cyrilzakka/clinical-trials huggingface dataset:
Online Education Intervention to Reduce Ageism Among Undergraduate Students

Ageism is common is healthcare workers, and that results in negative outcomes for elderly patients. This randomized controlled trial is to determine if age bias could be changed by an online learning activity in undergraduate students in an entry-level nutrition class.

This randomized controlled trial with two parallel arms is to determine the effect of an online educational intervention developed to reduce ageism in undergraduate students enrolled in an entry-level Nutrition class. Eligible study participants will be randomized into either the "Intervention group" (INT) or the "Control group" (CON). The two groups will have different learning material delivered online via Blackboard (Learning Management System/LMS). These include a collection of short videos developed by the researchers, as well as relevant videos available on the web. Participants in the INT group will learn about aging and ageism, while the CON group will learn about diversity and cultural competence. Sociodemographic data, percieved risk of COVID-19, preventative behaviors related ot COVID-19 will be collected using a questionnaire at baseline. Ageism will be assessed using standard questionnaires. Data collection will be done at three time points: Pre-intervention, immediate post intervention and 2-weeks post-intervention. Difference between groups for pre-post intervention changes will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Enrolled in 3 sections of the introductory level nutrition course taught by three different instructors.
A Comparison Between Two Techniques for Performing Decompressive Craniectomy

The purpose of this study is to compare two surgical techniques for a neurosurgical procedure used to treat cerebral edema (decompressive craniectomy): with watertight duraplasty vs. without watertight duraplasty (rapid closure decompressive craniectomy).

After clinical indication for unilateral decompressive craniectomy (DC), patients were randomized by numbered envelopes into 2 groups: with watertight duraplasty (control group) vs. without watertight duraplasty / rapid closure DC (test group). In all cases, a large trauma flap (i.e. large reverse question mark starting from the tragus and extending to the midline) was performed. Skin, galea and muscle layers were elevated according to surgeon preference. Thus a wide (at least 12x15cm) craniotomy was performed and the temporal bone was removed until flush with the middle fossa floor. After dural opening, watertight duraplasty with pericranium or an artificial graft (at surgeon's discretion) was performed in the control group, while no watertight duraplasty was performed in the test group, and exposed brain parenchyma was covered with Surgicel®. Usual closure was then performed. Patients were then monitored daily by evaluators blinded to the randomization (control or test group) from the date of surgery until hospital discharge or death.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the Neurotrauma Service of the Hospital of Restoration from January 2012 to December 2013, age range 18 to 60 years old and with clinical indication for decompressive craniectomy.

Exclusion Criteria:

* Indication for bifrontal decompressive craniectomy.
* Indication for Posterior Fossa decompressive craniectomy
* Patients with intra-axial contusions or hematomas requiring surgical evacuation in which case injury to the arachnoid could lead to an increased risk of cerebrospinal fluid leak
Fat Supplementation on Dumping Syndrome Associated Symptoms

The purpose of the study is the investigation of the effect of fat supplement on gastric emptying rate and the appearance of symptoms of Dumping Syndrome in patients who have undergone gastrointestinal- duodenal surgery. Patients who have undergone bariatric surgery have been examined for the presence of the Dumping syndrome, with glucose measurements, the Sigstad's questionnaire and questionnaire of Arts. Patients diagnosed positive, reiterated the examination process in a second meeting consuming an extra fat supplement. The data obtained on the different appointments were compared between the two groups in a cross over design.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Dumping Syndrome

Exclusion Criteria:

* Patients with diabetes mellitus type 1 and 2, Patients with impaired balance of fluids and electrolytes, Patients on diuretics pills or corticosteroids or hypoglycemic tablets and Insulin.
Erythropoietin in the Treatment of Anemia After Autologous Hematopoietic Stem Cell Transplantation

This is an randomized trial to evaluate the potential benefit of erythropoietin in the treatment of anemia in patients with lymphoma after autologous hematopoietic stem cell transplantation.

Lymphoma patients with anemia on day +15 post-transplant will be randomized to erythropoietin group or control group. Potential benefit of erythropoietin will be evaluatedon day +60 post-transplant.

