cyrilzakka/clinical-trials huggingface dataset:
A Trial Comparing Entacavir and Tenofovir in Patients With HBV Decompensated Cirrhosis

Entacavir and tenofovir are two first line therapies for chronic hepatitis B. Both agents have been claimed equivalent in treatment, there are no head to head trials available in the literature about there effectiveness in HBV Decompensated Cirrhosis. The investigators aimed to compare safety/efficacy and virological response in patients with HBV Decompensated Cirrhosis.

The effectiveness of entacavir and tenofovir has not been prospectively studied in HBV Decompensated cirrhosis? This prospective, randomised clinical trial will help us in better patient management more efficacy and cost effectiveness.

Eligibility Criteria:
Inclusion Criteria:

* Age (18 years- 70 years)
* Hbv surface antigen positive \> 6 months
* HbeAg (positive or negative both)
* Hbv DNA 10\^3
* ALT ULN
* No evidence of HCC
* Platelets count \> 30 thousands
* CTP score \> 7
* Hepatic encephalopathy (grade 1 - 2 only)
* No prior Drug resistance

Exclusion Criteria:

* Age \< 18 years
* HCC patients
* Prior drug resistance
* Current HE \> 2
* Solid organ transplantation
* Inadequate hematological function
* Co infection with hepatitis C and HIV
* Autoimmune disorders
* Pregnancy and Breast feeding
* Other hepatic diseases
* Patients on immunosuppressant or chemotherapy agents
Optimal Treatment for Spinal Cord Injury Associated With Cervical Canal Stenosis (OSCIS) Study

Controversy exists regarding the optimal management of acute traumatic cervical spinal cord injury (SCI), especially those without bone injury. Although surgical decompression is often performed in SCI patients with cervical canal stenosis, efficacy and timing of surgery continues to be a subject of intense debate. In this randomized controlled trial, the investigators compare two strategies: early surgery within 24 hours after admission and delayed surgery following at least 2 weeks of conservative treatment. The purpose of this study is to examine whether early surgery would result in greater improvement in motor function as compared with delayed surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients with acute traumatic cervical spinal cord injury (at C5 or below) admitted within 48 hours after injury

  1. No bone injury (no fracture or instability)
  2. American Spinal Injury Association (ASIA) Impairment Grade C
  3. Cervical canal stenosis due to preexisting conditions such as spondylosis and ossification of the posterior longitudinal ligament (OPLL)

Exclusion Criteria:

1. Unstable medical status
2. Difficult to undergo surgery within 24 hours after admission
3. Impaired consciousness or mental disorder that precludes neurological examination
4. Difficult to obtain informed consent in Japanese
Daily Sessions of rTMS to the Left DLPFC Modulate the Pain Thresholds and CPM

The main purpose of the study is to assess whether repeated sessions of repetitive trancranial magnetic stimulation (rTMS) applied on left dorsolateral prefrontal cortex main boost the pain thresholds.

Pain is the largest health-related burden on society and, despite many decades of pain research, there are still few effective treatments. Since pain experience is a construct of the central nervous system (CNS), chronic pain has been recently thought to be a CNS disorder.

Repetitive transcranial magnetic stimulation (rTMS) is a safe, non-invasive technique for cerebral cortex stimulation and the clinical applications of which have expanded considerably in recent years. Recent studies have been shown that 'classical' rTMS to different cortical areas temporary reduce chronic and acute pain, suggesting that rTMS may ´have some clinical application in future management of chronic pain. However, new rTMS paradigms involving theta burst stimulation (TBS) have recently been described with the major clinical advantage to be much shorter than 'classical' rTMS. The investigators hypothesize that cTBS would yield analgesic effects similar to or, possibly, even stronger than those produced by 'classical' rTMS. The investigators will carry out a sham-controlled, randomized, double-blind, crossover study in healthy volunteers, to compare the analgesic effects of two rTMS protocols over dorsolateral prefrontal cortex: classical high-frequency rTMS (10 Hz), and TBS. As rTMS-induced analgesia may be dependent on changes in pain modulatory systems, the investigators will analyze the effects of the stimulation on conditioned pain modulation (CPM). More specifically, the investigators will compare the effects of multiple sessions of rTMS on the inhibition of a test experimental stimulus induced by heterotopic noxious stimuli, to assess possible changes in diffuse noxious inhibitory controls.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Major medical conditions
Simple Bone Cysts in Kids

Simple bone cysts (SBCs) are cysts filled with fluid that occur most frequently in the long bones (arms or legs) of children. There are many ways to treat SBCs but it is unclear if one is better than another. The purpose of this research trial is to compare the effectiveness of two common treatments that are used by surgeons today.

