cyrilzakka/clinical-trials huggingface dataset:
Complete Removal of Neoplastic Large Colorectal Polyps: a Prospective Randomized Comparison of Endoscopic Mucosal Resection or Conventional Polypectomy

Recently, it was reported that the incomplete resection rate of neoplastic large polyps after conventional polypectomy was markedly high in clinical practice. The incomplete resection rate of neoplastic large polyps after endoscopic mucosal resection (EMR) is not known.

The aim of this study is to compare the incomplete resection rate of neoplastic large polyps after EMR or conventional polypectomy. The EMR technique is preferable to conventional polypectomy for the complete resection of the large polyps (\>15 mm in diameter)


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria were nonpedunculated neoplastic colorectal polyps from 10 mm to 25 mm in diameter.

Exclusion Criteria:

* less than 20 years old, history of previous colorectal surgical resection, American Society of Anesthesiologists class III and IV, allergic to propofol used or its components (soybeans or eggs), or poor bowel preparation.
SBRT Followed by Neoadjuvant Chemoimmunotherapy of Sindilizumab Plus Docetaxel and Cisplatin for Locoregionally Advanced Squamous Carcinoma of Oral Cavity and Oropharynx

In resectable locally advanced oral cavity cancer and oropharyngeal cancer, SBRT with the total dose of 18 Gy by three fractions will be delivered to the primary tumor and metastatic lymph nodes every other day. One week later, neoadjuvant chemoimmunotherapy of Sindilizumab (200mg) plus docetaxel (75mg/m2) and cisplatin (75mg/m2) will be administered every three weeks for three cycles. Then radical surgical resection will be performed and postoperative radiotherapy with or without chemotherapy will be supplemented according to the initial tumor staging and postoperative pathologic characteristics. The investigators aim to evaluate the pathological complete response rate and safety of the combined treatment of SBRT with chemoimmunotherapy in locally advanced cancers of oral cavity and oropharynx.


Eligibility Criteria:
Inclusion Criteria:

* pathologically confirmed squamous carcinoma of oral cavity or oropharynx
* III-IVa based on the eighth edition of AJCC
* aged 18 to 70
* ECOG PS 0-1
* no organ dysfunction
* Expected survival ≥ 3 months

Exclusion Criteria:

* diagnosed with other malignant tumors
* has autoimmune diseases or serious mental illness
* at high risk of hemorrhage
* Systemic or local glucocorticoid therapy within 4 weeks
* Comorbidities requiring long-term treatment with immunosuppressive drugs or systemic or topical corticosteroids in immunosuppressive doses
* Patients with active tuberculosis (TB) who are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year prior to screening.
* Prior use of anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, or anti-CTLA-4 antibody
* HIV or HCV
* HBsAg positive with positive HBV DNA copy number (quantitative test) ≥1000cps/ml
Lead-in Study to Collect Prospective Efficacy and Safety Data of Current FVIII Prophylaxis Replacement Therapy in Adult Hemophilia A Participants

The aim of this prospective, observational study is to establish a dataset on the frequency of bleeding events, as well as other characteristics of bleeding events and FVIII infusions, in patients with clinically severe hemophilia A receiving prophylactic FVIII replacement therapy as standard of care. The data collected from this study may assist in providing baseline information for comparison to the Spark's investigational hemophilia A gene therapy in future Phase 3 studies.


Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to provide written informed consent.
2. Males ≥18 years of age.
3. Clinically severe hemophilia A
4. Previous exposure to FVIII therapy
5. No prior history of hypersensitivity or anaphylaxis associated with an FVIII or intravenous immunoglobulin administration.
6. No measurable inhibitor against FVIII
7. Willing to participate and receive treatment in a future Spark hemophilia A gene therapy study.

