cyrilzakka/clinical-trials huggingface dataset:
Point of Care Optic Nerve Sheath Ultrasound to Assess Intracranial Pressure

Elevated intracranial pressure (ICP) is one of the most common symptoms encountered in a variety of traumatic injuries and diseases. Any tissue swelling within the rigid confines of the skull results in increased ICP, which may lead to life-threatening structural alterations in the brain or cerebral blood flow, thus causing oxygen deprivation and ischemia in the brain.

Methods for ICP monitoring can be divided into invasive and noninvasive approaches. In fluid-based systems, external ventricular drainage (EVD) has been considered the gold standard.

Clinicians have found several noninvasive methods that can be used as surrogates for invasive methods for ICP measurement. The optic nerve, as part of the central nervous system, is wrapped by the dural sheath. The optic nerve sheath (ONS) is the continuation of the subarachnoid space at the optic nerve, and its tissues are connected with the subarachnoid space. Thus, an increase in ICP results in a corresponding elevation of the ONS diameter (ONSD).

Hypertonic solutions such as mannitol and hypertonic saline (HTS) are recommended early in the management of ICH after severe TBI . They provide therapeutic benefit along with a wide therapeutic margin. The most recent BTF guidelines stated "although hyperosmolar therapy may lower intracranial pressure, there was insufficient evidence about effects on clinical outcomes to support a specific recommendation, or to support use of any specific hyperosmolar agent".


Eligibility Criteria:
Inclusion Criteria:

1. Patients who having Isolated traumatized brain injury (not for surgical intervention)
2. 3\<GCS ≤ 12.
3. Both genders.
4. Age ≥ 18 and ≤ 60Years.
5. Physical status ASA I - III.
6. Cut off value for optic nerve sheath diameter (ONSD) as 5.5 mm to diagnose increase in ICP\> 20 mm Hg.

2. Exclusion criteria

1. Patients' first-degree relatives' refusal to sign the consent.
2. GCS (Glasgow coma score) \>12 or GCS of 3.
3. Contraindication to hypertonic saline: pregnancy, coagulopathy and cardiac dysfunction.
4. Spinal cord injury, orbital injury, optic nerve injury and optic neuritis.
5. Multi organ affection.
6. Serum Na level ≥ 150 mmol/L at admission to ICU.
7. Hypotension requiring vasopressors to maintain MAP above 60 mmHg.
Evaluation 2% Chlorhexidine Gluconate

Medline 2% CHG cloth (Active) - A single cloth from the pack was used per treatment area. The investigational test article was applied topically by vigorously scrubbing the skin in a back and forth motion for three minutes (and halfway through the 3-minute application time, the cloth was turned over) over the treatment area (7" x 10" of the subject's back), and the skin was allowed to air dry.


Eligibility Criteria:
Inclusion Criteria:

Healthy males of at least 18 years of age having skin within 6 inches of the test regions that were free of tattoos, dermatoses, abrasions, cuts, lesions or other skin disorders, with no history of sensitivity to CHG and were able to lie prone for up to 30 minutes.
Effect of Changes in Dialysate Bicarbonate on Serum Calcification Propensity and Calciprotein Particles in Hemodialysis Patients

This is a single-center, prospective, proof-of-priciple, pilot study in 24 end-stage renal disease patients on chronic hemodiaysis.

This single-arm, proof-of-principle study will be conducted at the dialysis facility of the Ordensklinikum Linz Elisabethinen Hospital. The dialysate bicarbonate prescription will be decreased from standard of care (usually 35mmol/l) in a stepwise fashion (2 mmol/l per change) to 27 mmol/l and subsequentially increased in a stepwise fashion (2 mmol/l per change) to 37 mmol/l over the course of 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years
* chronic (≥3 months) treatment with hemodialysis or hemodiafiltration
* stable clinical condition

Exclusion Criteria:

* inability to provide informed consent
* dialysis treatment less than thrice weekly
* morbid obesity (body mass index \>40 kg/m2)
* chronic inflammation (C reactive protein \>10 mg/dL, reference: \<0.5 g/dL)
* current immunosuppressive medication,
* severe chronic obstructive pulmonary disease (COPD stage III or IV)
* history of severe hypercapnia or hypoxemia
* overt congestive heart failure
* history of severe hypokalemia (\<3.0 mmol/l) or hyperkalemia (\>6.5 mmol/L) within 3 months prior to study inclusion.
Cue2Walk, Cost-effectiveness of Automated Freezing Detection and Provision of External Cues in Comparison to Usual Care in People With Parkinson's Disease

The majority of people with Parkinson's disease incur Freezing of Gait (FoG), which is not addressed adequately by medication. Cueing is a proven strategy to overcome FoG. The Cue2Walk is a device with automated detection of FoG and provision of rhythmic cues. In this study, the (cost-)effectiveness of the Cue2Walk device as compared to usual care is investigated.

Freezing of gait (FoG) is one of the most common and disabling motor symptoms of Parkinson's disease and is associated with poorer quality of life. However, current pharmacological or even surgical treatments do not address FoG adequately and innovative rehabilitation strategies are needed. Cueing is a proven strategy to overcome FoG episodes and an essential part in the management of FoG. The Cue2Walk, a Medical Device Class I CE-certified leg-worn device, addresses the debilitating effects of FoG episodes at home with 'smart cueing' by combining automatic detection of a freezing episode with manual or automatic rhythmic cues (auditory or vibro-tactile). This study aims to investigate the (cost-)effectiveness of the Cue2Walk device as compared to usual care. This study is a multicenter randomized clinical trial with 2 parallel groups (24-week intervention group and 24-week 'waiting list' group). After 24 weeks, an 8-week naturalistic follow-up will be implemented for the intervention group, while participants in the waiting list group will also receive the intervention, but for 8 weeks. Frequently repeated assessment of outcomes measures will be conducted.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Parkinson's disease according to UK Brain bank criteria
* Daily Freezing of Gait
* Hoehn-Yahr stage 2-4
* Stable medication regime and/or DBS settings as determined by the treating neurologist
* Ability to walk 5 minutes while unassisted by another person

Exclusion Criteria:

* Participation in another clinical study
* Use of a personal cueing device at home
* Previous use of the Cue2Walk medical device
* Presence of co-morbidities that would hamper participation
* Cognitive impairment preventing understanding of therapeutic instructions (Montreal Cognitive Assessment (MoCA) Score \<16)
A Retrospective Study in Patients with Liver Injury After the Use of Novel Antineoplastic Agents

This is an open-enrollment, retrospective, observational study without interventions. Its primary objective is to understand 1) incidence of liver injury among all the hospitalized patient from participating centers after the administration of immune checkpoint inhibitors or molecularly targeted agents; 2) epidemiologic and clinical characteristics of liver injury, including suspected medications, clinical types, histological characteristics, severity, treatment and outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Abnormality of liver biochemistry after the administration of any molecularly targeted agent or immune checkpoint inhibitor

Exclusion Criteria:

* Missing major baseline or clinical data
* Prior liver loco-regional therapy or surgery
Volar Plating or External Fixation of Dorsally Displaced Fractures of the Distal Radius?

Promising results have been reported after volar locked plating of unstable dorsally displaced fractures of the distal radius. It offers stable fixation and early mobilization. The investigators' aim is to test if volar locked plating results in better patient-perceived, objective functional and radiological outcomes compared to the less invasive external fixation that has been the standard operation for decades.


Eligibility Criteria:
Inclusion Criteria:

* An acute unilateral Colles' fracture (AO class A and C1) with a dorsal angulation of more than 20 degrees or radial shortening of 4 mm or more, AND
* Patient aged 20-70 years with no previous fracture of either wrist.

Exclusion Criteria:

* Bilateral fractures,
* Other current injury to the upper extremities,
* Dementia, OR
* Severe comminution or too small distal fragment to allow plating.
Observational Cohort of Pancreatic Echo-endoscopy

Metabolic syndrome is defined by the presence of at least two of the following five criteria: abdominal perimeter\> 94 cm in men, 80 cm in women, high triglycerides, low HDL cholesterol, HTA and hyperglycemia.

The metabolic syndrome can lead to ultrasound hepatic steatosis in 20 to 40% of cases depending on the population studied (overweight vs obesity). What is the impact of this syndrome on pancreatic echogenicity?

