cyrilzakka/clinical-trials huggingface dataset:
Development of Scalable New Model(s) Focused on Care Co-ordination and Care Provision for Medically Complex, Co-morbid Chronic Disease Patient Segments Focusing on Heart Failure

The goal is to define a set of clinical pathways for heart failure patients, reflecting the period from prior to admission to the post-discharge period following hospitalisation, under the current system that exists at the two clinical sites \[as mentioned previously, the main site is at St Vincent's University Hospital in Dublin, but to ensure generalizability the project team will also carry out similar work Portsmouth Hospital, United Kingdom\]. These pathways have been drawn up using the experience of the clinical investigators, using an interactive workshop approach and a pilot study.

1. Pre-Admission Pathway
2. Emergency Department Pathway
3. In-Hospital management Pathway
4. Pre-discharge Pathway
5. Post-Discharge Pathway

During identification of these pathways, the research team identified the settings/personnel that require study to more fully comprehend the methods, strengths and weaknesses of the present processes. Study activities are focused on two aspects of the patient journey, immediately before discharge and three months post discharge during the outpatient phase.

Heart failure is a significant public health issue with a prevalence of over 2%, and is among the leading causes of hospital admission worldwide, particularly in those over-65 years. Patients with heart failure frequently require acute hospitalisation and are at increased risk of mortality (more than half of heart failure patients will die within five years of initial diagnosis, American Heart Association). The high hospital admission rate and readmission reduce quality of life and significantly drive up the costs of health care provision for these patients. Moreover, there is a high variability in the reported readmission rates across institutions and countries, indicating that the structure of health care delivery is variable and of significant importance to outcome in this population. This study sets out to investigate the most clinically effective and cost- efficient method of delivering care to patients with heart failure focusing on the phase immediately before hospital admission, the hospital stay and the immediate discharge period, through analysis of the current standards of practice in both Ireland and the United Kingdom.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years and above.
* With or without an established community diagnosis of heart failure.
* Admitted to the hospital through the Emergency Department or directly to the cardiology wards, for management of a primary problem/complaint of Acute Decompensated Heart Failure.
* Able and willing to provide written, informed consent.

Exclusion Criteria:

* Patients who present with primary non-heart failure presentation who may/may not have a secondary problem with heart failure, or stable heart failure not contributing to the present illness will be excluded.
* Also excluded will be those who cannot provide informed consent.
The Activation of Hippo Pathway in Nasal Polyps

Hippo-YAP pathway is a newly discovered pathway controlling the growth, and plays important roles in the regulation of stem cell function and tissue regeneration. Previously we found that a higher expression of YAP in NP, and LPS was able to activate the hippo-YAP pathway in NESCs. Thus, we hypothesize that the aberrant proliferation and differentiation of NESCs could be regulated via the hippo-YAP pathway.

Studies have shown that the development of nasal polyps (NP) are closely related to the epithelial remodeling.The investigators have shown that nasal epithelial stem cells(NESCs) derived from NP had reduced growth and proliferation dynamics in vitro culture,and differentiated into ciliated cells with impaired cilia architecture and ciliogenesis.Further studies demonstrated that NESCs were involved in the aberrant damage repair process of the epithelial remodeling in NP.Hippo-YAP pathway is a newly discovered pathway controlling the growth,and plays important roles in the regulation of stem cell function and tissue regeneration.Previously the investigators found that a higher expression of YAP in NP,and LPS was able to activate the hippo-YAP pathway in NESCs.Thus,the investigators hypothesize that the aberrant proliferation and differentiation of NESCs could be regulated via the hippo-YAP pathway,which may result in the epithelial remodeling.In this study,the investigators intend to investigate the mechanism of the hippo-YAP pathway in regulating aberrant proliferation and differentiation of NESCs and explore its upstream signaling and downstream target genes,using the NESCs gas-liquid interface culture system,and a silencing and overexpression of the hippo-YAP pathway component strategy.The investigators aim to unravel the effect and mechanism of the hippo-YAP pathway in the epithelial remodeling of NP,providing new targets and strategy for the improvement or reversal of NP epithelial remodeling.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of nasal polyps or deviation of nasal septum based on CT
* Must be able to withstand surgery
* At least 18 years old
* A sufficient level of education to understand study procedures and be able to communicate with site personnel and adhere to the follow-up;
* Accepted informed consent verbally and in writing

Exclusion Criteria:

* The Poor Health
* Be allergic to anesthetics
The Effect of Gender on Antidiuresis - Evaluated by Graded Low Dose Desmopressin Infusion

There is substantial evidence that women throughout life have significantly lower plasma levels of the antidiuretic hormone vasopressin (pAVP) compared to men. The importance of this is not yet fully elucidated, but in relation to the observations of lower pAVP levels, no significant difference in renal response parameters was found. This could be interpreted an increased renal sensitivity in females compared to males. The theory of increased renal sensitivity in females is supported by a few pharmacodynamic studies currently available on this topic. However none of the studies was designed with the purpose of investigate the gender difference.

