cyrilzakka/clinical-trials huggingface dataset:
Adaptive Cardiac Resynchronization Therapy Optimization at Rest and During Exercise (AdOPT CRT)

The AdOPT Cardiac Resynchronization Therapy (CRT) study is an acute, prospective, multi-center, non-randomized investigational study designed to compare indices of cardiac function at device settings optimized using the investigational Adaptive CRT (aCRT) algorithm versus nominal programming. The comparison will be performed during rest, atrial pacing and sub-maximal exercise. AdOPT CRT is a sub study of the Adaptive CRT Study (NTC00980057) being conducted in Europe.

Adaptive CRT is an implantable heart failure device feature that attempts to optimize CRT without echocardiographic testing.

Eligibility Criteria:
Inclusion Criteria:

* Subject is age 18 or greater
* Subject is willing to sign and date the study Informed Consent form
* Subject has been implanted with a clinically indicated CRT-D device (Medtronic Vision 3D or Protecta models) for at least 1 month but less than 7 months from the date of study enrollment

Exclusion Criteria:

* Subject has a history of persistent or permanent AF for which pharmacological therapy and/or cardioversion have been unsuccessful or have not been attempted.
* Subject has atrial or ventricular tachyarrhythmias or frequent atrial or ventricular ectopy at the time of enrollment.
* Subject's resting heart rate at the time of enrollment exceeds 90 bpm.
* Subject had CRT system implanted for more than 7 months from the date of the study enrollment
* Subject has complete AV block.
* Subject had previous mechanical valve surgeries.
* Subject has congenital heart disease.
* Subject has contraindication for an exercise test.
* Subject is unable to perform a sub-maximal exercise test.
* It is not possible to acquire technically acceptable echocardiographic images.
* Subject has medical conditions that would limit study participation.
* Subject is pregnant (all women of child-bearing potential must undergo a pregnancy test within seven days prior to the study visit).
* Subject is enrolled in the Adaptive CRT study
* Subject is enrolled in concurrent studies which could confound the results of this study.
* Subject meets exclusion criteria required by local law
Biliary Complication Rates in Living Donor Liver Transplantation: a Retrospective Comparative Study of Stent Versus Non-Stent Groups

Despite technological advancements in living donor liver transplantation (LDLT), biliary complications (BC), including biliary anastomotic stricture (BAS) and bile leak (BL), remain unresolved issues that significantly affect patient outcomes. Biliary stenting has emerged as a potential method for reducing BC in LDLT procedures; however, their necessity remains debated. This study aimed to assess the necessity of biliary stenting by retrospectively comparing the bile duct complication rates in LDLT using duct-to-duct anastomosis with or without biliary stenting.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged between 19 and 80 years at the time of liver transplantation.
* Patients who underwent liver transplantation surgery for liver disease performed by the Department of Surgery at Chungnam National University Hospital under the supervision of the principal investigator.
* Patients who signed the informed consent form before study registration (for future participants).

Exclusion Criteria:

* Patients who have not signed the informed consent form or have insufficient understanding of the clinical trial protocol, making it difficult to accurately express their intention to participate.
* Patients deemed unsuitable for participation in this clinical study by the investigator.
Engagement to Care South Africa

This study will evaluate the efficacy of two strategies for enhancing overall preventive behaviors, retention in HIV care, and adherence to medication for HIV positive individuals in South Africa: short message service (SMS) text messaging and peer navigation services.

Treatment-as-prevention represents a game changing potential to stem further HIV transmission by ensuring that infected individuals are tested, linked to care, retained in care, and adherent to their regimens. Little is known, however, about the most feasible and cost-effective means to promote overall engagement in care coupled with behavioral risk reduction for HIV positive individuals in South Africa. For this reason, the study proposes to first assess what engagement in care activities are underway in select clinics in the Bojanala Platinum District, North West Province, South Africa, and will then implement and evaluate the feasibility, acceptability, and potential efficacy of two strategies for enhancing overall preventive behaviors, retention in HIV care and adherence to medication. The first strategy will employ automated text message reminders to encourage patients to return for needed care, adhere to their antiretroviral therapy (ART) regimens, and practice safer sex and other risk reduction behaviors. This approach also includes designation of a retention, adherence, and prevention monitor to supervise the system. A second strategy builds on the first model, including the automated text message system, but also utilizes peer navigator-provider teams to serve as point people for care engagement. Peer navigators will work with providers to introduce patients to care and help them establish a care and prevention plan. They will also check in with patients to discuss and support resolution of challenges to engaging in care, adhering to drug regimens, and reducing transmission risk behavior.

