cyrilzakka/clinical-trials huggingface dataset:
The Effect of an Acute Bout of Exercise on High-sugar Meal Induced Endothelial Dysfunction

The purpose of this study is to determine if postprandial (after a meal) endothelial (inner lining of blood vessels) dysfunction induced by a high sugar meal improves with a bout of exercise

Endothelial dysfunction is due to an imbalance between vasodilating and vasoconstricting substances produced by the endothelium. An imbalance in these substances limits the ability of the blood vessel to relax in response to a shear stress stimulus. Endothelial dysfunction is a major risk factor for cardiovascular disease.

High-sugar intakes result in postprandial hyperglycemia and endothelial dysfunction. Exercise may attenuate the endothelial dysfunction induced by a high-sugar meal. There are only two studies that have examined the effect of exercise on endothelial dysfunction induced by high-sugar intake. Both studies found that a bout of aerobic exercise attenuated the impaired flow mediated dilation induced by high-sugar ingestion. Neither study measured important markers of endothelial dysfunction such as blood nitric oxide, endothelin I, and angiotensin II concentrations, however. In addition, whether the same results apply to older post-menopausal women is unknown. Understanding how acute exercise affects meal-induced endothelial dysfunction in older women is important given that age is related to endothelial dysfunction and cardiovascular disease.

Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal women
* Must be 45-70 years

Exclusion Criteria:

* Use of medications or supplements to lose weight
* Following a weight loss diet
* Smoking
* Heavy alcohol consumption
* Diabetes
* Heart disease
* Stroke
* Liver disease
* Kidney disease
* Untreated thyroid disease
* Anemia
* Uncontrolled hypertension
* Pulmonary disease that prevents exercise
* Orthopedic problems that prevents exercise
* Arthritis problems that prevent exercise
* Musculoskeletal problems that prevent exercise.
Studying Gene Expression in Samples From Younger Patients With Neuroblastoma

RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors find better ways to treat cancer.

PURPOSE: This research trial studies gene expression in samples from younger patients with neuroblastoma.

OBJECTIVES:

* Determine whether TβRIII expression and TGF-β signaling decrease in advanced-stage neuroblastoma (NBL) and whether these changes are confined to the Schwannian stroma.
* Determine whether sTβRIII levels and TGF-β signaling correlate with NBL stage, tumor stroma content, surface TβRIII expression, and TGF-β signaling.

OUTLINE: Archived paraffin-embedded tissue and plasma samples are analyzed for TβRIII expression, TGF-β signaling, and SMAD3 expression and phosphorylation by immunohistochemistry, enzyme-linked immunosorbent assay (ELISA), and other assays. Surface expression of TβRIII in the neuroblastic and stromal tumor components are correlated with matched circulating levels of soluble TβRIII. Results are then correlated with each patient's outcome data, including stage.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Tissue samples and matched plasma samples available from 1 of the following groups:

  * Patients with low-stage (International Neuroblastoma Staging System \[INSS\] stage 1 or 2) neuroblastoma (NBL)
  * Patients with advanced-stage (INSS stage 3 or 4) NBL
  * Patients with stage 4S NBL
* Clinical and/or outcome data associated with the tissue and plasma samples including INSS stage, age, MYCN amplification status, chromosomal alterations, and 5-year survival, if known

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Polygenic Risk-based Detection of Subclinical Coronary Atherosclerosis and Change in Cardiovascular Health

The goal of this randomized controlled trial is to assess the impact of disclosing a high polygenic risk result for coronary artery disease on change in cardiovascular health over one year.

The main question PROACT 1 aims to answer is whether cardiovascular health improves following disclosure of high polygenic risk result for coronary artery disease compared to standard of care.

