cyrilzakka/clinical-trials huggingface dataset:
Expanded Study of the HighLife 28mm Trans-septal Trans-catheter Mitral Valve in Patients With Moderate-severe or Severe Mitral Regurgitation and at High Surgical Risk

to evaluate the safety and performance of the HighLife 28mm transcatheter, trans-septal Mitral Valve in patients with moderate-severe or severe mitral regurgitation who are at high risk for surgical treatment.


Eligibility Criteria:
Inclusion Criteria:

* 1. Age ≥ 18 years 2. Moderate-severe or severe mitral regurgitation (≥ 3+) 3. Patient has New York Heart Association (NYHA) Functional Class II, III or ambulatory IV 4. Patient is under guideline directed medical therapy, as reviewed and confirmed by the local multidisciplinary Heart Team, for at least one month 5. Patient is high-risk for open-heart surgery based on the assessment of the multidisciplinary Heart Team using standard scoring systems and consideration of co-morbidities, frailty, and disability 6. Patient meets the anatomical criteria for HighLife valve 7. Patient is willing to participate in the study and provides signed informed consent

Exclusion Criteria:

1. Any stroke/TIA within 30 days
2. Severe symptomatic carotid stenosis (\> 70% by non-invasive imaging)
3. Active infections requiring antibiotic therapy
4. Active ulcer or gastro-intestinal bleeding in the past 3 months
5. History of bleeding diathesis, coagulopathy or refusal of future blood transfusion
6. Patients in whom TEE is not feasible
7. Patients who are pregnant or lactating, or plan to get pregnant in the next 12 months.
8. Patient is unable to comply with the follow-up schedule and assessments
9. Participation in another clinical investigation at the time of inclusion
10. Patient has known allergies to the device components or contrast medium
11. Patient cannot tolerate anticoagulation or antiplatelet therapy
12. Patients with a life expectancy of less than 12 months due to non-cardiac conditions
13. Patient had permanent pacemaker, or similar device with implantable cardiac leads (i.e. resynchronization therapy) within the last 3 months

    -
The Pathophysiology of Bortezomib Induced Peripheral Neuropathy

Since the pathophysiology of BIPN still remains unclear, in the present study we are going to assess the development of BIPN in newly diagnosed myeloma patients, based on clinical neurological examination and electrophysiological study (EMG) and trying to find out if there is any relationship between oxidative stress generation measured by serum malonyldialdehyde - (MDA) and urinary isoprostane, and the development of BIPN, which can explain important part of the BIPN pathophysiology and can suggest new ideas of treatment and prophylactic strategies of peripheral neuropathy.

The proteasome inhibitor bortezomib has shown impressive clinical activity alone and in combination with other novel agents for the treatment of multiple myeloma (MM).

Peripheral neuropathy is a significant dose limiting toxicity of bortezomib, which typically occurs within the first treatment cycles with bortezomib, reaching plateau around cycle 5, and does not appear to increase thereafter.

Although bortezomib is known to be selective proteasome inhibitor, the mechanisms of cytotoxicity are poorly understood.

It has been theoretically hypothesized that bortezomib abrogates the degradation of I-kB, which blocks the transcriptional activity of NF-kB, however, recent studies demonstrated that bortezomib elicits activation of multiple pathways in cancer cells, such as reactive oxygen species (ROS) pathway.

The involvement of oxidative stress is supported by emerging studies showing that ROS generation plays a critical role in the initiation of the bortezomib induced apoptotic cascade.

Oxidative stress is a complex and dynamic situation characterized by an imbalance between the productions of ROS and the availability and action of antioxidants.

Eligibility Criteria:
Inclusion Criteria:

1. A total of 30 newly diagnosed patients (age \> 18 years) with multiple myeloma (stage3 Durie and Salmon, ECOG-performance status \<2), who are candidates for bortezomib therapy will be enrolled in the study (duration of the study 6 months).

