cyrilzakka/clinical-trials huggingface dataset:
Gynecologic Extramammary Paget's Disease

In addition to evaluating treatment outcomes, tissue samples and swabs will be collected as part of this study to allow physicians to better understand Extramammary Paget's Disease (EMPD). The researchers also want to learn more about the microorganisms (microbiome) that live on or near the areas of skin affected by EMPD, in order to better understand this condition.

This is a prospective cohort study. Patients with Extramammary Paget's Disease (EMPD), specifically women with vulvar/perianal Paget's disease, will be identified during presentation to either the Dermatology Department or Gynecologic Surgery department at Mayo Clinic.

During physical exam, the patients will undergo skin/rectum/vagina cultures to evaluate the microbiome in these patients. The patients will be entered into the established care pathway for EMPD. They will be asked to complete sexual health questionnaires including: The Women's Health Clinical Questionnaires include the Menopause Rating Scale (MRS)1, Perceived Stress Scale2, Brief Resilience Scale (BRS)3, LASA Quality of Life Assessment4, Female Sexual Function Index (FSFI)5, Female Sexual Distress Scale-Revised6, Kansas Marital Satisfaction Scale7, and Pittsburgh Sleep Quality Index (PSQI)8.

The patients will be referred to Women's Health Clinic as part of the care pathway and will undergo preoperative genital sensory testing (GST) which measures sensation of the clitoris, vulva, and vagina. The patients will have a Dermatology consultation and Moh's micrographic procedure as indicated. If choosing to proceed with surgical intervention, the patients will then undergo an excisional procedure with the Department of Gynecologic surgery. Swabs, urine and tissue will be collected prior to procedures or surgery for microbiome analysis.

Eligibility Criteria:
Inclusion Criteria:

* Females
* Age 18 years or older
* Diagnosed with primary or recurrent EMPD of vulva and/or perianal region of the body
* Willing and able to provide signed informed consent

Exclusion Criteria:

* Males
* Diagnosis of Paget's Disease in body areas other than vulvar or perianal region
Emotional Freedom Techniques and Virtual Reality Application for Fear of Childbirth

Fear of labour in primiparous pregnant women is an important factor that directly affects the mother-infant relationship and the mental health of the mother. In this process, it is common for expectant mothers to experience feelings of uncertainty and anxiety about labour. Such intense fear of birth may weaken maternal attachment and make it difficult for her to establish a healthy emotional relationship with her baby. In addition, this fear may negatively affect the mother's mental well-being and increase the risk of depression and anxiety.

In this context, emotional liberation techniques (EFT) and virtual reality (VR) applications stand out as effective nonpharmacological methods used to reduce fear of childbirth in primiparous pregnant women. EFT is a technique that provides relaxation by touching the energy meridians that help the person to regulate negative emotions and cope with stress. SG, on the other hand, allows expectant mothers to interact with simulations similar to the real world in a virtual environment, providing therapeutic benefits through distraction, stress reduction and cognitive restructuring, allowing them to manage their fears about birth and enter the process more prepared. The use of SLT and SG, especially for primiparous pregnant women, can alleviate these women's anxiety about childbirth and enable them to approach the process in a safer and more conscious manner. Thus, it may also help to reduce the negative effects on the mother's postnatal attachment and mental health.

This study aims to examine the effects of SLT and SG practices on fear of childbirth, attachment and mental well-being, and to reveal the effects of these two methods on primiparous pregnant women. In this context, this study will fill the gap in the literature by providing a new perspective in clinical practice and antenatal education programmes and will make important contributions to increase antenatal attachment and mental well-being in primiparous pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* No verbal communication problems
* Primiparous pregnancy
* 32/0-38/0 weeks of gestation
* Having a single, viable foetus
* No psychiatric disorder
* No obstetric complications
* Absence of scar tissue or an obstacle to touch at the points of EFT application

Exclusion Criteria:

* Not wanting to continue the research
* Early labour
Erector Spinae Plane (ESP) Block For Postoperative Pain Management In Lumbar Spine Surgery

Lumbar vertebra surgery is one of the most common surgical procedures. After lumbar veretebra surgery, patients complain of excessive pain. Postoperative pain usually occurs in the early postoperative period and delays patient mobilization and thus lengthens hospital stay.

