cyrilzakka/clinical-trials huggingface dataset:
Multi-level Supermarket Discount Study

The study team's objective is to test the effect of supermarket discount levels on fruit and vegetable (F\&V) and non-caloric beverage purchasing and consumption, as well as health outcomes. The study team will implement this economic intervention in a local supermarket chain to assess the effects of a 32-week intervention of fruit and vegetable (F\&V) and non-caloric beverage discounts of 30%, 15%, and 0% (control group) on purchasing, dietary intake, and health outcomes, including body weight and composition, blood pressure, and biochemical markers of cardiovascular disease risk. The 32-week intervention will be preceded by an 8-week baseline and will have a follow-up period of 16 weeks. There will be no discounts in effect during the baseline and follow-up periods.

The objective is to test the effect of supermarket discount levels on fruit and vegetable (F\&V) and non-caloric beverage purchasing and consumption, as well as health outcomes. The study team will implement this economic intervention in a local supermarket chain to assess the effects of a 32-week intervention of fruit and vegetable (F\&V) and non-caloric beverage discounts of 30%, 15%, and 0% (control group) on purchasing, dietary intake, and health outcomes, including body weight and composition, blood pressure, and biochemical markers of cardiovascular disease risk. The prediction is that the impact will increase with the level of discount. The 32-week intervention will be preceded by an 8-week baseline and will have a follow-up period of 16 weeks. There will be no discounts in effect during the baseline and follow-up periods. The prediction is that some of the interventional effects will carry over to the follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* BMI: 24.5 - 50
* Weight Stable (±5% body weight in last 3 mo)
* Accessible by telephone
* Living in NYC and not planning move
* Primary household food shopper
* ≥50% of food shopping at Foodtown/Brooklyn Harvest and agrees to 100% shopping at store during study
* Consumption of \>50% of food shopping
* Eat out or take out ≤5 times weekly

Exclusion Criteria:

* Pregnant or contemplating pregnancy
* Enrolled in related studies
* Active weight loss program
* Presence of serious medical (e.g. cancer, diabetes) or psychiatric disease (e.g. bipolar)
* Changes in medications or smoking in past 3 mo
* Excessive alcohol use (≥4 drinks/day) or illicit drug use
* Planning a vacation ≥ 4 consecutive weeks or 6 total weeks during study
* Receiving SNAP benefits
The Value of Placental Vascularization and Placental Volume in Pregnancy in APLS

Antiphospholipid antibodies are autoantibodies directed against phospholipid-binding proteins. Among these groups of antibodies, lupus anticoagulant (LA) and anticardiolipin antibodies (aCL)

APLS can be primary when no evidence of autoimmune disease is found, or secondary to autoimmune processes like systemic lupus erythematous (SLE) in a 40% of the cases.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy.

  * Gestational age of 34-37 weeks.
  * Pregnant women with antiphospholipid syndrome

Exclusion Criteria:

* Twin or multiple pregnancies.
* Congenital fetal anomalies.
* Gestational age of less than 34.
* Gestational age of more than 37.
* Women with placental or umbilical artery anomalies.
* Antepartum hemorrhage (placental abruption, placenta previa and vasa previa).
* Posterior placenta.
* History of rupture of membrane.
* Patient refusal or fall outs.
Mucosal Injury Using Pharyngeal Packing

After approval of the Institutional Review Board and written patient´s informed consent patients with indication for surgery of the sinuses were randomly assigned to one of the two study groups. After standardized anaesthetic management and PONV prophylaxis routinely applied the patients were screened for mucosal injury on second postoperative day. Furthermore, the amount of analgetic and anti-emetic drugs and the severity of pain and PONV were recorded throughout the hospital stay.

Aim of the study

Post-operative nausea and vomiting (PONV) is a complication of anaesthesia and responsible for malaise of surgical patients. Furthermore, PONV has been shown causing additive costs due to anti-emetic drugs and prolonged hospitalisation. The occurrence of PONV is multifactorial. Beside individual patients factors, opioid use and type of surgery seem to be responsible for occurrence of PONV. Especially, sinus surgery carries a high risk of PONV. Blood from the operation site entering the stomach has been discussed the potential cause for PONV in this specific patient population.

