cyrilzakka/clinical-trials huggingface dataset:
Assessment of Inflammatory Biomarkers Expressed in a Sjogren's Population: Effect of a Topical Steroid Intervention

The primary purpose of this study is to quantify the change in expression of biomarkers on the ocular surface of Sjogren's Syndrome participants after treatment with Maxidex.


Eligibility Criteria:
Inclusion Criteria of Sjorgren's Population:

Inclusion Criteria:

* 17 years or older
* LogMar visual acuity of 0.6 or better
* Ocular inflammation associated with Sjogren's Syndrome

Exclusion Criteria:

* Has had an adverse reaction to either topical of systemic steroids in the past
* Has diabetes (type 1 or 2)
* Has glaucoma or evidence of ocular hypertension in either eye or treatment of either within six months of Visit 1
* Has worn contact lenses within one week prior to Visit 1
* Has received ocular prescription therapy in the last 30 days
* Has active ocular infections or inflammation not associated with Sjogren's Syndrome.
* Has any finding in the vitreous, macula, retina or choroid that show signs of inflammation and/or any structural change that in the opinion of the investigator is considered abnormal or unstable for that participant
GoldenCareTM for the Treatment of Bacterial Vaginosis

GoldenCare is a copper intravaginal device that may be useful for the treatment of symptomatic bacterial Vaginosis (BV). Standard treatment for BV is metronidazole. Although the reported cure rate is as high as 90%, the recurrence rate is 58% after 12 months. The study hypothesis is that GoldenCare will cure BV. This is a proof of concept study to collect preliminary evidence of the safety and efficacy of GoldenCare.

GoldenCare is a copper intravaginal device that may be useful for the treatment of symptomatic bacterial Vaginosis(BV). Standard treatment for BV is metronidazole. Although the reported cure rate is as high as 90%, the recurrence rate is 58% after 12 months. The study hypothesis is that GoldenCare will cure BV. This is a proof of concept study to collect preliminary evidence of the safety and efficacy of GoldenCare.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Female aged 18 years or older
* Subject has clinical bacterial Vaginosis with 4 of 4 positive Amsel's criteria
* Negative pregnancy test
* For 7 day treatment period, subject agrees to refrain from using douches and intravaginal products (i.e. feminine deodorant sprays, spermicides, Nonoxynol-9 products, tampons, and condoms). Subject also agrees to refrain from taking oral or intravaginal antibiotics (unless enrolled in comparator arm),or antifungal agents during the entire study period.

Exclusion Criteria:

* Subject has another infectious or noninfectious cause of vulvovaginitis such asymptomatic candidiasis, Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Herpes simplex, human papilloma virus, atrophic vaginitis, lichen sclerosus, or genital warts.
Influences of Leadership Style on Team Climate for Quality

This study is to discuss how different personalities of leaders and employees result in the effect of quality and efficiency in different organizational climate and also how the leadership style of different leaders affect the organizational climate. The investigators hope that this study will improve the key factor of quality and efficiency among leaders. Besides, the investigators want to provide the reference of quality control for the groups of healthcare quality in order to avoid unnecessary time and costs and achieve the goal of improvement quality.

The specific purpose of this study is the following:

1. to discuss the relationship of organizational climate due to different leadership styles.
2. to discuss the relationship of quality efficiency due to different organizational climates.
3. to discuss the relationship of quality efficiency due to different leadership styles.

Eligibility Criteria:
Inclusion Criteria:

* employees in the hospitals

Exclusion Criteria:

* none employees in the hospitals
Examining the Effects of an Improvisation Group

This study is taking place to examine the preliminary effects of improvisational therapy (improv group) on social anxiety for youth at the Youth Wellness Centre (YWC). The improv group will run for 12-weeks as a drop-in group. A typical session will begin with stretching, simple breathing and an activity to promote group cohesion. Following this, improvisation games and activities will be introduced with the goal of promoting the following skills: assertiveness, acceptance, problem solving, co-operate skills, non-verbal communication, mindfulness, and memory. Youth who consent to the study will be asked to complete a set of brief questionnaires the first time they attend one of the sessions. Youth who have attended at least 3 sessions will be asked again to complete questionnaires following the completion of week 12 session. Youth will also rate their anxiety and distress on a simple rating scale at the beginning and end of each session. Additionally, all participants (who have attended three or more sessions) will be invited to complete a 30 to 45 minute qualitative interview following the 12 week session. Participants are predicted to show a decrease in social anxiety, generalized anxiety and depression symptoms, and an increase in self-esteem, and perceived social support.


