cyrilzakka/clinical-trials huggingface dataset:
Design of Patient Specific Guides (PSG) for Reverse Shoulder Arthroplasty

This is a two steps observational study

In the first part we will compare the accuracy of the commercial guide against a in-hospital designed patient specific guide. As a secondary goal, the problems detected during the design phase will be described.

Once the accuracy of the guide is acceptable, we will implant the glenosphere of future patients using the PSG guide following the same engineering design process.

Reverse shoulder arthroplasty is a treatment for both non-synthesizable fractures and arthropathy degenerative. This implant is based on two main components: glenosphere and stem. The stem in turn is integrated in its upper part by a polyethylene that reduces the friction torque between the glenosphere and the stem.

Correct positioning of the glenosphere is critical for functionality and survival of the implant. Malpositioning of glenosphere can be related to:

In recent years, given the

* The scapula is a flat bone, without any reference axis;
* Surgical approaches expose only the glenoid cavity, with few bone landmarks;
* The humerus and deltoid make access to the glenoid difficult;
* The morphology of the scapula is very variable.

Preoperative planning even without PSG improves the positioning accuracy of the guide in the glenoid. In glenoids with only a slight deformity, PSGs improve the accuracy of the guide entry point (\&amp;amp;amp;lt;1 mm error, compared to \&amp;amp;amp;gt; 4 mm under visual control) and orientation (\&amp;amp;amp;lt; 3◦ error compared to \&amp;amp;amp;gt; 7◦). In glenoids with more significant deformities, planning also showed superiority.

Eligibility Criteria:
Inclusion Criteria:

* Patient with proximal humerus fracture candidate for reversed shoulder arthroplasty
* Patient with degenerative arthropathy candidate for reversed shoulder arthroplasty

Exclusion Criteria:

* Previous surgeries on the proximal humerus or glenoid
* No desire to participate in the study
* Lack of ability to accept the study (tutored patients)
* Open fractures
Effect of Glucocorticoids on Inflammation and Bone Metabolism in Patients With Glomerular Disease

The aim of the study is to assess the influence of high doses of intravenous corticosteroids on plasma inflammation and bone markers in patients with primary glomerular disease. The study would include 40 patients with chronic kidney disease. The main inclusion criterion is clinical and histopathological diagnosis of primary glomerular disease and urine protein excretion \>2.0 g/24h. The exclusion criteria include secondary glomerular disease, acute kidney injury, acute or chronic inflammation, history of non-compliance.

Glucocorticoids are one of the most widely used classes of drugs to treat inflammatory and autoimmune diseases. They increase formation of osteoclasts and enhance bone resorption thereby increasing risk of bone fractures and osteoporosis.

Sirtuin-1(SIRT-1) belongs to family of proteins involved in protection against inflammation and oxidative stress. A role of SIRT-1 in regulation of bone metabolism during high-dose steroid therapy is unknown.

The study protocol was approved by the local Bioethics Committee and the study is conducted according to the Declaration of Helsinki. Adult patients with the previous diagnosed primary glomerular disease based on both clinical and renal biopsy findings are included.

Plasma concentration of SIRT-1, interleukin-6 (IL-6), fibroblast growth factor 23 (FGF-23), sclerostin, calcium, phosphate, parathormone (PTH) and urine excretion of total protein, albumin, creatinine, calcium and phosphate are measured at baseline. Then the patients receive three intravenous pulses of methylprednisolone of 500 mg followed by oral prednisone 0.8-1.0 mg/kg/24h. The same measurements are repeated 4, 7 and 30 days after starting the steroid treatment.

Eligibility Criteria:
Inclusion Criteria:

* previous diagnosed primary glomerular disease based on both clinical and renal biopsy findings
* an estimated glomerular filtration rate ≥15 ml/min/1.73m2
* proteinuria ≥2.0 g/24h

Exclusion Criteria:

* secondary glomerular disease
* acute kidney injury
* acute or chronic inflammation
* malignancy
* uncontrolled hypertension with systolic blood pressure higher than 160 mmHg
* symptomatic hypotension
* advanced heart failure
* history of non-compliance, dementia or depression
PERL Continuous Glucose Monitoring (CGM) Study

