cyrilzakka/clinical-trials huggingface dataset:
Adapting Web-based Instruction to Baseline Knowledge of Physicians-in-training

The purpose of this study is to compare an adaptive Web-based learning system to a non-adaptive system for teaching physicians-in-training about ambulatory medicine.

Not all Web-based instruction is equally effective at facilitating learning. Adaptation to characteristics of individual learners may enhance Web-based learning by emulating a face-to-face teacher's response to a learner's needs. Learner baseline knowledge level is one variable to which Web-based instruction may adapt. We will enhance Web-based instructional modules used in the Internal Medicine resident continuity clinics so that they adapt to learner baseline knowledge. We will then compare the adaptive Web-based format to the standard format. We hypothesize that the adaptive format will have higher learning efficiency, and that achievement will be similar for the two groups. We also hypothesize that residents will prefer the adaptive format and find it to be more motivating than the standard format.

Eligibility Criteria:
Inclusion Criteria:

* Internal medicine residents (Mayo-Rochester campus)
A Safety Evaluation of ECG Intervals and Blood Pressure in Normal Healthy Volunteers After Use of Nebivolol, Atenolol, Moxifloxacin, or Placebo

Nebivolol is one of a class of drugs known as beta-blockers. These drugs are useful in the treatment of high blood pressure, angina, abnormal heart rhythms and following a heart attack. The purpose of this study is to explore the potential of nebivolol to cause a certain type of abnormal heart rhythm, known as QTc prolongation. The potential of nebivolol to cause this adverse event will be compared to three other drugs: atenolol, a beta-blocker approved by the FDA; Avelox (moxifloxacin), an anti-biotic approved for use by the FDA which is known to cause QTc prolongation; and placebo, a drug look-alike that contains no drug. The working hypothesis was that 20 or 40 mg of nebivolol would not prolong corrected QT intervals measured during peak nebivolol concentrations (i.e., 2 hours after dosing) on Day 7.


Eligibility Criteria:
Inclusion Criteria:

* Men and nonpregnant, nonlactating women were 18 years or older.
* Women declaring postmenopausal or surgical sterility.
* Women of childbearing potential who had a negative serum HCG within 2 weeks of dosing.
* Male subjects weighed at least 60 kg (132 lb), and female subjects weighed at least 48 kg (106 lb). All volunteers weighed within 15% of their ideal body weight (IBW).

Exclusion Criteria:

* Institutionalized
* Reported or was known to have done the following:

  * Used any tobacco product.
  * Ingested any alcoholic, caffeine or xanthine containing food or beverage within the 48 hours prior to the initial dose of study medication
  * Consumed grapefruit or grapefruit containing products within 7 days prior to the initial dose of study medication.
  * Ingested any vitamins or herbal products within the 48 hours prior to the initial dose of study medication.
  * Recently changed dietary or exercise habits significantly
* Used any medication (including over-the-counter \[OTC\]) within the 14 days prior to the initial dose of study medication.
* Used any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication.
* Received an investigational drug within 30 days prior to the initial dose of study medication.
* History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, or neurologic disease.
* History of drug and/or alcohol abuse within 1 year prior to the study.
* Acute illness at the time of either the pre study medical evaluation or dosing.
* Any laboratory results deemed clinically significant by the physician.
* Abnormal and clinically relevant ECG tracing.
* Donated or lost a significant volume of blood or plasma (\>450 mL) within 28 days prior to the initial dose of study medication.
* Allergic or hypersensitive to nebivolol, atenolol, or other β blocking drugs or to moxifloxacin or other quinolone antibiotics.
* History of seizures or cerebrovascular disease.
Access to EyeGlasses for School-aged Children

