cyrilzakka/clinical-trials huggingface dataset:
The ARRC III Trial of Advanced Recovery Room Care (ARRC).

A postoperative high-acuity model of care (ARRC) has been shown, in a prospective cohort study of approximately 850 patients, to produce a marked improvement in patient and hospital outcomes, and hospital costs, in medium risk patients (Ludbrook G et al., JAMA Surgery 2023).

The goal of this observational study is to examine the outcomes after non-cardiac surgery of a larger group of medium risk patients receiving different forms of care -ARRC and usual ward care. The main questions it aims to answer are:

what are the outcomes for patients and hospital after the different forms of care, who receives benefit from high acuity care, what underlies the improved outcomes seen with high acuity care.

Demand for essential surgery is growing, yet we face an increasingly complex casemix and budget challenges. New paradigms to deliver high value care are essential.

Advanced Recovery Room Care (ARRC) is a model of care which, at RAH, has been shown to provide substantial improvements in patient outcomes, hospital utilisation, and costs of care. Specifically, it showed when compared to usual ward care: improved Days at Home after Surgery (primary outcome), decreased in-hospital complications, and decreased mortality at 1, 3 and 12 months. This model was cost-effective compared to usual ward care: ICER of approximately -$250 per DAH

It is essential to collect high quality data on this model relevant to consumers and hospitals, in order to:

* provide a robust mechanism to ensure outcomes are maintained, and ideally improved, within our institution
* provide a mechanism to potentially allow benchmarking in the future, across institutions
* better identify which surgical subgroups receive benefit from ARRC
* provide a resource to generate and test hypotheses as to how these benefits are achieved.

To that end, the ARRC II study database is to be refined to function in essence as an ongoing registry.

This will be initially piloted at RAH, the subject of this study.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for elective or unplanned surgery
* Scheduled to stay in hospital at least one night after surgery
* 30-day mortality of 0.5% to 8% by the US National Safety and Quality Improvement Program risk score (NSQIP)

Exclusion Criteria:

* Undergoing cardiac surgery
* Scheduled for postoperative Intensive Care Unit management
Neo-MASCT Immunotherapy for Advanced NSCLC.

Neoantigen （Neo）is a new targets for immune cells，that the DC neoantigen immunotherapy was more effective in triggering specific T-cell responses. Neo-MASCT using the DC vaccine and neoantigen T cells .Dendritic cells(DC) was induced from autologous peripheral blood，and be loaded with antigens and re-infused. In vitro, antigen-pulsed DC can stimulate autologous T-cell proliferation and induction of autologous specific cytotoxic T-cells(CTL)，similarly re-infused.

The study is aimed to evaluate the safety of Neo-MASCT in patients with advanced NSCLC.

This study is divided into two stages. The first stage is the safety study in small samples, and the second stage is the sample size expansion phase.

20 failed standard treatment patients with advanced or recurrent NSCLC will be recruited .

Eligibility Criteria:
Inclusion Criteria:

1. The age is 18 to 80 years old.
2. The failure standard treatment subjects with advanced or relapsed NSCLC.
3. Informed consent of the patient/legal representative was signed.
4. Other anti-cancer treatments are at least one month apart from the study .
5. The eastern cancer cooperative group (ECOG) was rated 0-2.
6. According to the The reaction of solid tumors v1.1 (RECIST1.1 standard), there must be at least one measurable lesion .
7. The baseline blood and biochemical targets met the following criteria: The hemoglobin ≧ 85g/L ;White blood cells ≧ 3.0 x10 \^ 9 / L;Platelet ≧ 50 x10 \^ 9 / L;alanine aminotransferase (ALT), serum aspartate transaminase(AST) ≦ 2.5 times normal value limit; For patients with live metastases, ALT and AST are five times the normal limit; The alkaline phosphatase(ALP) ≦ 2.5 times the normal value; Serum bilirubin less than 1.5 times the normal value limit;

Exclusion Criteria:

1. Participate in the planning or implementation of the research .
2. In addition to other clinical studies, unless it is an observational clinical study .
3. Being pregnant or planning a pregnancy.
4. Refuse to provide a blood specimen .
5. Allergic to sodium hydroquinone .
6. There is a history of organ transplantation
7. Brain transfer of the active period
8. Immunosuppressant drugs are currently in use or within 14 days prior to treatment.
9. The following exceptions are:Nasal, inhaled, topical use of steroid, or topical steroids (such as interjoint injection) .
10. Use a corticosteroid, no more than 10mg/day of prednisolone or its equivalent .
11. The use of steroids as a preventative treatment for hypersensitivity (such as CT scans) .
Randomized Control Trial: Elbow Extension Versus Flexion Cast in Proximal Half Both Bone Forearm Fractures

The purpose of this study is to compare outcomes between two immobilization methods for pediatric proximal half both bone forearm fractures.

