cyrilzakka/clinical-trials huggingface dataset:
Sexual Dysfunction in Type 2 Diabetic Women

Type 2 diabetes mellitus is becoming an increasingly problem for public health and it is related with various complications such as sexual problems. The prevalence of erectile dysfunction has been widely studied in men as a complication of diabetes; the prevalence of sexual dysfunction in women, instead, has not been well investigated. The aim of this study is to evaluate the prevalence of sexual dysfunction in type 2 diabetic women using international validated questionnaires.

In an estimated temporal space of about 3 years, 306 women will be recruited consecutively.

After collection of written informed consent, the following data will be collected:

* History: type of diabetes, comorbidities, current medication, duration of diabetes and complications, voluptuary habits such as tobacco smoke (both number of packets/year and n° packets/day), alcohol consumption, coffee consumption, physical activity.
* Physical exam, general anthropometric parameters such as weight, height, circumference, body mass index, waist-hip ratio, and blood pressure.
* Assessment of glycemic variability (fasting plasma glucose and post-prandial glucose)
* Each patient will be self-administered Female Sexual Function Index (FSFI) and Female Sexual Distress Scale (FSDS) questionnaires to assess the prevalence of sexual dysfunction and Self-Rating Anxiety Scale (SAS) and Self-Rating Depression Scale (SDS) of Zung for an accurate assessment of the state of anxiety and depression.
* We will collect blood and urine samples to assess: ematology, glycated hemoglobin, fasting plasma glucose, fasting plasma insulin, total cholesterol, HDL cholesterol, triglycerides, LDL cholesterol, creatinine, urea, transaminases, electrolytes, complete urinalysis, 24-hour microalbuminuria, homocysteine, high sensitivity C-reactive protein (hs-CRP), metalloproteinase-2 (MMP-2), metalloproteinase-9 (MMP-9), soluble adhesion molecules (sICAM-1, sVCAM-1), sE-selectin, lipoprotein (a) \[Lp (a)\], Plasminogen Activator Inhibitor-1 (PAI-1).
* We will also conduct a clinical and instrumental exam of the foot using Neuropad, recently validated as a screening tool for diabetic neuropathy. Patients will also undergo autonomic tests (deep breathing, lying to standing, Valsalva maneuver, and orthostatic hypotension).

We will also evaluate the presence of neuropathy through the administration of the Michigan Neuropathy Screening Instrument (MNSI) and the Neuropathy Disability Score (NDS).

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes mellitus

Exclusion Criteria:

* previous surgery for hysterectomy or ovariectomy
* hormone replacement
The Effect of Mindfulness-Based Cognitive Therapy Program Applied to Nursing Students

Among the stress factors of nursing students are traumatic experiences such as death and encountering a dying patient from the first moments of their education years, fear of making mistakes in the clinic, patient care, not getting enough support from the instructor or clinic staff, and communication problems. Exposure to long-term and uncontrollable stress negatively affects students' professional identity development and health. Students who cannot cope with their stress feel stress at a higher level and as a result they may experience anxiety and depression.It is important for nurse candidates to graduate by being supported in all aspects, both in terms of individual and professional development. For this reason, nursing educators should use effective and innovative interventions to help students recognize the stress they experience and help them reduce stress. Mindfulness-Based Cognitive Therapy Program (MBCT) is one of these programs. Although studies with MBCT are found in the literature, our country In the literature, no randomized controlled studies were found with nursing students. In line with this information, it was thought that mindfulness-based studies were needed. This study was planned to determine the effect of MBCT program on depression, anxiety, stress and cognitive flexibility of nursing students.

Inclusion criteria for research

* to be nursing students
* to have a score of 4 or more (General Health Questionnaire)
* Internet access to participate in online sessions
* Individuals who voluntarily agree to participate in the research will be included.