Uncorrected refractive error is a leading cause of visual impairment in children and can impact vision, quality of life, and academic performance. Despite Boston Children's Hospital serving patients from a wide range of socioeconomic backgrounds, there are health disparities in access to eyeglasses as a consequence of patients' health insurance. The investigators will examine whether the use of an in-clinic app for 3-D printed glasses reduces disparities in access to eyeglasses for our patients on Medicaid. The intervention will address social determinants of health and improve pediatric health outcomes namely, how and when children having publicly funded health insurance receive eyeglasses. The short-term objectives are (1) to compare the time to receive glasses between publicly funded MassHealth eyeglasses and an in-clinic order of 3D printed glasses (2) to evaluate compliance with glasses wear in these two groups, and (3) to evaluate visual function and quality-of-life outcomes in these two groups. This prospective randomized control study will evaluate barriers to accessing eyeglasses in school-aged children. The investigators will recruit children enrolled in MassHealth and randomize them into two cohorts: (1) the control group will receive MassHealth glasses as per standard of care, through an optical shop of their choosing, or (2) the intervention group will use an app for immediately ordering glasses (paid for by the study) in clinic following their appointment. The investigators will evaluate the time needed to receive eyeglasses, compliance with glasses wear, quality of life, and visual outcomes between the cohorts at one-, three-, and six-month intervals. Through this project, the investigators will not only evaluate, quantify, and bring awareness to disparities in our patient population, but will also look toward finding a solution through the use of a novel application that addresses many of the barriers faced by patients insured through Medicaid.


Eligibility Criteria:
Inclusion Criteria:

* Masshealth insurance
* first-time glasses wearers
* receive a diagnosis of refractive amblyopia, myopia, hyperopia and/or astigmatism requiring spectacle correction for optimal vision at distance and near.
* Glasses must be recommended for full time wear by the attending optometrist or ophthalmologist

Exclusion Criteria:

* strabismus
* developmental or learning delay
* other ocular pathology
Therapeutic Play and Its Effect on Children's Psychosocial Well-Being

The aim of this study was to evaluate the effectiveness of the Therapeutic Play-Based Intervention Programme (TOTEM), which was developed to reduce the negative psychosocial effects of the earthquake in children aged 4-6 years, and its effect on children's psychosocial well-being.

Earthquakes are among the most impressive geological processes and are defined as an unpredictable natural disaster due to their destructive effects on people and structures. In Turkey, a 7.7-magnitude earthquake occurred on 6 February 2023 at 04.17 local time, centred in Kahramanmaraş, and another 7.6-magnitude earthquake occurred about nine hours later. In addition, more than 1000 aftershocks were recorded in the region and these events further increased the scale of the disaster. Earthquakes have the potential to have profound and traumatic effects on people's psychological functioning. Children are particularly affected by these effects due to their vulnerability during natural disasters. Children who experience disasters may face various problems in physical, cognitive and socio-emotional development.

Therapeutic play intervention is based on the belief that play is a universal language that allows children to easily express their feelings and thoughts. This approach is an effective strategy that helps the child to explore their problems, seek solutions, express their feelings and emotional regulation. It also promotes cognitive development, reduces anxiety and stress, and increases confidence.

Providing appropriate support to children after a traumatic event such as an earthquake is critical for preventing future psychological problems. In this context, providing children with supportive approaches such as play therapy and conducting these methods by expert teams can contribute to children's well-being. Therapeutic games play an important role by providing a universal language for children to express their emotions and cope with stress.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 4-6
* Having literate parents
* Having adequate Turkish receptive-expressive language skills
* Not having a previously diagnosed psychiatric problem declared by the parents
* Not having participated in a training programme on psychosocial well-being before
* Not attending any pre-school education institution at the time of the training
* Volunteering to participate in the study by themselves and their parents

Exclusion Criteria:

* The participant wants to leave the study
* The participant has not participated in one or more of the trainings to be given within the scope of the programme
* The participant shows any diagnosed atypical development
* Children who show a level of resistance that disrupts their adaptation to normal life in pre-tests, during the study or in post-tests, children with anxiety disorder or other psychiatric problems
Zero Ischemia Robot-Assisted MWA Assisted Suture-less Tumor Enucleation of RCC With T1 Stage

Zero ischemia laparoscopic radio frequency ablation assisted tumor enucleation has been proved to enable tumor excision with relatively better renal function preservation comparing with conventional laparoscopic partial nephrectomy for T1a renal cell carcinoma (RCC) in a randomized clinical trial in single center. The investigators want to explore this technique to robotic surgery and add suture-less technique to T1 RCC patients in randomized clinical trial.

