cyrilzakka/clinical-trials huggingface dataset:
Post Intubation Laryngeal Hazards in Children in the Pediatric Intensive Care Unit

this study aims to detect the effect of endotracheal intubation on the larynx of the pediatric population in order to allow early detection of any hazards

Laryngeal lesions in children can be caused by a number of risk factors, including patient variables (prematurity, cardiac comorbidities), intubation method (in an emergency, by an unskilled team), and endotracheal tube use. (large size, cuffed tube), longer duration of intubation, infection, and insufficient patient sedation are just a few risk factors that can contribute to the development of laryngeal lesions in children. Endoscopic imaging of the larynx is essential in pediatric intubation-related laryngeal injuries since the intensity of symptoms may not necessarily be correlated with the extent of laryngeal injury that is actually present. Therefore, after intubation, we will evaluate neonates, babies, and kids who have laryngeal problems. The flexible fiberoptic nasopharyngo-laryngoscope, or laryngoscopy, is the preferred technique to assess these children's issues and represents a substantial development in the diagnosis of laryngeal pathology in children. As well as rigid bronchoscopy and direct laryngoscopy, under general anesthesia. The risks associated with anesthesia and instrumentation are two key drawbacks of this method. Without transferring to the operating room or requiring general anesthesia, the infant can be assessed in the outpatient clinic. Direct observation of the nasopharynx and larynx in a professional environment

Eligibility Criteria:
Inclusion Criteria:

1. Age: from 2 month to 18 year
2. Gender: both sexes will be included in the study
3. Endotracheal intubation in emergency or elective sitting for 24hr or more

Exclusion Criteria:

* 1-Congenital laryngeal lesions 2-Head and neck surgery 3-CNS infections 4-Craniofacial malformations
Safety and Immunogenicity Study of Aleph Inactivated Split Influenza Vaccine

The objective of this study was to evaluate the safety and immunogenicity of one inactivated split influenza vaccine, a primarily Chinese-marketed trivalent vaccine.

A total of 3308 subjects were stratified equally into four age groups and receive either influenza vaccine or recombinant hepatitis b vaccine (seen as placebo). Systematic and local adverse reactions were reported for 28 d after the vaccination. Antibody levels were detected through hemagglutination inhibition assay before vaccination (Baseline) and 28d after the vaccination.

Eligibility Criteria:
Inclusion Criteria:

* more than three years in good healthy

Exclusion Criteria:

* current infectious fever or acute disease
* upper respiratory infectious symptom within 6m
* a history of allergy
* laboratory confirmed influenza
* autoimmune disease
* have get influenza vaccine since 2008
Effect of Cumulative Chloride Dose on Development of Acute Kidney Injury in Critically Ill Children

The investigators would like to investigate the effect of chloride dosing on the development of acute kidney injury in critically ill patients. The investigators hypothesis is that administering intravenous fluids with higher chloride content are more likely to lead to acute kidney injury.

Retrospective chart review from 2008-2012 evaluating chloride dosing and serum chloride levels and their effects on acute kidney injury in the pediatric ICU. Patients will be included for the first seven days of their PICU stay.

Eligibility Criteria:
Inclusion Criteria:

* age less than 18 years
* PICU admitting diagnosis of sepsis, respiratory failure, or hepatic failure.

Exclusion Criteria:

* hyponatremia or hypernatremia at PICU admission
* preexisting diagnosis of End-stage renal disease or renal transplant
* presence of neurologic comorbidities.
Exercise Versus Cognitive Behavioural Therapy on Cancer-related Fatigue

The investigators compare the effects of two interventions, an endurance exercise program and a cognitive behavioural therapy, on the fatigue, quality of life, mood and physical performance of patients with a cancer-related fatigue syndrome. The intervention will be carried out for 4 weeks. Tests will be carried out at the beginning and at the end of the study.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-70
* Histologically confirmed neoplastic disease
* Treatment (chemotherapy or radiation) completed.
* No treatment in the previous 4 weeks
* Ability to understand written German

Exclusion Criteria:

* Health conditions which can be aggravated by exercise
A Study to Compare Safety and Efficacy of OPT-80(Fidaxomicin) With Vancomycin in Subjects With Clostridium Difficile-associated Diarrhea (CDAD)

The primary objective of this study is to investigate the safety and efficacy of OPT-80 versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).