The aim of this study was to investigate the effect of this field block on postoperative pain and respiratory function in patients undergoing ESP with lomber vertebra surgery and with ultrasound guidance for postoperative analgesia.

Lumbar vertebra surgery is one of the most common surgical procedures. After lumbar veretebra surgery, patients complain of excessive pain. Postoperative pain usually occurs in the early postoperative period and delays patient mobilization and thus lengthens hospital stay.

The aim of this study was to investigate the effect of this field block on postoperative pain and respiratory function in patients undergoing ESP with lomber vertebra surgery and with ultrasound guidance for postoperative analgesia.

ASA I-III, 68 patients between 18-75 years of age were planned to be included in the study. 34 participants were expected to be included in the control and implementation group.

In our study, the ESP block was planned to be applied to the patients in the block group. Peroperative analgesia plan will be applied to all patients in the same way. In this protocol, intravenous paracetamol 1 gr and tramadol 1 mg / kg were determined. Then, every eight hours, paracetamol and contromal infusion.

At the end of the operation, the patients will be determined by the Numeric Rating Scale (NRS) system at the 30th hour, 1st, 6th, 12th and 24th hours after the first hour of the operation. Tramadol PCA and paracetamol are administered every eight hours.

Age, sex, weight, body mass index, application of ESP block, time of surgery, duration of surgery, evaluation of pain in postoperative recovery room and 24-hour follow-up will be recorded when the patient is mobilized and discharged.

It is thought that the ESP block will decrease postoperative pain by providing effective pain control after surgery in patients undergoing lumbar vertebra surgery. In addition, it is thought to accelerate mobilization in the postoperative period and shorten the time of discharge.

Eligibility Criteria:
Inclusion Criteria:

* 68 patients
* ASA I-III,
* Aged 18-75 years
* underwent lumbar spine surgery under elective conditions

Exclusion Criteria:

* Presence of contraindications to LA agents used in this study
* Use of chronic opioids,
* Psychiatric disorders.
* Surgical procedures that lasted \<60 minutes or\> 300 minutes
* The presence of infection at the injection area.
Human Menstrual Blood-derived Mesenchymal Stem Cells Transplantation in Treating Type 1 Diabetic Patients

The purpose of this study is to investigate whether the treatment of human menstrual blood-derived mesenchymal stem cells which would be applied to diabetes patients is safe and effective.

Diabetes mellitus is chronic metabolic diease caused by absent or rejection insulin from pancreatic b cells.The traditional treatment strategies for diabetes are daily injections with insulin and transplantation of islets from cadaver. However, daily injuection is very inconvenient and there is a shortage of organs and life long immunosuppression. Therefore, such therapy can be offered to a very limited number of patients only. MSC-based therapeutic intervention has become an emerging strategy for the replacement of injured tissues. MSCs also have been noted to possess immunomodulatory effects in vivo. Thus, their potential for clinical use as a cell-based therapy should be focused and observation.

Eligibility Criteria:
Inclusion Criteria:

* male and female patients at the age of 18 to 75.
* agreement to receive written informed consent.
* voluntary submission to the procedures of the study protocol.
* clinical diagnosis is classified to type 1 diabetes(T1DM).
* T1DM duration ≥ 1 and ≤ 20 years from the time of enrollment.

Exclusion Criteria:

* renal dysfunction, eye disease or other organ disease.
* cardiovascular disease, existing congestive cardiac failure on physical exam and/or acute coronary syndrome in past 6 months.
* pregnancy
* mental disorders
* hepatitis C, HIV, RPR,active tuberculosis or blood diseases
* any malignancy
* any other severe diseases that could potentially influence the infusion results
A Study of Participants With Moderate or Severe Major Depressive Disorder (MDD) Requiring Urgent Symptom Control in a Psychiatric Emergency

The purpose of the study is to describe the clinical outcomes (severity of depression, severity of suicidality \& frequency of suicidal thinking, suicide events) and quality of life (QoL) of participants with symptoms of major depressive disorder (MDD) that have current suicidal ideation with intent.