Little is known about the pathogenesis of the fatty pancreas. Fat can replace acinar cells and / or pancreatic endocrine cells (1). To date, there are no biomarkers allowing the detection of a fatty pancreas. It appears that older age, male, obesity, alcohol consumption, high triglycerides, high ALT, diabetes or insulin resistance, fatty liver and metabolic syndrome are risk factors for a fatty pancreas (2,3,4).To the investigator's knowledge, these different factors have not been evaluated on the impact of pancreatic echogenecity in endosonography. The objective of this study is to correlate the factors making up the metabolic syndrome with pancreatic echogenecity.

Eligibility Criteria:
Inclusion Criteria:

* any consecutive patient, having a high echo-endoscopy
* for an extra pancreatic cause, such as the search for a cholelithiasis, (the pancreas will be studied completely)
* for esophageal pathologies, (the pancreas will be studied completely)
* for gastric pathologies, (the pancreas will be studied completely)
* for cystic lesions of the pancreas (pancreas studied upstream and downstream)
* for submucosal tumors (esophageal / gastric / duodenal)
* for abdominal pain of undetermined origin

Exclusion Criteria:

* Patients with pancreatic and / or tissue damage with dilated wirsung canal and / or acute or chronic pancreatitis.
* Patients having contraindication to general anesthesia
Treatment of Iron Deficiency Anemia With Pregnancy

Iron deficiency anemia is a very common problem accompanying pregnancy. in this study, the investigators are going to compare the efficacy and tolerability of two preparations of oral iron in treatment of iron deficiency anemia with pregnancy.

In this study, the investigators are going to compare two preparations of oral iron in treatment of iron deficiency anemia with pregnancy. a total of 300 pregnant women will be randomly divided into two equal groups (each containing 150 pregnant woman). one group will receive amino acid chelated iron and the other group will receive iron salt (ferrous fumarate). All pregnant women attending the obstetrics outpatient clinic of kasr al aini hospital at 14-18 weeks gestation will be submitted to complete blood picture and serum ferritin. those who prove to have iron deficiency anemia (hemoglobin less than 11g/dl and serum ferritin less than 12ug/l) will be included in the study. All eligible women will be followed up at 22-23, 29-30 and 36-37 weeks' gestation for the change in hemoglobin level and ferritin level. all women will be also enquired about different side effects during treatment period.

Eligibility Criteria:
Inclusion Criteria:

* Age: 20-40 years
* Pregnant 14-18 weeks
* Singleton fetus
* Hb 7-10.9 g/dl
* Serum ferritin \<12 microgram/L

Exclusion Criteria:

* history of anemia due to other causes as chronic blood loss, hemolytic anemia or thalassemia
* Multiple pregnancy
* known hepatic, renal or cardiovascular abnormality.
* Known peptic ulcer, esophagitis, gastritis or hiatus hernia.
* Family history of thalassemia, sickle cell anemia, or malabsorption syndrome.
* Iron preparation intake within 24 hours of inclusion
The Effect of Peripheral Neuropathy Symptoms on Temporomandibular Joint Functionality

The aim of this observational case-control study was to investigate the effect of diabetic peripheral neuropathy symptoms on temporomandibular joint functionality in patients with type 2 diabetes.

The number of participants planned to be included in the study was decided with the G-Power programme. While calculating the number of individuals to be included in the study, it was calculated that the sample size to obtain an effect size of 0.6 for the purpose of evaluation within the 95% confidence interval in a way to provide 80% study power at 5% Type 1 and 20% Type 2 error limits should be 74 (n=37) individuals. This study included 70 individuals (DM study group=40 individuals, control group=30 individuals).

Peripheral neuropathy symptoms of all participants were evaluated with the Michigan Neuropathy Screening Test. In the evaluation of TMJ functionality, the presence of pain, maximum pain-free mouth opening, mandibular dysfunction and dysfunction were assessed with the help of scales. Duration of diabetes mellitus was recorded and quality of life was evaluated with Ferran Powers Quality of Life Index.

