cyrilzakka/clinical-trials huggingface dataset:
SBRT for Hepatocellular Carcinoma Patients With Partial Response to TACE

This is a pilot study where patients with Hepatocellular Carcinoma (HCC) that have failed Transarterial Chemoembolization (TACE) will be treated with Stereotactic Body Radiation Therapy (SBRT). The focus of the study will be to evaluate safety and efficacy in our population of patients.


Eligibility Criteria:
Inclusion Criteria:

* HCC diagnosis according to the American Association for the Study of Liver Diseases (AASLD) 2010 criteria
* Tumor Stage
* liver only disease
* tumor thrombus at segment is allowed
* no extra hepatic metastases
* tumor encompassing less than 50% of hepatic volume
* previous treatment with Transarterial Chemo Embolization (TACE) - patient must have performed at least 2 sessions of TACE and have signs of viable tumor in CT or MRI performed 30-40 days after last TACE
* presence of measurable lesion (at least one lesion that can be measured equal or more than 1 cm in CT or MRI).
* Maximum lesion size of 10 cm.
* Liver residual volume equal or more than 700cc or 40% of total liver volume
* Child-Pugh A or absence of hepatic cirrhosis
* absence of encephalopathy or ascitis on clinical exam
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Lab exams:
* hemoglobin \> or equal 8 mg/dl
* neutrophils \> or equal 1.200/mm³
* platelets \> or equal 45.000/mm³
* alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than 6 times the upper normal limit
* bilirubin equal or \< 2 mg/dl
* international normalized ratio (INR) \< 1.7
* serum creatinine equal or \< 1.5 times the upper normal limit or creatinine clearance \> or equal 60 ml/min
* Albumin \>2.8 mg/dl
* not being pregnant - a negative pregnancy test is required (for women). Patients in fertile age should use a contraceptive method during treatment and 4 months after.

Exclusion Criteria:

* Patients with more than 5 discrete lesions in the liver
* Main or common biliary duct invasion
* Patients with main portal vein tumor thrombus or more than 2 portal branch thrombus
* Patients in systemic treatment (sorafenib, chemotherapy). There should be an interval of at least 4 weeks between any medication for treatment of HCC and the current study treatment
* Previous radiation to upper abdomen
* Patients with other malignant neoplasms or previous malignant neoplasms will be accepted in the study if HCC prognosis is worse
* Patients with ischemic myocardial infarction within the last 6 months
* Patients with large esophageal varices with red color sign or bleeding within the last 3 months
* Patients with symptoms of colitis, enteritis, esophagitis, fistula, ileus, necrosis, stenosis or ulcer
* Patients with severe anorexy, constipation, dehydration, diarrhea or vomiting
* Patients unable to understand and sign written informed consent
Validity and Reliability of a Self-evaluation Tool for Cognitive Deficits in the Acute Stage After Stroke

Cognitive disorders are common early after stroke but can be overseen in patients with mild stroke who seem to be functionally recovered but are at risk to experience difficulties in advanced daily activities affecting social, vocational and family responsibilities. Acute stroke units admit a large number of patients and adequate referral to rehabilitation services is essential in terms of quality of care. A self-evaluation tool to evaluate cognitive function was developed by the occupational therapy department.

Patients with mild strokes and pre-stroke independent for instrumental daily activities fill out this self-evaluation tool, which is a paperwork task. Semi-structured interpretation is performed by physician and may result in referral to the occupational therapist for comprehensive evaluation.

In this study the validity and reliability of the self-evaluation tool will be examined.


Eligibility Criteria:
Inclusion Criteria:

* diagnose of stroke
* written consent
* age 18 years or older
* less than 1 week after stroke onset

Exclusion Criteria:

* not able to write/read
* not able to understand Dutch
* unilateral motor deficit in upper limb (NIHSS score for upper limb +2)
* referred to stroke unit with Transcient Ischemic Attack
Lateral Crural Strut Graft vs Bone-Anchored Suspension for Treatment of Lateral Nasal Wall Insufficiency

Lateral nasal wall insufficiency is a source of nasal obstruction which plagues many people as the sidewall of the nose collapses due to negative pressure and structural weaknesses of the nose. Bone anchored suture suspension is used by many surgeons to treat it, and involves anchoring the nasal sidewall to the bony rim below the eye. Lateral crura strut graft is another well described and universally used technique involves strengthening lateral crus of lower lateral cartilage of the nose with piece of cartilage. This study aims to compare the two well known and universally used treatments to each other. Based on expert opinions these procedures are both safe and efficient but given lack of randomized clinical trials comparing these 2 techniques, it is difficult to extrapolate which procedure is superior.