In general, few randomized clinical trials have been undertaken in paediatric orthopaedics, and only one to date has addressed the problem of simple bone cysts (SBCs). Also known as unicameral bone cysts, they are the commonest bone lesion in children. Despite general opinion, these cysts do not resolve at skeletal maturity.

Many forms of treatment have been recommended but none, including the popular methods of corticosteroid or bone marrow injections, have reliably eradicated SBC. Although the lesions are considered benign (non-cancerous), they cause pain, frequently interfere with function, dramatically restrict play activity, may re-fracture leading to growth arrest and/or deformity, and cause enormous anxiety for children and their families.

With a well-developed network of surgeons and researchers, we will provide evidence comparing the effectiveness of two treatment interventions for SBC. More specifically, our goals for this study are:

1. to compare the rate of radiographic healing between two standard treatments including curettage with puncture alone, and curettage with puncture followed by injection with Vitoss morsels;
2. to identify prognostic radiographic factors associated with simple bone cyst healing and fracture;
3. to determine the impact of simple bone cyst on children/family functioning.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a confirmed simple bone cyst in a long bone (ie. arm or leg) within last 3 months
* At least 3 weeks must have elapsed since last fracture
* At least 3 months must have elapsed since last cyst treatment
* Patients and/or their legal representatives willing to provide written informed consent (and assent, when appropriate)
* Patients with stabilizing implants in the bone where the cyst is located

Exclusion Criteria:

* Patients with bone disease (ie. osteogenesis imperfecta, cancer, osteoporosis, Paget's disease)
* Pregnant or breastfeeding female
* Patients with cysts crossing the growth plate (area where bone grows)
Intraoperative Neuromonitoring Recording With a Novel SCS Paddle: Phase II

The purpose of this study is to demonstrate safety and efficacy of a new spinal cord stimulation paddle electrode which is able to target the dorsal horns, dorsal nerve roots, and dorsal columns. The research electrode ("Study Electrode") is designed to answer basic physiological clinical research questions. It may inform future device therapy development, but the Study Electrode is not a product that will be marketed or sold. The Investigators believe the protocol is a Non-Significant Risk study answering basic physiological research questions, which may be performed under hospital IRB approval.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing a spinal cord stimulation procedure for neuropathic pain.
* have undergone a successful SCS trial and are determined eligible for a permanent SCS implant.
* Patients must be fluent in English as well as mentally competent to read and answer the questionnaires, as well as complete pain assessment exams.-
* subjects must be able to give informed consent.

Exclusion Criteria:

* patients who are not undergoing thoracic spinal cord stimulation for chronic neuropathic pain
An Observational Study on Predictive Factors of Response in Patients With Chronic Hepatitis C Treated With Pegasys (Peginterferon Alfa-2a) and Ribavirin

This observational study will evaluate predictors of early on-treatment response and sustained virological response in patients with chronic hepatitis C receiving Pegasys (peginterferon alfa-2a) and ribavirin. Data will be collected from patients on treatment (24 or 48 weeks) and 24 weeks after the end of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Serologically confirmed chronic hepatitis C (all genotypes)
* Treatment with Pegasys and ribavirin according to the current standard of care and in line with current summaries of product characteristics (SPCs)/local labelling

Exclusion Criteria:

* Coinfection with HIV and/or hepatitis B
* Contraindications according to the SPC for Pegasys/ribavirin
Reproducibility and Repeatability of Multifunctional MRI Biomarkers of the Body

Advanced MRI (Magnetic Resonance Imaging) technique called DCE (Dynamic Contrast Enhanced) and DWI MRI can provide valuable information regarding tumor biology and response to treatment through various parameters. Validating stability of these parameters will further establish robustness and reliability of these promising biomarkers.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of metastatic liver cancer proven by pathology
* At least one liver tumor should be \> 2cm in long diameter
* Patients with viable tumor proven in the other imaging modalities

