cyrilzakka/clinical-trials huggingface dataset:
Safety and Tolerability of Interferon-Beta-1a and Estroprogestins Association in MS Patients

Clinical and experimental evidences suggests an immunomodulatory effect of sex hormones in multiple sclerosis.

The role of oral estroprogestins in the pathogenesis and in the clinical course of the disease is actually unknown.

The aim of the study is to investigate safety and tolerability of association of estroprogestins in two different doses with interferon-beta 1a in patients with relapsing-remitting multiple sclerosis.

Phase 2, randomised, single blind, three arms study.

Follow-up of 24 months.

The study will include relapsing-remitting multiple sclerosis female patients.

Patients will be equally randomised into three groups: 1) patients treated with IFN-beta 1a (44 mcg for three times a week), 2) patients treated with IFN-beta 1a and lower-dose estroprogestins (desogestrel 150 mcg, etinilestradiol 20 mcg), 3) patients treated with IFN-beta 1a and higher-dose estroprogestins (desogestrel 25 mcg, etinilestradiol 40 mcg).

Safety and tolerability of the treatment will be evaluated using neurological examination and MRI analysis.

A complete neurological examination (with EDSS) will be performed at month 0, 6, 12, 18 and 24.

MRI examination will be assessed at baseline and at month 12 and 24. In the same day of MRI examination we'll collect blood samples for hormonal analysis (we'll measure sex hormones in the follicular and in the luteal phase of a single menstrual cycle).

During the follow-up patients will be evaluated also with: MS-Functional Composite at month 0, 6, 12, 18, 24; neuropsychological evaluation at month 0, 12, 24; Fatigue Severity Scale at month 0, 12, 24; Hamilton Depression Scale at month 0, 12, 24; Quality of Life scale (MSQOL54) at month 0, 12, 24.

Eligibility Criteria:
Inclusion Criteria:

* Female patients
* Clinically definite relapsing-remitting MS according to the McDonald criteria
* Age between 18-40 y.o.
* EDSS from 0 to 4.0, inclusive

Exclusion Criteria:

* History of migraine or thromboembolic events
* Reproductive system disorders
* Pregnancy or suspension of pregnancy within 12 months prior to randomisation
* Prior use of estroprogestins within the last 3 months prior to randomisation
* Prior use of immunosuppressive drugs within the last 12 months prior to randomisation
* Prior use of immunomodulating drugs within the last 6 months prior to randomisation
* Prior use of corticosteroids within the last 3 months prior to randomisation
* Have clinical relapse 30 days prior to randomisation
The Influence of Upright Feeding Position on Pulmonary and Ear Morbidity

Does upright feeding position of 3 month old infants reduce respiratory and ear morbidity during the following year?

The investigators examined the influence of teaching mothers to feed infants with their head in an upright position and evaluated the infant ear and respiratory morbidity during a one-year follow-up. Mothers of 88 infants born during 2011 were instructed by trained nurses at Maternal-Child-Health clinics to feed their infants with their head in upright position (intervention group). The control group consisted of 75 mothers of infants of similar socioeconomic background who fed their infant regularly without any instructions and were followed at another Maternal-Child-Health clinic. Feeding position was evaluated at the beginning and the end of the study, and morbidity data of both groups were evaluated at every 3-month follow-up meeting. The study was part of the PhD thesis of Efrat Danino, Head Nurse of Pediatric Department at Hadassah Medical Organization.

Eligibility Criteria:
Inclusion Criteria:

* healthy 3 month old infants, bottle fed at least once a day, parent agreeing to participate

Exclusion Criteria:

* Prematurity, need of supplemental oxygen, broncho-pulmonary dysplasia, cystic fibrosis, familial dysautonomia, cleft lip or cleft palate, any ear-throat-lung or airway congenital anomaly, congenital heart disease, any other chronic disease of childhood or malignancy
Yoga in Patients With Fibrosing Interstitial Lung Diseases

Fibrosing interstitial lung diseases are characterized by loss of lung function, which leads to a decrease in quality of life and physical capacity. Several studies have shown an increase in quality of life and physical capacity after increasing physical activity in patients. There is evicence that yoga has a positive influence in patients with chronic obstructive pulmonary diseases, but so far, studies examining the effect of yoga in patients with fibrosing interstitial lung diseases are missing.

