cyrilzakka/clinical-trials huggingface dataset:
SODIUM-HF: Study of Dietary Intervention Under 100 MMOL in Heart Failure

SODIUM-HF is a multicenter clinical trial in ambulatory patients with chronic HF to evaluate the efficacy of a low sodium containing diet on a composite clinical outcome composed of of all-cause mortality, cardiovascular hospitalizations and cardiovascular emergency department visits. The hypothesis of this study is that patients following a low-sodium containing diet will have fewer clinical events (fewer hospital readmissions or emergency department visits, longer survival) than those randomized to Usual Care.


Eligibility Criteria:
Inclusion Criteria:

* Patients recruited if they are 18+ years or older, with confirmed diagnosis of HF (both reduced and preserved systolic function are eligible), NYHA class II-III, and willing to sign informed consent.

Exclusion Criteria:

Subjects will be excluded if:

* Average dietary intake of \<1500 mg/ day by a quantitative or semi-quantitative method
* Serum sodium \<130mmol/L
* Renal failure (glomerular filtration rate \<30 mL/min)
* Hepatic failure
* Uncontrolled thyroid disorder
* Cardiac device (ICD or CRT) or revascularization procedure (PCI or CABG) in previous month or planned in next 3 months
* Hospitalization due to cardiovascular causes in previous 1 month
* Uncontrolled atrial fibrillation (resting heart rate \>90 bpm)
* Active malignancy
* Moderate-severe dementia
* Enrolled in another interventional research study
* Patients will be excluded, if in the opinion of the investigator, another condition exists that would preclude dietary compliance or compliance with the protocol.
Home With TablO outcoMEs (HOME) Registry

Prospective, multicenter, single arm, post-market study to evaluate real world clinical outcomes in ESRD patients receiving in-home dialysis on the Tablo Hemodialysis System.


Eligibility Criteria:
Inclusion Criteria:

* Participant (patient and/or care partner) is at least 15 years of age and has provided informed consent and has signed a Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliant authorization statement.
* Participant weighs ≥ 34kg.
* Participant has end stage renal disease (ESRD) adequately treated by maintenance dialysis.
* Participant plans to start or has started home treatment (≤ 6 months) with the Tablo Hemodialysis System.
* Participant is willing and able to comply with the Protocol requirements and perform all site required treatments and clinical evaluations.

Exclusion Criteria:

* Participant and/or care partner is unable to read English or Spanish.
* Participant has a home environment that is deemed inappropriate for home dialysis.
* Participant and/or care partner is unable to successfully complete the Tablo training program
* Participant is pregnant or plans to become pregnant.
Safety & Efffficacy of Genakumab in Patients With Frequent Flares

The purpose of this study is to evaluate the efficacy and safety of Genakumab Injection in patients with Gouty Arthritis (GA).

A multicenter, randomized, double-blind, double-dummy, active-controlled study was to demonstrate the efficacy of Genakumab versus compound betamethasone injection in adult patients with frequent gouty arthritis attacks in whom non-steroidal anti-inflammatory drugs (NSAIDs) and/or colchicine are contraindicated, are not tolerated, or do not provide an adequate response.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 years ≤ age ≤75 years
* BMI≤40kg/m2
* Meeting ACR 2015 preliminary criteria for the classification of acute arthritis of primary gout.
* Start of acute gout flare within 4 days prior to enrolled
* History of ≥ 2 gout flares within the 12 months prior to study start
* Evidence of contraindication (absolute or relative), or intolerance, or lack of efficacy for either NSAIDs and/or colchicines
* Baseline pain intensity ≥ 50 mm on the 0-100 mm visual analog scale (VAS)

Exclusion Criteria:

-
Journey II vs Persona Knee Systems - RCT

This study compares and evaluates differences in patient-reported outcome, survivorship and radiological analysis between patients undergoing total knee arthroplasty with use of either Zimmer Biomet PERSONA Posterior Stabilized (PS) system and Smith\&Nephew Journey II Bi-Cruciate Stabilized (BCS) system

The aim of this study is to assess patient-reported outcome, survivorship and radiological analysis in patients after total knee arthroplasty, who will undergo the surgery with the use of either Zimmer Biomet PERSONA Posterior Stabilized (PS) system and Smith\&Nephew Journey II Bi-Cruciate Stabilized (BCS) system.