Eligibility Criteria:
Inclusion Criteria:

For Participant and Carer

* Capacity to provide consent
* Must sign an informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements
* Sufficient command of English language to understand the study information and requirements For Participant
* Participant must be deemed to have current suicidal ideation with intent at the point of study enrollment and be within four days of presenting with suicidal ideation with intent in relation to the current episode For Carer
* Participant and/ or carer report that the carer has a personal relationship with the patient and provides unpaid support or care

Exclusion Criteria:

* Capacity to provide consent
* Participant is known to be diagnosed with any of the following conditions: mania, bipolar disorder, psychotic disorder, depression with psychotic features, autism, dementia, intellectual disability
* Participant is known to be diagnosed with any of the following conditions: mania, bipolar disorder, psychotic disorder, depression with psychotic features, autism, dementia, intellectual disability
Examining the Effect of Ondansetron on Bowel Prep Success

This is a pilot randomized-controlled trial assessing the utility of ondansetron for improving pediatric pre-colonoscopy bowel prep outcomes using the boston bowel preparation score, as well as assessing the impact on patient experience of bowel preparation.

The study will compare two approaches to pre-colonoscopy cleanout, one with traditional laxatives only, and one with laxatives + anti-emetic therapy. The medication to be added will be Ondansetron (brand name: Zofran). Classically, the bowel prep entails drinking large amounts of water with an osmotic laxative and being only on a liquid diet the day prior to the procedure. Drinking this mixture of water with an osmotic laxative may cause nausea and discomfort in some patients that may prevent them from finishing the bowel prep. This will therefore affect the visualization of the colon during the procedure, as there will still be retained, hard stool. Having large amounts of stool in the colon during the procedure can make the colonoscopy more difficult, takes a longer time to complete, can make the study inconclusive, unable to properly diagnose, and difficult to take biopsies. This study assesses the impact of anti-emetic medication (ondansetron) on the bowel prep experience with the goal of improving participant tolerance and preparation success. This will eliminate concern for retained stool and less chance of cancelling a procedure due to improper bowel prep.

Eligibility Criteria:
Inclusion Criteria:

* Age \>2, \<20
* clinically indicated for a colonoscopy

Exclusion Criteria:

* known arrhythmia or long QT
Pilot Observational Study Examining the Effect of Endocrine Therapy on Aging

The goal of this pilot observational study is to learn about the feasibility of collecting patient-reported data and stool and blood samples from patients age 65 and older treated with aromatase inhibitor therapy for breast cancer. Participants will be treated with standard of care aromatase inhibitor therapy and will undergo serial phlebotomy, complete patient-reported questionnaires, and submit serial stool samples.

The main exploratory translational questions it aims to obtain preliminary data for are:

* What are the effects of aromatase inhibitor therapy on biomarkers of aging?
* What are the effects of aromatase inhibitor therapy on the microbiome? These data will be used for the development of future definitive studies.


Eligibility Criteria:
Inclusion Criteria

* Female gender.
* Cohort 1: Age 65 or greater. Cohort 2: Age younger than 65 years
* Cohort 1 Participants (starting AI therapy): Histologically proven stage 0-III carcinoma of the breast or at high risk for development of breast cancer who are planning to undergo treatment with neoadjuvant or adjuvant aromatase inhibitor therapy (anastrozole, letrozole, or exemestane).
* Cohort 1 Controls (no endocrine therapy): Histologically proven stage 0-III carcinoma of the breast or high risk for development of breast cancer and who are not planning to undergo treatment with any endocrine therapy (AI or tamoxifen).
* Participants Cohort 2 (starting AI therapy): Histologically proven stage 0-III carcinoma of the breast or at high risk for development of breast cancer who are planning to undergo treatment with neoadjuvant or adjuvant aromatase inhibitor therapy (anastrozole, letrozole, or exemestane).
* Concurrent treatment with GnRHa therapy, radiation therapy, CDK4/6 inhibitor, bisphosphonate, PARP inhibitor, and/or anti-HER2 therapy is permitted. Prior tamoxifen is permitted.
* The patient is aware of the nature of her diagnosis, understands the study requirements, risks, and discomforts, and is able and willing to sign an informed consent form.
* Able to read and understand English.

