cyrilzakka/clinical-trials huggingface dataset:
Usage of the Home Macular Perimeter (HMP)

Demonstrate the ability of the current interactive tutorial and 1-800 support to teach an AMD patient to use the HMP device.

The pilot study purpose is to demonstrate that the tutorial which is part of the device software, is giving sufficient training for the intended users.

Eligibility Criteria:
Inclusion Criteria:

* Capable and willing to sign a consent form and participate in the study
* Subjects diagnosed as intermediate AMD in at least one eye
* Age \>50 years
* VA with habitual correction \>20/60 in the study eye
* Ability to speak, read and understand instructions in Hebrew
* Familiar with computer usage

Exclusion Criteria:

* Evidence of macular disease other than AMD or glaucoma in the study eye
* Presence of any significant media opacity that precludes a clear view of the macular area as identified in the study eye by biomicroscopy, CFP.
* Any non-macular related ocular surgery performed within 3 months prior to study entry in the target eye
* Participation in another study with the exclusion of AREDS study
* Patients diagnosed with geographic atrophy (GA)
imPulse™ Una Full-spectrum, Over Clothing E-stethoscope

This study generates robust clinical data to train ML/AI algorithms of the Sponsor's imPulse™ Una full-spectrum e-stethoscope for digital diagnostic feature synthesis of symptomatic SARS-CoV-2/COVID-19 biosignatures for rapid and accurate mass screening.

This study is designed to evaluate the ability of the imPulse™ Una e-stethoscope to differentiate vibroacoustic signals in inpatients with and without confirmed COVID-19 as the first step to establish the performance characteristics - sensitivity, specificity, positive and negative predictive value - of the imPulse™ Una device for early and rapid, point-of-care diagnosis of COVID-19. This will inform the utility and design of further larger-scale studies using the device.

Eligibility Criteria:
Inclusion Criteria

* Individuals hospitalized within a Johns Hopkins-affiliated hospital
* Able to understand and willingness to comply with study procedures
* Cases - inpatients with positive COVID-19 PCR test, collected from a respiratory sample within the last 7 days, AND pulmonary symptoms within 72 hours of enrollment
* Controls - inpatients without COVID-19 diagnosis and no pulmonary diagnosis or symptoms
* Cases or Control not able to sit or stand will be allowed to participate in just the parts of the staircase exam they're capable of doing.

Exclusion Criteria

* Assisted ventilation, including high flow nasal cannula, or ventilator support
* Unable to comply with study procedures, defined at investigator's discretion
* Participants with any visible skin infections or open wounds in areas where the imPulse™ Una device would be applied
Umbilical or Peripheral Catheter Insertion for Preterm Infants on Admission to the NICU

Preterm infants are at risk of hypothermia following delivery and in the first few hours of life. Hypothermia in extremely low birth weight infants' is an independent risk factor for death. These infants' are at additional risk of hypothermia when they undergo procedures such as central catheter insertion following admission.

The investigators think that in extremely preterm infants, placing a peripheral intravenous cannula on admission to the NICU, instead of umbilical catheters (UVC and/or UAC), will increase the proportion of infants with a rectal temperature in the normal range at 2 hours of life.

Hypothermia is an independent risk factor for death in preterm newborns.(1) Despite measures to improve temperature in preterm newborns in the delivery room (DR), hypothermia on admission to the neonatal intensive care unit (NICU) at NMH is common. In a cohort of infants \< 32 weeks' gestation born at NMH in 2019, 54% of infants had a rectal temperature \< 36.5 oC on admission to the NICU.(2)

Many preterm infants have procedures performed soon after admission to the NICU; in 2019, 98% of infants born before 29 weeks' gestation at NMH had an umbilical venous catheter inserted. This may/often involve(s) prolonged periods of handling and potential exposure to cold.

The investigators prospectively studied a cohort of 26 infants \< 32 weeks who had invasive procedures within 3 hours of birth performed in the NICU at NMH between November 2018 and June 2019. Almost three-quarters \[19/26 (73%)\] had an abnormal temperature at the beginning of the procedure; and 17/26 (65%) had an abnormal temperature at the end of the procedure. Only 3 (11%) infants maintained a normal temperature throughout the procedure. Perhaps more concerning is the severity of the hypothermia observed; 13 (50%) infants had a temperature \< 36.0oC before and 11 (42%) after the procedure. The median duration of procedure was 53 (37, 73) minutes.(3)

The investigators think that in extremely preterm infants, placing a peripheral intravenous cannula on admission to the NICU, instead of umbilical catheters (UVC and/or UAC), will increase the proportion of infants with a rectal temperature in the normal range at 2 hours of life.