Study aims are to determine the feasibilty of this study, and to determine the effects of yoga to patients' quality of life and physical capacity.

Twenty patients with a fibrosing interstitial lung disease will be recruited and randomly assigned to the intervention or control group. Several questionnaires regarding quality of life will be conducted. Furthermore, the 6 minutes walking test, a lung function test and a biomarker analysis will be conducted at baseline and follow-up. The intervention group will participate in a 12 week yoga class, whereas the controll group will not participate. Yoga classes will be offered to the control group after the study.

In addition, focus group interviews will be conducted at baseline and follow-up with the intervention group.

Patients with a fibrosing interstitial lung disease will be recruited. In total 20 patients will be recruited, 10 for the intervention group and 10 for the control group.

The Intervention group will participate in a 12 week yoga class with classes twice a week for about 1 hour. The control group will not participate in a yoga class.

At baseline all patients will conduct a 6 minutes walking test, a lung function test, several surveys to measure health related quaility of life (King's Brief Interstitial Lung Disease Questionnaire (K-BILD), Hospital Anxiety and Depression Scale (HADS), Interstitial Lung Disease Anxiety questionnaire), and some blood will be drawn for biomarker analysis.

Furthermore, participants in the Intervention group will participate in two focus group interviews, one at baseline and the second one at 12 week follow-up.

Eligibility Criteria:
Inclusion Criteria:

* ability to understand study and study procedure
* diagnosis of fibrosing interstitial lung disease
* Age: \> 18 years
* Ability to consent

Exclusion Criteria:

* Forced Vital Capacity \< 50%
* Oxygen therapy
* diagnosis of pulmonary hypertension
* participant does not understand the study
* pulmonary infection within the last 4 weeks
* acute exacerbation within the last 4 weeks
* other respiratory decline within the last 4 weeks
* co-morbidities which make yoga training impossible
Multi-center Project: Spinal Abnormalities in Neurofibromatosis Type1 (NF1) Patients

We propose to establish a multi-center study to investigate the outcome of scoliosis and spinal abnormalities in patients with NF1.

The three specific aims of this study are:

Specific Aim 1 - To assess health status and health-related quality of life (HRQL) in children and adolescents with NF1 and scoliosis. We hypothesize that children and adolescents with NF1 and scoliosis will experience an additional burden of morbidity due to scoliosis and a downward trajectory of health status and HRQL over time.

Specific Aim 2 - To assess the natural history and short-term response to therapy in a cohort of children with NF1 and scoliosis prospectively diagnosed during the course of the four-year study period. We hypothesize that some NF1 patients with idiopathic scoliosis will modulate to the dystrophic form. We also hypothesize that NF1 patients with earlier presentation are more likely to have or modulate to the dystrophic form.

Specific Aim 3 - To assess biochemical markers of bone metabolism in NF1 individuals. We hypothesize that NF1 individuals will have statistically significant differences in biochemical markers of bone metabolism compared to controls. We also hypothesize that NF1 individuals with scoliosis will have differences in biochemical markers of bone metabolism compared to NF1 individuals without scoliosis.

The three specific aims of this study are:

Specific Aim 1 - To assess health status and health-related quality of life (HRQL) in children and adolescents with NF1 and scoliosis. We hypothesize that children and adolescents with NF1 and scoliosis will experience an additional burden of morbidity due to scoliosis and a downward trajectory of health status and HRQL over time.

Specific Aim 2 - To assess the natural history and short-term response to therapy in a cohort of children with NF1 and scoliosis prospectively diagnosed during the course of the four-year study period. We hypothesize that some NF1 patients with idiopathic scoliosis will modulate to the dystrophic form. We also hypothesize that NF1 patients with earlier presentation are more likely to have or modulate to the dystrophic form.

