cyrilzakka/clinical-trials huggingface dataset:
OTC Hearing Aid and MCI

The goal of this study is to better understand if, in patients with mild to moderate hearing loss who are also experiencing mild cognitive impairment (MCI) or Alzheimer's disease and related dementias (ADRD), Over-the-Counter (OTC) hearing aids:

1. improve communication
2. Whether the magnitude of benefit depends on the patient's level of cognitive disability,
3. Whether alternative remediation (such as targeted communication strategies) offer similar benefits.

Participants and a communication partner will be randomized into an OTC first or Communication Strategies first arm, where participants will receive communication strategy information customized for those with cognitive impairment.

This is a single blind cross-over study comparing OTC Hearing Aids to communication strategies information/counseling and their impact on communication between a person who has hearing loss and MCI and a communication partner. Due to the nature of the study, it will not be possible to blind the participants to which arm they are in, but the scorers will be blinded.

Eligibility Criteria:
Inclusion Criteria:

* Over 60 years of age
* Mild dementia or mild cognitive impairment. Diagnosis will be made at participating memory evaluation centers (see recruitment).
* Mild to moderate bilateral hearing loss and no current hearing aid use.
* A communication partner who is able and willing to participate in the study.
* No vision impairment that would interfere with the ability to complete study tasks (i.e., legally blind, severe cataracts, or macular degeneration)
* Able to provide own consent as evaluated by the Consent Assessment

Exclusion Criteria:

1. Clinically significant unstable or progressive medical conditions, or conditions which, in the opinion of the investigator(s) places the participant at unacceptable risk if he or she were to participate in the study.
2. History of unresolved communication difficulties following another neurological problem (i.e., stroke or brain tumor), neurodevelopmental disorder (i.e., Down's syndrome), or head/neck cancer
3. Positive history of major psychiatric disorder (i.e., schizophrenia, significant untreated depression)
4. Co-enrolled in other intervention studies targeting hearing, language, or communication strategies.
5. History or current fluctuating hearing loss
Addressing Unmet Basic Needs to Improve Adherence Among Women With an Abnormal Pap

The investigators aim to improve adherence to follow-up recommendations for an abnormal Pap and effectively reduce disparities in cervical cancer risk and disease among rural and low-income urban women.


Eligibility Criteria:
Inclusion Criteria:

* Newly referred patients to colposcopy clinic at SIUM and WUSM
* Aged 18 years or older
* English speaking
* Able to provide verbal consent
* Diagnosis of abnormal pap will be confirmed by pathology report
* Member of all races and ethnic groups

Exclusion Criteria:

* Male
* Established colposcopy clinic patients
* Known diagnosis of cancer
* Pregnancy
* Incarcerated
* Unable to consent
* No access to a working contact phone number
ONCOTIPNET: Multicenter Study on Risk Factors and Outcome in Cancer Pediatric Patients Admitted in Italian PICUs

The study will describe characteristics of pediatric cancer patients admitted to Italian PICUs and will analyze risk factors of PICU admission, neurological outcome, and mortality. After a retrospective analysis (2019-2020), investigators will perform a prospective study over 12 months gathering data from 15-20 Italian PICUs.

The study aim to evaluate:

1. characteristics of pediatric cancer patients admitted to Italian PICUs
2. risk factors of PICU admission, neurological outcome and mortality.

Inclusion criteria: age \<= 18 years, informed consent. Exclusion criteria: informed consent not obtained. After a retrospective analysis (2019-2020), investigators will perform a prospective study over 12 months (March 2021 - February 2021) gathering data from 15-20 Italian PICUs. Each Center can decide whether to participate only in the prospective phase. Data will be recorded in an electronic data collection form in Red Cap.

