cyrilzakka/clinical-trials huggingface dataset:
Evaluation of ARi with OpSens SavvyWire

The goal of this observational study is to establish the degree of agreement to Aortic Regurgitation (AR) severity during aortic valve intervention between the Aortic Regurgitation Index (ARi) measured by the Opsens SavvyWire, Echography and Aortography in subjects with severe aortic stenosis (AS) undergoing echo guided valve intervention. The main question it aims to answer is how the ARi measured with the Opsens SavvyWire compared with regurgitation evaluation derived by Echography and Aortography.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing TAVR suitable for intraoperative acquisition of TEE/TTE
* Age \> 18 years
* Able and willing to give informed consent.

Exclusion Criteria:

* Hemodynamic instability making use of additional hemodynamic measurement inappropriate or 24-hour survival unlikely
* Subject is considered part of a vulnerable population.
Intracardiac Echocardiography-Guided Catheter Ablation for Premature Ventricular Contractions Originating From the Papillary Muscles

This randomized, prospective, parallel, single-blind, multicenter clinical trial investigates the efficacy and safety of intracardiac echocardiography (ICE)-guided catheter ablation versus pressure-sensing catheter ablation alone in reducing PVC recurrence among patients with confirmed papillary muscle-originating premature ventricular contractions (PVCs). Participants were randomly allocated to either the ICE-guided intervention group or the conventional ablation control group following definitive diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥18 years.
* Diagnosed with premature ventricular contractions (PVCs) originating from the papillary muscles.
* Symptoms refractory to antiarrhythmic drug therapy.
* Patients must be capable and willing to provide written informed consent for study participation.

Exclusion Criteria:

* History of cardiac surgery or any prior cardiac interventional procedures.
* Ischemic heart disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy.
* Severe hepatic or renal dysfunction:

AST/ALT \>3× upper limit of normal (ULN); Serum creatinine (SCr) \>3.5 mg/dl or creatinine clearance (Ccr) \<30 ml/min.

* Prior ablation for papillary muscle PVCs.
* Life expectancy \<1 year.
* Pregnancy or lactation.
Maternal Fetal Device Performance Twins

Maternal Fetal Monitoring devices assist the health care professional in acquiring, monitoring, and storing fetal and maternal physiologic data which support clinical decision making for pregnant women and assesses the overall fetal health status during pregnancy and delivery. This study aims to support a new maternal fetal monitoring device with clinical data by collecting simultaneous, continuous, external, distinguishable FHRs from twin pregnancies using ultrasound Doppler transducers from the new maternal fetal monitoring investigational device and a marketed ultrasound imaging device.

This study aims to support a new maternal fetal monitoring device with clinical data by collecting distinguishable FHRs from twin pregnancies using ultrasound Doppler transducers from the investigational device and a marketed ultrasound imaging device. This study will collect twin fetal heart rate data from the new monitor on twin gestations.

Funding for this study will be provided by GE HealthCare. This study does not include patient advisors.

Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to provide written informed consent.
2. Twin pregnancy.
3. Aged 18+.
4. Greater than or equal to 30 0/7 weeks gestation.
5. Patient has none of the exclusion criteria.

Exclusion Criteria:

1. Non-twin pregnancy.
2. Involvement in another clinical trial currently or previously in this pregnancy that, in the investigator's opinion, would affect the conduct of this study.
3. Medical or obstetric problem that in investigator's opinion would make the patient incapable of taking part in the study.
4. Inability to understand the consent information due to medical illness, diminished intellectual capacity, or insurmountable language barrier.
Anti-eryptotic Effect of a Food Supplement with Plants Sterols in Hypercholesterolemia Treated with Statins

Potential anti-eryptotic effect of a regular intake of a plant sterol (PS)-containing food supplement, in moderate hypercholesterolemic patients treated with the PS-containing food supplement or placebo supplement.

