cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetics of Ghrelin

The main purpose of this study is to determine the half life of the hormone "ghrelin" in the human body. Other purposes are to investigate the effect of ghrelin on appetite and cardiovascular function.

Ghrelin is a recently described acylated peptide hormone produced by the enteroendocrine cells of the mucosal epithelial layer in the ventricle. Ghrelin is the endogenous ligand for the growth hormone (GH) secretagogue receptor (GHS-R).

Ghrelin stimulates pituitary GH release by binding to the GHS-R at both hypothalamic and pituitary levels.

Several studies show that bolus injections of ghrelin have positive effects on cardiac function in healthy humans as well as in humans with cardiac disease. We investigate the changes in cardiac function during ghrelin infusion in healthy subjects.

The pharmacokinetics of ghrelin is described in few studies only, and we aim to elucidate this aspect further.

Comparisons: In a double blind, placebo controlled, cross over study we investigate the effect of 180 minutes ghrelin infusion on 1. cardiac function (tissue Doppler, stroke-velocity index), 2. vascular tone (a. brachialis dilatation), 3. ghrelin-half-life (acylated and des-acylated) and other pharmacokinetic parameters and 4. effect on appetite.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Male
* BMI \< 25 kg/m2
* Non-smoker
* Age \< 40 yrs

Exclusion Criteria:

* Any known disease
* Any medication (except OTCs)
* Former malignant disease
* Alcoholism
* Blood donation (with in 6 months)
* Allergy to test medication
Association Between COVID-19 and UTIs Caused by ESBL Organism in Infants

Urinary tract infections (UTIs) in infants and young children are one of the most common bacterial infections, usually febrile illness without source, frequently due to Enterobacteriaceae, mainly Escherichia coli.

Multidrug-resistant organisms including extended-spectrum beta-lactamase (ESBL) producing bacteria are becoming more prevalent. Due to the risk factors of ESBL-producing organisms in community-acquired (CA)-UTIs in infants in QATAR and Arab countries are still not studied because of the limited therapeutic options. hence, the importance of this study is to get knowledge about how to decrease the rapidly increasing in ESBL- producing bacteria, in infants, and to use antibiotics in a suitable guideline.so, The aim of this retrospective case-control study is to determine the clinical manifestations, and investigations of urinary tract infections among infants and the association with COVID-19 infection, in pediatric emergency centers at Hamad General Hospital - Qatar. From 1st January 2015 till 1st January 2022.

In this retrospective, case-control study investigators will include all infants (0-1 year) with UTIs who were treated at Hamad General Hospital, pediatric division- PEC Doha, Qatar, using the electronic medical records from 1st January 2015 till January 1st, 2022, diagnosed by a positive urine culture. Investigators will look for the clinical manifestations, radiological and laboratory findings, renal scarring, ESBL-organisms, prevalence, median age, gender, and ethnic background. Participants are divided into two groups: early infancy and late infancy, ESBL UTIs and non-ESBL UTIs, and upper UTIs and lower UTIs. Finally, UTIs ESBL with COVID-19 and without COVID_19.

Eligibility Criteria:
Inclusion Criteria:

* All infants with UTIs who had been treated

Exclusion Criteria:

* Patient with a mixed urine culture.
A Prospective Study of Human Bone Adaptation Using a Novel in Vivo Loading Model

The purpose of this study is to understand how different types of mechanical forces can influence bone adaptation (and make bones stronger, potentially). Forces acting on bones cause mechanical strain. In small animals, strain magnitude and rate have been shown to stimulate bone adaptation. This study is designed to test the degree to which strain magnitude and rate govern bone adaptation in healthy adult women.

The study consists of three Aims:

Aim 1: compare the effect on bone structure of mechanical signals with low strain magnitude, high strain magnitude, and control groups over a 12-month prospective period.

Aim 2. Compare the effect on bone structure of mechanical signals with low strain rate, high strain rate, and control groups over a 12-month prospective period.

Aim 3: Examine the effect of withdrawing mechanical signals, by measuring bone structure during the 12 months after the intervention is withdrawn.

The intervention is a voluntary forearm compression task, consisting of leaning onto the palm of the hand to produce a target force.

The primary outcome measure is change in distal radius bone mineral content (BMC).