Eligibility Criteria:
Inclusion Criteria:

* help-seeking youth
* ages 17-25

Exclusion Criteria:

* will NOT be excluded on the basis of mental health or addiction concerns
Feasibility of Remote Data Collection With a Point of Care Device to Measure HbA1c

Conduct a pilot study to test feasibility of doing remote data collection with a point of care device that measures HbA1c.

The foundation for cardiovascular health (CVH) is laid in early life by intergenerational interactions, passed from parent to child, that have long-lasting biological and behavioral consequences. Lifestyle interventions can promote CVH among mothers and their children over time. Academic partnerships with home visiting organizations that reach families experiencing health disparities advance intergenerational CVH equity. For this pilot study we are testing the feasibility of doing remote data collection with a point of care device that measures HbA1c to use in the main study.

Eligibility Criteria:
Inclusion Criteria:

* English speaking
* Screened or participating in NCT04253977
* Able to give informed consent for participation

Exclusion Criteria:

-
Contribution of the Podiatrist-Posturologist in the Evaluation of the Link Between the Stabilometric Parameters and the Pain Felt in Patients With Chronic Low Back Pain

Chronic low back pain is one of the major causes of disability worldwide. Knowledge about the pathophysiology of low back pain is insufficient, and an accurate diagnosis can only be obtained in 10 to 15% of cases. The absence of a precise diagnosis leads to a therapeutic challenge due to the large number of treatments available, the overall efficacy of which is low to moderate. Therefore, the identification of subgroups of non-specific chronic low back pain patients is essential and will allow the optimization of therapeutic management. A detailed description of the stabilometric parameters associated with the evaluation of pain, kinematic disturbance and the degree of kinesiophobia would allow us to establish specific postural profiles, to propose a relevant clinical model and to improve the accuracy of the diagnosis of people with chronic low back pain. The objectives of this research project are to evaluate the relationship between stabilometric parameters and pain (main objective), lumbar kinematics, kinesiophobia, and quality of life (secondary objectives) in order to propose specific postural profiles in chronic low back pain patients.


Eligibility Criteria:
Inclusion Criteria:

* Suffering from low back pain, possibly associated with painful gluteal radiation in the form of mono or bilateral pygalgia (non-radicular) evolving for at least three months (chronic low back pain
* Understanding and being able to express himself in French
* Giving informed, dated and signed consent

Exclusion Criteria:

* Neurosurgical criteria: (i) presence of clinical signs of compression and/or single or multi-root pain (Lumbosciatica with or without deficit signs, intermittent claudication of the cauda equina roots with possible sphincter signs), (ii) history inflammatory arthropathy (ankylosing spondylitis, rheumatoid arthritis), and (iii) history of lumbar spine surgery.
* Radiographic criteria: (i) presence on the lumbar MRI of multi-level discopathy (more than 2 discopathy), (ii) spinal instability confirmed by CT or MRI (degenerative spondylolisthesis or by isthmic lysis).
* Pregnant or breastfeeding women
* Visually impaired patient
* Patient suffering from neurological and/or orthopedic disorders that may affect balance.
Effect of Khat Chewing on Blood Pressure and Heart Rate Among Healthy Adults

This study is a cross sectional study

Objective: This study aims to investigate .ht short-term effect of khat on the diastolic and systolic blood pressure (DBP, SBP) and heart rate (HR) of yemeni adults. Factors associated with Khat chewing and Khat-dependence were also investigated. That the khat chewing is a growing public habit among yemeni people.

Eligibility Criteria:
The participant should be free of any disease and should avoid eating or drinking anything that could affect on BP and HR within two khat before hours chewing (zero time)
Effectiveness of US-Guided PCNL Different Positions in Renal Stones Treatment

The aim of this study is to compare the effectiveness of Ultrasound-Guided Percutaneous nephrolithotomyin different positions supine, prone positions and flank suspend supine position in renal stones treatment.

