cyrilzakka/clinical-trials huggingface dataset:
Management of Cancer Therapy Related Vulvovaginal Atrophy

The goal of this clinical trial is to:

1. evaluate the efficacy of PRP injection and PRP injection mixed with non-cross-linked hyaluronic acid compared to the control group receiving standard therapy with topical non-cross-linked hyaluronic acid gel in the treatment of cancer therapy-induced or worsened vulvovaginal atrophy.
2. To evaluate the impact of vulvovaginal atrophy treatment on the sexual satisfaction of both partners.

Patients will be divided randomly into 3 groups:

Group 1: 15 female patients will receive vaginal PRP injections. Group 2: 15 female patients will receive vaginal PRP injections combined with non-cross-linked hyaluronic acid.

Group 3: 15 female patients will receive topical non-cross-linked hyaluronic acid gel as a control group.

1. The first group will receive two treatment of sub-mucosal PRP injection at the outer 3 cm of the vagina with one month interval in between. (17)
2. The second group will receive two treatment of PRP injection mixed with non-cross linked hyaluronic acid at the outer 3 cm of the vagina with one month interval in between.

9. 3-The third group will receive one applicator (5gm) three times per week of topical hyaluronic acid gel for vaginal application which will be prepared in the faculty of pharmacy for 2 months.

Clinical assessment Patients will be assessed for symptoms and signs of vulvovaginal atrophy (VVA) at baseline, one month, two months, and, three months after the end of treatment.

1. Vulvovaginal atrophy (VVA) symptoms (dryness, dyspareunia) will be assessed on a subjective 10-point scale.

   Also, patient satisfaction with each type of treatment will be assessed with a questionnaire at the end of treatment and they will be asked if they wish to repeat the treatment to maintain effectiveness over time (yes or No).
2. For assessment of VVA signs on physical examination, vaginal health index including assessment of pH, overall elasticity, epithelial mucosa, fluid secretion type, and consistency and moisture will be used as an objective method of evaluation of therapy.
3. Assessment of sexual satisfaction of both male and female partners:

Sexual satisfaction was measured using the Arabic version of the Index of Sexual Satisfaction (ISS) and female sexual function index (FSFI) questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Patients have symptoms of VVA (vaginal dryness, burning, itching or dyspareunia)

  * Patients with vaginal health index \< 15.
  * All patients have already finished cancer therapy or are on anti-estrogen treatment.
  * Married sexually active
  * Patients who are not receiving any VVA treatment for at least 30 days before starting therapy.

Exclusion Criteria:

* Active or recent history of vulvovaginal inflammation or infection

  * History of vulvar or vaginal cancer.
  * Suspicious lesion in the vulvovaginal area on the gynecological examination
Knowledge, Attitude and Practice in Utilization of Vital Pulp Therapy in Permanent Teeth by Pediatric Dentists in Egypt

Conducting this questionnaire will help in collecting information about the extent of knowledge, attitude, and practice of utilization of vital pulp therapy in permanent teeth among pediatric dentists in Egypt. This will aid in identifying the knowledge gap, interest, attitude, and practice challenges regarding vital pulp therapy.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric dentists who work in Egypt.
* Dentists who finished any postgraduate study in pediatric dentistry.
* The workplace should be anywhere in Egypt

Exclusion Criteria:

* Dentists who did not practice for the last 5 years.
* Responses with incomplete information
Haemodynamics of Mitral Regurgitation Reduction

There is uncertainty in terms of the superiority of conventional valve surgery or percutaneous transcatheter intervention for the treatment of severe mitral regurgitation (MR) in high risk patients. The post procedural haemodynamics of the different treatment options in those at high surgical risk is poorly understood. This study seeks to characterise the physiological changes and functional outcomes of patients undergoing either surgery or transcatheter intervention.

Conventional surgery for mitral regurgitation (MR) in high risk patients is associated with reduced benefit and increased risk of perioperative complications.Percutaneous transcatheter intervention (edge to edge repair) is an alternative treatment option is associated with clinical benefit and reduced peri-procedural risk. The post procedural haemodynamics of the different treatment options in those at high surgical risk is poorly understood.