Exclusion Criteria:

1. Patients with relapsed or progressive multiple myeloma.
2. Performance status \> 2.
3. Prior treatment with neuropathic agents such as Oncovin and thalidomide.
Validation of the French Version of the CQR (Compliance Questionnaire Rheumatology)

The purpose of this study is to develop a French language version of the Compliance-Questionnaire-Rheumatology for use in French and Francophone rheumatology services


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan
* The patient is at least 18 years old
* The patient has rheumatoid polyarthritis as defined by the ACR-EULAR 2010 criteria, treated orally or subcutaneously with MTX for at least 3 months with a stable (unchanged) dosage for at least 1 month, and a stable (unchanged) route of administration for at least 1 month. And no planned change in Methotrexate intake at least until the second study visit. Other treatments at the same time are authorized

Exclusion Criteria:

* The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
* The subject refuses to sign the consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* The subject has a contraindication to taking methotrexate (including a patient with a desire to become pregnant).
Acute Normovolemic Hemodilution in High Risk Cardiac Surgery Patients.

Transfusions are one of the most overused treatments in modern medicine, and saving blood is one important issue all around the world. Cardiac surgery makes up a large percentage of the overall blood components consumption in surgery.

Acute normovolemic hemo-dilution (ANH) is a well-known strategy which has been used for years without the support of high quality evidence based medicine to improve post-cardiopulmonary bypass coagulation and reduce red blood cells (RBC) transfusion. We designed a multicenter randomized controlled trial to investigate the effect of ANH in reducing the number of cardiac surgery patients receiving RBC transfusions during hospital stay. We will randomize 2000 patients to have sufficient power to demonstrate a 20% relative and 7% absolute risk reduction in the number of patients' RBC transfusion. If the results of the study will confirm our hypothesis, this will have a great impact on blood management in cardiac operating room.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Any cardiac surgical intervention on CPB
* Elective surgery

Exclusion Criteria:

* Medical decision (e.g.: planned pre-CPB ANH considered undeniable for ethical reasons or not applicable for safety issues)
* Unstable Coronary Artery Disease: Recent (\< 6 weeks) myocardial infarction, unstable angina, severe (\> 70%) left main coronary artery stenosis
* Critical preoperative state (ventricular tachycardia or ventricular fibrillation or aborted sudden death, preoperative cardiac massage, preoperative ventilation before anesthetic room, hemodynamic instability, preoperative inotropes or IABP, preoperative severe acute renal failure (anuria or oliguria \<10ml/hr.)
* Emergency surgery
* Pregnancy
* Unfeasibility to withdraw ≥ 650 ml without inducing hemodynamic instability
* Unfeasibility to withdraw ≥ 650 ml without inducing pre-CPB anemia (Htc \<30%)
* Unfeasibility to withdraw ≥ 650 ml without inducing low Htc during CPB (Htc \<24%)
Adelphi Primary Sjogren's Syndrome (pSS) Disease Specific Programme (DSP)

Sjogren's Syndrome is a chronic autoimmune disease characterized by sicca (dryness) symptoms of the mouth and eyes. This autoimmune disease is less commonly studied and there are no licensed treatments to treat the underlying cause of disease and current management is based on clinical experience and/or small clinical studies. This study is based on DSP methodology, a multinational, cross-sectional, multi-sponsor survey of robust real-world data. DSP methodology collects quantitative market research data. The pSS DSP will survey a sample of approximately 230 to 325 rheumatologists and their prospectively consulting pSS subjects in France, Germany, Italy, Spain and the US. The data will be collected via physician interviews, physician workload questionnaires, detailed patient record forms (PRFs) to be completed by physicians, and a self-completion questionnaire by pSS subjects. The data collected using this method includes subjective and objective evidence, clinical information about individual patients, their disease and their treatment. This DSP will follow three key phases: preparatory phase, data collection phase and data processing/analysis phase.