Oxidative damage has been related to the externalization of phosphatidylserine in erythrocytes, an event associated with eryptosis (programmed death of erythrocytes). In addition, an increase in eryptosis has been observed in patients with hypercholesterolaemia. PS-enriched food supplements could be a nutritional strategy to improve risk factors in patients with moderate hypercholesterolemia treated with statins, constituting a synergistic treatment with these drugs. The present study aims to evaluate the eryptotic process (externalization of phosphatidylserine) after regular intake of a food supplement containing PS (2g/day) in patients with moderate hypercholesterolemia treated with statins. This is a case-control study with 32 cases (intake or a PS-containing food supplement) and 16 controls (placebo intake based on the excipient), with an intervention period of 6 weeks. The evaluation of eryptosis is carried out by determining the externalization of phosphatidylserine, the size of the erythrocytes and an ex vivo assay of adhesion of eryptotic erythrocytes to the vascular endothelium. In addition, the redox state (GSH), the in vivo oxidation of cholesterol (COPs), and biochemical and hematological parameters are evaluated. All parameters are evaluated at the beginning (week 0) and at the end of the intervention period (week 6).

Eligibility Criteria:
Inclusion Criteria:

* Participants with hypercholesterolemia (LDL cholesterol ≥ 160mg/dl at the time of diagnosis), receiving treatment with moderate intensity statins (atorvastatin 10-20 mg or simvastatin 20-40 mg or rosuvastatin 5-10 mg)
* No previous episodes of cardiovascular disease
* Absence of other analytical abnormalities or previous illnesses

Exclusion Criteria:

* Diabetes mellitus
* Participants in secondary prevention
* Treatment with lipid-lowering drugs other than atorvastatin, simvastatin or rosuvastatin
* Liver disease
* Renal failure
* Uncontrolled hypothyroidism
* Smokers
* Participants consuming foods enriched with PS or food supplements that contain PS
OPTIM-EHPAD Optimization of Drug Prescription for Each Resident Entering in Nursing Home (EHPAD).

Elderly people are at high risk of multiple medication which increases drug interactions and side effects. This problem is accentuated in EHPAD due to the multiplication of prescribers (the referring physician, the hospital physician, the specialist, the emergency physician, the coordinating physician). The lack of optimization of drug prescriptions in EHPAD can be responsible for iatrogenic, underuse and overuse of treatment, impacting the autonomy and quality of life of residents in EHPAD in France.

A method for optimizing diagnostic and drug management at the entry of a new EHPAD resident, called OPTIM EHPAD, has been tested in Languedoc-Roussillon (France) and validated. This is a consultation between the referring physician and the EHPAD coordinating physician. Some improvements have been made to this method in order to have an optimized version.

Physician's cooperation seems to promote decision-making and change in therapies. The objective of this study is to assess the theoretical effectiveness and efficiency of this approach.

It is supposed that the provision to the EHPAD coordinating physician of a method for optimizing the diagnostic and drug management of the new EHPAD resident (based on a decision following consultation between the referring doctor and the coordinating doctor) would impact on the resident care process, on their care results and on communication and coordination between the coordinating physician and the referring physician.


Eligibility Criteria:
Inclusion Criteria:

* - Coordinating physician of EHPAD who don't have an indoor pharmacy (PUI) from the Languedoc-Roussillon-Midi-Pyrénées region and the Auvergne-Rhône-Alpes region.
* New resident entering a participating EHPAD

Exclusion Criteria:

* - Residents who don't have a referring physician when entering EHPAD
Efficiency and Safety a Fixed Combination of Orphenadrine and Diclofenac for Postoperative Analgesia

The study will include 60 patients after cardiac surgery. The first group will include 30 patients who will use the drug Neodolpasse manufactured by Fresenius Kabi, which is a fixed combination of 30 mg of orphenadrine and 75 mg of diclofenac; the second group will consist of 30 patients who will use patient-controlled morphine analgesia (РСА) in the form of monotherapy.

The patient signs an informed consent to participate in the study after tracheal extubation.The application of one or another method of influence is carried out by the method of random sampling (the envelope method). The drug Neodolpasse is used according to the following plan: in the form of an intravenous infusion of 250 ml for 2 hours 1 or 2 times a day with intervals between infusions about 12 hours. The second injection will be prescribed at VAS \> 40 mm no earlier than 12 hours after the first. The first injection will begin immediately after tracheal extubation. Morphine analgesia controlled by the patient will begin 2 hours after tracheal extubation (the concentration of the drug will be 1 mg /ml; the initial or loading dose is 3 mg; the bolus dose was 1 mg; the lockout interval is 6 minutes; the 4-hour maximum dose is 10 mg; the rate of constant infusion is 0.1 mg / hour).