This is a 1:1 randomized controlled trial of middle-aged participants with no known cardiovascular disease, are not on lipid-lowering therapy, who have high polygenic risk score for coronary artery disease, and do not have quantifiable plaque on coronary computed tomography angiography. Participants will be randomized into two equal groups: one group will receive their high polygenic risk result for coronary artery disease at baseline, and the other group will receive their result after study completion at 1 year. Change in cardiovascular health as measured by the American Heart Association Life's Essential 8 score from baseline to one-year will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Males and females between 40 and 75 years of age capable and willing to provide informed consent
* Participant has high CAD PRS as defined on a clinical test

Exclusion Criteria:

* Participant with a history of cardiovascular disease, defined by a diagnosis of coronary artery disease, peripheral artery disease, or cerebrovascular disease
* Participant with quantifiable plaque on a coronary computed tomography angiography
* Participant with a history of Liver disease (cirrhosis, active hepatitis, or severe hepatic disease) or any of the following recent lab results and determined to be non-transient: alanine aminotransferase greater than 3 times the upper limit of normal or total bilirubin greater than 2 times the upper limit of normal (unless due to Gilbert syndrome)
* Participant with estimated glomerular filtration rate \<60 mL/min/1.73 m2 or creatinine greater than 2 times the upper limit of normal
* Patient with history of an allergic reaction or significant sensitivity to iodinated contrast, colchicine, or statins
* Patient currently taking LDL cholesterol lowering or anti- inflammatory medications including colchicine
* Participants requiring regular drugs known to be potent CY2P inhibitors (eg. ketoconazole, clarithromycin)
* Female patient who is pregnant, or breast-feeding or is considering becoming pregnant during the study
* Participant with BMI ≥ 40 kg/m2
* Participant unable to provide informed consent
* Participant unable to hold breath for 10 seconds
The Effects of Two Volitional Interventions to Improve Oral Health Behaviour Among Iranian Adolescents

the present study had two main aims. First, due to the current underconsumption of dental brush adolescents, the investigators should apply a volitional intervention to increase oral health behvaiour in adolescents. Second, the investigators aim to compare the effectiveness of action planning intervention and implementation intention will improve oral health behavior in adolescents.

This is a study to explore the impact of two volitional interventions on brushing intentions , behaviors and clinical characteristics among a sample of adolescent students.

Eligibility Criteria:
Inclusion Criteria:

* 14 Years to 19 Years
* Ability to understand Persian language Adolescents attending high schools in Qazvin

Exclusion Criteria:

* participate in any kind of oral health education and promotion programs
* undergoing orthodontic treatment
A Single Dose Trial in Growth Hormone Deficient Children Investigating Safety, Pharmacokinetics and Pharmacodynamics of Long Acting Growth Hormone

This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics (the determination of the concentration of the administered medication in blood over time) and pharmacodynamics (the determination of the effect over time and the duration of action) of a long-acting growth hormone (NNC126-0083) in growth hormone deficient children.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of growth hormone insufficiency as defined by two different GH provocation tests, defined as a peak of GH level less than 7ng/ml
* Pre-pubertal children
* Growth hormone replacement treatment for at least three months

Exclusion Criteria:

* Evidence of tumour growth or malignant disease
* Growth hormone deficient children with overt diabetes mellitus (fasting blood glucose more than 126mg/dl)
Personalized Voice Activated Wellness Assistants for Patients With Heart Failure

The Alexa+ Study will compare the use of the Amazon Echo Dot with Alexa voice technology in patients with chronic heart failure to those receiving standard of care heart failure management on changes in health and patient-centered outcomes.

Integrating data from virtual voice activated assistants (Amazon Echo Dot with Alexa voice technology), with the rich medical history available in Electronic Health Records (EHR) will allow a truly customized, interactive, and automated personal healthcare assistant. This technology will be validated in patients who have chronic heart failure (HF). Half of the study patients will receive an Amazon Echo Dot (Alexa) enhanced with a HF Care custom Alexa Skill that is patient-specific, or Alexa+. Data on patient interactions with the device will be followed for three months. The control groups will receive standard of care (SOC) HF management. Both study and control groups will receive regular follow up from the HF nurse and data from all hospital or clinic visits will be captured from the EHR.