This is a multicenter, double-blind, randomized, parallel group study. The subjects who meet all of the inclusion criteria and none of the exclusion criteria will be randomized, and will orally receive either OPT-80 twice daily or vancomycin powder four times daily for 10 days. A follow-up investigation will be performed 28 (±3) days after the completion of study drug administration.

Eligibility Criteria:
Inclusion Criteria:

* Inpatients who have symptoms of CDAD as defined by;

  * (1)Diarrhea: with ≥4 unformed bowel movements (or ≥200 mL unformed stool for subjects having rectal collection devices) and
  * (2)Presence of either toxin A and/or B of C. difficile in the stool
* Subjects who have not received antibacterials (vancomycin, metronidazole, et.al.) aiming at CDAD treatment before the study

Exclusion Criteria:

* Life-threatening or fulminant CDAD
* Ileus paralytic or toxic megacolon
* Likelihood of death before the completion of study from any cause
* Concurrent use of oral vancomycin, metronidazole, et.al. aiming at the treatment of CDAD
* The anticipated need to continue other antibacterials for a period exceeding seven days from providing the informed consent
* Subjects who in the opinion of the investigator require other drugs to control diarrhea
* Need of change in dosage regimen of opiates during the study period
* Need of change in dosage regimen of probiotic products during the study period
* History/complications of ulcerative colitis or Crohn's disease
* Multiple occurrences of CDAD within the past three months
* Hypersensitivity to vancomycin
* Previous exposure to OPT-80 (fidaxomicin)
* Female patients who are pregnant, breastfeeding or possibly pregnant, or wishing to become pregnant during the course of study
* Participation in other clinical research studies or Post Marketing Clinical Trials utilizing an investigational agent within one month prior to providing the informed consent or within five half-lives of the investigational agent, whichever is longer
Heme Arginate in Functional Magnetic Resonance Imaging (fMRI)

Ischemia reperfusion injury may be attenuated by HO-1 induction. Heme arginate showed protective effects during prolonged ischemia in animal studies. Functional blood oxygen level dependent (BOLD) magnetic resonance imaging (MRI) shall evaluate the effects of HO-1 induction during short-time ischemia in skeletal muscle of healthy subjects.

Ischemia reperfusion injury may be attenuated by HO-1 induction. Heme arginate showed protective effects during prolonged ischemia in animal studies. The investigators previous data confirmed strong HO-1 induction following heme arginate infusion in healthy humans. Therefore, the investigators next approach is to evaluate the direct effects of heme arginate on short time Ischemia-reperfusion (IR) injury in healthy humans. This will be done by the following surrogate markers of IR injury.

Functional blood oxygen level dependent (BOLD) magnetic resonance imaging (MRI) can measure alterations in tissue oxygenation in a high spatial and temporal resolution. This non-invasive methods therefore represent a promising technique to evaluate the effects of HO-1 induction on energy metabolism and oxygen saturation during ischemic stress and short time reperfusion in skeletal muscle.

As additional outcome, levels of myoglobin and creatine-kinase will be measured in plasma according to standard laboratory procedures.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Men aged between 18 and 46 years (inclusive)
* Nonsmoker for more than 3 months
* Body mass index between 18 and 27 kg/m2
* Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Negative results from urine drug screen if performed
* Ability to communicate well with the investigator in the local language and to understand and comply with the requirements of the study

Exclusion Criteria:

* Known hypersensitivity to the study drug or any excipients of the drug formulation
* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Treatment with another investigational drug within 3 weeks prior to screening
* History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study drug
* Evidence of hypertension, pathologic hyperglycemia, hyperlipidemia
* Treatment in the previous 3 weeks with any drug including over-the-counter drugs (including herbal medicines such as St John's Wort)
* Symptoms of a clinically relevant illness in the 2 weeks before the first study day
* Blood donation during the previous 3 weeks
* Any metallic, electric, electronic or magnetic device or object not removable
* Claustrophobia
Epidermoid Cancer Development in Esophageal Achalasia

Esophageal achalasia is a precancerous condition for epidermoid carcinoma; incidence and risk factors for cancer development are not defined. Incidence and risk factors for epidermoid carcinoma development in achalasia patients were investigated.

