cyrilzakka/clinical-trials huggingface dataset:
The Effect of Massage on Growth And Stress And Stress ,Department of Nursing,

The aim of this thesis is to exprementally investigate the effect of massage applied to preterm infants on growth and stress. While the population of the research is preterm infants at the neonatal intensive care unit of a Medicalpark Batman Hospital between January 2018 and February 2019, the sample is 60 preterm infants suitable for inclusion criteria. Research data was collected using Preterm Infant Information Form, Preterm Follow-up Form and Newborn Stress Scale. While massage was applied to the infants in the experimental group three times daily for 10 days, the control group received the usual care. Weight, length and head circumference of infants in both experimental and control group were measured by the researcher on 1., 5. and 10. days. In order to evaluate stess level of the massage applied infants, camera records of the infants were taken 15 minutes before and after the massage on 1., 5. and 10. days. Camera records of the infants in the control group were also taken at the same time with those in the experimental group. Camera records were watched and stress level of the infants were evaluated by two observers blind to the research. The data analyses were carried out using In-class Correlation, Frequency, Levene, Two-Way ANOVA for Mixed Measured, Repeated ANOVA tests

The aim of this thesis is to exprementally investigate the effect of massage applied to preterm infants on growth and stress

Eligibility Criteria:
Inclusion Criteria:

- Gestational age at birth below 36 weeks + 6 days, Body weight over 1000 g, Do not have any diseases or congenital disorders, Babies who are allowed to be massaged by the NICU's neonatologist was determined as .

Exclusion Criteria:

-
Comparison of Curosurf and Infasurf in the Treatment of Preterm Infants With Respiratory Distress Syndrome

Premature infants frequently have trouble breathing after birth. If the respiratory disorder is caused by surfactant deficiency or dysfunction, the disease is treated with a medication called surfactant that is given to the infant through a tube inserted into the windpipe. This study will compare the safety of two of the commonly used surfactants, poractant and calfactant,in the United States. Poractant has added chemicals called phospholipids which are known to cause inflammation and irritation in the body of premature infants. The investigators will compare this to another similar surfactant that does not contain these chemicals by looking at samples from the windpipe, while the tube is in place, and from blood tests in the first few days of life.

The investigators are hoping to learn whether calfactant is a safer therapeutic agent to treat respiratory distress syndrome in preterm infants compared to poractant.

30 infants were randomized to receive either poractant or calfactant for Respiratory Distress Syndrome.

Tracheal aspirates were obtained to look for increase in macrophage and blood samples were drawn to look for markers of inflammation.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled prior to delivery with signed informed consent and HIPAA by parents
* Gestational age of less than 35 weeks
* No maternal chorioamnionitis of other maternal or fetal infection
* Respiratory Distress Syndrome (RDS) determined by the attending neonatologist that needs to be treated with exogenous surfactant and mechanical ventilation

Exclusion Criteria:

* Major Birth Defect, Malformation Syndrome
* Chromosomal or Inherited Metabolic Disorder
* Proven Presence of an Immunodeficiency
* Antenatal exposure of illicit substance (e.g., methamphetamines, cocaine, etc., but not marijuana)
* Birth Asphyxia (cord pH \<7.0, Apgar score of 3 or less at 10 minutes of age)
* HIV or other congenital viral, bacterial or fungal infection
* Lack of Parental consent of refusal of attending neonatologist to allow participation
* Discretion of the investigator
* The legal representative of the infant or the patient's primary physician are not committed to providing full, aggressive life support
Bone Mineral Density in Israeli Female Vegans and Omnivores

A vegan diet is more and more prevalent in the general population in Israel in recent years. There have been some concerens that a vegan diet may lack in bone-health related nutrients (such as calcium, protein and vitamin D), and therefore may cause a decreased bone mineral density. The study aims to compare bome mineral density and other biochemical bone health parameters in vegan and omnivore non-menopausal Israely females.