Exclusion Criteria:

1. Documented active hepatitis B or C within the past 12 months of Screening
2. Currently on antiviral therapy to treat hepatitis B or C;
3. Documented significant liver disease within the past 6 months of Screening
4. Have serological evidence of HIV-1 or HIV-2
5. Anti-AAV-Spark 200 neutralizing titers ≥1:1
6. Previously received SPK-8011;
7. Previously dosed with any investigational or approved gene therapy product at any time or treated with an investigational drug within the last 12 weeks;
8. Planned surgical procedure in the next 12 months requiring FVIII prophylactic treatment.
9. Any history of chronic infection or other chronic disease, concurrent clinically significant major disease (such as liver abnormalities or type I diabetes) including active malignancy, except for non-melanoma skin cancer, any other condition or any other unspecified reasons that, in opinion of the Investigator or Sponsor, makes the participant unsuitable for participation and dosing in a future clinical study for Spark's hemophilia A gene therapy.
10. Unable or unwilling to comply with the schedule of visits and/or study assessments described in the protocol.
Reproductibility of Cystometry in Multiple Sclerosis Patient

This study evaluates the reproductibility (quantitative and qualitative) of cystometry in mutiple sclerosis patients.

Some studies have evaluated the reproductibility of urodynamics in women with stress incontinence, and demonstrated a poor reproductibility of urodynamic parameters for a part of the studies and a good reproductibility for the others. There is only three studies investigating the reproductibility of repeated cystometries in patients with overactive detrusor and neurogenic lower tract dysfunction. The most common etiology in these studies is spinal cord injury. Only one article includes MS patients with lower urinary tract symptoms (22 patients among 226 with other etiologies).

The aim of this study was to assess the short term reproductibility in multiple sclerosis patients with qualitative and quantitative urodynamic data.

The authors conducted a prospective analysis in our Neuro-urology department of a University Hospital . All patient with Multiple Sclerosis referred for urinary disorders, coming for a urodynamic evaluation with multiple cystometries during the study were included if they had a detrusor overactivity for a filling of 300 ml or less on the first cystometry. The main exclusion criteria were a significate difference between the filling volume during the study and the volume truly of water truly collected after catheterization, an urinary tract infection, or an other acute disease.The investigators performed a first cystometry and looked for a detrusor overactivity, if the investigators discovered an involuntary detrusor contraction for a filling of 300 ml or less, the authors realized two others cystometries (filling rate of 50 mL/min) after informed consent. The volume and pressure at which the first and the maximal involuntary detrusor contraction, MCC were documented.

Eligibility Criteria:
Inclusion Criteria:

* All patient with Multiple Sclerosis referred for urinary disorders,
* coming for a urodynamic evaluation with multiple cystometries during the study - detrusor overactivity for a filling of 300 ml or less on the first cystometry.

Exclusion Criteria:

* significate difference between the filling volume during the study and the volume truly of water truly collected after catheterization,
* an urinary tract infection,
* an other acute disease.
Photoprovocation Testing in Subjects With Cutaneous Lupus

Photosensitivity is well documented among lupus patients and is one of the diagnostic criteria for systemic lupus erythematosus (SLE). Photosensitivity is highly prevalent in lupus and has a wide range of clinical presentations. However, photosensitivity is a poorly defined in lupus and its pathogenesis is not well understood. The purpose of this study is to characterize the early clinical and histopathological changes in lupus skin that occur as a response to ultraviolet light.


Eligibility Criteria:
Inclusion Criteria:

* Participants who have a diagnosis of CLE based on either the Gilliam classification of DLE and SCLE, or SLE based on the American College of Rheumatology criteria.

Exclusion Criteria:

1. Participants who do not meet criteria for either CLE or SLE.
2. Participants with a diagnosis of Erythropoietic Protoporphyria and Solar Urticaria, or another photodermatoses other than Polymorphous light eruption.
3. Participants who are not yet 18 years old or who are not capable of giving written informed consent prior to enrolling in the study.
4. Participants who have undergone any recent phototesting, or phototherapy exposure, or those who are suspected of having a drug-induced photosensitivity.
5. Female participants who are pregnant or breastfeeding will be excluded from the study. This will be determined by patient self-reporting.
Effects of Mandala Coloring on Anxiety and Quality of Life of Women in the Climacteric Period

This research was planned as a randomized controlled experimental study in order to reduce the anxiety felt and improve the quality of life by women in the climacteric period.