The following variables will be collected:

* Demographic variables: age, sex, ethnicity;
* TIP pre-admission clinical variables and at the time of admission: basic diagnosis, comorbidity, Hemopoietic Stem Cell Transplantation (TCSE) number and type, treatment phase, HLA matching, Graft Versus Host (GVH) and grade, veno-occlusive disease, Venous Occlusive Disease
* Variables upon entering TIP: PIM3, POPC score, organ failure cause and staging, high intensity treatments, high flow oxygen therapy, dialysis, inotropes or other, fluid overload, immunodeficiency
* Clinical variables during hospitalization: organ failure cause and staging, ventilation, modality, presence of pARDS and severity, need for inotropic support, sepsis and severity score (SOFA), inotropes (VIS score), arrest event cardiac, need for HFOV, Extra-Corporeal Membrane Oxygenator, Nitric Oxide, dialysis, Intracranial Pressure monitoring, drugs used for sedation, development of withdrawal syndrome, development of delirium.

Considering the participation of 15-20 centers involving 20 patients in a year, the expected number is 600 patients considering the retrospective phase (optional, therefore some Centers may not contribute) and the prospective phase.

Study sites will also take part to a survey designed to collect data in order to describe Italian PICUs involved in providing care to cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* age \<= 18 yeras
* informed consent\*

Exclusion Criteria:

* informed consent not obtained\*

  * only for next prospective part of the study
FDG PET-CT for Lymphoma Radiotherapy Planning Version 1.3

Chemotherapy followed by radiotherapy is used to treat early stage lymphomas with excellent cure rates. However, a significant proportion of these patients develop cancers and heart diseases years later as a result of the radiotherapy. Therefore, there is a move to reduce radiation exposure without compromising cure rates. Radiotherapy is planned using a CT scan taken following chemotherapy when many of the original sites of the lymphoma are no longer visible using a CT scan taken following chemotherapy when many of the original sites of the lymphoma are no longer visible.

In order to safely minimise the volume treated with radiotherapy it is necessary to accurately reconstruct the extent of the lymphoma prior to chemotherapy on this 'planning' CT scan. A PETCT prior to chemotherapy is the best way of demonstrating the original extent of the lymphoma, but is taken in a different position to the radiotherapy treatment position. This aim of this study is to explore whether a PETCT scan taken prior to chemotherapy in the radiotherapy treatment position, in conjunction with advanced software to combine this scan with the subsequent radiotherapy planning CT, can be used to more accurately identify the lymphoma target. The study aims to recruit up to 20 patients with early stage Hodgkin lymphoma or high grade nonHodgkin lymphoma. A routine staging PETCT will be followed at the same session by a PETCT in the radiotherapy treatment position appropriate radiotherapy immobilisation devices. Participation in the study will not affect treatment decisions or the radiotherapy planning process. The PETCT in the radiotherapy planning position will be made available to the treating clinicians. The process of planning radiotherapy will not be systematically altered by the study. The study is aimed at determining how to improve the radiotherapy planning process in the future, in the hope of a reducing in the long term side effects of treatment whilst retaining high cure rates.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18
* WHO Performance status 02
* Histologically proven Hodgkin lymphoma or high grade nonHodgkin lymphoma
* Ann Arbor Stage I/II disease based upon clinical examination and any radiology investigations performed
* Clinical decision to proceed with sequential chemotherapy and radiotherapy if stage I/II disease is confirmed on subsequent 18FDGPETCT staging
* Residual disease in situ after biopsy
* Able to provide fully informed written consent
* Able to lie flat for 1 hour
* Not be pregnant or breast feeding. Female patients of childbearing potential must agree to use effective contraception, be surgically sterile, or be postmenopausal.

Exclusion Criteria:

* Hypersensitivity to fluorine18 FDG
* Hypersensitivity to iodinated contrast media or Gadolinium
* Poorly controlled diabetes
* Acute renal failure or moderate renal impairment (estimated glomerular filtration rate \< 30 mL/min)
* Uncontrolled pain
* Urinary incontinence
* Female patients must not be pregnant and if of child bearing age using adequate contraception
* Breast feeding
* Serious psychiatric comorbidity
Factors Contribute to Very Late Stent Thrombosis After New Generation DES Implantation in China

The investigators sought to identify and verify the potential correlates and mechanisms of Very Late Stent Thrombosis (VLST) after the implantation of new generation drug eluting steng in China from an analysis of multicenter registries.