This is a a prospective observational study, involving patients with severe MR undergoing mitral valve surgery (MVRR) and transcatheter intervention (TMVI) as standard of care being recruited into two separate cohorts. Patients will undergo investigations at baseline, in hospital post-operative, and at 6 months to characterise cardiac structure and function.

Eligibility Criteria:
Inclusion Criteria:

* Severe mitral regurgitation as per European Society of Cardiology guidelines
* Patients undergoing MVRR or TMVI as standard of care
* Patients at high, prohibitive surgical risk as judged by the Heart Team

Exclusion Criteria:

* Pregnancy and patients under the age of 18 years
* Congenital heart disease
* Moderate or severe mitral stenosis, aortic, pulmonary valve disease
* Patients currently enrolled in any other study where involvement in this study would involve deviation from either protocol
Study of Prophylactic Effect of Rivaroxaban on Venous Thromboembolism in AECOPD

AECOPD increases the risk of VTE.VTE prevention is a long way to go for high-risk VTE patients in China.The incidence of AECOPD complicated with VTE in Asian population is high and the mortality rate is high.Rivaroxaban, a new oral anticoagulant, has been widely used in the treatment and prevention of VTE.However the question about the efficacy and safety of new oral anticoagulant compared with LMWHs for the prevention of symptomatic VTE and VTE-related death post-hospital discharge in high-risk AECOPD patients is still unknown. Thus this study is to evaluate if the prophylactic anticoagulation effect by Rivaroxaban is non-inferiority than Enoxaprine in high risk AECOPD and to evaluate the safety of using Rivaroxaban to prevent VTE in high risk AECOPD comparing with Enoxaprine.

The acute exacerbation of COPD increases the risk of venous thromboembolism.VTE prevention is a long way to go for high-risk VTE patients in China.The incidence of AECOPD complicated with VTE in Asian population is high and the mortality rate is high.Rivaroxaban, a new oral anticoagulant, has been widely used in the treatment and prevention of VTE.However the question about the efficacy and safety of new oral anticoagulant compared with LMWHs for the prevention of symptomatic VTE and VTE-related death post-hospital discharge in high-risk AECOPD patients is still unknown. Thus this study is to evaluate if the prophylactic anticoagulation effect by Rivaroxaban is non-inferiority than Enoxaprine in high risk AECOPD and to evaluate the safety of using Rivaroxaban to prevent VTE in high risk AECOPD comparing with Enoxaprine.

Eligibility Criteria:
Inclusion Criteria:

* AECOPD patients meeting the eligibility criterion by GOLD2017 in hospitalization；Padua score \> 4；Age from 40-80y

Exclusion Criteria:

* Patients whose admitting diagnosis was VTE；Patients whose duration of hospital stay was \<3 days or \>30 days ；Patients who received therapeutic doses of anticoagulants or thrombolytic therapy for any indication before hospitalization；an organic lesion that could bleed; severe liver or renal failure; confirmed or uncontrolled hypertension; a congenital or acquired coagulation disorder; a history of hypersensitivity or thrombocytopenia to heparins of any type；Patients who were contraindicated to anticoagulant therapy, venography, or angiography
Impact of Adrenoreceptor Expressions on Inflammatory Pattern in Refractory Cardiogenic Shock Under VA ECMO

Refractory cardiogenic shock is characterized by a decreased in cardiac output with hypo-responsiveness to increasing doses of catecholamines resulting in a profound tissular ischemia. VAECMO, by restoring a circulatory flow, could be associated to a major reperfusion syndrome which may lead some patients to multiple organ failures and death. Pathophysiology of this syndrome includes 1/an hyper-adrenergic state secondary to the over activation of the sympathetic system and 2/ a major release of pro-inflammatory cytokines. As adrenoreceptors are also exhibited on immunes cells, the pro-inflammatory state might be enhanced by the over-activation of the sympathetic system.