The aim of this study is to investigate possible gender differences in the renal sensitivity to dDAVP and the effect of age on these differences. This will be done by low dose graded infusion of the synthetic AVP analog dDAVP.

Participants are 80 healthy volunteers equally distributed between four age groups, 8-10 years of age, 16-18 years of age, 25-40 years og age and 65+ years of age.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Normal clinical examination
* Normal residual urine measurements
* Normal urine dip stick
* Informed consent by participant or legal guardian

Exclusion Criteria:

* Smoking, alcohol or drug abuse
* Conditions of importance to the results (endocrinological, renal or cardial)
* Current or previous history of incontinence, bedwetting or nocturia
* Drug use of importance (diuretics, hormone replacement therapy, birth control pills, desmopressin)
* Pregnancy
* Allergy towards dDAVP/desmopressin
A Drug Interaction Study of the Effects of PPI-668 on the Pharmacokinetics of Midazolam and Omeprazole

The primary objectives of the study are to:

* Evaluate the potential effects of PPI-668 at steady state on the pharmacokinetic (PK) profile of midazolam following a single oral dose in human subjects.
* Evaluate the potential effects of PPI-668 at steady state on the PK profile of omeprazole following a single oral dose in human subject


Eligibility Criteria:
Inclusion Criteria:

1. Subject or legally authorized representative signs an Institutional Review Board (IRB)-approved written informed consent and privacy language as per national regulations (e.g., Health Insurance Portability and Accountability Act \[HIPAA\] authorization for sites in the United States) before any study-related procedures (including withdrawal of prohibited medication, if applicable) are performed
2. Age 18 to 50 years
3. Body mass index (BMI) 18-32 kg/m2
4. Clinical and laboratory findings consistent with good health in the opinion of the investigator
5. Women of non-childbearing potential or men who agree to utilize adequate contraception throughout the study

   1. Women of non-childbearing potential must be one of the following:

      * Postmenopausal (\>2 years amenorrhea and postmenopausal status confirmed by follicle-stimulating hormone levels)
      * Surgically sterile (documentation of prior tubal ligation, hysterectomy, or oophorectomy is required)
   2. Male subjects who are not surgically sterile must agree to use one of the following birth control methods if sexually active:

      * Double-barrier contraceptive (e.g., condom plus diaphragm, condom or diaphragm with spermicidal gel/foam)
      * Female partner is at least two years postmenopausal or surgically sterile

Exclusion Criteria:

1. Positive results on any of the following tests at Screening or Day -1:

   urine pregnancy (women only), urine drugs of abuse and alcohol, hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus antibody
2. Concurrent clinically significant medical diagnosis that would potentially interfere with the subject's study compliance or confound the study results
3. Concurrent social conditions (e.g., drug or alcohol abuse, transportation difficulties) that would potentially interfere with the subject's study compliance
4. Clinically significant illness within 30 days preceding entry into the study
5. Participation in an investigational drug study within 30 days or 5 half-lives, whichever is longer, before Screening
6. Use of prescription medications within 14 days before Day 1 and throughout the study. (The use of non-prescription or over-the-counter medications is prohibited within 7 days before Day 1 and throughout the study. This includes all herbal supplements or remedies and vitamins.)
Clinicial Trial to Evaluate the Efficacy and Safety of DWJ211 in Patient With Moderate or Severe Submental Fat

evaluate the efficacy and safety of DWJ211 in patient with moderate or severe submental fat

DWJ211

_ reduction of moderate or severe submental fat

Eligibility Criteria:
Inclusion Criteria:

1. submental fat grade by the investigator as 2 or 3 using the PA-SMFRS and graded by the subject as 2 or 3 using the SA-SMFRS as determined on Visit 1.
2. Dissatisfaction with the submental area expressed by the subject as a rating of 1\~3 using the SSS as determinded on Visit 1.
3. less than 35kg/m2 in body mass index on Visit1.
4. subject who will agree with the no treatment for the procedure that may affect to reduction or the submental fat.
5. subject who will agree with maintaining their body weight.

Exclusion Criteria:

1. History of any intervention to treat SMF
2. History of trauma associated with the chin or neck areas that in the judgement of the investigator may affect evaluation of safety or efficacy of treatment.
3. Evidence of any cause of enlargement in the submental area.
4. history or current symptoms of dysphagia.
5. a result on coagulation tests that indicates the presence of any clinically significant bleeding disorder.
Usability Study of a Smoking Cessation Intervention During a Dental Cleaning

The goal of this usability study is to pilot test the recruitment procedures, data acquisition methods, and text message program integration required to support the planning of a future clinical trial. Approximately 15 smokers who are patients of the Boston University Goldman School of Dental Medicine (BUGSDM) patient treatment center and have an upcoming dental prophylaxis or scaling and root planing (henceforth referred to as 'teeth cleaning') appointment will be recruited. During the dental cleaning, participants will watch a brief educational video that provides guidance and advice on smoking cessation.

