cyrilzakka/clinical-trials huggingface dataset:
Liver Ablative Radiotherapy Utilising Kilovoltage Intrafraction Monitoring (KIM)

Primary and secondary liver cancer patients will receive liver SABR with or without KIM intervention.

This is a single arm, phase II, two stage study designed to evaluate cancer targeting accuracy, treatment outcomes and treatment efficiency in 46 patients eligible for SABR for either primary or secondary liver malignancy with the incorporation of KIM.

Eligibility Criteria:
Inclusion Criteria:

* ECOG performance status 0-1
* Life expectancy \>6 months
* Number of lesions: ≤ 3
* Lesion size : \< 10 cm for a single lesion (and up to 10 cm cumulative diameter for multiple lesions)
* Child-Pugh A or B7 within 6 weeks prior to study entry
* Unsuitable for RFA or resection or transplant
* Distance from GTV to luminal structures (i.e., oesophagus, stomach, duodenum, small or large bowel) ≥ 10mm
* All blood work obtained within 6 weeks prior to study entry with adequate organ function
* May have had previous surgery, RFA or ethanol injection
* Patient must have been discussed at multidisciplinary tumour board with consensus opinion for SBRT

Exclusion Criteria:

* HCC/cholangiocarcinoma with evidence of metastatic disease including nodal or distant metastases
* Metastatic disease with complete liver disease response to first-line chemotherapy (i.e. no target for SBRT)
* Previous radiation to the liver (including SIRTEX)
* Untreated HIV or active hepatitis B/C
* On systemic antineoplastic drug therapy within 7 days before inclusion
* Pregnant or lactating women
Knowledge, Attitude and Practices Regarding Green Eco-Friendly Dentistry Among a Group of Dentists

Global warming, reduction in resources, increase in prices are all factors leading to more direction towards reuse, recycling, and reduction in use of materials. The World Dental Federation (FDI) considers sustainability to be an indispensable principle of Dentistry, which "must be practiced ethically, with high levels of quality and safety, in the pursuit of optimal oral health. Sustainability requires more attention from dental health professionals to reduce, recycle and reuse available resources.

The direction towards more reuse, recycling and reduction in the use of materials is a global direction. The Egyptian society needs to address the concepts, however, there is lack of knowledge on the knowledge, attitude, and practices of Egyptian dentists regarding green eco-friendly Dentistry.

Research question:

What is the knowledge, attitude, and practices of a group of dentists regarding green eco-friendly Dentistry?

Eligibility Criteria:
Inclusion Criteria:

* Graduated dentists.
* Dentists graduated from Egyptian universities.

Exclusion Criteria:

* Refusal of participation.
Intra-Venous Acetaminophen and Muscle Relaxants After Total Knee

This is a prospective, three-arm, randomized, open-label trial to determine if a new pain control protocol which includes regular dosing of intravenous acetaminophen and orphenadrine for 48 hours after total knee surgery reduces the need for opioid pain medication and reduces average pain scores.

This research will be a prospective, three-arm, randomized, open-label trial to assess opioid use and patient reported outcomes after 48 hours of regular IV acetaminophen and muscle relaxant (IVAM) orphenadrine administration following total knee replacement surgery. 180 patients (60 in each arm) will be randomized to receive the standard group treatment, the IVAM group treatment, or to the control grouptreatment.

Standard Group Treatment: includes peripheral nerve single injection or catheter infusions (48 hours) as requested by the surgeon; preoperative (single dose) intravenous acetaminophen (1000 mg) and orphenadrine (60 mg); intraoperative spinal anesthesia or general anesthesia as determined by the anesthesia attending physician; postoperative oral oxycodone (5 mg) with acetaminophen (325 mg) (PRN dosing), oral orphenadrine (100 mg) every 12 hours for 3 doses, and intravenous hydromorphone (PRN dosing) for breakthrough pain.

