cyrilzakka/clinical-trials huggingface dataset:
Imaging Parameters to Predict Future Vertebral Fracture in Osteoporosis

After vertebroplasty, many patients will suffer from 2nd fracture in the vertebral column. With analyzing of the images done right after the 1st vertebroplasty, we can define the parameters from different imaging and they can be predictors of the future fracture.

Vertebroplasty is considered one of the alternatives for the treating of spine compression fracture associated with pain especially for those patients with osteoporosis. However, after vertebroplasty, the compliance of the bone becomes stronger than the adjacent vertebrae that is not treated. So there is always a consideration of future fracture of the adjacent vertebral bodies after vertebroplasty done on certain body. In this study, we try to follow the patients (5 years) to see if the adjacent vertebral bodies are prone to have fracture than the others away from the site of vertebroplasty.Then we try to find out the image biomarkers to predict the future fracture in the vertebral bodies. The should be done with CT scan raw data, analysis with different algorithms.

Inclusion criteria; patients with osteoporosis and receiving vertebroplasty and with secondary fracture occurring in other spine exclusion criteria: No second vertebral body fracture occurred. Primary measurement: the time and location of the 2nd fracture secondary measurement: the imaging biomarkers from CT scan.

Eligibility Criteria:
Inclusion Criteria:

* All the patients received vertebroplasty treatment between 2005.01-2011.12 with 2nd fracture in the vertebral column.

Exclusion Criteria:

* No image available
The Investigation of Therapeutic Effect and Platelet Activity After ILIB for Ischemic Stroke Patient

The aim of our study is to therapeutic effect and platelet activity after intravenous laser irradiation of blood for ischemic stroke patient

Background : This research is designed through randomization, control, and double-blind trial to explore the clinical effectiveness of intravenous laser irradiation of blood for ischemic stroke patient; The research will further explore the changes in platelet activity after treatment. The light accelerates blood and cells circulation in the human body, so that protein molecular structure would promote changes. Pain control is indicated in such treatment, but still lacking evidence of neurological symptoms and functional improvement.

Purpose:This research is designed through randomization, control, and double-blind trial to therapeutic effect and platelet activity after intravenous laser irradiation of blood for ischemic stroke patient. Furthermore, to establish a new way of clinical rehabilitation therapy.

Method: The investigators plan to recruit 20 patients who are between the ages of 20 to 80 years old. The participants are required to have clear conscious and be able to communicate. The patient with mild to moderate stroke ( NIHSS=1-15), which onset between one month to 2 years will be included. The treatment group will receive an intravenous helium-neon laser phototherapy. A vein indwelling needle will be placed in their veins located in the upper elbow, and the laser fiber catheter will be introduced through the indwelling cannula. The power is set between 2.5 \~ 3.0Mw, 60 minutes each time, once a day for five consecutive days each week, for 2 weeks (total 10 times in one course). The steps for the control group are the same, except that the output power is adjusted to zero intensity. This plan will be explained to the patient in detail during the outpatient visit and patients will sign the consent form upon agreement. Before intravenous laser irradiation, three days, one month, and three months after the therapy, 20 ml of autologous peripheral venous blood need to be drawn for basic blood tests and platelet activity tests. At the same time, the clinical functions of patients will be evaluated, including NIHSS, mRS and Stroke Impact Scale (SIS).

Eligibility Criteria:
Inclusion Criteria:

* Aged between 20 to 80 years old
* Able to speak and understand Mandarin/Taiwanese
* No cognitive impairment
* Residual motor function impairment (mRS\>1)
* Mild stroke (NIHSS=1-4) or Moderate stroke(NIHSS=5-15)
* No psychological disease

Exclusion Criteria:

* Severe stroke (NIHSS=16-42)
* History of intracerebral hemorrhage and other major surgery
* History of malignancy, chronic kidney disease
* Active infection
* Chronic hepatitis B or Chronic hepatitis C
* Unstable angina or acute myocardial infarction within 6 months
* Severe cognition impairment
* Pregnancy
Airway Code Calls - Survey of Management

This is a survey of airway codes, which are emergency mobile phone requests for anaesthetic help to manage acute airway crises in the hospital (out of theatre, out of Surgical Intensive Care Unit, SICU).