This study represents a patient-level pooled analysis of patients undergoing percutaneous coronary intervention with stent implantation for acute coronary syndrome. Multiple aspects including clinical, angiographic, procedural characteristics , intravascular imaging results and blood samples were collected at index PCI and the time of VLST or CAG during follow-up, in order to reveal the potential mechanisms or risk factors that contribute to the development of VLST.

Eligibility Criteria:
Inclusion Criteria:

* Patients\>18y,admitted for acute coronary syndrome,successfully underwent PCI with at least one stent, sign informed consent.

Exclusion Criteria:

* Expected lifetime was less than 1 year for any severe disease(such as tumor,severe respiratory failure et al). There is a surgical plan for important organs within 1 year after surgery and anti-platelet drugs should be discontinued. Refusing to sign informed consent.Died prior to discharge. Poor compliance, unable to participate in regular follow-up.
Epigenetic Modifications of Diabetes Mellitus Type I

This research is being done to find out if significant changes in blood glucose cause bad outcomes in patients with diabetes.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old
* Diagnosis of Type I diabetes
* Willing to wear continuous blood glucose monitor as specified in protocol

Exclusion Criteria:

* Pregnant or planning to become pregnant during the study

Healthy control group Inclusion:

* 18-65 years old
* Willing to wear continuous blood glucose monitor as specified in protocol

Exclusion:

* Pregnant or planning to become pregnant during the study
* Diagnosis of Type I or II Diabetes
Hemodynamic Impact of Epidural Anesthesia in Relation to Age in Pediatric Patients.

Epidural analgesia is established as the gold standard in the management of post-surgical pain in multiple modalities, including the pediatric patient. It is a technique that is not without risks, but with multiple benefits such as less response to stress, less incidence of chronic pain after surgery, less incidence of nausea and vomiting and other adverse effects derived from opioids, faster recovery and increased patient and family satisfaction.

However, as it has been mentioned, the epidural carries risks both in the technique itself (wet or intravascular puncture) and subsequently after the injection of medication that generates a sympathetic blockade with arterial hypotension and an increase in compensatory heart rate. Unlike in adult patients, in pediatric patients epidural and subarachnoid anesthesia are better tolerated hemodynamically due to less vagal and sympathetic activity and almost no systemic venodilation. This lower activity of the autonomic nervous system is due to its immaturity, which is why, with the growth of the infant, this anesthetic technique increasingly affects its hemodynamics, being similar to the adult at the age of 8-12 years.

The study hypothesis does not differ from that stated in physiology books and studies, but the investigators seek to identify the direct correlation of age with the different hemodynamic parameters available with current technology (cardiac output, systemic vascular resistance, blood pressure ) in pediatric patients after epidural anesthesia.

The study will be carried out in pediatric patients undergoing major surgery that requires the placement of an epidural catheter and invasive blood pressure, without modifying in any way the usual practice of the responsible anesthesiologist. The patient's hemodynamic data will be collected at time 0 (prior to catheter placement), one minute, 5 and 10 minutes after the bolus of local anesthetic administered to measure the child's hemodynamic response and relate it to their age and development. .

Through this work the investigators seek to establish statistically and numerically a hypothesis affirmed in physiology books. In this way, if it is found a positive correlation with age and hypotension, the responsible physician can be alerted to the need for possible vasoconstrictor requirements or more advanced monitoring in order to reduce intraoperative risks.

Eligibility Criteria:
Inclusion Criteria:

* Patients under 12 years of age undergoing major surgery with epidural catheter placement and invasive blood pressure.

Exclusion Criteria:

* Allergy to local anesthetics (LA).
* Congenital diseases which affect the central nervous system.
* Inability to place an invasive arterial catheter.
Informed Consent in Endoscopy: Read, Understood or Merely Signed?

Informed consent form is a legal document that, ethically, should be obtained before any endoscopic procedure is performed.