Percutaneous nephrolithotomy (PCNL) has become the choice of modality for the treatment of large and complicated renal calculi. Initially, percutaneous access to the kidney was only performed in the prone position, as described sixty years ago.

Eligibility Criteria:
Inclusion Criteria:

* patients who underwent Percutaneous nephrolithotomy
* Patient's age from \>18 - 70 years old.
* Body mass index (30-40 kg/m2).
* Both sex
* Renal stones diameter ≥2 cm
* Cardiac patients

Exclusion Criteria:

* Patient refusal.
* Pregnant women.
* Patients with renal anomalies.
* Transplanted kidney.
* Uncorrected coagulopathy, or active infection.
Second Line Treatment of Knee Osteochondral Lesion With Treated Osteochondral Graft

Patient with IKDC score \< 65, pretreated with mosaicplasty or ACI ( with matrix or not) within \> 18 months, with one or two osteochondral lesions are recruited to have treated osteochondral allografts in mosaicplasty.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients between the ages of 18 and 55

  * osteochondral lesions of the knee due to trauma or osteochondritis dissecans or removal treatment ( lesion post autograft)
  * Osteochondral lesion \> grade II- ICRS
  * One lesion or 2 concomitant lesions (tibial plateau, patella and condyles )at least one lesion has been pretreated by mosaicplasy or ACI. These treatment would have to have been made at least 18 months before inclusion
  * Presence of disabling and clinically meaningful symptoms (subjective IKDC \< 65, no improvement for 3 months)
  * No significant obesity (BMI \< 30)
  * Accompanying ligamentous and meniscal lesions, joint malalignment and patella femoral instability are authorized and corrected concurrently.
  * Patient able to understand, sign and date the informed consent form
  * Patient affiliated with a national health insurance system or who is the beneficiary of such as system
  * Women of childbearing age may not be included in the clinical trial unless their pregnancy test is negative. If this test is negative, they will be asked to use an effective birth control method during the entire the study.

Exclusion Criteria:

* - Pregnant or breast feeding women: Women of childbearing age will be asked to undergo a pregnancy test before being enrolled into the study and to use an effective birth control method.
* Presence of osteoarthritis, rheumatoid arthritis, any other condition of knee joint that, in the surgeon's opinion, is likely to compromise the allograft's outcome
* Excessive laxity or recurrent instability that could affect the score evaluation without concomitant ligamentoplasty
* Presence of an ulcerative disease, heavy smoking, tuberculosis, chronic psychiatric disorder or disease requiring long-term treatment with a medication that would affect bone or joint metabolism
* Persons with cancer or a history of cancer
* Persons deprived of their freedom by a judicial or administrative decision
* Adults subject to legal protection measures or who are unable to provide their consent
Efficacy and Safety of the Pediatric Formulation of Artemether- Lumefantrine in Children With Uncomplicated P. Falciparum Malaria.

This study will evaluate the safety and efficacy of artemether-lumefantrine against uncomplicated malaria caused P. falciparum in children of 5-35 kg bodyweight.


Eligibility Criteria:
Inclusion Criteria:

* male or female infants and children ≤12 years of age
* body weight of ≥5 kg and \<35 kg,
* with a confirmed diagnosis of uncomplicated malaria caused by the P. falciparum parasite

Exclusion Criteria:

* complicated malaria
* persistent vomiting
* malaria due to parasites other than P. falciparum
* antimalarial treatment received in the past 2 weeks
* known chronic disease e.g. positive HIV status, severe cardiac, renal, or hepatic disease
Angiogenic Profile and Non-invasive Imaging May Predict Tumor Progression of High Risk Group Low Grade Glioma (LGG)

The low grade glioma (LGG) is a type of brain tumor which is generally more common in younger age group patients. Most patients with LGG undergo surgery which is mostly incomplete due to concern about loss of function. This is an incurable disease. More than half of these patients progress to a higher grade with a worse outcome within five years of their diagnosis and only one-third survive for up to ten years. Post-operative radiation treatment improves local control without survival advantage. Efforts are being made without great success to select the patients with a higher risk of progression based on physical characteristics and histological features.