Eligibility Criteria:
Inclusion Criteria:

* Heart failure patients seen at the MedStar heart failure clinic and the MedStar Washington Hospital Center inpatient heart failure service
* At least 18 years of age
* Have access to in-home Wi-Fi

Exclusion Criteria:

* Participation in another interventional clinical trial
Efficacy of Tenofovir Disoproxil on Mother-to-child Transmission of HBV in Tokombéré, Cameroon in Pregnant Women

IIn this study, pregnant women with HBeAg-positive viral hepatitis b or high viral load will receive Tenofovir disoproxil fumarate from the 28th week of amenorrhoea until 6 weeks after delivery. Their newborns will receive the hepatitis B vaccine, starting with one dose at birth and followed by three booster doses, according to the Expanded Programme on Immunisation. The investigators hypothesise that a short course of TDF could greatly reduce the risk of HBV MTCT in pregnant women at high risk of MTCT (HBeAg positive or with high viral load).

This is a prospective, single-arm, open-label, descriptive, phase IV clinical trial in HBsAg and HBeAg positive pregnant women. Eligible pregnant women will receive 245 mg of tenofovir disoproxil fumarate once daily from 28 weeks of pregnancy until 6 weeks after delivery. Newborns will receive the hepatitis B vaccine, starting with one dose at birth, followed by three booster doses, in accordance with the expanded programme of vaccination.

The study aims to show that the addition of maternal antiviral treatment to vaccination at birth followed by three booster doses can be favourably considered in the context where vaccination alone is not sufficient to prevent transmission of the hepatitis B virus from mother to child. A total of 150 pregnant women will be included in the Tokombéré district.

Eligibility Criteria:
Inclusion criteria:

* Pregnant women with a term of less than 24 weeks of amenorrhea;
* HBsAg positive ;
* HBeAg positive or HBeAg negative with a high viral load ( \> 200 000 UI/ml) ;
* 16 years old or more on the inclusion day ;
* Signature of free and informed consent (for pregnant women aged 16 to 21, the participant's consent as well as the authorization of a parent/adult husband/ legal tutor will be collected) which also includes consent for the children

Exclusion criteria :

* HIV co-infection;
* Women treated for HBV;
* Creatinine clearance \<30 ml / min;
* Suspicion of poor monitoring of children's vaccination schedule for HBV (vaccination at birth + boosters);
* Disease or treatment contraindicating the taking of TDF.
Retrospective Review of Xen Gel Stent Implantation With Open vs. Closed Conjunctiva Approach

To measure surgical success of open vs closed conjunctiva with Xen implantation.

This retrospective, single-arm multicenter study included \>100 eyes (\>100 patients) with glaucoma refractory to medical therapy. All surgeries were performed by two groups of surgeons at Johns Hopkins University and the sub-investigator group at New York University. Group 1: Xen with open conjunctiva for positioning and application of mitomycin. The Xen was placed through the sclera either ab-interno or ab-externa. Group 2 had Xen placed ab-interno or ab-externa (trans conjunctival), but the conjunctiva was not opened for positioning or application of mitomycin-C.

Success rates will be determined based on need for re-intervention and intraocular pressure control.

Eligibility Criteria:
Inclusion Criteria:

* Require surgery for uncontrolled glaucoma

Exclusion Criteria:

* None
Natural History of Treated Neurocysticercosis and Long-Term Outcomes

Neurocysticercosis is a brain disease due to the larval stage of the pork tapeworm (Taenia solium). The most common symptoms patient experience from infection inside the substance of the brain (parenchymal disease) are seizures and headaches. When the infection is either inside the fluid pockets inside the brain (ventricular disease) or in the space around the brain (subarachnoid disease) patients can have chronic headaches, relapsing aseptic meningitis, hydrocephalus, stroke, and may require neurosurgical intervention. The purpose of this study is to treat patients with anthelmintic therapy (praziquantel and/or albendazole) and anti-inflammatories in alignment with currently accepted best practices and guidelines, depending on the neurocysticercosis subtype. The purpose of the study is to better understand and characterize clinical, biologic, and management factors during treatment that influence long term outcomes. In order to understand this further we collect patient clinical information, patient survey responses, blood, urine samples, and additional cerebral spinal fluid if already being collected for clinical care.

