cyrilzakka/clinical-trials huggingface dataset:
Ventricular Tachycardia Mechanisms

The purpose of this study is to understand why certain hearts have ventricular arrhythmias and help identify areas of the heart that cause arrhythmias. There is still a significant gap in understanding why ventricular arrhythmias occur. This study will examine the electrical properties of the heart tissue to understand how these arrhythmias occur, and hopefully identify areas that might lead to ventricular arrhythmias. The hope is that studying this might be able to improve outcomes during ventricular tachycardia (VT) ablations.

Ventricular tachycardia (VT) ablation remains the cornerstone treatment for drug refractory VT. Previous studies have reported success rate of VT ablation ranging from 23 to 49%. Despite improvements in mapping and catheter technology, there is a high recurrence rate and numerous patients who fail VT ablation.

Reasons for failure in VT ablation include the inability to identify critical areas of myocardium responsible for VT and hemodynamic instability of VT during mapping. Several studies have attempted to study electrical properties of cardiac tissues to identify potential circuits in sinus rhythm avoid mapping during unstable VT. This includes mapping fractionated electrical potentials, isochronal late activation mapping (ILAM), and ablation of low voltage regions. However, these techniques have yielded modest improvement in success rates with poor specificity of identifying important regions.

Monophasic action potentials (MAP) demonstrate cellular action potential of the myocardium. Recent evidence suggests that changes in MAP morphology can predict sudden cardiac death by ventricular arrhythmias. However, cellular activation has not been studied in VT. The researchers of this study propose that MAP signals can better elucidate electrophysiological characteristics of the myocardium, and thus identify sites critical to VT.

During a standard of care VT ablation, the researchers will use the MAP catheter to study cellular action potential of the ventricular myocardium, which cannot be done on traditional catheters. The design of this catheter is similar to other diagnostic catheters that are currently used for VT ablation. The MAP catheter is a bipolar catheter, two with electrical poles at the distal tip. The catheter is placed on the myocardium (similar to other traditional catheters) and a recording signal is transmitted to the workstation. Using the MAP catheter the will not interrupt or distort any of the standard treatment procedures.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ischemic cardiomyopathy
* Single or dual chamber implantable cardioverter-defibrillator (ICD)

Exclusion Criteria:

* Non-Ischemic cardiomyopathy
* Contraindication to catheter ablation
* Severe peripheral arterial disease or medical condition that prohibit arterial access
* Ventricular tachycardia (VT) or sudden cardiac arrest (SCA) within 30 days of acute coronary syndrome or within 90 days of coronary revascularization
Reconstructive of Multiple-digit Soft-tissue Defects Using Regional Dorsal Digital Flaps

Reconstruction of soft-tissue defects in multiple digits poses a significant challenge. This article reports simultaneous reconstruction of multiple small-to-moderate soft-tissue defects using regional dorsal digital island flaps and evaluated the efficacy of their application in such complex situation. A retrospective study will be conducted with 26 patients who had multiple-digit soft-tissue defects treated with regional dorsal digital island flaps. At the final follow-up, we will evaluate the efficacy of their application in such complex situation.

For the recipient where sensory restoration is important, sensation of the flaps is assessed using static two-point discrimination (2PD) and Semmes-Weinstein monofilament (SWM) testing at final follow-up. The cold intolerance of the injured finger is measured using the self-administered Cold Intolerance Severity Score questionnaire that was rated into mild, moderate, severe, and extreme (0-25, 26-50, 51-75 and 76-100). The pain of the injured finger is given subjectively by the patient using a grading system that included grade 1, none; grade 2, mild, no interference with daily activities; grade 3, moderate, patient works but has some limitation in use of the hand because of pain; and grade 4, severe, cannot work or use hand. To sum up, patients report their satisfaction with functional recovery of the injured finger according to the Michigan Hand Outcomes Questionnaire that was based on a 5-point response scale.

