cyrilzakka/clinical-trials huggingface dataset:
Inspiris Resilia Durability Registry

Prospective, open-label, multicenter, European registry with a follow-up of 5 years to assess the clinical outcomes of patients younger than 60 years who undergo surgical AVR with the INSPIRIS RESILIA Aortic Valve™.

The INSPIRIS RESILIA Aortic Valve™ is a stented tri-leaflet valve comprised of bovine pericardial tissue. The tissue is created by treating bovine pericardial tissue with Edwards Integrity Preservation. It incorporates a stable capping anticalcification process, which blocks residual aldehyde groups known to bind with calcium. Tissue preservation with glycerol allows the valve to be stored without a traditional liquid-based solution, such as glutaraldehyde. Therefore, valve is stored under dry packaging conditions and consequently does not require rinsing prior to implantation.

The novel tissue preservation technology significantly improves hemodynamic and anticalcification properties compared with the standard Perimount valve in an ovine model. In this registry, data is collected over a period of 5 years to demonstrate these properties in a clinical real-life setting. Clinical outcomes, hemodynamic as well as safety parameters and quality of life data are documented into e-CRF at baseline, surgery, pre-discharge, 3-6 months and annually up to year 5.

The required sample size was calculated using the online calculator at http://www.surveysystem.com/sscalc.htm. It was estimated, from COMMENCE Trial dataset that freedom from time-related valve safety events at 1 year (composite endpoint according to VARC-2) is around 0.915. The following table illustrates 95% CIs at different levels of risk:

Sample Size Observed freedom from event 95%CI 400 0.900 ± 0.0294 400 0.910 ± 0.0280 400 0.915 ± 0.0214 400 0.920 ± 0.0266 400 0.930 ± 0.0250

20% of registry sites will be monitored with 100% source data verification

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 60 years inclusive
2. Subject requiring a planned replacement of their native aortic valve as indicated in a preoperative evaluation
3. Subject is scheduled to undergo planned aortic valve replacement with or without concomitant root replacement and/or coronary bypass surgery
4. Subject is scheduled to attend yearly follow-up visits at the registry center up to 5 years follow-up
5. Subject provides written informed consent prior to the procedure

Exclusion Criteria:

1. Active endocarditis/myocarditis or endocarditis/myocarditis within 3 months prior to the scheduled aortic valve replacement surgery
2. Previous aortic valve replacement
3. Valve implantation is not possible in accordance with the device IFU
4. Subject has a life expectancy ≤ 12 months for any reason

Intraoperative Exclusion criteria:

1. Valve implantation is not possible in accordance with the device IFU
Tai Chi Versus Conventional Exercise to Improve Cognitive Performance in Older Adults With Mild Cognitive Impairment

This randomized controlled trial aims to evaluate the effectiveness of Tai Chi and conventional exercise on improving cognitive function in older adults with mild cognitive impairment (MCI). Participants will be randomized into three six-month programmes, namely Health Education group, Tai Chi group and Conventional Exercise group. Assessments will be conducted at baseline, after the 26-week interventions, and 26-week after the competition of the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Chinese older adults aged equal or larger than 50 years
* Ethnic Chinese
* MCI under criteria of Mayo Clinic, including the following

  i. people with subjective complaint about a decline in cognitive function. ii. total score in the Montreal Cognitive Assessment is equal or below the 7th percentile of the age- and education- corrected normative data of Hong Kong. iii. the decline in cognitive function does not impair daily functioning, as revealed by getting ≥2 marks in every item on the Chinese Lawton Instrumental Activities of Daily Living 4-point Scale).