Study Description:

The purpose of this protocol is to follow participants with cysticercosis during and after completion of treatment, to characterize the disease course during both short- and long-term follow-up, assess biomarkers associated with infection and response to treatment, improve diagnostic assays, and explore host-parasite interactions.

Primary Objective:

The primary objective is to characterize the biochemical and clinical course of neurocysticercosis (NCC) during and after treatment with long-term follow-up.

Secondary Objectives:

1. To develop novel biomarkers associated with active infection
2. To further understand host-parasite interactions, including the inflammatory response
3. Understand the basis for the pleiomorphic clinical manifestations, including the possible contributions of parasite and host genetics
4. Develop a screening paradigm

Primary Endpoint:

Description of clinical presentation, imaging features, morbidity, response to treatment, and outcomes in all forms of NCC.

Secondary Endpoints:

1. Central and peripheral immune cell phenotyping and cytokine measurements
2. Including, but not limited to bulk transcriptomics, referral to study for participant whole genome sequencing, cestode-specific genome sequencing
3. Biobanking cerebrospinal fluid (CSF), serum, plasma, urine
4. Test known and novel biomarkers, serologic responses in the pre-clinical stage of neurocysticercosis, correlate findings with imaging.

Eligibility Criteria:
* INCLUSION CRITERIA:

Arms 1-5 (NCC):

1. Aged 3 years and older.
2. Ability of participant (or legally authorized representative, LAR) to understand and the willingness to sign a written informed consent document.
3. Patients with proven or likely NCC

Arm 6 (Endemic Exposures):

1. Patient with epidemiologic history compatible with possible exposure to NCC
2. Aged 18 years and older.

EXCLUSION CRITERIA:

Not applicable
Evaluation of the Nella Women's Care Line

Evaluation of the Nella Women's Care Line

The Nella Women's Care Line is being studied in women undergoing a gynecological exam and other gynecological procedures that require visibility and access to the cervix.

Eligibility Criteria:
General inclusion criteria (applies to all study groups):

* Subject is female
* Subject is 18 - 65 years of age, inclusive, at the time of consent
* Subject is undergoing a gynecological examination (as defined above) as part of their regular clinical care
* Subject has undergone one or more prior gynecological exams
* Subject is willing and able to provide written informed consent
* Subject is able and willing to perform the functions required by the study protocol

General exclusion criteria (applies to all study groups):

* Subject has undergone hysterectomy
* Subject has a known history of allergies to latex or plastics
* Subject is pregnant
* Subject is post-partum (≤ 12 weeks)
* Subject has had an induced or spontaneous abortion in the prior 12 weeks
* Subject has an active gynecologic complaint that, in the opinion of the clinician, would confound study results
* Subject has dyspareunia
* Subject has a known history of vulvodynia such as vulvular vestibular syndrome
* Subject has a known history of vaginismus
* Subject has a planned surgical procedure along with the gynecological exam
* Subject is under incarceration
* Subject is unable to provide written informed consent

Device specific inclusion criteria:

In addition to the general inclusion, the subject must meet all device specific criteria associated with their assignment group. Below are device-specific criteria. There is no device-specific exclusion criterion.

Nella VuSleeve (Group 1) inclusion:

• Subject has a BMI ≥ 30 and/or 3 or more vaginal births

NellaSpec (Group 2), Nella NuSpec (Group 3), and Nella Insert (Group 4) inclusion:

• Subject has a BMI \< 35
Clinical Effects of Incobotulinum Toxin vs Corticosteroid in Plantar Fascitis

Objectives: To evaluate the clinical effects of intralesional application of incobotulinum toxin vs corticosteroid in patients with plantar fasciitis .