Eligibility Criteria:
Inclusion Criteria:

* Female
* Age 21-40
* Body Mass Index \[18-29\]
* 9-14 menstrual cycles/year
* Dual energy X-ray Absorptiometry total radius bone mineral density (BMD) T-score \[-2.5-+1\]
* Free of endocrinopathies
* No known thyroid, vitamin D, or calcium abnormalities

Exclusion Criteria:

* Fracture to wrist \<5 years ago
* Wrist Arthritis
* Injury to the non-dominant elbow or shoulder \<5 years ago
* Diabetes
* Severe disabling conditions
* Cancer \<5 years ago
* Metabolic bone disease
* Androgen, estrogen, progesterone, calcitonin, Selective Estrogen Receptor Modulators, Parathyroid hormone, gonadotropin-releasing hormone or analogs used \<6 months ago
* Corticosteroids \<3 months ago
* Bisphosphonates or fluoride \<3 years ago
* Cardiovascular/pulmonary disease
* Uncontrolled hypertension
* Regular Tobacco use
* Marijuana use \>1 time/week
* Alcohol \>4 drinks/day
* Pregnancy or lactation \<2 years ago
* Plan to become pregnant or donate eggs within 1 year
* Depot medroxyprogesterone acetate contraceptive \<6 months ago
* Current participation in upper extremity loading sports (gymnastics, tennis, softball, hockey) \>2 times/month
* Low calcium intake (avoiding dairy products without taking calcium supplement)
Evaluate the Effect of ReSpace™ Hydrogel on Reducing Rectal Radiation Dose in Radiotherapy for Cervical Cancer

This phase II clinical study plan to recruit 100 subjects, 1:1 divide them into experimental group and control group, and the cumulative D2cc dose for rectum during brachytherapy will be recorded and compared.

This phase II prospective, multicenter, randomized, parallel-controlled, superiority clinical study will select more than three hospitals with national clinical trial institution qualifications as clinical trial centers, plan to recruit 100 subjects, 50 in experimental group and 50 in control. The patients in expermental group will receive brachytherapy after the hydrogel injection while patients in control group will receive brachytherapy without hydrogel. The aim of the study was to evaluate whether the use of ReSpace™ hydrogel results in a reduction of radiation exposure to the anterior rectum, and to assess its safety.

Eligibility Criteria:
Inclusion Criteria:

* • Patients with pathologically confirmed cervical cancer who must be scheduled to undergo radical radiotherapy by means of intensity-modulated radiotherapy combined with 3D brachytherapy.

  * Karnofsky score ≥ 70.
  * Subjects aged ≥ 18 years and ≤ 75 years.
  * Subjects must be able to cooperate in completing the entire study.
  * The subjects' pelvic and abdominal cavity and joints are free of metal implants and can tolerate MRI.
  * No contraindications to CT scanning.
  * Subjects must be able to understand the purpose of the trial, voluntarily participate and sign an informed consent form

Exclusion Criteria:

* •Subjects who have received prior pelvic radiotherapy.

  * Subjects whose target tumors have been previously treated (chemotherapy, immunotherapy, surgical treatment, etc.)
  * Subjects with other primary malignancies
  * Subjects with contraindications to radiotherapy, as determined by the investigators
  * Subjects with injection site infections.
  * Subjects who are allergic to the ingredients of the device.
  * Subjects whose tumors invade the injection site and affect the injection process and injection safety, as determined by the investigators
  * Persons with severe mental illness, cognitive impairment and thinking disorders.
  * Participants in other drug clinical trials or medical device clinical trials 1 month prior to screening
  * Pregnant or lactating women or those who plan to get pregnant within the last six months
  * Subjects who cannot be followed up as prescribed by the doctor
  * Other conditions that, in the judgment of the investigator, make the subject unsuitable for enrollmen
Changes of Left Ventricular Mass and Cardiac Function in Patients With Active Acromegaly During Treatment With the Growth Hormone Receptor Antagonist Pegvisomant

The purpose of this study is to evaluate changes in left ventricular mass and cardiac function in patients with active acromegaly before and after treatment with the growth hormone receptor antagonist pegvisomant for one year.