Eligibility Criteria:
Inclusion Criteria:

* Individuals diagnosed with type 2 DM

Exclusion Criteria:

* Having diabetic foot ulcer,
* Mini Mental Test score below 24,
* History of psychiatric illness, cancer, neurological problems, congenital anomalies, musculoskeletal problems, systemic disease, facial paralysis, surgical operation related to spine, abdomen and/or TMJ problem
* Receiving any treatment related to spine and TMJ in less than 6 months
Biological Standardization of Blomia Tropicalis Allergen Extract

The objective of this study is to determine the biologic activity of a Blomia tropicalis allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house reference preparation (IHRP).

This is an open, unblinded and non-randomized biological assay. The study design is a slight modification of the recommendations proposed by the Nordic Guidelines.

Four concentrations of Blomia tropicalis allergen extract, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively, will be tested in every patient in duplicate on the volar surface of the forearm.

Eligibility Criteria:
Inclusion Criteria:

1. A documented positive case history with inhalation allergy (rhinitis and/or rhinoconjunctivitis and/or asthma) related to Blomia tropicalis.
2. Subject has provided written informed consent, appropriately signed and dated by the subject (or legal representative, if applicable).
3. Subject can be male or female of any race and ethnic group.
4. Age \> 18 years and \< 50 years at the study inclusion day.
5. Positive skin prick test with a standardized commercially available preparation of Blomia tropicalis allergen extract. The skin prick test will be considered positive if the test results in a wheal major diameter of at least 3 mm and at least the size of the positive control. Positive skin prick test results are valid if performed within one year prior to the inclusion of the subject in the study
6. A positive test for specific IgE to Blomia tropicalis(CAP-RAST ≥ 2). IgE results are valid if performed within one year prior to the inclusion of the subject in the study.
7. Allergic symptoms during the season of Blomia tropicalis.
8. Mean of the forearm major diameters of the wheals provoked by histamine dihydrochloride (10 mg/ml) ≥ 3 mm.

Exclusion Criteria:

1. Immunotherapy in the past 5 years with an allergen preparation known to interfere with the allergen to be tested (e.g., mites group extracts).
2. Use of drugs that may interfere with the skin reactions (e.g., antihistamines). See Appendix 1
3. Treatment with any of the following medications: tricyclic or tetracyclic antidepressants, β-blockers or corticosteroids (\> 10 mg/day of prednisone or equivalent).
4. Pregnancy.
5. Dermographism affecting the skin area at the test site at either study visit.
6. Atopic dermatitis affecting the skin area at the test site at either study visit.
7. Urticaria affecting the skin area at the test site at either study visit.
8. Participation in another clinical trial within the last month.
9. Subjects suffering from pathologies or conditions in which adrenalin is contraindicated (heart disease, severe hypertension,...)
Efficacy and Safety of Biphasic Insulin Aspart 30 in Type 2 Diabetes Mellitus When Failing on OADs

This trial is conducted in Europe.

This is a clinical trial investigating the effectiveness and the safety of using biphasic insulin aspart 30 both for initiation and intensification of insulin treatment in type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes Mellitus for more than 12 months
* HbA1c: 7.5 - 11.0%
* An antidiabetic regimen that has been stable for at least 3 months prior to screening
* An antidiabetic regimen that includes a minimum of 2 oral anti-diabetic drugs (OADs) or 1 OAD plus evening or bedtime basal insulin
* OADs dosed at 50% or more of the maximum recommended dose

Exclusion Criteria:

* Use of any insulin preparations other than NPH or glargine within the past 6 months
* Use of more than 60 units of insulin per day
* Morning time insulin administration
* Use of more than one insulin dose daily
Evaluating the Efficacy of a Brief Online Intervention Among Current Heavy Drinkers

Unhealthy alcohol consumption is common in the UK and causes tremendous harm to the individual, as well as harm to others. A significant gap in providing alcohol support is that most people with unhealthy alcohol consumption will never receive advice to cut down on their drinking. However, many are interested in self-directed interventions to help them evaluate their drinking and to motivate reductions in alcohol use. One such promising intervention uses online personalised normative feedback (PNF) which compares a person's drinking with others in the general population of the same age and sex. PNF interventions are thought to work because many people with unhealthy alcohol consumption overestimate how much others drink. Multiple trials have demonstrated that providing PNF to people with unhealthy consumption reduces their alcohol use . While several UK websites do provide feedback on assessment of risk (e.g., Down Your Drink introductory section, Alcohol Change UK), there appears to be no online intervention that provides PNF for unhealthy alcohol consumption.