Exclusion Criteria:

* Severe claustrophobia
* Presence of MRI-incompatible metallic objects or implanted medical devices in body
* Renal failure, as determined by glomerular filtration rate (GFR) \< 30 mL/min/1.73 m2
* Weight greater than that allowable by the MRI table
* Chemotherapy within 28 days prior to enrollment
* Prior external radiation therapy to the liver, prior transarterial chemoembolization
A Phase I Study of Episcleral Dexamethasone for Treatment of Macular Edema

This phase I trial will assess primarily the safety and secondarily anti-inflammatory effect of Episcleral Dexamethasone in patients suffering from refractory diabetic macular edema.

This phase I trial will assess primarily the safety and secondarily anti-inflammatory effect of Episcleral Dexamethasone in patients suffering from refractory diabetic macular edema. Numerous studies have documented the anti-inflammatory activity of Dexamethasone in macular edema associated with diabetes, branch retinal vein occlusion, and non-infectious posterior uveitis. The investigators hypothesize that Episcleral Dexamethasone is safe, tolerable and that its anti-inflammatory activity will reduce macular edema and improve vision in patients with diabetic macular edema.

Eligibility Criteria:
Inclusion Criteria:

* Type I or II diabetes;
* Age \>= 18 years;
* Visual acuity letter score in study eye \< 70 and ≥ 25 letters (approximate Snellen equivalent 20/32 to 20/320);
* Ophthalmoscopic evidence of center-involved DME, within the central subfield (CSF);
* OCT CSF thickness value (microns):

  * Zeiss Cirrus: ≥290 in women; ≥305 in men
  * Heidelberg Spectralis: ≥305 in women; ≥320 in men
* Previous treatment with laser, anti-VEGF therapy and/or intravitreal steroids;
* No previous history of glaucoma or steroid-induced intraocular pressure response in either eye.

Exclusion Criteria:

* History of chronic renal failure requiring dialysis or kidney transplant;
* Retinal or optic nerve neovascularization on clinical exam, fundus photographs, or fluorescein angiograms;
* Evidence of external ocular infection;
* History of open-angle glaucoma or intraocular pressure \>= 25 mmHg;
* History of steroid-induced IOP elevation that required IOP-lowering treatment;
* History of prior herpetic ocular infection;
* History of intravitreal or periocular corticosteroids within 3 months prior to enrollment;
* History of macular laser photocoagulation within 4 months prior to enrollment;
* History of antiangiogenic therapy within 4 weeks prior to enrollment;
* History of panretinal photocoagulation (PRP) within 4 months prior to enrollment or anticipated need for PRP in the next 6 months following enrollment;
* Presence of vitreomacular traction, epiretinal membrane, tractional retinal detachment, vitreous hemorrhage and or any ocular condition that the investigator judges could interfere in the safety and efficacy assessments;
* No other major non-diabetic pathology, or anticipation of such in the next 6 months following enrollment that in the opinion of the investigator would substantially and adversely affect assessment of safety and toxicity during the study;
* Participation in another clinical trial of non-approved medical treatment within 3 months prior to enrollment;
* Degenerative myopia;
* Malignant intraocular disease;
* Inability to understand informed consent, cooperate with testing or return to follow up visits; Pregnant or lactating women; Co-existent ocular disorder of the cornea, lens or media that will interfere with assessment of safety or efficacy.
Clinical Efficacy of Bovine Freeze-dried Amniotic Membrane on Wound Healing in Laser Treatment

Bovine amniotic membrane may show better efficacy than hydrocolloid dressing.

Bovine amniotic membrane as a biological dressing can be applicable to wound after laser treatments. Comparing with hydrocolloid dressing material, which is the most widely used after laser treatment now, amniotic membrane will show better efficacy. Thus, with amniotic membrane, epithelization time will shorten and redness which is usually left after laser will disappear quickly.