Control Group Treatment: includes peripheral nerve single injection or catheter infusions (48 hours); preoperative (single dose) intravenous acetaminophen (1000 mg) intraoperative spinal anesthesia or general anesthesia as determined by the anesthesia attending physician; and postoperative oral oxycodone and acetaminophen (PRN dosing), and intravenous hydromorphone (PRN dosing) for breakthrough pain.

IVAM Group Treatment: includes peripheral nerve single injection or catheter infusions (48 hours); preoperative intravenous acetaminophen (1000 mg) and orphenadrine (60 mg); intraoperative spinal anesthesia or general anesthesia as determined by the anesthesia attending physician; postoperative intravenous acetaminophen (1000 mg) every 6 hours routine for total of 8 doses and intravenous orphenadrine (60 mg) every 12 hours for total of 4 doses; oral oxycodone (5 mg) (PRN dosing), and intravenous hydromorphone (PRN dosing) for breakthrough pain.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-85
2. Primary, unilateral total knee arthroplasty
3. American Society of Anesthesiologist (ASA) physical status I, II, or III

Exclusion Criteria:

1. Chronic pain (as determined by regular opioid use in the month preceding surgery)
2. Preoperative use of centrally acting muscle relaxants in the 24 hours preceding surgery
3. Peripheral regional anesthesia procedures other than femoral nerve injections or catheters for postoperative pain control (such as popliteal block)
4. Severe renal dysfunction, creatinine \> 2.0
5. Allergy or other contraindications to use of orphenadrine and/or acetaminophen
6. Pregnant or breast feeding
7. Abnormal Liver Function Tests(LFT) and / or history of chronic/excessive alcohol abuse.
8. History of Hepatitis, B or C,
9. History of cirrhosis or hepatic insufficiency
Chronic Obstructive Pulmonary Diseases and Proprioceptive Neuromuscular Facilitation

To investigate the effects of resistant proprioceptive neuromuscular facilitation exercises on physical fitness, respiratory muscle strength, walking distance and quality of life in chronic obstructive pulmonary patients.

The study was carried out between January 2017 and January 2019, with patients followed up with the diagnosis of COPD in Çanakkale Mehmet Akif Ersoy State Hospital and Çanakkale Onsekiz Mart University Medical Faculty Hospital, Department of Chest Diseases. It was approved by Istanbul Medipol University Non-Interventional Clinical Research Ethics Committee (Date: 30.12.2016, Decision No. 573) and was done in accordance with the Declaration of Helsinki. All participants were informed about the purpose of the study, the total duration of treatment and the applications to be made, and a consent form was signed. The study was conducted as a prospective and randomized controlled study, and inclusion and exclusion criteria were determined.

Thirty-five patients diagnosed with COPD were referred to the study, four patients were excluded because they did not meet the inclusion criteria, and the study was conducted with a total of 31 participants.

The 31 patients included in the study were randomized after their initial evaluation and divided into two groups as experimental and control groups. Patients meeting the inclusion criteria were divided into 2 groups. Randomized by ordering by date of application.

Eligibility Criteria:
Inclusion Criteria:

* To be diagnosed with stage 1, stage 2 and stage 3 COPD according to GOLD (Global Initiative for Obstructive Lung Diseases) criteria
* Having FEV1/FVC \<70% according to pulmonary function test
* Being clinically stable
* Being over 18 years old
* Volunteer to participate in the program

Exclusion Criteria:

* Having a COPD exacerbation in the last 8 weeks
* To have participated in a regular exercise training program in the last 1 year
* Having a musculoskeletal disease and neuromuscular disease that may prevent exercise
* Inability to cooperate for pulmonary function test and respiratory muscle strength measurement
* Being on long-term oxygen therapy
A Study to Assess Efficacy, Long Term Safety and Tolerability of RT001 in Subjects With Friedreich's Ataxia

The purpose of this study is to assess the Efficacy, Long Term Safety and Tolerability of RT001 in subjects with Friedreich's Ataxia

This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, tolerability, in subjects with FRDA following the oral administration of study drug (active or placebo capsules). Sixty eligible patients will undergo various assessments at different time points during the the study. The study duration is 13 months which includes screening, treatment and safety follow up phone call.