Eligibility Criteria:
Inclusion Criteria:

* generaly healthy
* vegan group: vegan diet for the past 3 years
* omnivore group: comsumption of animal products at least 3 times a week

Exclusion Criteria:

* pragnent / breastfeeding women
* amenorrhea (absence of a menstrual period) for more than 3 months
* amenorrhea in the past
* significant underweight in the present/past (BMI \< 17.5)
* taking medicine that affect bone density
* hypo/hyper thyroidism
* hypo/hyper parathyroidism
* smokimg in the past 10 years
* over consumption of alcohol (more than 7 units a week)
Efficacy of Neoadjuvant Hyperthermic Intraperitoneal Chemotherapy in Advanced High-grade Serous Ovarian Cancer (the NHIPEC Trial)

Background: Neoadjuvant chemotherapy (NACT) is an important treatment option for patients with ovarian cancer. Although intravenous NACT can improve optimal resection rates and decrease surgical morbidity and mortality, these advantages do not translate into a survival benefit. Ovarian carcinoma is mainly confined to the peritoneal cavity, which makes it a potential target for hyperthermic intraperitoneal chemotherapy (HIPEC). Our previous study showed that HIPEC could be used in the neoadjuvant setting, which was named neoadjuvant HIPEC (NHIPEC). Since hyperthermia is an excellent chemosensitiser, we hypothesised that the combination of NHIPEC and intravenous NACT could show superior efficacy to intravenous NACT alone. Methods: This study is a single-centre, open-label, randomised (1:1 allocation ratio) phase 2 trial. A total of 80 patients will be randomly assigned into an experimental group (NHIPEC+intravenous NACT) or a control group (intravenous NACT). Patients in the experimental group will receive NHIPEC following laparoscopic evaluation, and four tubes will be placed via the laparoscopic ports, which will be used to administer NHIPEC. Then, perfusion with docetaxel (60-75 mg/m2) will be performed (43°C for 60 min, Day 0) followed by cisplatin (75 mg/m2, Day 1) infusion (43°C for 60 min) 24 hours later. After NHIPEC, two cycles of intravenous NACT will be given. Patients in the control group will receive three cycles of intravenous NACT. The primary endpoint is the proportion of patients who achieve a Chemotherapy Response Score (CRS) of 3 according to the CRS system. The secondary endpoints include progression-free survival, overall survival and the rates of complete resection and NHIPEC-related adverse events.


Eligibility Criteria:
Inclusion Criteria:

1. International Federation of Gynecology and Obstetrics(FIGO) stage IIIC-IVA, HGSOC
2. Patients with Fagotti score ≥8
3. Adequate kidney function (blood creatinine 58-96 µmol/L)
4. Adequate haematological function (haemoglobin ≥110g/L, leucocytes ≥4.0×109/L, neutrophils ≥2.0×109/L, platelets≥100×109/L)
5. Adequate liver function (serum total bilirubin 3.4-22.2µmol/L, alanine aminotransferase (ALT) 7-40U/L, aspartate aminotransferase (AST) 13-35U/L, AST/ALT ≤1.5)
6. World Health Organization(WHO) score 0-2

Exclusion Criteria:

1. Patients who had received chemotherapy, radiotherapy or any kind of targeted therapy.
2. Patients with complete intestine obstruction.
3. Expected life span ≤8 weeks.
4. Complicated with any other known malignancies.
5. Patients with poor cardiopulmonary function, which would limit compliance with study requirements.
Mechanisms of Dysfunction and the Influence of Exercise on Cardiac and Musculoskeletal Function

Primary Objective: To determine if impairments in cardiac and musculoskeletal function and metabolism exist in Fontan children.

Secondary Objectives:

1. To determine if impairments do exist, are they related to exercise capacity.
2. To determine if a 12-week exercise training intervention improves cardiac and/or musculoskeletal metabolism.

Hypothesis: The investigators hypothesize that abnormalities in cardiac and skeletal function are evident, influence exercise capacity, and can be improved with exercise training.