Eligibility Criteria:
Inclusion Criteria:

* the separate soft tissue defects with exposed bone or tendon in different digits
* the soft-tissue defect≥1.5 cm and ≤3.5 cm in length
* necessity to preserve digit length
* local tissue near the defect can be used as the donor
* a patient between 15 and 60 years of age

Exclusion Criteria:

* concomitant injuries to the dorsum of the injured finger
* a defect \< 1.5 cm and\>3.5 cm in length
* a finger degloving injury
* the defect of the thumb
Comparing Monofocal IOLs in Highly Myopic Cataract Patients

Comparison of Postoperative Outcomes in Patients with High Myopia Undergoing Cataract Surgery Implanted with Extended Depth of Focus Intraocular Lens (ICB00) and Monofocal Intraocular Lens (ZCB00)

In this study, we aim to compare the visual outcomes and quality of life between highly myopic patients with cataracts who receive implantation of extended depth of focus (EDOF) intraocular lenses (ICB00) and monofocal intraocular lenses (ZCB00). This is a case-control study, planning to recruit 64 highly myopic patients with cataracts, aged between 40 and 70, with 32 in each group. The primary endpoints of the study are the best-corrected visual acuity (BCVA) and defocus curve at 6 months postoperatively. Secondary endpoints include uncorrected visual acuity (UCVA), contrast sensitivity, intraocular pressure, and assessments of patient satisfaction and quality of life. These will be evaluated using standardized questionnaires such as the VF-14, the PRSIQ spectacle dependency scale, and reading speed tests to quantify changes in vision-related quality of life. Patients will undergo comprehensive ophthalmic examinations preoperatively and at 6 months postoperatively, including slit-lamp anterior segment examination, fundus examination, corneal topography, and intraocular pressure testing. Additionally, questionnaires will be used to assess patients' subjective satisfaction with visual improvement and spectacle needs in daily life. All data will be statistically analyzed to compare the effects of the two types of intraocular lenses. Continuous variables will be analyzed using t-tests or Mann-Whitney U tests, and categorical variables will be analyzed using chi-square tests. The level of statistical significance is set at p\<0.05. Through this study, we hope to determine whether the use of EDOF intraocular lenses provides better visual outcomes and quality of life compared to monofocal intraocular lenses in highly myopic patients with cataracts. The results of this study will provide a more scientific basis for the choice of intraocular lenses in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* 1: The patients are between 40 and 70 years old.

  2: Ocular axis \> 26mm

  3: Able to understand, cooperate and complete all follow-up.

Exclusion Criteria:

* 1: Moderate and severe dry eye

  2: There is macular degeneration complicated by high myopia.

  3: Combined with other ophthalmic diseases

  4: Previous history of ophthalmic surgery.

  5: There are intraoperative or postoperative complications.
Imaging Modality Effects on the Multi-dimensional InfraRed Analysis (MIRA) Technology

The purpose of this study is to evaluate the effect of everyday practice modalities (mammography, US) on the MIRA technology.

The objective of the current clinical study is to collect sufficient MIRA imaging data of subjects arriving for a routine screening mammography, before and after they undergo the mammography. This is in order to reach a conclusion whether the the firm breast compression involved in the mammography procedure affects the performance of the MIRA technology. At the current stage of the development of the device, the goal of this clinical trial is in no way to arrive at a statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* Gender: female
* Age: 50 years and older
* Subjects summoned for a routine screening mammography, ultrasound, diagnostic mammography or breast biopsy.
* Subject who have signed an informed consent form.

Exclusion Criteria:

* Subjects who have had a mammography, ultrasound, and/or MRI examination performed on the day of the study, PRIOR to their FIRST imaging session with the RealImager.
* Subjects who have undergone any type of breast surgery throughout the 6 weeks preceding the study.
* Subjects who have had a breast biopsy performed throughout the 6 weeks preceding the study.
* Subjects who have undergone a mastectomy.
* Subjects who have undergone a lumpectomy.
* Subjects who have a large scar (causing breast deformation).
* Subjects who have previously undergone or are currently undergoing breast radiation therapy.
* Subjects who have previously undergone or are currently undergoing chemotherapy.
* Subjects with prior breast reduction surgery or breast augmentation surgery.
* Subjects who are pregnant.
* Subjects who are breast-feeding.
A Phase I Clinical Trial of a 13-valent Pneumococcal Conjugate Vaccine and 14-valent Pneumococcal Conjugate Vaccine in Adults