To this study 45 consecutive patients undergoing total knee arthroplasty will be recruited to each group. Study protocol is designed as a prospective, blinded, parallel-group, superiority trial, with balanced randomization \[1:1\]. All participants will be operated in single clinical orthopedic department, by single high-volume surgeon, who performed more than 3000 total knee arthroplasties in his professional career.

Before the surgery patients will fulfill the author's questionnaire concerning their age, height and body mass, level of activity, WOMAC and KOOS scales.

1-day posteoperatively patients will undergo standard computed tomography examination to assess components placement

Eligibility Criteria:
Inclusion Criteria:

* Listed for a primary total knee replacement (TKR) at the Orthopaedic and Rehabilitation Department Medical University of Warsaw
* Indication for the TKR is primary osteoarthritis of the knee joint involving one or more compartments
* Aged 18 or over
* Patient willing to provide full informed consent to the trial

Exclusion Criteria:

* Listed for a single-stage bilateral TKR procedure
* Severe symptoms in the contralateral knee so as to require staged bilateral knee replacements within 6 months of the primary procedure
* Fixed flexion deformity of 15 degrees or greater who will require excessive resection of the distal femur
* Clinically assessed uncorrectable varus/valgus deformity of 15 degrees or greater
* Any co-morbidity which, in the opinion of the investigator, is severe enough to present an unacceptable risk to the patient's safety
* Inflammatory arthritis
* Previous septic arthritis in the affected knee joint
* Previous surgery to the collateral ligaments of the affected knee
* Patients on warfarin or novel oral anticoagulants (NOACs)
* Will not be resident in the catchment area for at least 6 months post-surgery
* Undertaking the surgery as a private patient
* Patients who, in the opinion of the clinical staff, do not have capacity to consent
* Patients who are pregnant
* Unable to understand written and spoken Polish
Parecoxib for Pain Management After Total Knee Arthroplasty and Total Hip Arthroplasty

Evaluated the effect of perioperative parecoxib administration on postoperative pain, analgesic use, function recovery, inflammatory response and bleeding risk.

Non-steroid anti-inflammatory drugs are recommended for multimodal postoperative pain management.

We evaluated the effect of perioperative parecoxib administration on postoperative pain, analgesic use, function recovery, inflammatory response and bleeding risk.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients who have underwent primary unilateral total knee arthroplasty (TKA) and total hip arthroplasty (THA).
2. Age between 18-65 years.
3. Chinese ethnicity.

Exclusion Criteria:

1. patients who underwent a reversion or a previous TKA or THA, emergency TKA, or TKA as result of a trauma.
2. patient exhibited allergy to parecoxib sodium.
3. lactating or pregnant.
4. any other conditions not suitable for surgery as evaluated by the surgeon in charge.
Drain Placement for Seroma Prevention After Mammosite/SAVI Catheter Removal

The proposed study is randomised controlled trial where informed and consenting patients who have a Mammosite/SAVI device placed, are randomized into two groups: a control group that has the device removed in the traditional manner without having a drain placed, and an experimental group that will have a penrose drain placed under sterile conditions at the time of removal of their device. The drain will be placed in the same site used for the APBI device and no additional surgery will be performed. The drain will remain for 2-3 days and it will be removed by the patient at home. They will return for their routine follow-up appointments and be monitored for development of a seroma with the use of standard ultrasound and physical exam. Hypothesis: Based on the null hypothesis there will be no difference in the rate of seroma formation after the APBI device removal if a drain is placed.