Exclusion Criteria

* Distant metastatic disease
* Prior aromatase inhibitor therapy except in the context of fertility treatment.
* Use of exogenous estrogen supplementation other than vaginal estrogen preparations.
Evaluation of the Effect of Flow Rate on Swallowing Function in Young Infants

The purpose of this study is to evaluate the effect of nipple flow rate on swallowing function in infants less than 3 months corrected age (up to 11 weeks and 6 days) who have been referred for videofluoroscopic swallow study.

Feeding difficulties are common in infants born premature and with medical complexity, particularly those with congenital heart disease. One of the most common strategies for managing feeding difficulties is changing the milk flow rate of the bottle nipple. Milk flow is the rate at which milk transfers from the bottle to the infant's mouth. During swallowing, the vocal folds must close to prevent aspiration of fluid into the airway. When milk flow is fast, the infant must swallow frequently to clear the bolus of fluid and prevent aspiration; this is done at the expense of respiration. When the milk flow rate is slowed, the infant can swallow less frequently, allowing better integration of respiration, and has more time to coordinate an effective swallow. While there is some very limited evidence that slower milk flow rate improves feeding in infants born premature and with congenital heart disease, the underlying mechanisms for improvement of feeding remain unknown. This project will be the first to evaluate the effect of milk flow rate on swallowing function under fluoroscopy to better understanding how swallowing changes under different conditions of flow in young infants. This research will provide the evidence needed to support the use of this simple intervention (i.e., changing the flow rate) in infants at risk for feeding difficulty and swallowing dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* Infant less than 3 months corrected age
* Must be referred for video fluoroscopic swallow study (VFSS) at Boston Children's Hospital

Exclusion Criteria:

- Infant unsafe to trial all study conditions as determined by clinician(s) conducting the VFSS.
Open Label RCT for Chronic Severe AR : Entresto vs. CCB/ARB

The purpose of this study is to assess the efficacy of sacubitril-valsartan compared to the combination of ARB/CCB on left ventricular remodeling in patients with chronic aortic valve regurgitation.

After being informed consent about the study and potential risk, all patients giving written informed consent will undergo a 1 month screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomized in an open-label manner in a 1:1 ratio to sacubitril-valsartan or amlodipine/losartan.

Eligibility Criteria:
Inclusion Criteria:

1. Participant over 20 years of age who has not been hospitalized for heart failure
2. Participant with hypertension or systolic blood pressure 125 mmHg or higher
3. NYHA I
4. Participant with chronic severe aortic regurgitation (VCW \>0.6cm)
5. Participant with AV regurgitant volume ≥ 60mL or effective regurgitant orifice area ≥ 0.3 cm2
6. Participant with left ventricular ejection fraction ≥ 55%

Exclusion Criteria:

1. A history of hypersensitivity or allergy to clinical trial drugs or similar compounds or ARB/NEP inhibitors
2. History of angioedema
3. Patients with an ascending aorta dilated by more than 55 mm
4. Patients with aortic valve insufficiency due to hereditary aortic disease (Marfan syndrome, Ehlers-Danlos syndrome)
5. Patients with moderate to severe aortic stenosis
6. Patients with claustrophobia or with metallic implants unsuitable for magnetic resonance imaging
7. History of acute heart failure within 6 weeks and dyspnea of NYHA II or higher
8. Symptomatic hypotension or SBP \< 100 mmHg at screening
9. Patients with renal failure (Estimated GFR \< 30 mL/min/1.73 m2) or on dialysis
10. Significant increase in blood potassium level (Potassium \> 5 mmol/L)
11. Blood AST or ALT value is more than twice the upper limit of normal or symptoms and signs of cirrhosis (history of hepatic coma, history of esophageal varices, history of symptomatic ascites)
12. In case of acute coronary syndrome, stroke, thoracic surgery, and percutaneous coronary angioplasty within 3 months
13. If aortic valve surgery is scheduled within the next 6 months
14. In case of severe mitral valve disease
15. Patients with primary hyperaldosteronism
16. If a woman of childbearing potential has not used double contraception
17. Women who are currently pregnant or lactating
18. When it is judged that there are clinically significant abnormalities in physical examination, diagnostic examination, electrocardiogram, etc. at the time of the screening visit
Nordic Cystectomy Study I - Neutrophil-lymphocyte Ratio (NLR)