Exclusion Criteria:

* medical history of major chronic diseases such as cancer, stroke, cerebro- and cardio-vascular diseases, and renal disease
* uncontrolled diabetes
* diagnosed with dementia or using anti-dementia medication
* diagnosed with psychiatric diseases or using psychiatric medication
* with diseases or on medications known to severely affect cognitive performance
* somatic condition (e.g., limb lost) that prevent participation in exercise
* impaired mobility by chronic diseases (e.g., neurological, musculoskeletal and autoimmune diseases)
* incapable to perform physical exercise
* regular exercise habit (\>3 times 60-min Tai Chi or moderate-intensity conventional exercise weekly) in the past 3 months
Study of Nivolumab and Relatlimab in Patients With Microsatellite Stable (MSS) Advanced Colorectal Cancer

The purpose of this study is to evaluate the safety and clinical activity of nivolumab and relatlimab in patients with metastatic or locally advanced microsatellite stable (MSS) colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years.
* ECOG performance status 0 or 1
* Have metastatic or locally advanced microsatellite stable (MSS) colorectal adenocarcinoma.
* Cohort A: Primary lesion has a composite PD-L1/Mucin (CPM) score ≥ 15%.
* Cohort B: Primary lesion has a composite PD-L1/Mucin (CPM) score \< 15%.
* Cohort C: Prior surgical resection of primary tumor. Prospective biomarker evaluation not required.
* Must have received at least one chemotherapy regimen.
* Patients with the presence of at least one measurable lesion using RECIST 1.1.
* Patients must have available archival tissue from the surgical resection of their primary tumor.
* Patient's acceptance of tumor biopsies.
* Life expectancy of greater than 3 months.
* Patients must have adequate organ and marrow function defined by study - specified laboratory tests.
* Documented LVEF ≥ 50% - 6 month prior to drug administration.
* Must use acceptable form of birth control while on study.
* Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

* Known history or evidence of brain metastases. Patients with previously treated brain metastases may participate if they are stable for 4 weeks prior to beginning treatment, have no new or enlarging brain metastases, and are not using steroids for at least 1 week prior to initiation of study treatment.
* Require any antineoplastic therapy.
* History of prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or anti-Lag-3 antibodies.
* Had chemotherapy, radiation, or steroids within 14 days prior to study treatment.
* Had any cytotoxic drug within 4 weeks prior to initiation of study treatment.
* Hypersensitivity reaction to any monoclonal antibody.
* Has uncontrolled intercurrent acute or chronic medical illness.
* Has an active known or suspected autoimmune disease.
* Has a diagnosis of immunodeficiency.
* Prior tissue or organ allograft or allogeneic bone marrow transplantation.
* Requires daily supplemental oxygen
* History of interstitial lung disease.
* Requires daily supplemental oxygen.
* Significant heart disease
* History of encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent.
* Infection with HIV or hepatitis B or C at screening.
* Has an active infection.
* Unable to have blood drawn.
* Patient with uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Woman who are pregnant or breastfeeding.
Neuromodulation to Treat Patients With Heart Failure With Preserved Ejection Fraction

Heart failure with preserved ejection fraction (HFpEF) is a leading cause of mortality in the elderly. Outcomes of patients with HFpEF are poor and so far, no treatment has been shown to decrease morbidity or mortality. Recent animal and human studies suggest that a systemic proinflammatory state, produced by comorbidities, including aging, plays a central role in the development of HFpEF, supporting the notion that attenuating the proinflammatory state is an attractive therapeutic target for HFpEF. We have previously shown that low-level transcutaneous electrical stimulation of the vagus nerve (tVNS) suppresses inflammation in patients with atrial fibrillation. The overall objective of this proposal is to examine the effects of tVNS on diastolic dysfunction, exercise capacity and inflammation in patients with HFpEF. Our specific aims include: 1. To examine the effect of intermittent (1 hour daily for 3 months) tVNS on diastolic dysfunction and exercise capacity, relative to sham stimulation, in patients with HFpEF and 2. To examine the effect of intermittent (1 hour daily for 3 months) LLTS on inflammatory cytokines relative to sham stimulation, in patients with HFpEF. The proposed proof-of-concept studies will provide the basis for the design of further human studies using LLTS among populations with HFpEF. In light of the increasing number of elderly patients with HFpEF and the poor success of the currently available treatment options, an alternative and novel approach such as tVNS has the potential to impact clinical practice and improve health outcomes among a large number of patients. It is anticipated that these investigations will contribute to the broader understanding of the role of inflammation in the pathogenesis of HFpEF and how its inhibition can be used to provide therapeutic effects. Moreover, it is anticipated that a better understanding of how modulation of inflammation affects one of the hallmarks of HFpEF, diastolic dysfunction, will lead to the development of novel pharmacological and non-pharmacological approaches to treat this disease.


