cyrilzakka/clinical-trials huggingface dataset:
Identifying Vitamin D Deficiency in Very Low Birth Weight Infant (VLBW) Infants Part 2

This study is to determine the amount of vitamin D required for a very low birth weight infant to reach vitamin D sufficiency and achieve optimal calcium health and bone growth.


Eligibility Criteria:
Inclusion Criteria:

* Any infant born at the Medical University of South Carolina \<34 weeks gestation
* Less that 1500g at birth
* AGA
* Must be African American or Caucasian
* Each infant born of twin and triplet pregnancies will be eligible

Exclusion Criteria:

* Infants with major congenital anomalies or with hemolytic disease requiring exchange transfusion
* Infants born small for-gestational-age (SGA) or large for-gestational-age (LGA)
* Maternal uncontrolled thyroid disease
* Maternal Parathyroid disease
* Infants of races other than African American or Caucasian
Effect of Metoprolol on Thalassemia Cardiomyopathy

effect of B blocker was first evaluated in patient with cardiomyopathy not induced by ischemia and idiopathic which as the most common causes of cardiomyopathy. Effect of BB on Thalassemia cardiomyopathy was evaluated in this study

In this clinical trial, 45 patients with thalassemia cardiomyopathy were randomized to receive either metoprolol (n = 26) or placebo (n = 19). Echocardiography and 6 minute walk test was performed at baseline and repeated after 6 months and the values were compared.

Eligibility Criteria:
Inclusion Criteria:

* documented LVEF \< 50% by echocardiography
* B thalassemia
* No decompensated heart failure for at least 4 weeks (hospitalization for CHF, worsening lower extremity edema, worsening dyspnea on exertion, , and orthopnea)
* have no evidence of acute myocarditis and
* hemoglobin level above 7 gr⁄dL.

Exclusion Criteria:

* pulse rate below 60/min
* systolic blood pressure less than 90 mmHg
* evidence of peripheral vascular disease
* major depression, history of asthma, PR interval more than 240 msec, second or third degree AV block
* major medical diseases including diabetes mellitus requiring insulin injection, hypothyroidism, hypoparathyroidism, chronic renal failure (glomerular filtration rate below 30 ml/min), hepatic cirrhosis, hepatitis-B and hepatitis-C, positive tests for human immunodeficiency virus, and other hemoglobinopathies
A Web-Based Multimedia Intervention for Head and Neck Cancer Patients

The overall goal is to develop and examine the acceptability of a web-based (Internet) intervention program for patients with head and neck cancer who have recently completed radiation therapy.

The overall goal is to develop and examine the acceptability of a theory-guided, web-based multimedia intervention program for head and neck cancer patients who have recently completed radiation therapy. The effects of this intervention on patients' quality of life (QOL) will also be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients with squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx
* Are receiving or have completed radiation therapy within in the past 12 months

Exclusion Criteria:

* Inability to read and/or communicate in English
* Head and neck cancers of non-squamous histology (e.g., adenoid cystic carcinoma, adenocarcinoma, sarcoma)
* Blindness or severity of visual impairment that precludes one's ability to view images/text
* Inability to provide informed consent
Use of Microscopy, Cultures and Molecular Biological Methods for Diagnosing Nosocomial Pneumonia

Nosocomial pneumonia in the Intensive Care Unit is often not properly diagnosed mainly due to ongoing antimicrobial therapy. The study investigates the feasibility of more advanced diagnostic technics.

ICU patients fulfilling the CDC criteria for nosocomial pneumonia and mechanically ventilated for no more than 24 hours are included in the study. The material for the diagnostic procedure is pulmonal secretion collected by 1. suctioning in the tracheal tube and 2. bronchioalveolar lavage. The diagnostic procedures are culturing, 16S and18S gene PCR and subsequent sequencing. The 3 diagnostic methods will be compared in order of proper diagnosis and the ability to determine a specific antimicrobial treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients intubated because of respiratory failure following nosocomial pneumonia

Exclusion Criteria:

* Terminal patients
* Patients with lung cancer
* Intubated for more than 24 hours at the sampling time
* Not fulfilling the CDC criteria for nosocomial pneumonia
A Study of the Relative Bioavailability of Single Dose RO4917838 and the Effect of Food in Healthy Volunteers

