cyrilzakka/clinical-trials huggingface dataset:
Cardiac Deformation: Correlation With Conventional Echocardiographic Hemodynamic Variables (An Intraoperative Study)

The aim of this research is to apply cardiac tissue characterization in order to assess left ventricular function in cardiac surgical patients pre and post cardiopulmonary bypass. The procedures to be used include a retrospective review of transesophageal images obtained during conventional intraoperative transesophageal echocardiography (TEE) for cardiac surgery, as well as a secondary analysis with Tissue Doppler. The results will be compared with hemodynamic data obtained from a pulmonary artery catheter (PAC).

Patients included in this study are between the ages of 18 to 99 years of age, who presented to the operating room for cardiac surgery, and received both a pulmonary artery catheter and a routine intra-operative TEE. We will only be looking at patients whose TEE images were of good quality.

Subjects underwent cardiac surgery and received both a PAC and a routine TEE exam. We will review the data from the PAC, the images from the conventional TEE exam, and a secondary analysis with Tissue Doppler.

A potential benefit to society is a novel means for assessing left ventricular function. Our research will not benefit our subjects directly. There is no additional risk to our subjects beyond the insertion of the PAC and the TEE probe, which are routinely placed in our patients under-going cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients \>18 years of age Patients scheduled for cardiac surgery and will receive both a pulmonary artery catheter and a routine intra-operative TEE

Exclusion Criteria:

* TEE images that are of poor quality
Remote Ischemic Preconditioning in Patients Undergoing Isolated Aortic Valve Replacement Surgery

The goal is to investigate the efficacy, safety and possible neuro- and cardioprotective effects of remote ischemic preconditioning (RIPC) in adult cardiac patients undergoing isolated aortic valve replacement surgery with a biological prosthesis. Neuropsychological evaluation preoperatively and at 30d after surgery will establish if there are any differences in neuropsychological performance between groups. A large array of biochemical markers will be analyzed from plasma samples taken at different time points. Additionally skin biopsies from the lower limb will be taken before and after performing RIPC on said limb. During the venous cannulation phase a atrial biopsy will be taken. The biochemical markers from plasma and tissue samples will be used to asses brain tissue damage, inflammation and cardiac tissue damage between groups.

This will be a single center prospective randomized study with two groups. A intervention group (RIPC) and a control group. Study size is: 40 patients in total, 20 patients per group.


Eligibility Criteria:
Inclusion Criteria:

* Non-emergency aortic valve replacement with a biological prosthesis with perfusion and cardiac arrest

Exclusion Criteria:

* Recent myocardial infarction
* Carotid stenosis requiring intervention
* Any other concomitant surgical procedure
* Increased troponin baseline before surgery
* Critical ischemia of lower limbs
* Peripheral arterial disease (ASO, media sclerosis)
* Morbid obesity (Incompatible cuff-to-thigh diameter)
* Severe heart insufficiency
* Moderate to severe venous insufficiency lower limbs
* Recent acute stroke \<90d
* Difference in cardioplegic protocol
* Diseased aorta in epiaortic ultrasound
Plasma Adiponectin Concentration, Activity and Isoforms in Newly Diagnosed and Untreated Type 2 Diabetes Mellitus

The objective of present study were to compare plasma adiponectin isoform status, their bioactivities newly diagnosed Chinese with healthy volunteer.

Adiponectin, circulates as trimer, hexamer and high molecular weight form (HMW) in human blood, is a promising biomarker for indication diabetes and cardiovascular disease. Both adiponectin complexes concentration and their bioactivities are decreased in pathological state. Disulﬁde-bond A oxidoreductase-like protein (DsbA-L) is a key regulator for adiponectin biosynthesis and its expression level is down-regulated in obese mice and humans. However, the alteration of circulating adiponectin multimers distribution, their bioactivities and adiponectin regulator, DsbA-L level, in newly diagnosed Chinese type 2 diabetes patients are unknown. The objective of present study were to compare plasma adiponectin isoform status, their bioactivities and DsbA-L concentration in newly diagnosed Chinese with healthy volunteer.