Seven-point capillary profiles have shown that mean glucose correlates with both diabetic retinopathy and nephropathy risk. However, there remains great controversy as to whether the degree of variability around mean glucose may also contribute to these microvascular complications. The PERL trial (NCT02017171), testing whether treatment with allopurinol can slow down kidney function loss in type 1 diabetes, provides a unique opportunity to assess the role of glycemic variability in the progression of diabetic kidney disease in individuals who already have mild to moderate kidney disease. By applying Continuous Glucose Monitoring (CGM) in the PERL Study population, the investigators will be able to better understand how metrics of glycemia (mean, time above and below range, and various measures of variability) are associated with renal outcomes in the PERL population as a whole, but also in important subgroups (e.g., albuminuric vs. normoalbuminuric subjects with ongoing GFR decline, allopurinol vs. placebo arms). The nvestigators also aim to obtain precise information on the range of blood glucose corresponding to any given HbA1c value in this population since previous studies generally excluded patients with renal disease.

Participants who consent to the study will have an Abbott Freestyle Libre Pro sensor placed on the back of their upper arm at their first PERL visit after this ancillary study has begun and at all subsequent PERL Visits. The sensor will be continuously worn by participants for 14 days. At the end of the 14 days, the sensor will be removed and mailed by the participant to the Coordinating center. Since subjects are at various stages of the PERL protocol, the number of remaining visits at which the CGM will be applied will vary among subjects.

STUDY AIMS

1. To assess the effect of glycemic variability, as measured by the coefficient of variation of CGM glucose (CV, the ratio of standard deviation and the mean of CGM glucose values), on the PERL renal functional endpoint (iohexol GFR at the end of study).
2. To assess the effect of other glycemic parameters measured by CGM (mean glucose, % time 70-180 mg/dL, % time below 54 mg/dL, % time below 70 mg/dL, % time above 180 mg/dL, % time above 250 mg/dL, mean amplitude of glucose excursions \[MAGE\], low blood glucose index \[LBGI\], high blood glucose index \[HBGI\]) on the PERL renal functional endpoint.
3. To assess the relationship between CGM-measured glycemic parameters and HbA1c at various levels of renal function.
4. To compare the effects of CGM metrics on the PERL renal endpoint and the corresponding effect of HbA1c.
5. To assess the effect of allopurinol treatment on all of the different glycemic metrics including HbA1c, CV, etc. and on their association with the PERL renal endpoint.

Eligibility Criteria:
Inclusion Criteria:

• Being an active participant in the PERL clinical trial

Exclusion Criteria:

* Having completed PERL Visit 16
* Pregnancy
* History of skin reactions in relation to the application of Abbott Freestyle Libre Pro
The Comparison of Cognition, Depression and Anxiety, and Quality of Life After Hip Fracture Surgery Under General or Regional Anesthesia

Postoperative cognitive dysfunction is a relatively common in elderly patients after hip surgery, but exact mechanism of its onset is still unclear as well as contributing factors. There is also increased incidence of depression and anxiety. Both affect the recovery after surgery, slow it down and reduce the quality of life. Patients will be divided into two groups, operated under regional anaesthesia and operated under general anaesthesia, and monitored after surgery. Patients will be tested before and after surgery to evaluate postoperative cognitive deficits, depression and anxiety scale and health-related quality of life questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* Patients intended for surgical treatment of hip fractures ≥ 60 years
* Patients who are category ASA I to ASA III will be included in research
* Sufficient cognitive ability
* Only those patients who have agreed to be participants in the research and have signed the consent for participation and informed consent.

Exclusion Criteria:

* Patients who refused to participate in the survey and who did not sign informed consent
* Patients with ASA IV or more
* Patients under 60 years
* Severe psychiatric disorders involving the use of psychopharmaceuticals back three months
* All patients who have other fractures in addition to hip fractures
* Polytrauma
* All patients scheduled for more than one surgical intervention during the procedure, or within the next 8 weeks
* Patients who have been diagnosed with dementia, and / or are receiving anti-dementia drugs
Ranibizumab as a Rescue Therapy for Diabetic Macular Edema

Treatment with Ranibizumab of the residual diabetic edema in patients with failed response to Bevacizumab.