Tumor vascularity is thought to be the key element in tumor progression. Tremendous progress has been made in functional imaging by using magnetic resonance imaging (MRI) 3-Tesla (3T) and in biotechnology which can be used to investigate angiogenic gene profiles in order to identify gene signature for these tumors. In this study the investigators are proposing that patients of LGG with a higher risk of tumor progression may be selected by functional imaging and angiogenic profiles. These higher risk patients may be candidates for post-operative radiation in the future with a potential survival benefit.

Summary: Comprehensive analysis of the angiogenesis-related gene expression profiles and tumor perfusion of patients with LGG will provide a novel understanding of subgroup (low and high-risk) of LGG. Thus, this study will allow identifying clinically relevant factors predictive for tumor progression and to select patients in high-risk group for adjuvant radiation therapy.

Eligibility Criteria:
Inclusion Criteria:

* Greater than 18 years of age
* Brain tumor with no contrast enhancement on conventional MRI and confirmed histological of LGG
* No adjustment treatment
* Consent to participate in study
* No contra-indication for dynamic contrast-enhanced (DCE)-MRI
Evaluation of Outcomes of Discectomy With Dynesys in Treatment of Lumbar Disc Herniation

To explore the clinical outcomes of discectomy with dynamic neutralization system(Dynesys) on treatment of single-segmental lumbar disc herniation(LDH) versus simple discectomy.

The study was to explore the clinical outcomes of discectomy with dynamic neutralization system(Dynesys) on treatment of single-segmental lumbar disc herniation(LDH) versus simple discectomy. 128 patients with single-segmental LDH were randomly divided into discectomy with Dynesys group(group A) and simple discectomy group(group B). Both groups were evaluated by Visual Analogue Score(VAS), Oswestry Disability Index(ODI), radiological evidence of intervertebral height and range of motion(ROM) of the treated segment at pre- and post-operation. Operation duration and blood loss was recorded. The clinical outcomes and complications were evaluated afterwards. All patients received a 2-year follow-up.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria was Single-segmental LDH with low back pain and radicular pain.

Exclusion Criteria:

Exclusion criterias were lumbar stenosis(LSS), lumbar spondylolysis and degenerative spondylolisthesis, spinal deformity, lumbar surgery history, obviously osteoporosis, vertebral fracture, cauda equina syndrome, ankylosing spondylitis, tuberculosis, infection, tumor, obesity.
Early Warning Model of Susceptibility and High-risk Population of Cervical Cancer Related to HPV

Most uterine cervical high-risk human papillomavirus (HPV) infections are transient, with only a small fraction developing into cervical cancer. Family aggregation studies and heritability estimates suggest a significant inherited genetic component. Candidate gene studies and previous genome-wide association studies (GWASs) report associations between the HLA region and cervical cancer. Adopting a genome-wide approach, we aimed to establish an early warning model for a high-risk population of cervical cancer.


Eligibility Criteria:
Inclusion Criteria:

* (1) Case group a) Aged 25-75 years. b) Han nationality. c) Patients with cervical cancer or cervical precancerous lesions above CIN2 diagnosed by biopsy or postoperative pathological diagnosis.
* (2) Control group: a) Aged 25-75 years. b) Han nationality. c) No family history of cervical cancer or precancerous lesions. d) The results of TCT examination showed no abnormality.

Exclusion Criteria:

* (1) suffering from other neoplastic diseases.
* (2) pregnant women.
* (3) those with a history of bone marrow transplantation.
In-Hospital Electronic Registry of Severe Trauma of the Fondazione I.R.C.C.S. Policlinico San Matteo

The objective of establishing an in-hospital Trauma Registry, aimed at collecting data on patients who are victims of major trauma and treated at our Center, is to develop a comprehensive and in-depth tool for the analysis and monitoring of clinical activity within a Level I Trauma Center. The purpose of building such databases-specifically the proposed Trauma Registry-is to provide the hospital with a unique instrument for analyzing and monitoring the epidemiology and management of a specific patient population.