Specific Aim 3 - To assess biochemical markers of bone metabolism in NF1 individuals. We hypothesize that NF1 individuals will have statistically significant differences in biochemical markers of bone metabolism compared to controls. We also hypothesize that NF1 individuals with scoliosis will have differences in biochemical markers of bone metabolism compared to NF1 individuals without scoliosis.

Eligibility Criteria:
Inclusion Criteria:

* Meet NIH diagnostic criteria for NF1
* Radiographic documentation of scoliosis will be necessary for inclusion as a "scoliosis case"
* Age between 3 and 18 years

Exclusion Criteria:

* Do not have NF1
Testing of Different Methods for Determining Whether Breast Cancer Has Spread to the Lymph Nodes

Sentinel lymph node biopsy (SLNB) has recently emerged as a less invasive alternative to axillary lymph node dissection (ALND) in the treatment of breast cancer. However, SLNB has a number of limitations, and we believe that alternative strategies for staging of the axilla should be explored. The hypothesis of this proposal is that the combination of preoperative high-resolution axillary ultrasound (AUS), fine needle aspiration biopsy (FNAB), and molecular analysis using real-time reverse transcription-polymerase chain reaction (RT-PCR) represents a viable, minimally invasive alternative to SLNB. We propose a prospective cohort study to rigorously assess the diagnostic accuracy of molecular analysis of AUS-FNAB specimens. The primary endpoint of this study is to determine the feasibility of AUS-FNAB and real-time RT-PCR to predict the pathologic status of the axilla in a proof-of-principle study. In the short term, validation of this innovative strategy is likely to reduce the number of sentinel node procedures. In the long term, we believe that AUS-FNAB may ultimately replace SLNB.


Eligibility Criteria:
Inclusion Criteria:

* Female patients, aged 18 and over.
* Patients must be newly diagnosed with clinical stage I or II breast cancer and be eligible for breast surgery and core breast biopsy of their proven breast carcinoma.

Exclusion Criteria:

* Inability to give informed consent
* Contraindications for breast surgery or biopsy

Patients with no evidence of malignancy scheduled to undergo procedures under general anesthesia must fulfill the following eligibility requirements:

* Female patients, aged 18 and over
* Patient must be scheduled to undergo a procedure under general anesthesia with access to lymph nodes that can be biopsied by FNA biopsy at minimal risk to the patient
* Patient must be willing to give informed consent
* Patient with no history of malignancy
A Study to Assess the Acceptability and Usability of a New Device for Intradermal Vaccination

The aim of this study was to assess the acceptability and usability of a newly developed intradermal device in healthy adults


Eligibility Criteria:
Inclusion Criteria:

* healthy adults

Exclusion Criteria:

* people who have regular experience with needle injections, e.g. diabetic patients
* pregnant women
Essential Pro Study ( rEPIC04E-HK )

Single center, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Essential Pro to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Essential Pro.

This study intends to analyze:

* Device effectiveness (in its individual use, technical performance) and procedural effectiveness (technical outcome at the end of lesion treatment with the device under study and any other device being used).
* Device safety (in its individual use, technical performance) and procedural safety (technical outcome at the end of lesion treatment with the device under study and any other device being used).
* Clinical outcomes at the end of the procedure and during the specified follow-up period for each device. The follow-up timeframe is established based on the conditions of use and type of device being used, according to the requirements established by the relevant Notified Body.

Eligibility Criteria:
Inclusion Criteria:

* Patient treated with Essential Pro according to routine hospital practice and following instructions for use
* Informed consent signed

Exclusion Criteria:

* Not meet inclusion criteria
Peripheral Treg Cell Senescence & Serum Total Cholesterol Level

Hypercholesterolemia is a risk factor for the occurrence and development of atherosclerosis. Recent animal studies have found that increased serum cholesterol level is associated with peripheral Treg cell senescence, but clinical evidence is still lacking. The purpose of this study is to analyze the correlation between human peripheral Treg cell senescence and serum total cholesterol level using clinical blood samples, thus laying a foundation for the establishment of novel therapeutic strategies for atherosclerosis based on the regulation of Treg cell senescence.