Eligibility Criteria:
Inclusion Criteria:

* Active acromegaly in adult subjects (≥ 18 years) after surgery and/or radiation therapy with elevated IGF-1 levels despite treatment with somatostatin analogues or dopamine agonists
* Pegvisomant therapy is indicated (i. e. patients who have had an inadequate response to surgery and/or radiation therapy and/or other medical therapy, or for whom these therapies are not appropriate)
* Evidence of left ventricular hypertrophy (infero-lateral wall thickness ≥ 12 mm assessed by echocardiography) or
* Evidence of impaired diastolic function (≥ stage 2 as assessed by echocardiography) or
* Evidence of systolic dysfunction (Ejection fraction \< 50% assessed by echocardiography)
* Stable medication for arterial hypertension and heart failure for 3 months
* Written informed consent.

Exclusion Criteria:

* Pregnancy and lactation period
* Previous therapy with Pegvisomant
* Suspected or known hypersensitivity to the drug or any of its components
* Contraindications for MRI
* History of malignancy during the last 5 years
* Suspected or known drug or alcohol abuse
* Patients who are neither able to self administer study medication on a daily basis nor have a caregiver who can administer study medication to the patient on a daily basis
* Any condition which in the opinion of the investigator makes the patient unsuitable for inclusion
* Participation in another clinical trial
* Pituitary adenoma with a distance to the optic chiasm of \< 3 mm
* Any other drug for treatment of acromegaly (e.g. dopamine agonists, Somatostatin analogues) which would be necessary during the study or patients who apply for radiotherapy
* Instable heart insufficiency classified as NYHA IV.
* Severe renal insufficiency, liver transplantation
Online Hemodiafiltration vs Conventional Hemodialysis in Acute Kidney Injury

Only limited data exist on the benefit of online hemodiafiltration in patient with Acute kidney injury. The objective of this pilot RCT is to assess the feasibility of a large multicentre RCT to determine whether, in patients with AKI requiring acute renal replacement therapy, does exposure to Online Hemodiafiltration reduce the inflammatory status and improve renal recovery compared to conventional intermittent hemodialysis at the ICU.

Despite sparse data on the advantages of hemodiafiltration over conventional hemodialysis for intermittent dialysis, there is limited data comparing these modalities in AKI from various aetiologies in critically ill patients. As RCTs involving renal replacement therapy at the ICU are exceptionally challenging to complete, thus a rigorous RCT based on appropriate sample size and relevant clinical outcomes is crucial. The objective of this pilot RCT is to assess the feasibility of a larger multicentre RCT to determine whether, in patients with AKI requiring acute renal replacement therapy, does exposure to Post-dilution Hemodiafiltration or Pre-dilution Hemodiafiltration reduce the inflammatory status and improve renal recovery compared to conventional intermittent hemodialysis at the ICU. As post-dilution HDF has never been adequately evaluated in an ICU context, comparison between pre-dilution and post-dilution HDF is also required to confirm feasibility.

This proof-of-concept pilot trial will focus on three feasibility endpoints. It will be considered successful if the following criteria are achieved :

* Protocol adherence: If ≥85% of overall dialysis sessions are administered per-protocol according to the allocated modality
* Adherence to follow-up: If it was possible to obtain end-of-study outcomes in ≥90% of participants, and
* Participant accrual: If the average monthly enrolment is 4 or more participants per months.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalised in the ICU
* Acute kidney injury stage 3 (KDIGO-AKI Criteria)
* Requiring RRT for AKI, as judged by the attending clinician (initiation) or conversion from CRRT to intermittent dialysis
* Adult of 18 years or more

Exclusion Criteria:

* Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study.
* Subjects who are participating in another study involving dialysis interventions
* Subjects or relatives/next-of-kin unable to provide written informed consent
* Creatinine clearance (CrCl) \< 30 mL/min measured by 24-hour urine collection or eGFR or on chronic dialysis at baseline
* Subjects on active immunosuppressive therapy (\>10mg of prednisone, biologic therapies, calcineurin inhibitors, mTOR inhibitors or antimetabolites)
* Subjects with active contraindication to anticoagulation during dialysis session
* Subjects whose RRT is not part of their life goal
Non-interventional Study, Long Term Treatment on Glabellar Lines With Dysport® in Subjects of Chinese Origin

This is a prospective, longitudinal, non-interventional, multi-center study to collect subject and physician satisfaction, and treatment experience with Dysport in real clinical practice in subjects of Chinese origin.

