cyrilzakka/clinical-trials huggingface dataset:
Impact of Percutaneous Transvenous Mitral Commissurotomy on The Left Atrial Appendage Function in Patients With Mitral Stenosis.

• Evaluation of the effect of PTMC on LAA function by TEE at least one month after the procedure and its effectiveness in prevention of thrombi formation and cerebrovascular complications.

* Mitral stenosis (MS) is a disabling disease that limits the normal physical abilities of patients and considered as a major reason for hospital admissions . The leading cause of MS globally is rheumatic heart disease(RHD), which remains common in economically developing countries and continues to be a significant cause of morbidity and mortality.
* Chronic pressure and volume overload imposed by MS causes left atrial (LA) and Left Atrial Appendage (LAA) dysfunction leading to reduced blood flow velocities thereby producing stasis of blood, reduced LA and LAA ejection fraction and atrial fibrillation (AF).
* These factors predispose to formation of LA and LAA thrombi in MS and result in thromboembolic episodes. Risk of cerebrovascular accident (CVA) is increased approximately five-fold in non-rheumatic AF and 17-fold in patients with MS with AF. Even patients of MS in sinus rhythm with depressed LA and LAA function are at increased risk of CVA. Assessment of LAA function is helpful in predicting the risk of thromboembolism .
* PTMC can improve the function of the LAA by reducing the left atrial pressure and increasing the blood flow through the mitral valve.
* Echocardiography, particularly transesophageal echocardiography (TEE), is currently the modality of choice for evaluation of the LAA. Transesophageal echocardiography (TEE) allows semi-invasive, highly accurate imaging of the functional efficiency of LAA by LAA Doppler and Doppler tissue imaging (DTI) .
* MS causes decreased LAA Doppler and DTI velocities in patients even with sinus rhythm . So, this study aims to evaluate effect of successful PTMC on LAA function by TEE Doppler and DTI (doppler tissue imaging).
* Fractional area change (FAC): The FAC is a measure of the percentage of change in the area of the LAA during systole. A higher FAC indicates a more contractile LAA.

Eligibility Criteria:
Inclusion Criteria:

* • Patient eligible for PTMC as anatomical characteristics àpatient with sever MS (area 1.5cm2, echocardiographic score (Wilkins score ≤ 8, Cormier score 1 and 2 ...), contraindication or high risk to surgical MVR.

Exclusion Criteria:

* Patient with mitral regurgitation more than grade II .
* Patient not eligible to PTMC.
* Patient with severe heart failure (NHYA class IV) .
* Patient with previous Cerebrovascular accident .
* Patient with contraindication to TEE ( esophageal disease like stricture , diverticuli, varices, ..., uncooperative patient )
A Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia

This Phase 3 study assesses two drug regimens as the initial treatment of patients who are at least 70 years of age and have newly diagnosed acute myeloid leukemia (AML) for whom the doctor does not recommend the use of standard intensive treatment or the patient has decided not to receive standard intensive treatment after being fully informed about its benefits and risks by his/her doctor. The two drug regimens are sapacitabine administered in alternating cycles with decitabine or decitabine alone. The purpose of the study is to learn which drug regimen is more likely to keep AML in check as long as possible.

This is a multicenter, randomized, Phase 3 study ("SEAMLESS") comparing two drug regimens (arms) as the front-line treatment of elderly patients aged 70 years or older with newly diagnosed acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy. In Arm A, sapacitabine is administered in alternating cycles with decitabine, and in Arm C decitabine is administered alone. The primary efficacy endpoint is overall survival. The study is designed to demonstrate an improvement in overall survival of Arm A versus Arm C.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed AML based on WHO (World Health Organization) classification
* Age 70 years or older for whom the treatment of choice is low-intensity therapy by investigator assessment or who has refused intensive induction therapy recommended by investigator
* ECOG (Eastern Cooperative Oncology Group) performance status 0-2
* Adequate renal function
* Adequate liver function
* Able to swallow capsules
* Agree to practice effective contraception
* Ability to understand and willingness to sign the informed consent form

Exclusion Criteria:

* AML is of the sub-type of acute promyelocytic leukemia or extramedullary myeloid tumor without bone marrow involvement
* Having received any systemic anti-cancer therapy for AML or received treatment with hypomethylating agents or cytotoxic chemotherapy for preceding myelodysplastic syndrome (MDS) or myeloproliferative disease (MPD)
* Known or suspected central nervous system (CNS) involvement by leukemia
* Uncontrolled intercurrent illness
* Known hypersensitivity to decitabine
* Known to be HIV-positive
Study of Alirocumab (REGN727/SAR236553) added-on to Rosuvastatin Versus Other Lipid Modifying Treatments (LMT) (ODYSSEY OPTIONS II)

To evaluate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab (REGN727/SAR236553) as an add-on therapy to other LMT in patients with hypercholesterolemia at high cardiovascular (CV) risk.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with LDL-C greater than or equal to 70 mg/dL at the screening visit and who are not adequately controlled with a stable daily dose of rosuvastatin, with or without other LMT.