Eligibility Criteria:
Inclusion Criteria:

Physician eligibility criteria:

* Primary physician specialty identified as Rheumatologist
* Physicians who currently treat 7 or more pSS subjects in a typical month
* Physicians who are actively involved in the management and treatment decisions of pSS subjects

Subject eligibility criteria:

* Subjects with a diagnosis of Sjogren's syndrome in the opinion of the rheumatologist in the absence of Systemic Lupus Erythematosus (SLE), Rheumatoid Arthritis (RA) or Systemic Sclerosis.
* For main sample (6 subjects per rheumatologist)
* Subjects with age \>=18 years and with confirmed diagnosis of pSS and are currently, or have previously, exhibited disease activity in one or more of the categories: fever of non-infectious origin, lymphadenopathy/lymphoma, glandular swelling/enlarged parotid gland, arthralgia/synovitis, erythema/vasculitis/purpura, pulmonary involvement, renal involvement, myositis, peripheral nervous system involvement, central nervous system involvement, cytopenia of autoimmune origin (with neutropenia) and/or anemia and/or thrombocytopenia and/or lymphopenia, hypocomplementemia and/or hypergammaglobulinemia and/or cryoglobulinemia or hypogammaglobulinemia and/or Ever received immunosuppressant or biologic treatment.
* For oversample (1 subject per rheumatologist)
* Subjects with age \>=18 years and with confirmed diagnosis of pSS that fit the following criteria: Has never exhibited disease activity in any of the categories above, Moderate or severe fatigue (in the opinion of the rheumatologist)

Exclusion Criteria:

* Not applicable
Phase 2 Study to Evaluate RPT193 in Adults With Moderate to Severe T2-high Asthma

Randomized, multi-center, double-blind, placebo-controlled, parallel group, proof of-concept study with RPT193 in subjects with T2-high, moderate-to-severe asthma who are partially controlled on medium or high doses of inhaled corticosteroids (ICS) in combination with long-acting beta 2 agonist (LABA).

Randomized, multi-center, double-blind, placebo-controlled, parallel group, proof of-concept study with RPT193 in subjects with T2-high, moderate-to-severe asthma who are partially controlled on medium or high doses of inhaled corticosteroids (ICS) in combination with long-acting beta 2 agonist (LABA).

After a screening period subjects will receive standardized, inhaled therapy during a run-in period. Subjects will be randomized to receive RPT193 or placebo through Week 14. All enrolled subjects will receive background inhaled therapy with ICS and LABA.

Eligibility Criteria:
Inclusion Criteria:

* Physician diagnosis of asthma for ≥6 months
* Pre-bronchodilator FEV1 of \>40% and \<80%
* History of treatment with corticosteroid or hospitalization for worsening asthma
* Medium- or high-dose inhaled corticosteroid use

Exclusion Criteria:

* History of smoking/vaping
* History of severe COVID
* Serious and/or uncontrolled pulmonary, cardiac, immune system conditions
* Requires systemic oral or IV corticosteroids in the month prior to screening
Response to Clenbuterol in Humans

Due to the long half-life (\~36 hr) of clenbuterol, detection methods such as dried blood spots (DBS) are a potentially suitable method to easily and non-invasively detect doping misuse of this compound for several days after ingestion. If, and how long, the compound can be detected by DBS has not yet been investigated but is of interest due to its potential in doping-control. The aim is to evaluate whether abuse of clenbuterol can be detected at relevant concentration levels in samples obtained using DBS and to assess the physiological response to clenbuterol in skeletal muscle..


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Male
* 18-40 years of age
* No known contraindications for anabolic drugs (e.g. cancer)

Exclusion Criteria:

* Abnormal ECG
* Steroid abuse
* Ongoing use of prescription medication
* heavy resistance training more than 2 times weekly
* Disease deemed by the MD to infer a risk to participate in the trial
Combined Transcranial Magnetic Stimulation and Cognitive Treatment in Blast Traumatic Brain Injury

This study investigates the efficacy of a novel neurorehabilitation program combining noninvasive brain stimulation (transcranial magnetic stimulation or TMS) and cognitive therapy, on cognitive function and quality of life in individuals with blast-induced traumatic brain injury (bTBI).

The most common blast-induced traumatic brain injury (bTBI)-associated problems are cognitive deficits, such as executive functioning and memory. This study evaluates a combined rehabilitation program: transcranial magnetic stimulation (TMS) and cognitive therapy for treatment of patients with bTBI. TMS is a noninvasive way of stimulating the brain, which is not painful and does not involve any needles or any form of surgery. It acts by delivering a magnetic stimulation to a particular brain region. Half of the study participants will receive cognitive intervention with active TMS, and a control group will receive cognitive intervention with sham TMS. This study takes place in Boston, Massachusetts: at the VA Boston Healthcare System and Beth Israel Deaconess Medical Center.