This single center, randomized, single dose, open-label, four period cross-over study will evaluate the relative bioavailability of RO4917838 and the effect of food following oral administration in healthy volunteers. Subjects will receive in randomized order single oral doses of RO4917838 film coated tablets, either in the fasted or fed condition, or RO4917838 hard gelatin capsules or RO4917838 oral suspension, with a washout period of at least 21 days between treatments. Anticipated time on study will be up to 23 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female volunteers, 18 to 65 years of age, inclusive
* Body mass index (BMI) 18 to 30 kg/m2 inclusive
* Healthy as determined by the Investigator on the basis of medical and surgical history and a complete physical examination
* Non-smoker or smoker of fewer than 10 cigarettes per day; subject must be able to refrain from smoking during the in-patient stays
* Females who are not postmenopausal or surgically sterile must agree to use two adequate methods of contraception as defined by protocol during the treatment period and for at least one month after the last dose of study drug

Exclusion Criteria:

* Any condition or disease detected during the medical interview/physical examination that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the Investigator
* History of alcoholism, drug abuse and/or drug addiction within the last year prior to Period 1. Day -1 of the study
* History of any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, allergic, dermatologic, hematologic, neurologic, psychiatric disease, or cancer
* Any history of depressive episodes or treatment with antidepressants
* Any significant allergic reactions against any drug, or multiple allergies in the judgement of the Investigator
* Pregnant or lactating females
* Positive for hepatitis B, hepatitis C or HIV infection
* Participation in another investigational study of any type within 90 days of RO4917838 administration or within 6 times the elimination half-life of the tested drug, whichever is longer
The Results of Middle-sized Posterior Malleolus Fractures: Fixed Versus Non-fixed

This study aims prospective randomized comparison of mid-term clinical outcomes of middle-sized posterior malleolus fractures with and without internal fixation.

Although it has traditionally been accepted that posterior malleolar fractures involving less than 25 percent of the tibial plafond do not require operative fixation, this belief is now questioned. A number of studies have shown that the posterior malleolus contributes significantly to ankle stability. Many studies have also demonstrated that postoperative outcomes are better in patients who underwent posterior malleolar reduction and fixation.

The aim of this prospective study is to show how internal fixation of the posterior malleolus, including middle-sized posterior malleolar fractures (10-25%), affects clinical outcomes and to discuss the factors that may lead to arthritis of the ankle joint. The groups will be randomized. The clinical and functional results of 40 patients who will be operated between 2015-2019 due to ankle fracture will be evaluated at short to mid-term (2-5 years). According to our hypothesis, internally fixed posterior malleolar fractures give better clinical and functional scores.

Eligibility Criteria:
Inclusion Criteria:

Patients who were operated for ankle fractures, including posterior malleolar fracture between 10-25% of the joint surface. Two to five years of follow-up with functional and radiological outcome.

Exclusion Criteria:

Posterior malleolar fractures accompanied by severe soft tissue damage after high-energy injury will not be included in the study. Written consent will be obtained from all participants, patients who do not give consent or refuse to participate will not be included in the study. Patients who left the study voluntarily will not be included in the statistics. Patients with additional joint disorders, previous surgery or previous history of ankle complaint will not be included.
Primary Aldosteronism in Western Norway

In this study the investigators aim to identify and include consecutively patients with primary aldosteronism (PA) diagnosed in the Western and Mid-parts of Norway, to describe the characteristics of these patients, to explore the cardiac effects of PA before and after specific treatment, and to identify long-term outcomes after treatment. One subgroup of the PA patients perform echocardiography to assess left ventricular systolic myocardial function before and after treatment. One subgroup of PA patients perform cardiac MRI to assess myocardial mass, myocardial fibrosis and myocardial function in rest and during stress, before and after treatment. For the cardiac MRI substudy, the PA patients are compared with a group of healthy controls, also included in the study.

From 2022 onwards, PA patients diagnosed or subtyped with adrenal vein sampling at Oslo University Hospital will additionally be included in the study, thereby providing a national registration of PA patients.