   OR
2. Patients with screening LDL-C greater than or equal to 100 mg/dL who are not adequately controlled with a stable daily dose of rosuvastatin before the screening visit, with or without other LMT.

Exclusion Criteria:

1. LDL-C less than 70 mg/dL at the screening visit in patients with history of documented cardiovascular disease (CVD)
2. LDL-C less than 100 mg/dL at the screening visit in patients without history of documented coronary heart disease (CHD) or non-CHD CVD, but with other risk factors
3. Homozygous familial hypercholesterolemia (FH) (clinically or previous genotyping)
4. Recent (within 3 months prior to the screening visit) myocardial infarction (MI), unstable angina leading to hospitalization, percutaneous coronary intervention (PCI), coronary bypass graft surgery (CABG), uncontrolled cardiac arrhythmia, stroke, transient ischemic attack, carotid revascularization, endovascular procedure or surgical intervention for peripheral vascular disease
5. Newly diagnosed (within 3 months prior to randomization visit) or poorly controlled diabetes
6. Presence of any clinically significant uncontrolled endocrine disease known to influence serum lipids or lipoproteins

(The inclusion/ exclusion criteria provided above is not intended to contain all considerations relevant to a patient's potential participation in this clinical trial).
NIHR CV Health Informatics Collaborative

The National Institute for Health Research (NIHR) Cardiovascular Health Informatics Collaborative is an observational, multi-centre and longitudinal study of clinical data from collaborating hospitals. A dataset of the longitudinal record for patients who presented with a suspected acute coronary syndrome, characterised by the request of a troponin test, has been developed (NHIC-Troponin Study).

The NHIC Cardiovascular Project in the United Kingdom was established to enable the sharing and repurposing of routinely captured clinical data for re-use in research. Data sharing for this study has been enabled by establishing a data sharing agreement between each of the collaborating hospitals. The data sharing agreement allows data to be shared between National Health Service (NHS) hospitals in accordance with an anonymisation and de-identification profile approved by each information governance department, ensuring that patient identities are protected. Ethics approval for each dataset has been obtained which detailed the further de-identification steps to ensure that research datasets are fully anonymised.

The cardiovascular theme clinical leads developed a standard target data model specification to capture the longitudinal record for patients who presented with a suspected acute coronary syndrome, characterised by the request of a troponin test (NHIC-Troponin Study). The data model was patient centric allowing for minor discrepancies between dataset areas such as missing discharges or test results returning outside of episodes of care. The model included 156 data points, grouped into demographics, cardiovascular risk factors, emergency department attendance and inpatient episodes, biochemistry, revascularisation and mortality. All patients were followed up on the NHS Spine Application, Summary Care Record until death or censoring on 1st April 2017.

This dataset comprised all patients who had a troponin measured at each of the five major academic centres between 2010 (2008 for University College Hospital) and 2017. The investigators identified a total of 257948 patient records who underwent troponin testing during the study period.

A Committee of Experts validates the protocol methodology and supervises the data management. A Steering Committee oversees study proposals including hypotheses, study design and statistical analyses including planned outcome measures.

Eligibility Criteria:
Inclusion Criteria:

* All patients presenting to one of the collaborating hospitals.

Exclusion Criteria:

* Nil
FastFrame Knee Spanning and Damage Control Kit PMCF

The purpose of this prospective study is to confirm safety and performance of the FastFrame External Fixation System and corresponding instrumentation.

Study Title: FastFrame™ External Fixation System Post-Market Clinical Follow-Up Study (Knee Spanning Kit and Damage Control Kit)

Sponsor: Zimmer Biomet

Study Design: Prospective enrollment, prospective follow-up, single cohort study

Clinical Phase: Postmarket

Number of Sites: Up to three sites

Study Duration per Subject: Subjects will be enrolled in the study until the time of exchange of their FastFrame Kit to another device. Typically, this exchange occurs 2-4 weeks after injury.

Primary Objective: The objective of this observational, prospective study is to confirm safety and performance of the FastFrame External Fixation System and corresponding instrumentation.

Primary Endpoint: Frequency and incidence of device-related adverse events and device deficiencies before the FastFrame External Fixation System is exchanged by another device (i.e. plates, screws, etc.).

Secondary Endpoint: Adverse events that occur between application of the FastFrame External Fixation System and exchange with another device that do not fall within the primary endpoint.