NB : A repartition according to other ongoing study (HYPOECMO NCTNCT02754193) is planned

Eligibility Criteria:
Inclusion Criteria:

* Patients in ICU
* Refractory cardiogenic shock

  * Cardiogenic shock: Systolic Arterial Pressure \<90mmHg, or Mean Arterial Pressure \<65mmHg, adequate volemia, peripheral hypoperfusion symptoms, cardiac index \< 2.2 l/min/m2)
  * Refractory state: hypo responsiveness to norepinephrine AND/OR persisting profound hypo perfusion clinical symptoms despite optimal resuscitation
* needing an Extra-Corporeal-Life-Support
* informed consent from relatives or patient
* Affiliation to a social security regimen
* Preliminary medical examination

Exclusion Criteria:

* Patients under ECLS for a/an :

  * Cardiotoxic poisoning
* Human immunodeficient Virus or Viral hepatitis C
* Patient \< 18 yo
* Pregnancy
* Patient under protective supervision
Influence of G-CSF and EPO on Associative Learning and Motor Skills

In the study we want to prove whether the subcutaneous application of granulocyte-stimulating factor (G-CSF) and erythropoetin (EPO) influence associative learning and/or motor skills of patients, who suffer from chronic stroke or amyotrophic lateral sclerosis. The study hypothesis is that G-CSF and EPO improve associative learning and/or motor skills.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic stroke or amyotrophic lateral sclerosis

Exclusion Criteria:

* leucocytes \> 10000/µl
* hematocrit \> 48%
* thrombocytes \< 150000/µl
* severe rheumatoid arthritis
* severe infection
* severe liver or renal failure
* severe arterial hypertension
* recurrent thromboembolic events
* severe coronary heart disease
* myocardial infarction
* malignant tumor
* leukemia
* peripheral arterial occlusion disease
Manual Therapy, Kinesiotape and Strength Training in Soccer Players With Recurrent Ankle Sprains

Introduction. The ankle sprain is one of the most prevalent injuries in soccer players. The muscle strength deficit is one of the variables that can most influence the development of a sprain. It has been indicated how the Kinesiotape and the myofascial direct induction technique can improve functionality.

Aim. To verify the effectiveness of the KinesioTape and the myofascial technique combined with strength training, in the reduction of pain, Rom increase, stability and strength in subjects who suffered ankle sprains.

Study design. Randomized, multicentric clinical study with follow-up. Methods. A random assignment of the subjects recruited in two study groups will be carried out: experimental and control group. The treatment will last 4 weeks, with 2 weekly sessions, of 50-60 minutes. The intervention includes the application of kinesiotape and myofascial treatment with strength training. The study variables will be pain (VAS), mobility (goniometer), stability (ProKin balance) and strength (MicroFet). A descriptive statistical analysis will be carried out calculating the main statistical characteristics. By means of the Kolmogorov-Smirnov test the distribution of the normality of the sample will be assessed. With the t-student test for related samples we will calculate the difference of means between the evaluations made in both groups. With an ANOVA of repeated measures we will calculate the intra and intersubject effect. The calculation of the effect size will be done with the Cohen formula.

Expected results. Improvement in stability, increase in range of motion, decrease in pain and increase in strength.


Eligibility Criteria:
Inclusion Criteria:

* Male soccer players
* 18 to 35 years old
* History of ankle sprain recurrences

Exclusion Criteria:

* Players who suffered a sprain in the previous month
* Footballers who were taking anti-inflammatory drugs
* Players undergoing another type of physiotherapy treatment at the time of the study
* Soccer players who do not sign the informed consent document.
StatStrip A Glucose/Creatinine Meter System Lay User Study Evaluation

The primary objective of this study is to assess the performance of the Nova StatStrip A Glucose/Creatinine Meter System in the hands of the subject (lay user) and compare the result to an accepted Glucose/Creatinine reference method in the hands of a trained technician.

To assess the performance of the StatStrip A Glucose/Creatinine assay in the hands of lay users on capillary whole blood obtained by finger stick and compare with the performance characteristics to a central laboratory traceable reference method.

To assess the Ease of Use of the StatStrip Glucose / Creatinine Meter System in the hands of the intended lay users. Lay users will be provided with all package insert sheets, a Quick Reference Guide and Instructions for Use (IFU) Manual. No training, coaching, or prompting will be provided to the lay users other than clarifying the protocol.

Eligibility Criteria:
Inclusion Criteria:

* Adult subjects (≥ 18 years old) with diabetes.
* Adult subjects (≥ 18 years old) with kidney diseases (CKD, ESRD) and/or in dialysis.
* Adult subjects (≥ 18 years old) that are healthy.
* Subjects willing to complete all study procedures.
* Subjects whose pre-screen glucose or creatinine medical history is deemed of value by the study site
* Subjects able to read, write, speak in English.