Eligibility Criteria:
Inclusion Criteria:

* HFpEF, defined as signs and symptoms of heart failure, LV ejection fraction ≥50%, brain natriuretic peptide ≥35pg/mL and echocardiographic evidence of diastolic dysfunction (left atrial volume index ≥34mL/m2, mitral E-wave velocity/mitral annular velocity ratio \[E/e'\]≥13 and e'\<9cm/s) plus 2 of the following 4 comorbidities:

  * age ≥ 65,
  * diabetes,
  * hypertension and
  * obesity, defined as body mass index ≥30kg/m2

Exclusion Criteria:

* LV ejection fraction \<40%
* significant valvular disorder (i.e., prosthetic valve or hemodynamically significant valvular diseases)
* recent (\<6 months) stroke, myocardial infarction or hospitalization for heart failure
* severe heart failure (class III or IV)
* end stage kidney disease
* recurrent vasovagal syncope
* history of vagotomy
* pregnancy
* sick sinus syndrome and 2nd or 3rd degree AV block (without a pacemaker).
Ability of the Polar Wearables to Detect Fetal Heart Rate - Pilot Clinical Study

The aim of this clinical pilot study is

1. to evaluate the ability of the wearables to detect fetal heart rate
2. to evaluate the ability to distinguish the fetal ECG from the ECG of the mother

The participating pregnant women will wear the Polar wearables (chest band, smart watch, arm band) for 15 minutes during of which, the data will be collected with all three wearables and patient monitor (reference device). The data from the wearables will be compared with the patient monitor data referred as golden standard. Background information will be collected with questionnaires from the participants. The data collection will be conducted in hospital environment.


Eligibility Criteria:
Inclusion Criteria:

* duration of pregnancy at least 29+0 weeks
* single pregnancy
* age at least 18 years
* ability to participate in Finnish. No exclusion criteria
Infrared Thermal Imaging in Evaluating the Percutaneous Transluminal Angioplasty for Peripheral Artery Disease

Determination of IRTI (infrared thermal imaging) can be used to evaluate PAD patients with critical limb ischemia with different degrees of lesion.

IRTI can be used to evaluate the foot blood perfusion after percutaneous transluminal angioplasty (PTA) treatment and determine the success rate of surgery.

IRTI can be used as an effective follow-up tool for patients after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Rutherford grade 3, 4, 5, or 6.
* Patients with indications for lower extremity arterial PTA: severe intermittent claudication, rest pain, ulceration or gangrene.
* Patients who required PTA of only one limb (left versus right).

Exclusion Criteria:

* Patients with body temperature above 37 ° C.
* Patients with indications for open surgery.
* Patients requiring major amputation (above the ankle).
* Patients with acute occlusive or embolic limb ischemia.
* Patients with deep venous thrombosis of the lower extremity.
Postoperative Immobilization and Physical Therapy Following Volar Locked Plating for Distal Radius Fractures

The purpose of this study is to see if splinting and formal physical therapy are necessary following surgical fixation (open reduction internal fixation) of distal radius fractures (broken wrist). Currently there is no consensus for post-operative protocol following fixation of distal radius fractures. The decision to splint (late mobilization) and prescribe formal physical therapy vs. not to splint (early mobilization) and use self-guided physical therapy is based on surgeon or institutional preference. The goal of this study is to determine if early mobilization leads to improved outcomes and decreased costs without increasing pain or the loss of hardware fixation.

188 patients treated for distal radius fractures with open reduction internal fixation using volar locked plating will be split into two study groups: a group that is immobilized in a splint post operatively and given formal physical therapy and a group that does not receive either of these post operative interventions. The primary outcome will be loss of fixation. Secondary outcomes will include pain, cost, Quick Dash, range of motion, and grip strength. Data will be recorded at the pre-operative visit, as well as at post-operative visits at 2 weeks, 6 weeks, 3 months and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Isolated displaced distal radius fractures, +/- ulnar styloid fracture, treated with volar locked plating and screws.

  1. \> 10 degrees of dorsal tilt
  2. Volar displacement (Volar Barton's type fracture)
  3. Shortening \> 3 mm
  4. Intra-articular displacement or step off \> 2mm.