This proposed research provides an interdisciplinary approach to understanding exercise intolerance by examining cardiac and musculoskeletal metabolism in a unique cohort of children with congenital heart disease. Study findings may more importantly lead to evidence-based exercise interventions that promote improvements in overall physical health, quality of life, and functional status for Fontan children. Furthermore, this pilot study will lead to the development of a novel research protocol which may be applied to larger Fontan and other congenital heart disease cohorts. This study will also provide preliminary data to develop and conduct a larger clinical research project.

Eligibility Criteria:
Inclusion Criteria:

Fontan Patients:

1. Patients who have had the Fontan cardiac procedure
2. 10-16 years of age
3. Written Informed Consent

Healthy Controls:

1. 10 - 16 years of age
2. Written Informed Consent

Exclusion Criteria:

Fontan Patients:

1. Contraindication to exercise
2. Physically active (i.e., ≥ 60 minute of moderate-vigorous activity) (Strong et al., 2005)
3. Patients in whom MRI is contraindicated (e.g. pacemaker, ocular metal, claustrophobia, tattoos)
4. Patients with a known allergy to gadolinium.
5. Patients with a history of allergic disposition or have anaphylactic reactions
6. Moderate-to-severe renal impairment (defined as having a GFR/ eGFR \< 60 mL/min)
7. Have Sickle Cell anemia
8. Known pregnancy, or breast feeding
9. Patient is uncooperative during a MRI without sedation or anesthesia

Healthy Controls:

1. Contraindication to exercise
2. Physically active (i.e., ≥ 60 minute of moderate-vigorous activity) (Strong et al., 2005)
3. Patients in whom MRI is contraindicated (e.g. pacemaker, ocular metal, claustrophobia, tattoos, pregnancy)
4. Patient is uncooperative during a MRI without sedation or anesthesia
Serum Lipase and Severity of Pancreatic Injury.

Diagnosis of pancreas injury is not easy at first consult. It's a retrospective study, in children under 15 years and 3months, between January 1st 2010 to August 31th 2019, to prove that the first level of lipase is correlated with the severity of pancreatic injury.

Every children with elevated serum lipase after trauma during those years will be selected.

The children with pancreatic tumors will be excluded. American Association of Surgeon Trauma (AAST) classification of pancreas injury will be used to grade severity.

Children will be divided in two groups : one including pancreatic lesion with duct injury and one without duct injury.

Data will include mechanism of injury, associated injury, length of stay, maximal lipase level, nutritional care and local complications will be noted.

The main objective of this study is to determine if there is a correlation between the initial serum lipase and the severity of the pancreatic injury.

Eligibility Criteria:
Inclusion Criteria:

* Children under 15 years 3 months with elevated lipase serum level after trauma.

Exclusion Criteria:

* Elevation of lipase secondary to pancreatic tumor
Effects of OCTA-guided PDT in Acute CSC

OCTA-guided PDT is as safe and effective as ICGA-guided PDT in the treatment of acute central serous chorioretinopathy. Or OCTA-guided PDT is more effective than ICGA-guided PDT in the treatment of acute central serous chorioretinopathy, safe as well.


Eligibility Criteria:
Inclusion Criteria:

* Idiopathic detachment of the neurosensory retina with a focal leak at the level of the RPE with FA
* Presence of SRF and/or serous pigment epithelial detachment on OCT
* Presence of abnormal dilated choroidal vasculature in ICGA

Exclusion Criteria:

* Patients with other ocular conditions commonly associated with SRF, such as choroidal neovascularization, polypoidal choroidal vasculopathy (PCV), diabetic retinopathy, retinal vascular occlusion, Coat's disease
* Any disease that may affect the quality of imaging (quality of OCTA images \< 6), such as cataract, high myopia or nystagmus
* History of ocular surgeries including retinal laser
* Pregnancy
* Any uncontrolled systemic disease
* Any condition rendering patients intolerable to image acquisition
Autologous Platelet Lysate in Corneal Epithelial Defects

Patients diagnosed with persistent corneal epithelial ulcers will be treated with autologous platelet lysate.