Therefore, hypopharyngeal packing following orotracheal intubation is a common clinical practice to prevent blood passing through the esophagus and so to lower the incidence of PONV.

Unfortunately, there are limited data data supporting the effectiveness of this procedure. In contrast, some references suggest that hypopharyngeal packing may be associated with postoperative mucosal injury and sore throat with high impact on patients´ well-being.

To evaluate the usefulness and safety of hypopharyngeal packing the investigators perform prospective randomized study with the following objective:

1. Does pharyngeal packing during sinus surgery increase the incidence of mucosal injury?

Eligibility Criteria:
Inclusion Criteria:

* Surgery of the sinuses
* Patients over 18 years of age
* Duration of surgery \> 1h

Exclusion Criteria:

* Refusal of the patient
* Patients under 18 years of age
* Chemotherapy with antiemetic medication
* Combined surgery (for example tonsillectomie and sinus surgery)
* Pregnancy
Evaluating Symptom Control in in Allergic Rhinitis at Three Years After Starting Immunotherapy

Allergic rhinitis (AR) is defined as inflammation of the nasal mucosa after exposition to an allergen in sensitized patients. AR causes not only nasal symptoms such as sneezing, itchy nose, rhinorrhea and nasal obstruction, but also has a significant impact on quality of life. Symptom control and overall satisfaction in patients undergoing subcutaneous immunotherapy (SCIT) or sublingual immunotherapy (SLIT) on the long term has not yet been investigated so far.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with at least 2 AR symptoms and a positive skin prick test for the 20 most prevalent inhalant allergens (house dust mites, grass pollen, tree pollen, animal dander, Alternaria, Penicillium and Cladosporium) in Belgium.
2. Moderate/severe and/or persistent AR according to ARIA guidelines
3. Age \> 18 and \< 60 years.
4. Written informed consent
5. Dutch, French or English speaking patients

Exclusion Criteria:

Exclusion criteria

1. Age \< 18 and \> 60 years
2. Patients with mild AR
3. Patients not being able to give an informed consent
4. Patients being enrolled in other clinical trials
5. No knowledge of Dutch, French or English
Head-perineum Distance and Delivery Mode

In a prospective cohort of patients in the second phase of labor, the investigators measured the head-perineum distance and correlate it to the mode of delivery (spontaneous delivery - instrumental delivery - ceasarean section).

Head-perineum distance measured by transperineal ultrasound is a simple and well-known tool to help diagnose the fetal head engagement and predictive value to instrumental extraction succeeds.

It is performed in labor room and is a non-invasive test, realized on a healthy skin.

The investigators performed a systematical measure of head perineum distance at the beginning of the expulsive labor phase. The investigators made the hypothesis, based on our clinical experience, that starting expulsive labor phase with head perineum distance greater than forty five millimeters, lead to an increased risk of instrumental extraction and therefore an increase in materno-fetal morbidity and mortality.

The investigators sought to evaluate the optimal head perineum distance at the beginning of expulsive efforts.

Eligibility Criteria:
Inclusion Criteria:

* Single pregnancy
* In labor (spontaneous or induced)
* Term superior at 37 SA
* Delivery by summit presentation

Exclusion Criteria:

* Non single pregnancy
* Suspected malformative abnormalities in the unborn fetus
* Refusal of participation
* Minor patient
* Adult patient subject to legal protection or patient deprived of liberty
* Poor French language understanding
Understanding Pine Bark Extract as an Alternative Treatment (UPBEAT) Study

The purpose of this study is to investigate the efficacy of Flavangenol® (Toyo Shinyaku, Japan), a pine bark extract, in lowering blood pressure and improving glycemic control and plasma lipoprotein profile.

