cyrilzakka/clinical-trials huggingface dataset:
The Application of Negative Atrioventricular Hysteresis in Cardiac Resynchronization Therapy With MultiPoint Pacing

The purpose of this study is to evaluate the application of Negative AV Hysteresis (NAVH) to improve electrical synchrony in MultiPoint Pacing (MPP) Cardiac Resynchronization Therapy (CRT) patients.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for implantation of an MPP-enabled SJM Quadripolar CRT Pacing System
* QRS duration \> 140 ms
* Left bundle branch block documented
* Ability to provide informed consent for study participation
* Willing to comply with the study evaluation requirements
* At least 18 years of age

Exclusion Criteria:

* Resting ventricular rate \>100 bpm
* Intrinsic PR interval \> 300 ms
* Paroxysmal or persistent atrial tachycardia or atrial fibrillation documented
* A recent myocardial infarction, ablation, drug intoxication, electrolyte imbalance, or any condition within the last 90 days that would be contraindicated for CRT programming changes in the opinion of the investigator
* Women who are pregnant or who plan to become pregnant during the study
Platelet Transfusion in Acute Intracerebral Hemorrhage

* To prove whether use of antiplatelet agents results into a rapid enlargement of hematoma after onset of acute intracerebral hemorrhage.
* To prove the efficacy and safety of platelet transfusion for prevention of hematoma growth in patients who were stricken by acute intracerebral hemorrhage while being on antiplatelet medication.

* Hematoma growth is a well-known powerful determinant of mortality and poor outcome after intracerebral hemorrhage.
* Some observations suggest that previous use of antiplatelet agents associates with rapid hematoma enlargement and poor outcome after cerebral hemorrhage.
* Immediate platelet transfusion for such patients may prevent hematoma growth but also cause thromboembolic complications.

Eligibility Criteria:
Inclusion Criteria:

* being on either aspirin or clopidogrel or a combination of aspirin and dipyridamole
* acute primary ICH
* \> 17 years
* admitted within 6 h after onset of ICH
* ICH score \< 4

Exclusion Criteria:

* other type of ICH than acute primary intracerebral hemorrhage
* patients who need neurosurgery
* life expectancy less than 3 months due to comorbid disorders
* confirmed malignant disease (cancer)
* confirmed acute myocardial infarction
* hepatitis and/liver cirrhosis
* renal failure
* infectious disease (HIV, endocarditis etc.)
* current or previous hematologic disease
* women of childbearing age if pregnant
* participation in another study within the preceding 30 days
Pilot Study of the Endologix Fenestrated Stent Graft System

The purpose of this study is to determine whether the Endologix fenestrated stent graft system is safe and feasible in the endovascular repair of juxtarenal or pararenal aortic aneurysm.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent understood and signed and pt agrees to all follow-up visits;
* Abdominal aortic aneurysm with diameter ≥5cm or ≥4cm which has increased by 0.5cm or more in the past six months
* Adequate iliac/femoral access compatible with the required delivery systems
* Non-aneurysmal infrarenal aortic neck \<15mm in length
* Most caudal renal artery to aortoiliac bifurcation length at least 70mm
* Proximal non-aneurysmal aortic neck below the SMA with: diameter 18 to 34 mm; length at least 15 mm; angle (clock face) \<60° to the aneurysm sac;
* Angle \<60° (clock face) between the SMA and celiac artery
* Renal arteries both distal to the SMA by 0-35mm, within 30mm of each other axially, with 4 to 8mm lumen diameter, and with clockface angle of 90° to 210° to each other
* Iliac anatomy suitable for commercial bifurcated stent graft;
* Minimum 3cm overlap achievable between fenestrated and bifurcated stent grafts

Exclusion Criteria:

* Life expectancy \<1 year as judged by the investigator;
* Psychiatric or other condition that may interfere with the study;
* Participating in the enrollment or 30-day follow-up phase of another clinical study;
* Known allergy to any device component;
* Coagulopathy or uncontrolled bleeding disorder;
* Contraindication to contrast media or anticoagulants;
* Ruptured, leaking, dissecting, or mycotic aneurysm;
* Serum creatinine (S-Cr) level \>2.0 mg/dL;
* Traumatic vascular injury;
* Active systemic or localized groin infection;
* Connective tissue disease (e.g., Marfan's Syndrome);
* Recent (within prior three months) cerebrovascular accident or myocardial infarction;
* Prior renal transplant;
* Length of either renal artery to be stented \<13mm;
* Significant occlusive disease or calcification of either renal artery;
* An essential accessory renal artery;
* Indispensable inferior mesenteric artery;
* Untreated aneurysmal disease of the descending thoracic aorta;
* Clinically significant mural thrombus circumferentially in the suprarenal segment;
* Prior iliac artery stent implanted that may interfere with delivery system introduction;
* Unsuitable vascular anatomy
* Pregnancy (female patient of childbearing potential only)
Preventing Non-communicable Diseases in Guatemala Through Sugary Drink Reduction

Sugar-sweetened beverages are a significant contributor to adult and childhood obesity in Guatemala. Policies to place health warning labels on sugar-sweetened beverages are being pursued, but there is little empirical data on how such labels influence people. The primary aim of this study is to test the association between sugar-sweetened beverage (SSB) warning posters compared to control posters and change in SSBs purchased compared to baseline by adolescents shopping at school cafeterias in Guatemala City, Guatemala. The hypothesis is that posters with information warning people of the health harms associated with overconsuming SSBs and promoting low sugar beverages will be associated with greater reductions in SSB purchases compared to a control poster.


Eligibility Criteria:
Inclusion Criteria:

* Between 12 and 18 years old
* Made a food or beverage purchase
* Has permission from parent or caregiver to participate
* Has not yet completed the purchase assessment

Exclusion Criteria:

* Under 12 or over 18 years old
* Did not make a food or beverage purchase
* Parent or caregiver refused to give child permission to participate
* Already participated in the purchase assessment
Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19

Retrospective single center analyses of COVID-19 patients admitted to the ICU between 01/02/2020 and 31/07/2021.

All adults (\>18 years) with acute hypoxaemic respiratory failure due to diagnosed COVID-19 pneumonia and admitted to ICU from 01/02/2020 until 31/07/2021 were included in the study. Following the World Health Organisation (WHO) protocol 19, laboratory confirmation of COVID-19 infection was defined as a positive result on polymerase chain reaction (PCR) assays of nasopharyngeal swab samples or bronchoalveolar lavage. Only laboratory-confirmed patients were included in the analysis.

Additional data collection

Additional collected parameters are listed below and are collected as a standard-of-care in our hospital:

* Demographics: i.e age, gender, BMI
* DNR code
* Comorbidities: smoking, obesity, hypertension, diabetes, cardiovascular disease, respiratory disease, malignancies, renal failure (AKI), liver failure, gastrointestinal disease, neurological conditions, mental state, other
* Symptoms at the time of admission to ICU: i.e fever, body temperature, dyspnoea, headache, diarrhea etc...
* Laboratory results of all standard parameters measured
* Treatment: antiviral agents, antibiotics, etc...
* Complications: shock, heart failure, sepsis, stroke, etc...
* Ventilation: method, PEEP, FiO2, P/F ratio ..

Eligibility Criteria:
Inclusion Criteria:

* All adult COVID-19 patients (\>18 years) admitted to the ICU between 01/02/2020 and 31/07/2021 with a laboratory confirmation of COVID-19 infection with a positive result on polymerase chain reaction (PCR) assays of nasopharyngeal swab samples or bronchoalveolar lavage

Exclusion Criteria:

* All adult patients admitted for other reasons to the ICU (no COVID-19 pneumonia)
Electronic Harm Reduction Treatment for Alcohol

The goal of this project is to transform a successful, face-to-face harm-reduction treatment (HaRT-A) into a digital format, creating eHaRT-A. This new platform is specifically designed for people who have experienced homelessness and an alcohol use disorder (AUD), living within the framework of permanent, supportive, Housing First (HF) facilities. We hypothesize eHaRT-A will be more effective than the standard HF services in reducing alcohol-related harm and improving the overall quality of life for participants.


Eligibility Criteria:
Inclusion Criteria:

* Being at least 21 years of age
* Speak English fluently
* Currently a registered client at one of the Housing First sites
* Currently drinking (has used alcohol in the past 2 weeks)
* Meeting criteria for "current" (e.g., past-year) AUD according to the Diagnostic and Statistical Manual of Mental Health Disorders, Fifth Edition (determined as scoring \>= 2 on the SCID-5-CV)

Exclusion Criteria:

* Enrollment in any related treatment studies (including studies by this research team)
* Refusal or inability to consent
* Constituting a risk to the safety and security of residents or staff
Ulimorelin Study of Efficacy and Safety (ULISES 007)

Post-operative administration of ulimorelin is expected to reduce time to recovery of Gastrointestinal (GI) function in patients who have undergone partial large bowel resection.