Eligibility Criteria:
Inclusion Criteria:

* Patient must be 18 years of age or older
* Patient must be treated with either the Knee Spanning or Damage Control FastFrame External Fixation System according to the European Economic Area (EEA) indications\*

EEA Indications (a subset of the cleared US indications):

The FastFrame External Fixation System - Knee Spanning Kit is indicated for use in treatment of long bone (distal femur, proximal tibia) fractures. Specifically, the system is intended for temporary stabilization of open or closed fractures about the knee, typically in the context of polytrauma or where open or alternative closed treatment is undesirable or otherwise contraindicated.

The FastFrame External Fixation System - Damage Control Kit is indicated for use in treatment of mid-shaft long bone (femur, tibia) fractures. Specifically, the system is intended for temporary stabilization of open or closed fractures of the femur and tibia, typically in the context of polytrauma or where open or alternative closed treatment is undesirable or otherwise contraindicated.

Exclusion Criteria:

* Patient has an active or suspected infection
* Patient has conditions that limit their ability and/or willingness to follow instructions during the healing process
* Patient has inadequate skin, bone, or neurovascular status
* Patient is a prisoner
* Patient is pregnant and/or breastfeeding
* Patient is a known current alcohol and/or drug abuser in the opinion of the Investigator
* Patient has a mental or neurologic condition that will not allow for proper Informed Consent and/or participation in follow-up program in the opinion of the Investigator
Epanova® for Lowering Very High Triglycerides

The primary objective of the study is to determine the efficacy of Epanova (omefas) compared to placebo in lowering serum triglycerides in subjects with severe hypertriglyceridemia.


Eligibility Criteria:
Inclusion Criteria:

* Men or women, \>=18 years of age.
* Very high serum TG values in the range \>=500 mg/dL and \<2000 mg/dL (\>=5.65 mmol/L and \<22.60 mmol/L)

Exclusion Criteria:

* Allergy or intolerance to omega-3 fatty acids, omega-3-acid ethyl esters, or fish.
* Known lipoprotein lipase impairment or deficiency or apolipoprotein C-II deficiency or familial dysbetalipoproteinemia.
* Unable to discontinue use of omega-3 drugs/supplements.
* Unable to discontinue use of bile acid sequestrants, fibrates or niacin (other than niacin-containing vitamins \<200 mg), or any supplement used to alter lipid metabolism.
* Women who are pregnant, lactating, or planning to become pregnant. Women of childbearing potential who are not using acceptable contraceptive methods.
* Use of tamoxifen, estrogens or progestins that has not been stable for \>4 weeks prior to Visit 1.
* Use of oral or injected corticosteroids or anabolic steroids.
* History of pancreatitis.
* History of symptomatic gallstone disease, unless treated with cholecystectomy.
* Uncontrolled diabetes.
* Uncontrolled hypothyroidism or thyroid stimulating hormone (TSH).
* History of cancer (other than basal cell carcinoma) in the past 2 years.
* Cardiovascular event (i.e., myocardial infarction, acute coronary syndrome, new onset angina, stroke, transient ischemic attack, unstable congestive heart failure requiring a change in treatment) or revascularization procedure within six months prior to Visit 1.
* Use of anticoagulants (e.g. warfarin \[Coumadin®\], coumarin, heparin, enoxaparin, clopidogrel).
* Presence of an aortic aneurysm or resection of an aortic aneurysm within six months prior to Visit 1.
* Recent history (within six months prior to Visit 1) or current significant nephrotic syndrome, pulmonary, hepatic, biliary, gastrointestinal or immunologic disease.
* Poorly controlled hypertension.
* Any of the following laboratory criteria: serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST), glucose, glomerular filtration rate (GFR), platelet count,or hemoglobin outside of study range.
* Recent history (past 12 months) of drug abuse or alcohol abuse.
* Exposure to any investigational product, within 4 weeks prior to Visit 1.
* Presence of any other condition the Investigator believes would interfere with the subject's ability to provide informed consent, comply with study instructions, or which might confound the interpretation of the study results or put the subject at undue risk
Mode of Drainage Of Bilaterally Obstructed Kidneys

Bilaterally obstructed kidneys could be caused by benign or malignant causes it could lead to renal failure which can be avoided by urgent drainage either by PCN or DJ , The aim is to determine whether unilateral or bilateral drainage make a difference in improvement of renal function of bilaterally obstructed kidneys and whether that improvement relays on the cause of the obstruction.

The investigators will do that by doing a prospective comparative study on patients presented to our department by bilaterally obstructed kidneys , by either benign or malignant causes , with high serum chemistry. Intervention to this cases will be done by inserting JJ or PCN either unilateral or bilateral depending upon lab workups , our staff decision and patients fittness and agreement .