Cardiovascular disease is the number one cause of death in the Unites States. Our study tests the efficacy of pine bark extract in improving a number of cardiovascular disease risk factors. We are conducting a randomized, placebo-controlled, double-blind, parallel trial that will investigate the efficacy and safety of Flavangenol® (Toyo Shinyaku, Japan), a pine bark extract, among 130 study participants. These participants will be individuals at mildly or moderately elevated risk of cardiovascular disease (CVD) because of having prehypertension, excess body weight, and insulin insensitivity. We aim to determine (in order of priority):

1. The efficacy of Flavangenol in lowering blood pressure.
2. The efficacy of Flavangenol in improving glycemic control and plasma lipoprotein profile.
3. Changes in body weight, antioxidative capacity, anti-inflammatory markers, blood coagulation factors, and liver function tests in response to Flavangenol.
4. The safety of Flavangenol, as confirmation of past studies.

Eligibility Criteria:
Inclusion Criteria:

* Systolic blood pressure between 125 and 159 mmHg and diastolic blood pressure (DBP) \< 100 mmHg
* Body mass index (BMI) 25.0-34.9
* Triglycerides (TG) \< 450 mg/dL
* Low Density Lipoprotein (LDL) \< 200 mg/dL
* Fasting blood glucose (FBG) \< 126 mg/dL

Exclusion Criteria:

* DBP \> 95 mmHg
* LDL \> 170 mg/dL
* TG \> 300 mg/dL
* FBG \> 110 mg/dL
Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (CRVO)

This is a phase 3 study to determine the efficacy of VEGF Trap-Eye injected into the eye on vision function in subjects with macular edema as a consequence of central retinal vein occlusion.


Eligibility Criteria:
Inclusion Criteria:

* Subjects at least 18 years of age with center-involved macular edema secondary to CRVO with mean central retinal thickness ≥ 250 μm on OCT
* ETDRS best corrected visual acuity of 20/40 to 20/320 (73 to 24 letters) in the study eye

Exclusion Criteria:

* Previous treatment with anti-angiogenic drugs in the study eye (Pegaptanib sodium,anecortave acetate, bevacizumab, ranibizumab, etc.)
* Prior panretinal laser photocoagulation or macular laser photocoagulation in the study eye
* CRVO disease duration \> 9 months from date of diagnosis
* Previous use of intraocular corticosteroids in the study eye or use of periocular corticosteroids in the study eye within the 3 months prior to Day 1
* Iris neovascularization, vitreous hemorrhage, traction retinal detachment, or preretinal fibrosis involving the macula in either the study eye or fellow eye
High-dose Cytarabine/Mitoxantrone Followed by Autotransplantation for t-MDS/t-AML

The purpose of this study is to determine the effectiveness of a particular combination of drugs used to treat cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have received cytotoxic chemotherapy,radiation,or a drug known to affect the properties of DNA or cell growth for some condition other than acute myeloid leukemia prior to diagnosis.
* Patients must have t-MDS/t-AML
* To be eligible for allogeneic transplantation, patients must have a suitable donor who is HLA compatible.
* Patients must be over the age of 10.
* Patients must be reviewed and discussed at the Leukemia and Transplant Conferences of the Section of Hematology/Oncology.

Exclusion Criteria:

* Patients must not have any other serious medical condition(e.g.uncontrolled or severe cardiovascular disease, diabetes, pulmonary disease, or infection)
* Psychiatric condition which would prevent compliance or possibly be worsened by treatment
The Impact of Glycemic Control on Rheumatoid Arthritis Disease Activity on Diabetic Patients

The incidence of DM is unclear in RA but most prior data suggest that DM or insulin resistance in RA has risen because of activation of the immune system and/or RA therapy .

Besides, RA causes joints to become stiff, swollen, and agonizing. As a result, the patient may not want to exercise or move. One study found that 42% of people with RA are not physically active. the aim of this study is To evaluate the glycemic status among RA patients with Type 2 diabetes and its association with disease activity.