Eligibility Criteria:
Inclusion Criteria:

* inborn infants admitted to the NICU with;
* gestational age \< 29 weeks (up to 28+6 weeks) OR
* birth weight \< 1250g.

Exclusion Criteria:

* end of life (palliative) care
* large abdominal wall defects
* imperforate anus.
Plasma Copeptin Levels in Children With Diabetic Ketoacidosis

Children with diabetic ketoacidosis risk neurological complications such as cerebral edema with high morbidity. To prevent cerebral edema, it is essential to control correction of hypovolemia, hyperglycemia and natremia. Markers usually used in management of diabetic ketoacidosis don't always permit an optimal care.

Plasma copeptin levels reflect vasopressin secretion which is high in diabetic ketoacidosis.

Therefore, monitoring of plasma copeptin levels could be of interest in children with diabetic ketoacidosis and risk of sévère neurological complications.

Biological risk factors for severe complications in diabetic ketoacidosis are described (high blood glucose level, metabolic acidosis, high blood urea nitrogen, hypernatremia) but their dosage and monitoring are not sufficient to distinguish high risks situations.

Several studies suggest that vasopressin secretion is increased in diabetic ketoacidosis. This high level could be important in occurrence of cerebral edema. Monitoring of vasopressin levels could then have an interest in patients at risk of severe complications but reliability of copeptin dosage depend of collection conditions and its packaging. These conditions are difficult to ensure and copeptin dosage, which represent vasopressin secretion, is easier to perform.

Copeptin dosage could then be a new biological marker, more accurate and specific, for an optimal management of diabetic ketoacidosis.

This type of study has never been carried out neither in children nor in adults.

Eligibility Criteria:
Inclusion criteria:

* Children between 6 months and 16 years
* Diagnosis of diabetes mellitus type 1 (cardinal syndrome, blood glucose level \> 7 mmol/L in the fasted state or \> 11 mmol/L not in fasted state, no signs for another type of diabetes mellitus)
* Children who need an exclusive intravenous rehydration for 36 hours
* Written informed consent of legal representative and of the child if possible
* Beneficiary of State Social Insurance

Exclusion criteria:

* Child under the age of 6 months or older than 16 years
* Non exclusive intravenous réhydration for at least 36 hours
* Child moved from another institution and for whom an intravenous rehydration or insulin therapy have already begun
* Non type 1 diabetes mellitus
* Non affiliation to State Social Insurance
Rolled Pericardium Versus Cryopreserved Allograft to Treat Native or Prosthetic Aortic Infection

While surgery with anatomic reconstruction of prosthetic aortic infections and native infectious aortitis has become established over time, the ideal substitute is not clearly defined. The cryopreserved arterial allograft (AAC) recognized as resistant to infections not only presents availability problems making its use complicated, particularly in emergencies, with a certain number of long-term aneurysmal developments. The tubulized pericardium patch (PP), available in all cases, seems to give promising results in recent literature. The investigators propose a comparative study of these two substitutes in this indication.

We carried out a two-center observational study including retrospectively from January 2010 to July 2023 all patients operated on for aortic prosthesis infection and native infectious aortitis with AAC reconstruction and prospectively PP patch reconstructions from July 2018 to July 2023. The diagnosis of infection was established according to the MAGIC criteria. The patients' preoperative comorbidities were collected to compare the groups. Postoperative morbidity and mortality was then compared. The medium-term evaluation consisted of comparing according to the Kaplan Meier method: postoperative mortality, permeability, reinfection rate, reoperation rate.


