cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Guanfacine and Lidocaine Combination in Trigeminal Nerve Block for Pain Management in Trigeminal Neuropathy

A phenome-wide association study (PheWAS) identified an association between a loss of function variant in the human alpha 2B adrenergic receptor gene and trigeminal nerve disorders. Guanfacine is the oldest alpha-2 adrenergic agonist in clinical use and is approved for hypertension and attention deficit hyperactivity disorder. We hypothesize that guanfacine will be an effective adjunct to lidocaine for the treatment of neuropathic pain by enhancing and prolonging pain relief due to its activation of alpha-2 adrenergic receptors. The objectives of the study will be to evaluate the efficacy and safety of guanfacine in combination with lidocaine for trigeminal nerve block procedures for pain management in trigeminal neuralgia patients. This study will evaluate the efficacy of guanfacine in reducing acute pain and extending duration of pain relief when delivered in combination with lidocaine as a trigeminal nerve block, measured by Visual Analog Scale (VAS) data collected at specific time points after each injection.


Eligibility Criteria:
Inclusion Criteria:

* Ability to understand and read English
* History of painful trigeminal neuropathy with persistent background facial pain severity \> 5/10 on VAS
* Experience pain with a score of greater than 5 on a 0-10 scale (VAS) in the previous 24 hours before procedural treatment and at the time of procedural treatment.
* Eligible for trigeminal nerve block procedure and have not had a trigeminal nerve block procedure for pain management prior to the enrollment in the current study.
* Able to provide informed consent.

Exclusion Criteria:

* Presence of a significant structural lesion (e.g., tumor) as the cause of pain as shown in at least one neuroimaging study.
* Current diagnosis of fibromyalgia, temporomandibular disorders (TMD), odontogenic pain or other orofacial pain deemed unrelated to the trigeminal nerve as the origin.
* Allergy or any other hypersensitivity reactions to guanfacine or lidocaine or local anesthetic of the amide type, or to both iodinated contrast and gadolinium contrast.
* Females who are pregnant or breastfeeding and/or plan to become pregnant or to breastfeed during study participation.
* Participation in another investigational drug study within 30 days before randomization.
* Inability to understand the requirements of the study, inability to abide by the study restrictions, inability to fill out the questionnaires, or inability to return for the required treatments.
* Any clinically significant medical or surgical condition that in the investigator's opinion could interfere with the administration of study drug, interpretation of study results, or compromise the safety or well-being of the subject (i.e. infection, unable to stop anticoagulants).
* No reliable access to telephone service to allow for contact with study personnel.
Individualized Data-based High Simulation of Bronchoscopy Operations in Preoperative Bronchoscopy Informed Consent

A prospective randomized controlled study was conducted to investigate whether preoperative replacement of patients based on AI training instruments could alleviate preoperative anxiety.

Patients who met the criteria were randomly assigned to either the personalized data-based group or the control group. Prior to the preoperative account examination, each patient's anxiety level was assessed, after which a 30-40-minute informed consent form was read.

The traditional group underwent a preoperative account and question-and-answer session with an experienced bronchoscopy laboratory physician, after which the scale was reassessed.

The experimental group underwent a simulated surgical procedure on an AI simulation instrument based on the patient's CT personalized data, performed by an experienced bronchoscopist. The bronchoscopist explained the surgical precautions and answered the patient's questions throughout the procedure. Following the responses to the questions, the scale was reassessed. Following surgery, patients are invited to complete a satisfaction survey prior to discharge or following the discussion of bronchoscopy findings.


