cyrilzakka/clinical-trials huggingface dataset:
AI-assisted Migraine Education: Efficacy, Safety and Patients' Acceptance

Migraine affects 1 in 7 people globally, significantly impacting quality of life and economic productivity. Despite its prevalence, limited awareness leads to misdiagnosis, inadequate treatment, and stigmatization. AI can enhance migraine management through improved diagnosis, prediction, and personalized education. The primary objective of this study is to determine if adding AI-assisted migraine education to standard education improves patients' understanding of their condition more effectively.

Migraine affecting approximately 1 in 7 individuals globally, significantly impacts quality of life and economic productivity due to its associated healthcare and social burdens. Despite its prevalence, awareness and understanding of migraine remain limited, contributing to misdiagnosis, inadequate treatment, and the perpetuation of stigmatization.

Artificial Intelligence (AI) may advance migraine management by improving diagnosis, prediction, and educational outreach. AI applications are currently being employed in diagnosing migraines more accurately by analyzing comprehensive patient data, thus differentiating migraine from other types of headaches. Additionally, AI algorithms predict migraine episodes, enabling preemptive measures. They also streamline medication management through reminders and monitor patient adherence, which is crucial for preventing medication overuse and optimizing treatment outcomes.

Moreover, AI can bridge the educational gap in migraine understanding. By using adaptive learning technologies, AI platforms can deliver personalized educational content, tailored to an individual's knowledge level and learning pace, enhancing understanding and engagement. This approach not only facilitates better management of the condition but also promotes a broader societal awareness essential for destigmatizing migraine.

The primary objective of this study is to ascertain if the addition of AI-assisted migraine education to standard migraine education yields a superior improvement in the patients' understanding of their condition.

Eligibility Criteria:
Inclusion Criteria:

* aged between 18 and 65 years at the time of signing the informed consent
* Newly diagnosis of migraine, confirmed through the medical chart
* The participant must be capable of giving signed informed consent
* Access to a laptop, computer, smartphone, or tablet

Exclusion Criteria:

* Insufficient knowledge of the protocol language (italian)
* Patients with cognitive impairment and/or unable to use or access the AI-powered learning platform developed in this study.
* Vulnerable participants (e.g. minors, participants incapable of judgment or participants under tutelage)
DPP-4 Inhibitor and Serum BNP Level of Diabetic Patients With Congestive Heart Failure

We thought to investigate the influence of DPP-4 inhibitor on the serum BNP level of diabetic patients with congestive heart failure. This study consists of two protocols. In the first protocol, diabetic patients with high level of serum BNP (100-2000 pg/ml) receiving outpatient treatment with any type of DPP-4 inhibitor at our institution will be enrolled. After baseline data collection, DPP-4 inhibitor will be suspended for one month and serum BNP will be measured. The DPP-4 inhibitor will be resumed and after another month, serum BNP will be measured again. In the other protocol, diabetic patients who were hospitalized due to heart failure were enrolled. DPP-4 inhibitor will be started (if the patient is not taking a DPP-4 inhibitor) or suspended (if the patient is taking a DPP-4 inhibitor) after stabilization of heart failure, and serum BNP will be measured before and after the drug administration or suspension.


Eligibility Criteria:
Outpatient arm

Inclusion Criteria:

* Type 2 diabetes patient with congestive heart failure under treatment with DPP-4 inhibitor (sitagliptin, vildagliptin, alogliptin, linagliptin, teneligliptin, anagliptin or saxagliptin) .
* High serum BNP (100-2000pg/ml).
* Patients who have given informed consent to participation in the study.

Exclusion Criteria:

* HbA1c over 9.0%.
* Patients who changed medication within 1 months before inclusion.
* Judged as ineligible by clinical investigators.

Hospitalization arm

Inclusion Criteria:

* Type 2 diabetes patient who were hospitalized for congestive heart failure.
* Patients who have given informed consent to participation in the study.

Exclusion Criteria:

* Patients on insulin therapy.
* Judged as ineligible by clinical investigators.
A Study to Evaluate the Different Doses of VAC52416 (ExPEC10V) in Japanese Adults

The purpose of this study is to evaluate the safety and reactogenicity of different doses of extraintestinal pathogenic Escherichia coli 10 valent (ExPEC10V) in Japanese participants greater than or equal to (\>=) 60 to less than or equal to (\<=) 85 years of age.