Eligibility Criteria:
Inclusion Criteria:

* All aortic intervention performed for native aortic infection reconstruction with patch or allograft
* All aortic intervention performed for infected graft reconstruction with patch or allograft

Exclusion Criteria:

* no
The Cohort Study of the Correlation Between Serum 25(OH)D Level and Pregnancy Outcome

The objective of this single-center prospective observational study is to clarify the trend of maternal serum 25(OH)D levels before pregnancy and during pregnancy, and to explore the correlation between serum 25(OH)D levels and subsequent pregnancy outcomes of patients with abortion, so as to provide certain scientific evidence for finding the optimal serum level of 25(OH)D and optimal vitamin D supplementation to maintain a healthy pregnancy.

Women of reproductive age who meet the inclusion criteria are recruited from the outpatient department of Renji Hospital from November 2022 to December 2023. Subjects fill in the basic information at the outpatient clinic. After being included in the study, peripheral blood is collected before and during the first trimester (\< 10 weeks), second trimester (22-24 weeks) and third trimester (32 weeks) to detect 25(OH)D, calcium, phosphorus and PTH levels. B-ultrasound examination is performed before pregnancy to record endometrial thickness, endometrial hemodynamic index (PI, RI and S/D) and uterine arterial hemodynamic index (PI, RI and S/D) during the luteal phase. Data are comprehensively analyzed through questionnaire form filling, laboratory examination, and clinical information records including pregnancy outcomes (final live birth rate, cesarean section rate, pregnancy loss rate, etc.), obstetric complications, and neonatal delivery information.

Eligibility Criteria:
Inclusion Criteria:

* ≥20 years old
* The chromosome karyotype of the couple is normal
* Color ultrasound examination results indicated that there was no organic disease related to reproductive tract
* No serious complications of surgery and medicine
* Agree and voluntarily sign informed consent

Exclusion Criteria:

* There are contraindications to pregnancy
* the initiative to give up pregnancy
* Severe medical and surgical complications, for example, liver disease was defined as serum alanine aminotransferase \[ALT\] or aspartic aminotransferase \[AST\]\>3 x upper normal limit \[ULN\] after repeated testing
* Concomitant malignant tumor, malignant tumor developed in the last 5 years (except for the skin squamous basal cell carcinoma that has been removed and considered cured). Subjects who developed malignant tumors more than 5 years ago should provide evidence of remission or cure. Subjects with a history of cervical cancer were eligible if they could demonstrate that their cervical cancer had been cone removed or cured within the past 3 years
* Known human immunodeficiency virus (HIV) positive and/or hepatitis B surface antigen or hepatitis C virus antibody positive at screening visit
* With a history of chronic infections such as mycoplasma, chlamydia, cryptococcus, and invasive fungal infections should be discussed with the principal investigator
Recognition and Treatment of Dysglycemia. AGS - Acute Glucose Service

AGS (Acute Glucose Service ) is an inpatient glucose management service consisting of Nurse Practitioner and physician. Team manages not - consulted- based preoperative assessment, perioperative glucose control, patient education and supervision, but also transition of care postoperatively. The goal is to detect and treat dysglycemias , but also provide an active and constantly ongoing education to other hospital teams.

AGS improves better overall- survival of arthroplastic patients and is an effective way to recognize and treat dysglycemias and to organize constantly ongoing education.

600 elective knee and hip arthroplastic patients are collected. 200 patients before AG- service will be compared to 400 patients after AGS. The latter group is divided to two 200 patients groups: 1) with AGS 2) with AGS extended to first control in 3 months (AG- nurse may be contacted by phone). Patients are followed up up to 5 years. Controls will be held after 3 months, 1 year and 5 years after operation including B-Hba1c, 15 D Quality of life assessment and patient interview.

There are several aims of the team and study: to detect, diagnose and optimize treatment (including medication) of diabetic/ dysglycemic patients from preoperative assessment 1 week before operation to postoperative care. With blood glucose target 42 - 86 mmol/mol results better overall survival, lesser complications (i.e. infections, cardiovascular or renal complications) and shorter length of hospital stay. Other aim is to find undiagnosed diabetics or those at risk of developing diabetes. One aim is to find risk factors, which lead to stress hyperglycemia during perioperative period or diabetes in 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged \> 18 years
* Elective knee and hip arthroplasty patients

Exclusion Criteria:

* Patients who are incompetent to give informed consent
* Patients who are incompetent to assess their Quality-of-Life personally
Evaluation of the Relationship Between Breastfeeding Attitudes and Nutrition Knowledge Levels

The importance of breast milk, whose physiological nutritional properties for an infant are not equal to any other food, has been the subject of many studies. In this study, it is aimed to evaluate the relationship between breastfeeding attitude and nutritional knowledge levels of mothers who have 0-6 months infants.