Material and methods: Prospective, experimental, randomized, controlled clinical study; the population will be recruited in the outpatient clinic of the rehabilitation service meeting the inclusion criteria, two randomized study groups will be formed: GROUP A: Patients who accept intralesional infiltration with incobotulinum toxin . GROUP B: Patients who accept intralesional infiltration with dexamethasone.

Both groups will be assessed before application, at 1 month, at 2 and 4 months post intervention. The visual analogue scale (VAS), the American Orthopaedic Foot and Ankle Society (AOFAS) scale and the Foot and Ankle Disability Index (FADI) will be used to assess pain, foot functionality, functional disability index in activities of daily living, in physical activity and measurement of the dorsiflexion arch in 2 visits at the beginning of diagnosis and at 4 months, collecting the variables and establishing a hypothesis analysis to accept or discard normality criteria of the same with tendency and its significance in relation to p \<0.05 to establish contrast of the results with parametric or non-parametric variables according to whether or not the hypothesis of normality is discarded.

The investigators want to compare the effects on pain, ankle and foot functionality, as well as activities of daily living; of the application of incobotulinum toxin vs corticosteroid in people suffering from plantar fasciitis.

Eligibility Criteria:
Inclusion Criteria:

1. Age over 18 years.
2. Any sex.
3. Diagnosis of plantar fasciitis (pain in the medial plantar calcaneal tubercle which gives rise to the site of plantar fascial insertion into the heel bone and/or pain along the path of its three bands) made by a physician specializing in Physical Medicine and Rehabilitation.
4. Voluntary acceptance of participation in the study.
5. Patients entitled to the Mexican Social Security Institute.

Exclusion Criteria:

1. Diagnosis of ankylosing spondylitis.
2. Pregnant women.
3. Previous infiltration treatment with any medication or substance applied to the plantar fascia or gastrocnemius muscles in the last six months.
4. Anticoagulant treatment.
5. History of local infection in the plantar fascia in the last three months.
6. Allergic to lidocaine, incobotulinum toxin or dexamethasone.
7. Patients not entitled to the Mexican Social Security Institute.
8. Patient's refusal to participate in the study.
The Early Nasojejunal Tube to Meet Energy Requirements in Intensive Care (ENTERIC) Study

This is a multi-centre randomised controlled trial comparing early jejunal feeding (using a frictional nasojejunal \[NJ\] tube) and standard feeding in critical illness.


Eligibility Criteria:
Inclusion Criteria:

ICU patients are eligible for enrolment if they meet all of the following:

* Age \> 18 years old
* In ICU for \< 48 hours prior to enrolment
* Receiving invasive mechanical ventilation (through an endotracheal tube or tracheostomy, but NOT a facemask) with an anticipated need for \> 48 hours of mechanical ventilation
* Receiving a continuous infusion of any one of:

  * morphine \> 2 mg/hour,
  * fentanyl \> 20 mcg/hour, or
  * pethidine \> 20 mg/hour
* Either a single GRV \> 150 mls (whilst receiving EN via a NG tube) or nasogastric drainage \> 500 mls over 12 hours (whether receiving EN or not)

Exclusion Criteria:

Patients will be ineligible for enrolment if they meet any of the following:

* Previous or recent surgery which has altered the anatomy of the upper gastrointestinal tract (eg. oesophagectomy, gastrectomy, any gastric anastomosis surgery, gastroplasty, pyloroplasty, pancreaticoduodenectomy \[Whipple's procedure\])
* Known gastric malignancy
* Known oesophageal varices
* Current admission for peptic ulceration
* Current mechanical bowel obstruction
* Current gastrostomy, jejunostomy, or surgically-placed enteral tube in situ
* Contraindication to the use of the nose and mouth for enteral tube insertion (eg. recent facial trauma or surgery)
* Receiving nutritional support prior to ICU admission
* Severe coagulopathy (defined by platelet count \< 20 and/or international normalized ratio \[INR\] \> 4.0)