cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Program for Length Based Weight Estimation

The purpose of this prospective single center study is to investigate if a developed program is more accurate than the anesthesia tape ("Anästhesie-Lineal"). For this study 1000 patients are required to collect anonymized data (length, weight, age, anesthesia material used during anesthesia) for achieving a power of 80% during statistical analysis. The main hypothesis ist that the program has a better accuracy than the anesthesia tape ("Anästhesie-Lineal").

This prospective single center study is performed at the university children's Hospital zurich. Patients planned for surgery in general anesthesia with intubation, aged 0 to 16 years and with a body length suitable for the emergency tapes can be included in this study. Patient and parental information is performed during the pre-anesthetic visit. After written consent the patient will be included. Patient ́s length and weight will be measures earliest one day before data collection. Data collection during anesthesia has no influence on the daily anesthesia routine and has no impact on patient safety and anaesthesia. Patient's data is made anonymous for further inspection. Data is documented in Microsoft Excel and statistical analysis calculated with SPSS. 1000 patients are needed for a power of 80%. Primary outcome parameter is length based weight estimation, secondary outcome parameters are length based age estimation and the correctness of recommended anesthesia material (endotracheal tube, laryngeal mask, oropharyngeal mask and face mask). Both tools (program and anesthesia tape \["Anästhesie-Lineal"\]) will be compared with each other regarding primary and secondary outcome parameters.

Eligibility Criteria:
Inclusion Criteria:

* body length suitable with the investigated emergency tapes
* all patients aged 0 -16 years
* receiving general anesthesia with intubation or laryngeal mask

Exclusion Criteria:

* Already included in this study once
* missing patient or parental consent
SNIFF - 3-Week Aptar CPS Device

The SNIFF 3-Week Aptar Device study will involve using a device to administer insulin or placebo through each participant's nose or intra-nasally. Insulin is a hormone that is produced in the body. It works by lowering levels of glucose (sugar) in the blood. This study is measuring how much insulin the device delivers. In addition, this study will look at the effects of insulin or placebo administered intra-nasally using an intranasal delivery device on memory, blood, and cerebrospinal fluid (CSF).

The proposed study will examine whether an intranasal delivery device can be used by adults with preclinical Alzheimer's disease (cognitively normal but with abnormal brain levels of the hallmark peptide Aβ) to reliably deliver insulin or placebo four times daily over a 4 week period. We will also examine effects of treatment on cognition, CSF biomarkers, and cerebral perfusion. If successful, information gained from the study will inform the design of future Phase III trials of intranasal insulin.

Eligibility Criteria:
Inclusion Criteria:

1. Age 55 to 85 (inclusive)
2. Fluent in English
3. Cognitively normal or diagnosis of amnestic mild cognitive impairment (aMCI) or mild Alzheimer's disease (AD)
4. Amyloid positive by positron emission tomography (PET) or cerebrospinal fluid (CSF) criteria
5. Stable medical condition for 3 months prior to screening visit
6. Stable medications for 4 weeks prior to the screening and study visits (exceptions may be made on a case by case basis by the study physician)
7. Clinical laboratory values must be within normal limits or, if abnormal, must be judged to be clinically insignificant by the study physician

Exclusion Criteria:

1. A diagnosis of dementia other than Alzheimer's disease (AD)
2. History of a clinically significant stroke
3. Current evidence or history in past two years of epilepsy, head injury with loss of consciousness, any major psychiatric disorder including psychosis, major depression, bipolar disorder
4. Diabetes (type I or type II) insulin-dependent and non-insulin-dependent diabetes mellitus
5. Current or past regular use of insulin or any other anti-diabetic medication within 2 months of screening visit
6. History of seizure within past five years
7. Pregnancy or possible pregnancy
8. Use of anticoagulants
9. Residence in a skilled nursing facility at screening
10. Use of an investigational agent within two months of screening visit
11. Regular use of alcohol, narcotics, anticonvulsants, anti-parkinsonian medications, or any other exclusionary medications (exceptions may be made on a case by case basis by the study physician)
Effects of Low Protein Diet Supplemented Keto-/Amino Acid in Preventing the Progression of Chronic Kidney Disease (CKD)- ELPD Study

The purpose of this study is to determine whether low protein diet and very low protein diet supplemented keto-/amino acid is effective in preventing the progression of chronic kidney disease (CKD , stage 3b and 4).