Eligibility Criteria:
Inclusion Criteria:

1. age from 18 years to 80 years inclusive
2. surgical access - median sternotomy
3. the first 2 hours after tracheal extubation
4. clear consciousness and productive contact with the patient
5. absence of erosive or ulcerative lesions of the mucous membrane of the esophagus, stomach and duodenum during preoperative esophago-gastro-duodenoscopy and clinical manifestations of gastrointestinal bleeding
6. no signs of renal dysfunction (KDIGO 0)
7. stable state of hemodynamics

Exclusion Criteria:

1. a history of mental illness
2. the presence of contraindications to the appointment of diclofenac and orphenadrine or individual intolerance to drugs of these groups
3. renal and hepatic insufficiency
4. perioperative brain lesions
5. postoperative bleeding\>1.4 ml/kg/hour
6. severe cardiovascular (inotropic index\>10) and/or respiratory (RaO2 /FiO2\<200 mmHg) insufficiency
Impact of High-fat Meals Varying in Fatty Acid Composition on Adipose and Systemic Metabolic-inflammatory Responses

Cardiometabolic disorders are a leading cause of death worldwide. Replacing saturated fatty acids (SFA) with unsaturated fatty acids is recommended as a way of lowering cardiometabolic disease risk.

Consuming a diet rich in SFA may lead to a greater metabolic-inflammatory response in white adipose tissue during the fasting state, when compared to eating a diet rich in monounsaturated fatty acids (MUFA). Since individuals spend most of the day in the fed (or postprandial) state, it is important to see how different types of dietary fatty acids affect postprandial white adipose tissue and systemic metabolic-inflammatory responses.

This study will investigate the effect of a SFA-rich meal on markers of white adipose tissue and systemic metabolic-inflammation, compared to a MUFA-rich meal in overweight adults. In a randomised, single blind controlled, cross-over manner participants will consume either a SFA- or MUFA-rich meal and sequential blood and white adipose tissue samples will be collected before and until 6 hours postprandially.


Eligibility Criteria:
Inclusion Criteria:

* 18-50 years
* BMI = 25-40 kg/m2
* Male or Female
* Waist circumference \>94 cm (men) and \>80cm (women)\*
* Physically active (\> 3 x 30 min moderate intensity exercise per week)
* Systolic blood pressure \< 160 mmHg and diastolic blood pressure \< 100 mmHg
* No cardiometabolic (e.g. heart disease, high blood pressure, type 2 diabetes) or inflammatory illness

  * NOTE: If waist circumference falls below 94 cm for men or 80cm for women but BMI is \>25 kg/m2 volunteers may still be recruited at the PI's discretion.

Exclusion Criteria:

* Smoker
* Previous diagnosis of anaemia
* Women who are pregnant or lactating
* Taking medication known to interfere with study outcomes (e.g. treatment for hyperlidaemia, hypertension, inflammation or hypercoagulation) or prescribed antibiotics within the last 3 months
* Taking nutritional supplements known to interfere with study outcomes (e.g. fish oil or evening primrose oil)
* Unstable weight history (\>3 kg loss or gain in the previous 3 months)
* An allergy to lidocaine
* Those with known or suspected food intolerances, allergies or hypersensitivity to any components of the meal (e.g. lactose/wheat intolerance)
* Alcohol consumption \>28 units per week for a man or \>21 units per week for a woman
* Any other unusual medical history or diet and lifestyle habits or practices that would preclude volunteers from participating in a dietary intervention or metabolic study
* Parallel participation in another intervention study
Associations Between Self-Reported Sleep Duration and Sarcopenia in Community-Dwelling Older Adults

1. BACKGROUNDS: Currently, elderly people comprise more than 10% of the total Taiwanese population. However, within the context of self-reported sleep duration and health risks, research into the association between sleep duration and body composition changes in older people is limited. It is important to gain an understanding of such an association of older people to estimate the public health burden.
2. OBJECTIVES: To assess the association between self-reported sleep duration and sarcopenia as well as obesity in community-dwelling older adults.
3. HYPOTHESIS: Self-reported sleep duration is associated with prevalence of sarcopenia and obesity in community-dwelling older adults.
4. DESIGN: A cross-sectional investigation.
5. SETTING: Communities in Zhongzheng district, Taipei.
6. PARTICIPANTS: Four hundred and forty-eight community-dwelling adults (224 men and 264 women) aged 65 years and older.
7. MEASUREMENTS: The investigators evaluated self-reported sleep duration by deriving from the Pittsburgh Sleep Quality Index and 7-d recall physical activity diary. Skeletal muscle mass was estimated by the predicted equation from a bioelectrical impedance analysis measurement. The Groningen Activity Restriction Scale and the Chinese Geriatric Depression Screening Scale were used to evaluate physical disability and depression, respectively.