In order to define incidence and risk factors for epidermoid carcinoma 681 patients affected by esophageal achalasia observed since 1973 were followed up with no time limits according to a prospective follow-up protocol. The local institutional review board approved using the database from the division of thoracic surgery for research purposes. Clinical, radiological and endoscopic data of achalasia patients were collected and analyzed.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of primary esophageal achalasia achieved by means of radiology, endoscopy and manometry

Exclusion Criteria:

* pseudoachalasia
Clinical Effectiveness of Erector Spinae Plane Block in Peri-operative Analgesia for Laparoscopic Nephrectomy/Nephron Sparing Surgery (NSS)/Hynes-Anderson Procedures.

62 patients age of 20 to 85, (ASA) physical status I-III undergoing laparoscopic nephrectomy/NSS/Hynes Anderson procedures in 1st Department of Anesthesiology in Warsaw will be enrolled in the study. Patients will be randomised into 2 groups - patients from the first group will undergo General Anaesthesia (GA) with intravenous analgesia peri-operatively, patients from the second group will receive GA plus the Erector Spinae Plane Block (ESP block) bilaterally performed under ultrasound guidance with catheter left on the side of surgery. Ultrasound transducer will be placed in a longitudinal orientation 3 cm lateral to the Th7 spinous process. Three muscles will be identified superficial to the hyperechogenic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. An 8-cm 18-gauge block needle will be inserted in a cephalad-to-caudad direction until the tip gets in the interfascial plane between rhomboid major and erector spinae muscles, as evidenced by visualization of local anesthetic spreading in a linear pattern between erector spinae and the bony acoustic shadows of the transverse processes. . Patients in this group will be anesthetized with 20ml 0,25% bupivacaine + Adrenaline 1:200 000 for each side. ESP block will be performed at the level of Th7-8 after proper positioning he patient in the sitting position before GA then standard technique of catheter application will be applied. After the surgery the elastomeric pump will be attached to the catheter with 0,125% bupivacaine with Adrenaline 1:200 000. Anaesthesia will be standardised In the both groups.


Eligibility Criteria:
Inclusion Criteria:

* pts undergoing laparoscopic nephrectomy/NSS/Hynes Anderson procedures in 1st Department of Anaesthesiology in Warsaw
* pts consented for the study prior to surgery
* ASA 1-3

Exclusion Criteria:

* Pts without consent for trial
* Pts ASA 4-5
* Coagulation abnormalities
* Allergy to local anesthetics
* Skin lesions in the place of needle insertion
Development of Novel Psychological Assessment Tools and Anxiety Intervention for Phenylketonuria

While previous PKU intervention research has largely focused on pharmacological treatment of elevated Phe levels, the adaptation of evidence-based psychosocial therapy holds promise for addressing cognitive and psychological symptoms and significantly improving quality of life. Study goals include: (1) to demonstrate the efficacy and feasibility of a short-term skills-based intervention (Show Me FIRST) for anxiety and depression in adolescents with PKU, and (2) to further establish the psychometric validity of novel assessment measures recently developed by the Investigators that utilize ecological momentary assessment (EMA) to capture "in the moment" neurocognitive and psychological function. The Investigators propose to conduct a randomized controlled trial wherein 30 adolescents with PKU will be randomized to either an immediate intervention group or wait-list/delayed intervention group.

A sample of 30 adolescents (age 10-17) with PKU and a history of elevated anxiety and/or depression symptomatology will be recruited to participate in a randomized control trial. Following screening and informed consent, participants will be randomized to an immediate intervention group (n=15) or wait-list/delayed intervention group (n=15). Participants will receive the 10-week Show Me First program for treatment of anxiety and depression. Participants will complete extensive psychological and neurocognitive evaluations at three timepoints: Weeks 0, 11, and 22. The assessments and intervention will all be administered remotely via secure videoconference and cell-phone based applications.