Eligibility Criteria:
Key Inclusion Criteria:

1. Male or female 12 to 50 years of age
2. Medical history consistent with the symptoms of FRDA at ≤ 25 years of age
3. Detection of biallelic pathogenic variants in frataxin gene (FXN)
4. Ambulatory (with or without assistive device) and capable of performing other assessments/evaluations.
5. Must be able to walk 25 feet during the timed 1-minute walk

Key Exclusion Criteria:

1. Received treatment with other experimental therapies within the last 30 days prior to the first dose
2. Previously participated in the RT001 trial
3. Refusal to discontinue fish oils or other oil-based supplements for the duration of the study (Screening till last study procedure completed)
4. History of malignancies (other than basal cell carcinomas)
5. Inability to complete CPET protocol
6. Female who is breastfeeding or has a positive pregnancy test
7. History of uncontrolled diabetes mellitus (Type 1 or 2)
Measurement of the Skin Sympathetic Nerve Activity During Stellate, Thoracic, and Lumbar Sympathetic Ganglia Block

Sympathetic nerve activity can be measured transcutaneously in awake patients by computer-based filtering of raw signal obtained via skin leads attached on the chest and the right arm. Electrocardiogram can be removed by applying a high-pass filter setting of 150 Hz. Electromyogram can be filtered by applying a high-pass filter setting of 500 Hz or a band-pass filter setting of 500-1000 Hz.

Currently, the therapeutic effect of stellate, thoracic, and lumbar sympathetic ganglia block (SGB, TSGB, and LSGB, respectively) in patients with chronic pain is generally evaluated by using thermogram/thermography (change in temperature of the upper or lower extremeties) or questionnaire-based scoring.

However, it is not known whether the skin sympathetic nerve activity (SKNA) can be measured in patients undergoing SGB/TSGB/LSGB and used as an alternative tool for assessing the therapeutic effect of SGB/TSGB/LSGB.

Therefore, we planned this pilot study to observe whether the SKNA can be obtained in patients undergoing SGB/TSGB/LSGB and whether it is well correlated to thermogram or questionnaire-based scoring. If the SKNA is observed and decreases after SGB/TSGB/LSGB, it will be presented in milivolt (uV) and compared to that of pre-block values.


Eligibility Criteria:
Inclusion Criteria:

* Outpatient patients undergoing stellate, thoracic, and lumbar sympathetic block for chronic pain disease

Exclusion Criteria:

* patients denial
* peripheral vascular disease in the head and the upper extremities.
* prior thoracic sympathectomy/sympathicotomy
* prior resection or ablation (chemically or mechanically) of stellate, thoracic, and lumbar sympathetic
* coagulapathy
* infectious disease
* allergy to local anesthetics
Optic Nerve Sheath Diameters in Idiopathic Intracranial Hypertension Patients

Idiopathic intracranial hypertensionis a type of increased intracranial pressure. Diagnosis is made by lumbar puncture, which is an invasive technique. The relationship between ICP and optic nerve sheath diameters (ONSD) were examined in our study. Thus, it was investigated whether the optic nerve sheath diameter could be used in the diagnosis of IIH. In the present study, it was found that ONSD measurement by optic USG significantly reflects increased ICP and decreasing pressure via LP is rapidly reflects to ONSD measurement. And it is suggested that ONSD measurements by optic USG, a non-invasive method, can be used in the diagnosis and follow-up of IIH patients.

Backgrounds: Idiopathic intracranial hypertension (IIH); symptoms include headaches, blurred vision and papilledema which may lead to permanent visual loss. Definitive diagnosis of IIH usually requires the measurement of intracranial pressure (ICP) via lumbar puncture (LP) which is an invasive technique. In our study, the relationship between ICP and optic nerve sheath diameters (ONSD) were examined. Thus it was investigated whether optic nerve ultrasonography (USG) is a useful tool instead of LP for the diagnosis of IIH.