Kidney obstruction means obstruction of urinary flow with back pressure on the kidney, which may be unilateral or bilateral, may have many causes either benign e.g; urolithiasis, retroperitoneal fibrosis, renal papillary necrosis or malignant e.g; urinary tract tumors as bladder cancer and prostate cancer, or Extrinsic tumor as cervical cancer(5) , lymphoma or other pelvic tumors When kidney obstruction occurs bilaterally this raises serum chemistry and may lead to post-renal AKI which represents about (1-10%) of all causes of AKI. Post-renal AKI is an emergency case that requires an urgent and minimally invasive procedure to drain the urine either by PCN or ureteric stents.

There has been always a debate about which one is better to drain the obstructed kidneys percutaneous nephrostomy or ureteric stents and which is better in improvement of renal function and with less effect on life style . Also the mode of drainage of the obstructed kidneys, bilateral or unilateral, also has been a point of debate. Unless bilateral renal obstruction is due to benign or treatable malignant cause, unilateral nephrostomy is always the rule according to some authors . some authors, reported better improvement in renal function with bilateral PCN with pelvic tumors The investigators will do prospective comparative study for studying mode and laterality of drainage in benign and malignant causes in bilaterally obstructed kidneys .

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients ( \>18 yrs ) with bilateral obstructed kidneys
2. Bilateral obstructed kidneys due to benign causes
3. Bilateral obstructed kidneys due to malignant causes
4. Bilateral obstructed kidneys with high serum creatinine

Exclusion Criteria:

1. Age \< 18 yrs
2. Bilateral obstructed kidneys with normal serum creatinine
3. patients with chronic kidney disease
4. Vesicoureteric reflux
5. Severe comorbidity preventing intervention
An Open Label, Proof of Concept Study to Evaluate the Effects of Dalfampridine Withdrawal on Gait and Balance Parameters in Subjects With Multiple Sclerosis (MS)

The purpose of this study is to determine changes on overall gait as well as in multiple gait and balance parameters after withdrawal of dalfampridine-ER 10mg in MS subjects who are receiving the medication consistently for at least two weeks prior to screening.

Longitudinal study design

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of multiple sclerosis
* Receiving Ampyra® consistently for at least 2 weeks prior to the screening visit
* No history of seizures except simple febrile seizures

Exclusion Criteria:

* Sexually active woman of childbearing potential who is not surgically sterile, \<two years post-menopause or is not using effective birth control methods
* Subject who is pregnant or breastfeeding
A Phase 1 Study of NOV1601(CHC2014) in Adult Subjects With Solid Organ Malignancies

This study is a first-in-human (FIH) study which is required to understand the PK characteristics, MTD, and safety profile of NOV1601(CHC2014) in subjects with solid organ malignancies.

This is the first-in-human, Phase 1, open-label, multicenter, dose-escalation study to investigate the safety, tolerability, PK, and clinical activity of NOV1601(CHC2014) in subjects with solid organ malignancies. The primary goal of the study is to determine the RP2D of NOV1601(CHC2014) in adult subjects with solid organ malignancies.

Dose escalation will follow a 3+3 design and will be based on prior cohort review. There will be 2 branches of the dosing schedule, once a day(QD) and twice daily(BID).

Eligibility Criteria:
Inclusion Criteria(partial):

* Pathological confirmation of malignancy and evidence of metastatic or surgically unresectable disease
* At least one evaluable or measurable lesion should be present and identified according to Response Evaluation Criteria in Solid Tumors(RECIST) version 1.1 or Response Assessment in Neuro-Oncology(RANO)
* Relapse after or refractory to systemic drug therapy to malignancy, at least one regimen of cytotoxic chemotherapy, kinase inhibitors including tyrosine kinase inhibitors or immunotherapy which is considered as standard of care if there is no standard regimen recommended, then no experience of systemic drug therapy is acceptable
* Patients with primary central nervous system(CNS) tumors or metastasis, if they have been neurologically stable

  * Symptoms should be under control by stable dose of glucocorticoids and analgesic drugs for symptom control at least 2 weeks prior to starting the treatment
  * Stable dose of glucocorticoids and analgesic drugs for symptom control should be maintained throughout the study
  * Subjects should be off from radiotherapy for at least 14 days prior to the start of study treatment(C1D1) without symptom aggravation

Exclusion Criteria(partial):

* Prior high-dose chemotherapy requiring hematopoietic stem cell transplantation
* History or evidence of suspicious leptomeningeal disease
* Previous surgery of gastrectomy, gastrostomy or any medical condition which interferes with oral ingestion of capsule
* Indwelling percutaneous drainage of bile and chest tube
* Evidence of or suspicious symptomatic spinal cord compression, unless appropriately treated and neurologically stable off glucocorticoid for at least 2 weeks