Autologous platelet lysate (PL) will be given to patients diagnosed with persistent corneal epithelial ulcers (PED) who are unresponsive to conventional therapy to promote the healing of PED. PL will be dispensed into sterile eye droppers, and these eye droppers will be stored ideally at -20C and thaw once for use, then will be kept in the refrigerator at +4C, to be taken in multiple doses.

Eligibility Criteria:
Inclusion Criteria:

1. Cognitive ability to understand and sign the consent form.
2. Corneal ulcers that did not re-epithelialise after 1 week of conventional treatment (therapeutic contact lenses, topical artificial tears, eye packs and antibiotic eye-drops).
3. Clinical indications: corneal ulcer due to caustic substances, corneal epitheliopathy, corneal lesions following cataract surgery, recurrent ulcerative keratitis, corneal lesions due to a foreign body.
4. Good compliance with the study regimen and availability for the duration of the entire study period.

Exclusion Criteria:

1. Corneal ulcers which developed tissue scars.
2. Pregnant or lactating women.
The Efficacy of VESPA 2.0 for Cognitive Rehabilitation in Patients With Mild Cognitive Impairment

VESPA 2.0 is based on an integrative and ecological approach used for the treatment of cognitive dysfunction in patients with MCI or other neurodegenerative disorders.

The goal of this study is to verify the effectiveness of the intensive-individual cognitive participation intervention (SCI-i) on the general cognitive functioning and specific cognitive functions of patients with mild or moderate cognitive decline affected by Alzheimer's dementia, Parkinson's and Multiple Sclerosis.

Participants will be subjected to cognitive training (tasks on attention, memory, language, executive functions, and visual-spatial functions) through software. They will take place using virtual cameras and virtual reality (VR) viewers. All subjects will undergo follow-up evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Alzheimer Disease, Multiple Sclerosis, Parkinson Disease
* Severity of mild to moderate cognitive impairment
* Sign informed consent

Exclusion Criteria:

* Important comorbidities with psychiatric syndromes
* Failure to sign the informed consent
* Atypical parkinsonisms
* Clinical conditions that involve vision-related problems.
Study to Evaluate the Efficacy and Safety of MY008211A in Subjects with Primary Immunoglobulin a Nephropathy (IgAN)

Efficacy and safety of MY008211A in IgAN patients

This was a multicenter, randomized, double-blind, dose-ranging, parallel-group study. Two doses of MY008211A (200mg, 400mg) were compared with placebo. The study comprised a screening period of this study for 90 days, an efficacy observation period for 24 weeks, a long-term study for 80 weeks, and a follow-up period for 2 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females ≥ 18 and ≤ 75 years of age at Screening.
2. Estimated GFR(eGFR) ≥30 mL/min/1.73m2.
3. Subjects with a biopsy-confirmed diagnosis of IgAN.
4. Urine protein ≥0.75 g/24h from a 24h urine collection.
5. All patients must have been on stable supportive care including a maximally tolerated dose or approved maximal dose of ACEi or ARB therapy for at least 90 days prior to the first administration of study drug.
6. Subjects who received SGLT2i must have been on a stable treatment with the maximum allowed or tolerated dose prior to the first administration of study drug.
7. Vaccination against Neisseria meningitidis(MenACWY) is required within 3 years.
8. Vaccination for the prevention of S. pneumoniae is required within 5 years.

Exclusion Criteria:

1. Systolic blood pressure \>130 mm Hg or diastolic blood pressure \>80 mm Hg.
2. Presence of any secondary IgAN.
3. Presence of rapidly progressive glomerulonephritis.
4. Presence of other chronic kidney diseases.
5. Patients with a diagnosis of type 1 or type 2 diabetes mellitus.
6. A history of invasive infections caused by encapsulated bacteria, e.g., meningococci or pneumococci.
7. Patients previously treated with immunosuppressive agents exposure within 90 days prior to start of study drug dosing.
8. Patients previously treated with traditional Chinese medicine containing immunosuppressive ingredients within 90 days prior to start of study drug dosing.
9. Patients who had been treated with any systemic corticosteroids within the 180 days before treatment ≥20 mg/d for primary IgAN indication.
10. Patients who previously have received biologic agent or monoclonal antibodies prior to start of study drug dosing within 5 half-lives or 30 days (whichever is longer).
11. Patients who have received live/attenuated vaccines within the 4 weeks prior to randomization, or plan to receive during the trial.
Physical Activity in the Medical Workplace