The anaesthetists are doctors trained in advance airway management. Patients in the hospital may suffer airway crises e.g. airway obstruction or need for tracheal intubation (insertion of breathing tube) for various reasons. The on call SICU anaesthetists responds to the airway code by attending the patient in need and managing the patient at their own discretion.

Airway management will depend on the anaesthetist's knowledge, skills and experience. it will also depend on the available airway equipment.

We plan to evaluate airway codes for a 24 month period. Parameters include: type of incident; patient factors (including airway assessment); type of equipment used; anaesthetic drugs used; airway management chosen by the attending anaesthetist; and, airway complications.

Airway codes will be managed as standard care. These calls are taken and managed by anaesthetists on call on SICU. The audit form is filled in by the on call anaesthetist after the airway code has been managed. This is an audit looking at:

Primary outcome

•Evaluate the type of airway codes that the SICU anaesthetist is called for

Secondary outcomes:

* Patient factors (including airway assessment)
* Type of equipment used
* Type of anaesthetic drugs used
* Airway management chosen by the attending anaesthetist
* Airway complications.

Eligibility Criteria:
Inclusion Criteria:

* adults outside operating theatre and Surgical Intensive Care Unit requiring emergency anaesthetic airway support

Exclusion Criteria:

* Nil
The Effect of Aromatherapy Applied to the Patients in the Urodynamic Procedure

This randomized controlled study is planned to determine the effect of aromatherapy applied to patients in the urodynamic procedure on patients' anxiety and serum cortisol levels.

This study assumes that lavender inhalation in aromatherapy has positive effects on physiological parameters such as blood pressure, heart rate, respiratory rate, serum cortisol level, as well as reducing stress and anxiety.

98 patients in each group will be included in the study (Aromatherapy group=49; Control group=49). In addition to the routine treatment and care practices of the unit, aromatherapy will be applied to the patients included in the study group. Aromatherapy application will be applied to all patients by the same researcher. Aromatherapy application will be started 5 minutes before the urodynamic procedure after the patient is taken to the urodynamics room and lavender essential oil will be used with a diffuser until the end of the procedure. Routine treatment and care interventions will be applied to the patients included in the control group during the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Those who signed the 'Informed Voluntary Consent Form' to participate in the research,
* 18 years and older,
* Conscious, oriented and cooperative,
* Able to communicate
* Urodynamic procedure applied,
* No problem in sense of smell,
* No chronic respiratory disease (lung cancer, chronic obstructive pulmonary disease, asthma, chronic bronchitis, etc.),
* No history of dermatitis against cosmetic odor,
* Patients without a known history of allergy to the essential oil used

Exclusion Criteria:

* Those who did not sign the "Informed Consent Form" to participate in the research,
* Under 18 years of age,
* Unconscious, without orientation and cooperation,
* Unable to communicate,
* Urodynamic procedure is not applied.
* Having problems with the sense of smell,
* Having chronic respiratory disease (lung cancer, chronic obstructive pulmonary disease, asthma, chronic bronchitis, etc.),
* Having a history of dermatitis against cosmetic odor,
* Having a trait anxiety scale score of 60 and above,
* Patients with a known history of allergy to the essential oil used
A Study of LCAR-AIO CAR-T Cells for Treating Relapsed/Refractory Neurological Autoimmune Diseases

This is a prospective, single-arm, open-label, dose-exploration and expansion clinical study of LCAR-AIO in adult subjects with relapsed/refractory neurological autoimmune diseases.