Eligibility Criteria:
Inclusion Criteria:

* confirmed lymphoma
* first autologous hematopoietic stem cell transplantation
* hemoglobin level less than 100 g/L on day +15 post-transplant
* written informed consent given by patient or his/her guardian if of minor age.

Exclusion Criteria:

* HIV positive
* Known allergy to recombinant human erythropoietin
* Uncontrolled infection
TACE Combined With Lenvatinib and PD-1 Inhibitor for Ruptured Hepatocellular Carcinoma

Hepatocellular carcinoma (HCC) with spontaneous rupture is a potentially fatal complication and usually has poor prognosis. In most conditions, the tumors could not be radically moved. Then minimally therapy like transcatheter arterial chemoembolization (TACE) could effectively stanch the ruptured tumor and bleeding vessels. Then TACE combined the Lenvatinib and PD-1 inhibitor for this subtype HCC could effectively inhibit the tumor and improve the prognosis.

Spontaneous rupture of HCC is a life-threatening complication. HCC rupture is considerably higher in China. The tumor size in ruptured HCC is significantly greater than that in non-ruptured HCC. In the acute phase, hemostasis is the first concern and then tumor treatment is secondary. TACE can effectively induce hemostasis. Conservative treatment is usually system therapy for unresectable ruptured HCC. Thus, we conduct this multicenter single arm study to explore the efficacy, safety of TACE combined lenvatinib and PD-1 inhibitor for unresectable ruptured HCC. This study focuses on the efficacy of TACE combined with lenvatinib and PD-1 inhibitor as first-line therapy.

Eligibility Criteria:
Inclusion Criteria:

1. diagnosis of primary HCC, confirmed histologically or clinically according to the criteria of the American Association for the Study of Liver Diseases;
2. presence of hemostasis in the enhanced CT scan;
3. integrity of the tumor is disrupted and there is hematoma around the liver;
4. receipt of Lenvatinib and PD-1 inhibitor as the first-line systemic therapy;
5. transarterial artery chemoembolization (TACE) as local therapy;
6. classified as Child-Pugh class A or B and having an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2;
7. no history of other malignancies.
8. life expectancy more than 3 months;
9. agreed to participated in this clinical trial;
10. Hemameba ≥3.0 x109/L, neutrophil ≥1.5x109/L, hemoglobin≥10.0 g/L, platelet≥100x 109/L, ALT; AST; bilirubin ≤1.5-fold normal, GFR≥60ml/min.

Exclusion Criteria:

1. recurrent HCC;
2. non-ruptured HCC;
3. Lenvatinib and PD-1 inhibitor treated with as second systemic therapy;
4. age \< 18 years or \> 75 years;
5. HCC with more than five metastases;
6. History of hepatic encephalopathy and gastrointestinal bleeding
7. life expectancy less than 3 months.
Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution

The use of venetoclax-based therapies for pediatric patients with relapsed or refractory malignancies is increasingly common outside of the clinical trial setting. For patients who cannot swallow tablets, it is common to crush the tablets and dissolve them in liquid to create a solution. However, no PK data exists in adults or children using crushed tablets dissolved in liquid in this manner, and as a result, the venetoclax exposure with this solution is unknown.

Primary Objectives

• To determine the pharmacokinetics of venetoclax when commercially available tablets are crushed and dissolved into a solution

Secondary Objectives

* To evaluate the safety of crushed venetoclax tablets administered as an oral solution
* To determine the pharmacokinetics of venetoclax solution in patients receiving concomitant strong and moderate CYP3A inhibitors
* To determine potential pharmacokinetic differences based on route of venetoclax solution administration (ie. PO vs NG tube vs G-tube)
* To determine the concentration of venetoclax in cerebral spinal fluid when administered as an oral solution

Peripheral blood will be drawn at multiple time points to evaluate venetoclax pharmacokinetics in patients who are receiving venetoclax solution made from crushed tablets as part of their oncology treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age: Patients must be \<39 years of age at time of study enrollment
* Diagnosis: Patients may have a diagnosis of any hematologic malignancy
* Central access: Patients must have an existing venous or arterial access line for PK blood draws
* Weight requirement: Patients must weigh at least 5.5 kg at the time of enrollment
* Venetoclax: Patients must be receiving any dose of venetoclax given as a solution made from crushed tablets by mouth (PO) or via nasogastric (NG), or G-tube as prescribed by their treating oncologist.
* Concurrent chemotherapy medications: Patients may receive venetoclax as a single agent or in combination with any other chemotherapeutic agents.