Eligibility Criteria:
Inclusion Criteria:

* requiring elective bronchoscopy
* Older than 18 years

Exclusion Criteria:

· Dementia, limited speech, or other problems affecting communication
Treatment of Breast Cancer-related Lymphedema With Stem Cells and Fat Grafting

Breast cancer-related lymphedema is one of the most common and feared consequences of breast cancer treatment. Currently, lymphedema is primarily addressed conservatively with compression garments. Regenerative medicine may provide a new treatment option for lymphedema. This Phase 3 trial will examine the efficacy, effectiveness and safety of freshly isolated adipose-derived stromal cells administered in conjunction with a fat grafting procedure to the affected axillary region.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral arm lymphedema secondary to breast cancer treatment including lymph node dissection.
* Cancer free for at least 1 year
* The patient understands the nature and purpose of this study and the study procedures and has signed informed consent.
* The opposite upper extremity is healthy (no lymphedema).
* ASA score of 1 or 2.
* The patient is able to read, understand, and complete Danish questionnaires.
* Pitting lymphedema ISL grade 1 or 2.
* A minimum circumference difference of 2cm or a minimum volume difference of 200mL.

Exclusion Criteria:

* Pregnant or lactating.
* Bilateral lymphedema
* Current or previous malignancies other than breast cancer.
* Insulin-dependent diabetes.
* Diagnosed with any form of psychotic disorder, which may impact study participation.
* Not ceased smoking during treatment.
* Active implantables (e.g. pacemaker or neurostimulator)
* Unrealistic treatment expectations.
* Known hepatitis, HIV or syphilis infection.
The Effect of Laughter Therapy On The Food Craving

Premenstrual syndrome (PMS) is characterized by physical, emotional, and behavioral symptoms in the luteal phase that significantly disrupt women's daily lives, including work and personal activities, and resolve spontaneously within a few days of the onset of menstruation. The premenstrual syndrome causes emotional eating, excessive consumption of certain foods, and increased appetite. These unhealthy eating patterns in eating behavior affect health negatively. Women with PMS have an increased appetite and food cravings. It has been stated that the increase in appetite and food cravings are reduced by laughter therapy. Thus, the laughter therapy method, which has no side effects in PMS and negative eating behaviors, can be used and recommended or applied by health professionals.

The universe of the research will be all young women with PMS who study at the designated Faculty of Health Sciences in the Spring semester of the 2022-2023 academic year. The sample of the study will be all young women studying at the Faculty of Health Sciences, meeting the inclusion criteria and agreeing to participate in the study. All young women with a Premenstrual Syndrome Scale total score of 110 and above will be included in the study. Since all women who have a Premenstrual Syndrome Diagnostic Scale of 110 and above, volunteer to participate in the study, and meet the inclusion criteria will be included in the study, no additional sample selection will be made. The application and control group will be determined on random.org among the group that constitutes the sample of the study. Laughter therapy sessions will be applied online for 25-30 minutes once a week for 2 months by the researcher who has the Laughter therapy certificate to the application group. At the end of two months, the Personal Information Form, Premenstrual Syndrome Scale, and the Food Craving Scale will be administered again to both the application group and the control group.

Eligibility Criteria:
Inclusion Criteria:

* Being a nursing student,
* Being a female student,
* Volunteering to participate in the study.
* Having a PMS score of 43 and above

Exclusion Criteria:

* Not to study as a nursing student
* Being a male student
* Not to volunteer to participate in the study
* Participants who have a PMS score of 42 and below
Automatic Ventilation in Prehospital Resuscitation on OHCA

The goal of this randomized controlled trial is to compare prehospital ventilation strategies in out-of-hospital cardiac arrest. The intervention group is automatic ventilation and the control group is manual ventilation. The main questions it aims to answer are:

1. How does automatic ventilation affect OHCA patients' survival and prognosis comparing to manual ventilation.
2. What are the differences on resuscitation qualities between automatic ventilation and manual ventilation.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years old at the time of occurrence of out-of-hospital cardiac arrest (OHCA).
* Attended by the Hsinchu County Fire Department for emergency medical assistance.

Exclusion Criteria:

* Pregnant women.
* OHCA caused by trauma.
* Return of spontaneous circulation (ROSC) observed at the scene.
* Clearly deceased at the scene (reaching conditions such as decomposition, rigor mortis, severe burns, decapitation, evisceration, or trunk fracture).
* Refusal of medical transportation by family members.
* No placement of an advanced airway throughout the procedure.
Study on the Effectiveness of an Emollient Cream Containing Pre and Postbiotic and Niacinamide 4% in the Treatment of Skin Xerosis and Itching in Oncological Patients Treated with Anti-EGFR

Study on the Effectiveness of an Emollient Cream Containing Pre and Postbiotic and Niacinamide 4% in the Treatment of Skin Xerosis and Itching in Oncological Patients Treated With Anti-EGFR.