Eligibility Criteria:
Inclusion Criteria:

* Participant must be Japanese as determined by participant's verbal report
* Must be healthy or medically stable, in the investigator's clinical judgment, as confirmed by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests performed at the screening visit
* Willing and able to adhere to the lifestyle restrictions
* Agrees not to donate blood until 12 weeks after receiving the study intervention
* Must be willing to provide verifiable identification, has means to be contacted, and to contact the investigator during the study

Exclusion Criteria:

* Clinically significant illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature greater than or equal to (\>=) 38.0 degree Celsius (100.4 degree Fahrenheit ) within 24 hours prior to the administration of study intervention; enrollment at a later date is permitted (provided the screening window of 28 days is respected)
* History of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)
* Known allergies, hypersensitivity, or intolerance to ExPEC10V or its excipients
* Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine excipients
* Contraindication to Intramuscular (IM) injections and blood draws example, bleeding disorders
Intravenous Remifentanil Patient-controlled Analgesia (PCA) and Epidural Patient Controlled Epidural Analgesia (PCEA) for Labor Analgesia

Women requesting analgesia do not always wish to receive a potent analgesic method, and may fear the risks of epidural analgesia.

Study Aim: To determine whether remifentanil is effective for labor analgesia when compared with standard treatment (epidural analgesia).


Eligibility Criteria:
Inclusion criteria:

* Healthy women
* American Society of Anesthesiologists physical status class I or II
* Body weight less than 110 kg
* In active labor (including induced labor and premature rupture of membranes)
* Cervical dilatation at 2-6 cm
* Regular contractions
* Age between 18 and 40 years old
* Gestational age greater than 36 completed weeks
* Singleton pregnancy and vertex presentation

Exclusion criteria:

* Contraindication for epidural analgesia (bleeding diathesis, neuropathy, severe scoliosis, previous spine surgery, local anesthetic allergy)
* Narcotic administration in the previous 2 hours
* Previous uterine surgery
* Pre-eclampsia and the inability to adequately understand the consent form
* Blocked nose, and any indication patient for whom epidural analgesia is medically indicated (cardiac disease, suspected difficult airway)
EAP of Apitegromab for Patients With Spinal Muscular Atrophy

The purpose of this expanded access program (EAP) is to provide access to apitegromab for eligible patients with spinal muscular atrophy (SMA) prior to approval by the local regulatory agency . A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.


Eligibility Criteria:
Inclusion Criteria:

1. ≥2 years of age.
2. Documented diagnosis of 5q SMA.

Exclusion Criteria:

1. Previous history of a hypersensitivity reaction to a monoclonal antibody or recombinant protein bearing an Fc domain (eg, a soluble receptor-Fc fusion protein), apitegromab, or excipients of apitegromab.
2. Enrolled in a clinical study for any investigational drug.
3. Pregnant or breastfeeding.
Tele-CBT Following Bariatric Surgery: Randomized Control Trial

Bariatric (weight loss) surgery is the most effective treatment for extreme obesity, but surgery does not treat underlying psychological and behavioural issues. Currently, psychotherapy ("talk therapy") for eating problems is not routinely offered with surgery, and many people start to regain weight one year later. Objective: This study will examine if adding a convenient and accessible psychotherapy by phone one year after surgery will lead to increased weight loss two years after surgery. Primary Hypothesis: Relative to the Control group (who will get routine care), the group of individuals who get psychotherapy will have lower weights 2 years after surgery. Secondary Hypotheses: Relative to the Control group, the psychotherapy group will report significantly less maladaptive eating behaviours and medical burden, and significantly greater quality of life. Method: Participants recruited from the Bariatric Surgery Programs at Toronto Western Hospital will be randomly assigned to 1 of 2 groups: 1) Control (Usual Standard of Care) or 2) Tele-CBT (a 7-session telephone-based cognitive behavioural therapy \[a type of "talk therapy"\] intervention focused on developing coping skills to improve maladaptive thoughts, emotions, and eating behaviours, specifically designed for bariatric surgery patients, delivered 1 year post-surgery). They will have their weight measured and will complete measures of eating behaviour and quality of life prior to the intervention, and again at several time points extending to 2 years post-surgery. Implications: If Telephone-Cognitive Behavioural Therapy (CBT) is found to improve bariatric surgery outcomes, it could become the standard of care in Canadian bariatric surgery programs and beyond, and be routinely offered to patients who cannot feasibly attend CBT sessions due to physical or practical barriers.