Zero ischemia laparoscopic radio frequency ablation assisted tumor enucleation has been proved to enable tumor excision with relatively better renal function preservation comparing with conventional laparoscopic partial nephrectomy for T1a renal cell carcinoma (RCC) in a randomized clinical trial in single center. The investigators want to explore this technique to robotic surgery and add suture-less technique to T1 RCC patients in randomized clinical trial. This project is based on the previous research and aims to develop an approach of the combination of intraoperative real time contrast-enhanced ultrasonography technology, sutureless technology and the zero ischemia robot-Assisted tumor enucleation of the kidney. By using the real time contrast-enhanced ultrasonography technology, the current shortcomings of the zero ischemia laparoscopic radio frequency ablation assisted tumor enucleation were overcome. The degree of elimination was monitored during surgery to avoid excessive bleeding caused by insufficient ablation during the surgery. Beside, the difficulty of zero ischemia laparoscopic radio frequency ablation is reduced, and doctors can quickly grasp the learning curve of this technology.

Eligibility Criteria:
Inclusion Criteria:

1. patients with sporadic, unilateral, newly diagnosed T1 presumed renal cell carcinoma
2. patients scheduled for robot-assisted laparoscopic nephron sparing surgery
3. patients with normal contralateral renal function (differential renal function of \>40% as determined by radionuclide scintigraphy)
4. patients agreeable to participate in this long-term follow-up study

Exclusion Criteria:

1. patients' age \>80 years
2. patients with other renal diseases (including kidney stone, glomerular nephritis, etc.)which might affect the renal function of the operative kidney
3. patients not able to tolerate the robot-assisted laparoscopic procedure
4. patients with previous renal surgery or history of any inflammatory conditions of the operative kidney
5. patients with the renal tumor involving urinary collecting system or distance from the tumor edge to the collecting system ≤ 4 mm
Observational Study on Safety of Self-titration of Once Daily Levemir®

This study is conducted in Europe. The main objective of the study is to assess the safety of self-titration in type 2 diabetic patients on antidiabetic tablets who are receiving insulin for the first time. The study will also look at the blood glucose control, frequency of dose adjustment, clinic visits, and time spent training patients to self-titrate.

The objective of diabetes management is to achieve blood glucose levels as close as possible to normal in order to avoid late stage diabetic complications. Self-titration (where patients adjust insulin dosage themselves) offers the potential for better blood glucose control than titration only at clinic visits. In recent years treatment of type 2 diabetes in the United Kingdom has moved from hospitals to GP surgeries or local clinics. Patients with type 2 diabetes, in general, have not been trained in self-titration to the same degree as patients with type 1 diabetes. Less experience in self-titration could impact the level of blood glucose control and outcome for these patients.

Data from this study will be pooled with data from NN304-3714 (NCT00825643) and will be reported in the final study report for NN304-3714.


Eligibility Criteria:
Inclusion Criteria:

* After the participating physician/nurse's decision has been made to initiate once daily Levemir® therapy (within the license of the product), any patient with type 2 diabetes of 18 years or older who is currently treated with diet, exercise and one or more OADs can be offered to participate

Exclusion Criteria:

* Patients unable to give written informed consent
* Current treatment with insulin
* Patient deemed unable or unwilling to self-titrate
* Known or suspected allergy to study product or related products
* Pregnancy or breastfeeding or intention of becoming pregnant within the next 6 months
Digital Body Mindset Intervention for Young Cancer Survivors

The aim of this study is to assess whether a digital body mindset intervention - EMBody - can instil adaptive mindsets and improve health and wellbeing in young cancer survivors aged 16-25.

EMBody (Exploring Mindsets about the Body) is a brief digital intervention comprising documentary-style films and reflection activities which aim to instil adaptive mindsets in young people who have previously completed cancer treatment. EMBody was co-created with young cancer survivors, paediatric oncologists with decades of clinical experience, and documentary filmmakers.