Eligibility Criteria:
Inclusion Criteria:

* HIV positive (diagnosed within the last 12 months prior to study/patient contact)
* Has access to a mobile phone
* Willing to receive and respond to text messages and calls from clinic and study staff (all arms)
* Willing to communicate and meet with PN (PN arm)
* Willing to meet with study staff for survey at study start, 6 months, and 12 months (all arms)
* regard study clinic area as the regular clinic for accessing healthcare

Exclusion Criteria:

* First tested positive over 12 months prior to recruitment
* Under the age of 18
* Unable to give informed consent
* Unable to read basic English and with no one to read study sms to participant
* Principally accesses care through a clinic not in the study
* Planning to permanently move away from the area served by the clinic within next 6 months (following enrollment)
Retinal Nerve Fiber Layer Thickness Changes in Parkinson Disease: A Meta-analysis

Optical coherence tomography (OCT) is a non-invasive retinal imaging technology that can provide high-resolution cross-sectional images of the peripapillary retinal nerve fiber layer (RNFL) and measure its thickness. A reduction of the RNFL thickness has been detected in several neurodegenerative diseases, such as multiple sclerosis, CADASIL and Alzheimer's disease. Different studies have reported RNFL changes also in Parkinson's disease (PD),a common neurodegenerative disease characterized by motor dysfunctions, originally described by James Parkinson in 1817. PD is characterized by selective dopaminergic neuronal cells loss, which may correlate with RNFL thinning. Previous studies on this subject, however, reported contradicting results. Some investigations reported reductions of the RNFL thickness while others did not. In the present study, in order to determine whether RNFL thickness is reduced in PD patients, we performed a meta-analysis and systematically evaluated RNFL thickness measurements with OCT in a series of PD patients and in the healthy control groups.


Eligibility Criteria:
Inclusion Criteria:

1. case-control studies;
2. patients with PD were compared with healthy controls;
3. all subjects underwent RNFL thickness measurement by OCT;
4. studies should provide the data of peripapillary RNFL thickness;
5. sample size ≥10 in each group.

Exclusion Criteria:

1. authors did not make RNFL measurements;
2. study without healthy control group;
3. the outcome values can not be used for meta-analysis;
4. duplicated articles.
Detection of hCG in Early Pregnancy Clinical Samples

To evaluate the detection of hCG in the early pregnancy urine samples by Human chorionic gonadotropin (HCG) test system.


Eligibility Criteria:
Inclusion Criteria:

* Female；
* 18-55 years of age；
* In a state of preparing for pregnancy;
* Voluntary and sign informed consent form.

Exclusion Criteria:

* Within 8 weeks of childbirth or abortion；
* The investigator has reason to believe that it is inappropriate for subjects to participate in the study.
A Study of VAH631 in Patients With Essential Hypertension (Factorial Study)

The purpose of this study is to compare the effect of the fixed combination of valsartan+hydrochlorothiazide (HCTZ) on blood pressure reduction with valsartan and HCTZ alone and whether the combination treatments are safe and well tolerated. The study aims to establish a dose response relationship for both monotherapies and the combinations.

This study is being conducted in Japan.


Eligibility Criteria:
Inclusion Criteria:

* Essential hypertension measured by mercury sphygmomanometer
* Outpatients

Exclusion Criteria:

* Secondary hypertension or suspected of having secondary hypertension.
* A history of malignant hypertension
* Severe hypertension
* Significant heart, renal, hepatic diseases or significant cerebrovascular disorder
* Gout Other protocol-defined inclusion/exclusion criteria may apply
Study to Determine Racial and Gender Differences in Platelet Aggregation

The purpose of this study is to see if there is a racial and/or gender difference in platelet aggregation.

Genetic variability of various components of the coagulation system has been reported. Data on racial and gender differences in platelet aggregation are lacking.