Around 7200 cases of Muscle Invasive Bladder Cancer are diagnosed annually in the Nordic countries combined. Muscle Invasive Bladder Cancer is an aggressive disease and it is linked with high mortality rates. The golden standard of treatment is radical cystectomy (RC) (the surgical removal of the bladder) and radical removal of lymph nodes in the pelvis. In addition to surgical treatment, and especially in cases where the tumour invades tissues surrounding the bladder or lymph nodes, chemotherapy is recommended. Chemotherapy can be administered before or after surgery, in a neoadjuvant (NAC) or adjuvant setting (AC). Although most patients recover well from surgery, there are significant risks regarding radical cystectomy. The greatest challenges in planning the treatment are making individual risk assessments and prognosis for the treated patients. Neoadjuvant chemotherapy is also insufficiently used and it is hard to predict how the tumour responds to chemotherapy.

The purpose of this study is to collect prospective clinical data on radical cystectomy -patients in co-operation with other Nordic countries: Sweden, Denmark, Iceland and Norway. The collected data is used to validate existing prediction tools and discover novel tools for prediction of morbidity related to RC and prediction of oncological outcome after RC. The study is divided into three sub-studies. The second sub-study is on the preoperative neutrophil-lymphocyte ratio (NLR). Some studies suggest that NLR might be a predictor of oncological outcome of BC after RC. In addition, NLR has been suggested to correlate with NAC response and outcome after NAC and RC. The used cut-off value for NLR has varied between 2.26-3.0.

Patients will be allocated into two groups: low NLR ratio (NLR\<3), and high NLR ratio (NLR≥3). The lab test will be retrieved before RC at the time of routine clinical laboratory testing for all patients and also before the initiation of NAC for patients planned to have chemotherapy. The primary end-point is bladder-cancer specific survival and, and secondary endpoints include progression-free, and overall survival.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed urinary BC planned to be treated with RC with or without neoadjuvant chemotherapy.
2. Histologically confirmed urinary BC planned to be treated with palliative cystectomy 2) Signed informed consent 3) Patient age \>18 years

Exclusion Criteria:

1. RC for other reasons than BC
2. Other forms of surgical treatment of BC than RC (e.g. bladder resection).
3. Patient unwillingness to participate in the study for any reason (i.e. lack of signed consent).
STAMPP-HTN in a High-risk Rural Population of Women

The purpose of this study is to determine if monitored blood pressure paired with education reduces maternal mortality and morbidity during the post-partum period in a high-risk rural population of women.

Women with hypertension during pregnancy are at an increased risk of maternal mortality (death during or within 42 days of termination of pregnancy) and hypertension related morbidity. Black women, women with lower education and less access to health care resources also have increased maternal mortality and morbidity. This project will use Bluetooth enabled blood pressure devices to monitor blood pressure in a population of postpartum women at increased risk for maternal mortality and morbidity. We will compare the number of postpartum hypertensive incidences and severities to a population of women who did not have a postpartum blood pressure control intervention.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent in a postpartum woman between 18-45 years of age at the time of study enrollment
2. Hospitalized for delivery with a hypertensive disorder of pregnancy as defined by ACOG 2019 Guidelines (chronic hypertension, HELLP syndrome, eclampsia, preeclampsia, gestational hypertension or new onset postpartum hypertension).
3. Ability to understand English or Spanish
4. Reliable access to the Internet and a Bluetooth mobile device
5. Willingness to download Omron Connect App and ability to use blood pressure monitor

Exclusion Criteria:

1. Does not meet Inclusion criteria
2. Postpartum or operative complication that prolongs hospital stay beyond postpartum day 10.
3. Patients who are currently participating in another clinical trial to evaluate a therapeutic intervention for control of blood pressure.