Dietary protein restriction represents a basic therapeutic approach in chronic kidney disease(CKD), by reducing the accumulation of nitrogen catabolic substances, and by delaying the progress of CKD and proteinuria, but the effects of the different degree's protein diet on the renal progression remain to be determined.

The aim of this study is to evaluate the efficacy of low protein diet and α-keto acid tablet in retard the progress of CKD. This is a randomized, open-label, prospective study, 120 patients who meet inclusion and exclusion criteria will be randomized into three groups at the ratio of 1:1:1. Group I patients will receive low protein diet(0.6g/kg BW), group II will receive low protein diet supplemented with α-keto acid, while group III will take very low protein diet(0.3g/kg BW) supplemented with α-keto acid. The changes of glomerular filtration rate in CKD will be evaluated after 1 year treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic kidney disease in stage 3b and 4(15ml/min/1.73m2\<GFR\<45 ml/min/1.73m2, estimated by EPI formula) receiving conservative treatment for CKD

Exclusion Criteria:

* With diagnosis of diabetic mellitus;
* Incapable of following study requirements to control diet;
* Glomerular filtration rate \< 15 ml/min/1.73m2;
* Hypercalcemia or hyperkalemia (\> normal upper limit);
* Other serious disease(eg.heart,lung,brain) within the last 3 months;
* Cardiac failure stage IV NYHA;
* With cirrhosis of liver or obvious symptoms of liver diseases, ALT or AST two times normal upper limit;
* Severe edema or serous cavity effusion;
* Drug abuse;
* Final diagnosis of malignant tumor;
* Receiving the long-term systematic steroid hormone or immunosuppressive agents(eg. Cyclophosphamidum,Cyclosporine, Prograf,Azathioprine) treatment;
* Gestation already, prepares to be pregnant in the period of the trial, lactating women;
* Participate in other product clinical trial within 30 days prior to this trial
Comparison Between Positive and Negative sUPP

Urodynamic stress incontinence is a prevalent condition among women, characterized by involuntary urine leakage during activities that increase intra-abdominal pressure, such as coughing, sneezing, or physical exertion. Stress urethral pressure profile measurement is an important diagnostic tool used during urodynamic studies to assess urethral function. In some women with urodynamic stress incontinence, involuntary urine leakage occurs during this measurement, yet the clinical and urodynamic significance of this leakage remains unclear. This study aims to elucidate the differences in clinical and urodynamic findings between women with urodynamic stress incontinence who experience involuntary urine leakage during stress urethral pressure profile measurement and those who do not. Between July 2009 and December 2023, a total of 481 women with urodynamic stress incontinence were included and divided into positive and negative sUPP groups. The medical records, including urodynamic study, 3-day bladder dairy and questionnaires regarding lower urinary tract symptoms were reviewed.

Hypothesis / aims of study Involuntary urine leakage has been observed during stress urethral pressure measurement in women with urodynamic stress incontinence (USI). However, to our knowledge, its clinical significance and urodynamic association remained undetermined. Therefore, the objective of this study is to elucidate the above differences between those with versus without involuntary urine leakage during the measurement of stress urethral pressure in women with USI.

Study design, materials and methods Between July 2009 and December 2023, medical records, including urodynamic data, bladder dairy data and questionnaires, including patient perception of bladder condition (PPBC), urgency severity scale (USS), overactive bladder symptom score (OABSS), urogenital distress inventory (UDI-6), incontinence impact questionnaire (IIQ-7), and King's Health Questionnaire (KHQ), of all women with USI were reviewed to see if there was any involuntary leakage of urine during stress urethral pressure measurement.