The proposed study is randomised controlled trial where informed and consenting patients who have an APBI device placed, are randomized into two groups: a control group that has the device removed in the traditional manner without having a drain placed, and a experimental group that would have a penrose drain placed under sterile conditions at the time of removal of their device. The procedure will be performed at the MSU Surgery outpatient clinic by residents, the senior investigator or a trained nurse/PA. Additional data will be collected on each patient from their medical record including demographic data, cancer diagnosis, lesion size, date of procedure, date Mammosite/SAVI was inserted and removed, total dose of radiation, ER, PR, HER2Neu status, and any chemotherapy or hormone therapy being administered. Drains will remain in place for 2-3 days and will be removed by the patient upon removing the dressing. Patients will continue their antibiotic regimen prescribed while the APBI device was in place for the 2-3 days the drain is in place for infection prophylaxis. Patients will be followed for 4 weeks to determine if a seroma or other complication has developed. Patients in both the experimental and control groups will have the same standard follow up and monitoring for seroma development with the use of ultrasound. All postop cancer care will be standard and this study will not alter or delay any aspect of breast cancer treatment. Statistics will be performed and reported based upon data collected.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of breast cancer
* received accelerated partial breast irradiation

Exclusion Criteria:

* any metastatic breast cancer
* infection
* skin with radiation injury
Impact of Ascorbic Acid on Post-Cardiothoracic Surgery Inflammation

The purpose of this study is to see if ascorbic acid (Vitamin-C) therapy will reduce inflammation following heart surgery.

Atrial Fibrillation is a significant cause of morbidity following cardiothoracic surgery. Despite prophylactic therapy with beta-blockers and amiodarone, post-operative atrial fibrillation occurs in approximately 22% of patients. We believe that by reducing the inflammation that is caused during CTS, we can see further improvements without any negative effects on hemodynamics. Ascorbic acid, a free radical scavenger has been found to lower inflammation mediators but never in a CTS population. This study will help determine the affect of ascorbic acid on the inflammation associated with CTS.

Eligibility Criteria:
Inclusion Criteria:

* Cardiothoracic surgery

Exclusion Criteria:

* Pregnancy
* Prior hypersensitivity to ascorbic acid
* Renal Calculi
Cancer Risk in Organ Transplant Recipients and End-Stage Renal Disease

Background:

* Solid organ transplantation provides life-saving treatment for end-stage organ disease but is associated with an increased cancer risk because of the need for long-term immunosuppression
* End-stage renal disease (ESRD), the most common type of end-stage organ disease leading to transplant, is itself linked to increased risk for some cancers
* The role of immunosuppression and other factors causing cancer in this setting are not fully understood.

Objectives:

* To characterize cancer risk in transplant recipients and identify risk factors.
* To characterize risk for transmission of cancer from organ donors to recipients.
* To describe cancer risk in ESRD.

Eligibility: Patients are not required for this study. Data are gathered from existing databases of ESRD patients, organ transplant patients and cancer registries.

Design:

* Databases of 1) U.S. transplant recipients, donors and wait list candidates and 2) U.S. ESRD patients will be linked to multiple U.S. cancer registries to identify cancers in transplant recipients and ESRD patients.
* The spectrum of cancer risk in transplant recipients and ESRD patients will be evaluated in detail.
* The cancer risk in transplant recipients will be examined in relation to whether the donors had cancer.
* The proposed cancer risk factors (e.g., underlying medical condition, infection with cancer-causing viruses, immunosuppressive medications) documented in transplant and ESRD files will be studied for association with increased risk of particular types of cancer.

Solid organ transplantation provides life-saving treatment for end-stage organ disease but is associated with substantially elevated cancer risk, largely due to the need to maintain long-term immunosuppression. Despite previous research, important research questions remain concerning the role of immunosuppression and other factors in causing cancer in the setting. Staff at two federal agencies, the National Cancer Institute (NCI) and the Health Resources and Services Administration (HRSA), will link a database containing information on U.S. transplant recipients, wait list candidates, and donors to multiple U.S. cancer registries. These data will be used to conduct research concerning the spectrum of cancer risk in transplant recipients. The data will also be used by HRSA in its public health role overseeing the U.S. solid organ transplant network to maintain and improve safety of organ transplantation.

Eligibility Criteria:
* This study will include as subjects all individuals included in the transplant data set. All U.S. solid organ transplant recipients, candidates for transplant, and living related donors.