Eligibility Criteria:
Inclusion Criteria:

* Having a diabetic history within 12 months
* BMI smaller than 30kg/m2

Exclusion Criteria:

* Having any kinds of treatment affecting glucose
* pregnant
* uncontrolled hypertension, active cardiac disease, or other major liver, kidney disease
Patients With Acute Hip Fractures Will Receive Either the PENG Block or no Block Respectively.

Hip fracture pain is often severe and traditionally managed by systemic opioids which have increased risk of side effects in frail elderly patients. Inadequately controlled pain may lead to delirium which increases mortality and morbidity. The overall aim of this RCT is to investigate the potential for improved pain relief accomplished by the addition of the PENG block to current standard practice of pre-operative analgesia (systemic morphine), compared to the control group, which involves no block (operator will still go through the motion as if performing a block) plus standard pre-operative analgesia.

The investigator hypothesize that the addition of a single shot PENG block at the side of hip fracture in addition to traditional systemic morphine provides good preoperative pain relief on movement and reduces the need for breakthrough opioid requirements. The investigator hypothesize that the interventional group dynamic pain score assessed at 30 minutes after the block compared to control group dynamic pain score at 30 minutes after the "block" will be at least a 3 point difference between the 2 groups .

Specific Aim1: To determine difference in pain scores on movement (dynamic pain scores) in patients who receive the PENG block in the intervention group compared to no block in the control group at 30 minutes after performance of the block.

Specific Aim2: To determine if there is any difference in pain at rest between the intervention group and the control group, and if so, the magnitude of the difference in pain scores.

Eligibility Criteria:
Inclusion Criteria:

1. Age 60 years old and above
2. Provided consent for the study
3. Patients with solitary hip fracture (no other fracture) - intracapsular neck of femur fracture, intertrochanteric fracture
4. Either awaiting hip fracture surgery or no plans for hip fracture surgery within the next 24 hours

Exclusion Criteria:

1. Patients with cognitive impairment or inability to give consent, or refusal to give consent
2. Multiple fracture cases
3. Peri-prosthetic fractures and revisions
4. Subclinical vertebral fractures
5. Hip fractures due to major accidents such as road traffic accidents, fall from height or more than 2 meters
6. Multiple trauma
7. Pathological fractures secondary to metastases
8. Patients with contraindications to block performance

   * Coagulopathy as demonstrated by PT/PTT/INR
   * On antiplatelets or anticoagulation
   * Infection/ compromised skin integrity at site of block performance
   * Allergy to local anaesthetics and opioids
Quantitative Assessment of Orofacial Muscle Function in FSHD

The goal of this study is to validate a new method for the assessment of orofacial muscles in FSHD affected individuals, using maximal expiratory pressures (MEPs).

Our hypothesis is the following:

- The pressure drop observed when using circular mouthpieces (versus ovoid mouthpieces) is a reflection of orofacial dysfunction in FSHD affected individuals


Eligibility Criteria:
Inclusion Criteria:

* Genetic diagnosis of FSHD type 1 and/or type 2

Exclusion Criteria:

* Pregnant women
* Presence of other associated neuromuscular conditions
* Any unstable interfering clinical situation
Li-Hep vs. Non-Li-Hep Coated Transfer Device

This study is a prospective, diagnostic, cohort study within the standard care of acute coronary syndrome (ACS) patients. It compares the analytical performance of Siemens® point-of-care high sensitive troponin I testing in venous, plasma and capillary sample types. The investigators hypothesize that there is a good correlation between the Siemens® POC HS cTnI assay results for the three sample types and that the bias between different POC sample types reduces from \~10% to ≤ 5% when using heparinized transfer device for the capillary sample.

In September 2019, the validation study 1.0 started, in which the cTnI result of the Siemens POC device on three sample types are compared. Interim analysis of the sample comparison was performed by regression analysis using Passing and Bablock, and calculating the Pearson correlation coefficient.

The Li-hep Plasma vs Li-hep venous blood show a very good correlation of 1.00-1.03 with an R of \>0.99, so the results between these sample types can be used interchangeably. For the capillary sample vs the Li-hep sample (both blood and plasma) the slope is 8-12% higher. With a 8-12% higher response, the capillary test results may not be interchangeably used with the other 2 sample types.