Eligibility Criteria:
Inclusion Criteria:

* Youth 10-17 years old and at least one parent/guardian
* Formal diagnosis of PKU (as confirmed/reported by caregiver): identified by newborn screening with PKU as evidenced by a blood Phe level ≥ 360μmol/L; received treatment within the first 30 days of life.
* Interest in receiving a brief, psychotherapeutic skills program to prevent and treat symptoms of anxiety and/or depression, according to parent- and youth-report
* Located in Missouri, Kansas, or Illinois.

Exclusion Criteria:

* Have significant intellectual disability (IQ\<70) or significant expressive or receptive language that would interfere with psychotherapy, according to parent- or youth-report
* Plans to receive non-study psychotherapy during the course of study participation, according to parent- or youth-report
* Plans to change current psychoactive or PKU-related medication during the course of study participation, according to parent- or youth-report
* Have active suicidal ideation that would necessitate immediate treatment or require higher level of care than brief psychotherapy, according to parent- or youth-report
Efficacy of Changing to DuoTrav® (Travoprost 0.004%/Timolol 0.5% BAK-Free Fixed Combination) From Prior Therapy

The purpose of this study is to assess efficacy and tolerability of changing to DuoTrav® (Travoprost 0.004%/Timolol 0.5% BAK-free) from prior Xalacom® or Ganfort® fixed combination pharmacotherapy in patients with open-angle glaucoma or ocular hypertension with uncontrolled intraocular pressure (IOP).


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of ocular hypertension, open-angle glaucoma, or pigment dispersion glaucoma in both eyes.
* On a stable IOP-lowering regimen of prostaglandin fixed combination (either Xalacom or Ganfort) within 4 weeks prior to the Screening Visit.
* IOP between 19 and 35 mmHg at any time of day in at least 1 eye.
* Best corrected visual acuity (BCVA) of 6/60 (20/200 Snellen; 1.0 LogMAR) or better in each eye.
* Willing to discontinue the use of all other ocular hypotensive medication(s) prior to receiving the study medication for the entire course of the study.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Known medical history of allergy, hypersensitivity, or poor tolerance to any component of DuoTrav® deemed clinically significant in the opinion of the Principal Investigator.
* Corneal dystrophies in either eye.
* Risk of visual field or VA worsening as a consequence of participation in the study, in the investigator's best judgment.
* Any disease or condition that would preclude the safe administration of a topical beta-blocker, present a special risk to the subject, or interfere with optimal participation in the study.
* Women who are pregnant or lactating.
* Participation in any other investigational study within 30 days prior to the Screening Visit.
* Other protocol-defined exclusion criteria may apply.
Behavioral Studies and Practices

The focus of this study is to evaluate whether a new fraud material will be suitable for a technological device and or software. \*\*\*For consultation purposes only.\*\*\*


Eligibility Criteria:
Inclusion Criteria:

* College Student

Exclusion Criteria:

* Age Over 40
Pelvic Floor Muscle Function, Pelvic Floor Dysfunction and Diastasis Recti Abdominis in Postpartum Women

Background: Pregnancy and childbirth are factors that affect a woman's pelvic floor. Pelvic floor disorders (PFD) often occur in the perinatal period. Symptoms and difficulties related to urinary continence and/or pelvic organ prolapse significantly affect daily activities, including physical activity, but also the quality of life and sexual activity. Patient education that includes both the anatomy and function of the pelvic floor, as well as information on the prevention of PFD during pregnancy and postpartum is an important part of the prevention of these dysfunctions. Diastasis recti abdominis (DRA) is another common musculoskeletal issue related to pregnancy and postpartum period. In addition to the cosmetic consequences, it can be associated with abdominal pain, the occurrence of pelvic floor dysfunction and a negative correlation with the image of a woman's own body.

Material and Methods: Primiparous women after vaginal delivery will be invited to this study. The study will consist of three stages. First phase (baseline measurements) will take place at the hospital and the following assessments will be performed: pelvic floor muscle palpation examination (PERFECT scheme, OXFORD scale, Reissing scale), palpation and ultrasound examination of diastasis recti abdominis. After 12-16 weeks postpartum participants will complete questionnaires about pelvic floor dysfunctions and diastasis recti and their impact on quality of life. Third part, 12-16 weeks postpartum, the pelvic floor muscle examination, palpation and ultrasound examination of diastasis recti abdominis will be repeated.