Eligibility Criteria:
Inclusion Criteria:

Subjects will be eligible if the following criteria are met:

1. Age \> 18 years
2. Diagnosis of diabetes mellitus (type 1 or 2)
3. Residual edema as determined by mean foveal thickness on Spectralis OCT (optical coherence tomography) \> 300 microns and leakage seen on FA at baseline
4. Clinical evidence of retinal thickening due to macular edema involving the center of the macula, associated with diabetic retinopathy.
5. Previous history of at least 3-5 or more consecutive 1.25 mg of intravitreal bevacizumab injections for the treatment of diabetic macular edema (consecutive injections administered no more than 6 weeks apart).
6. BCVA of 20/32-20/400 using Early Treatment Diabetic Retinopathy Study (ETDRS)
7. Media clarity, pupillary dilation and patient cooperation sufficient to allow OCT testing and retinal photography

Exclusion Criteria:

1. Pregnancy (positive pregnancy test) or known to be pregnant; also pre-menopausal women not using adequate contraception.
2. Participation in another ocular investigation or trial simultaneously.
3. Systemic use of anti-VEGF within 3 months prior to day 0.
4. Blood pressure \> 180/110 (systolic above 180 OR diastolic above 110)
5. Any condition that, in the opinion of the investigator, would preclude participation in the study (e.g. chronic alcoholism, drug abuse).
6. Evidence of vitreoretinal interface abnormality after ocular exam or OCT that may be contributing to the macular edema.
7. An eye that, in the investigator's opinion, has no chance of improving in visual acuity following resolution of macular edema (e.g. presence of subretinal fibrosis, ischemic maculopathy or geographic atrophy).
8. Presence of another ocular condition that may affect the visual acuity or macular edema during the course of the study (e.g. Age-related Macular Degeneration, uveitis, Irvine-Gass).
9. Evidence of active neovascularization of the iris or retina.
10. Evidence of central atrophy or fibrosis in the study eye.
11. Presence of substantial cataract, one that might decrease the vision by 3 or more lines of vision at sometime during the study.
12. History of vitreous surgery in the study eye.
13. History of cataract surgery within 6 months of enrollment.
14. History of YAG capsulotomy within 2 months of enrollment.
ReliefLink: A Preventative Mobile Toolkit for Follow-Up Care of Psychiatric Patients

The purpose of this study is to increase use and availability, as well as assess the feasibility of the ReliefLink (RL) application for use in conjunction with standard care to promote psychological health and prevent suicidal behavior.

The aims of this study of ReliefLink application are to determine the utility of ReliefLink self-reports of suicidal ideation, negative emotions, loneliness, subjective well-being, flourishing, mental toughness, positive emotions, learned optimism, resilience, and post-traumatic growth. Additional aims are to evaluate the impact of ReliefLink on perceived access to/usage of care and resources and to explore participant acceptance of ReliefLink as a technological support for standard treatment through human systems engineering of treatment plan adherence and user interview.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled as patients seeking behavioral health treatment through the Grady Health System
* Speak English
* Sought inpatient and/or outpatient treatment with Grady Health System following a suicide attempt or ideation.
* Has personal access to a functioning iPhone and service plan.

Exclusion Criteria:

* Has significant cognitive impairments.
* Is actively psychotic or has an imminently life-threatening medical/psychiatric condition per provider evaluation.
Neurofilament Light Chain And Voice Acoustic Analyses In Dementia Diagnosis

This cohort study aims to determine if a blood test can aid with diagnosing dementia in anyone presenting with cognitive complaints to a single healthcare network. The investigators will measure levels of a brain protein, Neurofilament light chain (Nfl), and assess changes in language using speech tests.

Participants will have a single blood test and speech test, and will be followed up at 12-months to complete questionnaires and cognitive scales over the phone. The speech test will also be completed again at 12-months.

Individuals at risk of a Fronto-temporal dementia syndrome will be eligible to complete optional genetic testing involving an 'at home' saliva sample.

Problem: There is no "gold-standard test" to detect all forms of dementia. People can present with subtle changes that are missed on standard cognitive screening tests, which are not designed for people whose first language is not English or from diverse cultural and educational backgrounds. State-of-the art brain imaging is only available to Australians living in large urban centres, further entrenching health care inequities. The lack of validated diagnostic tests and pathways causes diagnostic delays, increases patient and caregiver stress. Therapies are on the horizon for many forms of dementia - not only Alzheimer's disease - meaning that the lack of identification of simple dementia diagnostic biomarkers represents a critical knowledge gap.