This is a prospective, single-arm, open-label exploratory clinical study to evaluate the safety, tolerability, pharmacokinetics and efficacy profiles of LCAR-AIO, a chimeric antigen receptor (CAR) -T cell therapy in subjects with relapsed/refractory neurological autoimmune diseases. Patients who meet the eligibility criteria will receive LCAR-AIO infusion. The study will include the following sequential stages: screening, apheresis, pre-treatment (cell product preparation: lymphodepleting chemotherapy), treatment (LCAR AIO infusion) and follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects voluntarily participate in clinical research.
2. Age 18-70 years.
3. Adequate organ function at screening.
4. Clinical laboratory values meet criteria at screening visit.
5. Indications include:

MS;

1. Have been diagnosed of MS at least 6 months before screening.
2. Fulfill relapsed/refractory MS conditions.

NMOSD/MOGAD:

1. Have been diagnosed of NMOSD/MOGAD at least 6 months before screening.
2. AQP-4 IgG (NMOSD), or MOG-IgG (MOGAD) should be positive by CBA (Cell based transfection immunofluorescence assay).
3. Fulfill relapsed/refractory NMOSD/MOGAD conditions.

MG:

1. Have been diagnosed of MG at least 6 months before screening.
2. AChR-IgG or MuSK-IgG should be positive.
3. Fulfill relapsed/refractory NMOSD/MOGAD conditions.

Exclusion Criteria:

1. Active infections such as hepatitis and tuberculosis.
2. Other autoimmune diseases.
3. Serious underlying diseases such as tumor, uncontrolled diabetes and clinically significant cardiovascular disease.
4. Female subjects who were pregnant, breastfeeding, or planning to become pregnant while participating in this study or within 1 year of receiving LCAR-AIO treatment.
Discharge Criteria of Preterm Infants

This retrospective study aims to compare discharge criteria and their impact on the length of stay using two neonatal intensive care units from two countries. The possible discharge criteria include temperature control, apnea observation, periodic respiration, least weight limit, and parents' readiness.

The data were collected retrospectively in each study site.

Aims: To compare discharge criteria and their impact on the length of stay among preterm infants in Japan and Finland. The possible discharge criteria include temperature control, apnea observation, periodic respiration, least weight limit, and parents' readiness.

Study design and settings: This is a retrospective comparison study in two NICUs: a Level IV in Japan and a Level III in Finland.

Patients: Eligible infants are those who were born between 28+0 and 31+6 weeks of gestation and who were discharged home from the study sites between January 2020 and December 2021. Infants will be excluded if (1) they have major anomalies at birth, (2) they are not discharged home from the study sites, or (3) they are discharged home with oxygen and/or after tracheostomy.

Outcome measures: The primary outcomes are the most common last discharge criterion between the two NICUs, and the potential shortening effects of each discharge criterion on the length of stay. The secondary outcome is the postmenstrual age (PMA) for each discharge criterion.

Statistics: The comparison between two continuous variables will be carried out by the student t test.

Ethics: The Ethics Committee of Nagano Children's Hospital gave ethical approval to this study. The study permission was obtained in both study sites.

Eligibility Criteria:
Inclusion Criteria:

* Born between 28 and 31 weeks of gestation and
* Discharged home from the study sites between January 2020 and December 2021

Exclusion Criteria:

* Having major anomalies at birth
* Need for home oxygen therapy, tracheostomy, and/or gastrostomy at discharge
Effect of Chitin and Ascorbic Acid on Dietary Insect Iron Absorption

Iron is involved in many vital metabolic processes such as oxygen transport, electron transport in cells, DNA synthesis and repair, and muscle metabolism. However, iron deficiency and iron deficiency anemia continue to affect many people, particularly preschool children (\<5 years), adolescents, and pregnant and non-pregnant women of childbearing age. Iron deficiency is characterized by a lack of total iron stores in the body, which is mainly caused by insufficient dietary iron intake, physiologically increased iron requirements, poor intestinal iron absorption, or chronic blood loss. Animal foods are important sources of highly bioavailable iron in the human diet. Meeting human nutritional needs for the rapidly increasing world population while targeting food production within the planetary boundaries will require the identification of sustainable iron sources, such as edible insects. A previous iron absorption study showed that insect iron is absorbed moderately well. The present study will examine if and to which extent chitin, a polysaccharide within the insect biomass, inhibits iron absorption. In addition, the enhancing iron absorption of ascorbic acid on iron absorption from Tenebrio molitor larvae will be studied. This knowledge can support to optimize the composition of an insect-based meal to increase its iron absorption.