From June 2013, all newly diagnosed patients with primary aldosteronism (PA) either diagnosed at Haukeland University Hospital (HUS) or admitted to HUS for subtype testing with adrenal vein sampling, have been asked for inclusion in the study. All included patients have a base-line study visit where clinical information is registered, and baseline blood and urine samples are collected. Echocardiography will be performed in a subgroup of patients before and 1 year after start of specific PA treatment. After start of definite medical or surgical treatment the patients are followed up with regularly new study visits. From 2025 onwards, PA patients diagnosed or subtyped with adrenal vein sampling at Oslo University Hospital will additionally be included in the study, thereby providing a national registration of PA patients.

A subgroup of the included PA study patients also perform a Cardiac MRI. Cine-MRI, velocity-encoded MRI, MRI images during continuous adenosine infusion and MRI images after gadolinium contrast injection are performed, and compared to a group of age- and sex-matched healthy controls.

From 2025 onwards, PA patients either diagnosed or performing subtyping with adrenal vein sampling at Oslo University Hospital will likewise be asked for study inclusion.

Eligibility Criteria:
Inclusion Criteria:

* Verified diagnosis or strong suspicion of primary aldosteronism
* Age 18-85

Exclusion Criteria:

* Active cancer disease at time of inclusion

Exclusion criteria for subgroup of primary aldosteronism-patients and healthy controls who perform cardiac MRI:

* Asthma/chronic obstructive pulmonary disease ,
* Use of dipyridamole
* Claustrophobia
GlobalSurg-CovidSurg Week

Observational study to determine the optimal timing for surgery following SARS-CoV-2 infection and assess key global surgery indicators.

* Prospective, observational international cohort study.
* Any hospital worldwide can participate (including hospitals that have not admitted SARS-CoV-2 infected patients).
* All patients undergoing a surgical procedure in an operating theatre will be included. All consecutive eligible patients should be included.
* 7-day data collection period, with follow-up at 30 days after surgery for each patient. However, no changes should be made to normal patient care/ follow-up pathways
* Primary outcome is 30-day mortality.
* All collaborators will be included as PubMed-citable co-authors on resulting publications.

Eligibility Criteria:
Inclusion criteria

* Any operation (elective or emergency) done in an operating theatre by a surgeon.
* All surgical specialties including: acute care surgery, breast surgery, cardiac surgery, colorectal surgery, general surgery, gynaecology, hepatobiliary surgery, neurosurgery, obstetrics, oesophagogastric surgery, ophthalmology, oral and maxillofacial surgery, orthopaedics, otolaryngology, paediatric surgery, plastic surgery, thoracic surgery, transplant surgery, trauma surgery, urology, vascular surgery.
* Day case surgery and inpatient surgery included.
* Any SARS-CoV-2 status (positive at any time, negative, not tested).
* All ages including children and adults.

Exclusion criteria:

Minor procedures (full list will be available in the protocol).
Evaluation of the Efficacy and Neurological Effects of Dry Needling in the Treatment of Myofascial Pain Syndrome

AIM OF INVESTIGATION: To evaluate in a prospective, randomized, sham-controlled study the pattern of analgesic efficacy of trigger point dry needling in Myofascial Pain Syndrome (MPS) patients.

This study will be performed in patients with shoulder pain due to excess of nociception associated with chronic Myofascial Pain Syndrome in asymmetrical unilateral trapezius muscle trigger points.

Patients will be randomly assigned to two treatment arms: Active (A) (n=20) and Sham (S) (n=21). Group A will receive actual treatment with trigger point dry needling. Group S will receive a sham treatment, with the needle inserted superficially in the skin, without reaching the muscle underneath it.

The duration and pain elicited during active and sham dry needling will be controlled for. Patients will be evaluated one week before needling (D-7), on the day of dry needling (D0) and seven days after the procedure (D+7).

Patients will fill out the Brazilian version of the Douleur Neuropathique 4, Beck Depression Inventory, Brief Pain Inventory (BPI), McGill Pain Questionnaire-SF (SFMPQ), Hospital Anxiety and Depression Scale and Global Impression of Change, and also a 14-day Carnet to more accurately evaluate their daily pain before and after the treatment.

For the evaluation of neurologic changes, we will evaluate local hyperalgesia, tactile, mechanical, static and thermal sensitivity with thermal quantitative sensorial testing (TQS), and also mapping of the painful area, before and after treatment in both D0 and D+7.