The main purpose of this research study is to assess the readability, comprehensibility and applicability of the new informed consent proposed by the Portuguese Society of Digestive Endoscopy as a way to standardize the information provided to patients prior to endoscopic exams.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients able to autonomously give informed consent
* Patients refered to elective endoscopic procedures (upper digestive endoscopy and/or colonoscopy) without deep sedation.

Exclusion Criteria:

* Patients refered to urgent endoscopic procedures
* Patients refered for endoscopic procedures with deep sedation
rTMS in Treatment of Spasticity

This is an open-label clinical trial to determine the safety and efficacy of rTMS in reducing spasticity and improving quality of life among patients with upper motor neuron predominant motor neuron disease (MND).

The study's objective is to evaluate the role of rTMS for symptom reduction of spasticity among patients with upper motor neuron predominant motor neuron disease. This study is 12-week open label safety and efficacy trial. A total of 10 subjects with PLS and UMN/ MND will be enrolled in this study.

Eligibility Criteria:
Inclusion Criteria

* Age ≥ 18, men or woman
* Diagnosis of upper motor neuron predominant ALS, which also includes patients with primary lateral sclerosis (PLS), as defined as only upper motor neuron features in at least 2 body segments.
* EMG within 3 months of enrollment with minimal or no evidence of lower motor neuron disease.
* Time from symptom onset \> 18 months
* On a stable dose of, or has not taken, Riluzole for at least thirty days.
* Has not taken, or has received at least 2 cycles of dosing of, Edaravone prior to screening.
* Able to communicate clearly the desire to withdraw from the procedure at any stage.
* Impaired walking as measured by a Hauser Ambulation index of greater than 1 and less than 7 (2 to 6, inclusive).
* MMSE ≥ 22 and deemed by the PI as being capable of providing informed consent and following trial procedure.
* Has spasticity, equal or above 1 in the Ashworth Scale for spasticity in 2 or more muscle group of at least 3 months duration.
* Absence of exclusion criteria.

Exclusion criteria

* Patient has a history of drug or alcohol abuse within the past year;
* Patient has clinically significant abnormal laboratory values.
* Any concomitant disease or disorder that has spasticity-like symptoms or that may influence the subject's level of spasticity
* Received Botulinum Toxin during the preceding 6 months
* Bedridden and patients with tracheostomy.
* Fixed-tendon contractures
* Poorly controlled epilepsy or recurrent seizures (Subjects who have had one or more seizures in the year prior to Visit 1 will be excluded)
* Unable to provide an informed consent
* Unable to comply with the procedures
* Unable to communicate clearly if the subject wants to withdraw from the procedure at any stage
* History of brain surgery for any indication
* Has pacemaker, cochlear implants, brain stimulators, infusion pumps, intracardiac lines, metallic clips, other implanted electronic or ferroelectric metallic devices above the neck (Dental implants are permitted), piercing or body modification above the neck, known history of TMS related complications or side effects.
* MMSE \<22.
* Female patients of child bearing period who are not practicing contraception.
* Female patients who are pregnant.
* Inability to perform either rTMS due to insufficient MEP amplitude (\< 50 µv).
Thrombophylaxis in Transurethral Surgery With Dalteparine

The rationale for thrombophrophylaxis is well known. Without prophylaxis the incidence of objectivlely confirmed, hospital-acquired deep venous thrombosis is approximately 10% to 40% among medical or general surgical patients. In urology the prevalence is 15-40%. The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy1 recommend against specific prophylaxis in patients undergoing transurethral procedures. Our study is the first double-blind, placebo-controlled study with Dalteparine as thrombophrophylaxis in transurethral surgery. The aim of the study is to proof that thrombophrophylaxis causes not more complications in transurethral surgery than without.

The aim of our study is to proof that transurethral surgery under thrombophylaxis with dalteparine is safe. The study design is double-blind placebo controlled.