     Exclusion Criteria:
* Ipsilateral upper limb concomitant fracture
* Fracture fixation other than volar locked plating and screws
* Dislocation or neurologic injury
* Gustilo-Anderson grade III open fractures
A Prospective, Multicenter, Randomized, Open-label Study of 12 Week Duration to Evaluate the Effect of VILDagliptin Added to Insulin on Glycaemic Control in haemoDIALyzed Patients With Type 2 Diabetes: Probe Analysis of CGM

Diabetes is a major concern for dialysis units, as it is now the most common cause of end-stage renal disease in France. In 2010 at initiation of dialysis treatment, more than one patient out of two had at least one cardiovascular disease and 40 % diabetes (94 % Type 2 diabetes) and especially in East part of France.

Diabetic patients on dialysis have a high burden of morbidity and mortality, particularly from cardiovascular disease. Tight glycaemic and blood pressure control in diabetic patients has an important impact in reducing risk of progression nephropathy. Data are scarce on how diabetes should best be treated in dialysis patients. The evidence for improving glycaemic control in patients on dialysis having an impact on mortality or morbidity is sparse. Indeed, many factors make improving glycaemic control in patients on dialysis very challenging, including therapeutic difficulties with hypoglycaemic agents, monitoring difficulties, dialysis strategies that exacerbate hyperglycaemia or hypoglycaemia.

Standard oral drugs therapy for hyperglycaemia (eg, metformin, sulfonylureas, ) are contraindicated in patients on dialysis. Thus insulin has been the mainstay of treatment. Newer therapies for hyperglycaemia, such as gliptins and glucagon-like peptide-1 analogues have become available, but until recently, renal failure has precluded their use. Newer gliptins, however, are now licensed for use in 'severe renal failure', although they have yet to be trialed in dialysis patients.

The investigators study, using continuous glucose monitoring as a new tool for monitoring of therapy should provide information on vildagliptin in add on therapy to insulin in this population.


Eligibility Criteria:
Inclusion Criteria:

* Patients treated by haemodialysis for more than 3 months with 1g/L glucose in dialysate fluid
* Patients treated by stable doses of insulin (any regimen) for Type 2 diabetes without any oral antidiabetic agent
* Age \> 18 years
* TGO, TPO and lipase \< 3x ULN
* effective means of contraception

Non-inclusion Criteria:

* Blood transfusion in the 2 previous months
* Life expectancy less than 1 year
* Chronic inflammatory disease
* Steroid treatment \> 5mg/day
* Cancer (evolutive or requiring chemotherapy or radiotherapy) with the exception of breast intraductal carcinoma operated
* Patient waiting for programmed surgery
* History of cardiovascular disease (stroke, coronary heart disease, hospitalization for heart failure) in the 4 previous months
* Patients suffering from stage 3 and 4 cardiac insufficiency
* Non-compliant patients
* History of pancreatitis
* History of angioedema
* Hypersensitivity to the active substance or to any of the excipients of Galvus®
* Pregnancy or breastfeeding
Cardiovascular Outcomes Study of Alogliptin in Patients With Type 2 Diabetes and Acute Coronary Syndrome

The purpose of this study is to evaluate the cardiovascular outcomes of alogliptin, once daily (QD), compared with placebo, in addition to standard of care, in patients with type 2 diabetes mellitus and acute coronary syndrome.

Alogliptin is a selective and potent dipeptidyl peptidase-4 inhibitor developed by Takeda for use in patients with type 2 diabetes mellitus.

Cardiovascular outcomes is of special interest in the type 2 diabetes mellitus population, particularly in type 2 diabetes mellitus patients who have cardiovascular disease and are at high risk for major adverse cardiac events, such as those patients who have had recent acute coronary syndrome.

This study has been designed to evaluate the cardiovascular safety of alogliptin versus placebo in addition to Standard of Care in adults with type 2 diabetes mellitus and acute coronary syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 2 diabetes mellitus
* Is receiving monotherapy or combination antidiabetic therapy with a glycosylated hemoglobin level between 6.5% and 11.0%, inclusive, at Screening (between 7.0 and 11.0%, inclusive, if the participant's antidiabetic regimen includes insulin)
* Diagnosis of acute coronary syndrome within 15 to 90 days prior to randomization.