Eligibility Criteria:
1. hyper- or hypothyroidism.
2. taking prescribed medications (such as growth hormone, testosterone, or progesterone) known to alter body composition.
3. any condition that prevented them from completing our questionnaires or the functional capacity test (e.g., amputee, nonambulatory even with the use of a walker or a cane, blind, or deaf).
A Study to Determine Whether EGFR Status by FISH Can Predict Results in Non Small Cell Lung Cancer (NSCLC) Patients Treated With Cetuximab, Carboplatin and Paclitaxel

The purpose of this study is to determine if EGFR status (positive or negative) by FISH can predict response to cetuximab therapy in NSCLC patients treated with carboplatin and paclitaxel


Eligibility Criteria:
Inclusion Criteria:

* Subjects who present with Stage IV, Stage IIIB NSCLC or recurrent disease following radiation therapy or surgical resection
* No prior chemotherapy or anti-EGFR targeted therapy
* Sufficient tumor material for FISH testing
* Measurable disease (RECIST)
* ECOG performance status 0 or 1

Exclusion Criteria:

* Symptomatic or uncontrolled CNS metastases
* Inadequate hematologic function defined as ANC \< 1,500/mm3, platelet count \< 100,000/mm3, or a hemoglobin level \< 9 g/dl
* Inadequate hepatic function defined as total bilirubin \> 1.25 x ULN, AST level \> 1.5 x ULN, or alkaline phosphatase \> 5.0 x ULN
* Inadequate renal function defined by a serum creatinine level \> 1.5 x ULN
Non-Invasive Screening for Fetal Aneuploidy

The purpose of this study is to determine if a laboratory test developed by the Sequenom Center for Molecular Medicine (SCMM) that uses a new marker found in the mother's blood can better identify pregnancies that have a child with a chromosome abnormality such as Down syndrome (Trisomy 21), Edwards syndrome (Trisomy 18), or other chromosome abnormality.


Eligibility Criteria:
Inclusion Criteria:

* Subject is willing to provide written informed consent
* Pregnant female with singleton gestation 18 years of age or older
* Subject agrees to provide a 20 to 30 mL venous blood sample
* Subject is one of the following: A) currently scheduled to undergo an amniocentesis and/or CVS procedure, OR B) currently in the first trimester of pregnancy and planning to undergo an amniocentesis in the second trimester
* Subject will receive results of a genetic analysis that includes evaluation of the fetus for aneuploidy

Exclusion Criteria:

* Subject lacks the capacity to provide informed consent
* Twins, triplets or other multiple gestation
Treatment for Word Retrieval Impairments in Aphasia

In this study the investigators are examining the effectiveness of two different speech therapy protocols for word retrieval impairments experienced by individuals with stroke-induced aphasia. One treatment involves errorless naming treatment and the other employs verbal plus gestural facilitation of word retrieval. Participants will receive one of the two treatments over several months. Before and after treatment the investigators will administer several tests and conversational samples to examine changes associated with the treatments. The investigators hypothesize that, whereas both treatments will lead to improvements in words rehearsed in therapy, communication outcomes in conversation will be broader for the verbal plus gestural protocol.

In this study the investigators are examining the effectiveness of two different speech therapy protocols for word retrieval impairments experienced by individuals with stroke-induced aphasia. One treatment involves errorless naming treatment and the other employs verbal plus gestural facilitation of word retrieval. Participants will receive one of the two treatments over several months. Before and after treatment the investigators will administer several tests and conversational samples to examine changes associated with the treatments. The investigators hypothesize that, whereas both treatments will lead to improvements in words rehearsed in therapy, communication outcomes in conversation will be broader for the verbal plus gestural protocol.