STATA software was used for statistical analysis. The Wilcoxon rank sum test or the Chi-square test were used for statistical analysis, as appropriate. A p \< 0.05 was considered statistically significant. Linear regression analysis was also performed with an adjustment of overactive bladder syndrome (OAB) to elucidate the real clinical and urodynamic associations about the leak during stress urethral pressure measurement.

Eligibility Criteria:
Inclusion Criteria:

* \>20 y/o
* Women with lower urinary tract symptoms
* Received urodynamic stress incontinence and was diagnosed with urodynamic stress incontinence

Exclusion Criteria:

* Women who are pregnant
* With chronic pelvic inflammatory disease
International Study of Cerebral Oxygenation and Electrical Activity During Major Neonatal Surgery

The goal of this observational study is to determine the incidence of perioperative cerebral desaturation in neonates undergoing surgery for congenital malformations. The main questions it aims to answer are:

1. The perioperative factors associated with occurrence of cerebral desaturation
2. The association between perioperative cerebral desaturation, perioperative/hospital outcomes, and physiological conditions.

Participants will undergo Near-infrared spectroscopy (NIRS) and electroencephalogram (EEG) monitoring for one hour before surgery, during surgery, and up to 24 hours after surgery.

The NIRS EEG sensors will be placed about an hour before surgery. The recording will start once sensors are placed, continue throughout the duration of surgery, and end 8-24 hours after end of surgery. Sensors will be removed at the end of recording. No additional anesthesia and/or sedation will be required for the preoperative and postoperative recordings. The EEG and NIRS monitors will be blinded to clinical staff. EEG and NIRS monitoring will not prolong anesthesia or the duration of the surgical repair, and should not interfere with routine patient care. NIRS and EEG data will be downloaded from the monitors at the end of recording for analysis.

Medical record review will be conducted at 100 days postop or hospital discharge (whichever is sooner). The information below will be extracted:

* Respiratory record
* Post-op recovery, ICU, and discharge records
* Cardiac and Neurologic records
* Neurologic test such as radiology and lab tests
* Mortality status

Eligibility Criteria:
Inclusion Criteria:

1. Infants ≤ 60 weeks post-menstrual age on day of surgery.
2. Neonatal surgery for congenital abdominal/gastrointestinal malformations (diaphragmatic hernia, gastroschisis, omphalocele, intestinal atresia, Hirschsprung's disease, imperforate anus, necrotizing enterocolitis), congenital cystic adenomatoid/pulmonary airway malformation (CCAM/CPAM), esophageal/tracheoesophageal fistula (EF/TEF), and spinal malformations (myelomeningocele, sacrococcygeal teratoma).
3. The same patient may be enrolled multiple times for repeat or different procedures that meet the above criteria. These subjects will be counted more than once towards the enrollment goal.
4. Parental/guardian permission.

Exclusion Criteria:

1) Patients with hydrocephalus limiting frontal-parietal brain volume, interventricular hemorrhage (grades 3 or 4), malformation or cerebral infarction of frontal-parietal brain.
Can Contrast-Enhanced Spectral Mammography Improve the Accuracy of a Diagnosis

The purpose of this study is to test whether contrast-enhanced spectral mammography (CESM) may be able to reduce the number of unnecessary biopsies in women whose screening mammograms had abnormal findings.


Eligibility Criteria:
Inclusion Criteria:

* Women called back from a screening mammography by either FFDM or tomosynthesis with soft tissue abnormalities including masses, asymmetries, focal asymmetries or architectural distortion with or without calcifications. Patients will be questioned regarding the possibility of pregnancy and will need a negative pregnancy test prior the study intervention.

Exclusion Criteria:

* Age \<30 years old
* Screening mammography with only calcifications abnormalities
* Male patients
* Pregnant or lactating patients
* Patients with any allergy to iodinated contrast
* Patients with eGFR \< 45
* Patients that may be treated with radioactive iodine
Convalescent Plasma Treatment in Severe 2009 H1N1 Infection

Treatment of severe 2009 H1N1 infection with convalescent plasma will reduce mortality.