After being informed of the study including potential risks and benefits, all patients giving assent and guardian/parents consent who meet eligibility will undergo randomization of the casting technique used (elbow extension or elbow flexion casting). Randomization will occur using a random umber generator. Even numbers generated will result in an extension cast and odd numbers generated will result in a flexion cast.

The patients will be followed in clinic with an examination and x-rays at 2, 3, 5, and 8 weeks after casting to evaluate alignment of the fracture maintained by each cast. The two cohorts will be compared at the end of the study to determine which casting technique is the superior immobilization for pediatric proximal half both bone forearm fractures.

Eligibility Criteria:
Inclusion Criteria:

* Ages 3-18
* Skeletally immature
* Unilateral Radius and Ulna Fracture located within the proximal ½ of each bone
* Fracture requires reduction and casting

Exclusion Criteria:

* Ages \< 3
* Distal ½ Radius and Ulna Forearm Fracture
* Isolated radius or ulna fracture
* Humerus Fracture of the Ipsilateral Arm (including floating elbow)
* Metabolic Bone Disease
* Open Fractures
* Monteggia and Galeazzi Fractures
* Deformity or abnormality not allowing for standard casting (limb deficiency, contracture)
* Parent speaks language other than english
Tisagenlecleucel vs Blinatumomab or Inotuzumab for Patients With Relapsed/Refractory B-cell Precursor Acute Lymphoblastic Leukemia

This trial aims to compare the benefits and risks of tisagenlecleucel to blinatumomab or inotuzumab in adult patients with relapsed or refractory ALL. This trial investigates tisagenlecleucel as an additional treatment option for this patient population with high unmet medical need.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent.
2. Age ≥ 18 years.
3. Subject with CD19-expressing B-ALL.
4. Adequate organ function.
5. Patients considered in any of the following settings are eligible:

   1. Untreated first or second relapse
   2. Refractory to primary induction therapy
   3. Refractory to first salvage therapy or
   4. Relapse after allogenic stem cell transplant.

Exclusion Criteria:

1. Patients presenting with untreated first relapse of ALL more than 24 months after initial diagnosis
2. Presence of extra-medullary disease.
3. History or presence of clinically relevant CNS pathology, or uncontrolled CNS leukemia.
4. History of Veno-occlusive Disease (VOD).
5. Active neurological autoimmune or inflammatory disorders.
6. Active acute Graft-versus-Host Disease (GvHD), grade 2-4.

Other protocol-defined Inclusion/Exclusion may apply.
Hemoglobin and INR Out of Nose Blood

Nose bleeding (epistaxis) is a common emergency. It is often difficult to estimate blood loss and the current hemoglobin of patients. In patients with oral anticoagulation, it is important to measure the level of hemodilution. Several situations with the importance of the fast determination of these parameters have been identified in previous studies \[1,2\]. The blood sampling from the venous punction is the standard in these investigations. However, this requires the corresponding painful puncture and also the time required at the laboratory.

Since many patients present themselves with active bleeding, it is obvious that this blood could be used for determining the following parameters: Hemoglobin and INR/Quick. The nose blood can be analyzed with commercial rapid test devices. If these devices could generate same or similar results and after further validation of the method, painful punctures could be waived.

Patients with active epistaxis are verbally elucidated about the study and the verbal consent is obtained. According to the agreement a few drops of nose blood are preserved. Subsequently the standard therapy is performed. This blood sample is promptly analyzed with the rapid test devices.

We successfully applied the exception to the analysis of blood samples prior to obtaining the written consent due to following reasons: Analysis with the rapid test devices needs to be immediate and without delay in order to satisfy quality standards prescribed by the manufacturers. In addition, patient's treatment should not be delayed.

