cyrilzakka/clinical-trials huggingface dataset:
Improvement in Medication Adherence Through the Implementation of Personalized Nudges: the ENCOURAGE Trial

This study will determine whether a complex, data-driven protocol for assessing patient needs and providing "nudges" (reminders to be adherent with medication prescriptions) improves adherence with cardiovascular medications. This will be accomplished by performing a 12-month clinical trial of patients with an indication for statin therapy. Participants will be randomized to either an intervention or standard-of-care arm and will be followed via passive electronic means to determine if they are adherent with medication prescriptions.


Eligibility Criteria:
Inclusion Criteria:

* Indication for statin therapy (regardless of statin use history), either: 1) the presence of coronary artery disease (CAD) (either a new diagnosis or prior diagnosis), 2) low-density lipoprotein cholesterol (LDL-C) ≥190 mg/dL, 3) the presence of diabetes and LDL-C of 70-189 mg/dL in patients aged 40- 75 years, or 4) CAD-free and diabetes-free patients aged 40-75 years who have LDL-C 70-189 mg/dL and an estimated 10-year risk of CAD ≥7.5% based on the Pooled Cohort Risk Equations (http://my.americanheart.org/professional/StatementsGuidelines/Prevention Guidelines/Prevention-Guidelines_UCM_457698_SubHomePage.jsp)
* Enrollment in a SelectHealth insurance plan
* Age ≥18 years
* Planned discharge to home

Exclusion Criteria:

* Age \<18 years
* Alzheimers/Dementia
* Receipt of or expected receipt of palliative care or discharge to hospice, skilled nursing facility, inpatient rehabilitation, or long-term care facility
* Any contraindication to statin agents
Green Tea and Ultraviolet Light-induced Skin Damage

The purpose of this study is to investigate whether topically applied constituents of green tea \[caffeine or (-)-epigallocatechin gallate; EGCG\] have a protective effect on skin exposed to ultraviolet light (UV).

The purpose of this study is to investigate if topically applied constituents of green tea \[caffeine or (-) - epigallocatechin gallate; EGCG\] have a protective effect on skin exposed to ultraviolet light (UV). In the double-blinded study all subjects will receive 311 nanometer UVB light at a dose that is 0.5-1.5X their individual minimal erythema dose (MED). One part of the experiment will involve applying a topical natural product (caffeine or EGCG) and placebo to bilateral symmetric sites. The natural product and the placebo will be applied immediately after and at 1/2 hour, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 24 hours, 25 hours, and 27 hours after exposure to a 0.5-1.5 MED dose of UV light. Another part of the study involves performing skin biopsies. One will be done prior to UVB exposure, 2 will be done at 24 hours and 2 more will be done at 48 hours.

Eligibility Criteria:
Inclusion Criteria:

* The subjects will be normal adult volunteers who are 18 to 65 years of age.

Exclusion Criteria:

* Subjects who drink more than two cups of coffee, tea, or caffeinated soda/beverages per day.
* Subjects who are unable to get an erythemic response (i.e., a sunburn).
Microcirculatory Perfusion in Patients With Coma After Out-of-hospital Cardiac Arrest

The hypothesis is: In patients after an out of hospital cardiac arrest, treated with therapeutic hypothermia (33°C) will be found significantly more microcirculatory abnormalities, compared to the same group of patients treated with 36°C.

The purpose of this study is to investigate the (sublingual) microcirculation in patients after an out of hospital cardiac arrest (OHCA). The microcirculation is measured in this study by Sublingual Side Stream Darkfield (SDF) Imaging and Near InfraRed Spectroscopy (NIRS) at admission and after 12 and 24 hours.

Eligibility Criteria:
Inclusion Criteria:

* out-of-hospital cardiac arrest
* \> 18 years
* informed consent
* ROSC (return of spontaneous circulation) \< 4 hours

Exclusion Criteria:

* recent maxillofacial surgery
* participation in other clinical trials
The Effect of Vitamin A Supplementation on Cytokine Profile in Obesity

In this double blind placebo controlled trial,cytokine secretion of CD4+ T-cells after 4 month supplementation of vitamin A will be compared with placebo intaking group.