Exclusion Criteria:

* Pregnant women are excluded from this study because venetoclax has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with venetoclax, breastfeeding should be discontinued if the mother is treated with venetoclax.
* Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while on study treatment and for six months following completion.
Safety and Treatment Effect of QBECO in Moderate to Severe Crohn's Disease

The purpose of this study is to evaluate the safety profile and to obtain an indication as to the therapeutic effect of QBECO induction treatment on clinical improvement in moderate to severe Crohn's Disease.


Eligibility Criteria:
Inclusion Criteria:

* An adult, age 18 and above
* Diagnosed with Crohn's disease AT LEAST six (6) months prior to screening
* Crohn's disease diagnosis was verified by one of these procedures: 1) Colonoscopy 2) Capsule endoscopy 3) Computed Tomography (CT) scan 4) Magnetic Resonance Imaging (MRI) 5) Ultrasound
* Active Crohn's disease at the time of screening
* Female participants: Agree to practice two effective methods of contraception, at the same time, from the time of signing the informed consent form, during the entire study treatment and for two (2) months after taking the last dose of study treatment.
* Male participants: Agree to practice effective barrier contraception during the entire study treatment period and for two (2) months after taking the last dose of study treatment.

Exclusion Criteria:

* Currently pregnant or breastfeeding
* Have known or suspected hypersensitivity to any component of the product
* Had more than three (3) small bowel resections or diagnosis of short bowel syndrome
* Currently anticipate undergoing any major surgical intervention for Crohn's disease during the next six (6) months
* Previously been treated with any Qu Biologics' Site Specific Immunomodulators (SSIs) for any disease
* Diagnosed with chronic (i.e., long term) hepatitis B or C infection
* Diagnosed with congenital (i.e., existing at or before birth) or acquired immunodeficiency (i.e., lack of body defense system). For example, human immunodeficiency virus (HIV) infection, organ transplantation (i.e., specifically received an organ from a donor), etc.
* Daily use of narcotic drugs containing opiates (such as morphine, codeine, etc.) for pain control
* Have a current or recent history (within the past 12 months) of alcohol dependence or illicit drug use, with the exception of medicinal marijuana prescribed by a physician
* Have a history of cancer within the last five (5) years. Exceptions may apply for cervical cancer and some forms of skin cancer
The Prevalence and Associated Factors of Early Deterioration After Successful Recanalization in Acute Ischemic Stroke

stroke is a leading cause of morbidity and mortality worldwide. More than half (54.5%) of the 56.9 million deaths worldwide in 2106 were due to the top 10 causes.

Ischemic heart disease and stroke are the world's biggest killers, accounting for a combined 15.2 million deaths in 2106. These diseases have remained the leading causes of death globally in the last 15 years.

Recent clinical trials have shown that endo-vascular thrombectomy is an effective and safe recanalization modality for acute ischemic stroke patients .

Meta-analysis results show that endovascular treatment is associated with a high ratio of successful recanalization rate and a low rate of symptomatic hemorrhage .

Approximately 2.2-37.5% of patients with acute ischemic stroke might encounter early neurological deterioration (END).

Definition of END: An increase in NIHSS ≥4 or an increase in Ia of NIHSS ≥1 within 72 h after recanalization treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Ischemic stroke of both sex.
2. More than 08 years.
3. Accepting all study requirements.
4. within time window for thrombolysis or thrombectomy
5. fulfilling criteria for thrombolysis or thrombectomy

Exclusion Criteria:

(A)Absolute Contraindications :

1. Intracerebral hemorrhage history or presence on imaging
2. Time of onset more than 465 hours
3. Blood pressure greater than 085/000 mm Hg
4. Recent severe head trauma or neurosurgical intervention
5. Coagulopathy (INR \>067, thrombocytopenia, recent use of heparin or direct oral anticoagulants)
6. Endocarditis (infective)
7. Aortic dissection (B)Potential Contraindications :