To distinguish iron absorption from insect biomass from other sources, insects are labeled with stable iron isotopes (Fe-57, Fe-58, Fe-54) and iron absorption in the blood is measured.


Eligibility Criteria:
Inclusion Criteria:

* Female aged between 18-45 years
* Normal BMI (18.5 - 24.9 kg/m2)
* Body weight \< 70 kg
* Low iron status (being in the lower half of the serum ferritin distribution at screening)

Exclusion Criteria:

* Anaemia (Hb \< 12 g/dL)
* Inflammation (CRP \> 5.0 mg/L)
* Pregnancy or intention to become pregnant during the study or within 30 days after the discontinuation of the study intervention
* Lactating up to 6 weeks before the study initiation
* Chronic digestive, renal and/or metabolic diseases
* Antibiotics in the last 4 weeks prior to the study and during the study
* Mineral and vitamin supplementation in the last 2 weeks prior to the study and during the course of the study
* Chronic medication intake (except for oral contraceptives)
* Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 4 months
* Earlier participation in a study using stable isotopes or in any clinical study within the last 30 days
* Food allergies, especially known hypersensitivity to crustacea, dust mites, sea food, gluten, milk, or eggs
* Cigarette smoking (\> 1 cigarette per day)
Energy Device Study in Transoral Endoscopic Thyroidectomy

Open label randomized controlled study, for Harmonic versus Ligasure in transoral endoscopic thyroid surgery.

* This is a prospective randomized controlled study. The principal investigator or another clinical investigator in charge will individually inform the patients about the study, on the day before surgery.
* When informed consent is obtained, an investigator in charge of randomization only, will randomize the patients.
* According to randomization, the experimental group will Ligasure and the control group will use Harmonic ACE 7+. Other than the randomized use of energy devices, the protocol for TOETVA is performed as usual.
* Operation time (from insertion of the laparoscopic camera to removal of the camera), number of times the camera was cleaned, intraoperative blood loss will recorded.
* Postoperative hospital stay, visual analog pain scale, blood cell count and inflammatory parameters, postoperative drain amount will recorded.
* Complications of thyroid surgery (vocal cord dysfunction, hypoparathyroidism) are compared for safety assessment.

Eligibility Criteria:
Inclusion Criteria:

* Patients who planned to transoral endoscopic thyroidectomy
* Age between 20 to 70
* Voluntarily consenting to the study and study agreement
* No local invasion or distant metastasis
* Normal vocal cord function in laryngoscopic exam
* No significant abnormalities in preoperative laboratory tests

Exclusion Criteria:

* Take aspirin or antiplatelet drugs within 7 days before admission
* Uncontrolled hypertension, diabetes, chronic renal failure, or coagulation disease
* History of cardiovascular disease (angina pectoris, heart failure, myocardial infarction, history of coronary artery disease, stroke, transient ischemic attack)
* Substance abuse and alcohol abuse
* History of esophageal and airway diseases
* Patient was participated in other clinical trials within 30 days
* History of neck irradiation or surgery
* History of severe drug allergies
* Pregnant or lactating women
Study of a Red Blood Cell Deformability Parameter in Patients With Sickle Cell Disease

Sickle cell disease is the most common genetic disease in the world. It results in the synthesis of an abnormal hemoglobin (HbS) which, in its deoxygenated form, polymerizes and causes structural changes in red blood cells (RBCs). They become more rigid and less deformable. The fragility of sickle-cell RBCs leads to their massive destruction, leading to chronic anemia (i.e. low hemoglobin in the blood) and to low tissue oxygenation. More rigid and less deformable, sickle-shaped RBCs tend to obstruct microvessels, leading to particularly painful vaso-occlusive crisis (VOC), which can cause organ failure (spleen, kidneys, brain, lungs, heart, liver, bone ...) and patient's lifethreatning. A preliminary work on red blood cells of sickle cell patients showed alteration of a parameter measuring the overall deformability of RBCs by assessing the nature of their movement in a shear flow. This parameter is altered sickle cell patients at basal state compared to a population of healthy individuals. This alteration is increased when sickle cell patients are in crisis.