Eligibility Criteria:
Inclusion Criteria:

* Men or women, 18 to 80 years of age, inclusive
* Scheduled to undergo open bowel resection with colonic anastomosis.
* For women who can potentially become pregnant a pregnancy test at screening and admission must be negative.

Exclusion Criteria:

* Weight more than 200kg (441 pounds)
* Pregnant or breastfeeding
* Known history of drug or alcohol abuse within the previous year.
Patient Decision Aid for Opioid Use Disorder

The aim of the study is to test the effectiveness of the Patient Decision Aid for Opioid Use Disorder (PtDA-MAT) by conducting a stepped-wedge cluster-randomized trial in CA H\&SS (stratified by rural vs. non-rural areas) for adults with OUD. Patient outcomes will be tracked by (1) personal assessments (baseline, 3 months, and 6 months): drug use, overdose, healthcare utilization, and (2) clinical and administrative records (over approximately 24 months): drug treatment status and retention, physical and mental health diagnoses, arrest, incarceration, controlled substance use, and mortality. Multilevel models will be applied to test the intervention effects, controlling for possible temporal trends.

In response to RFA-DA-18-005 (Expanding Medication Assisted Treatment for Opioid Use Disorders in the Context of the SAMHSA Opioid STR Grants, R21/R33), this project will develop and test a patient decision support tool called Patient Decision Aid for Medication-Assisted Treatment (PtDA-MAT) for use in the CA H\&SS. The PtDA-MAT is designed to (1) improve patient knowledge and involvement and to subsequently improve treatment adherence and outcomes and (2) to support clinicians in informing and communicating with their patients with OUD along a continuum of care. The 3 year project will assess the effectiveness of the PtDA-MAT in a stepped-wedge cluster-randomized trial in CA H\&SS (stratified by rural vs. non-rural areas) for adults with OUD. Patient outcomes will be tracked by (1) personal assessments (baseline, 3 months, and 6 months): drug use, overdose, healthcare utilization, and (2) clinical and administrative records (over an average of 24 months): drug treatment status and retention, physical and mental health diagnoses, arrest, incarceration, controlled substance use, and mortality. Multilevel models will be applied to test the intervention effects, controlling for possible temporal trends.

Eligibility Criteria:
Inclusion Criteria:

* Opioid Use Disorder diagnosis and agreement to follow study procedures (including permission to share medical records and other administrative records)

Exclusion Criteria:

* Significant or unstable medical or psychiatric illness that may interfere with study participation
High Frequency Jet Ventilation for Percutaneous Interventional Radiology

Evaluate benefits of High Frequency Jet Ventilation compare to standard ventilation during general anesthesia in patient undergoing peri diaphragmatic percutaneous tumor ablation.

The investigators hypothesis that procedure is shorter and more accurate in High Frequency Jet Ventilation group reducing target movement induced by ventilation.


Eligibility Criteria:
Inclusion Criteria:

* use of percutaneous ablation tumor techniques (\<3cm) for inferior lung, superior kidney, superior liver or adrenal gland lesion

Exclusion Criteria:

* Severe chronic obstructive pulmonary disease
* Recent pneumothorax (one month)
* Recent thoracic surgery (one month)
* Body Mass Index \> 40
Predictive Factors of Lymph Node Metastasis in Patients With Papillary Microcarcinoma of the Thyroid

Papillary thyroid microcarcinoma (PTMC), defined as a tumor with larger diameter ≤ 1 cm, is considered a tumor with an indolent course and an excellent prognosis. Nevertheless, the incidence of lymph node metastasis in PTMC is not negligible, reaching up to 65% in some series. The aim of this study was to assess the incidence of lymph node metastasis in patients with PTMC and to evaluate predictive factors for lymph node metastasis.