It is remarkable that capillary samples give a higher response, since it was anticipated that the result may be slightly lower due to the possible dilution by interstitial fluid. The investigators hypothesize that the presence of the Li-heparin anti-coagulant in the venous draw lead to a slight reduction of the apparent cTnI concentration. By using a heparin coated transfer device for the capillary samples instead of an uncoated transfer device, this hypothesis will be tested.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older.
* Referred to cardiac ED with chest pain suspected of ACS; inclusion at arrival (T=0) or one hour after arrival (T=1).
* Subacute STEMI or NSTEMI patients admitted at the CCU who have an indication for coronary angiography but do not need rescue/emergency PCI.
* STEMI patients who already underwent rescue/emergency PCI; inclusion post PCI.

Exclusion Criteria:

* Out of hospital cardiac arrest.
* Patients with sudden onset tachycardia and a frequency of 110 bpm or higher (supraventricular or ventricular).
* Patients who are hemodynamically unstable or in which an acute non-coronary diagnosis is suspected, e.g. pulmonary embolism, thoracic aortic dissection etc.
* Patients recently already admitted for the same set of symptoms at a previous healthcare institution before being transferred to the participating clinical site.
* Patients not willing or not able to provide informed consent due to their medical condition as judged by the physician.
A Phase Ia/Ib Study of IBI315 in Patients With HER2-expressing Advanced Solid Tumor

The primary objective of this phase I study is to evaluate the safety and potential efficacy and to determine the recommended phase 2 dose (RP2D) of IBI315, a HER2/PD-1 bi-specific antibody in patients with advanced solid tumors

This phase Ia/Ib, open-label, multicenter study has two stages. The Ia stage is a dose-escalation study that will focus on safety, tolerability, efficacy and RP2D . Patients with HER2-expressing advanced solid tumor who failed from previous standard of care will be enrolled in the phase Ia study. DLT observation period is 28 days.

Eligibility Criteria:
Inclusion Criteria:

* Written (signed) informed consent.
* Life expectancy ≥12 weeks.
* Patients with HER2-expressing advanced solid tumor who failed on current standard of care
* According to RECIST 1.1, at least one measurable lesion (radiation-naïve) exists.
* ECOG performance status 0-1.
* Adequate organ and marrow function evaluated by laboratory tests as follow:

  * CBC: absolute neutrophil count (ANC) ≥ 1.0×109/L (Ia stage) or 1.5×109/L (Ib stage); Platelet (PLT) ≥ 75×109/L; Hemoglobin (HGB) ≥ 9.0g/L;
  * Liver function: Total bilirubin (TBIL) ≤ 1.5×upper limit of normal value (ULN) for patients without hepatic metastases, ≤ 2×ULN for patients with hepatic metastases or Gilbert syndrome; Alanine aminotransferase (ALT) ≤ 2.5×ULN; Aspartate transferase (AST) ≤ 2.5×ULN;
  * Renal function: Clearance of creatinine (CCr) by Cockcroft-Gault formula or 24-hour urine collection ≥ 50ml/min;
  * Urinalysis: urine protein \< 2+ or urine protein in 24-hour urine collection \< 1g;
  * Coagulation function: activated partial thromboplastin time (APTT）≤ 1.5×ULN; international normalized ratio (INR）≤ 1.5
* left ventricular ejection fraction (LVEF) ≥ 50% by echocardiography;
* Accumulative exposure to doxorubicin ≤ 360mg/m2; accumulative exposure to epirubicin ≤ 720mg/m2;
* Agree to use an approved contraceptive method during the treatment period, until 180 days after last dose of treatment.
* Post-menopause female subject or pre-menopause female with negative HCG level in urine or blood.