Eligibility Criteria:
Inclusion Criteria:

* Skin lesions treatable by ablative lasers
* More than two skin lesions of similar size at the same area
* Available during the study period (2 weeks)

Exclusion Criteria:

* Taking steroid or nonsteroidal antiinflammatory drug, isotretinoin
* underlying diabetes mellitus, keloid or any malignancy
Pulse Checks Using Femoral Artery B-Mode Ultrasound With Compressibility Assessment

The goal of this prospective observational study is to investigate B-mode point-of care ultrasound with arterial compressibility assessment on the femoral artery as a method to determine the presence of a pulse and to compare it with concurrently conducted manual pulse checks.

In this prospective observational study, a dedicated research team will be dispatched to cardiac arrest patients treated in the prehospital environment by emergency medical services (EMS). The team will use a portable ultrasound device to identify the femoral artery and employ B-mode ultrasound during rhythm checks. These ultrasound pulse checks will be conducted in parallel with the normal treatment of the patient, including manual pulse checks, and will only be conducted if ultrasound is possible without interference in the resuscitation. All treatment decisions will rest with the treating EMS team.

Eligibility Criteria:
Inclusion Criteria:

* Out-of-hospital cardiac arrest treated by EMS
* Minimum age of 18 years

Exclusion Criteria:

* Pregnancy or suspected pregnancy
* Disapproval of the treating EMS team
* Adults under legal guardianship
* Inability to perform femoral artery doppler ultrasound due to limited access to the patient and possible interference with the treating EMS team
* Inability to perform femoral artery doppler ultrasound due to injuries or anatomic abnormalities in the femoral region or necessary emergent medical interventions in the femoral region
* Decision to transfer the patient to the hospital with ongoing CPR for emergent procedures such as extracorporeal CPR before femoral artery doppler ultrasound could be attempted
* Inability to safely perform femoral artery doppler ultrasound due to environmental hazards
Intensive Glycemic Control on Infectious Morbidity In Patients With Acute Leukemia

RATIONALE: Controlling blood sugar levels may be effective in preventing infections in patients receiving chemotherapy for acute myeloid leukemia or acute lymphoblastic leukemia.

PURPOSE: This randomized phase I trial is studying how well controlling blood sugar levels works in preventing infection in patients with acute myeloid leukemia or acute lymphoblastic leukemia.

OBJECTIVES:

Primary

* To determine whether intensive glycemic control over an eight week time period will decrease the incidence of infections from initiation of chemotherapy treatment in patients with acute myeloid leukemia or acute lymphoblastic leukemia.

Secondary

* To compare the number of episodes of infection.
* To compare the duration of neutropenia.
* To compare the number of days of bacteremia/fungemia.
* To compare the number of days of fever.
* To compare the duration of nutrition.
* To compare the duration of mucositis.
* To compare the duration of hospital stay.
* To compare the duration of antibiotic use.
* To compare the incidence of thromboembolic events.
* To compare body weight changes.
* To compare the median survival.
* To compare the remission rate with induction or salvage chemotherapy.
* To conduct comparative analysis between intervention and standard of care groups of mean daily capillary blood glucose monitoring.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

* Arm I (intensive glycemic control): Patients with goal blood glucose 80-140 mg/dL receive the Robert Wood Johnson University Hospital IV insulin infusion protocol to maintain blood glucoses in the target range. Beginning 24 hours after maintenance of oral or enteral feedings patients receive an intensive regimen of insulin glargine and insulin glulisine (Apidra™) subcutaneously for 4 weeks as needed. Patients may also receive insulin in the total parenteral nutrition (TPN) mixture.
* Arm II (standard care control): Patients with goal blood glucose \< 250 mg/dL are started on subcutaneous insulin sliding scale at the discretion of the treating physician with blood glucose monitoring and adjustment according to the insulin sliding scale. Insulin may also be added to TPN if needed at the investigator's discretion.

After completion of study treatment, patients are followed up for 4 weeks.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed acute myeloid leukemia or acute lymphoid leukemia

  * Newly diagnosed or relapsed disease
* Undergoing induction or salvage chemotherapy treatment
* Must demonstrate 2 random blood sugars of ≥ 140 mg/dL while on total parenteral nutrition (TPN) OR 2 preprandial sugars of ≥ 140 mg/dL if patient is not on TPN

PATIENT CHARACTERISTICS:

* ECOG performance status 0-3
* Not pregnant or nursing
* Negative pregnancy test
* Prior diagnosis of diabetes mellitus allowed
* No known history of an allergy to insulin
* No documented active infection

PRIOR CONCURRENT THERAPY:

* Concurrent corticosteroids allowed
* No concurrent oral hypoglycemic agents
The Effect of Telerehabilitation on Clinical Stress Level and Stress Responses in Nursing Students

It was aimed to examine the effect of telerehabilitation on clinical stress level and stress responses in nursing students.