Patients with lateral nasal wall collapse who are eligible for surgical repair will be presented with the opportunity to participate. Once consented, standard pre-operative evaluation will be performed including evaluation of degree of lateral nasal wall collapse. They will also be screened with validated quality of life screening tools for nasal congestion, which include the NOSE scale and a visual analog scale. They will then be randomized to treatment either with Lateral crura strut graft or bone anchored suture suspension, in combination with likely other areas of functional rhinoplasty such as septoplasty and turbinate reduction. All of our patients will be seen 1 week, 2-3 month and 1 year after surgery

Eligibility Criteria:
Inclusion Criteria:

- Eligible subjects with be healthy, adults with lateral nasal wall collapse with or without septal deviation, turbinate hypertrophy, or narrowed internal nasal valve. They must have failed prior medical management with topical nasal steroid or topical or oral antihistamines. They must be able to read, sign, and demonstrate understanding of the research protocol, including agreement to randomization for treatment of their lateral nasal wall collapse

Exclusion Criteria:

* All subjects shall be excluded with evidence or history of prior rhinoplasty, immunocompromise, smokers, chronic sinusitis, history of radiation to the head and neck, septal perforation, granulomatous disease, or pregnancy.
Efficacy Study of a Novel Device to Clean the Endotracheal Tube

The purpose of this study is to evaluate the in-vivo efficacy of a novel device (endOclear) for cleaning the endotracheal tube (ETT) lumen from secretions. The investigators hypothesize that a protocol of routine ETT cleaning with endOclear may increase the ETT luminal volume measured at extubation compared to the current standard of care. The device may therefore be clinically useful by better maintaining the ETT original function.

After a few days of mechanical ventilation (MV), the lumen of the endotracheal tube (ETT) is coated with a thick bacterial biofilm, which is a potential source for bacterial colonization of the lower respiratory tract and ventilator-associated pneumonia (VAP). Accumulation of mucus/secretions on the interior of the ETT also effectively lowers the cross section of the ETT and increases significantly the work of breathing in intubated patients, who then require increased MV support, with prolonged intubation and ICU stay.

A primary goal for all ICUs is to shorten the time of MV, to decrease the incidence of ETT microbial colonization and ultimately VAP incidence. To meet this goal several airways technologies to maintain the ETT free from debris/bacteria have been developed in order to improve the current ventilator-liberation standards in intubated critically ill patients.

Based on preliminary laboratory, animal and clinical data, The investigators now wish to test the hypothesis that a novel commercially available ETT cleaning device can be effective in targeting two specific issues:

* Specific aim 1: To evaluate the mean difference in ETT luminal volume of ETTs cleaned with the novel cleaning device (EndOclear) vs. ETT cleaned in the standard manner.
* Specific aim 2: To determine whether ETTs cleaned with the novel device show a lower degree of microbial colonization for the entire period of mechanical ventilation.

Data about in-vivo respiratory mechanics measurements, microbial diversity and antibiotic resistance analysis, users' feedbacks and safety of the device will also be collected.

The investigators will conduct a clinical trial on 74 intubated patients randomized to receive standard ETT cleaning or cleaning with the EndOclear.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patients expected to be intubated for at least 48 hours or longer
* Enrollment within 24 hours from intubation time

Exclusion Criteria:

* Current and past participation in another intervention trial conflicting with the present study
* Pregnant women and prisoners
Diaphragm Function After Reversal of Rocuronium-induced Neuromuscular Blockade With Sugammadex or Neostigmine in Children

This study is to evaluate the recovery of diaphragm function and atelectasis after reversal of neuromuscular blockade with Neostigmine and Sugammadex using lung ultrasound and diaphragm ultrasound for children aged 2 to 7 who are scheduled for the surgical procedure under general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 2 and 7 who are scheduled for surgery lasting more than 1 hour under general anesthesia using a neuromuscular blocking agent