1.Seizure at onset 2.Noncompressible arterial puncture 3.Recent surgery 4.Gastrointestinal or genitourinary bleeding 5.Multiple cortical microbleeds (\>00) 6. Large intracranial aneurysms or arteriovenous malformations 7.Recent transmural myocardial infarction 8. Small NIHSS with nondisabling stroke symptoms
The Role of Vitamin D Supplementation on Well Being and Symptoms of Depression During the Winter Season in Health Service Staff

The purpose of this study is to investigate whether vitamin D3 (70 micrograms) is better than placebo in preventing depression symptoms among employees in health care

Vitamin D3 is produced in the skin after exposure to ultraviolet B light from the sun. Vitamin D3 is metabolised sequential in the liver into 25-hydroxy-vitamin D \[25(OH)D\], which is the storage form of vitamin D in the body, and then in the kidney into the steroid hormone, 1a,25-dihydroxyvitamin 1a,25-dihydroxyvitamin D \[1,25(OH)2D\].

At higher latitudes ultraviolet B light is stopped by the atmosphere during winter season. Half of Danes have low levels of \[25(OH)D\] in the blood and especially in the early spring months the levels of \[25(OH)D\] are low. In addition, Vitamin D3 is absorbed through the gut from vitamin D-rich food sources. But several studies show that it is not possible through a recommended diet, which consists of 300 g of fish per week to consume adequate amounts of vitamin D3.

New research suggests link between vitamin D3 and brain function.In the Central Nervous System (CNS) there are specific nuclear receptors for 1,25(OH)2D (VDR) and the enzymes necessary for the hydroxylation of 25(OH)D to 1,25(OH)2D are also present in CNS.

In clinical studies, low serum levels of 25(OH)D, have been associated with reduced cognitive function, anxiety and depression.

The objective of this randomized clinical trial is to investigate whether indoor employees, with tendency to depressive symptoms in the winter season, should be offered vitamin D3 supplements during the Winter season, or it has no significance in relation prevent depressive symptoms.

The study is carried out in the winter season in the Region of Southern Denmark for 12 weeks and offered to health service staff, who have a tendency for depressive symptoms in the winter season.

Eligibility Criteria:
Inclusion Criteria:

* Health service staff and employee in the Region of Southern Denmark.
* Tendency to depressive symptoms in the winter season SPAQ\>7.

Exclusion Criteria:

* clinical diagnosis sarcoidoses
* tuberculosis
* bipolar affective disorder
* schizophrenia
* hypercalcemia
* hyperphosphatemia
* pregnancy
* hyperparathyroidism
* reduced kidney function
Multi-Omics for Maternal Health After Preeclampsia

To develop strategies to identify postpartum women at risk for adverse cardiovascular outcomes and provide them with preventative therapies.

The investigators will recruit and retain a diverse population of pregnant women who are high- and low-risk for hypertensive disorders of pregnancy/preeclampsia (HDP/PE) for longitudinal collection of phenotypic and environmental exposure measures and biosamples for integrative analysis of phenotypic, environmental, and multi-omic data to understand links between development of HDP/PE and associated fetal pathologies during pregnancy, as well as postpartum maternal health. Participation in the study will begin no later than the second trimester of pregnancy (enrollment by 24 weeks of gestation) and continue through the first year postpartum. Over the course of the study, biospecimens and relevant surveys and cardiovascular assessments will be collected at specified intervals/time-points, as outlined in the table below. In-person study visits should take no more than 30 minutes. Relevant medical information collected as part of routine clinical care will be obtained from the electronic medical record (EMR). The study will take place at UCSD and VUMC prenatal clinics and hospital labor and delivery units, or another private location of the participants choosing, such as their home or office.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women 18 years of age to 50 years of age
* 10-24 weeks gestation at time of enrollment
* Singleton pregnancy
* Planning to deliver at a study site (UCSD or VUMC)

Exclusion Criteria:

* Inability to give informed consent
* Intrauterine fetal demise
* Fetal genetic or structural anomaly
* Institutionalization for psychiatric disorder, mental deficiency or incarcerated
* Active or history of malignancy requiring major surgery or systemic chemotherapy
* Multi-fetal gestation or a twin demise at any gestational age
* Known maternal or fetal chromosomal anomalies
* Patients who plan to keep their placenta after delivery
Non-Interventional Study Of Indian Patients With Advanced Renal Cell Cancer Receiving Therapy With Sutent

The Sutent® Observational Study is being proposed to assess the real-world usage patterns and effectiveness and tolerability of treatment of Indian patients with advanced renal cell cancer with Sutent®. Generation of such information is expected to aid everyday clinical decision-making by Indian doctors and will add to the body of generalizable evidence.

The assignment of the patient to Sutent® treatment is not decided in advance by this noninterventional study protocol, but falls within current practice. The decision to prescribe Sutent® is clearly not driven by the decision to include the patient in this study.The sample size for this study is not based on statistical considerations. It is expected that a minimum of 100 patients will be enrolled in the study by the end of the first year and the data collected would be adequate to fulfill the observational objectives of the study.The study will be initiated at 10 sites across India during the 1st year. The study may be expanded with the addition of new sites during the 2nd year.

Eligibility Criteria:
Inclusion Criteria:

* Patients with advanced renal cell cancer
* Treatment naïve or cytokine refractory

Exclusion Criteria:

* Patients presenting with a known hypersensitivity to Sunitinib or its metabolites
Healthy Growth Abbreviated Pilot Study

This is a single-group feasibility pilot trial of a peer-based, social media intervention to prevent obesity in infants.

This novel intervention, delivered to mothers primarily through private Facebook groups, will promote behavior change through peer and self-modeling photo/video activities.

In this study, we will implement an abbreviated 2-month version of the intervention with a single peer group of up to 10 mothers. We will assess the feasibility and acceptability of both the intervention and our intended outcome measures, in preparation for a randomized pilot trial of the full intervention.

Eligibility Criteria:
Inclusion Criteria:

* Women age 18 years and older
* Enrolled in Medicaid at the time of study enrollment
* Overweight or obese (BMI \>= 25, calculated using self-reported pre-pregnancy height and weight)
* Subjects able to speak, read and write in English
* Attend their infant's (up to 1 month old) primary care visit at a CHOP Primary Care Network site
* Received prenatal care
* Own a smartphone with both a data and text plan
* Able to use their phone to obtain photographs and videos prior to enrollment

Exclusion Criteria:

* Cannot provide consent.
* Non-English speaking.
* Score 10 or greater on Patient Health Questionnaire (PHQ-9) measure for clinical depression
* Diagnosed with gestational diabetes during pregnancy with their newborn
* Had a multiple pregnancy.
* Premature delivery (before 37 weeks) of their newborn.
* Have a newborn who was hospitalized in the Neonatal Intensive Care Unit (NICU) for one week or longer.
A Study Investigating the Movement of Lu AF28996 Into, Through, and Out of the Body of Healthy Men

The main goal of this study is to learn about how Lu AF28996 moves into, through, and out of the body after a single dose is given to healthy male participants.


Eligibility Criteria:
Key Inclusion Criteria:

* The participant has a Body Mass Index (BMI) \>=18.5 and \<=30 kilograms per square meter (kg/m\^2) and body weight ≥60 kg at the Screening Visit and at the Baseline Visit.
* The participant has a resting supine pulse \>=50 and \<=100 beats per minute (bpm) at the Screening Visit and at the Baseline Visit.
* The participant is, in the opinion of the investigator, generally healthy based on medical history, a physical examination, a neurological examination, vital signs, an electrocardiogram (ECG), and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests.

Key Exclusion Criteria:

* The participant has participated in a clinical trial \<30 days prior to the Screening Visit.
* The participant has taken any investigational medicinal product \<3 months or \<5 half-lives of that product, whichever is longest, prior to the first dose of investigational medicinal product (IMP).
* Participants with exposure to significant diagnostic or therapeutic radiation (eg, serial X-ray, computed tomography scan, barium meal) or current employment in a job requiring radiation exposure monitoring within 12 months prior to check-in.

Other protocol-defined criteria apply.