Exclusion Criteria:

* Any greater than NCI CTCAE 0/1 adverse event exists within 4 weeks before enrollment, not including hair loss and fatigue;
* Received major surgery or having unhealed wound, ulcer, or bone fracture;• Received whole pelvic radiation;
* Plan to receive any other anti-cancer therapy not specified in the protocol, except for palliative radiotherapy;
* CNS metastasis, spinal compression, or carcinomatous meningitis
* Active autoimmune disease or inflammatory disorders.
* Primary immunodeficiency diseases;
* Pregnant or breast-feeding female.
Evaluate the Effect of Atorvastatin on Cerebrovascular Reactivity in Mild Cognitive Impairment (MCI)

The purpose of this study is to evaluate the effect of atorvastatin on brain vessel reactivity and with it on blood flow in people with mild cognitive impairment.

Participants are first being informed about potential benefits and risks of the study and are required to give written consent. After that participants will undergo detailed phone screen to determine eligibility for study entry. At week 0, participants who meet eligibility requirements will be prescribed atorvastatin (40 mg, once in the evening) in an open-label manner.

Eligibility Criteria:
Inclusion Criteria are chosen to include participants with MCI, enriched for vascular risk factors:

* MCI defined by Clinical Dementia Rating (CDR) of 0.5 or 1.0.
* Memory, processing speed, executive function, language - cognitive scores \> 1.5 standard deviations below age-education norms.
* Not demented by history.
* Not taking statins currently or in the last 6 months.
* Cognitive/functional impairment not likely due to another neurological disease or delirium.

Exclusion Criteria:

* Taking a statin currently or have taken a statin in the last 6 months.
* Contraindications to taking a statin.
* Transplant patient taking cyclosporine.
* Unable to undergo MRI procedures (such as having an implanted pacemaker or defibrillator or stimulator or having non MRI compatible metal).
* Diagnosis of dementia by history.
* Current diagnosis of substance abuse.
* History of stroke or myocardial infarction in past 6 months.
* History of HIV.
Bupropion SR for Treating Smokeless Tobacco Use

To determine the efficacy and safety of bupropion SR for quitting tobacco in smokeless tobacco users.

CONTEXT: No pharmacotherapies have been shown to increase long-term (\&#8805; 6 month) tobacco abstinence rates among smokeless tobacco (ST) users, although bupropion SR has demonstrated potential efficacy in pilot studies.

OBJECTIVE: To determine the efficacy and safety of bupropion SR for tobacco abstinence among ST users compared with placebo.

DESIGN, SETTING, AND PARTICIPANTS: A randomized, double-blind, placebo-controlled trial conducted between August 2003 to May 2005 at two research centers with a 12-week treatment period and follow-up of smoking status to week 52.

INTERVENTION: Bupropion SR titrated to 150 mg twice daily or placebo for 12 weeks plus weekly behavioral interventions.

Main Outcome Measures: The primary endpoint was 7-day point-prevalence tobacco abstinence rate at week 12. Secondary outcomes included the prolonged and continuous tobacco abstinence rates at weeks 12, 24, and 52.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* used ST daily for at least one year
* in good general health
* willing to complete all study procedures
Clinical-genetic Investigations in Children With Early Infantile Epilepsies

The project strives to discover novel genetic defects that cause monogenic epilepsy or that genetically modify a preexisting epileptic phenotype. Our main aim is to find genetic causes for the idiopathic West Syndrome (infantile seizures) that are not caused by known cerebral malformation, lissencephaly or metabolic disorders and which have a comparatively benign prognosis.

The investigators hypothesize that mutations in genes coding for ion channels or genes that modify the action of ion channels might be causative.

For that the investigators will perform a sequence analysis of the coding exons of a large set of genes in all recruited patients and verify found mutations in their parents.


Eligibility Criteria:
Inclusion Criteria:

* Hypsarrhythmia in the first year of life
* Infantile seizures in the first year of life
* Freedom of seizures at the age of 5 years

Exclusion Criteria:

* brain malformation
* metabolic disorder
* intracranial hemorrhage
* lissencephaly
A Study of HRXG-K-1939 and Adebrelimab in Patients With Advanced Solid Tumors

This is a Phase 1, open-label study evaluating the efficacy and safety of HRXG-K-1939 in combination with Adebrelimab (anti-programmed death-ligand 1 \[anti-PD-L1\] antibody) in patients with advanced solid tumors. HRXG-K-1939 will be administered to patients in a dose escalation regimen to determine a recommended dose for expansion.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntarily signed the informed consent form and complied with protocols requirements;
2. Patients with advanced solid tumors that are suitable for immunotherapy;
3. ECOG Performance Status of 0 or 1;
4. Life expectancy ≥ 12 weeks;
5. At least one measurable disease per RECIST v1.1;
6. Tumor specimen availability;
7. Adequate marrow and organ function;
8. Have resolution of toxic effects from prior therapy to Grade 1 or less (except for Grade ≤2 alopecia or neuropathy) per CTCAE v5.0;
9. Patients with fertility are willing to use an adequate method of contraception.