Eligibility Criteria:
Inclusion Criteria:

* OEF/OIF active-duty personnel or veterans exposed to blast
* Meets criteria for mild TBI
* LOC of 30 min or less
* Age: 21-50
* Primary language is English

Exclusion Criteria:

* Evidence of penetrating head injury
* History of previous neurological diagnosis
* History of previous psychotic disorder prior to the blast exposure
* Hearing or vision impairment
Development of a Weight Maintenance Intervention for Bariatric Surgery Patients

Although bariatric surgery is highly effective for inducing significant weight loss and resolution of comorbidities, weight regain following surgery is a common problem. This pilot study will test the feasibility and acceptability of an intervention designed to help bariatric surgery patients maintain weight loss. Findings from this pilot will provide the foundation for a randomized controlled trial to evaluate the efficacy of the intervention.

The first intervention telephone call will occur one week following the baseline assessment. Calls will be made weekly in the first month (weeks 1, 2, 3, 4) and biweekly calls during months 2-4 (weeks 6, 8, 10, 12, 14). The goal of this intervention is to increase adherence to recommendations that patients are already receiving from their bariatric team as part of standard of care. Thus, each call will address maintenance skill building and anticipatory problem solving based on the processes outlined in the investigators' conceptual model and operationalized in the investigators' previous weight loss maintenance protocol. Relapse prevention planning will help patients identify situations in which overeating is common in the bariatric population (e.g., loss of control eating related to emotions, disinhibition).

Eligibility Criteria:
Inclusion Criteria:

* Bariatric surgery at a participating VA site
* Laparoscopic Roux-en-Y gastric bypass (RYGB) or laparoscopic vertical sleeve gastrectomy (SG) six to 18 months prior to the time of data pull
* English as preferred language
* Regular access to a telephone

Exclusion Criteria:

* Receipt of procedure to prevent gastric cancer
* Revisional bariatric surgery
* Hearing impairment
* Cancer not in remission
Using Boot Camp Translation to Address Rural Disparities in Adolescent Vaccination

The overall goal of this project is to implement the Boot Camp Translation process to develop a replicable approach for increasing adolescent vaccine uptake that can be adaptable and feasible to use in rural settings more broadly.

Boot Camp Translation (BCT) is a process to identify strategies that help communities improve health. It is a 6-month, facilitated, iterative community engagement process that brings together relevant stakeholders to develop and implement locally meaningful messages, materials, and strategies for health topics of interest.

This is a novel community engagement process that has a proven ability to result in meaningful and impactful strategies to improve compliance with recommended health behaviors in rural communities. The investigators will expand this work by testing BCT on its ability to improve vaccination with all recommend adolescent vaccines (Tdap, MenACWY, HPV, Flu).

The investigators will conduct a randomized, controlled trial in which 4 rural communities in Western Colorado will undergo BCT to develop and implement strategies to increase adolescent vaccination. Vaccination rates will be compared to 4 control communities that do not undergo BCT.

Eligibility Criteria:
Inclusion Criteria:

* Must live in one of the designated Colorado communities

Exclusion Criteria:

* Does not live in one of the designated Colorado communities
New Biological Tests in Patients With Antiphospholipid Antibodies

Antiphospholipid syndrome (APS) is an autoimmune disease characterized by thromboembolic events or pregnancy complications associated with circulating antiphospholipid antibodies (aPL-Abs). APS diagnosis needs the presence of both clinical and serological criteria (SAPORRO criteria, updated with Sydney criteria in 2006). However, no correlation between laboratory assays and the clinical thrombosis risk in patients with aPL-Abs was observed as only few patients with aPL-Abs developed clinical manifestations. Thrombin generation assays (TGA) is a global coagulation test that may represent a certain interest to evaluate thrombosis risk as a high thrombin generation capacity seems to be an independent risk factor for recurrent thromboembolic events. Another point of interest to assess the thrombotic risk is the detection of autoantibodies recognizing domain 1 of β2Gp1 (aβ2GP1-dm1). These autoantibodies are strongly related correlated with thrombotic and pregnancy manifestations. Recently, a commercial chemiluminescence immunoassay (CLIA) for detection of aβ2GP1-dm1 became available on Acustar® analyzer (HemosIL Acustar®, Instrument Laboratory, Bedford, USA) to facilitate aβ2GP1-dm1 research.