Exclusion criteria from the research

* Those who are in the acute depression period
* Risk of suicidal
* Having participated in MBSR-MBCT programs before

Application Protocol Principles

* to consider students individuality, to provide correct information/education,
* Guiding to increase motivation,
* Giving feedback and supporting individuals,
* to provide accessibility for individuals' concerns and questions,

Eligibility Criteria:
Inclusion Criteria:

* Being a student of Düzce University, Faculty of Health Sciences, Department of Nursing
* Individuals who voluntarily agree to participate in the research

Exclusion Criteria:

* Those in acute depression
A Study of Ribociclib in Combination With Hormonal Therapy in HR+/HER2- Advanced or Metastatic Breast Cancer

This is a non-interventional, ambispective, observational cohort study describing the real-world safety data of approximately 550 Hormone receptor / Human epidermal growth factor receptor 2 (HR+/HER2-) advanced/metastatic breast cancer patients who have received ribociclib combined with hormonal therapy in pre-and postmenopausal women or men in Middle Eastern countries.

The investigators will have a six-month recruitment period to include the eligible subjects as per the protocol selection criteria. Retrospective patients should have been on Ribociclib in combination with hormonal therapy for at least 18 months and stopped the medication before the patient's recruitment.

Ambispective patients should have initiated Ribociclib, in combination with hormonal therapy, for at least 12 months before the patient's recruitment date and are still on Ribociclib in combination with hormonal therapy at recruitment. These patients will be followed up till progression, death, Ribociclib discontinuation due to adverse events, or till a maximum period of 6 months, whichever comes first.

Data will be collected from patient electronic medical records in the sites chosen for patients who received Ribociclib, in combination with hormonal therapy, in the first or second-line setting available in the relevant institutions.

A total of 550 patients is planned for this study. The planned sample size should capture very common adverse events reported in previous studies as well as adverse events ≥ 10% occurring in grade 3 and grade 4 with precision ±2.5%.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients ≥ 18 years old at the time of receiving Ribociclib in combination with hormonal therapy.
2. Advanced /metastatic breast cancer
3. Estrogen-receptor-positive and/or progesterone receptor-positive breast cancer.
4. HER2-negative breast cancer.
5. Patients who received or currently receiving Ribociclib in combination with hormonal therapy in the first or second-line settings as per the routine practice.
6. For the ambispective part, patients should have initiated the Ribociclib, in combination with hormonal therapy, line of treatment at least 12 months before the patient's recruitment date and still continuingcontinuing the drug at the baseline visit.
7. For retrospective patients only, the patients should have been on Ribocilib, in combination with hormonal therapy, for at least 18 months and stopped Ribociclib before the SIV date.enrollment
8. For ambispective part, patients agree to sign informed consent before their enrollment.

Exclusion Criteria:

1. Ribociclib-based treatment regimen beyond the second line.
2. Patients are currently participating in any other clinical trials.
3. Patient with a known hypersensitivity to any of the excipients of Ribociclib.
4. Patients who previously received any other CDK4/6 inhibitor .
5. For ambispective patients, patients who refuse to sign the informed consent
Overcoming Barriers to Accessing Genetic Medicine

To learn about patient barriers to accessing genetic medicine, we will analyze anonymous posts from a membership-based online community \[Inspire.com\], and investigate how these barriers differ for various populations. We will then test whether these barriers can be addressed by providing online access to a genetic counselor to answer patient questions for one group of patients (virtual advisory board group) and compare to that of a control group who does not have access to a genetic counselor (virtual peer-to-peer board group).

Genomic medicine has the potential to advance diagnoses, predict risk, support prevention efforts, and inform treatment decision-making. Though technologies for measuring genetic variants have improved and become more cost-effective, clinical integration of genomic medicine has been surprisingly slow. For genomic medicine to be successfully implemented across specialties and across demographics, the systemic barriers that patients experience need to be identified and addressed.