It was aimed to examine the effect of telerehabilitation on clinical stress level and stress responses in nursing students.There is no study in the literature examining the relationship between telerehabilitation and clinical stress in nursing students. Since our study will be the first to investigate the subject, we foresee that it is scientifically important and will shed light on future studies. In addition, national or international publications are planned after the study is completed.

Eligibility Criteria:
Inclusion Criteria:

* to be between the ages of 18-24
* to do the first clinical internship in the hospital

Exclusion Criteria:

* have joint limitation
* have congenital anomaly
* have any orthopedic problem
* have any serious psychological problems
Pharmacokinetic and Comparative Bioavailability Study of Codeine Sulfate Under Fasted Conditions

The objective of this study designed to characterize the pharmacokinetics and comparative bioavailability of Roxane Laboratories' codeine sulfate tablets after oral administration of 60 mg doses as 1 x 60 mg, 2 x 30 mg and 4 x 15 mg under fasted conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to codeine sulfate or any comparable or similar product.
Ultra-portable Ultrasound vs. Standard Ultrasound to Help Place a Peripheral Catheter in Patients at Risk of Difficult Puncture

The placement of an intravenous (IV) line is a common procedure when treating adult patients in critical care, in the emergency room or in the operating room. This simple and minimally invasive procedure can sometimes be made difficult depending on the patient's morphology or their clinical condition. The procedure then becomes time-consuming, anxiety-provoking, painful and its success is uncertain.

The placement of intravenous (IV) lines under ultrasound by nurses is a rapidly developing alternative in intensive care, emergencies and the operating room.

The main objective is to test the hypothesis that intravenous puncture guided by an ultraportable ultrasound machine is faster than puncture guided by a conventional ultrasound machine.

Eligibility Criteria:
Inclusion Criteria:

1. Patient aged at least 18 years old
2. Patient with an A-DIVA (Adult Difficult Intravenous Access) score \> 1
3. Supported by a nurse trained in all the techniques used in the protocol
4. Patient having given free, informed and oral consent -

Exclusion Criteria:

1. Patient who has already been included in the study
2. Patient whose inclusion in the study would lead to a delay in treatment
3. Adult patient protected by law
4. Pregnant woman
5. Patient not benefiting from French Social Security system -
The Incidence of Postoperative Re-stratification for Recurrence in Well-differentiated Thyroid Cancer - A Single Tertiary Israeli Center Experience

Background After diagnosing well-differentiated thyroid cancer (WDTC), careful assessment of the risk for disease-specific recurrence is essential for deciding between partial (low risk) and completion (high risk) thyroidectomies. Patients' preoperatively determined risk levels are re-stratified according to surgical and final histopathological findings. The American Thyroid Association 2015 guidelines suggest that patients with WDTC between 1-4 cm in size and without suspicious features may be suitable candidates for partial thyroidectomy. The incidence and clinical implications of high-risk features discovered postoperatively in patients with preoperatively determined low-risk WDTC have not been previously reported.

Methods All thyroidectomies performed between 2006-2018 in the Tel Aviv Sourasky Medical Center were included. Pre- and postoperative risk stratifications were performed, and the rate of completion thyroidectomy was determined. Patients with 1-4 cm WDTC without evidence of positive cervical lymph nodes, invasion to adjacent structures, or high-risk cytology were considered at low risk for disease-specific recurrence and therefore suitable for lobectomy.


Eligibility Criteria:
Inclusion Criteria:

* All patients who underwent thyroid surgery (partial and total) between 2006-2018 at Tel Aviv Sourasky Medical Center (TASMC) were included

Exclusion Criteria:

* Patients with evidence of cervical lymph node metastasis, other malignancies, adverse imaging features (i.e., extracapsular spread of thyroid malignancy, vocal cord paralysis or immobility in physical examination) were excluded from the study.