Mission: New technologies now allow us to test abnormal brain protein levels in a routine peripheral blood test, record a voice sample to analyse its acoustics and reveal brain disease, and perform "mail-out" genetic tests using a simple saliva sample. The levels of a brain derived blood protein, neurofilament light chain (NfL), will be estimated and natural language processing and acoustic analysis will be measured in all patients presenting with cognitive complaints to a single healthcare network servicing 1 million ethnically and culturally diverse Australians. Researchers will investigate the utility of early genetic testing for those at high risk of a genetic cause for their disease. They will use these data to develop diagnostic pathways, leveraging existing collaborations to develop future screening programs. Early to mid-career researchers will be supported to translate new technologies into clinical practice in the shortest practicable time-frame.

Significance: Accessible and cost effective tests will inform new pathways to dementia diagnosis. This will transform the dementia landscape, shortening time to diagnosis, increasing diagnostic certainty, and allowing more Australians access to appropriate care, education, and future therapies.

Eligibility Criteria:
Inclusion Criteria:

* All patients presenting to Eastern Health services with a cognitive complaint or potential neurodegenerative disorder

Exclusion Criteria:

* Individuals not likely to live for 12 months
Subthreshold Micropulse Laser Treatment of Acute Central Serous Chorioretinopathy

To evaluate the efficacy and safety of 532 nm green subthreshold micropulse laser (GSML) as a treatment for acute central serous chorioretinopathy (CSCR).

This prospective study included 42 eyes of 42 patients with acute CSCR treated with IRIDEX™ IQ 532 nm GSML. The study was conducted at Minia University Hospital and Genaidy Ophthalmology Center, Minia, Egypt between October 2019 and May 2022. All patients were subjected to a complete ophthalmological examination, fluorescein angiography (FA) and optical coherence tomography (OCT) at baseline and each follow-up visit 1, 3 and 18 months after laser treatment

Eligibility Criteria:
Inclusion Criteria:

* acute CSCR

Exclusion Criteria:

* chronic CSCR Previously treated case of Acute CSCR
Azithromycin as a Quorum-Sensing Inhibitor for the Prevention of Pseudomonas Aeruginosa Ventilator-Associated Pneumonia

The purpose of this study is to assess the clinical efficacy of azithromycin, used as a quorum-sensing blocker, when compared to placebo for preventing or delaying the occurrence of pneumonia in ventilated patients colonized with Pseudomonas aeruginosa.


Eligibility Criteria:
Inclusion Criteria:

* Male and non pregnant female aged 18 to 75 years
* Patients hospitalized in ICU, under mechanically assisted ventilation expected to be mandatory for 3 days or more
* Reasonable survival chance within next few days with an Apache score 10-25
* Tracheal aspirate found positive for P. aeruginosa
* The subject (or a close family member in case of incompetence) understands the procedure, agrees to participate, and is willing to give written informed consent
* Informed consent must be obtained for all subjects before enrollment in the study, by patient or by a close family member

Exclusion Criteria:

* Poor prognosis as judged by Apache score II score \>25
* Pregnant female
* Grossly under-or overweight (BMI\<18or \>29)
* Ongoing therapy with a macrolide
* Known allergy to any macrolide
* Proven P. aeruginosa pneumonia
* Ongoing anti-pseudomonal therapy with a proven susceptible colonizing strain
* Anticipated short duration of mechanical ventilation (\<3 days)
* Known drug interaction that could either decrease efficacy or raise safety concerns
* Severe hepatic failure (type C, score \>10 on Child Pugh scale)
* Sick sinus syndrome or long QT syndrome
* Recent donation of blood or participation in another clinical trial within 3 months
* Any situation exposing the patient to higher risk or possibly confounding results
Parameters of 2 Phaco Tips Designs in Torsional Phacoemulsification

To compare the efficiency of surgical procedures using 2 phaco tip designs in torsional phacoemulsification using the bevel-down technique.