Obesity is a chronic disease consisting of the increase in body fat stores. Obesity is an important health concern because of its well known relationships with metabolic and endocrine disorders such as cardiovascular disease, type 2 diabetes, hypertension and immune dysfunction. Low-grade systemic inflammation, confirmed by the increase of inflammatory markers such as C-reactive protein and interleukin-6 has been observed in obesity. CD4+ T-helpers are the most important regulators of immune system. Epidemiological evidence has linked obesity to several (but not all) autoimmune disorders, including inflammatory bowel disease (IBD) and psoriasis .Some sublineages of T- helpers plays core roles in immune dysfunction, and recent evidence demonstrates that an imbalance of T-cell subgroups including Th1, Th2, Th17 and Treg has occurred in obesity. This imbalance is the redirection of the immune response from most often Th2 and Treg like responses to Th1 and Th17 like responses respectively, however the opposite is desired. Vitamin A (VA) or VA-like analogs known as retinoids, are potent hormonal modifiers of type 1 or type 2 responses but a definitive description of their mechanism(s) of action is lacking. High level dietary vitamin A enhances Th2 cytokine production and IgA responses, and is likely to decrease Th1 cytokine production. Retinoic acid inhibits IL-12 production in activated macrophages, and RA pretreatment of macrophages reduces IFNγ and TNF α production and increases IL4 production in antigen primed CD4 T cells. Supplemental treatment with vitamin A or retinoic acid (RA) decreases IFNγ and increases IL5, IL10, and IL4 production.

Eligibility Criteria:
Inclusion Criteria:

waist to hip ratio \>0.8 and BMI\>30 kg/m2 for obese individuals waist to hip ratio \<0.8 and BMI 18.5 - 24.9 kg/m2 for Non obese individuals

Exclusion Criteria:

* subjects who have diseases which affect on Th1/Th2 balance such as asthma, active viral infections, and autoimmune diseases, OR
* subjects with pregnancy, lactation, menopause, diabetes
* subjects who have allergy to vitamin A compounds, OR
* subjects who have used vitamin supplements or in last 3 months, OR
* subjects with morbid obesity(BMI \>40 kg/m2),OR
* overweight subjects (25 \<BMI\<29.9 kg/m2)
Logan Basic During Pregnancy on Labor and Childbirth

The purpose of this study is to determine if women who have chiropractic care, according to the Logan Basic Protocol for adjusting, during pregnancy have an easier, shorter labor and delivery as compared to women who haven't had chiropractic care during pregnancy.

This study will be designed to test if the Logan Basic Technique system of adjusting pregnant women can reduce labor time and increase the ease of labor and delivery as compared to the labor times reported by Kilpatrick and Laros in the obstetric literature. It is proposed that women who have regular chiropractic care throughout pregnancy or at least for the third trimester will have an easier labor and delivery as well as a shorter labor time than is reported in the literature.

Eligibility Criteria:
Inclusion Criteria:

* 20-24 weeks pregnant
* enrolled in a separate pre-natal care protocol with an outside provider
* a Logan College Student or member of the family of a Logan Student ("family" as defined by CCE designation)

Exclusion Criteria:
Nostril Side on Epistaxis

The purpose of the study is to investigate the effect of the nostril side on epistaxis during nasotracheal intubation.

This prospective randomized controlled study was approved by the IRB of our institute.

Patients requiring nasotracheal intubation will be screened for eligibility for the study. Then, patients will be randomized to one of two groups; (Group I: tube will be inserted through the left nostril and advanced into the oral cavity / Group II: tube will be inserted through the right nostril and advanced into the oral cavity). After induction of anesthesia and muscle relaxation, the preformed nasal RAE (Ring-Adair-Elwyn) tube will be inserted via the nostril, which is assigned to each patient according to the group, approximately 3-4 cm. Next, an anesthesiologist will advance the tube into the oral cavity. After the tube is placed in the oral cavity, the anesthesiologist will perform nasotracheal intubation with Magill forceps. After that, an investigator will check the occurrence of epistaxis due to nasotracheal intubation and its severity with a fiberoptic bronchoscope. After obtaining all data, investigators will analyze the incidence of epistaxis and its severity between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* adult patients requiring nasotracheal intubation for elective surgery