Approximately 250 subjects are planned to be included in the study.

Eligibility Criteria:
Inclusion Criteria:

* Adult male or female up to 65 years of age, and of Chinese origin.
* Moderate (grade 2) or severe (grade 3) glabellar lines at max frown.
* Prior to and independent of study, subject is seeking long term treatment of their glabellar lines.
* Prior to and independent of the study participation, physician intended to treat the subject with Dysport.
* Time and ability to complete the study and comply with instructions.
* Understands the study requirements and signed the informed consent form (ICF)

Exclusion Criteria:

* Hypersensitive to Dysport or its excipients.
* Presence of contraindications to Dysport treatment as specified in the approved leaflet in China.
* Subject is at risk for precautions, warnings, and/or contraindications to Dysport as specified in the approved leaflet in China.
Non-operating Room Anesthesia Experiences in Pediatric Magnetic Resonance Imaging Cases

In recent years, out patient anesthesia applications have been increasing for diagnostic and interventional procedures for pediatric patients. In this study, we aimed to retrospectively analyze the anesthesia applications performed in pediatric MRI cases in our hospital.

It is a retrospective study

In recent years, applications with sedation and/or general anesthesia for diagnostic purposes in pediatric cases with Magnetic Resonance Imaging (MRI) method have been increasing. Although imaging methods are useful in diagnosis and treatment, they carry minimal risk for patients. As the demands for anesthesia increase during Magnetic Resonance Imaging, questions have arisen about what can be done safely in anesthesia management. The type of anesthesia applied for Magnetic Resonance Imaging is called non-operating room anesthesia.

Cross-sectional imaging techniques such as MRI require pediatric patients to remain calm for up to one hour, and thus these patients need anesthesia. In the induction of anesthesia with agents used in anesthesia outside the operating room, the patient sleeps quickly, the vital functions are stable in its maintenance, the patient recovers quickly after anesthesia, the physical and mental activities return to normal as soon as possible after recovery, and there are no side effects such as nausea, vomiting, dizziness and pain that will delay the discharge. is necessary. Sedation or general anesthesia carries risks and can have unintended consequences if poorly managed.

Eligibility Criteria:
Inclusion Criteria:

* Elective cases under the age of 18 will be included in the study between 01.01.2020 and 01.01.2022.
* Patients to undergo elective magnetic resonance imaging

Exclusion Criteria:

* Magnetic resonance without anesthesia will not be included. Over the age of 18 will be excluded from study
Focal Radiotherapy for Previously Treated Prostate Cancer Patients

To examine the feasibility, safety and toxicity of focal stereotactic radiation treatment (SBRT) for locally recurrent prostate cancer.

Participants must have biopsy proven locally recurrent prostate cancer. Biopsy will be performed by a Urologist. Participants will have PSMA-PET (prostate-specific membrane antigen and positron emission tomography) scan and MRI in Radiology and Nuclear Medicine by experienced Radiologists in the Royal North Shore Hospital. before starting stereotactic radiotherapy. Participants will require fiducial markers inserted in the prostate and may require hydrogel insertion depending on the location of the recurrence. If these are required, it will be done by experienced radiation oncologists. Fiducial markers insertion involves inserting three gold markers into the prostate. It will be used to locate the prostate accurately during radiation treatment. Hydrogel is a temporary gel being injected into the space between the prostate and rectum to reduce the dose of radiation received by the rectum to minimise side effects from the treatment, Focal Stereotactic Body treatment (SBRT) will be used in the study. There are three groups of participants. Each group will receive different level of radiation dose to test the safety of increasing radiation dose. Group 1 will receive 36 grays (radiation dose unit, Gy)) in 6 treatments. Group 2 will receive 38 grays in 6 treatments and Group 3 will receive 40 grays in 6 treatments. The incremental dose escalation will cease if any excess acute toxicity or late grade 3 toxicity. SBRT will be delivered two to three times per week, every second day. The number of treatments per week will depend on the day of the week participants start their treatment. Participants will be reviewed weekly or second weekly. Toxicity will be recorded. A Safety Committee will be formed containing multi-disciplinary team members. All serious adverse events will be reported to the Principal Investigator and Human Research Ethics Committee within 24 hours.