Eligibility Criteria:
Inclusion Criteria:

* Received bariatric surgery 1 year ago
* Fluent in English
* Have Internet access to complete online questionnaires.

Exclusion Criteria:

* Current active suicidal ideation
* Current poorly controlled psychiatric illness that would render Tele-CBT very difficult, including serious mental illness (i.e., psychotic disorder, bipolar disorder), severe depression (i.e., current major depressive episode diagnosis and Patient Health Questionnaire \[PHQ-9\]61 score \> 20), or severe anxiety (i.e., current anxiety disorder diagnosis and Generalized Anxiety Disorder \[GAD-7\]62 score \>15)
* Current poorly controlled medical illness that would render Tele-CBT very difficult.
An Analysis of Medication Adherence Using Televideo and Telephonic Monitoring and Utilization of an Education Protocol

The objective of this study is to evaluate adherence to oral oncologic medication regimens utilizing a standardized education tool to explain the dosing, side effects and purpose of oral chemotherapy via televideo or telephonic interactions. Researchers aim to evaluate whether the modality of education and monitoring impact adherence.

The study will consist of eight total interactions. We will allow for a 72 hour window for each encounter to allow for patient flexibility and scheduling. The first encounter will include medication education using the standardized tool. The remaining seven interactions will include toxicity and adherence assessment through patient interviews, the OCAS, pill counts, and pharmacy fill data. All interactions will be completed via telephonic outreach or televideo platform by either CRNP, PA-C or PharmD. The patient will be approached when an OCA is prescribed to be given a copy of the OncoLink® patient education material and consent form for review. Patients will be randomized 1:1 to either televideo or telephonic interactions using a block size of 4. All study staff will be blinded to block size. Once a patient is randomized, s/he will be scheduled for the series of follow up encounters via the assigned modality. The first telemedicine interaction will occur within 72 hours of the patient receiving their prescribed OCA(s) at which time the standardized educational information regarding the agent(s), dosing of the medication and potential medication side effects will be reviewed with the patient and/or caregiver. The second encounter will occur approximately 2 weeks after the patient starts the medication to assess for adherence and toxicity. The third through eighth encounters will take place every 2 weeks thereafter through the study timeframe up to four months. At each visit, an adherence assessment including pill count, and Oral Chemotherapy Adherence Scale (OCAS) (Bagcivan and Akbayrak 2015) will be completed per standard of care in addition to patient interview to assess adherence and toxicity. Fill history will be obtained prior to each interaction to verify medication possession ratio and proportion of days covered.

Each patient in the study will participate for a duration of up to 4 months. All of the research will take place at the Abramson Cancer Center at Penn Presbyterian Medical Center.

Eligibility Criteria:
Inclusion Criteria:

1. Has a diagnosis of cancer
2. Receives cancer care at Abramson Cancer Center at Penn Presbyterian Medical Center
3. Physically and cognitively able to provide informed consent
4. Is 18 years or older
5. Is starting an oral cancer agent
6. Has access to the UPENN televideo platform
7. Lives in Pennsylvania

Exclusion Criteria:

1. Does not desire to participate in the study
2. Cannot consent for himself/herself
3. Does not have access to the UPENN televideo platform
4. Does not live in Pennsylvania
5. Chemoradiation patients
Pizza-Salami Study in Children and Adolescents With Type 1 Diabetes

The Pizza-Salami-Study aims to investigate the efficacy of carbohydrate plus fat/protein (CFP) counting compared with carbohydrate (CARB) counting using normal and dual-wave bolus in sensor-augmented pump therapy in children and adolescents with type 1 diabetes. For fat/protein counting the model used by Pankowska et al. will be applied.