Taking the potential link between DM and RA into consideration, detection and control of DM will significantly increase prolonged prognosis and therefore decrease the economic burden of RA patients and death rate. The aim of this research is to examine diabetic RA's glycemic status and to assess the relationship between RA and DM's clinical characteristics as well as the therapy response in RA patients with diagnosed DM. Keeping an eye on glycemic control in RA patients could prevent metabolic and cardiovascular comorbidities in those susceptible patients.

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetic patients
* rheumatoid arthritis patients

Exclusion Criteria:

* gestional diabetes
* type 1 diabetic patients
Web Based Therapist Tutorial on Prolonged Grief

Death of a loved one is a difficult life experience. About 1 in 10 bereaved people are strongly affected by the loss and grieve intensely for a long time. As a result of the COVID-19 pandemic, more people may struggle with grief. The investigators have developed and tested a talk therapy for prolonged grief.

The investigators have developed an online grief training for clinicians. The investigators will test if clinicians benefit from the online training and if they find it helpful and engaging. The investigators will recruit 30 mental health professionals as trainees to undergo the training. The mental health professionals will complete questionnaires before and after training to determine how much they learned and how much they liked the training.

The investigators developed a short-term, manualized Prolonged Grief Disorder Therapy (PGDT), originally known as Complicated Grief Treatment and found it efficacious in three large National Institute of Mental Health (NIMH) sponsored randomized controlled trials. Facilitating access to training in Empirically Based Treatments has been identified as a national priority by both mental health professional organizations and NIMH. One way to help disseminate therapist training on EBT of Prolonged Grief Disorder (PGD) is through the use of new technologies. The investigators recently developed an online therapist training program in PGDT and a patient facing therapist-assisted web-based form of PGDT. The investigators are now looking to evaluate the acceptability and effectiveness of each of these online tools in pilot studies.

The tutorial contains 10 modules, each about 20-40 minutes long with information needed for effective delivery of PGDT. Participants will be encouraged to space out the tutorial vs. taking it in a few long sessions, to facilitate knowledge retention. A post-test will be given immediately after completing each module, as testing done closer to when the material was learned also improves retention. Participants will be encouraged to complete the tutorial within 5 weeks (about one hour or two modules per week). Consistent with continuing education guidelines, successful completion will require an overall score of 80% on post-tests. Participants would need to retake the module until a passing score is obtained. Interactive Patient Scenarios will be integrated into the tutorial at strategic points, in order to integrate conceptual and applied knowledge. All participants will be asked to evaluate whether the stated learning goals of each module were met and complete user satisfaction questionnaires on both the technical aspects of the on-line tutorial (using the System Usability Scale), and the clinical content (using the User Satisfaction Questionnaire). Participants will have access to the tutorial indefinitely, in order to provide a resource that they can refer back to as they begin to use these skills with patients.

Eligibility Criteria:
Inclusion Criteria:

* Mental health professional

Exclusion Criteria:

* Student or employee of Columbia University
Absorption and Systematic Pharmacokinetics of Topically Applied IDP-120 Gel

Study designed to assess the safety and plasma PK of tretinoin and its metabolites from topically applied IDP-120 gel.

An Open-label study designed to assess the safety and plasma PK of tretinoin and its metabolites from topically applied IDP-120 gel.

Eligibility Criteria:
Key Inclusion Criteria:

* Male or female between the ages of 9 and \<17 (16 years 11 months)
* Written and verbal informed consent must be obtained. Subjects less than age of consent must sign an assent for the study and a parent or legal guardian must sign the informed consent.
* Subject must have a score of 3 (moderate) or 4 (severe) on the Evaluator's Global Severity assessment.
* Subject with facial acne inflammatory lesion count no less than 20 but no more than 40.
* Subject with facial acne non-inflammatory lesion count no less than 20 but no more than 100.