Eligibility Criteria:
Inclusion Criteria:

* Men \> 4yrs from external beam radiotherapy (EBRT) meeting the Phoenix definition of biochemical failure or men \> 5yrs from EBRT if neo-adjuvant and/or adjuvant androgen deprivation therapy (ADT) also used
* Recurrence localised to less than 1 lobe of prostate on both PMSA and multi-parametric MRI (less than equal to cT2a)
* Recurrence must be biopsy proven, with positive biopsies limited to the PET and MRI suspicious region.
* Life expectancy at least 10yrs from time of SBRT
* PSA \< 10

Exclusion Criteria:

* Recurrence in immediate proximity to rectum (unless able to have hydrogel)
* Grade 3 or more toxicity from previous EBRT
* Contra-indicated for fiducial insertion
* GS 8,9 or 10 disease previously (relative - consider if decent disease free interval)
Acute Otitis Media: Adjuvant Therapy to Improve Outcome

Acute otitis media is one of the most common diseases of childhood and is one of the major causes of hearing loss in children. Despite the availability of effective antibiotic therapy for otitis media, treatment failures, persistent effusions, and recurrences are common. This Phase III outpatient study aims to test whether adjuvant therapy (an antihistamine or a corticosteroid), in addition to antibiotic therapy, improves the acute and long-term outcomes of patients with acute otitis media. This study is targeted to recruiting 200 infants (age less than one year); patient (and parent) participation is estimated to continue for one year after enrollment.


Eligibility Criteria:
Inclusion Criteria:

* Have had two documented prior episodes of acute otitis media.
* Have no current middle ear effusion (fluid).

Exclusion Criteria:

* Have chronic otitis media.
* Have acute otitis media in addition to chronic otitis media.
Analysis of a Training Intervention for Pulmonary Embolism Diagnosis in Emergency Department (APEED)

The purpose of this study is to analyze the clinical impact of an educational intervention on adherence to Clinical Practice Guidelines in an Emergency Department (ED), by using a standardized training, for improving diagnostic sensibility and reducing unnecessary scans, adverse effects and stays in the ED.

The Hospital de la Santa Creu i Sant Pau Emergency Department (ED) implemented a training program between May and June 2015 to improve compliance and adherence to recommended clinical practice and optimize the diagnosis and management of patients with suspected Pulmonary Embolism (PE). The training program was standardized, systematic and continuous, with subsequent reinforcement to ensure implementation. This paper aims to evaluate the clinical impact of the training intervention. The establishment of training measures to improve adherence to guidelines implies clinical practice improvement and benefits patients and health system. Moreover, it is a simple and inexpensive intervention, and can be easily reproduced in other ED.

All adult patients (\<18 y) with suspected pulmonary embolism attended at Emergency Department will be included. Retrospective information from two different periods (before and after the training intervention) will be collected. First period: 1/1/2012 - 31/12/2012 and second Period: 01.06.2015 - 30/11/2015, pre and post intervention.

OBJECTIVES

A. Primary:

1. Analyze adherence to guidelines for the evaluation of suspected PE in the ED.
2. Determine the clinical impact of training intervention (change in adherence to guidelines after training measures among staff in Emergency Department)
3. Implementation and consolidation of a systematic, standardized, continuous training intervention for improving processes and results.

B.- Secondary

1. Analyze PE cases (presentation, clinical features, treatment, clinical evolution)
2. analyze the clinical differences in three subgroups of patients with PE: young patients (\<50 years), elderly patients (\<65 years) and cancer
3. Analyze the value of D-dimmer corrected by age in diagnostic algorithms
4. Analyze the results of a new algorithm (EPC + Dimmer corrected age) in the elderly population group (\<65 years).

Eligibility Criteria:
Inclusion Criteria:

* Are included
* those patients who underwent a D-dimmer for suspected PE
* all those who underwent the diagnosis of PE at discharge
* those who died from EP.

Exclusion Criteria:

* Are excluded:
* all patients who underwent D-dimmer test with a different diagnosis of EP and those who had a chronic EP