Climacteric period; It is a life process in which the ovarian hormone and activity ends with a decrease, and the transition from the reproductive period to the non-reproductive period takes place, and includes perimenopause, menopause and postmenopausal stages. During the menopausal transition period, women experience many physical and psychological symptoms such as vasomotor symptoms, sleep disorders, depressed mood, and stress that negatively affect their quality of life. When the literature is examined, it can be seen that these menopausal symptoms experienced by women affect and trigger anxiety. Effective management of anxiety, which can negatively affect psychosocial well-being, social relations and mood, trigger or exacerbate menopausal symptoms, can improve the quality of life of women in the climacteric period. Therefore, anxiety management can be effective for women to cope with menopausal symptoms.

Carl Gustav Jung, a Swiss psychiatrist, discovered the therapeutic effect of coloring mandala, which is one of the art therapy methods in reducing anxiety. When the studies are examined, there have been many studies investigating the effect of Mandala coloring on reducing anxiety. Curry and Kasser (2005), Van der Vennet and Serice (2012), Flet et al (2017) stated that coloring mandala reduces anxiety on students; Gürcan and Atay Turhan (2021) and Yakar et al (2021) found that it reduces anxiety and depression in cancer patients; Khademi et al (2021) reported that it reduced anxiety in hospitalized covid-19 patients; Amelia et al (2020) found that it reduced anxiety in pregnant women.

When the studies are examined, there are studies showing that coloring mandala reduces anxiety in cancer patients, children, and pregnant women, but no study has been found on the effect of reducing anxiety related to menopausal symptoms and improving the quality of life of women in the climacteric period. This research was planned as a randomized controlled experimental study in order to reduce the anxiety felt and improve the quality of life by women in the climacteric period.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the research
* Fully answering survey and scale forms.
* Ability to read and understand Turkish
* Being in the climacteric period (42-65 years)
* Having 40 or more from STAI

Exclusion Criteria:

* Unwilling to continue working
* Having any problem that prevents communication (such as hearing, speaking, and understanding abilities),
* Taking medication for menopausal symptoms
* Using one of the pharmacological or non-pharmacological methods to reduce anxiety and receiving psychiatric treatment (Pharmacotherapy or psychotherapy).
* Surgical menopause
* Having a mental illness
Nurses' Knowledge and Attitude About Opioids

Opioid analgesics used in moderate or severe pain have potential side effects and addiction. Therefore, nurses have hesitations about opioid administration.This descriptive study aimed to evaluate the attitude and knowledge of nurses working in a university hospital about opioids. One hundred twenty-seven nurses were interviewed in the research population. The research data were obtained from the questionnaire, prepared by the researchers, between 01-05 June 2018. It consisted of three parts: descriptive characteristics, attitudes, and knowledge on opioid administration, and evaluation of basic nursing skills and pharmacology about opioids. Statistical Package for Social Sciences (SPSS) 24.0 package program was used for statistical analysis.

Analgesics do not eliminate the cause of pain but reduce or eliminate that feeling. Non-steroid analgesics are preferred in mild and moderate, and opioids are used to moderate or severe pain that does not respond to anti-inflammatory agents. However, nurses avoid the administration of opioids because of side effects and addiction risk.The first step in the effectiveness of pain management in the emergency department is evaluation and control. Pain control should be included in the emergency management system from the stage of triage assessment of the patient and should be concluded with the correct analgesic use, if necessary. In emergency departments, waiting for analgesia can be prolonged unnecessarily, and mostly insufficient doses of analgesics administered.Mainly the use of opioids in the emergency department is not preferred much because it reduces the symptoms and masks the examination findings. However, against this conventional idea, recent studies have shown that opioids use reduces pain-related anxiety.Also, it increases the patients' participation in the examination, thus making it more effective. While patients feel better, symptoms such as tenderness and defense were generally not affected by analgesia.This descriptive study was conducted to evaluate the attitude and knowledge of nurses working in a university hospital about opioid analgesic administration, after the ethical committee approved.