Key Exclusion Criteria:

* Use of an investigational drug or device within 30 days of enrollment, previous participation in a research study with IDP-120 Gel, or participation in a research study concurrent with this study.
* Any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobate, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gram-negative folliculitis.
* Any underlying disease or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion counts inconclusive.
* Subjects with a facial beard or mustache that could interfere with the study assessments
* Subjects with more than 2 facial nodules.
Photobiomodulation With Red and Infrared LED Device for Temporomandibular Dysfunction

Temporomandibular Dysfunction - TMD is considered the main cause of orofacial pain of non-dental origin, and a public health problem. Due to their complexity there are already treatments using various forms of therapy. Photobiomodulation using different light sources, in a single or combined form, makes it possible to use it as another therapeutic resource to be explored. The objective of this study will be to evaluate the effects of photobiomodulation with simultaneous use of light emitting diodes (LEDs), red and infrared, on clinical aspects in individuals with TMD. A randomized, controlled and blind clinical trial is proposed, which will involve 33 individuals (n = 11 per group) of both genders, aged 18-45 years in three groups: Group 1 - LED; Group 2 - placebo and Group 3 - control, submitted to 6 nonconsecutive sessions of photobiomodulation totaling 2 weeks of treatment. The Research Diagnostic Criteria for Temporomandibular Disorders - RDC/TMD will be used to determine the TMD and evaluate the participants. Pain will be assessed using the visual analog scale (VAS), mandibular range of motion will be determined with the aid of a digital caliper, and the electrical activity of the masticatory muscles will be verified by electromyography. A mixed plate of 18 red LEDs - 660 nm and 18 infrared LEDs - 850 nm with power of 3.5 mW per LED, 4.45 mW/cm2, radiant exposure of 5,35 J/cm2, irradiated area of 14.13 cm2, and energy of 75.6 J, in the temporomandibular joint (TMJ) region and in the masseter and temporal muscles, bilateral in 6 sessions. Participants from all groups will be reassessed after the first therapeutic intervention, and again at the end, following the same evaluation procedures used initially.


Eligibility Criteria:
Inclusion Criteria:

* Present TMD;
* Complete dentition (except third molars);
* Present mandibular deviation and/or deflection.

Exclusion Criteria:

* Occlusal changes;
* Use of any type of dental prosthesis;
* Current orthodontic or physiotherapeutic treatment;
* Use of any type of medication during the phases of the study.
Beta-lactam Pharmacokinetics in Patients With Infective Endocarditis

The recommended length of antibiotic treatment to patients with infective endocarditis is 4-6 weeks. All patients receive the same dosis except for those with renal impairment who receive a smaller dose. For Beta-lactam antibiotics, a plasma concentration above the minimal inhibitory concentration (MIC) for at least 50% of the time in a dosing interval maximize bactericidal activity. To estimate the time for which the antibiotic concentration is above the MIC (T\>MIC) and to see if there might be a relationship between the concentration of antibiotics and possible side-effects, toxicity and treatment failure, all patients admitted with infective endocarditis will be followed and have two blood tests withdrawn once a week during antibiotic treatment, an expected average of 5 weeks.

Comorbidity is common in patients admitted with infective endocarditis and this may effect the pharmacokinetics of antibiotics. The same dose of antibiotics may therefore result in different plasma concentrations in different patients, and this might influence possible side-effects, toxicity and treatment failure.

To investigate this further, all patients admitted with infective endocarditis, treated with Beta-lactam antibiotics, will be followed and have two blood tests withdrawn once a week during antibiotic treatment, an expected average of 5 weeks. Beta-lactam is administered every 6th hour. The first blood test will be withdrawn three hours after antibiotic infusion. The second blood test will be withdrawn right before the next antibiotic infusion. There is no intervention in the study, the results are observational. The results will contribute to assess the efficacy and quality of the treatment and help evaluate whether plasma concentration of antibiotics should be taken as a routine blood test every week in patients with infective endocarditis.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted with infective endocarditis
* Treatment with Beta-lactam antibiotics

Exclusion Criteria:

* Under 18 years of age