Exclusion Criteria:

* Signs of type 1 diabetes mellitus
* Currently receiving a glucagon-like peptide-1 analogue for glycemic control of type 2 diabetes mellitus at Screening
* Received a dipeptidyl peptidase-4 inhibitor for either more than 14 days total or within the 3 months prior to Screening.
Pilot Subsidized and Culturally-adapted Community Supported Agriculture (CSA) Program

This study aims to apply community-engaged methods to refine and implement a culturally adapted systems-level program for improving diet in low income, Chinese American immigrants. Guided by the regular partner engagement, The researchers have organically developed a systems-level program to bring a subsidized community-supported agriculture (CSA) model to the community in a way that is aligned with cultural values, and that includes culturally appropriate produce and nutrition education.

This is a single-site proof of concept pilot program that will be evaluated using a pre-post-design.


Eligibility Criteria:
Inclusion Criteria:

* Adult age 18 years and over
* Currently living in Brooklyn
* Willing and able to provide consent

Exclusion Criteria:

• Unable to complete the baseline survey in English, Mandarin, or Cantonese
Classification and Characterization of Patients Treated With Efalizumab for Plaque Psoriasis

The main objectives of the project are:

* To classify patients suffering from plaque psoriasis responding on a given treatment (efalizumab) based upon reduction in Psoriasis Area and severity Index (PASI), Psoriasis Disability Index 8PDI) and dermatology Life Quality Index 8 DLQI)
* To characterize patients suffering from plaque psoriasis responding to or not responding to subcutaneous administrated efalizumab.

This is an investigator initiated,prospective, longitudinal, observation study. Before starting treatment with efalizumab we will record factors such as demographic data, type of psoriasis, previous treatment, other diseases etc.

We will follow the patients and classify them as responders and non-responders. We hope to find 4-5 factors which we can use later to predict response of this drug.

Eligibility Criteria:
Inclusion Criteria:

* moderate to severe plaque psoriasis for more than six months
* eligible for efalizumab treatment according to current Norwegian guidelines

Exclusion Criteria:

* Pregnant or breast-feeding patients
* Patients with a history of uncontrolled bacterial, viral, fungal or atypical mycobacterial infection.
* Patients suffering from HIV, Hepatitis B or C, active tuberculosis, hepatic cirrhosis and hospital admission for cardiac disease, stroke or pulmonary disease within last year.
* Patients with history of cancer in the preceding 5 years, including lymphoproliferative disorders. patients with history of fully resolved basal cell or squamous cell skin cancer may be enrolled.
* Patients with impaired renal or hepatic function.
The Effects of Milk and Banana as a Night Meal to Primary Insomnia on Sleep Quality, BDNF and Appetite Mechanism

The aim of this study to determine the impact of banana and milk on sleep and appetite

Sleep is one of the main components of the continuity of circadian rhythm. It restores energy and enhancement, memory. Sleep disturbances and short sleep duration are important risk factors for many diseases. Nutrition is one of the main determinants of health status in many diseases related to inflammation. Especially the night meal, known as the foods consumed before bedtime, has a strong effect on sleep. Although there are methodological differences, most studies show that unhealthy eating habits are associated with short sleep duration. It is thought that consuming foods with high tryptophan and melatonin content can reduce sleep problems. This study will give a chance to observe the effects of nutrients on sleep and appetite mechanisms.

Eligibility Criteria:
Inclusion Criteria:

* Applying to the Sleep Polyclinic,
* 18-45 years old,
* Body Mass Index (BMI) between 18.5-25 kg/m2,
* Male and female patients diagnosed with primary sleep disorder for the first time

Exclusion Criteria:

* Individuals with any psychiatric illness,
* Those who use cigarettes, alcohol, drugs or sedative drugs,
* Individuals with any chronic disease (diabetes, etc.),
* Pregnant and/or lactating
* Individuals with lactose intolerance,
* athletes,
* Individuals who are allergic to bananas
* Individuals with lactose intolerance or milk intolerance