Decreased physical activity is not only associated with multiple chronic medical conditions, including obesity, but also with depressed mood, and other negative emotions. As many employed adults spend a great deal of time at work where we are predominantly sedentary, strategies to increase physical activity at work are being pursued to help improve the physical and mental health of Americans. This 17 week randomized controlled trial will investigate changes of occupational physical activity in three groups: those provided with a FitBit® but not able to monitor their activity level, and those provided with activity goals and individual physical activity challenges, and those who do not use a FitBit®.

All subjects will be entered into a 4 week run-in phase where subjects will wear a blinded Fitbit during work hours. The baseline work activity is collected at this time. This phase is followed by a randomization to one of 3 groups: the blinded Fitbit group, the unblinded Fitbit group, and the group which will not wear any activity monitors. During these 12 weeks we will collect data on activity levels during work hours. Everyone will have a final contact at week 17 to close out the study.

Eligibility Criteria:
Inclusion Criteria:

* Be between 18 - 65 years of age
* Be a Mayo Clinic employee at 0.75 FTE or more
* Have no previous use of any activity monitor for 14 consecutive days or more
* Not be pregnant by subject self report
* Have a stable weight - defined as self-reported weight that has not changed more than 10% in the past 3 months
* Not have any previous history of joint problems that limit free movement, as determined by the PI
* Be able to participate fully in all aspects of the study
* Have understood and signed study informed consent.

Exclusion Criteria:

* Have a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence or skew data collection - such as a position where they predominantly provide transport as part of their job.
Study of the Role of the Induced Membrane in the Reconstruction of Bone Loss in the Limbs

Masquelet's induced membrane technique is a two-stage reconstructive surgery for severe bone fractures commonly used by military orthopedists. The particularity of this technique relies on the synthesis of a biological membrane induced by the transient implantation of a surgical cement (= 1st stage surgery). The presence of the induced membrane in the reconstruction space defines a microenvironment or "biological chamber" favourable to osteogenesis, positively influencing the repair of the lesion after implantation of an autologous bone graft (= 2nd stage of surgery).

In view of the excellent clinical results obtained with this procedure, the Masquelet technique has gradually become a reference treatment in the field of orthopedic and trauma surgery.

However, orthopedic surgeons sometimes observe failures in bone consolidation. To our knowledge, the role played by induced membrane in these therapeutic failures has never been studied.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patient with traumatic bone loss
* Patient eligible for the induced membrane technique

Exclusion Criteria:

* Patients with post-tumor bone loss
* Patients who are immunocompromised or under immunosuppressive treatment
* Patients with chronic inflammatory disease (diabetes, inflammatory bowel disease)
* Patients with collagenosis
* Patient with a contraindication to sampling
* Pregnant or breastfeeding women
A Study for Tysabri Participant Preference

The primary objective of this study is to collect, evaluate and compare data on participant preference between subcutaneous (SC) and intravenous (IV) natalizumab. The secondary objectives of this study are to evaluate the immunogenicity of SC natalizumab for natalizumab-naïve participants and collect and evaluate data on the multiple sclerosis (MS) disease-relevant parameters (relapse rate, time to first relapse, disability improvement and progression) over 12 months, in participants with natalizumab therapy starting on SC natalizumab or switching from IV natalizumab.


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of highly active RRMS according to McDonald criteria (2018) and initiating natalizumab treatment is indicated based on current summary of product characteristics (SmPC)
* In RRMS participants who are already on natalizumab therapy, continued treatment must be indicated based on current SmPC

Key Exclusion Criteria:

* Progressive forms of MS
* Contraindication to natalizumab treatment according to natalizumab SmPC
* Concomitant treatment with other drugs for treating RRMS
* Participation in any interventional clinical trial NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.