In addition, the study will include all individuals in the U.S. ESRD data set.
Karolinska-Rennes (KaRen) Prospective Study of Exercise Stress Echocardiography in Heart Failure With Preserved Ejection Fraction

Background:

Heart failure with preserved ejection fraction (HFPEF) is common but not well understood. Electrical dyssynchrony in systolic heart failure is harmful. Little is known about the prevalence and the prognostic impact of dyssynchrony in HFPEF.

Methods:

We have designed a prospective, multicentre, international, observational study to characterize HFPEF and to determine whether electrical or mechanical dyssynchrony affects prognosis. Patients presenting with acute heart failure will be screened.

Inclusion criteria will be:

acute presentation with Framingham criteria for heart failure, left ventricular EF ≥45%, BNP \>100 ng/L or NT-proBNP \>300 ng/L. Patients will return in stable condition 4-8 weeks after the index presentation and undergo questionnaires, serology, ECG and Dopplerechocardiography. Thereafter, patients will be followed for mortality and heart failure hospitalization every 6 months for at least 18 months. Sub-studies will focus on echocardiographic changes from the acute presentation to the stable condition and on exercise echocardiography.

Conclusion:

KaRen aims to characterize electrical and mechanical dyssynchrony and to assess its prognostic impact in the HFPEF. The ancillary study of the exercise stress echocardiography sought to improve our understanding of HFPEF and generate answers to the question whether dyssynchrony could be a target for therapy in HFPEF.


Eligibility Criteria:
Inclusion Criteria:

1. Acute presentation to the hospital with clinical signs and symptoms of HF, according to the Framingham criteria \[19\].
2. LVEF ≥ 45% by echocardiography within the first 72 hours. The measurement will be carried out according to guidelines
3. BNP \>100 ng/L or NT-proBNP \>300 ng/L.

Exclusion Criteria:

1. Evidence of primary hypertrophic or restrictive cardiomyopathy or systemic illness known to be associated with infiltrative heart disease
2. Known cause of right heart failure not related to left ventricular dysfunction
3. Pericardial constriction
4. Clinically significant pulmonary disease, as evidenced by requirement of current home oxygen
5. End-stage renal disease currently requiring dialysis
6. Bi-ventricular pacemaker (CRT). (Patients who have a conventional pacemaker may be included)
7. Anticipated or indication for cardiac surgery. (Patients who have indication for surgery but may not undergo surgery because of some contraindication, for example age, may NOT be included).
8. Anticipated percutaneous intervention on aortic stenosis. (Patients who undergo other percutaneous intervention, for example PCI, may be included).
Rehabilitation Following Reverse Total Shoulder Arthroplasty

Reverse total shoulder arthroplasty (RTSA) has been successful in patients with rotator cuff arthropathy, proximal humerus fractures, failed primary total shoulder arthroplasty or failed hemiarthroplasty, and massive irreparable rotator cuff tear. Patients who undergo an RTSA report pain relief and functional range of motion. It has been more than 20 years since the advent of the RTSA construct but an immediate post-operative rehabilitation with active shoulder range of motion has not been prospectively studied in comparison to the traditional post-operative rehabilitation highlighted by Boudreau et al.12 Investigators plan to prospectively follow our patients following RTSA undergoing an immediate active shoulder rehabilitation (IASR) vs traditional rehabilitation in a randomized controlled fashion. Investigators plan to document clinical outcomes, complications and cost effectiveness out to 1 year.

The study will hopefully fulfill the Triple Aim model for HealthPartners by improving the health of the population, improve the experience of each individual, and make healthcare affordable by decreasing the total cost of care.


Eligibility Criteria:
Inclusion Criteria:

* \> 55 years of age.
* Candidate for a primary reverse total shoulder arthroplasty.
* Capable of completing self-administered questionnaires.
* Be willing and able to return for all study-related follow-up procedures.
* Able and willing to give informed consent.
* Proficient in the English language.