Exclusion Criteria:

* refuse to participate in the study
* severe deformity in the nose
* current severe epistaxis
* cannot insert the tube into a specific nostril side due to any reason
The Interaction Between Mucosal Microbiota Colonization and the Immune Response to an Intranasal Influenza Live Attenuated Vaccine

This is a single-center, randomized, open-label trial designed to explore the interaction between mucosal microbiota colonization in the nasal cavity and gut and the immune response to an intranasal live attenuated influenza vaccine (LAIV). The study plans to enroll 200 children and adolescents aged 6-17 years, with approximately 50% in the 6-11 years age group and 50% in the 12-17 years age group. Participants and their guardians must be able and willing to comply with the clinical trial protocol and provide informed consent. Eligible participants will be randomly assigned in a 1:1 ratio, stratified by age groups, to either the immediate vaccination group or the delayed vaccination group. Nasal swabs will be collected for all participants of both the immediate vaccination group or the delayed vaccination group after randomization for the detection of nasal and gut microbiota. Then, the immediate vaccination group will receive one dose of 0.2 mL of LAIV 28 days after randomization, while the delayed vaccination group will receive one dose of 0.2 mL of LAIV 56 days after randomization. Blood and mucosal samples (nasal stool) will be collected on the day before vaccination and on 28 days after vaccination for humoral and mucosal immunogenicity analysis. Moreover, the occurrence of adverse events within 28 days after vaccination will be collected.


Eligibility Criteria:
Inclusion Criteria:

1. Individuals aged 6-17 years.
2. Volunteers and their guardians are able and willing to comply with the requirements of the clinical trial protocol and sign the informed consent form.

Exclusion Criteria:

1. Allergy to any component of the vaccine product, including eggs, excipients, or gentamicin sulfate.
2. Individuals with acute illnesses, severe chronic illnesses, acute exacerbations of chronic illnesses, or fever.
3. Pregnant or lactating women.
4. Individuals with Leigh syndrome who are receiving treatment with aspirin or aspirin-containing medications.
5. Individuals with immunodeficiency, immunosuppression, or those undergoing immunosuppressive therapy.
6. Individuals with uncontrolled epilepsy, other progressive neurological disorders, or a history of Guillain-Barré syndrome.
7. Individuals with rhinitis or asthma.
8. Individuals with a personal or family history of seizures, chronic diseases, epilepsy, or allergic tendencies.
9. Individuals who have received immunoglobulin injections within the last 3 months prior to vaccination.
10. Individuals who have used other live attenuated vaccines within 1 month prior to vaccination.
11. Individuals planning to use antiviral drugs for influenza within 48 hours before or 2 weeks after vaccination.
12. Individuals planning to use any other intranasal medication within 2 days after vaccination.
Extracorporeal Shockwave Lithotripsy, Electroconductive and Electrohydraulic Types

To evaluate the efficacy and safety of electroconductive (EC) and electrohydraulic (EH) extracorporeal shock wave lithotripsy (ESWL) for the treatment of ureter and kidney stones, this study conducted a randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* The analysis included cases of stones in the upper kidney and ureter, with diameters ranging from 5 mm to 15 mm.

Exclusion Criteria:

* Patients with musculoskeletal deformities, ongoing urinary tract infections requiring prioritized infection treatment, blood clotting disorders, and ureteral obstruction that made stone expulsion difficult were excluded from the study.
Identify Clinical Conditions That Increase Circulating DNA Levels

The investigators are developing a test that is expected to measure the amount of radiation a patient has been exposed to after a nuclear bomb. The investigator will do this by measuring the DNA in the patients blood from cells killed by the radiation.

Many diseases and medical conditions can put DNA in the blood. The investigator needs to know how much DNA in order to better interpret our radiation detection test. Therefore, the investigator is collecting blood from several patients with different diseases or medical conditions and also healthy volunteers to measure their DNA content.

Patients that will be included in this study are pregnant women, patients who have suffered a pulmonary embolism within the past 48 hours, patients who have suffered from myocardial infarction in the past 48 hours, patients with autoimmune diseases and health patients.