Eligibility Criteria:
Inclusion Criteria:

* Assymetric shoulder pain (VAS on painful side : VAS on non painful side \> 2:1)
* Pain due to unilateral Myofascial Pain Syndrome of the trapezius muscle.
* Chronic pain, with duration of at least 3 months and VAS \> 40/100
* Patients with pain at least 4 days in a week
* Patients without neurological pain, as in DN4 score less than 4
* Age over 18 years
* Patients with stable drug treatment over at least 15 days, without any acute pharmacological changes during the study
* Patients who read, understood and signed the Free and Clarified Consent Term

Exclusion Criteria:

* Patients with major depression, according to DSM-IV criteria
* History of bipolar mood disorder, panic syndrome or psychosis
* Intermittent pain history
* Refusal to sing the Consent Term
* Patients not able to attend all the follow-ups
* Patients with another pain syndrome in shoulders
Acute Airway Vascular Smooth Muscle Effects of Inhaled Budesonide

Glucocorticosteroids recently have been shown to have non-genomic actions that are plasma membrane-mediated and do not require gene transcription and translation. One of these non-genomic effects is the inhibition of adrenergic agonist transport into airway vascular smooth muscle cells with an increase of adrenergic agonist concentrations at adrenergic receptor sites and enhance the physiological effects of endogenous adrenergic agonists (e.g. locally released norepinephrine from noradrenergic neurons) or exogenous adrenergic agonists (e.g. inhaled beta-adrenergic agonists).

Inhaled glucocorticosteroids typically are not recommended for the treatment of acute asthma attacks. This practice is based on the fact that glucocorticosteroids by themselves do not cause rapid bronchodilation. However, the acute inhibition of adrenergic agonist disposal by the non-genomic action of glucocorticosteroids could lead to bronchial vasoconstriction by locally released norepinephrine thereby decongesting the airway wall, and potentiate the bronchodilator effect of a concomitantly administered beta-adrenergic agonist through the same mechanism. The purpose of this study is to assess the vasoconstrictive effects of single and repetitive high-dose budesonide inhalations in moderate to severe asthmatics who use inhaled glucocorticosteroids regularly. As a secondary endpoint, airway inflammation and airway function will also be measured with the expectation that acute improvements in airflow might be detectable as a result of airway decongestion, notably in subjects with moderately severe asthma who have lower baseline lung function.

Eligibility Criteria:
Inclusion Criteria:

Twenty lifetime nonsmokers moderate or severe asthmatics; FEV1≥50 of predicted on the screening day

Exclusion Criteria:

Women of childbearing potential who do not use accepted birth control measures; pregnant and breast feeding women; Cardiovascular disease and/or use of cardiovascular medication; Subjects with known beta-adrenergic agonist or glucocorticosteroid intolerance; Acute respiratory infection and or acute exacerbation of asthma within four weeks prior to the study; Use of systemic glucocorticosteroids within 4 weeks prior to the study; Daily ICS dose (fluticasone or budesonide) \> 500ug; Diabetes mellitus
The Surveillance of Hepatocellular Carcinoma

Early detection of hepatocellular carcinoma is vita to the prognosis of patient. In this study, the occurrence and development of liver cancer were supervised by imaging examination, and the dysplastic nodules will be distinguished from early hepatocellular carcinoma through macro-imaging and micro-pathological features.


Eligibility Criteria:
Inclusion Criteria:

- Patients with Hepatitis B and cirrhosis Accept regular imaging examination. Pathological diagnosis of liver cancer.

Exclusion Criteria:

- Can't tolerate the enhanced imaging examination Poor medical compliance
Study of a Model-based Approach to Blood Glucose Control in Very-low-birthweight Neonates

Very low birthweight neonates commonly develop high blood sugar levels. There is an association between high blood sugar levels and poorer short term outcomes but it is not known whether the high sugar level itself actually causes the problems.

There are a range of ways to manage high sugar levels but there are no consensus guidelines to follow. One option is to manage the high sugar levels with an infusion of insulin. Studies looking at insulin infusions have often used fixed protocols to guide the amount of insulin to be given and are often complicated by hypoglycaemia.