Exclusion Criteria:

1. Previously detected positive driver genes (EGFR, ALK, ROS1, etc.);
2. Have leptomeningeal, or actively progressing CNS metastases (patients with stable brain metastases can be enrolled);
3. Uncontrolled pleural effusion, pericardial effusion, or ascites;
4. Major surgical procedure within 28 days prior to initiation of study treatment or anticipation of need for a major surgical procedure during the course of the study;
5. Prior anti-cancer therapy (e.g., chemotherapy, radiotherapy, hormonal therapy, targeted therapy, immunotherapy, any other investigational or immunomodulatory drugs) within 21 days prior to initiation of study treatment;
6. Live-attenuated vaccination within 28 days prior to initiation of study treatment through 60 days after the end of study;
7. Systemic steroid therapy or other form of immunosuppressive therapy within 14 days prior to initiation of study treatment;
8. Any history of an immune-mediated Grade 4 adverse event or Grade 3 adverse event that resulted in permanent discontinuation;
9. Active or history of autoimmune disease;
10. Active tuberculosis or infection requiring treatment;
11. History of interstitial lung disease;
12. Allergic to research drug ingredients;
13. Prior malignancy within 5 years prior to study entry;
14. Solid organ or allogeneic bone marrow transplant;
15. HIV positive, HCV positive, HBV DNA copies ≥ 10\^3;
16. Significant cardiovascular disease;
17. Other situations that are not suitable for inclusion in this study judged by investigator
Comparative Study to Evaluate ISV-305 Compared to Vehicle in Blepharitis Subjects

The purpose of this study is to evaluate the clinical efficacy and safety of ISV-305 (Dexamethasone in DuraSite® 2) compared to Vehicle in the treatment of subjects with active, symptomatic Blepharitis.


Eligibility Criteria:
Inclusion Criteria:

* Are at least 1 years of age and have a clinical diagnosis of active, symptomatic blepharitis
* Signature of the subject or parent(s) or legally authorized representative on the Informed Consent Form, and when appropriate the minor's assent in accordance with local regulations
* Are willing and able to follow all instructions and attend all study visits (this applies to parent or caregiver for subjects too young to self-apply investigational product)
* Are willing to avoid disallowed medication for the duration of the study
* If female is of childbearing potential, agree to and submit a urine sample for pregnancy testing (prior to enrollment and at the end of the study) and use effective contraception for the duration of the study
* Male subjects whose female partners are not post-menopausal must agree to one of the following: 1) completely abstain from sexual intercourse, 2) use a barrier method (condoms) with spermicide during sexual intercourse for the duration of the study, 3) provide documentation for having had a vasectomy (with documented infertility)
* Additional inclusion criteria also apply

Exclusion Criteria:

* Have known sensitivity or poor tolerance to any component of the study drugs
* Have had eyelid surgery in the study eye within twelve (12) months prior to Visit 1 or plan to have eyelid surgery during the study
* Have an acute ocular infection (bacterial, viral or fungal) or active ocular inflammation other than blepharitis in the study eye
* Have used topical medications on the eyelids or topical ophthalmic corticosteroid medications or systemic use of a corticosteroid mediation within 14 days prior to dosing and/or plan to use them throughout the duration of the study
* Be currently pregnant, nursing, or planning a pregnancy; or be a woman who has a positive urine pregnancy test
* Have prior (within 30 days prior to dosing) or anticipated concurrent use of an investigational drug or device
* Have a condition or a situation which, in the investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation
* Additional exclusion criteria also apply