Eligibility Criteria:
Inclusion Criteria:

Patients with papillary microcarcinoma of the thyroid

Exclusion Criteria:

Patients with thyroid nodules \> 1 cm; incomplete data
Relaxation Guided Imagery for Treatment of Parkinson's Disease

Parkinson's disease patients may have pronounced ON-OFF motor fluctuations. These motor fluctuations are currently treated with medication and surgery, which are limited by their efficacy and side effects. Our study aims to determine whether relaxation guided imagery can alleviate the OFF state of PD patients and therefore can be used as an adjunct to conventional medication.

Parkinson's disease patients with pronounced ON-OFF motor fluctuations without dementia will participate in this study aimed to examine a possible beneficial effect of relaxation guided imagery on motor fluctuations. The study will include a baseline period two sessions of relaxation and a follow-up period. The relaxation sessions will be conducted individually. In one session patients will hear relaxing music and in the second they will undergo relaxation guided imagery. After each relaxation session patients will receive a CD with either relaxing music or RGI to listen to at home. They will be asked to fill out a diary at baseline and after each session. Before and after each relaxation session patients will be examined according to the Unified Parkinson's Disease Rating Scale and the examination will be videotaped. All patients will continue to receive the usual care from their medical providers. The main measure is change in UPDRS and secondary measure is change in daily OFF time.

Eligibility Criteria:
Inclusion Criteria:

* Patients with idiopathic Parkinson's disease suffering from motor fluctuations
* H\&Y \>2

Exclusion Criteria:

* Dementia
* hearing impairment
Predictive Factors of Ranibizumab Treatment in Macular Edema With CRVO

Recent studies have shown that intravitreal injection of anti-VEGF agent, Lucentis (Ranibizumab) is effective for macular edema associated with central retinal vein occlusion (CRVO). However, there is little information on whether there are any predictive factors of treatment outcome after this treatment. We plan to perform comprehensive functional and imaging tests to determine significant predictive factors.

The purpose of the present study is to investigate predictive factors of treatment outcome after intravitreal injection of Lucentis (Ranibizumab) in eyes with macular edema associated with central retinal vein occlusion (CRVO) using various comprehensive clinical tests including visual filed, spectral-domain optical coherence tomography (SD-OCT), ultra wide-field fluorescein angiography, new flicker electroretinogram (ERG) using skin electrodes. Corrected visual acuity, visual filed, spectral-domain optical coherence tomography (SD-OCT), ultra wide-field fluorescein angiography, and new flicker electroretinogram (ERG) using skin electrodes are performed before and 3, 6, 9, 12 months after the treatment. Predictive factors of treatment outcome are statistically analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Macular edema associated with central retinal vein occlusion
* Best corrected visual acuity \< 20/30
* Central macular thickness \> 300
* Period from symptom onset to treatment \< 12 months

Exclusion Criteria:

* Any past history of treatment for macular edema (e.g. anti-VEGF injection, steroid, vitrectomy)
The Informed Genetics Annotated Patient Registry

This prospective and retrospective registry will evaluate the clinical effectiveness of Germline Genetic, Genomic, and other Biomarker testing results over time in different clinical populations, in order to shape guidelines for testing, patient management, and precision therapy.

Interest and knowledge about the genetics and biology of an individual's inherited risk of disease and progression of disease is growing. Physicians are increasing using tests and technology, including Germline Genetic, Genomic, and Biomarker Testing, to provide insight into a healthy individual's risk and an affected individual's disease characteristics, in order to provide individualized clinical treatments. However, many barriers to widespread and appropriate Germline Genetic, Genomic, and Biomarker Testing persist due to complex guidelines for use, varied quality and cost, rapid advances, and adequate understanding of appropriate implementation by medical professionals. The iGAP Registry is a multi-center ongoing database designed to capture information on disease risk assessment, Germline Genetic, Genomic, and Biomarker Testing, and their utilization and impact on treatment practices and outcomes to help determine, over time, the most effective use of testing in varied patient populations and to support the increased use of precision medicine.

Eligibility Criteria:
Inclusion Criteria for Retrospective Subjects:

* Men and women 18 years or older;
* Is or was a patient of a Participating Practice and was previously tested with Germline, Genomic, or other Biomarker Tests; and
* For Germline Genetic Test patients, have a diagnosis of cancer or pathogenic or likely pathogenic (P/LP) result.