Hypercholesterolemia is a risk factor for the occurrence and development of atherosclerosis. Recent animal studies have found that increased serum cholesterol level is associated with peripheral Treg cell senescence, but clinical evidence is still lacking. The purpose of this study is to analyze the correlation between human peripheral Treg cell senescence and serum total cholesterol level using clinical blood samples, thus laying a foundation for the establishment of novel therapeutic strategies for atherosclerosis based on the regulation of Treg cell senescence.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 30 and ≤ 60 years old with independent behavior ability.
2. The participants need to fully understand the purpose and content of the study, and voluntarily participate in the study and sign the informed consent.

Exclusion Criteria:

1. Pregnant or lactating women.
2. Acute and severe diseases in the last 3 months, including but not limited to, acute myocardial infarction, acute cerebral infarction, cerebral hemorrhage, circulatory failure, respiratory failure (internal diseases), trauma requiring hospitalization, or undergoes surgery under general anesthesia (surgical diseases).
3. History of severe diseases, including but not limited to, tumors, serious hematological diseases, serious cardiopulmonary diseases (interventional therapy for coronary artery disease, atrial fibrillation, chronic obstructive pulmonary disease, etc.), renal failure, liver failure, old stroke with serious sequelae.
4. Have participated in clinical trials in the past 3 months.
5. The investigator considers that not appropriate for inclusion.
Mckenzie Versus William Exercise for Non Specific Low Back Pain in Adolescents

MCKENZIE EXERCISE VERSUS WILLIAMS EXERCISE ON DECREASING PAIN IN ADOLESCENT WITH NON SPECIFIC LOW BACK PAIN

Low back pain is uncommon in the first decade of life,but prevalence increases steeply during the teenage years; around 40% of 9-18-year olds in high-income, medium-income, and low-income countries report having had low back pain. NSLBP represents about 85% of LBP patients seen in primary care. Non-specific low back pain is one of the most common health problems and is the leading cause of disability in young adults. During school age, the overall risk of low back pain is similar to adults, with prevalence rates as high as 70% to 80% by the age of 20 years old Non-specific low back pain is defined as low back pain not attributable to a recognisable, known specific pathology.

Understanding back pain in adolescents is crucial to obtain timely diagnosis and determine appropriate treatment. Proper treatment and management of LBP in the adolescent years can minimize back pain lasting into adulthood Non pharmacological treatments are emphasised over pharmacological interventions in the management of persistent non-specific low back pain.

natinal institute for health and care excellence(NICE) 2016 draft guideline endorses self-management, exercise, manual therapy, psychological therapies, combined physical and psychological programmes, return-to-work programmes, and radiofrequency denervation.

Back exercises can be an inexpensive and easy option of treatment for NSLBP and proven to be effective. McKenzie extension exercise and William flexion exercise are the most common types of back exercises.

Selection the appropriate treatment method is important. So this study will be aimed to compare between Mckenzie and William's exercises in order to find which method has better effect on adolescents with NSLBP.


Eligibility Criteria:
Inclusion Criteria:

* Age range from 14 to 18 years.
* Diagnosed as non-specific low back pain.
* Medically and clinically stable.
* All participants are within normal range weight and height.

Exclusion Criteria:

Adolescents have one or more of the followings will be excluded:

* Any spinal deformities.
* History of spinal or pelvic surgery.
* Specific spinal pathologies as cauda equina syndrome, cord compression, infection, fracture, neoplasm, inflammatory disease, whiplash associated disorders and vertebro-basilar insufficiency.
* Any visual or auditory problems that interfere with the rehabilitation program.
* Children with significant mental or psychological problems that interfere with understanding instructions.
Open-Label Extension of the Dose Finding Study (DSC/08/2357/36) in Patients With Poly Juvenile Idiopathic Arthritis

Primary Objective of the study:

the purpose of this extension study was to determine the safety of Givinostat in a long term treatment of patients who participated in DSC/08/2357/36 study with good results (clinical benefit at least pediACR30 response);

Givinostat is expected to exert a clinically relevant therapeutic effect on polyarticular JIA through the inhibition of the production/release of pro-inflammatory cytokines, such as IL-1β, IL-6 and TNFα, which are involved in the pathogenesis of the arthritic process.