EMBody comprises three modules which include seven short films and accompanying reflection activities. The films feature young cancer survivors sharing their challenges of life after cancer and how their mindsets have supported them through these challenges. The films also feature oncology clinicians sharing their experience of the importance of mindsets in life after cancer, and psychological scientists who share information about what mindsets are and how they can be harnessed.

The main objective of the study is to assess whether a digital body mindset intervention (EMBody) can instil adaptive mindsets and improve health and wellbeing in young cancer survivors aged 16-25 years.

Researchers will compare the EMBody digital intervention with a waitlist attention control group to see if EMBody can instil adaptive mindsets and improve indicators of health and wellbeing in comparison to being enrolled in a study and completing study measures alone.

Eligibility Criteria:
Inclusion Criteria:

* Ages 16-25 years
* Previously received a cancer diagnosis including but not limited to leukemia, Hodgkins/non-Hodgkins lymphoma, osteosarcoma, Ewing sarcoma, or CNS tumour
* Completed active, primary cancer treatment
* Are up to seven years off treatment

Exclusion Criteria:

* Significant cognitive impairment that would interfere with engagement with digital materials
* Not able read or write in English
* Active suicidal intent
* Currently receiving active treatment for primary or secondary cancer
* Completed cancer treatment more than seven years ago
A Trial of n-3 PUFA-Enriched Ready to Use Therapeutic Food for Childhood Severe Malnutrition

The investigators will perform a randomised controlled trial of the provision of food designed for rehabilitation of malnourished children that is supplemented with n-3 fatty acids compared to usual composition. The investigators want to see whether the provision of such a food normalises the deficiencies in essential fatty acids observed in severely malnourished children faster than standard composition.

Randomized controlled trial of n-3 Polyunsaturated Fatty Acid-Enriched Therapeutic Food for Severe Malnutrition.

Description of Study Design: Randomized Controlled Trial

Study Duration: 6 months (Trial); 12 months (All trial-related activities)

Description of Intervention: Provision of ready to use food (RUTF) enriched with flax seed oil, with or without fish oil, compared to conventional-composition RUTF. Interventional product will be given until nutritional recovery to a maximum of 12 weeks.

Design: Flax-enriched or standard RUTF allocation is randomised and double blind. Fish oil allocation is randomised within those receiving flax-enriched RUTF and is open label.

Location: Kilifi District, coastal Kenya.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 6 months to 5 years old
* Provision of informed consent
* Severe malnutrition (one or more of mid-upper arm circumference \<11.5cm, weight for height z score \<-3, or nutritional oedema)
* Stabilised and eligible to receive RUTF according to national guidelines

Exclusion Criteria:

* Known HIV disease, tuberculosis or other chronic infection\*
* Known allergy or hypersensitivity to any of the product ingredients

  * Chronic infections such as HIV and tuberculosis and their treatments are likely to cause alterations in lipid metabolism that may confound interpretation of this pilot trial. national guidelines recommend offering provider-initiated testing for HIV for all severely malnourished children, and referral for comprehensive care in the case of a positive test.
Pilot Study Of Pregabalin And Prediction Of Treatment Response In Patients With Postherpetic Neuralgia

The primary objective is to explore whether sensory symptom cluster analysis is useful for predicting treatment response in Postherpetic Neuralgia.

The study was stopped on 26 April 2013 due to feasibility issues (low enrollment) not safety. The overall risk-benefit of Lyrica has not changed at all due to termination of this trial. Only 9 of the 150 patients were enrolled into the trial, so we are unable to get adequate results from this study.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have pain present for more than 3 months after the healing of the herpes zoster skin rash.
* At screening (V1) and baseline (V2), subjects must have a score of \>=4 on the Numeric Rating Scale for Pain (1 week recall period).
* At baseline (V2), at least 4 pain diaries must be completed satisfactorily within the last 7 days and the average pain score must be \>=4.