Patients presented with severe 2009 H1N1 infection responded poorly to antiviral agents. Meta-analysis of reports from 1918 H1N1 pandemic suggested that convalescent plasma might be an effective treatment option for patients with severe 2009 H1N1 infection.

Eligibility Criteria:
Inclusion Criteria:

* adult patients ≥ 18 years old with written informed consent given by patient or next-of-kin
* laboratory confirmatory diagnosis of 2009 H1N1 infection by positive RT-PCR from respiratory specimens
* required intensive care within 7 days of onset of symptoms

Exclusion Criteria:

* age 18 years old or below
* known hypersensitivity to immune globulin
* known IgA deficiency
Magnetic Resonance Imaging (MRI) Staging of Cervix Cancer

The researchers propose that it may be corpus invasion, rather than tumour volume per se, which is one of the important determinants of ultimate outcome in cervix cancer. The aim of the proposed prospective, multicentre study, is to confirm the results of our retrospective studies, specifically that corpus invasion or tumour volume or both contribute important prognostic information over and above that provided by the currently used International Federation of Gynecology and Obstetrics (FIGO) staging system. A successful outcome would have important implications for the staging, and management as well as the biologic understanding of the behaviour of cervical cancer.

This will be a prospective, multicentre, prognostic factor, follow-up study. The study is designed to be as simple as possible: newly diagnosed cervical cancer patients will have key prognostic variables collected at baseline. The treatment received will be documented at the end of treatment and patients will then be followed for first relapse and survival.

Registration of a patient on this study can be undertaken after EUA, biopsy confirmed diagnosis, anatomic staging diagram and MRI have been done and before any treatment has commenced.

Treatment must be curative in intent (termed radical therapy) but otherwise can be at the discretion of the investigator. Radical hysterectomy alone, hysterectomy followed by adjuvant radiotherapy, radical chemo-radiotherapy or radical radiotherapy will be allowed. Details of the planned and given treatment regimen will be recorded.

All patients will have the following trial data documented at the time of registration:

* Age
* ECOG performance status
* smoking status
* date of histological diagnosis
* histologic type and features
* presenting haemoglobin
* standard FIGO staging
* maximum clinical tumour diameter measured at EUA
* detailed staging diagram drawn at EUA
* nodal status (by surgical pathology or CT or MRI or both and PET if available)
* date of MRI
* MRI tumour diameters
* presence or absence of corpus invasion on MRI
* planned treatment details

All patients will be assessed pre-treatment, immediately following treatment and will be followed up for local control and survival at yearly intervals from the date of registration.

It is intended to collect follow up information on all patients until one year after the final patient is registered on study.

Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed, biopsy proven carcinoma of the uterine cervix.
2. Squamous cell, adenocarcinoma, adenosquamous or large cell carcinoma histology.
3. FIGO Stage Ib -IVa.
4. Maximum clinical tumour diameter recorded.
5. MRI done within 30 days prior to registration.
6. Intention to treat radically
7. Treatment not yet started.
8. Written informed consent.
9. Available for follow-up.

Exclusion Criteria:

1. Lymphoma, small cell carcinoma and melanoma histology.
2. Previous hysterectomy
3. Pregnancy
Surveillance Study to Estimate the Proportion of Rotavirus Gastroenteritis in Children < 5 Years of Age in Romania

The purpose of this hospital based study is to estimate the proportion of rotavirus gastroenteritis in children \< 5 years of age in Romania.

The study consist of a main study and a health economics study

Main study: The study will focus on three different groups of patients:

* Subjects who are hospitalised for acute gastroenteritis.
* Subjects who visit an emergency room for acute gastroenteritis.
* Subjects who have rotavirus positive laboratory results and developed acute gastroenteritis at least 48 hours after hospitalisation.