Exclusion Criteria:

* Subjects unable to consent to participating in the study.
* Subjects possessing a cognitive disorder or other condition, which, in the opinion of the investigator, would put the person at risk or seriously compromise the integrity of the study.
* Subjects taking prescription anticoagulants (such as Warfarin or Heparin) or has clotting problems that may prolong bleeding.
* Subjects having hemophilia or any other bleeding disorder.
* Subjects having an infection with a blood borne pathogen (e.g. HIV, hepatitis).
* Subjects working for a medical device or diagnostic company.
Early Detection Neurodevelopmental Disorders of Children and Prevention of Postnatal Depression by Mobile Health App

The goal of this observational study is to confirm the impact of using this app adapted to be more specific for screening for 5 neurodevelopmental disorders and to evaluate the mothers' support program on the incidence of postpartum depression in of young parents with a minimum of 1 child under 10 years of age at the time of inclusion and using Malo on a regular basis. The main questions it aims to answer are :

* the median age of possible neurodevelopmental disorders notification of infants
* the median time of the mothers' postnatal depression notifications after childbirth subsequently to the support and prevention program Participants will agree with use of their data


Eligibility Criteria:
Inclusion Criteria:

* Youg parent with a minimum of 1 child under 10 years
* User of the app (downloaded)
* Having given informed consent (in-app)

Exclusion Criteria:

* none
Long Term Function Outcomes and Pain in Implant-based Post-mastectomy Breast Reconstruction

The objective of this proposal is to broadly assess patient physical functioning following breast reconstruction.


Eligibility Criteria:
Inclusion Criteria:

* Female
* At least 18 years of age
* Had a mastectomy for breast cancer or cancer prevention any time between 01/01/2010 and 06/30/2021.
* Has undergone breast reconstruction surgery with plastic surgery faculty at the Washington University School of Medicine Division of Plastic and Reconstructive Surgery.
* Able to understand and willing to sign an IRB-approved written informed consent document.

Exclusion Criteria:

-Known distant metastatic disease
Pain in Different Office Hysteroscopy Diameter

The purpose of the investigators'study was To compare 2 different diameter rigid hysteroscopy in vaginoscopic approach regarding pain during and after the procedure.

And to evaluate patient acceptability and tolerability in order to determine the best way to perform hysteroscopy in an outpatient setting.

Office hysteroscopy is used as diagnostic tool to investigate abnormal uterine bleeding and other diseases involving the uterine cavity one of The main limitation to its widespread use is feared from pain and low patient tolerability Narrower diameter hysteroscopy and endometrial biopsy devices are being developed to improve the acceptability of office hysteroscopy. Miniature optical systems allow performance of most diagnostic and operative hysteroscopy (after proper patient selection) in an outpatient or office setting .Flexible hysteroscopy seem to be less painful at the beginning and during the procedure ,but the optical qualities are poor Hysteroscopy is safe, feasible and accurate procedure for diagnosing intrauterine pathology.

Provision of outpatient based diagnostic and operative services are gaining prominence as a standard of cure but the experience of pain can be off-putting for patients having outpatient diagnostic hysteroscopy.

saline solution is an excellent alternative to carbon dioxide in women undergoing outpatient hysteroscopy, and there are fewer complications

Eligibility Criteria:
Inclusion Criteria:

* Woman with nulliparous cervix

Exclusion Criteria:

* Pregnancy.
* female genital cancer
* Active pelvic infection
* Multipara
* patient not receiving misoprostol
Frailty Assesment in the Congestive Heart Failure Clinic

Frailty is known as an independent risk factor for morbidity and mortality in older cardiac patients, including patients with congestive heart failure. It is an important factor taken into the cardiologists decision making in the clinic, and influences the intensity of follow up treatment, invasive intervention and the need to ensure a stronger social support system for the patient. Frailty assessment is usually made subjectively by the cardiologist, known in the literature as eyeball testing.

In this study the investigators will compare the cardiologists subjective eyeball testing to objective frailty assessment tests based on Fried score and Edmonton frail scale

Elderly patients visiting the congestive heart failure clinic at Meir Medical Center will be assessed for frailty twice. Once in an "eyeball" test by their cardiologist at the clinic, and a second time in an objective test based on fried and Edmonton frailty scores.