Epidermal growth factor receptor inhibitors (EGFRi) are drugs approved as treatment options in several solid tumors, such as advanced colon, head-neck, breast and lung cancers, because overexpression or mutation of EGFR is implicated in the pathogenesis of these types of cancer. EGFR, in addition to being expressed by neoplastic cells, is also present constitutively on basal keratinocytes, and its inhibition can determine in these cells apoptotic effects, cell growth inhibition, alteration of physiological cell migration and inflammatory processes through the release of pro-inflammatory cytokines, recruitment of leukocytes and the release of pro-apoptotic molecules.

Among the possible adverse skin events (cae), the papulo-pustular rash is the most frequent in the course of therapy with EGFRi (45-90%). In addition to the papulopustulous rash, xerosis and itching are the main dermatological AE associated with EGFRi therapy, with a significant negative impact on the quality of life (qol) of cancer patients.

The reduction of itching and subsequent scratching can therefore be effective in preventing the exacerbation of skin lesions and improving qol in cancer patients, especially in those who experience intense skin xerosis. Emollients containing urea and ceramides have proved useful in skin hydration in case of cutaneous xerosis and in attenuating the associated itching. However, there are few articles in the literature that compare the moisturizing and antipruritic effects of the various basic components of emollients, especially in patients undergoing oncological treatment with EGFRi.

The goals are to examine the effectiveness of an emollient cream containing the prebiotic α-glucan oligosaccharide, the postbiotic Lactobacillus ferment pure (obtained by patented extraction method BPTech) and niacinamide 4%, in the treatment of xerosis, and to test the effectiveness and superiority of this topical preparation in skin hydration and in soothing pruritic symptoms compared to a 10% urea cream commonly used in clinical practice in patients with skin xerosis.

Eligibility Criteria:
Inclusion Criteria:

1. patients aged 18 who have been receiving anti-EGFR therapy for more than three months,
2. signature of the informed consent.

Exclusion Criteria:

1. Patients diagnosed with Grade II papulopustulous skin reaction according to the Common Terminology Criteria for Adverse Event (CTCAE) scale at the time of enrolment;
2. concomitant use of emollients and/or steroidal creams;
3. personal history of xerotic pathologies (e.g. lichen, ichthyosis) and/or itching of n.d.d.;
4. inability to provide informed consent or inability to complete the procedures required for enrollment in the study.
Effects and Tolerability With Clenpiq and Low Residue Diet

The Efficacy of Clenpiq utilized per FDA labeling, with a low residue diet the day before colonoscopy.

This study proposes to assess the use of a low residue diet of a prescribed nature the day before colonoscopy for breakfast, lunch and early dinner. Clinical outcomes utilizing the low residue diet will be compared to the Food and Drug Administration (FDA) approved split dose labeling, including the traditional clear liquid diet the day before colonoscopy utilizing the Clenpiq (Ferring Pharmaceuticals) bowel preparation.

Eligibility Criteria:
Inclusion Criteria:

* All subjects age 18-80 requiring colonoscopy for appropriate indications

Exclusion Criteria:

* Active diarrhea (Greater than 3 unformed stools daily)
* Constipation (Less than 3 spontaneous bowel movements per week) Each within 2 weeks of the scheduled Colonoscopy.

Additional exclusion criteria would include;

* Subjects with a history of inflammatory bowel disease
* Colonic resection of any length
* Pregnant women
* American Society of Anesthesiologists (ASA) score greater than 3
* Body Mass Index (BMI) greater than 50
* Previous reaction to this bowel preparation or contraindications to taking Clenpiq per the package labeling guidelines.
* Subjects unable to give their own informed consent.
Folinic Acid in Autism

An examination of changes in urinary metabolites with use of folinic acid in children with autism spectrum disorder (ASD). Investigators will also measure behavioral measures and academic measures monthly at school with teachers and parents report.