The aim of this study is to evaluate two additional laboratory assays to improve the correlation between laboratory assays and the clinical thrombosis risk in patients with antiphospholipid (APL): thrombin generation assay and aβ2GP1-dm1. Each biological result (Antibodies to Domain 1 (Dm1) of β2-Glycoprotein 1 (aβ2GP1-dm1) and Thrombin Generation Test (TGT) parameters: endogen thrombin potential (ETP), lag time and time to peak) will be compared to the history of clinical thrombosis (venous or arterial thrombosis and/or obstetrical complications such as defined by the Saporro criteria updated with Sydney criteria in 2006) for each patient.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with confirmed aPL-Abs (at least two positive determinations at least 12 week apart)
* Subject non opposition

Exclusion Criteria:

* Age \< 18 years
* Patient under the protection of justice, under guardianship or under curatorship
* Patient with anticoagulant treatment, except heparin
* Clinically symptomatic liver disease, supported by e.g. diagnosis of cirrhosis, portal hypertension, ascites, PT superior or egal to 5 seconds above upper normal limit
* Platelet count \< 100 G/L (giga/liter)
* Poor venous access
* Non confirmed suspicion of APS
SystemCHANGE™ Intervention on Medication Adherence in Older Adults With Heart Failure

The purpose of this pilot RCT study is to evaluate the acceptability and feasibility of a SystemCHANGE™ intervention to improve medication adherence in older adults with heart failure. The intervention focuses on changing the individual's environment by incorporating medication taking into existing routines using small experiments with feedback, and receiving support from people who impact routines.


Eligibility Criteria:
Inclusion Criteria:

* age 50 years or older
* HF diagnosis confirmed by their physician utilizing their most recent ejection fraction
* prescribed diuretics
* self-administering medications
* able to open an electronic cap
* able to speak, hear and understand English
* not hospitalized,
* no cognitive impairment as determined by a score of 4 or greater on the 6-item mini-mental status exam.
Influence of Preoperative Nutritional Status on Perioperative Period in Cardiac Surgery in Patients With Frailty

The aim of the study is to determine whether the optimisation of the preoperative nutritional status affects the course of the perioperative period in patients with frailty.

Subjects: Patients 65 and over years of age with frailty or risk of it, with suboptimal nutritional status who are prescribed to elective cardiac surgery .

Research methods: Edmonton Crispness Scale, a Mini Nutritional Assessment (MNA-SF) test will be used to select subjects. Body composition will be examined by bioelectrical impedance analysis (BIA) to determine the degree of phase angle. Changes in laboratory blood tests will be recorded and evaluated The subjects randomly will be divided into control and study groups.

The diet of the patients in the study group will be optimised by protein supplements before elective heart surgery.

The benefits of optimising nutritional status will be evaluated comparing laboratory blood tests, changes in organ function, adverse outcomes, the need for vasoactive drugs, artificial lung ventilation time and length of hospitalisation between the groups.


Eligibility Criteria:
Inclusion Criteria:

* Patients 65 years of age and older.
* Patients for whom cardiac surgery will be performed on a scheduled basis.
* Patients able to move without the help of others except for an aid: a stick, a walker.
* Patients who speak and understand Lithuanian perfectly.
* Patients who have read the informed consent form and confirmed their consent to participate in the study in writing.

Exclusion Criteria:

* Patiens younger than 65 years.
* No written consent of a person to participate in a biomedical research has been obtained;
* Patients with a history of mental illness or central nervous system disorders that interfere with the perception and proper assessment of their health and the meaning and content of the questionnaire / tasks.
* Patients with amputated lower extremities.
* Patients with hepatic insufficiency, one or more of viral hepatitis.
* It is not possible to perform a qualitative physical examination for other reasons (hearing, vision, etc.)
* Allergy to B vitamins.