Simultaneously, a venous blood sample for the corresponding values is carried out according to medical indications. After the treatment of the acute emergency and thus after the greatest stress situation, we ask the patient again whether he agrees to the study conditions. The written consent is obtained in the end of the acute treatment.

Both inception and termination of the research project will be reported within 90 days of the Ethics Committee.

Eligibility Criteria:
Inclusion Criteria:

* Patients with active nose bleeding
* Indication for routine blood sampling
* Aged 18 to 99 years
* Verbal informed consent before implementation takes place
* Written consent of the participating person after investigation and completion of treatment

Exclusion Criteria:

* No active bleeding
* Routine blood sampling for medical reasons not indicated
* Lack of understanding of the study or investigation
Evaluation of Chemotherapy Prior to Surgery With or Without Zometa for Women With Locally Advanced Breast Cancer

This study is designed to evaluate the impact of Zometa on clearance of bone marrow micrometastases; the protective effect on chemotherapy-induced loss of bone mineral density; and quality of life in women undergoing treatment for locally advanced breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed primary invasive ductal or invasive lobular breast adenocarcinoma
* Tumor classified as clinically large T2 (2-5 cm), T3, T4 or any T with N1, N2
* Prior malignancies: limited to curatively treated basal or squamous carcinoma of the skin or history of previous malignancies, treated and now \> 5 years disease free
* \>= 18 years of age
* Normal left ventricular function by echocardiogram or radioventriculogram
* Karnofsky Performance \>= 70

Exclusion Criteria:

* No evidence of distant metastasis present by CT, Bone scan, or physical exam
* If the bone scan or CT scans demonstrate indeterminate lesions, the nature of these lesions may be further clarified by additional testing such as PET or MRI
* No current treatment with Zometa or other bisphosphonates
* No serious functional disorders of the liver or kidneys:
* Serum Creatinine \<=2
* ALT/AST/ALK Phos \<= 1.5 x upper limit of institutional normal.
* Bili \<= 1.5 x upper limit of institutional normal.
* Currently not pregnant
Epidemiology and Acute Oral Effects Electronic Cigarette

Electronic cigarettes are battery-powered vaporizers which have a similar feel to tobacco smoking. They do not produce cigarette smoke but rather an aerosol, which is frequently referred to as vapor. E-cigarettes are marketed as less harmful alternatives to smoking. Use and awareness of these devices has grown exponentially in recent years, with millions of people currently using them.

The benefits and risks of electronic cigarette use are uncertain. There is no research on the acute oral effects of electronic cigarette in the scientific literature and no hungarian epidemiological survey has been performed in this topic.

Regulation of electronic cigarettes varies across countries in the European Union, ranging from no regulation to banning them entirely.

The investigators research could help to integrate the regulation of this device in Hungary and in the EU as well.

The measurement of acute oral effects of e-cigarette and a hungarian epidemiological survey would be novel in this topic.

The epidemiological survey is performed with online questionnaires, which are published on e-cigarette-selling websites and on other forums dealing with this topic.

The main outcome of interest was whether or not e-cigarette use helped people to quit smoking or reduce the number of conventional cigarettes. Participants were also asked about the reason for starting e-cigarette use. Nationality, habitation, citizenship status were included as demographic predictors in analyses.

Measurements of acute oral effects before and after using electronic cigarette with nicotine, without nicotine, conventional cigarette and placebo device:

* measurement of exhaled CO changes by Smokerlyzer piCO
* measurement of saliva MMP-8 by PerioSafe Home
* measurement of saliva pH, buffering capacity, and flow rate changes by Saliva Check Buffer Kit (GC)
* measurement of oral mucosal blood flow changes by Perilam PSI System High Resolution (LASCA method)

Eligibility Criteria:
Inclusion Criteria:

* age: 19-49 years
* signed consent form
* smoking regularly e-cigarette and/or conventional cigarette for \> half year

Exclusion Criteria:

* not pregnant and not planning pregnancy in the next 6 month
* BMI index \< 30
* no severe parodontal disease
* no acute illness in the last 2 weeks
* no chronic disease (eg.: diabetes)
* no diet which can influence the oral pH
Nasal Packing as a Drug Delivery System Postoperatively in Chronic Sinusitis With Polyposis

That high-dose steroid applied to the nasal cavity immediately post-operatively will improve olfaction and healing following endoscopic sinus surgery.