Methods: A total of 25 patients who applied to the neurology clinics of Ankara Numune Training and Research Hospital between May 2014 and December 2015 and were diagnosed with IIH were included in the study. The control group consisted of 22 individuals who applied with other complaints than headaches. ONSD was measured from both eyes before and after the LP. After pre-LP measurements were taken, opening and closing CSF (cerebrospinal fluid) pressure was measured. In the control group, ONSD was measured with optic USG.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of idiopathic intracranial hypertension
* Adults aged 17-65

Exclusion Criteria:

* In cranial imaging, if pathology such as tumor, sinus vein thrombosis is detected
* People for whom lumbar puncture is contraindicated or cannot be performed
Hearing for Learning Initiative - a Health Facilitator Model for Otitis Media

The Hearing for Learning Initiative is a stepped-wedge cluster randomised controlled trial. The HfLI will implement and rigorously evaluate an innovative community-based service-enhancement model of ear and hearing health, in partnership with participating communities and health and education services.

This initiative will address the following research question: In urban, rural and remote Aboriginal communities in the Northern Territory, does employment, training and integration of local Ear and Hearing Clinical and Education Support Officers into health and education services (the Hearing for Learning initiative), compared to current practice, increase the proportion of children who receive an ear assessment, reduce the prevalence of ear and hearing problems and improve education outcomes of Aboriginal and Torres Strait Islander children, during a four year trial period?

Background: Australian Indigenous children achieve lower scores in school readiness and education outcomes than their non-Indigenous peers. Chronic otitis media and hearing loss during early childhood are associated with lower scores for these outcomes. Local problem: Failure to meet child health program schedules and evidence based practice in ear and hearing health is linked to high turnover of the health workforce, inadequate clinical skills and poor knowledge of ear and hearing health needs of children.

This Hearing for Learning Initiative aims to improve health care and education services.

Interventions: The intervention involves training and employing non-professional community members to facilitate busy primary health care services to deliver evidence-based ear and hearing health assessments in children 0 to 16 years of age, and to facilitate the teaching and home learning of hearing impaired children (the intervention).

Trial design: A stepped-wedge community (n=18) cluster-randomised trial will compare the proportion of children receiving an ear assessment (primary outcomes) in the HfLI (intervention) periods with no HfLI (control) periods. Participating communities will be randomly assigned in 6-monthly steps to shift from control to intervention on pre-specified start dates.

Outcomes: the primary outcome is the change in the proportion of Aboriginal and Torres Strait Islander children who receive an ear assessment, between intervention and control periods.

Eligibility Criteria:
Inclusion Criteria: Aboriginal or Torres Strait Islander, resident in participating community (cluster)

Exclusion Criteria: none
A Novel mHealth Application Guided by an Optimization Algorithm for T1D Sensor-Augmented Insulin Injection Users

The Artificial Pancreas lab at McGill University has developed an optimization algorithm for adults with Type 1 Diabetes (T1D) on Multiple Daily Injection (MDI) therapy with the adjunctive use of glucose sensor technology, collectively known as sensor-augmented MDI therapy. The algorithm is designed to estimate optimal basal-bolus parameters based on the patient's glucose, insulin and meal data over several days. The investigators hope that this algorithm will be better able to improve long-term glycemic targets by reducing HbA1c levels compared to sensor-augmented MDI therapy alone.

The changes in eligibility criteria indicated below are from a previously approved amendment but were inadvertently omitted in the previous PRS update made in November of 2020. Therefore, this note serves to clarify the order of updates.