Eligibility Criteria:
Inclusion Criteria:

* volunteering
* Having a baby 0-6 months

Exclusion Criteria:

* not breastfeeding
* Being a pregnant
Retrospective Study of the Biomechanical Properties of Large Allografts

Primary Objectives:

1. To evaluate the material properties, histomorphometric indices, bone mineral density (BMD), and presence of microfractures in retrieved large allograft cortical bone specimens removed from orthopaedic oncology patients.
2. To correlate physical properties to patient demographics and medical treatment received.

Allograft Surgery:

As a standard of care, you will be having surgery to remove allograft tissue that has failed or because there were other complications following your earlier transplant. You will be separately consented for this surgery, which will describe the procedure and its risks in detail.

Tissue Research:

If you agree to take part in this study, leftover sample of the removed allograft bone will be collected and used to learn about the properties (such as bone strength, bone density, and new bone formation) of the removed transplant tissue. This tissue will be stored at the University of Arkansas for use in this study. Any remaining leftover tissue will be destroyed by the end of December 2011.

Data Collection:

Before you have surgery, you will have an x-ray. This is also part of standard of care. If you take part in this study, this x-ray will be used to learn about the properties of the transplant tissue.

All other information will be coming from your medical record, either from your past visits or as a result of your surgery. The information being collected will include information about your graft during the time it was within your body and observations made by your surgeon at its removal.

Length of Study:

Your participation in this study will be over after your tissue and data are collected.

This is an investigational study. Up to 200 patients will be enrolled on this multicenter study. Up to 20 will be enrolled at M. D. Anderson.

Eligibility Criteria:
Inclusion Criteria:

* Patients that require retrieval of a previously implanted large allograft.

Exclusion Criteria:

* None
An Inpatient Study Of The Efficacy, Safety, And Tolerability Of PF-02545920 In The Treatment Of Acute Exacerbation Of Schizophrenia

This study aims to evaluate whether PF-02545920 is safe and effective in the treatment of acute exacerbation of schizophrenia during a 4-week inpatient treatment period. The study will use the Positive and Negative Syndrome Scale (PANSS) to measure change in symptoms for PF-02545920 compared to risperidone and placebo treatment.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia with acute exacerbation of illness
* The current acute exacerbation of schizophrenia must be less than 4 weeks duration prior to the initial evaluation.

Exclusion Criteria:

* Subjects with evidence or history of clinically significant uncontrolled medical illness
* Subjects with a current diagnosis of schizoaffective disorder, major depression, bipolar disorder, or obsessive compulsive disorder.
* Subjects who meet Diagnostic and Statistical Manual-IV (DSM-IV)defined diagnostic criteria for psychoactive substance dependence (excluding nicotine dependence) within 12 months of screening or DSM-IV defined substance abuse within 3 months prior to screening.
Management of Acute Bronchitis With Pelargonium Sidoides Extract

The aim of our study is to conduct a pragmatic RCT meeting all required standards to evaluate the effectiveness of Pelargonium sidoides extract, EPs® 7630, in the management of acute bronchitis with or without COVID-19 in PCP practices and walk-in clinics in French-speaking Switzerland. The RCT will be preceded by a pilot phase to ensure its feasibility.

The goal of this clinical trial is to evaluate the effectiveness of Pelargonium sidoides extract EPs® 7630, also known under the brand name Kaloba®, in the management of acute bronchitis.

The main questions it aims to answer are:

* Is Pelargonium sidoides extract EPs® 7630 effective to reduce the severity and the duration of symptoms related to acute bronchitis ?
* Does Pelargonium sidoides extract EPs® 7630 allow to reduce the prescription of antibiotics?

Participants will be randomize 1:1 either in the control group (usual care) or in the intervention group (Pelargonium sidoides extract EPs® 7630).

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (aged 18 and over) consulting for the first time, for the same episode, either for an acute cough (≤8 days) as the main symptom, suggestive of acute bronchitis, or for an illness (≤8 days) in which cough is not the main symptom but PCP believes that acute bronchitis is the most likely diagnosis.
* Patients tested positive to COVID-19 who meet the above-mentioned criteria will be included too.