Eligibility Criteria:
Inclusion Criteria: Nurses, working university hospital, accepted to join to study

-

Exclusion Criteria:

* Other health care personnel, did not accept to join to study, long term leaving from job
Study to Evaluate the Safety and Efficacy of PAZ320 in Patients With Type 2 Diabetes

This study is to evaluate the effect that PAZ320 has on post-prandial glucose excursions measured via continuous glucose monitoring and its adverse effect profile in humans.

In this study, the investigators seek to evaluate the effect that PAZ320 has on post-prandial glucose excursions measured via continuous glucose monitoring and its adverse effect profile in humans. Continuous glucose monitors (CGM) are minimally invasive devices that measure glucose levels in interstitial fluid. A small wire is inserted subcutaneously which transmits the ambient subcutaneous glucose concentration every 5 minutes to a wireless recorder. In usual use, the patient can see these data and graph the previous 1, 3 or 9 hours to identify trends or look back over time (ie over night). In our study, the patient will be blinded to the data so as not to confound results, as it has been noted in another study that patient's blood sugar control was better when they were able to see CGM results and modified their diet. CGM's have been shown to have clinical accuracies of 95.5-98.9% and have been used in clinical trials and found to be safe. Having the patient do a finger-stick glucose intermittently during the time they are wearing the CGM improves accuracy.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects, aged 18-75 years;
* Subjects diagnosed with Type 2 Diabetes mellitus;
* Subjects currently on oral agents or insulin;
* Body mass index 25 to 40 kg/m2;
* Subjects able to comply with study procedures and sign informed consent
* A1c less than or equal to 9%

Exclusion Criteria:

* Medication (other than diabetes medications or insulin) or dietary supplement known to affect glucose or galactose metabolism
* Use of acetaminophen-containing products
* Lactose or galactose intolerance
* History of eating disorder
* Food allergy or severe food intolerance
* Pregnant or lactating female
* Subjects with diabetes mellitus treated with very high dose of sulfonylureas (glyburide\>20 mg/day, , glimepiride \>8 mg per day, and glipizide \>20 mg per day) α-glucosidase inhibitors (acarbose ), or meglitinides (repaglinide \>6 mg per day)), ;
* Subject with gastrointestinal disease that may interfere with absorption of the investigational products at discretion of investigator, including but are not limited to malabsorption syndromes and gastric ulcer;
* Subject has received any investigational agent within 30 days prior to the first dose of investigational product
Pharmacokinetics of Vancomycin in ICU Patients

Vancomycin is frequently under-dosed in ICU patients during the first 24-48 hours of treatment. Glomerular hyperfiltration syndrome, increased drug volume of distribution, vasopressor use, male sex and hypoalbuminemia are identified risk factor for vancomycin underdosing in ICU patients, among others.

To date, bedside estimation of vancomycin volume of distribution is challenging, and new methods for optimizing drug administration are required.

The Picco device is a moderately invasive hemodynamic monitoring system, providing parameters that may help estimation of vancomycin pharmacokinetics parameter.

The aim of this study is to test whether addition of hemodynamic parameters would improve pharmacokinetics modelling of vancomycin concentration in ICU patients.


Eligibility Criteria:
Inclusion Criteria:

* patient hospitalized in intensive care unit
* under intravenous vancomycin started during current ICU hospitalization
* with at least one vancomycin serum concentration available
* under hemodynamic monitoring with the Picco ® device

Exclusion Criteria:

* vancomycin treatment for less than 24 hours
* vancomycin concentration in serum unavailable
* rare comorbidities influencing vancomycin pharmacokinetics

  * myeloma
  * cystic fibrosis
  * burn injury on more than 20 % of the body surface
* previous inclusion in present study
High-Density EEG-MEG-wearable EEG: Comparison of Quantitative Electroencephalographic Indicators as Neurophysiological Markers of Effectiveness of Mindfulness Therapy in Addition to Standard Treatment in Patients With High-frequency Episodic Migraine