Exclusion Criteria:

* Subjects having other severe pain that may confound assessment or self evaluation of the pain due to PHN.
* Neurolytic or neurosurgical therapy for Postherpetic Neuralgia
* Skin conditions in the affected dermatome that could alter sensation.
Respiratory Sarcopenia in Institutionalized Older Adults in the Region of Murcia

Objectives: The objectives of this study are to describe the prevalence of respiratory sarcopenia in institutionalized older adults. Methodology: A sample of approximately 120 older adults from 5 residences located in Murcia capital will participate in the study. A prospective observational study will be carried out, with one year of follow-up, with patients who have been diagnosed with respiratory sarcopenia. Sociodemographic and clinical variables, physical function (palm grip, 5STS, 4MGS), respiratory force variables (MIP and PEF) and diaphragmatic ultrasound (thickness, shortening fraction and diaphragmatic excursion) will be measured. Descriptive statistics, univariate and multivariate logistic regression models, Cox proportional hazards model and KaplanMeier curves will be used to analyze the data from the longitudinal study.


Eligibility Criteria:
Inclusion Criteria:

* To have functional ambulation and/or wheelchair.
* preserved cognitive status.
* have sufficient ability to Oral occlusion for carrying out respiratory tests.

Exclusion Criteria:

* presence of respiratory diseases or in treatment of respiratory diseases.
* serious orthopedic diseases that interfere with measurements and those with a diagnosis of dementia.
* those who present any contraindication for carrying out the procedure will be excluded.
* of the respiratory pressure measurement tests, as established in the SEPAR guidelines.
Lymph Node Aspiration to Decipher the Immune Response of Beta-variant Recombinant Protein Booster Vaccine (VidPrevtyn Beta, Sanofi) Compared to a Bivalent mRNA Vaccine (Comirnaty Original/Omicron BA.4-5, BioNTech-Pfizer) in Adults Previously Vaccinated With at Least 3 Doses of COVID-19 mRNA Vaccine.

In order to investigate whether a germinal center response occurs following vaccine boost and to characterize it based on the type of vaccine received, we aim to analyze Spike and/or RBD-specific germinal center B cells within the draining lymph nodes.

To achieve this, we will perform lymph node fine needle aspiration of the draining lymph node in 6 subjects in each study arm, 3 to 6 weeks after the booster vaccine injection.

Lymph nodes are secondary lymphoid organs essential for the establishment of the germinal center reaction, allowing the generation of long-lived B cell memory and high-affinity antibodies. In order to investigate whether a germinal center response occurs following vaccine boost and to characterize it based on the type of vaccine received, we aim to analyze Spike and/or RBD-specific germinal center B cells within the draining lymph nodes. Accessing germinal center through fine needle aspirations under ultrasound guidance has recently emerged as an innovative strategy in the United States to investigate vaccine response. This procedure under local anesthesia is well-tolerated, and no major side effects have been reported in a hundred patients who underwent fine needle aspiration. The technical details for performing this examination are now well-described.

Our previous work has highlighted the importance of repertoire diversity in responding to new variants of SARS-CoV-2. We thus aim to investigate whether a booster dose with mRNA or protein-based vaccine mobilizes memory B cells or naive cells, thereby contributing to a greater diversity of the Memory B cell comportment. To preserve the diversity of the memory B cell pool is absolutely essential for our immune system to adapt against variants.

To achieve this, we will perform lymph node fine needle aspiration of the draining lymph node in 6 subjects in each study arm, 3 to 6 weeks after the booster vaccine injection. Indeed, it has been shown that the response of germinal centers in response to a booster vaccination was detectable at 2- and 8-weeks post-injection vaccination.

This outpatient procedure will be performed by a radiologist under ultrasound guidance, aiming to collect 4 fine needle aspirations from 4 axillary draining lymph nodes under local anesthesia. Concurrently, a 35 mL blood sample will be collected from the subject to correlate the response in secondary lymphoid organs with the circulating response.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 years and over included in COVIBOOST 2

Exclusion Criteria:

* Hypersensitivity to lidocaine, to anaesthetics of the amide type or to any of the excipients
* Patient with recurrent porphyrias