Online health support is becoming an increasingly important part of healthcare as more patients use digital health networks. In the first part of this study, an analysis of online communication in a membership-based online support community \[Inspire.com\] will identify systemic, structural and individual barriers to accessing genomic medicine. A genetic counselor will be informed to these results and will be part of the intervention arm of the study.

To assess the extent to which online health networks can directly help genomic medicine implementation, participants will join one of two Virtual Discussion Boards (a Virtual Advisory Board and a Virtual Peer-to-Peer Discussion Board). In the intervention arm, the Virtual Advisory Board will have a genetic counselor answer patient questions online about genomic medicine once every week for a period of three months. In the control arm, participants will answer and comment on each others' questions in the Virtual Peer-to-Peer Discussion Board. We hypothesize that after six months, patients who participate in the Virtual Advisory Board are more likely to self-report receiving genomic medicine than those in the control arm. After completion of the study, participants in the Peer-to-Peer Discussion Board, we will give online access to the genetic counselor to answer any questions

Eligibility Criteria:
Inclusion Criteria:

Member of Inspire.com Genetic disease Genetic predisposition to disease -

Exclusion Criteria:

Not member of Inspire.com No genetic disease No genetic predisposition to disease

-
Combination Weekly Taxotere™ With Iressa™ /Placebo in Metastatic Breast Cancer

The purpose of this study is to determine if combination therapy of weekly Taxotere™ with Iressa™ will increase the objective responses in measurable leasions in metastatic breast cancer


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed mammary carcinoma

Exclusion Criteria:

* prior taxane chemotherapy for metastatic disease or prior treatment with tyrosine kinase inhibitors inhibiting the EGF receptor.
* Prior hormone treatment or one type of anthracycline based treatment regimen without taxane for metastatic disease is allowed prior to inclusion.
* If the patient has been treated in the adjuvant or neoadjuvant setting with taxanes, inclusion is allowed when the first cycle of trial medication is started 12 months after the last course of adjuvant treatment
Percutaneous Aponeurotomy in the Treatment of Dupuytren's Disease

The efficiency of percutaneous aponeurotomy in the treatment of Dupuytrens disease is well known. However, the duration of the clinical improvement after aponeurotomy is not well known.

This study aims primarily at measuring the incidence rate of local relapse of Dupuytrens-induced finger flessum, within two years following treatment by percutaneous aponeurotomy in Dupuytrens.


Eligibility Criteria:
Inclusion Criteria:

* Patient suffers from Dupuytren disease
* Patient has at least one finger with at least 20° flessum on the metacarpophalangeal joint and/or on the proximal interphalangeal joint
* Patient has chosen to benefit from local treatment

Exclusion Criteria:

* Pregnancy
* Breastfeeding
* No social insurance
Hysteroscopic Follow-up Following Conservative Stepwise Surgical Approach for Management of Placenta Previa Accreta

Conservative management of placenta accreta spectrum can preserve future fertility but should only be done in hospitals with enough experience as it carries a high risk of maternal complications.

Follow up after conservative management is crucial to detect complications early.

Placenta accreta is defined histopathologically as abnormal trophoblast invasion of part or all of the placenta into the myometrium of the uterine wall.1 Depending on the depth of villous tissue invasiveness, placenta accreta was subdivided by pathologists into "creta", "increta", and "percreta", in which the villi adhere superficially to the myometrium without interposing decidua, penetrate deeply into the uterine myometrium, and perforate through the entire uterine wall and may invade the surrounding pelvic organs, respectively.

The term placenta accreta spectrum (PAS) will be used in this manuscript to include both the abnormally adherent and the invasive forms of accreta placentation. Severe and sometimes life-threatening hemorrhage, which often requires blood transfusion, increases maternal morbidity and mortality.

Eligibility Criteria:
Inclusion Criteria:

1. Pregnant women with one or more previous cesarean deliveries
2. Women diagnosed with placenta previa accreta and underwent Conservative stepwise surgical approach for management.