At the end of the dental appointment, participants will complete a survey about their experience watching the video and their attitudes towards smoking cessation. Participants will also receive other smoking cessation resources with instructions on how to access the services. Participants will then use the one-month text message program developed by the investigators to motivate and facilitate contact with the smoking cessation resources.

At the end of the one-month text message program, participants will complete a survey about their experience during the text message program, their smoking habits, and attitudes towards smoking cessation. The duration of the study will be approximately six-weeks.


Eligibility Criteria:
Inclusion Criteria:

* Must be a patient of the Boston University, Henry M Goldman School of Dental Medicine patient treatment center
* Must have smoked 100 cigarettes or more (not e-cigarettes or vaping) in lifetime
* Must have smoked cigarettes (not e-cigarettes or vaping) 'most days' or 'every day' in the past week
* Must read and write fluently in English
* Must be willing to watch a video during the dental hygiene appointment
* Must have the visual capacity to watch a video
* Ability to wear in-ear headphones
* Must have a mobile phone capable of receiving and sending text messages (SMS)
* live in Greater Boston area for the next two months
* Have a cell phone carrier that can receive text message from our system

Exclusion Criteria:

-Planning to move out of the Greater Boston area within the next two months
Simo Decoction and Acupuncture on POI in Colorectal Cancer

Colorectal cancer resection is one of the most common types of abdominal surgery. Though most patients undergoing colorectal resection show recovery of bowel movements within a week, some have prolonged intestinal paralysis or postoperative ileus, resulting in decreasing patient comfort, increasing morbidity and mortality, a longer hospital stay and subsequent increased healthcare costs.

Prevention the incidence of postoperative ileus (POI) is quite important because of the negative clinical outcomes it causes. In the past two decades, many treatments and care approaches, such as fluid restriction, early enteral nutrition, and nonsteroidal anti-inflammatory drug are used for the management of POI. In theory of traditional Chinese medicine, oral simo decoction (SMD) or acupuncture at the tsusanli acupoint can boost gastrointestinal hypomotility. The efficacy of accelerating the return of gastrointestinal function by such single method or combination of them has been validated in randomized controlled trials and systematic review following several types of surgery. In recent years, chewing gum, a new and simple modality, has become a commonly applied method in order to prevent and reduce the POI. Systematic reviews and meta-analyses revealed that chewing gum provided significant benefits for the improvement of postoperative bowel function. More importantly, many official guidelines recommend chewing gum for an evidence-based approach in the prevention of POI. Despite these positive evidence, three newest randomized controlled trials are unable to demonstrate an effect of chewing gum on the recovery of bowel function after colorectal resection.

It is important to note that almost all previous randomized controlled trials are based on small sample size. This raises the question whether postoperative SMD, acupuncture at the tsusanli acupoint, or chewing gum can reduce risk of POI following colorectal resection among patients with large sample size. To examine this question, we conducted this randomized controlled trial to compare incidence of POI and length of hospital stay in colorectal cancer patients who received SMD and acupuncture, chewing gum or no intervention following resection.

Eligibility Criteria:
Inclusion Criteria:

* Underwent open or laparoscopic colorectal cancer resection
* Diagnosis of colorectal cancer was confirmed by histopathological examination of surgical samples in all patients

Exclusion Criteria:

* Previously underwent exploratory laparotomy
* Known Central Nervous System tumors including metastatic brain disease
* History of organ allograft
* Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
* Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
* Pregnant or breast-feeding patients
Implementing Fragmentomics Into Real World Screening IntervenTions to Evaluate Clinical Utility Among Individuals With Elevated Risk for Lung Cancer

The purpose of this study is to determine whether availability of DNA Evaluation of Fragments for Early Interception (DELFI) Lung Cancer Screening Test, FirstLook™ to practicing physicians affects overall lung cancer screening rates among their patients who are recommended and eligible for screening based on 2021 United States Preventive Services Task Force (USPSTF) but are not up to date with it. DELFI hypothesized that patients in the care of physicians or practice groups who have FirstLook™ will have increased lung screening rates compared to patients in the care of physicians or practice groups who do not have access to FirstLook™.

Despite compelling evidence of the benefits of lung cancer screening, rates among eligible individuals in the United States remain stubbornly low. Using a cluster randomized controlled trial, DELFI plans to evaluate whether lung screening rates can be increased if physicians and practice groups have the ability to order a validated, commercially available FirstLook™ as an initial test for eligible individuals who are not up to date with lung screening recommendations.