Eligibility Criteria:
Inclusion Criteria:

* subjects who had successfully completed the previous Dose Finding Study and were fully compliant to the inclusion/exclusion criteria described in the previous DSC/08/2357/36

Exclusion Criteria:

* patients with fever related to JIA or other systemic features of JIA during 12 months before entering the study
* active bacterial or mycotic infection requiring antimicrobial treatment
* episode of macrophage activation syndrome over the last 6 months
* baseline prolongation of QT/QTc interval, use of concomitant medications that prolong the QT/QTc interval or history of additional risk factors for TdP.
* clinically significant cardiovascular disease
* clinically significant illness i.e. any condition that in the opinion of the Investigator places the patient to unacceptable risk for adverse outcome if he/she were to participate in the study
* psychiatric illness/social situation that would limit compliance with study medication and protocol requirements
* inherited metabolic diseases
* presence of malignancy
* pregnancy or lactation
* positive blood test for HIV
* active EBV infection, active B and/or C hepatitis
* platelet count \<100x10(9)/L
The Proactive Diagnostic Value of Hemostatic Biomarkers in Disseminated Intravascular Coagulation

The project was undertaking by Qilu Hospital of Shandong University, aiming to evaluate diagnostic performance of hemostatic biomarkers in disseminated intravascular coagulation.

Disseminated intravascular coagulation (DIC) is a life-threatening condition with high mortality, necessitating timely and accurate diagnosis for effective management. However, current diagnostic systems can not recognize DIC at its reversible phase, causing suboptimal treatment outcomes. Consequently, the current diagnostic criteria for DIC lacks earlier laboratory indicators. Therefore, the investigators aimed to assess the diagnostic potential of selected hemostatic biomarkers, including thrombin-antithrombin complex (TAT), soluble thrombomodulin (sTM), tissue plasminogen activator inhibitor complex (tPAI-C), α2-plasmin inhibitor plasmin complex (PIC) and anti-thrombin III (ATIII), in evaluating DIC, allowing for proactive diagnosis before the disease progresses into its irreversible phase.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old, non-perinatal period, a hospitalization length of≥3 days.

Exclusion Criteria:

* primary hematologic diseases, decompensated liver cirrhosis, chemotherapy history.
Transoral Versus Transbuccal Placement of Bicortical Screws During Orthognathic Surgery

Bicortical screws have been widely used for mandibular osteosynthesis during orthognathic surgery.Transoral placement of bicortical screws is a rigid fixation method in orthognathic surgery, which is less often used.

The aim of this study was to compare postoperative outcome of transoral versus transbuccal bicortical screw placement during orthognathic surgery.

This study comprises an academic, retrospective, monocentric study in which the charts of orthognathic patients operated between January 2010 and December 2012 were retrospectively reviewed. Postoperative complications were registered. Demographic, dental and surgical parameters are examined as potential risk factors for the occurence of postoperative complications.


Eligibility Criteria:
Inclusion Criteria:

* patients of all ages
* patients of all genders
* patients who had undergone a bimaxillary osteotomy, a bilateral sagittal split ramus osteotomy (BSSO), a BSSO with a chin osteotomy or a trimaxillary osteotomy

Exclusion Criteria:

* patients where cement had been used at the osteotomy sites
* patients who had undergone a multisegmented mandibular osteotomy
* patients who had undergone an osteosynthesis with plates
* patients where the postoperative orthopantomogram was unavailable
* patients where data regarding the type of screw placement was unavailable