Objectives: The aim of this study is to assess the function of the pelvic floor muscles, prevalence of pelvic floor dysfunctions and diastasis recti abdominis in the primiparous women postpartum. Our secondary objective will be investigation if there are any prognostics factors during the early postpartum period, that can indicate higher risk of PFD and/or DRA 3 months postpartum.

Expected results: Results of this study will inform about prevalence of pelvic floor dysfunctions and diastasis recti in primiparous women in Poland. Additionally, we hope to obtain predictors suggesting pelvic floor or abdominal muscles dysfunction 3 months postpartum. Prevention of pelvic floor disorders may contribute to the early identification of problems and reduce cost of treatment of unrecognized dysfunction. To our knowledge this will be the first study in this area conducted in Poland.


Eligibility Criteria:
Inclusion Criteria:

* Vaginal delivery between 38-42 weeks of pregnancy
* First delivery
* Agreement to participate
* Good command of spoken and written Polish

Exclusion Criteria:

* Contraindications for the examination of the pelvic floor muscles (postpartum hematoma of the perineum, extensive perineal swelling, perineal wound dehiscence, bladder catheterization).
* Lack of consent to participate in the study
* Lack of good command of spoken and written Polish
Endocrine Determinants of Renal Function in Patients With Hypoparathyroidism

Endocrine determinants of renal function in patients with hypoparathyroidism on conventional treatment: a cross-sectional study (ENDORSE)


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* diagnosis of chronic (≥ 1 year) post-surgical and autoimmune hypoparathyroidism, as established with undetectable or insufficient PTH concentration in relation to the presence of hypocalcemia
* patients being treated with calcitriol or alfacalcidiol
* patients able to sign the written informed consent

Exclusion Criteria:

* pregnancy
* severe renal failure requiring dialysis treatment
* macroproteinuria
* use of antihypertensive drugs such as thiazides, ACE inhibitors, sartans, beta and alpha blockers, and antialdosterone drugs
* pazients affected by diabetes mellitus- insulin-treated
NAD+ Precursor Supplementation in Friedreich's Ataxia

The primary objective is to test the safety and tolerability of short-term therapy with a nicotinamide adenine dinucleotide (NAD+) precursor (MIB-626) in adults with Friedreich's Ataxia (FA) without overt heart failure and with a left ventricular ejection fraction ≥ 40%. A key secondary objective is to test the effects of MIB-626 on cardiac and skeletal muscle bioenergetics.

The primary focus for this protocol is safety and tolerability. We will systematically assess for adverse events using a safety monitoring uniform report form. We will also use cardiac 31-Phosphorus-Magnetic Resonance Spectroscopy (MRS) to measure the Phosphocreatine(PCr)/Adenosine triphosphate (ATP)- γ ratio before and after treatment with MIB-626. In addition, if time permits we will use proton (1H)-MRS to measure skeletal muscle nicotinamide adenine dinucleotide (NAD+) before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Molecular diagnosis of Friedreich's Ataxia (FA).
* Males and females, ages 18 years to \< 65 years.

Exclusion Criteria:

* Known sensitivity to nicotinamide-containing compounds.
* Concurrent use of Vitamin B3 supplements and/or any medications likely to increase risk of MIB-626 toxicity.
* HgbA1c \> (great than or equal to) 8.5% and or Diabetes Mellitus (DM) requiring insulin or insulin secretagogue.
* Kidney disease (Estimated Glomerular Filtration Rate (eGFR) \< 60 ml/min/1.73 m2) using serum creatinine and MDRD equation. The eGFR levels will be calculated using the Modified Diet in Renal Disease Study (MDRD) equation, which is the equation used by the Children's Hospital Of Philadelphia laboratory.
* Liver disease (Aspartate Aminotransferase (AST)/Alanine Aminotransferase (ALT) \> 3 x Upper Limit of Normal)
* Severe co-existing cardiac disease (Ejection Fraction (EF) \< 40%, known arrhythmia) as demonstrated by an echocardiogram within 12 months of screening.
* Any contraindication to MRI, including spinal rods (related to unknown safety considerations for cardiac 31-Phosphorus -MRS).
* Use of any investigational agent within 4 weeks of enrollment.
* Females: Pregnant/lactating or planning to become pregnant during their participation.
* Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the study.