Eligibility Criteria:
Inclusion Criteria:

1. Practice offers primary care services. Primary care services may include, but are not limited to: community health centers, academic outpatient facilities, private practices of family or general internal medicine, and Veterans Administration outpatient primary care clinics.
2. Practice has a lung cancer screening population of a minimum of 50 individuals. a. Lung cancer screening eligible population is defined as meeting the 2021 USPSTF guideline recommendations (current and former smokers 50-80 years of age, 20 pack-year or more smoking history, have not quit more than 15 years ago) b. Individuals have had a clinic visit in the past 12 months, and c. Individuals have not had a CT for lung cancer screening in the last 15 months.
3. Practice can complete EMR data extraction and EDC entry during the study.
4. Practice scores a 4 (agree) or 5 (strongly agree) on a 5-point Likert scale for physical and payer benefit access to LDCT.
5. Practice can identify a central phlebotomy site.

Exclusion Criteria:

1. Practice is currently participating or has previously participated in other DELFI studies.
2. Practice is participating in any other cancer screening blood-based biomarker studies which includes return of results.
CAndesartan vs LIsinopril Effects on the BRain

The aim of this study is to conduct a 1-year double blind randomized control trial comparing candesartan to lisinopril in 140 individuals with hypertension and executive mild cognitive impairment in their effects on executive function, neuroimaging markers, and vascular indicators.

* Hypertension is associated with cognitive impairment even in the absence of clinical dementia. To date, no specific treatment is available for this pattern of mild cognitive impairment related to hypertension.
* Objectives or purpose: The aims of this study are to investigate the effects of candesartan on executive function decline and on changes in cerebral perfusion, cerebrovascular reserve and microvascular brain injury. The study also intends to identify potential underlying mechanisms related to vascular structure and function, including atherosclerosis, vascular inflammation, vascular stiffness, and endothelial progenitor cells, by which candesartan may affect the cognitive and cerebrovascular outcomes.
* Study methodology:This is a double blind randomized clinical trial that will be conducted in 140 individuals (70 in the candesartan group, 70 in the lisinopril group). Our target population is subjects: 55 years or older with hypertension and Executive Mild Cognitive Impairment.
* Endpoints to be measured:Our measures include cognitive function, cerebral perfusion and reserve, markers of vascular brain damage, atherosclerosis, stiffness, vascular inflammation and endothelial function.
* Description of intervention, follow-up, and duration of study: Eligible participants will undergo randomization into 2 groups and will be seen frequently until their blood pressure is controlled (\<140/90 mmHg). Participants will be seen at 3, 6 and 12 months afterwards.

Eligibility Criteria:
Inclusion Criteria:

1. age: 55 years or older;
2. Hypertension: SBP≥140 mm Hg or DBP≥ 90 mm or receiving antihypertensive medications.
3. Executive MCI will be defined using these criteria:

   1. The Montreal Cognitive Assessment (MoCA) score less than or equal to 26
   2. Executive dysfunction: A performance at the 10th percentile or below on at least one of four screening tests for executive function: Trail Making Test, Part B (TMT-B), modified Stroop interference, Digit Span and Digit Sequencing, and Letter fluency.
   3. Minimal Functional limitation as reflected by the Functional Assessment Questionnaire (FAQ)≤7

Exclusion Criteria:

1. Intolerance to study drugs;
2. SBP \>200 or DBP \>110 mm Hg;
3. Renal disease or hyperkalemia
4. Active medical or psychiatric problems
5. Uncontrolled congestive heart failure;
6. History of stroke in the past 3 years;
7. Inability to perform the study procedures
8. Women of childbearing potential
9. diagnosis of dementia
10. In those who lack decision capacity, a study surrogate who can sign on their behalf will be required. Since we are enrolling only those with MCI, we anticipate that most participants will have decision capacity
11. Current use of Lithium, as most antihypertensive classes may lead to increased lithium toxic levels.
Comparison of Double Pad Fiber Optic Device Versus Conventional Phototherapy

A randomized study of phototherapy for neonatal hyperbilirubinemia. The intervention group is treated with a double pad fiber optic device and the control group with conventional blue ligt phototherapy from above. Both treatments are well known and used. The primary outcome is to explore the parents experience with the two different treatment modalities by questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Neonatal icterus and total serum bilirubin above threshold for phototherapy.
* Gestational age ≥ 33 weeks
* Birth weight ≥ 1800 gr
* Postnatal age \> 24 hours and \< 2 weeks

Exclusion Criteria:

* Hemolysis due to isoimmunization
* Very high or rapidly rising total serum bilirubin