We hypothesize that there are significant racial and gender differences on aggregatory response of platelets to commonly used agonists to evaluate platelet function such as adenosine diphosphate (ADP), epinephrine, collagen and arachidonic acid.

Eligibility Criteria:
Inclusion Criteria:

* Race of Caucasian, African American, or Hispanic

Exclusion Criteria:

* Chronic medical conditions
* Tobacco use
* Regular non-steroidal anti-inflammatory use, aspirin use, or use of one of the other anti-platelet drugs.
Intravascular Access of COVID-19 Patient Under Personal Protective Equipment

The current COVID-19 pandemic, this is especially since the transmission of SARS-CoV-2 is thought to occur mainly through respiratory droplets generated by coughing and sneezing, by direct contact with contaminated surfaces and because in a large number of patients COVID-19 disease may be asymptomatic. As recommended by the CDC medical personnel should be equipped with full personal protective equipment (PPE) for AGP in contact with suspected/confirmed COVID-19 patient. Therefore, it is reasonable to search for the most effective methods of intravascular access in those conditions.


Eligibility Criteria:
Inclusion Criteria:

* paramedic
* consent voluntary participation in the study
* none experience in resuscitation with personal protective equipment

Exclusion Criteria:

* refusal to participate in the study
Treatment for Reading and Writing Deficits Following Acquired Brain Injury

Many people with acquired brain injuries have deficits in reading decoding, reading comprehension, and written expression. Alexia is a phenomenon in which a person who previously could read has trouble doing so after having sustained a brain injury; likewise, agraphia is an acquired writing problem affecting one or more aspects of written communication. Alexia and agraphia sometimes co-occur with one another and/or with other language challenges, but they can also occur as isolated phenomena. Methods to treat alexia and agraphia often focus on single intervention techniques that address aspects of reading or writing in isolation-such as matching written and spoken letters or letter sounds, performing choral reading, tracing letters, etc. Existing research suggests that the effectiveness of these techniques is limited. However, when used in combination, such techniques may promote improved reading and written communication skills. As such, the purpose of this research is to determine the extent to which a multicomponent intervention program improves the reading and writing capabilities of people with acquired alexia and/or agraphia.


Eligibility Criteria:
Inclusion Criteria:

* Survivor of acquired brain injury
* Exhibits alexia and/or agraphia
* Past or current client of Quality Living, Inc., Omaha, Nebraska
* Fluent speaker of English

Exclusion Criteria:

* Vision impairment prohibiting reading of 24-point text
* Auditory comprehension problems precluding understanding of consent/assent information
tFUS Induced Transient Scotoma for Individual Dosing

The purposes of this research study is to:

1. Develop a technique of transcranial Focused Ultrasound Stimulation (tFUS) where meaningful effects on the brain can be easily measured.
2. Use this technique to measure threshold for effective tFUS in individuals.
3. Determine whether disruption of conscious visual detection, versus non-conscious visually-guided behavior have different thresholds for disruption with tFUS.

Transcranial focused ultrasound (tFUS) is a new noninvasive way to stimulate the brain in an awake and alert person. Investigators do not yet have an easily observable way to know whether they are in the right brain location with the correct dose for that person. Investigators wonder if they can produce a transient change in someone's visual field, called a scotoma, and whether they can use that to determine the minimum tFUS dose for that person.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Age 18-70
* Normal or corrected-to normal vision and hearing
* No neurological or psychological illness

Exclusion Criteria:

* Diagnosis of any depressive or anxiety disorder
* Diagnosis of schizophrenia or bipolar disorder
* Current use of any non-prescribed psychoactive medications or drugs
* Contraindication to enter the MRI environment.
* Pregnancy (or suspected/possible pregnancy or plan to become pregnant in the short term).
* Urine Pregnancy Test: If the subject is a woman of childbearing potential and /or a man capable of fathering a child before, during, and/or after participation precaution should be taken. Examples of acceptable methods of birth control for participants involved in the study include: birth control pills, patch, IUD, condom, sponge, diaphragm with spermicide, or avoiding sexual activity that could cause the subject to become pregnant.
* Inability to adhere to treatment schedule.
* Initiation of new antidepressant treatment at the time of study randomization.