The main objective of this project is to study the evolution of this parameter in sickle cell patients according to their health status (basal state vs vaso-occlusive crisis). The investigators hypothesize that the alteration of the RBC deformability parameter is significant before symptoms of vaso-occlusive crisis (several hours to several days). The main objective is a weekly analysis of the evolution of the parameter in 30 sickle cell patients (SS or SB°) in the basal state and daily in at least 6 patients at the beginning, during and just after a vaso-occlusive crisis. The comparison between the parameter measured in a subject in the basal state and in the same subject in crisis will be performed. The criteria for the presence of a vaso-occlusive crisis were: the appearance of a attacks of pain affecting at least two territories +/- fever\> 38.3 +/- dyspnea and / or sputum. The investigators will differentiate the moderate VOC managed at home with low-level analgesics and VOC requiring hospitalization. The number of days of hospitalization, the occurrence of thrombotic complications, the degree of anemia and hemolysis will be noted. The measurement of the parameter will be performed on a capillary sampling of 40 microliters performed at the fingertip, weekly outside crises and daily when a crisis occurs.


Eligibility Criteria:
Inclusion Criteria:

* Homozygous SS or SB° sickle cell patients
* Person without regular blood transfusion

Exclusion Criteria:

* Other general diseases
* Psychiatric disorder
* Alcoholics
* Minors
* Absence of informed consent
* Pregnant or lactating woman
* Person under guardianship
* Person living in a health or social institution
* Person in emergency
* Person out of healthcare system
* Person deprived of liberty
* Person who has received a blood transfusion in the previous 3 months
* Person with regular blood transfusion or in a blood transfusion program
Effect of Implementing Evidence Based Practices on Prevention of Associated Nasal Pressure Injuries Among Preterm Neonates With Non-Invasive Respiratory Support

This study aims to evaluate the effect of implementing evidence based practices on prevention of associated nasal pressure injuries among preterm neonates with non invasive respiratory support

The researchers explained the study's aim, benefits, and procedures for participation, after that the parents of the neonates provided an informed consent. Over a one-week period, staff education programs regarding Evidence-Based Guidelines for non-invasive respiratory support will be conducted for NICU nursing staff. These sessions, lasting 15 to 20 minutes, will be held during regularly scheduled work hours, with four different sessions will offer throughout the day. The preterm neonates' characteristics and clinical data will be extracted from their hospital records for the two groups on the first day of admission for both groups prior to intervention to identify those who fulfilled the current study's inclusion criteria. Neonatal baseline data was collected from their records on the first day of admission for the two groups prior to intervention in order to identify neonates who meet the required criteria of the study. Then the participants were selected and divided randomly (using a simple random method) into two equal groups. One subject for the control group, one for the study group and so on, distributed the participants into two equivalent groups as fellow:

Control Group: Consisted of 30 premature neonates who will receive conventional hospital care with no additional interventions.

Study Group: Consisted of 30 premature neonates who will receive 6 evidence-based practices on the prevention of nasal pressure injuries as follows:

* Use an appropriately sized nasal interface device.
* The Use of Skin Barrier Products between nasal skin and nasal interface device
* Visually examining the preterm newborn every hour to ensure appropriate nasal interface position
* Once every 12-hour shift, the protective barrier and nasal device are briefly removed to allow for a full nasal skin examination
* Follow developmental care principles by repositioning the infant every three to four hours.
* Pain scores should be taken at least every three to four hours.

Eligibility Criteria:
Inclusion Criteria:

* Preterm neonates receiving NIRS
* whose gestational ages ranges between 30 and 37 weeks, and both genders

Exclusion Criteria:

* all preterm neonates not receiving NIRS,
* have prior nasal trauma caused by tracheal intubation
* or Infants exhibiting evidence of nasal damage during the NIRS procedure,
* have upper respiratory abnormalities.
* preterm neonates who have undergone any type of surgery and had life-threatening congenital abnormalities.