In light of recent developments in the hospital's newly implemented clinical care pathway (PDTA) for the management of polytrauma patients, and the strategic enhancement offered by the opening of a dedicated helipad for the reception of such patients, our working group is committed to promoting a tool that may, both in the short and long term, foster clinical and scientific advancement at the Fondazione I.R.C.C.S. Policlinico San Matteo in Pavia.

Our general objective is the prospective collection of data on major trauma patients admitted to and treated at the Fondazione I.R.C.C.S. Policlinico San Matteo.

Our primary objective is to evaluate in-hospital mortality, used as a qualitative indicator of the Trauma Center's performance, among patients with severe trauma managed at our institution.


Eligibility Criteria:
Inclusion Criteria:

All consecutive patients presenting to the Emergency Department of the Fondazione I.R.C.C.S. Policlinico San Matteo who meet at least one of the following criteria will be included in the registry:

* They were transported to the Emergency Department by Emergency Medical Services (AREU - Regional Emergency and Urgency Agency) with a diagnosis of Severe Trauma / Major Trauma

or

- They arrived at the Emergency Department and were admitted with a diagnosis of "trauma", and were found, upon completion of the secondary assessment, to have an Injury Severity Score (ISS) \>15

Exclusion Criteria:

There are no exclusion criteria.
Ivabradine in Cirrhotic Cardiomyopathy

A total of 130 patients with liver cirrhosis who fulfill the criteria of the study, and who have been found to have left ventricular diastolic dysfunction on a screening 2D echocardiography, will then be randomized by Block randomization technique, to two arms in a ratio 1:1(Group A) will receive carvedilol+ Ivabradine targeted therapy for heart rate reduction while Group B will receive Carvedilol alone; and the dosage of drug in the treatment arm will be titrated every week to achieve target heart rate of 50-60/ minute. Patients in the treatment arms, who are unable to tolerate carvedilol due to hypotension episodes, will be offered ivabradine alone to allow achievement of targeted heart rate reduction. All patients will be evaluated at 0,6, and 12 months. The end points will be clinical events, cardiac function improvement, renal function, and mortality.

The investigators have already demonstrated the role of targeted heart rate reduction in the management of LVDD in cirrhosis, but the previous study could not demonstrate the role of ivabradine alone in absence of betablocker therapy. This trial will be a validation cohort for the initial data obtained on this novel drug. The use of ivabradine can treat patients who do not tolerate betablocker therapy due to contraindications or adverse effects especially hypotension.

Diagnosis of CCM will be as per 2020 CCMC criteria. CCM is defined as systolic or diastolic dysfunction in the absence of alternative cardiac pathology in concordance with the Cirrhotic Cardiomyopathy Consortium (CCMC) criteria. 9 Systolic dysfunction was defined as an ejection fraction (EF) ≤50% or an absolute value of GLS \<18%. CCM will defined as presence of 3 of the following 4 criteria: septal early diastolic mitral annular flow velocity (e') \<7 cm/s, early diastolic transmitral flow to early diastolic mitral annular velocity (E/e') ≥15, left atrial volume index (LAVI) \>34 mL/m2, tricuspid jet maximum velocity \>2.8 m/s, in the absence of pulmonary hypertension and the presence of measurable early to late diastolic transmitral flow velocity (E/A) ratio (E/A \>2 = grade 3 \& E/A 0.8-2 = grade 2 LVDD). Persons meeting only 2 criteria will be termed as indeterminate for LVDD grade.

Eligibility Criteria:
Inclusion Criteria:

* Age range of 18-65 years
* Cirrhosis, as diagnosed by histology or clinical, laboratory and USG findings,
* LV diastolic dysfunction on 2D echocardiography

Exclusion Criteria:

* Chronic renal disease
* Patient already on beta blocker
* Pregnancy and peripartum cardiomyopathy
* Hypertension
* Coronary artery disease
* Valvular heart disease
* Sick sinus syndrome/ Pacemaker
* Cardiac rhythm disorder
* Hypothyroidism
* Hyperthyroidism
* Portal vein thrombosis
* Transjugular intrahepatic porto systemic shunt (TIPS) insertion
* Hepatocellular carcinoma
* Anemia Hb \< 8gm/dl in females, and \< 9 gm/dl in males