Exclusion Criteria:

1. women who refused to participate in the study.
2. Associated other medical conditions as pregnancy-induced hypertension, heart diseases, and rheumatological diseases apart from iron deficiency anemia.
3. Presence of uterine anomalies
Anti-MERS-CoV Convalescent Plasma Therapy

Since the first report of the Middle East Respiratory Syndrome Corona virus (MERS- CoV) in September 2012, more than 800 cases have been reported to the World Health Organization (WHO) with substantial mortality.

World knowledge about this virus is accumulating but data about the clinical presentations of infected patients and common treatments, including ribavirin, interferon and methylprednisolone, lack evidence. Although drugs with anti- coronavirus (CoV) activities have been identified, as yet no anti- MERs- CoV drug has been approved and a vaccine has yet to be developed. Previous reports on other viral infections including SARS have suggested that convalescent plasma or serum is effective where no other treatment is available or in an emergency. A recently completed systematic review and meta-analysis by the University of Nottingham - World Health Organization Collaborating Center indicates that convalescent plasma therapy may be the most promising near-term therapy patients with for MERS- CoV infection. In this study, investigators will study the pharmacokinetics of immunoglobulin in response to convalescent plasma administration in order to inform a much larger study which will investigate the efficacy of convalescent plasma. Plasma will be collected from patients who recently recovered from MERS-CoV, Health Care Workers who had potential exposure and are tested for anti MERS-CoV serology and RT-PCR after obtaining their consent. This convalescent plasma will be stored in the blood bank as per their policies and procedures. Patients with MERS-CoV positive after meeting the eligibility criteria will receive 2 units of convalescent plasma . Clinical data as well as the standard laboratory studies will be collected at baseline, 30 mins after first dose, 30 mins after second dose, day 1, 3, 7, 14, 28 of hospital stay after enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 14 years of age
* Inpatients who are MERS-COV positive (by PCR)
* Willingness to have blood, respiratory and urine samples obtained and stored for subsequent analysis.

Exclusion Criteria:

* Clinical evidence (in the judgment of the site investigator) that the etiology of illness is primarily not MERS-CoV in origin.
* History of allergic reaction to blood or plasma products (as judged by the investigator)
* Known IgA deficiency
* Medical conditions in which receipt of 500mL volume may be detrimental to the patient (e.g., decompensated congestive heart failure)
* Females who are pregnant or breast feeding.
Integration of the 5G-based Remote Healthcare System in Critical Care

The primary objective of this initial report is to address the following questions: Under what circumstances do clinical teams at satellite locations utilize the 5G RHS? Does the implementation of 5G RHS result in significant clinical enhancements? Furthermore, additional analyses will be conducted to assess specific improvements in various use cases (e.g., emergency room, diagnosis, treatment, task guidance, and medical education) and to examine whether factors such as the expertise of central physicians, patient and physician locations, and the timing of calls influence clinical outcomes.

Background: Augmented Reality (AR) has undergone rapid development in recent years, gaining prominence in healthcare, especially when coupled with 5G internet technology. This study delves into the integration of 5G Augmented Reality in emergency medicine, with a focus on its impact on clinical outcomes.

Methods: This study will utilize the 5G-based Remote Healthcare System (5G RHS) to connect four satellite Emergency Room (ER) teams with central experts to assess its effectiveness in critical cases. Data will be collected from July 2022 to June 2023 to address key research questions, including the circumstances prompting the use of 5G RHS, the extent of clinical improvement achieved, and the influence of central physician expertise, patient and physician locations, and calling time on clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* 1) Age range (≥18 years old).
* 2) Patients with acute chest pain, stroke and trauma were diagnosed in the departments of emergency medicine of the relevant medical community, Branches of Run Run Shaw Hospital, Zhejiang University School of Medicine.
* 3) Voluntarily participate in the study and sign the informed consent; If the subject does not have the ability to understand or sign the informed consent, his/her guardian will represent him/her in the informed process and agree to participate in the study; If illiterate, his/her will need a witness to witness the knowledge process and his/her will decide to participate in the study.

