative drug or analgetic drug), whereas the third method involves cognitive behavioural pretreatment in form of an audio material. The patients in the control group receive placebo injections.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for both first or repeated punction of the bone marrow
* Age between 18 and 85 years
* Written informed consent

Exclusion Criteria:

* Contraindication for a punction of the bone marrow
* Administration of benzodiazepines or analgetic drugs prior to the bone marrow punction
* Known hypersensitivity to benzodiazepines or Piritramid
* Known contraindication to benzodiazepines (Myasthenia gravis in particular) or Piritramid (Pheochromocytoma or conditions affecting the consciousness)
* Poor general condition (ECOG Performance Status 3,4; Karnofsky Index \< 50%)
* Addictive disorders
* Administration of antidepressive drugs
* Administration of drugs that potentially depress the respiratory function
* Severe cardio-circulatory or respiratory insufficiency, sleep apnea syndrome
* Known bradycardia
* History of syncope(s) of unclear etiology
* Pregnancy or lactation
Follow-up of Patients With Implantable Cardioverter Defibrillators by Home Monitoring (ANVITE)

Patients with implantable cardioverter defibrillators (ICDs) should undergo regular device follow-ups every 3 months, to verify proper ICD function. However, many follow-ups are uneventful, revealing no relevant changes related to the implanted device and in the patient's diagnostic and therapeutic status. For time and economic reasons, longer follow-up intervals are frequently used although they are not according to recommendations. This may increase the delay in detection of relevant changes in the disease and in deviations from optimal ICD therapy in the individual patients. In the newest ICDs, the essential parameters reflecting safety and appropriateness of ICD therapy (threshold, impedance, intracardiac electrogram, etc.) are transmitted via Home Monitoring on a daily basis, to an internet platform accessible by the attending physician.

In the present study, the investigators evaluate safety and efficacy of 12-month follow-up intervals in ICDs with Home Monitoring capability, as compared with conventional 3-month follow-up scheme.


Eligibility Criteria:
Inclusion Criteria:

* Indication for a single-chamber implantable cardioverter-defibrillator (ICD)

Exclusion Criteria:

* Contraindication for ICD
* Indication for dual-chamber ICD or cardiac resynchronization therapy
Preventing Adverse Drug Events With PatientSite

This is a study to better understand the nature and extent of adverse drug events (ADEs), defined as injuries due to prescription medications, in primary care. We will study whether PatientSite (an internet-based communication program for patients and health care providers) can improve clinicians' ability to detect adverse drug events among primary care patients and to mitigate the consequences by sending electronic queries to patients after they receive new medication prescriptions.

* A drug safety module called MedCheck was developed for PatientSite. This allows physicians to query patients automatically 10 days after they receive a new prescription asking them questions about their new prescription. In this study new enhancements will be tested.
* Participants will be assigned at random to the intervention group or control group. The intervention group will receive a single electronic PatientSite message asking them questions about the new prescription which is then forwarded to their physician. The control group will receive a generic message about medication safety.
* To identify adverse drug events, a telephone survey and medical record review will be conducted of patients in the intervention group and controls.
* This study will run for 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients \>18
* Patients that receive a new prescription
* Proficient in spoken and written english

Exclusion Criteria:
Prevail-Us: A Study Of Pitavastatin 4 mg Vs. Pravastatin 40 mg In Patients With Primary Hyperlipidemia Or Mixed Dyslipidemia

Randomized, double-blind, double-dummy, 12-week, active-controlled study of pitavastatin 4 mg daily(QD) vs. pravastatin 40 mg daily(QD) in subjects with primary hyperlipidemia or mixed dyslipidemia.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects with primary hypercholesterolemia or mixed dyslipidemia who are ≥18 and ≤80 years of age at the time of consent
* Plasma Low-density lipoprotein cholesterol (LDL-C) ≥130 milligrams per deciliter (mg/dL) and ≤220 mg/dL and triglyceride (TG) levels of ≤400 mg/dL

Exclusion Criteria:

* Homozygous familial hypercholesterolemia
* Any conditions which may cause secondary dyslipidemia
* Uncontrolled diabetes mellitus
Flumatinib in CML-CP Patients With Ph+ Post Imatinib Failure

The purpose of this study is to explore the efficacy and safety of flumatinib in chronic phase of chronic myeloid leukemia (CML-CP) patients With Ph+ post imatinib failure.

A multicenter, single-arm, prospective, open-label study to detect the efficacy and safety of flumatinib by measuring rates of major molecular response (MMR) at 12 months in CML-CP patients with Ph+ in China. Approximately 200 Patients will be recruited consecutively from the study sites during the enrollment period and will be given flumatinib 600 mg QD. The duration of patient participation will be 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Diagnosis of CML-CP with Ph+.
* ECOG performance of 0-2.
* Adequate end organ function defined as the following: total bilirubin \<1.5x ULN, SGPT \<2.5x ULN, creatinine \<1.5x ULN.
* Treatment failure after imatinib at 3 or 6 months with BCR-ABL \>10%.
* Patients must sign an informed consent form (ICF) indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital.

Exclusion Criteria:

* Previously documented T315I mutation.
* History of TKI treatments except of imatinib.
* History of undergone major surgery within 4 weeks.
* Patients unwilling or unable to comply with the protocol.
* Pregnant or breast-feeding patients.
* patients with other malignant tumor.
The Effect of Probiotic Streptococci and pH-rising Components on the Oral Microbial Flora

The test group consisted of eighteen subjects with hyposalivation used probiotic tablets (≥ 4/day) and gel (once a week) (streptococci, bicarbonate and carbamide) for 3 months and 9 used placebo tablets and gel. The salivary secretion rates were measured and microbial samples collected and analysed using cultivation technique twice both at baseline and at the 3-month follow up (1-2 weeks between the appointments).