Inclusion: HbA1c ≥ 7.5% in the last 2 months (modification)

Exclusion:

* More than 1 slow-acting injection and unwilling to switch to once a day for the study (addition)
* Severe hypoglycemic episode within one month of admission (addition)

In the subsequent amendment, we modified the timeframe for the HbA1c inclusion criterion to obtain a more accurate representation of their current glucose control at the time of enrollment.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females ≥ 18 years of age
2. Clinical diagnosis of type 1 diabetes for at least 12 months. The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
3. Undergoing multiple daily injection therapy.
4. Baseline HbA1c value ≥ 7.5% (up to 7 days before or after screening).

Exclusion Criteria:

1. Serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
2. Failure to comply with the study protocol or with the team's recommendations.
3. Injection of isophane insulin (NPH) or any intermediate-acting insulin
4. More than 1 slow-acting injection and unwilling to switch to once a day for the study
5. Current or ≤ 1-month use of other antihyperglycemic agents (Sodium-Glucose Cotransporter 2 inhibitor (SGLT2), Glucagon-Like Peptide-1 (GLP-1), Metformin, Acarbose, etc....).
6. Pregnancy
7. Severe hypoglycemic episode within one month of admission.
8. Severe diabetic ketoacidosis episode within one month of admission
9. Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator
10. Recent (\<6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery
11. Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
High Power Short Duration Ablation for Paroxysmal AF With High Density Multi Directional Mapping (LOWE AF HD Study).

The LOWE AF HD is a prospective, single-center, non-randomized study to assess safety, efficacy, acute and long-term outcome data of a specific ablation approach as treatment of paroxysmal atrial fibrillation.

Pulmonary vein isolation using radiofrequency (RF) ablation is acknowledged used treatment strategy for atrial fibrillation, many different approaches are recently implemented. The specific approach used in this study includes:

* Multi-directional high-density mapping
* High power - short duration settings
* Contact force sensing ablation catheter The aim of LOWE AF HD is to assess the acute safety and success rate of this approach and also the long-term outcome assessed by atrial recurrences arrythmias collected by an implantable loop recorder.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive and unselected patients with a class I-IIa indication for ablation of paroxysmal AF
* 18 Years and older.
* Able and willing to provide written informed consent prior to any clinical investigation related procedure
* Able and willing to complete all required study procedures through 12 months
* Life expectancy less than 12 months

Exclusion Criteria:

* Persistent or long-standing persistent AF
* Presence of thrombus in left atrium and left atrium appendage
* MI, CABG or PCI within preceding 3 months
* Left atrial diameter \> 5.0 cm
* LVEF \< 35%
* NYHA class III or IV
* Previous atrial fibrillation ablation procedure with high density and high-power short duration approach
* Previous tricuspid or mitral valve repair surgery
Pretreatment of Patients Expecting Bariatric Surgery With the GLP-1 Analogon Liraglutid

The aim of this study is to investigate the effect of the treatment with the GLP-1 Analogon Liraglutide on the lipid metabolism an inflammation in adipose tissue.

The aim of this study is to investigate the effect of the treatment with the GLP-1 Analogon Liraglutide on the lipid metabolism an inflammation in adipose tissue. As GLP-1 is presumed to improve insulin sensitivity and associated parameters the investigators hypothesize that this might be due to changes in lipid metabolism which might be involved in the regulation of insulin sensitivity. Therefore the investigators intend to investigate changes of metabolic pathways before and after treatment with the GLP-1 analog liraglutide that could play a crucial role in pathogenesis as well as regulation of insulin sensitivity and atherogenic dyslipidemia such as: de novo lipogenesis and reverse cholesterol transport

Eligibility Criteria:
Inclusion Criteria:

* BMI 35-55 Kg/m2
* Fasting Blood glucose \>140mg/dl
* Planned bariatric surgery
* Diabetic Medication (Metformin, Sulfonylurea, Insuline)

Exclusion Criteria:

* Known hypersensitivity against Liraglutid
* Pretreatment DPP-4 Inhibitors or GLP-1 Analogue the last 3 months
* HbA1c \>10%