The purpose of this study is to evaluate the safety and immunogenicity of LBVE013 (Pneumococcal 13-valent conjugate vaccine \[diphtheria CRM197 protein\]) or LBVE014 (Pneumococcal 14-valent conjugate vaccine \[diphtheria CRM197 protein\]) in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult older than 19 years old and younger than 50 years old
* A subject who was informed of the purpose, method, and efficacy of the clinical study and signed the written informed consent form

Exclusion Criteria:

* A subject who participated in other clinical studies within 3 months before screening
* A subject who was vaccinated with other vaccines within 4 weeks before screening, or who is expected to receive other vaccination during the clinical study period
* A subject with medical history of hypersensitive reactions (e.g. anaphylaxis) to the test drug or its ingredients
* A subject who received immunoglobulin or blood-derived materials within 3 months before screening
* A subject with immunologic function disorders including congenital or acquired immunodeficiency disorders
* A subject who is receiving immunosuppressive therapy or drugs that can affect immunological reaction
* A subject with pyrexia of over 38 Celsius degrees on the day of the vaccination with the investigational products
* A subject with medical history of Invasive Pneumococcal Disease (IPD) or pneumonia caused by Streptococcus pneumoniae
* A subject who was vaccinated with any pneumococcal vaccine before screening
* A subject who received the vaccine containing diphtheria toxoid within 6 months before screening (e.g. adult Td vaccine)
Internet-based vs Face-to-face Treatment for Alcohol Dependence

A brief treatment program (MI/CBT) via face-to-face or via internet is tested in association with an outpatient addictions clinic.

A 5-module program based on motivational interviewing (MI) and cognitive behavioral therapy (CBT) is tested among help-seekers at one outpatient clinic within the Stockholm Center for Dependency Disorders: Riddargatan 1.The design is a two-armed randomized controlled non-inferiority study, and outcomes are measured in terms of changes in alcohol consumption, problematic alcohol use, alcohol dependence alcohol use disorder, anxiety, as well as depression and quality of life. 600 participants are recruited online from the clinic's website. Consenting participants will complete baseline questionnaires online and participate in face-to-face assessment by a physician at the clinic. Eligible individuals will then be randomized into one of two groups: 1.Internet-based treatment program with online counselor support. 2. Face-to-face treatment with 5 individual counselor sessions at the clinic. Follow-up will be conducted online after 3, 6, 12 and 24 months in both groups.

Eligibility Criteria:
Inclusion Criteria:

* AUDIT-score ≥16 points and/or fulfilling at least 3 criteria of alcohol dependence (ICD-10)

Exclusion Criteria:

* Risk of severe withdrawal symptoms.
* Risk of suicide.
* Other psychiatric diagnosis that requires current treatment.
* Need for medication for alcohol dependence.
* Inadequate Swedish language skills.
* No Internet access
Dietary Nitrate Intake in Vegetarians and Omnivores

Vegetarian diets are commonly associated with lower blood pressure levels. This has been related to greater consumption of inorganic nitrate, since vegetables are the main source of this anion. Dietary nitrate is reduced to nitrite by commensal bacteria in the mouth, which in turn leads to increased circulatory nitrite availability. Nitrite can form nitric oxide by several pathways promoting a reduction in the vascular tone and lower blood pressure.


Eligibility Criteria:
Inclusion Criteria:

* Healthy vegetarians (vegans and ovo-lacto vegetarians) following this dietary pattern for at least a year.
* Health omnivores

Exclusion Criteria:

* Smokers
* Individuals taking any medications or recreational drugs.
* Individuals with pre-existing medical conditions such as hypertension, diabetes, dyslipidaemia or dental conditions (gingivitis).
* Individuals using mouthwash or tongue scrapes were excluded from this study
Heart Rate Variability in White Coat Hypertension and Essential Hypertension

The aim of the study is to investigate heart rate variability in patients with white coat hypertension and patients with essential hypertension.