Eligibility Criteria:
Inclusion Criteria:

* transurethral surgery

Exclusion Criteria:

* oral anticoagulation
DSME or DSME + MI in T1DM on Glycemic Control

This study evaluates the effect of diabetic knowledge and self care behavior (DSME) alone or DSME plus motivational interviewing on glycemic control among children and adolescents with DM type 1. Half of participants will receive DSME along, while the other half will receive DSME plus MI.


Eligibility Criteria:
Inclusion Criteria:

* T1DM
* age more than 10 years old
* HbA1C more than 8%

Exclusion Criteria:

* other types of DM
* receive medications that may effect blood glucose
* mental retardation
Thoracic Manipulation in Patients With Cervical Radiculopathy

Hypothesis: The group of Cervical Radiculopathy patients receiving thoracic thrust manipulation will demonstrate immediate and short term significant clinically important changes in outcomes when compared to the sham manipulation group.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 yrs
* 3 out 4 Items positive of Clinical Prediction Rule for Cervical Radiculopathy

Exclusion Criteria:

* history of previous cervical or thoracic spine surgery
* bilateral upper-extremity symptoms, signs or symptoms of upper motor neuron disease,
* medical "red flags" (e.g., tumor, fracture, rheumatoid arthritis, osteoporosis, and prolonged steroid use).
Comparison of Single vs. Dual Perclose Devices for Large-Bore Access Closure in TAVR

This study will compare the use of one Perclose device to the usual approach of two devices during Transcatheter Aortic Valve Replacement (TAVR). The study will compare the time it takes for bleeding to stop using the different closure approaches. The study will also compare complications when using one Perclose device versus two.

This single-center randomized trial compares single versus dual Perclose devices for initial closure of vascular access for Transcatheter Aortic Valve Replacement (TAVR) and investigation will evaluate the efficacy and performance of these two closure approaches. The study will provide valuable insights into optimizing closure techniques, potentially enhancing patient outcomes and reducing complications associated with Transcatheter Aortic Valve Replacement (TAVR) procedures. The trial will aim to enroll patients undergoing TAVR, with an an equal number of patients randomized to each closure strategy arm.

Eligibility Criteria:
Inclusion Criteria:

* Patient age 18 or older
* Transfemoral transcatheter aortic valve replacement (TAVR)
* Implantation of CoreValve replacement valve
* Access using 14 or 16 French sheaths
* English speaking

Exclusion Criteria:

* Alternative Access Routes: Patients undergoing transcatheter aortic valve replacement (TAVR) via alternative access routes such as subclavian access or transapical access.
* Planned Surgical Cut-Down: Patients planned for surgical cut-down procedures rather than percutaneous access.
* Valve-in-Valve Procedures: Patients undergoing valve-in-valve procedures.
* Vascular Access Complications: Patients with known vascular complications at the femoral access site, such as residual hematoma, recent femoral arteriotomy or venotomy within the past 10 days, history of significant vascular complications or prior intravascular closure device use within the previous 30 days.
* Arterial or Venous Issues: Patients with small femoral arteries or veins (\<5 mm in diameter), patients with access sites located in vascular grafts.
* Infection or Inflammation: Active systemic or cutaneous infection or inflammation in the vicinity of the groin.
* Coagulation and Hematological Disorders: Known history of bleeding diathesis, coagulopathy, hypercoagulability, or platelet count \<100,000 cells/mm³. Pre-existing immunodeficiency disorder or chronic use of high-dose systemic steroids.
* Severe Morbidity: Severe co-existing morbidities with a life expectancy less than 12 months.
* Mobility Issues: Patients unable to routinely walk at least 20 feet without assistance.
* Recent Anticoagulation: Use of low molecular weight heparin (LMWH) within 8 hours before or after the procedure.
* Pregnancy and Lactation: Pregnant or lactating women.
* Obesity or Underweight: Class III Obesity (body mass index \> 40 kg/m²) or underweight (body mass index \< 20 kg/m²).
* Incompatible Procedure Plan: Patients receiving the Edwards Sapien valve (Edwards Lifesciences, Irvine, CA)
* Contraindications: Patients with contraindications for the use of Perclose device.