Exclusion Criteria:

In-Clinic:

* Patients planning on undergoing a Primary Reverse Shoulder Total Arthroplasty due to proximal humeral fracture.
* Previous shoulder surgery including previous total shoulder arthroplasty or reverse total shoulder arthroplasty or hemiarthroplasty, or instability repairs
* Active bacterial infection of the shoulder.
* Any concomitant shoulder procedure.
* Additional ipsilateral or contralateral upper limb pathology that requires active treatment (i.e. surgery or brace).
* Inflammatory arthropathy.
* Diagnosed with Rheumatoid arthritis
* Diagnosed with gout.
* Subject is on chronic anticoagulation due to a bleeding disorder or has taken anticoagulants within 10 days prior to surgery.
* Peripheral vascular disease or other vascular disorders that would impair healing.
* Peripheral neuropathy or other neurological disorders that may impair the patient to ambulate.
* Patient is on workers compensation.
* Any condition requiring chemotherapy.
* Active tobacco user or former tobacco user who is not free of using tobacco for 8 weeks.
* Uncontrolled Diabetes Mellitus with an HbA1C \> 7.5%.
* Current drug or alcohol abuse.
* Major medical illness (life expectancy less then 2 years or unacceptably high operative risk)
* Suspicion of cervical radiculopathy or myelopathy.
* Deltoid insufficiency on physical examination.

Intra-operative:

• Iatrogenic glenoid fracture

Post-operative:

* Neurological injury of the upper extremity.
* Complications from Primary Reverse Shoulder Total Arthroplasty (i.e. post-operative infection, bleeding, hardware failure).
Study of Trazodone & Cognitive Behavioral Therapy to Treat Insomnia

The purpose of this study is to evaluate the effect of a 3 month medication trial of Trazodone versus 3 months of Cognitive Behavioral Therapy (CBT) in patients with chronic insomnia.

Participants with chronic insomnia associated with objective short sleep duration will be recruited to participate in a 3 month clinical trial on the efficacy of trazodone versus CBT, with a 6 month follow up. The primary outcome measure will be objective sleep duration as measured by both actigraphy and polysomnography. The secondary outcome measure will be subjective severity of sleep disturbance.

Eligibility Criteria:
Inclusion Criteria:

* Chronic insomnia with duration of more than 1 year
* Objective short sleep duration (\< 6 hours)
* BMI \< 39
* Ages 30-60
* Men \& Women

Exclusion Criteria:

* Major Mental Illness
* Substance Abuse/Dependence
* Sleep Apnea
* Periodic Limb Movement Disorder
* Shift Work or circadian disorders
* Diabetes
* Chronic Renal Failure, Hepatic Insufficiency, Chronic Heart Failure
* Current Use of hypnotics or sleep inducing sedative antidepressants
Effects of Cocoa Flavanols on Human Cognitive Function

To determine the acute and chronic effects of cocoa derived flavonoids on cognitive function in healthy older adults.

This is a randomised controlled double blind cross over study investigating the acute effects of high flavanol (495mg) compared to low flavanol (23mg)cocoa drink on cognitive function in a healthy older adult population (n=60). The primary outcome measure of this study is to determine the effects of the flavanol intervention on cognitive measures of executive function and attention and the secondary measures of blood pressure and to determine whether any observed effects are paralleled by plasma flavanol levels.

Eligibility Criteria:
Inclusion Criteria:

* Aged 62 - 75 years
* A signed consent form

Exclusion Criteria:

* Blood pressure \> 160/90 mmHg
* Haemoglobin (anaemia marker) \< 125 g/l
* Gamma GT (liver enzymes) \> 80 IU/l
* Had suffered a myocardial infarction or stroke in the previous 12 months
* Suffers from any gastrointestinal/stomach disorder
* Suffers from any blood-clotting disorder
* On medication for hypertension
* Suffers from any metabolic disorders (e.g. diabetes or any other endocrine or liver diseases)
* Depression or major mental illness
* Any dietary restrictions or on a weight reducing diet
* Drinking more than 21 units per week
* On any medication affecting blood clotting
* Smoking
* Vegans