Recent studies suggest that Mindfulness may be an effective treatment for migraine, reducing the frequency of attacks, depression, anxiety and improving quality of life. However, the pathophysiological mechanisms underlying the effectiveness are not yet fully known. The identification of neurophysiological markers may help to better understand the mechanisms on which Mindfulness acts in migraine sufferers and to develop increasingly targeted and personalized Mindfulness interventions to optimize migraine treatment. The main objective of the study is to identify neurophysiological indicators of effectiveness of Mindfulness treatment in patients with migraine without high-frequency aura with clinically available devices (MEG and hdEEG). Another goal is to recognize the indicators also in the signal acquired with wearable devices in home use (wEEG). Finally, another goal will be to study the relationship between the identified neurophysiological markers and the change in neuropsychological test scores.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients will be included who fulfil the ICHD-3 criteria \[8\] for HFEM, code 1.3-Chronic Migraine (characteristics similar to CM but with a frequency of 8-14 migraine days per month) with stable therapy in the 3 months prior to the start of Mindfulness treatment. If the therapy is changed during the screening visit, the patient will wait 3 months before starting Mindfulness treatment.

Exclusion Criteria:

* in the presence of psychiatric comorbidities in the psychotic area, reported in the history or assessed by the clinician
* if pregnant
* in the presence of secondary headache comorbidities (e.g. idiopathic intracranial hypertension)
* if they have undergone symptomatic abuse detoxification at least twice in the previous two years
* if they have already undergone any kind of treatment with Mindfulness or meditation techniques
Pollutant Altered Allergic Responses

This study is designed to investigate whether exposure to particulate air pollution increases the allergic response to allergens. Research studies suggest that symptoms in individuals with allergies may be aggravated by exposure to particulate air pollution. We sought to experimental determine this by exposing human volunteers to combustion particles, a component of air pollution, and then challenge them with an allergen such as ragweed or oak tree pollen. Using biological tests we can measure whether the allergen response is magnified by prior particulate exposure.

To study whether particulates enhance the allergic response, we chose the upper airway as a model of allergic inflammation and nasal lavage as a non-invasive method for obtaining samples. The nasal cavity is both an excellent model of allergic inflammation and provides an easily accessible site for study. We measured inflammatory cells and cytokines in the nasal lavage fluid. Our specific hypothesis was that particulate exposure prior to allergen challenge would enhance inflammatory cell recruitment and expression of inflammatory cytokines.

Eligibility Criteria:
Adult without a history of asthma or respiratory disease.
Role of Magnesium Supplementation in the Treatment of Depression

The objective of this project is to test the hypothesis that magnesium supplementation will decrease depressive symptoms in adults.

This study takes place over 12 consecutive weeks. While the investigators will follow the volunteers for the full 12 weeks volunteers will only take magnesium supplements for 6 consecutive weeks. Volunteers will be randomly assigned to start the supplement at week 1 or week 7. Volunteers will take two supplement two times a day for a total of 248 mg elemental magnesium daily in the form of magnesium chloride. This amount of magnesium is less than the tolerable upper limit of 350 mg per day. The supplements will be provided. Volunteers will be asked to maintain their normal diet for the 12 weeks of the study.

The primary outcome measure is the PHQ-9 questionnaire, a validated measure of depression. Secondary measures include the GAD-7 for Anxiety and side effects.


Eligibility Criteria:
Inclusion Criteria:

* All adults at least 18 years of age
* A Patient Health Questionnaire-9 (PHQ-9) score of greater or equal to 5 but less than 20
* People who are currently being treated for depression are still eligible to participate but their treatment must be stable (no changes in medication dose or brand and/or no changes in therapy regimen for at least 2 months).

Exclusion Criteria:

* Active delirium or dementia
* Medicinal treatment for bipolar disorder, personality disorder or schizophrenia,
* Glomerular Filtration Rate of less than 60
* Irritable Bowel Disease
* Inflammatory Bowel Disease
* GERD
* Gastritis
* Pregnant as reported by potential volunteer
* Myasthenia Gravis
* Planned elective surgery
* Currently taking

  * Long Term Antibiotics
  * Fluoroquinolone
  * Trientine or Penicillamine
  * Long Term Antivirals
  * Digoxin
  * Bisphosphonates
  * Eltrombopag
  * Opiods
  * Calcium Channel Blockers
  * Deferiprone
  * Doxercalciferol
* Unable or unwilling to stop taking a magnesium supplement