The major objective of this pilot project is to conduct a two-arm, parallel group randomised controlled trial (RCT) in which 1,318 participants recruited from the Prolific website who have identified themselves as drinking 14 or more units per week are randomly assigned to one of two groups - a) those who are offered a PNF report, and b) those in a no intervention comparator group. Participants in the comparator group will not be provided any intervention materials but will instead be given a list of the different components of the PNF feedback and will be asked to think about how useful they would find each of them. Follow-up assessment will occur at 1 and 6 months post-randomisation. The project is described as a pilot because it is a preliminary evaluation of the PNF intervention in a UK context.


Eligibility Criteria:
Inclusion Criteria:

1) score 8 or more on the AUDIT (indicating current unhealthy alcohol use); and 2) endorsed the attention check questions correctly.

Exclusion Criteria:

Not meeting these inclusion criteria forms the exclusion criteria
Comparison of Emergence Agitation Between Sevoflurane and Desflurane Anesthesia After Orthognathic Surgery

Emergence agitation is a major concern in patients undergoing orthognathic surgery. The patients may experience the sense of suffocation during emergence due to nasotracheal intubation and orofacial edema. Postoperative pain is also associated with emergence agitation. Although there is a lot of studies about emergence agitation in children, there is a few in adults, furthermore, no data about comparison of emergence agitation between sevoflurane and desflurane anesthesia in adults. Therefore, the investigators would like to compare the incidence and severity of emergence agitation between sevoflurane and desflurane anesthesia in adults after orthognathic surgery.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists(ASA) physical status classification 1 or 2 patients
* patients scheduled for orthognathic surgery

Exclusion Criteria:

* severe cardiopulmonary disease
* psychological disease
* patients who cannot understand Korean
Modified Endotracheal Balloon Dilator to Improve Patient Oxygenation and Allow Ventilation During Airway Procedures

The purpose of the study is to prospectively assess the use of a modified tracheal balloon dilator that allows gas flow (oxygenation and ventilation) through the device while inflated during dilatation.

The primary aim is to determine the incidence of, and time to, arterial desaturation (defined as peripheral plethysmography below 90%). Secondary aims include quantitative and qualitative (waveform) end-tidal capnography levels throughout the procedure, quantitative assessment of dilatation, and incidence of adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Symptoms of tracheal or laryngeal stenosis or airway narrowing
* Endoscopic evidence of subglottic or tracheal stenosis
* Able to provide informed consent

Exclusion Criteria:

* Refractory stenosis not amenable to balloon dilatation
* Contraindication to balloon dilatation
* Lack of informed consent
Outcomes From a RCT Comparing Preventive Versus Delayed Ligation of DVC During Robot-assisted Radical Prostatectomy

Since its introduction, robot-assisted radical prostatectomy (RARP) have become the standard surgical approach for the treatment of prostate cancer in the United States and then in Europe. Continuous refinements of surgical technique has been described in order to maximise outcomes while minimizing morbidities.

The management of DVC is a crucial steps during RARP. It could be done prior or after its transection thanks to haemostatic effects of the pneumoperitoneum. This topic has been already investigated by some authors. However, no high quality evidence is available to opt in favour of either of the two approaches. Findings about estimated blood loss, positive surgical margins and urinary recovery differ among these studies and only one is a randomized controlled trial in a laparoscopic setting with a limited number of patients.

Therefore, our objective was to evaluate in a prospective randomised setting whether a delayed ligation of the dorsal vascular complex impacted on perioperative, functional and oncological outcomes as compared to preventive ligation during robot-assisted radical prostatectomy.


Eligibility Criteria:
Inclusion Criteria:

* male patients, aged 18-80 years
* patients willing and able to provide written informed consent
* voluntary partecipation
* clinical indication to robot-assisted radical prostatectomy

Exclusion Criteria:

* coagulation impairment at the time of surgery
* salvage radical prostatectomy