Exclusion Criteria:

* Patients with a history of severe respiratory disease with a high risk of bronchoconstriction
* Patients with abnormal findings on preoperative chest radiography such as severe atelectasis, pneumothorax, pleural effusion, or pneumonia.
* Patients with severe renal or liver disease, or neuromuscular disease
* Patients with a history of allergy to drugs (sugammadex, rocuronium neostigmine)
* Patients with significant bradycardia
* Patients scheduled for surgery where estimated blood loss during surgery is expected to be more than 30% of estimated blood volume, or cases where fluid imbalance is expected to be severe during surgery
* patients scheduled for lung parenchyme/diaphragm/thoracic surgery
* other researchers considered it inappropriate to participate in research.
Study to Assess Safety and Tolerability of G17DT in Patients With Colorectal Adenocarcinoma.

Pancreatic, gastric, and colorectal cancers have all been shown to overexpress the gastrin gene and to be sensitive to the trophic effects of the gastrin in animal models. The hypothesis of this study is that G17DT will elicit specific and high-affinity antibodies that will bind gastrin-17, thus preventing the trophic activity of cancer cells.


Eligibility Criteria:
Inclusion Criteria:

* Histologically verified adenocarcinoma of the colon or rectum
* Recurrent/ metastatic disease not amenable to curative surgery and/or radiotherapy
* measurable/ evaluable lesions
* Life expectancy \> 3 months
* Karnofsky index \> 50% or WHO performance rating of 0-2
* Biochemical markers:

  * renal function \< 25% above upper limit of normal range (creatinine, 140 imol/1 unless malignant involvement proven)
  * liver function \< 25% above upper limit of normal range (bilirubin \~25 mcmol/1 unless malignant involvement proven)
* Haematological status:

  * haemoglobin, 11 g/ dl
  * WBC, 4 X 109/1
  * platelets, 100 x 109/l
* Written consent

Exclusion Criteria:

* Other concomitant malignant disease except treated basal cell carcinoma of the skin or cancer of the uterine cervix stage 0-1
* H 2 receptor antagonist or proton pump inhibitor therapy
* Previous gastric surgery (including vagotomy)
* Active uncontrolled infection
* Autoimmune disorders
* Anticancer treatment within the last three months unless progression of the disease occurred in the interim
* Women of child-bearing age
* Patient is a poor medical risk because of non-malignant systemic disease
* Previous radiotherapy to all measurable or evaluable lesions.
Investigate Oral Bacteria in Adult Population

To compare the antimicrobial efficacy of three dentifrices on oral bacteria


Eligibility Criteria:
Inclusion Criteria:

* Males and females in good general health aged 18 to 70 years.
* A willingness to read, understand, and sign the Informed Consent Form after the nature of the study has been fully explained to them. Subject should demonstrate a willingness to comply with all study procedures and sampling schedules.
* A minimum of 20 natural teeth with facial and lingual scorable surfaces.
* Adequate oral hygiene and no signs of oral neglect.
* Good periodontal health. Enrolled subjects will have periodontal pockets no greater than 5 mm.
* Gingival and plaque indices will also be measured during the first visit. Subjects with gingival index greater than or equal to 1.5 (Lobene Index) and plaque index greater than or equal to 1.5 (Turesky modification of Quigley-Hein Index) will be enrolled.

Exclusion Criteria:

* History of significant adverse effects following use of oral hygiene products such as toothpastes and mouthrinses. Allergy to personal care/consumer products or their ingredients. Previous known allergy to dental materials, particularly to acrylic-like materials used to fabricate the stent device (this is a highly unlikely occurrence).
* Teeth that are grossly carious, fully crowned or extensively restored on facial and/or lingual surfaces, orthodontically banded, abutments, or third molars
* Difficulty having dental impressions taken such as excessive gagging.
* History of diabetes or hepatic or renal disease, or other serious medical conditions or transmittable diseases, e.g. heart disease or AIDS.
* History of rheumatic fever, heart murmur, mitral valve prolapse or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures.
* Subjects on antibiotic, antiinflammatory or anticoagulant therapy during the month preceding the baseline exam.
* Significant oral soft tissue pathology, systemically related gingival enlargement, severe gingivitis (based on a visual examinations).
* History of active severe periodontal disease with bleeding gums and loose teeth.
* Gross dental caries, severe generalized cervical abrasion and/or enamel abrasion, large fractured or temporary restorations (based on visual examinations).will not be included in the tooth count.
* Fixed or removable orthodontic appliance or removable partial dentures.
* Participation in a dental plaque/gingivitis clinical study involving oral care products, within the last 30 days. History of dental prophylaxis or treatments in the past month.
* Self reported pregnancy or lactation.
* History or current use of objects to pierce the lips or tongue.
* Subjects known to be an alcoholic, or a recovering alcoholic.
* History or current use of recreational drugs.
Miller Blade for Intubation in Adults