The second subjective assessment will be made by geriatric and internal medicine physicians, and the cardiologist won't be aware of the results of the objective assessment.

The results of both tests will be compared.

Eligibility Criteria:
Inclusion Criteria:

* patients an the Meir congestive heart failure clinic.
* age 70 and above
* can sign an informed consent

Exclusion Criteria:

* patients admitted in the last two month
CONcurrent vs SEqueNTial Adjuvant Treatments in Early Breast Cancer

Breast cancer is the most common form of cancer among women. For patients candidated for adjuvant chemotherapy and endocrine therapy the optimal timing for their has not been clearly defined yet.

Breast cancer is the most common form of cancer among women in North America, Europe and Latin America. Because nearly 80% of breast cancers are endocrine-responsive tumors, the majority of patients candidates for adjuvant chemotherapy (CT) are also candidates for endocrine therapy (ET). The optimal timing (i.e. concomitant vs sequential administration) for the integration of these two treatments has not been clearly defined yet.

In patients with hormone receptor positive early stage breast cancer who are candidates to adjuvant chemotherapy and endocrine therapy, the optimal timing for the integration of these two treatment modalities has not been clearly defined yet.

Eligibility Criteria:
Inclusion Criteria:

* Women with histological diagnosis of invasive breast cancer completely removed by surgery, any T, any N.
* Postmenopausal status defined by at least one of the following conditions:

  1. Aged ≥ 60
  2. Aged 45-59 and satisfying one or more of the following criteria:

     * amenorrhea for ≥12 months and intact uterus;
     * amenorrhea for \<12 months and follicle-stimulating hormone (FSH) within the postmenopausal range, including:

       * pts with hysterectomy
       * pts who have received hormone replacement therapy (HRT)
       * pts with chemotherapy-induced amenorrhea
  3. bilateral oophorectomy at any age \>18 years.
* Primary tumor positive for Estrogen Receptors (ER) and/or Progesteron receptors (PgR) (≥1% tumor cells positive by immunohistochemistry or ≥ 10 fmol/mg cytosol protein by ligand binding assay).
* Patients who are prescribed 5 years of endocrine therapy with an aromatase inhibitors (AI)
* Indication for adjuvant chemotherapy- Patients with HER-2 positive tumors are eligible provided that they are prescribed trastuzumab according to registered schedule.
* Signed informed consent.

Exclusion Criteria:

* HRT currently assumed or during the month before randomization
* Recurrent or metastatic disease
* HER-2 positive tumors if treatment with trastuzumab is considered not appropriate/feasible
* Concurrent illness that contraindicate adjuvant endocrine treatment and/or chemotherapy
* Patients who have received Tamoxifen as part of any breast cancer prevention trial
* Previous history of invasive breast cancer or other invasive malignancy within the previous 10 years, other than squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix, adequately cone biopsied
* Concomitant severe disease which would place the patient at unusual risk
* Concurrent treatment with experimental drugs
* Patients treated with systemic investigational drugs within the past 30 days
The Effect of Exercises on Young Adults

The aim of this study was to assess the treatment effect of plates and conventional exercises on health related quality of life, pain, functional level, psychological state in young adults. Randomised controlled study. Participants were randomly divided into 3 groups: a plates exercise group (n = 29), a therapeutic exercise group (n = 21), and a control group (n = 35). The therapeutic and plates groups underwent related training programs for 3 month, while the controls had no specific training. After demographic knowledge were collected the investigators carried out the following assessments on all participants: the Visual Analog Scale (VAS), Waist/ Hip ratio (WHr), Beck Depression Inventory (BDI), Oswestry Disability Index (ODI), Notthingham Health Profile (NHP). All subjects were evaluated at baseline and post-training.


Eligibility Criteria:
Inclusion Criteria:

• They were apparently healthy and had no systematic diseases or any problem preventing their participation in any exercise program.

Exclusion Criteria:

* Having a systemic pathology, including inflammatory, rheumatologic, or metabolic diseases
* Having any musculoskeletal injury, pathology, or structural deformity related to the spine or extremities
* Having any active intervention including corticosteroid or any medication in the previous 3 months.