NOTE: There will be no exclusion based upon gender or minority status. We anticipate that at least 50% of the participants will be women. The percentage of minority participants is expected to be at least 5%. We will make vigorous attempts to increase this number by posting advertisement flyers in minority communities.

Children, prisoners, and institutionalized individuals will not be recruited, because they are beyond the scope of the objectives. Moreover, we will emphasize that participation in this study is completely voluntary. Recruitment of women and minorities has been addressed above. Non-English speaking subjects will not be recruited because they may not be able to understand instructions, which could undermine the validity of the results.
4D FDG PET in Esophageal Cancer

FDG PET-CT image acquisition in the abdominal and thoracic region is influenced by organ motion. Respiratory movement blurs the metabolic signal of the esophageal tumor and lymph nodes. The investigators hypothesize that the metabolic signal obtained with motion compensation results in higher SUV-max values and clearer demarcation of the esophageal tumor and lymph nodes.

Patients will receive a normal 3D FDG PET-CT scan. By participating in this trial, one extra 4D CT scan will be made. For both the PET and the 4D CT acquisition, the patient gets an abdominal belt around the waist to register breathing motion. No extra FDG PET scan is required for this study. The 4D CT scan is the only intervention which increases the radiation dose exposure compared to the standard PET-CT scan. However, in comparison to the expected radiation dose delivered, if a patient will be treated with curative chemoradiotherapy, this increase in radiation dose is negligible and secondary risks due to this intervention are therefore not increased. For patients who are not eligible for curative treatment the extra dose is also not relevant, given the life expectancy of this group.

Eligibility Criteria:
Inclusion Criteria:

* Patients with pathology proven esophageal cancer or tumor highly suspicious for esophageal cancer
* \> 18 years
* Written informed consent

Exclusion Criteria:

* \<18 years
* Possibility of pregnancy
Effect of Combination Therapy on SCLC After Initial Treatment Failure

SCLC patients after initial treatment failure are treated with SBRT and low-dose radiotherapy concurrent with PARP inhibitors + temozolomide +PD-1/PD-L1 inhibitors for two cycles at least, then PARP inhibitors+temozolomide+PD-1/PD-L1 inhibitors two cycles, PD-1/PD-L1 inhibitors maintenance therapy lasted for up to 2 years.

SCLC is easy to relapse and drug resistance soon after initial treatment , although radiotherapy and chemotherapy is sensitive at first treatment. Topotecan monotherapy is recommended in the NCCN guidelines for second-line standard treatment and the CSCO SCLC guidelines for diagnosis and treatment 2020 edition, but its effective rate is low, 24% for platinum-sensitive relapse, 2-6% for platinum-resistant, overall PFS is about 3-4 months and OS is about 6-8 months. Although immunotherapy have been successful at the first-line and third-line treatments of SCLC in the extensive stage , the second-line treatment has not achieved a breakthrough, and the effective rate of third-line immune single drug is between 10-20%.It is an important challenge and breakthrough to effectively improve the efficacy and survival of second-line treatment of SCLC. Immunocombination therapy is an important strategy to improve the efficacy. Some studies have shown that PARP inhibitors and low-dose radiotherapy can improve the efficacy of immunotherapy. PARP inhibitors are not only sensitizers of chemoradiotherapy, but also immunomodulators. High dose radiotherapy has the effect of in situ vaccine and increases tumor antigen release presentation. Low dose radiotherapy promotes the penetration of immune cells into tumor stroma and tumor bed and increases immune response. The combination of high and low dose radiotherapy and immunization can improve the immune effect and increase the incidence of distant effect. So the objective of this study is to observe the efficacy and safety of second-line treatment of SCLC with SBRT and low-dose radiotherapy combined with PARP inhibitor + temozolomide and PD-1 /PD-L1 inhibitor.

Eligibility Criteria:
Inclusion Criteria:

Age ≥18 years old, ≤80 years old, expected survival ≥3 months;Pathologically confirmed SCLC with recurrence and metastasis after initial treatment;KPS score ≥70 points;Satisfied the following laboratory diagnostic indicators: hemoglobin ≥110g/L, leukocyte 4.0-10.0×109/L, neutrophils 2.0-7.5×109/L, platelet ≥100×109/L;Creatinine ≤ upper normal limit (UNL);ALT and AST≤2.5×UNL, alkaline phosphatase (ALP) ≤5×UNL, total bilirubin (TBIL) ≤ UNL;Signed informed consent.