Inclusion Criteria for Prospective Subjects:

* Men and women aged 18 years or older;
* Presents consecutively to a Participating Practice and who has previously been screened and tested (i.e., is a new patient scheduled for a visit at a Participating Practice or is an existing patient who returns to a Participating Practice);
* Receives or has received Germline, Genomic, or other Biomarker Testing, either through a prior healthcare provider or a Participating Practice; and
* Consents to be a part of the Registry.
Safety and Efficacy of APL180 in Healthy Volunteers and Patients With Coronary Heart Disease (CHD)

The purpose of this study is to determine: (1) the safety and pharmacokinetics of APL180 administered as a single intravenous infusion in healthy volunteers, and (2) the safety, pharmacokinetics and pharmacodynamics of single and multiple daily intravenous infusions of APL018 in patients with CHD


Eligibility Criteria:
Inclusion Criteria:

* Male and female healthy volunteers (ages 18-55 years) and patients with CHD (ages 18 to 75 years) on stable statin therapy for at least 8 weeks, with normal liver and kidney function.
* Women who are post-menopausal, surgically sterile, or practicing effective contraception. Additional birth control details to be provided at screening.
* Body mass index (BMI) must be within the range of 20 to 35 for CHD patients or CHD equivalents.
* Clinical CHD:
* Myocardial infarction (MI), angina, revascularization (e.g. CABG, stent) at least 6 months prior to inclusion
* CHD equivalents:
* symptomatic carotid artery disease (e.g. transient ischemic attack or stroke of carotid origin) or peripheral artery disease or abdominal aortic aneurysm or Diabetes Mellitus (HbA1c ≤9)
* 20% 10 year risk of CHD (Framingham point score: ≥16 (men), ≥23 (women))
* Other clinical forms of atherosclerotic disease including \>50 percent stenosis on angiography or ultrasound
* Male subjects, when sexually active, using one form of highly effective contraception (e.g. condom)

Exclusion Criteria for both healthy volunteers and patients:

* Smokers (use of tobacco products in the previous 3 months). Smokers who report cigarette use of more then 10 cigarette per day or have a urinary cotinine level greater then 500 ng/ml.
* Pregnancy.
* Use of any prescription drugs within four (4) weeks prior dosing, or over-the-counter (OTC) medication (vitamins, herbal supplements, dietary supplements) within two (2) weeks prior to dosing. Significant illness within two weeks prior to dosing.
* Significant illness within two weeks prior to dosing.
* A past medical history of clinically significant ECG abnormalities or a family history of a prolonged QT-interval syndrome.
* History of clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis). A known hypersensitivity to the study drug or drugs similar to the study drug or any allergic reaction to prior receipt of protein therapies or vaccines.
* Presence of NYHA Class III or IV CHF or unstable angina pectoris.
* MI or within angioplasty (including stenting), acute coronary syndrome (ACS), unstable angina or arterial embolic disease within 6 months prior to dosing.
* Use of certain medications prohibited by the protocol.
* Uncontrolled diabetes (HbA1c \> 9).
* Uncontrolled hypertension (Systolic BP \>160 mm Hg and/or Diastolic BP \>100 mmHg on two consecutive measurements).
* Liver or kidney disease confirmed by abnormal lab values or function.
* Serum creatine kinase CK (CPK) total \> 2x.
* CHD equivalent patients with a history of early positive exercise stress test.

Other protocol-defined inclusion/exclusion criteria may apply
Switch From Oral Iron to Intravenous Ferric Carboxymaltose in Non-dialysis Chronic Kidney Disease (CKD)

Investigation whether a switch from oral iron to intravenous ferric carboxymaltose can reduce dose requirements of erythropoiesis-stimulating agents (ESA) and improve Hb levels and iron status in adult patients with non-dialysis-dependent CKD who were on a stable ESA/oral iron schedule for 6 months prior to enrolment.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years of age
* Creatinine clearance ≤40 mL/min
* Hemoglobin 110-120 g/L
* Serum ferritin \<100 µg/L or transferrin saturation \<20%
* Monthly treatment with ESA and oral iron for at least six months before enrolment

Exclusion Criteria:

* Other obvious cause of acute or chronic anemia than iron deficiency
* Expectation to require hemodialysis within the next six months
* Short life expectancy (\<1 year)
* Pregnancy
* Decompensated heart failure
* History of allergic reactions to iron preparations and/or anaphylaxis from any cause
* Requirement of blood transfusions
* Chronic decompensated mental disorder or dementia