Health economics study: for a subset of subjects, additional economic data will be gathered by completing a questionnaire

Eligibility Criteria:
Inclusion Criteria:

* A male or female child aged \< 5 years at the time of admission. A child becomes ineligible on the day of her/his fifth birthday.
* A subject, who during the study period:

  * Is hospitalised for acute gastroenteritis Or
  * Visits an emergency room for acute gastroenteritis Or
  * Has rotavirus positive laboratory results and develops acute gastroenteritis at least 48 hours after hospitalisation

Exclusion Criteria:

Not applicable
Metformin for Prevention Gestational Diabetes in Pregnant Women With Polycystic Ovarian Syndrome

Randomized, placebo controlled clinical trial that evaluate the role of taking metformin therapy during pregnancy in women with polycystic ovarian syndrome(PCOS) in reducing the development of gestational diabetes(GDM) and improving pregnancy outcomes.

The study will include a total of 80 pregnant women who fulfill the inclusion and exclusion criteria. Participants will be distributed into two groups :

Group A: Active one (40 women) will receive metformin in a dose of 1500mg per day (500mg every 8hrs in the middle of meal), starting from 12th week of gestation till delivery.

Group B: control group (40 women) will receive placebo which will be folic acid 500 micro gram which looks like metformin tablet.

80 opaque envelope will be numbered serially from 1-80, in each envelope paper containing the group to which the participants will be allocated according to randomization table .The envelopes will be put in one box and when the first patient arrives the first envelope will be open and the patient will be allocated according to the paper inside.

Detection of glucose intolerance will be done using oral glucose tolerance test (OGTT), which based on 75 gm to exclude any case of pre-gestational DM. BMI and blood pressure will be also assessed for all cases at entry of the study.

Follow up of all cases in antenatal care clinic, with clinical assessment including weight gain, blood pressure, urine examination for proteinuria and fetal well being tests.

Detection of development of GDM or even glucose intolerance will be by using (OGTT), which based on 75 gm glucose between 24th-28th wk and also can be repeated between 32th- 34th wk of pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* All women had confirmed diagnosis of PCOS before pregnancy according to revised 2003 Rotterdam criteria.
* Age more than 20 and more than 40 years.
* BMI ranging from (25_35 )
* Written and signed informed consent is given from the patient to participate in the study.

Exclusion Criteria:

* Women with pre-gestational diabetes mellitus confirmed by 2hrs OGTT.
* Patients who take metformin in the first 12 wk of pregnancy.
* Patients who are unwilling to participate in the study.
Selection of Aspheric Diffractive Multifocal Intraocular Lens (IOLS) Based on Corneal Wavefront

Given the availability of aspheric diffractive IOLs with varying negative spherical aberration it may be feasible, by selecting the best fit IOL, to minimize aberrations and thereby maximize visual performance.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Scheduled to undergo bilateral cataract or refractive lens surgery
* Visual potential of 20/30 or better in each eye after lens removal and IOL implantation
* Naturally dilated pupil size (in dim light) \> 3.5 mm (with no dilation medications) for both eyes
* Preoperative regular corneal astigmatism of 2.5 D or less
* Clear intraocular media other than cataract
* Availability, willingness, and sufficient cognitive awareness to comply with examination procedures

Exclusion Criteria:

* Ocular disease other than cataract which could potentially limit uncorrected visual acuity or visual performance.
* Astigmatism not correctable by limbal relaxing incisions (greater than 2.5 D)
* Use of systemic or ocular medications that may affect visual outcomes
* Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus, immunocompromised, etc.)
* Uncontrolled systemic or ocular disease
* History of ocular trauma or prior ocular surgery
* Amblyopia or strabismus
* Known pathology that may affect visual acuity; particularly retinal changes that affect vision (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.)
* Diagnosed degenerative visual disorders (e.g. macular degeneration, or other retinal disorders) that are predicted to cause future acuity losses to a level of worse than 20/30
* Subjects who may be expected to require retinal laser treatment or other surgical intervention
* Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome)
* Pupil abnormalities (non-reactive, tonic pupils or abnormally shaped pupils)
* Contact lens usage within 6 months for PMMA lenses, 1 month for gas permeable lenses or 1 week for extended-wear and daily-wear soft lenses
* Requiring an intraocular lens power \<15.0 or \>26.0 diopters