Exclusion Criteria:

* 1) Incomplete clinical data.
* 2) Minors.
* 3) Pregnant women.
Establishment of Genomic and Phenotypic Database for Niemann-Pick Disease, Type C

Background:

Niemann-Pick type C (NPC) disease is a rare, progressive neurodegenerative disease that affects mainly the brain, liver, and spleen but also other parts of the body. There is no cure for NPC, and symptoms only get worse over time. Symptoms can include seizures, difficulty moving or talking, or dementia. But symptoms can vary among different people with the disease. Some may have seizures, while others do not, for example. Some people begin showing symptoms in childhood; in others, symptoms may not appear until they are adults. Researchers want to learn more about why NPC affects people differently. This natural history study will gather data from people with NPC in order to understand more about the disease and how it affects the body.

Objective:

This study will create the first and largest database about NPC.

Eligibility:

People of any age who have NPC.

Design:

Participants will have blood drawn from a vein. This will happen only once. The blood will be used to analyze the participants DNA.

The participants medical records will be reviewed. The study team will collect data on participants NPC diagnosis and symptoms; they will record how long participants have had each symptom. The study team will also collect data on each participants age, sex, race, height, weight, medications, and other test results.

The study team will communicate with participants. They will discuss the study and answer any questions.

Participants will receive up to $190.

Study Description:

The primary objective of this protocol is to investigate the phenotypic heterogeneity of NPC by using clinical and genomic data, and to establish a comprehensive database to facilitate future investigations.

Objectives:

1. Identify correlations between NPC clinical phenotypic findings and genomic markers to facilitate the understanding of the heterogeneity of this disease.
2. Identify genetic contributions to NPC disease progression that can be utilized as potential therapeutic targets.
3. Establish the first and largest database of genomic and phenotypic information for NPC to benefit the NPC research and patient community.

Eligibility Criteria:
* INCLUSION CRITERIA;

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, any age, demographic or ethnic background will be eligible for this study
4. Diagnosis of NPC will be based on clinical, biochemical or molecular testing.

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Unwilling to provide consent
2. Unable to provide biospecimen to obtain DNA
3. Unable to provide medical records or clinical data
Effects of Sustained Reading on the Ocular Surface

This research is being done to to see if changes in visual reading function correlate with changes in optical and retinal image quality. We hypothesize that changes and deterioration in tear film quality and dynamics may have a negative effect on reading function.

People with or without dry eye syndrome may enroll.


Eligibility Criteria:
General inclusion criteria for all subjects will include:

* Ages 50 to 89 years
* Capacity to give informed consent.
* Self-reported literacy (i.e. a "Yes" answer to the question "Have you learned how to read?")

Additional inclusion criteria for the dry eye group will include both of the below:

* A previous diagnosis of dry eye syndrome by an eyecare specialist
* Ocular Surface Disease Index total scoring of 13 or above

Additional inclusion criteria for the Sjögren's syndrome group will include:

- A previous diagnosis of Sjögren's syndrome by an immunology specialist, per ACR criteria 22

Additional inclusion criteria for normal control subjects will include:

* No previous history of dry eye diagnosis
* Ocular Surface Disease Index total scoring of 12 or under
* Total corneal and conjunctival staining score of 0

Exclusion criteria will include:

* A binocular vision below 20/25 (with habitual correction)
* Any ocular surgery within the last 3 months.
* Mental issues, illiteracy, or language problems which might possibly interfere with reading ability
* History of taking or current use of topical prescription anti-inflammatory eyedrops (including, cyclosporine and steroids as well as any glaucoma eyedrops). Subjects who are willing to discontinue their treatment for at least a period of 30 days can be placed on a "wash out period" as per the discretion of the investigator and subject safety, and be eligible at the end of this period, given all other criteria have been met. Otherwise, subjects on these medications will be excluded.