Eligibility Criteria:
Inclusion Criteria:

* age 30-70 years
* office BP \>150/95 mmHg and 24-h ambulatory BP =/\>135/85 mmHg
* office BP \>150/95 mmHg and 24-h ambulatory BP \<135/85 mmHg
* office BP \<150/95 mmHg and 24-h ambulatory BP \<135/85 mmHg

Exclusion Criteria:

* Clinical signs of disease of the heart, lungs, liver, kidneys, brain or endocrine organs
* neoplastic disease
* daily use of medicine
* alcohol abuse
* abnormal laboratory screening including blood-hemoglobin, blood-white cell count, plasma-creatinine, plasma-alanine-amino-transaminases, plasma-albumin, plasma-sodium, plasma-potassium, urinary glucose, urinary albumin; electrocardiogram
* pregnancy
* unwillingness to participate
Post Extubation Chest Physiotherapy in ICU

The purpose of this study is to examine the efficacy of chest physiotheray treatment in preventing pulmonary complications and weaning faliure, in extubated critically ill patients.


Eligibility Criteria:
Inclusion Criteria:ICU patients, over 18 years' old, mechanical ventilated over 24 hours, candidates for extubation -

Exclusion Criteria: Mental conditions, retardation, dementia, pregnancy, re-intubated patients

-
Impacts of Intraperitoneal Pressure and CO2 Gas on Surgical Peritoneal Environment

Use lay language.

The primary purpose is to compare the impacts of intraperitoneal pressure (8mmHg versus 12 mmHg) and CO2 gas (cool, dry CO2 gas versus warmed, humidified CO2 gas) on gene expression in peritoneal tissues during laparoscopic surgery. We hypothesize that combined use of a low Intraperitoneal pressure (8mmHg) and warmed, humidified CO2 gas during CO2 pneumoperitoneum may be better in minimizing adverse effects on surgical peritoneal environment and improving clinical outcomes compared to the standard intraperitoneal pressure (12mmHg) and standard cool, dry CO2 gas.

Patients undergoing laparoscopic hysterectomy with promontofixation are randomized into four groups: Group 1: 12mmHg intraperitoneal pressure with cool, dry CO2 gas (n=20), Group 2: 12mmHg intraperitoneal pressure with warmed, humidified CO2 gas (n=20), Group 3: 8mmHg intraperitoneal pressure with cool, dry CO2 gas (n=20), Group 4: 8mmHg intraperitoneal pressure with warmed, humidified CO2 gas (n=20).

Normal peritoneum is collected from the parietal wall at the beginning of laparoscopic surgery and at 1 and 2 hours. Expression of genes encoding components of the fibrinolytic system, extracellular matrix and adhesion molecules, and inflammatory cytokine signaling molecules in peritoneal tissues are measured by real-time PCR.

Quality of post-operative recovery by QoR-40, post-operative pain by Visual Analog Scale, per or post operative complications and intraoperative core temperature are assessed and compared.

Eligibility Criteria:
Inclusion Criteria:

* Age 45-75 years old
* Petients undergoing laparoscopic hysterectomy with promontofixation for uterine prolapse
* Menopaused
* ASA class I or II

Exclusion Criteria:

* Absolute contraindications to laparoscopy
* Previous history of pelvic surgery, endometriosis and/or infection
* Pathological peritoneal tissue
* BMI more than 30
* Height less than 150cm
A Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Itacitinib

This is a mutli-center open-label study to provide continued supply of itacitinib to participants from the following Incyte-sponsored studies of itacitinib: INCB39110-209, INCB39110-213, INCB39110-214, INCB39110-230, and 39110-309. Eligible participants will receive treatment with itacitinib as per the treatment dose and schedule they received in the study in which they were originally enrolled. The original study is referred to as the "parent protocol".