The investigator will collect 8 mL (one and one half teaspoons) of blood one time only. The investigator may also collect the patient's past medical history, test results and disease treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must be adults in one of the following categories:

   * Pregnant
   * Suffered a pulmonary embolism within the past 48 hours
   * Myocardial infarction in the past 48 hours
   * Diagnosed with an autoimmune disease
   * Adults age 18-80
   * Self-declared healthy adults
2. Patients must be willing to undergo a blood draw
3. Patients must provide study-specific informed consent prior to study entry

Exclusion Criteria:

1. Patients not meeting the above inclusion criteria
Rehabilitation for Patients With Persistent Symptoms Post COVID-19

A large proportion of persons who have had COVID-19 have reported persisted symptoms as fatigue and dyspnea months post infection which affect activities of daily living.

The aim of the study is to examine the feasibility and safety of a concentrated rehabilitation program with a mobile application follow-up for persons with persistent symptoms post COVID-19 infection. We will examine recruitment availability, adherence to the program, goal achievement, and resources requirements.

Methods: A feasibility study with one group pre-post test design with 10-20 persons between 18-67 years, with persistent symptoms post COVID-19 will be included. The intervention is 3+ 1-2 days concentrated rehabilitation with a mobile application follow-up for 3 months.

Following assessments wil be used: Cardiopulmonary exercise testing, lung function, functional performance tests, questionnaires regarding dyspnea, fatigue, anxiety, depression, work-status, health status, sleep behavior, physical activity level.

Demographic data before and after the intervention will be presented. Focus group interview will be done with the participants. The interview will be analysed using systematic text condensation.

In March 2020, the World Health Organization (WHO) declared the COVID-19 outbreak to be a pandemic, and a year later more than 120 000 000 people are confirmed with the disease. The disease has caused more than 2 700 000 deaths globally. Norway has a low mortality rate compared to rest of the world. However, a large proportion (10-33%) of the patients worldwide have reported persistent symptoms, such as dyspnea, reduced exercise capacity, loss of taste/smell and fatigue months after the infection. Persistent symptoms are also found in younger populations and in persons with an initially mild disease.

The intervention will take place at "Helse i Hardanger" (HiH)(Health center in Hardanger, Norway). The participants will stay for a 3 -day rehabilitation intervention, if needed, another 1 or 2-day stay will be offered about a month later. The concentrated treatment will be given by an interdisciplinary team, including doctors, physiotherapists, nutritionists, pharmacists, psychologists/psychiatrists, and nurses. The intervention is an individualized group treatment based on behavioural change.

Eligibility Criteria:
Inclusion Criteria:

* persistent symptoms minimum 2 months post COVID-19 infection
* reduced exercise capacity level
* symptoms of dyspnea and/or fatigue

Exclusion Criteria:

* diseases where exercise is contraindicated (e.g. unstable angina pectoris)
* drug abuse, severe mental illness where treatment in groups are contraindicated.
Serological Response to Retreatment of Serofast Early Syphilis Cases With Benzathine Penicillin

A continuing challenge to determining the response to treatment of early syphilis (primary, secondary, early latent syphilis) is exemplified by the substantial proportion of patients who fail to achieve serological cure and remain serofast. Although retreatment is often done in clinical practice, optimal management remains uncertain due to the paucity of data regarding serological response to retreatment and long-term outcomes. Furthermore, the investigators cannot rule out that the gradually increasing seroreversion/serological cure rates may have been due to the natural decline in rapid plasma regain (RPR) titers after initial therapy, rather than due to the additional dose of benzathine penicillin. Thus, the investigators would like to conduct a clinical trial to compare the serological response rates of serofast early syphilis cases retreated with three doses benzathine penicillin and absence of any retreatment (control group).