Exclusion Criteria:

* Infection requiring antibiotic treatment (ex. cystic fibrosis)
* Pneumonia
* Known hypersensitivity to Pelargonium sidoides extract or excipients of the trial medication
* Non-infectious causes (COPD, asthma, pulmonary embolism, heart failure, gastroesophageal reflux, allergy)
* Lacking the faculty of discernment (for example: dementia, decompensated psychosis or severe depression)
* Inability to fill out the diary (no ability to read and understand French)
* Pregnancy or breastfeeding
* Immunological deficiencies
* Hospitalization
* Severe hepatic disease
* Patients who have already started a treatment with Pelargonium sidoides EPs® 7630 for this current episode (Kaloba®, Umckaloabo®)
* Important risk of bleeding (severe thrombocytopenia and anticoagulant intake)
* If the patient is taking a drug among these classes of drugs:

anticoagulants, immunosuppressants, chemotherapy or immunotherapy
Study on the Impact of Desk and Chair Adaptation Intervention on the Occurrence and Development of Myopia in Primary School Students

This study is a randomized controlled trial of a desk and chair adaptation intervention involving primary school students and their parents or primary caregivers. We compared the myopia status of students in the intervention and control groups before and after the intervention to confirm the effect of the desk and chair adaptation intervention on the development of myopia in students.

In this study, two pilot schools in Anhui Province were selected , and all students were examined by ophthalmologists, and their heights and the heights of their desks and chairs were measured in order to investigate the association between desk and chair adaptations and myopia. One of the elementary school was randomly selected for a one-year desk and chair adaptation intervention to compare the occurrence of myopia and axial growth of the students before and after the intervention in the two schools.

Translated with DeepL.com (free version)

Eligibility Criteria:
Inclusion Criteria:

* Students and their families were informed and voluntarily participated in the study, with parents signing the informed consent form.
* Able to cooperate with eye examinations and questionnaires.

Exclusion Criteria:

* Communication barriers, unable to cooperate.
* Strabismus, amblyopia, or any other ocular or systemic diseases that may affect refractive development.
* Children currently using orthokeratology lenses or rigid contact lenses.
* Using other interventions (such as acupuncture, massage, medication, ear acupuncture, etc.) to control myopia, apart from school eye exercises.
Analgesic Control Following Knee Arthroscopy

This study aims to investigate the analgesic effects offered by bupivacaine and Durolane (a hyaluronic acid supplement) administered immediately following the completion of knee arthroscopy.

There is increasing evidence of the toxic effects of intraarticular administration of local anaesthetic. Hyaluronic acid supplementation given at the time of knee arthroscopy has not been fully evaluated as a possible alternative. We have studied the efficacy of a hyaluronic acid (HA) supplement (Durolane®) and a local anaesthetic (Bupivacaine) at providing early and short-term post-operative analgesic control following knee arthroscopy.Patients will be randomised to receive either 10mls of 0.5% Bupivacaine or 10mls of Durolane® into the joint immediately after completion of surgery. WOMAC and Tegner-Lysholm scores were obtained at baseline then at 1, 2, and 6-weeks post surgery. VAS pain scores were obtained at baseline; 1 and 24-hours; and 1, 2 and 6 weeks following surgery.

Eligibility Criteria:
Inclusion Criteria:

* those undergoing knee arthroscopy for: diagnostic purposes, removal of loose bodies, articular cartilage debridement or, meniscectomy
* age over 18 years

Exclusion Criteria:

* American Society of Anaesthesiologists (ASA) grade ≥3;
* arthroscopic assisted osteotomies;
* a history of two or more prior procedures on the ipsilateral knee;
* post-operative morbidities indirectly linked to the procedure (e.g. anaesthetic complications, DVT or PE);
* systemic steroid requirements;
* previous intra-articular anaesthetic or steroid injection within the last three months;
* intra-articular HA injection within the last nine months;
* intra-articular sepsis within the previous three months;
* prior history of knee arthroplasty, peri-articular fracture, ligamentous instability, inflammatory arthritis or a previous diagnosis of Complex Regional Pain Syndrome.