Participants who receive itacitinib in this study may continue treatment as long as the regimen is tolerated, the participant is deriving clinical benefit (in the opinion of the investigator), and the participant does not meet discontinuation criteria.


Eligibility Criteria:
Inclusion Criteria:

* Currently enrolled and receiving treatment in an Incyte-sponsored itacitinib (INCB39110)-based clinical study (parent Protocol).
* Currently tolerating treatment as defined by the parent Protocol.
* Currently receiving clinical benefit from itacitinib-based treatment, as determined by the investigator.
* Has demonstrated compliance, as assessed by the investigator, with the parent protocol requirements.
* Willingness and ability to comply with scheduled visits, treatment plans, and any other study procedures indicated in this Protocol.
* Willingness to avoid pregnancy or fathering children..
* Ability to comprehend and willingness to sign an ICF.

Exclusion Criteria:

* Able to access itacitinib therapy commercially.
* Participants with an uncontrolled intercurrent illness or any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the participant or compliance with the Protocol.
* Pregnant or breastfeeding women.
A Study Evaluating Safety And Immunogenicity Of Meningococcal B Rlp2086 Vaccine In Adolescents

The purpose of this study is to evaluate the safety and immunogenicity of an investigational meningococcal B rLP2086 vaccine in adolescents aged 11 to 18 years old.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects between the ages of \>=11 and \<=18 years at the time of enrollment.
* Negative urine pregnancy test for all female subjects.
* Parent/legal guardian or subject under supervision of the parent/legal guardian must be able to complete all relevant study procedures during study participation.

Exclusion Criteria:

* History of any invasive meningococcal disease.
* A previous anaphylactic or severe vaccine-associated adverse reaction.
* Any clinically significant chronic disease.
* A known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids. Topical, inhaled or intra-articular corticosteroids are allowed.
* Participation in another investigational study in the 1-month (30-day) period before study visit 1 and during the conduct of the study.
A Study of Nivolumab Safety and Pharmacokinetics in Patients With Severe Sepsis or Septic Shock.

A study to evaluate the safety, tolerability and pharmacokinetics of Nivolumab in participants with severe sepsis or septic shock.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Men and women ages ≥ 18 years old
* Documented or suspected infection
* Severe sepsis or septic shock for at least 24 hours
* Sepsis-induced immunosuppression
* In Intensive Care Unit (ICU) with no plans to discharge in next 24 hours

Exclusion Criteria:

* Previous episode of severe sepsis or septic shock with ICU admission during the current hospitalization
* Autoimmune disease
* Organ or bone marrow transplant
* Cancer treatment in the past 6 weeks
* Human immunodeficiency virus (HIV) infection and not on therapy prior to this episode of sepsis; hepatitis C virus(HCV) infection and still has virus (not cured); Chronic hepatitis B virus (HBV) infection and not on treatment

Other protocol defined inclusion/exclusion criteria could apply
A Phase 3 Study of NTLA-2001 in ATTRv-PN

This study will be conducted to evaluate the efficacy and safety of a single dose of nexiguran ziclumeran (NTLA-2001) compared to placebo in participants with ATTRv-PN.

This is a multinational, multicenter, double-blind, placebo-controlled study in approximately 50 participants, who will be randomized 1:1 to receive a single infusion of either nexiguran ziclumeran or placebo. To ensure all participants will have the potential to receive nexiguran ziclumeran, participants will have the option to cross over to the opposite study arm at Month 12 or Month 18, depending on study criteria.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ATTRv-PN
* Karnofsky Performance Status (KPS) ≥ 60

Exclusion Criteria:

* Other causes of amyloidosis (amyloidosis caused by non-TTR protein)
* Other known causes of sensorimotor or autonomic neuropathy
* Diabetes mellitus
* New York Heart Association Class III or IV heart failure
* Liver failure
* Hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection
* Prior receipt of a TTR silencer (Small interfering RNA (siRNA) or Antisense oligonucleotides (ASOs))
* Estimated Glomerular Filtration Rate \< 30 mL/min/1.73 m2
* Unable or unwilling to take vitamin A supplementation for the duration of the study