Eligibility Criteria:
Inclusion Criteria:

* hyposmia and nasal obstruction for \>12 weeks
* bilateral nasal polyposis
* candidate for surgery

Exclusion Criteria:

* immunocompromised
* non-English speaking
* prisoner
* pregnant/lactating
* will not attend follow up appointments
Prevalence of Synovitis in Patients With Haemophilia A

The aim of this study is to evaluate the prevalence of synovitis in adult patients with haemophilia A.

The bleeding disorder haemophilia causes recurrent spontaneous bleedings primarily into the joints and soft tissues. The reason is a congenital lack of factor VIII (haemophilia A) or factor IX (haemophilia B). In Germany, the most affected joints are the ankle, knee, and elbow. The joint bleedings are accompanied by pain and an inflammatory process that leads to synovitis and ultimately to degenerative joint changes resulting in haemophilic arthropathy: The synovial tissue is responsible for removing blood residuals from the joint cavity. However, blood components, especially iron, induce several changes in the synovial tissue. The resulting synovitis leads to damage of cartilage, bone cysts, osteophytes, and joint effusions. Synovitis can even become a bleeding-independent process, especially after repeated bleeding. According to current knowledge, there is no option to prevent synovitis except for preventing bleedings.

In the aftermath of recurrent joint bleedings, various changes in the synovial tissue, the articular cartilage, and the subchondral bone and blood vessels are observed. These changes are accompanied by restricted joint mobility and musculoskeletal dysfunction. In addition to these peripheral structural changes, various studies show that the entire musculoskeletal system is also affected by recurrent joint bleedings, as it adapts to pain.

Improved therapy over the past decades has led to a reduction in major joint bleeding rates. For this reason, it is important to examine whether this has improved the average joint status and how often patients with haemophilia (PwH) are affected by synovitis at all. Sonography is the radiation-free method of choice for the initial determination of synovitis.

In addition to the structural consequences, joint bleedings also lead to pain and reduction in physical performance. When considering the overall process of degenerative joint changes of PwH, it becomes apparent that this also reduces daily mobility and muscle strength. To the best of our knowledge, the effects of the degree of synovitis on pain perception and physical performance have not been evaluated in previous studies.

For this reason, the prevalence of synovitis in PwH and the consequences in relation to the pain situation and physical performance will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Participants (≥ 18 years old) suffering from moderate or severe haemophilia A, also with inhibitor or joint replacement
* Complete documentation of hemophilia severity, treatment history (past 12 months), and bleeding events (past 12 months), inhibitor status (at time of enrollment and in past medical history)
* Submitted written consent to participate in the study

Exclusion Criteria:

* Patients suffering from other bleeding disorders conflicting with the research question
* Patients in clinical studies with investigational drugs
A Study to Evaluate ALN-AGT01 in Patients With Hypertension

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) effects of subcutaneous (SC) ALN-AGT01 (zilebesiran) in participants with hypertension. The study will be conducted in 4 parts: Part A will be a single ascending dose (SAD) phase in hypertensive participants, Part B will be a single dose (SD) phase in hypertensive participants with controlled salt intake, Part D will be a MD phase in hypertensive participants who are obese, and Part E will be an open-label SD phase with co-administration of irbesartan in hypertensive patients.


Eligibility Criteria:
Inclusion Criteria:

* Has mild to moderate hypertension with mean sitting systolic blood pressure (SBP) of \>130 and ≤165 mmHg without hypertensive medication for Parts A, B and D, and \>135 and ≤165 mmHg without hypertensive medication for Part E
* Parts A and B: Has body mass index (BMI) ≥18 and ≤35 kg/m\^2; Part D: Has BMI \>35 and ≤50 kg/m\^2; Part E: Has BMI ≥18 kg/m\^2 and ≤50 kg/m\^2
* Has a normal 12-lead electrocardiogram (ECG)
* Is a nonsmoker

Exclusion Criteria:

* Has secondary hypertension
* Has orthostatic hypotension
* Has estimated glomerular filtration rate (eGFR) of \<60 mL/min/1.73m\^2
* Recently received an investigational agent
* Has diabetes mellitus
* Has history of any cardiovascular event
* Has history of intolerance to SC injection(s)
Assessment of the Anterior Loop of the IAN in a Sample of Egyptian Population Using CBCT

in this study the prevalence \& length of the anterior loop of the inferior alveolar nerve will be calculated and measured on retrospective CBCT patient's scans

The proper knowledge of anatomical structures and their precise position is of a paramount importance for different dental specialties. The inferior alveolar nerve (IAN) canal is one of the most important anatomical landmarks in the mandible Shaban et al., 2017. By definition the inferior alveolar nerve (IAN) is a terminal division of the mandibular branch of the trigeminal nerve, it is confined within the mandibular canal and innervates all the mandibular teeth. The IAN initiates from the mandibular foramen and goes obliquely downward and forward in the ramus, and then horizontally within the body of the mandible. The IAN gives off the mental nerve, which exits the mandible through the mental foramen, supplying sensory branches to the chin, lower lip, mucous membranes and the gingiva; from the midline to about the second premolar region. It then continues its path anteriorly and turn into the mandibular incisive nerve, which innervates the mandibular canines and incisors Siddiqui et al. 2018. Before leaving the mental foramen and branching into the incisive nerve, the IAN may continue anteriorly and form an anterior loop (Al). This anterior loop is the part where the IAN directs mesially and occlusally before reversing direction and coursing distally towards the mental foramen Ragu et al., 2019. During implant planning and other surgical procedures knowing the presence of the anterior loop and its length is very crucial to avoid its injury. Specially concerning implantology where the location of the mental foramen and anterior loop determines the most distal point for implant placement in the interforaminal area; in order to avoid any injury resulting in sensory disturbances in this area Panjnoush et al., 2016 Recently, several studies have been published discussing the prevalence and length measurement of the anterior loop in many populations. However, no published researches were done on the Egyptian population. Therefore, this study is designed to assess the presence of the anterior loop and its length in a sample of Egyptian population using CBCT.

Eligibility Criteria:
Inclusion Criteria:

* CBCT scans of adult Egyptian patients, males and females.
* CBCT scans with unilateral or bilateral anterior mandibles; with minimum 2 mm length distal to the mental foramen

Exclusion Criteria:

* CBCT images of poor quality or artifacts interfering with the assessment of the anterior loop of IAN.
* Scans showing any pathosis in the interforaminal area (tumor or impaction).
Treatment of HCV-Infected Recent Injection Drug Users in U.S. Liver Clinics

Direct antiviral therapy (standard of care) administered to chronic hepatitis C-infected patients, in two hepatology clinics, who had used intravenous drugs in the past 6 months of signing informed consent (IC). This cohort was compared to concurrently treated chronic hepatitis C patients who were not intravenous drug users, who signed IC in these same clinics. Follow-up expected two years after cure and relapse rates recorded.

Primary end point was SVR rate and secondary end points included reinfection rates in follow-up period.

Chronically HCV-infected participants were recruited and treated at two liver referral clinics in Georgia, but had been referred from opioid substitution therapy clinics, primary care and GI clinics, neighboring hospitals, and correctional centers. Once consented, a nurse navigator was assigned to each participant was responsible for all subjects' appointments, and med supplies. Drug testing was mandated at specified intervals. Patients with recent injection drug use (within 6 months) were assigned to the PWID (people who inject drugs) arm, and those who hadn't injected within 6 months, but agreed to be in the study and signed consents, were assigned to the non-PWID arm. Both groups were treated with velpatasvir (100 mg) and sofosbuvir (400 mg) once daily for 12 weeks (brand or branded generic). Adherence was assessed by pill counts. Mandatory treatment visits were scheduled for baseline, 4 and 12 weeks (+/- 2 weeks) and follow-up (FU) week 12 (+ 4 months). Long-term FU was flexible and could be virtual, but was mandated once yearly with HCV RNA testing.

Eligibility Criteria:
Inclusion Criteria:

* Chronic HCV infection and PWID arm: use of intravenous drug use at least once in preceding six months. In Non-PWID arm: no use of intravenous drug use at least once in preceding six months.

Exclusion Criteria:

* Co-infection with chronic hepatitis B; Decompensated cirrhosis current or by history; inability to sign informed consent; unwilling to take therapy or unable to obtain therapy