This is a prospective, international multi-centre, open randomized clinical trial to assess whether the use of Paradigm REAL-Time System from the onset of Type 1 Diabetes (T1D) leads to a better glycaemic control after 12 months of T1D compared with the use of Paradigm 515/715 insulin pump combined with conventional Self-Monitoring Blood Glucose finger-sticks in paediatric patients. Total randomized treatment duration of the study for a patient will be 12 months with an optional phase of follow-up of 3 months.Patients eligible according to inclusion and exclusion criteria will be randomized to one of the two treatment groups. A total of 160 patients will be recruited. Each subject will participate in the study for 15 months, which includes 12 months of treatment and 3 months of follow-up. Each patient is asked to use either the Paradigm REAL-Time System that provides a combination of insulin pump and the Real-Time continuous glucose monitoring or Paradigm 515/715 insulin pump combined to conventional SMBG finger-sticks. Main time-points of assessments are at baseline (within one month after T1D onset) and 12 months thereafter. In total, there will be 6 study visits at the local site. During study, patients will regularly attend the outpatient clinic according to local Standard care, i.e. every 8±2 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients with type 1 diabetes
* Age 6 - 21 years
* Diabetes duration \> 1 year
* Treatment with pump therapy (CSII) \> 3 months
* Written informed consent by patients and parents
* Patients must be willing to wear a glucose sensor for two days and to perform capillary blood glucose measurement twice a day
* Patients must be willing to performed all study procedures

Exclusion Criteria:

* Language barriers
* Eating disorders
* Pregnancy
* Drug abuse
* Patient refutes participation or study procedures
PSMA in Gastrointestinal Tumors (GIPSMA, Focusing on Neuroendocrine Neoplasms)

The theranostic principle is based on the use of radiolabeled compounds which can be applied for diagnostic molecular imaging and targeted delivery of radiation to the tumor. Gastrointestinal tumors (GIT), including gastroenteropancreatic neuroendocrine neoplasms (GEP-NEN) also express a phenotypic biomarker called prostate-specific membrane antigen (PSMA), thereby rendering it a potential diagnostic (through positron emission tomography (PET) scan imaging) and therapeutic target for radioligand therapy. Aim is to evaluate whether PSMA-directed in-vivo imaging can be also applied to GEP-NEN patients to determine if i) biopsy-derived tissue of newly diagnosed patients exhibit a PSMA expression profile, ii) PSMA-PET shows upregulated PSMA expression in-vivo, iii) such a molecular imaging approach identifies more disease sites relative to conventional imaging, and iv) if the PSMA PET signal predicts further clinical course and outcome under guideline-compatible treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients with newly diagnosed GEP-NEN prior to initiation of guideline-compatible, anti-tumor therapy
* Available tissue specimen to conduct PSMA expression profiling
* Male/female, above 18 years old
* Patients must provide written informed consent
* Patients must be willing to comply with study procedures and available for follow-up examinations

Exclusion Criteria:

* Curative setting
* Not sufficient tumor tissue available
* Male Patients: No prostate carcinoma
* Other malignant neoplasms in patient's history
* Pregnancy or Breastfeeding
* Contraindications for PET/CT
Laparoscopic Sleeve Gastrectomy and Gastroesophageal Acid Reflux

Symptomatic Gastroesophageal Reflux (GER) is considered by many a contraindication to laparoscopic sleeve gastrectomy (LSG). However, of the few studies that have investigated the relationship between LSG and GER the majority reported only changes in symptoms and manometric data, while assessment of GER using 24-hour pH monitoring is lacking.

The aim of this study is to evaluate the effect of LSG on GER in morbidly obese patients.

Consecutive morbidly obese patients selected for LSG are included in a prospective clinical study. Gastroesophageal function is evaluated using a clinical validated questionnaire, upper endoscopy, esophageal manometry and 24-h pH monitoring before and 24 months after LSG.

Eligibility Criteria:
Inclusion Criteria:

* history of obesity exceeding 5 years
* documented previous weight loss attempts,
* body mass index (BMI)) of 40-50 kg/m2
* age of 18-60 years.