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Exclusion Criteria:

1. Pregnant or lactating women;
2. Secondary tumor;
3. HIV carriers;
4. Serious medical diseases such as heart and lung;
5. Patients with uncontrollable mental history, unable to cooperate with treatment;
6. Autoimmune system disease, symptomatic interstitial lung disease;
7. Patients with active infection, chronic infection, acute infection, etc., and body inflammation;
8. Patients who had used hormones or antibiotics 1 month prior to treatment. -
Tissue Study of Bv8/PK-2 Inhibition in Human Cancer

Study hypothesis is that inhibition of Bv8 production in bone marrow cells of a mice wil reduce the rate of growth of a primary human tumor implanted in the mice. we will take mice and transform their bone marrow cells into non-Bv8 producing cells. than we will implant primary human tumor tissue (taken from surgical specimens after informed consent)in those mice and follow-up on the mice.

1-10 grams of human cancer tissue will be taken from surgical specimen without interference to the pathological data gathering process. those tissues will be implanted in nude mice that will either be treated with anti-Bv8 antibodies or will be transplanted with bone marrow in which Bv8 expression is silenced.

Eligibility Criteria:
Inclusion Criteria:

* ages 18-85 years
* Pathologically-confirmed diagnosis of pancreatic ductal adenocarcinoma undergoing surgical pancreaticoduodenectomy

Exclusion Criteria:

* refuse to take part
* preoperative chemotherapy
Rapid Evaluation of Pandemic H1N1 Influenza Vaccine in Aboriginal Children and Adults

The purpose of this study is to assess the safety and effectiveness (immune response) to a licensed H1N12009 influenza vaccine in aboriginal children and adults. The study will enroll 200 healthy adults (ages 20-59 years) and 75 healthy children (ages 6-35 months). Adults will receive one dose of a licensed H1N1 vaccine and children will receive two doses of a licensed H1N1 vaccine approximately 3 weeks apart. Study procedures include: medical history, blood samples and completing a memory aid. Participants will be involved in study related procedures for approximately 3 weeks (adults) or 6 weeks (children).

During the first wave of the H1N12009 pandemic in Canada, persons of aboriginal background were more often hospitalized with severe infections than were other Canadians. Among First Nations members the hospitalization rate was 5 times higher than the national average. Common risk factors were young age (children and younger adults) and underlying health conditions. A high proportion of aboriginal adults have health conditions that predispose to adverse influenza outcomes, including diabetes, asthma, obesity and smoking-related lung diseases.

Aboriginals could benefit substantially from timely, effective vaccination against pandemic influenza and are expected to be among the first Canadians to be offered vaccine when available. The vaccine dosing recommendation will be based on limited studies in the general population, leaving open the question of whether aboriginals will respond satisfactorily to the recommended dosing. Unique social and biological factors among aboriginals could affect their responses to vaccination, reducing protection or increasing adverse effects. Thus it would be optimal to evaluate the safety and immunogenicity of the pandemic vaccine among the earliest aboriginal recipients, to inform the subsequent vaccination of other aboriginal groups.

The objectives of this study are two-fold:

1. To evaluate the safety and immunogenicity of H1N12009 influenza vaccine in a convenience sample of children and adults of aboriginal background (First Nations, Metis and Inuit) with emphasis on subgroups at greatest risk of severe disease.
2. To complete this evaluation soon after the pandemic vaccines become available so as to inform the subsequent use of the vaccines in the aboriginal population.

Eligibility Criteria:
Inclusion Criteria:

* Good general health
* Written informed consent provided by or for the subject
* Aboriginal ethnicity (First Nations, Metis or Inuit)
* Adults 20-59 years of age
* Children 6-35 months of age

Exclusion Criteria:

* Allergies to eggs, thimerosal or gentamicin sulphate
* Life-threatening reaction to previous Flu vaccine
* Bleeding disorder
* Pregnancy
* Receipt of blood or blood products in past 3 months
* Compromised immune system
* Chronic illness
* Previous lab-confirmed H1N1/2009 infection