The aim was to analyse the effect of daily intake of probiotic alpha-haemolytic facultative anaerobic streptococci (Streptococcus oralis), pH-rising components and Stevia on the oral microflora in hyposalivated subjects.

Material and methods: Subjects with hyposalivation (unstimulated secretion rate of \< 0.1 ml/min and/or a stimulated secretion rate \< 0.7 ml/min) and ≥ 10 000 cfu/ml of mutans streptococci and/or lactobacilli on the tongue or in the supragingival plaque were included. Eighteen subjects used probiotic tablets (≥ 4/day) and gel (once a week) for 3 months and 9 used placebo tablets and gel. The salivary secretion rates were measured and microbial samples collected and analysed using cultivation technique twice both at baseline and at the 3-month follow up (1-2 weeks between the appointments).

Eligibility Criteria:
Inclusion Criteria:

* No open wounds in the oral cavity
* ≥ 10 own teeth
* Experienced dry mouth for at least 1 year
* An unstimulated salivary secretion rate \< 0.1 ml/min
* A stimulated secretion rate \< 0.7 ml/min and high numbers (≥ 10000 cfu/ml) of lactobacilli and/or mutans streptococci on the tongue and/or in dental plaque

Exclusion Criteria:

* Removable prosthesis
* Reduced immune defence
* Serious heart diseases
* Implanted joints or heart valves
* Lactose intolerance (the probiotic streptococci are freeze-dried in skim milk)
Lebrikizumab Pen Ease of Use in Participants With Atopic Dermatitis

The purpose of this study is to assess the ease of use of the lebrikizumab pen. Participants will use a practice pad to simulate administration of a dose. Participants will complete the modified Subcutaneous Administration Assessment Questionnaire (mSQAAQ) following the simulated injection.

This study involves one study visit.


Eligibility Criteria:
Inclusion Criteria:

* Self-report being diagnosed with atopic dermatitis (AD) by a physician and able to provide approximate diagnosis date.
* Autoinjector or Pen naïve \[have not used an autoinjector or pen previously; permissible to have used a pre-filled syringe (PFS) or vial and syringe\].
* Willing and able to attend an in-person interview session.
* Able to complete the protocol requirements.

Exclusion Criteria:

* Cognitive or physical difficulties that could interfere with ability to understand the training, perform the injection tasks, or complete the study questionnaires as judged by the investigator.
* Are currently enrolled or have participated in the last 3 months, in a clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
* Is a health care practitioner who is trained in giving injections.
* Currently pregnant.
* Known hypersensitivity to any component of lebrikizumab or its excipients.
* Treatment with a live (or live attenuated) vaccine within the past 12 weeks.
* Current or chronic infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) per participant self-report.
Identifying the Gaps in the Diagnosis and Management of Hepatitis C

The purpose of this study is to identify the gaps in diagnosing and managing hepatitis C infected patients so that interventions can be targeted to address these problem areas in order to optimize care of these patients.


Eligibility Criteria:
Inclusion Criteria:

* Every patient diagnosed with hepatitis C

Exclusion Criteria:

* Patients younger than 18 years old
Polycystic Liver Disease Registry (UK)

Multicentre, observational registry studying the natural course of polycystic liver disease.

The Polycystic Liver Disease (PLD) registry (UK) is the UK specific part of an international, multicentre, observational registry. The overall international PLD registry is led by Radboud University Medical Center, Nijmegan, Netherlands. Note- please direct any queries about the international registry to the team at Radboud University Medical Center.

All patients with Polycystic Kidney Disease (PKD) with PLD or patients with Isolated (without PKD) Polycystic Liver Disease are eligible for inclusion (\>10 liver cysts).

Data will be collected prospectively and retrospectively including a specific validated PLD questionnaire (PLD-Q).

This registry provides us insight in patient characteristics, risk factors, symptoms, quality of life and treatment strategies in the biggest international PLD cohort so far. Results of this registry will be published and shared at national and international congresses.

Eligibility Criteria:
Inclusion Criteria:

* Patients with PLD with more than 10 liver cysts
* Patients with PKD and PLD with more than 10 liver cysts

Exclusion Criteria:

* Patients with PKD or PLD with less than 10 liver cysts
EValuation of the Antioxidant and Anti-inflammatory Capacity of Nutraceutical IMMU·SYSTEM Food Supplement (EVAANIS)

The aim of the study is to verify the effectiveness of Nutraceutical IMMU·SYSTEM Dietary supplement in reducing the levels of oxidative stress and inflammation in a sample of healthy adult subjects with high baseline levels of oxidative stress.


Eligibility Criteria:
Inclusion Criteria:

* Caucasian ethnicity;
* Age between 30 and 65 years;
* Smokers who have smoked at least 100 cigarettes in their lifetime and smoke at least 10 cigarettes a day;
* Sportsmen who have been playing sports for at least 6 months between 4 and 8 hours per week;
* Signature of informed consent.

Exclusion Criteria:

* Systemic pathologies;
* Active drug therapy;
* Estrogen-progestogen therapy;
* Pregnancy;
* Allergies to the components of the raw material under study.
ACB A Randomized Study of 2.5ug/kg/Day vs. 5ug/kg/Day Dose of G-CSF After High Dose Chemotherapy Followed by Autologous Peripheral Blood Stem Cell/Marrow Transplant Recipients FILE#17159

Evaluate recovery time on 2.5 mg/Kg/day dose of G-CSF versus 5 mg/Kg/day dose.


Eligibility Criteria:
Inclusion Criteria:

* over age 18
* autologous stem cell/marrow transplant candidate in MM, lymphoma, AMG and testicular

Exclusion Criteria:

* age below 18 years
* sensitive to G-CSF