Exclusion Criteria:

* contraindications to pneumoperitoneum
* large esophageal hiatal hernia
* pregnancy,
* drug or alcohol abuse,
* psychological disorders (e.g., bulimia, depression)
* hormonal or genetic obesity-related disease,
* previous gastric surgery
Heart Failure Insomnia Treatment Study

The purpose of this study is to compare a short, behavioral treatment for insomnia with sleep monitoring to determine whether these approaches are effective in reducing insomnia and improving sleep quality among patients with heart failure (HF). This study will also examine the relationship between insomnia and cognitive functioning in HF and the effects of the behavioral treatment on cognitive functioning, self-care, distress, HF symptoms, and functional status.

Participants will be randomly assigned to four-sessions of a behavioral treatment (Brief Behavioral Treatment for Insomnia; BBTI) or sleep monitoring.

Comorbid insomnia is prevalent among heart failure (HF) patients and associated with poorer mental and physical functioning, including possible exacerbation of cognitive deficits. Initial investigations document the effectiveness of cognitive-behavioral therapy for the treatment of insomnia in HF. However, the high symptom burden of HF necessitates alternative interventions for these patients with fewer time and physical endurance demands.

Brief Behavioral Treatment for Insomnia (BBTI) is a four-session behavioral intervention that emphasizes stimulus control and sleep restriction techniques, along with providing education to patients about healthy sleep practices and behaviors that adversely affect sleep. The efficacy of BBTI has been previously documented in samples of older adults with insomnia, but the intervention has yet to be applied to a disease-specific patient population.

This study was designed to 1) evaluate the treatment effects of BBTI on insomnia among HF patients, 2) examine the relationship between insomnia, cognitive function, and decision-making in HF patients at baseline, and 3) evaluate the effects of BBTI on relevant correlates of insomnia in HF patients, including cognitive functioning, decision-making, distress, self-care, quality of life, and functional status.

Participants will be randomized to either the four-session behavioral intervention (BBTI) or a sleep monitoring condition. Measures of sleep (insomnia, sleep efficiency, sleep quality), cognitive functioning (memory, attention, executive functioning, and decision making), distress (anxiety and depression), HF-related quality of life, HF self-care, and functional status will be obtained from participants at baseline, post-intervention, and 6 months post-intervention. Repeated measures multivariate analysis of variance (MANOVA) will serve as the primary mode of data analysis.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Fluent in English
* Diagnosis of heart failure
* At least mild chronic insomnia

Exclusion Criteria:

* Restless legs syndrome
* Narcolepsy
* Perform night or rotating shift work
* Seizure disorder
* Excessive daytime sleepiness
* Current or past diagnosis of Bipolar disorder or psychotic disorder
* Significant cognitive impairments
* Untreated moderate to severe sleep apnea or high risk for sleep apnea
Vitamin C Supplementation as a Preventive Treatment of Diabetic Peripheral Neuropathy

The purpose of this pilot study is to determine whether vitamin C supplementation is beneficial in treating and/or preventing diabetic peripheral neuropathy in people with type 2 diabetes.

Painful diabetic peripheral neuropathy (DPN), a condition characterized by pain affecting the feet, legs and hands that is often characterized as burning or a "pins and needles" sensation, is estimated to affect up to 66% of the U.S. diabetic population. This pilot study will examine the effect of a daily dose of ascorbic acid, a known aldose reductase inhibitor, versus placebo, and the effect that it can have on intracellular erythrocyte (red blood cell) sorbitol levels, aldose reductase activity and aldose reductase enzyme levels utilizing benchtop methods, and effects on clinical DPN-associated pain reporting and changes in quantitative sensory testing in the lower extremities via touch discrimination and vibratory sensory testing in patients with Type 2 Diabetes Mellitus (T2DM) over the course of 90 days of treatment.

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes mellitus
* diabetic peripheral neuropathy
* A1C of 6.0-10.0%

Exclusion Criteria:

* Terminal diagnosis
* Dementia
* Anemia
* Significant renal dysfunction
* History of B-12 deficiency
* Peripheral vascular disease
* Current smoker
* History of kidney stones
* Current ascorbic acid use
* Presence or foot infection and/or ulcer