Children enrolled in Oak Hill School will enroll in this study and take folinic acid supplement twice a day for 12 weeks period. Behavioral measures and urinary metabolites will be collected pre and post treatment. Behavioral measures will be taken again at 16 weeks, after 4 weeks of not dosing.

Eligibility Criteria:
Inclusion Criteria:

* Between ages 5 and 25

Exclusion Criteria:

* Not currently taking folinic acid
Effect of BPA on Anchor Antibiotic Continuity in the ED: Randomized Controlled Trial

The objective is to compare the timeliness of anchor antibiotic administration in the emergency department (ED) after initial dosing with and without a Best Practice Alert in Epic (BPA) implemented to remind physicians to re-order the antibiotic.

We hypothesize that post-BPA implementation, physicians will have a higher rate of ordering subsequent doses of antibiotics on-time and with the correct dosages compared to pre-BPA implementation.

Antibiotics administration can sometimes be delayed in the emergency department (ED) environment, where antibiotics are frequently ordered in electronic medical record systems as a one-time dose and the second dose is delayed or missed. This has been described in the literature, a 2017 article in Critical Care Medicine noted in a single academic center that 33% of sepsis cases had 2nd-dose-antibiotic delays greater than 25% of the recommend interval and this was associated with significantly increased hospital mortality (OR 1.61) and mechanical ventilation (OR 2.44).

An Epic Best Practice Advisory (BPA) was created by the Mass General Brigham eCare Decision Support team to address this patient safety concern. The BPA alerts providers in the ED or ED Observation when the next dose of broad-spectrum antibiotic dose is due for a patient if no future administration has been ordered, based on patient characteristics (such as renal function) and antibiotic selection. The objective of this study is to analyze the impact of this BPA on our performance in terms of on-time antibiotics through a randomized controlled trial. Patients whose medical record number (MRN) are odd will be assigned to the treatment group, while those whose MRNs are even will be assigned to the control group. The BPA will only be displayed to the patient's providers for the treatment group. We will then compare the performance of on-time antibiotics between the groups and the resulting impact on patient outcomes, such as overall hospital length of stay, admission to the intensive care unit (ICU), and in-hospital mortality.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients (\>= 18 years old) who are seen in a Mass General Brigham Emergency Department who had a specific anchor antibiotic administered

Exclusion Criteria:

* None
Identification of Key Blood Molecular Markers for Immunotherapy

To identify unique blood markers in cancer patients so that we can identify patients with evidence of pre-existing immunity who may be a responder to immunotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with cancerous tumors based on biopsy or other clinical observations.
2. Patients diagnosed with non-cancerous tumors based on biopsy or other clinical observations.
3. Normal volunteers who do not have cancer or other medical conditions that may affect survival.

Exclusion Criteria:

1. Patients will be excluded if, upon clinical observation, they are under a severe septic or inflammatory condition. In these conditions, human body immune response against sepsis or inflammation should be the predominant response, and may shield or block the immune response against tumors.
2. Patients will be excluded if, upon clinical observation, they are under extremely illness situation like myocardial infarction. In such a case, the immune findings may be altered.
3. Patients will be excluded if, upon looking through their medical records, significant information required for data analysis is missing. This is because that patients' medical records will help us connect our research findings with their clinical observations, and further provide guidelines for subsequent treatment options.
PRagmatic Analysis of Vitamin D in ANCA-Associated Vasculitis

This prospective study will assess if 12 months of vitamin D3 (cholecalciferol) supplementation, in patients with AAV (GPA, MPA, and EGPA) who have deficient or insufficient 25(OH)D3 status at enrollment, correlates with improved disease activity and/or lower frequency of relapse (compared to historical data and a previously conducted cross sectional study (part I) that assessed vitamin D status in a cohort of similar patients).

1. Subject cohorts: Patients with a diagnosis of AAV from the MSH Rheumatology clinic in a cohort of consecutive patients over a 3 month recruitment period.
2. Study Design, Data Collection: Patients with insufficient and/or deficient vitamin D status at study enrolment will be instructed to take 12 months of vitamin D3 (cholecalciferol) supplementation (1000 IU for those not on vitamin D, or to increase the dose up to 2000 IU per day for those already on vitamin D) vs. those with sufficient status who will be observed for 12-months.
3. Study Duration: 12 months.
4. Study Endpoints: Vitamin D status vs. disease activity.