Eligibility Criteria:
Inclusion Criteria:

* Early Syphilis Cases Determined to Be Serofast at 6 Months after Initial Treatment

Exclusion Criteria:

* Human immunodeficiency virus (HIV)-infected
* Baseline serology showed a nonreactive RPR test
* follow-up is inadequate
* Allergic to penicillin
* Pregnant woman
Dry Needling for Shoulder Pain in Stroke Patients

Spasticity and pain, particularly int he shoulder region, are the most common impairments experienced by subjects who had experienced a stroke. There is preliminary evidence supporting the role of dry needling for spasticity in patients who had suffered from a stroke. Few data exists on the effects on shoulder pain. In addition, it has been shown that application of dry needling induces post-needling soreness in individuals with musculoskeletal pain. No previous study has investigated the presence and the duration of post-needling soreness in individuals who had experienced a stroke.


Eligibility Criteria:
Inclusion Criteria:

* first-ever unilateral stroke;
* hemiplegia resulting from stroke;
* age between 30 and 60 years old;
* presence of hypertonicity in the upper extremity;
* pain symptoms in the shoulder
* active trigger points in the shoulder muscles reproducing the shoulder pain symptoms

Exclusion Criteria:

* recurrent stroke;
* absence of active trigger points in the shoulder muscles reproducing shoulder symptoms
* previous treatment with nerve blocks, motor point injections with neurolytic agents for spasticity at any time;
* previous treatment with botulinum toxin-A in the 6 months prior the study;
* severe cognitive deficits;
* other neurologic diseases,
* underlying complex medical conditions, e.g., heart conditions, unstable hypertension, fracture
* fear to needles;
* any contraindication for deep dry needling, e.g., anticoagulants, infections, bleeding, or psychotic.
Clinical Significance of Detecting CEA and CK20 mRNA-positive Cells in Colorectal Cancer Patients

To determine whether the presence of circulating/disseminated tumor cells (CTCs/DTCs) in the blood and bone marrow of colorectal cancer (CRC) patients with localized disease is a negative prognostic factor, and to find correlations with other clinical/pathological disease characteristics.


Eligibility Criteria:
Inclusion Criteria:

- colorectal adenocarcinoma

Exclusion Criteria:

* prior neoadjuvant chemoradiotherapy
* prior colorectal cancer
* cancer duplicity
Clinical Research on Shenfu Injection in Septic Patients

Sepsis, characterized by organ dysfunction caused by infection, exhibits increasing incidence and mortality rates, posing a significant challenge to intensive care units. Early-stage sepsis involves hemodynamic disturbances, and severe and complex microcirculatory impairments can result in tissue hypoxia and accelerate organ dysfunction. Modern medical research has indicated that the effective and rapid restoration of microcirculatory function, along with the correction of microcirculatory disorders, is a crucial aspect in the treatment of sepsis. Current guidelines recommend the use of vasoactive drugs to address hemodynamic disturbances, but their administration may further damage the microcirculation. Additionally, in patients with severe sepsis, there often exists a disparity between macrocirculatory and microcirculatory hemodynamics, and conventional clinical indicators fail to directly reflect the level of microcirculatory perfusion.

Chinese guidelines have incorporated the use of traditional Chinese medicine (TCM) in the diagnosis and treatment of sepsis, offering a new therapeutic approach to ameliorate microcirculatory impairments. This study aims to include patients with sepsis and administer Shenfu Injection via intravenous therapy. Tongue microcirculation assessment will be employed to evaluate changes in microvascular health scores, while transcutaneous oxygen and carbon dioxide pressure alterations, as well as serum lactate level variations, will be monitored to ascertain the effects of Shenfu Injection on improving early-stage microcirculatory impairments and microvascular leakage in sepsis patients. This research will clarify the clinical efficacy of Shenfu Injection in sepsis patients with microcirculatory impairments, provide evidence-based medicine and clinical evidence for TCM treatment of sepsis, and offer a solid foundation for refining sepsis treatment strategies with distinct Chinese characteristics.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years;
* Signed informed consent form;
* Meets sepsis 3.0 diagnostic criteria;

Exclusion Criteria:

* Age \< 18 years;
* Known pregnancy;
* Inability to accept and complete signed informed consent within 24 hours of diagnosis of sepsis;
* Status of tracheal intubation;
* oral mucosal inflammation or damage;
* Patients with contraindications to transcutaneous oxygen partial pressure testing such as severe edema and burns;
* Concurrent participation in other treatment studies.