In this prospective, comparative, masked study, patients will be randomly assigned to have torsional coaxial microincision cataract surgery using either the mini-flared 45-degree Kelman tip or reversed mini-flared 30-degree Kelman tip. Clinical measurements will include preoperative and 3-month postoperative corrected distance visual acuity (CDVA), endothelial cell counts (ECC) and preoperative and 1-day postoperative central corneal thickness (CCT). Intraoperative measurements will include phaco time, torsional time, aspiration time, case time, cumulative dissipated energy (CDE) and balanced salt solution volume (BSS).

The study was performed according to established ethical standards for clinical research Institutional Review Board (IRB) of the University of Sao Paulo in Brazil, conducted between November 2010 and February of 2011. All surgeries will be performed at the University of Sao Paulo. Physicians conducting postoperative evaluation will not have access to patients' medical records. Exclusion criteria will be previous ocular surgery, central endothelial cell count less than 2000 cells/mm2, glaucoma or intraocular pressure greater than 21 mmHg, amblyopia, retinal abnormalities, steroid or immunosuppressive treatment and connective tissue diseases. Enrolled patients who have complicated cataract surgery (eg, posterior capsule rupture, vitreous loss, or an intraocular lens not placed in the capsular bag) will be subsequently excluded.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 40 years with age-related cataract, and a normal ophthalmologic examination besides senile cataract.

Exclusion Criteria:

* Previous ocular surgery, central endothelial cell count less than 2000 cells/mm2, glaucoma or intraocular pressure greater than 21 mmHg, amblyopia, retinal abnormalities, steroid or immunosuppressive treatment, connective tissue diseases, or an allergy or hypersensitivity to NSAIDs. Enrolled patients who had complicated cataract surgery (eg, posterior capsule rupture, vitreous loss, or an intraocular lens not placed in the capsular bag) were subsequently excluded
Efficacy and Mechanisms of Low-intensity Focused Ultrasound on Negative Symptoms in Patients With Schizophrenia

Based on our research background, we hypothesize that LIFUS has neuromodulation effects on brain cortex and the active LIFUS on left-DLPFC would improve negative symptoms in schizophrenia patients. It would firstly verify the safety of LIFUS on human as well. The multimodal MRI will be contributed to investigate the possible mechanism of negative symptoms.

Firstly, we plan to explore the short-term effects of LIFUS on cortical excitability by detecting the MEP amplitude. 40 patients and relatively well matched healthy-control would be enrolled. After MEP detection and baseline evaluations, the two groups will be treated with one-single intervention on the primary motor cortex. The cognitive function and MEP amplitude will be assessed respectively at the moment, after 15 minutes and 30 minutes. Then, it is a randomized double-blind sham-controlled LIFUS intervention trial in schizophrenia patients. After screening and baseline evaluations, the 40 patients with schizophrenia will be treated with active LIFUS or sham stimulation for 3 weeks on the left DLPFC. The multimodal MRI will be acquired. Clinical symptoms and cognitive function will be assessed respectively at baseline, at the end of fifth treatments and after the end of the treatment.

Eligibility Criteria:
* Inclusion Criteria (patients):

  1. Meet the DSM-5 diagnostic criteria for schizophrenia or schizoaffective disorder;
  2. Age18-50, right-handed, Han nationality;
  3. the score of at least 1 item from N1 to N7 is ≥4 (moderate or above);
  4. Be in a stable condition, received second-generation antipsychotics for at least 4 weeks or more;
  5. Written informed consent;
* Exclusion Criteria (patients):

  1. Current or past neurological illness, severe physical diseases, substance abuse or alcohol dependence, mental retardation, pregnant or lactation;
  2. Uncooperative or risky patients with high excitement, stupor, disorder of words and deeds, negative suicide, etc.;
  3. A history of MECT or other physical therapy within 6 months;
  4. A history of epilepsy, or epileptic waves on the baseline EEG;
  5. Ruled out share antiepileptic drugs, carbamazepine, valproic acid salt) or larger doses of benzodiazepines drugs (\> 10 mg/day, diazepam clonazepam 2 mg/day, 1 mg/day, alprazolam lorazepam 2 mg/day, midazolam 10 mg/day, 20 mg/day, Mr Shah diazepam triazolam 0.5 mg/day), avoid the use of chlorine drug, (in principle, to avoid the use of antiepileptic drugs and clonazepam;Other antipsychotic drugs, if necessary, remain unchanged during the course of treatment;
  6. Contraindications to LIFUS and MRI are present.