This study investigated whether using a model-based approach to individualise insulin administration to neonates with high sugar levels would provide a safe and effective management option for controlling blood sugar levels and avoid the complication of low blood sugar levels.


Eligibility Criteria:
Inclusion Criteria:

* Birthweight \<1500g
* Blood sugar \>/= 10mmol/L
* Clinician decision to start an insulin infusion

Exclusion Criteria:

* Infants who were moribund and not expected to survive
Clinical Study of Xingnaojing for the Treatment of Convulsive Diseases

The purpose of this study is to evaluate the efficacy of Xingnaojing for the treatment of convulsive diseases; to investigate whether convulsion episodes can be induced or aggravated by Xingnaojing and the role inflammation plays in the process.


Eligibility Criteria:
Inclusion Criteria:

1. Febrile convulsion: positive family history of febrile convulsion; aged between 6 months and 6 years old; in accordance with the diagnosis criteria of simple type of febrile convulsion
2. Frequent episodes of epilepsy: epilepsy episodes of all types; \> 3 times / week
3. Refractory epilepsy: no satisfactory efficacy after treatment by 2\~3 antiepileptic drugs; ≥ 1 time / month
4. Cerebral palsy: all types of cerebral palsy in children less than 3 years old. -

Exclusion Criteria:

1. Febrile convulsion: family history of epilepsy, complex type of febrile convulsion, epileptic episodes, febrile convulsion plus
2. Frequent episodes of epilepsy: combined with advanced diseases
3. Refractory epilepsy: epilepsy combined with advanced diseases
4. Cerebral palsy: advanced diseases combined with backwardness or retardation of brain function development.
Evaluation of the EarEEG System for Detection of Hypoglycaemia-induced Changes in the EEG in Subjects With Type 1 Diabetes

The EarEEG system is a novel non-invasive, unobstructed and discrete method for recording EEG in which the signal is recorded using dry-contact electrodes embedded on a customised ear piece. One intended medical indication of the EarEEG system is the detection of hypoglycaemia-induced changes in the EEG in patients with type 1 diabetes. Currently, no studies exist investigating the detection of hypoglycaemic episodes by use of ear electrodes. While a finger prick test accurately measures the blood glucose level, it does not provide continuous measurements, and hence it is unreliable as a hypoglycaemia alarm. Recent studies have indicated that the use of continuous glucose monitoring (CGM) reduces the risk of severe hypoglycaemia. However, some find these devices troublesome to use and utilisation of CGM has remained limited to date. Observational data show that only a small percentage of patients with type 1 diabetes are using CGM on an ongoing basis. Thus, there is a medical need for a reliable hypoglycaemia detection device which is easy and convenient to use.

This clinical study aims at investigating the feasibility of measuring hypoglycaemia induced changes in the EEG by use of the EarEEG system.


Eligibility Criteria:
Inclusion Criteria:

For a subject to be eligible, all inclusion criteria must be answered "yes":

1. Informed consent obtained before any study related activities1
2. Age 18-70 years
3. Patients with type 1 diabetes (duration ≥ 5 years)

Exclusion Criteria:

For a subject to be eligible, all exclusion criteria must be answered "no":

1. Severe cardiac disease

   1. History of myocardial infarction
   2. Cardiac arrhythmia
2. Previous stroke or cerebral haemorrhage and any other structural cerebral disease
3. Uraemia defined as s-creatinine ≥ 3 times upper reference value,
4. Liver disease defined as s-ALAT ≥ 3 times upper reference interval
5. Epilepsy
6. Use of antiepileptic drugs for any purposes
7. Use of the following drugs: Chemotherapeutic drugs of any kind, methotrexate, third generation antipsychotic drugs (aripiprazole, quetiapine, clozapine, ziprasidone, paliperidone, risperidone, sertindole, amisulpride, olanzapine)
8. Known or suspected abuse of alcohol defined as estimated consumption beyond that, which is recommended by the DHA1 or any other neuro-active substances
9. Use of hearing aid or cochlear implants2
10. Allergic contact dermatitis caused by metals or generally prone to skin irritation
11. Narrow or malformed ear canals
12. Patients that are judged incapable of understanding the patient information or who are not capable of carrying through the investigation
13. Pregnancy