Eligibility Criteria:
Inclusion criteria:

* Patients at least 18 years of age, women and men
* Followed at the Mount Sinai Hospital, Vasculitis clinic, Toronto
* With a diagnosis of AAV (GPA, MPA or EGPA) satisfying the modified American College of Rheumatology 1990 classification criteria and/or the revised 2012 Chapel Hill nomenclature definition.

Exclusion criteria:

* Current or history of hypercalcemia, primary hyperparathyroidism, sarcoidosis, hypervitaminosis D, Williams syndrome, other autoimmune, chronic inflammatory or infectious conditions, malabsorptive disorders, cancer, type 1 diabetes, liver disease
* Current or planned pregnancy within the next year.
* Intolerance, allergy to oral vitamin D, and/or contra-indication to take oral vitamin D
Differential Regulation of RAAS-axis in Patients Undergoing Cardiac Surgery

This study investigates the question of whether there are differences in the plasma concentration of hormones of the RAAS-axis between patients undergoing on-pump cardiac surgery and those receiving off-pump surgery

In patients undergoing cardiac surgery, the occurrence of vasoplegia or vasoplegic shock is a common and sometimes very severe complication. Although there are multiple factors that may affect the incidence and severity of vasoplegia, it remains unclear which role the use of cardiopulmonary bypass may play in the pathogenesis of this complication. The heart normally pumps blood through the lungs where the blood primarily gets oxygenated. However, it is also known that pulmonary blood flow is also essential for the activation of various hormones, some of which are central to the regulation of vascular tension and blood pressure. If the pulmonary circulation is bypassed, as is the case in on-pump cardiac surgery, it is likely that the resulting differential activity of hormones may cause or contribute to the incidence of vasoplegia. This study aims to show whether cardiopulmonary bypass leads to the differential regulation of hormones of the renin-angiotensin-aldosterone-system which could explain why some patients suffer from vasoplegia or vasoplegic shock following such procedures.

Eligibility Criteria:
Inclusion Criteria:

1. adult patients undergoing on- or off-pump coronary artery bypass graft surgery
2. written informed consent

Exclusion Criteria:

1. emergency surgery in the context of acute coronary syndrome
2. ACE-inhibitor or Angiotensin 1 (AT1)-receptor-blocker intake that was not paused on the day of surgery
3. Chronic kidney disease with estimated glomerular filtration rate (eGFR)\<30ml/min/1.73m²
4. Severe structural lung disease (asbestosis, silicosis, severe sarcoidosis, tuberculosis, severe emphysema, chronic obstructive pulmonary disease (COPD) Gold 3-4, lung fibrosis)
5. Chronic pulmonary hypertension
6. Pregnancy or breastfeeding
7. Persons with any kind of dependency on the investigator or employed by the institution responsible or investigator
8. Persons held in an institution by legal or official order
Collect of Cord Blood From Subjects at Risk for Sickle Cell Disease, for the Purpose of Laboratory Research

The study consists in collecting umbilical cord blood cells from newborns at risk of sickle cell disease, to perform laboratory experiments aiming to characterize the cells with HbS/HbS mutation, to develop methods to prepare, to gene-modify and to preserve these cells.

Pregnant individuals carrying at least one HbS allele will be included in the study to collect the umbilical cord blood of the child at birth. Collected cells will be used anonymously for genetic and bioexperimental laboratory research, aiming to develop autologous gene therapy for sickle cell disease.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women, giving birth at CHSF and consenting to the collect and study of placental blood after delivery
* Age 18 to 45 years
* Biological testing of the participant includes hemoglobin electrophoresis and shows at least one HbS allele

Exclusion Criteria:

* Lack of written consent
* Minors (not 18 years old) or under guardianship
* Diseases : HIV, Hepatitis B, Hepatitis C or HTLV (Human T Leukemia Virus).