The study compares laryngeal view obtained with standard Macintosh blade laryngoscope and Miller blade laryngoscope in adult patients. After introduction to general anesthesia anesthesiologist will perform laryngoscopy with one chosen blade and after evaluation of visualisation of entrance to larynx will change blade to second one and repeat evaluation.

Tracheal intubation is the gold standard of the airway in the operating theater in patients undergoing general anesthesia for surgery, in intensive care and emergency medicine, in patients with severe respiratory failure, which is life-threatening. The laryngoscope is a device used to visualize the entrance to the airway and the subsequent insertion of the tracheal tube into the trachea and main bronchus. Macintosh and Miller laryngoscopes have been used in clinical practice for several decades. The Macintosh laryngoscope is most commonly used for the intubation of adult patients, and the Miller laryngoscope for the intubation of newborns, including premature babies and pediatric patients. Currently, when we are dealing with the sars covid-19 virus epidemic and a large number of patients with respiratory failure requiring endotracheal intubation and replacement ventilation, searching for a device that facilitates endotracheal intubation, especially by people with little experience in using it, in the absence of anesthesiologists, seems to be justified. The aim of the study will be to assess the possibility of using the Miller's laryngoscope for intubation of adult patients and to compare it with the most frequently used Macintosh laryngoscope in this group of patients. The study will include patients scheduled for elective surgery under general endotracheal anesthesia. After a typical induction of anesthesia with the use of short-term intravenous anesthetics, opioids and muscle relaxants, appropriate for the planned surgery and a specific patient, after obtaining complete neuromuscular blockade, a Macintosh laryngoscope will be inserted to perform direct laryngoscopy and assess the exit to the respiratory tract with the help of the Cormack scale. Then the laryngoscope will be removed, the patient will receive active oxygen therapy to increase blood oxygenation to the value of 99-100%, and then an additional dose of intravenous anesthetic will be administered and a second direct laryngoscopy will be performed with the Miller's laryngoscope with a subsequent assessment of airway entry using the scale Cormack. The patient will then be intubated and connected to an anesthesia machine.

Eligibility Criteria:
Inclusion Criteria:

* all patients scheduled for elective procedures under general anesthesia with endotracheal intubation

Exclusion Criteria:

* patients with expected difficutl intubation requiring advanced intubation techniques
* with injuries of the cervical spine, or for surgery in the cervical spine
* patients with increased intracranial and intraocular pressure, with vascular changes in the CNS and other parts of the body
* patients with ASA III and above
* patients who do not consent to participate in the study
Prevalance of Sleep Bruxism Among a Group of Egyptian Children

The goal of this observational study is to detect the prevalence of sleep bruxism in a group of Egyptian children and detect its relation to screen-time and sugar consumption. The main questions it aims to answer are:

1. In a group of Egyptian Children what is the prevalence of sleep bruxism?
2. What is the relation between sleep bruxism and screen time and sugar consumption?

Parents of a group of Egyptian Children aged 6-8 years old will be asked to fill

1. An informed Consent
2. Children Sleep Habit Questionnaire to detect the presence of sleep bruxism or not?
3. Food Frequency Questionnaire of Health Behaviour Sugar Consumption questionnaire
4. Leisure Time, Television Use, Computer Use Sections of the Health Behaviour Sugar Consumption Questionnaire

Eligibility Criteria:
Inclusion Criteria:

* Positive Subject acceptance for participation in the study
* Healthy children aged 6-8 years old
* Both genders
* The presence of mixed dentition with permnant first molar erupted

Exclusion Criteria:

* Children with mental or neurological disorders
* Children with systemic disorders
* Children who use medications that could not interfere with the central nervous system
* Children suffering from sleep disorders. e.g: Obstructive Sleep Apnea
A Phase II, Randomized, Cross-Over, Vehicle-Controlled, Double-Blind, Multicenter Study of the Safety, Pharmacodynamics, and Preliminary Efficacy of GHRP-1/AG in Subjects With ESRD on Hemodialysis

Malnutrition and altered protein catabolism are serious problems in renal failure and hemodialysis (HD) patients. The purpose of this study is to characterize the safety of GHRP-1/AG in subjects with ESRD on HD; to characterize the pharmacodynamics (PD) of GHRP-1/AG in subjects with ESRD on HD by following GH and IGF-1; to describe the relationship between GHRP-1 PD and plasma concentrations of GHRP-1 and des-Ala-GHRP-1; and to evaluate the preliminary efficacy of GHRP-1/AG on nutritional status of subjects with ESRD on HD using subjective global assessment of malnutrition inflammation scores (MIS) and changes in caloric intake.

This is a randomized, cross-over, double-blind, vehicle-controlled study. Subjects will receive single subcutaneous injections of the active GHRP-1/AG study treatment and vehicle control (ATRIGEL delivery system) in a randomized sequence. Each injection will be followed by a 4-week period of treatment exposure and a 2-week period of washout/follow-up. Treatments will be administered on the 2nd dialysis day of a 3x/week dialysis schedule. The total duration of study participation will be 12 weeks. Safety will be followed throughtout the study with vital signs, electrocardiogram, clinical chemistry and hematology parameters, endocrine parameters, adverse events, and concomitant medications. PD effects of GHRP-1/AG will be evaluated by measuring GH, ICF-1, IGF-BP3, prolactin, and cortisol. Efficacy will be evaluated throughout the study with MIS, caloric intake, nPCR, dry weight, BMI, and albumin, BUN, creatinine, calcium, potassium, HGB, HCT, and CBC.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with ESRD who have been on HD for at least 3 months and have a urea reduction rate (URR) of at least 65%.
* Subjects who are 18 to 70 years of age.
* Subjects who have a body mass index (BMI) less than 30, albumin greater than 3.3 g/dL, and MIS of 5 to 10 (inclusive).

Exclusion Criteria:

* Subjects who have diabetes and are currently taking insulin.
* Subjects who have a history of or current significant central nervous system (CNS) disorders.
* Subjects who have active infection at baseline.
* Subjects who have active or unstable cardiac or arterial disease.
* Subjects who have uncontrolled tertiary hyperparathyroid condition.
* Subjects who have anemia.
* Subjects who have a history of hepatitis or current liver disease.
The Effect of Canal Dryness on the Quality of Obturation

The goal of this clinical trial is to evaluate root canal obturation quality. The questions to answer are

* what is the best protocol for canal dryness before obturation ?
* Is compaction necessary ? Volunteer participants will perform root canal treatment in teeth planned for extraction due to orthodontic reasons


Eligibility Criteria:
Inclusion Criteria:

* healthy males and females (Category: American Society of Anesthesiologists class 1)
* aged 23-25 years
* presenting with sound maxillary premolars (non-carious and not previously restored)
* a radiographically visible root canal outline

Exclusion Criteria:

* dental students of any level were not eligible to avoid including vulnerability factors.
* pregnant volunteers
* volunteers with complicating systemic disease (ASA 3-6)
* poor oral hygiene
* periodontal disease (probing depth \>3 mm) related to the tooth
Risk of Nerve Damage After Administration of Local Anesthesia

This research aims to evaluate of the risk of nerve damage following the administration of articaine 4% and lidocaine 2% for Inferior Alveolar nerve Block (IANB). A Randomized Controlled Clinical Trial will be conducted where the patient will be randomly assigned to one the two groups; articaine 4% and Lidocaine 2%. The type of LA will be concealed to the operator, investigators and assessors. The patients will be monitored for any aigns of nerve parathesia for 3 months after the procedure.


Eligibility Criteria:
Inclusion Criteria:

* Patients with age between 18-55 years old
* Patients need IANB
* healthy patient

Exclusion Criteria:

* medical conditions
* allergies
* medications
* pregnancy and breastfeeding
* inability to provide informed consent
* specific dental or medical history.