Eligibility Criteria:
Inclusion Criteria:

* left hemisphere stroke \>4 months earlier
* aphasia with word retrieval impairments
* \>21 years of age right handed
* speaker of English as the preferred language
* \>6 grade education

Exclusion Criteria:

* history of developmental learning difficulties
* history of prior neurological illnesses
* chronic medical illnesses that restrict participation in speech therapy
* alcohol or drug dependence
* severe uncorrected impairments of vision or hearing
Efficacy and Safety of Infliximab Biosimilar Remsima in Psoriasis

Psoriasis is a persistent condition which demands prolonged management, so it puts heavy financial as well as psychological burden on patients. Severe psoriasis makes work impossible for patients. If it affects exposed parts of the body, it may lead to decrease in self-esteem, social avoidance, and shame. Patients with even mild form of psoriasis have high stigma as compared to other cutaneous diseases. As a result, psoriasis affected individuals experience greater difficulty in social interactions and employment. Patients experience symptoms in psoriasis includes bleeding, itching and inflamed joints. Psoriatic patients develop psoriatic arthritis approximately at 40 years of age which contributes to fatigue in these individuals. Moreover, early age onset of psoriasis leads to more physical impairment. Hence, patients get trapped in a vicious cycle as stress leads to further aggravation of disease. The European Medicine Agency has given its approval regarding the usage of INFLIXIMAB bio similar REMSIMA for psoriasis after taking in consideration its effectiveness from other studies conducted on ankylosing spondylitis and rheumatoid arthritis. This study is being conducted as no data is present on REMSIMA SC in psoriasis patient in Pakistan.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18-59 years
* Both genders
* Diagnosed patient of Psoriasis
* Moderate to severe psoriasis
* Not responding to topical treatment
* Not responding to conventional systemic treatments i.e., methotrexate, cyclosporine and phototherapy.
* PASI score \>10.

Exclusion Criteria:

Patient with active systemic lupus erythematosus or ANA positive patients.

* Patient with active tuberculosis.
* Extremely immunocompromised patient.
* Patient with cardiac disease.
* Patient with allergic reaction to REMSIMA.
* Pregnancy and Lactation.
L-C Ligament Versus Hamstring Autograft for Primary ACL Reconstruction

The purpose of this study is to compare safety and efficacy outcomes of the L-C Ligament versus Hamstring Autograft for treatment of acute rupture of the ACL.


Eligibility Criteria:
Inclusion Criteria:

* Patients with acute ruptures of the ACL who are willing to undergo treatment within 18 weeks of injury

Exclusion Criteria:

* Prior ACL reconstruction or other surgical procedure on the affected (target) knee
* Chronic ACL injury; interventional surgery scheduled 127 days or more after ACL injury
* Professional athletes currently engaged in active sport
* Prior distal femoral and/or proximal tibial fracture(s) of the target leg
* Previous or current ACL injury on contra-lateral leg
* Multi-ligament reconstruction
* Malalignment or varus thrust
* Patient \> 193 cm tall (6' 4")
* The patient does not follow pre-operative rehabilitation that may have been prescribed post-injury (prior to Index Procedure)
* Confirmed connective tissue disorder
* Signs of moderate to severe degenerative joint disease
* Severe pain, swelling, or redness within 24 hours prior to surgery
* Complete or partial Posterior Cruciate Ligament (PCL) tear
* If concomitant meniscal injury is present, any of the following: 1/3rd meniscal resection; complex double-bucket tear; partially repaired meniscal tears
* Any type of lateral and/or medial meniscal tear which is not repairable (\<2mm from rim)
* Additional concomitant injuries to the knee or lower extremities requiring treatment, per surgeon's discretion, that are not allowable under the Inclusion criteria
* The patient is unwilling to not participate in sporting activities for at least 9 months post-procedure
* The patient is mentally compromised
* The patient has a neuromuscular disorder that would engender unacceptable risk of knee instability, prosthesis fixation failure, or complications in postoperative care
* The patient has an active or latent infection in or about the affected knee joint or an infection site distant from the knee that may spread to the knee hematogenously
* Pregnant based on a positive beta hCG serum or an in vitro diagnostic test result or breast-feeding
* The patient is obese with a BMI \> 35
* The patient has a known allergy to PLLA
* The patient has a medical condition or comorbidity that would interfere with study participation