cyrilzakka/clinical-trials huggingface dataset:
Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension).

The purpose of this study is to evaluate long-term safety and tolerability of ianalumab in participants with systemic lupus erythematosus who have previously completed the treatment period in one of the two SIRIUS-SLE core studies (CVAY736F12301 or CVAY736F12302).

The purpose of this extension study is to evaluate long-term safety and tolerability of ianalumab administered s.c. monthly or quarterly, compared to monthly placebo, in adolescent and adult participants with anti-nuclear antibody (ANA)-positive systemic lupus erythematosus of moderate-to-severe disease activity, who have completed either CVAY736F12301 (SIRIUS-SLE 1) or CVAY736F12302 (SIRIUS-SLE 2) core studies.

Eligibility Criteria:
Key Inclusion Criteria:

* Signed informed consent prior to participation in the extension study. Parent or legal guardian's signed informed consent and child's assent, if appropriate, are required before any assessment is performed for participants \<18 years of age. Of note, if the participant reaches age of consent (age as per local law) during the study, they will also need to sign the corresponding study Informed Consent Form (ICF) at the next study visit.
* Participants must have participated in either one of the two SIRIUS-SLE core studies, CVAY736F12301 or CVAY736F12302, and have completed the treatment period through Week 60 without treatment discontinuation.
* In the judgement of the investigator, participants must be expected to clinically benefit from continued study treatment.

Key Exclusion Criteria:

* Use of prohibited therapies.
* Active viral, bacterial or other infections requiring intravenous or intramuscular treatment for clinically significant infection which in the opinion of the investigator will place the participant at risk for participation.
* Plans for administration of live vaccines during the study period.
* Pregnant or nursing (lactating) women.
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, refusing or unable to use highly effective methods of contraception while on study treatment and for 6 months after stopping of study drug (or longer if required by concomitant medications).
* United States (and other countries, if locally required): sexually active males, unless they agree to use barrier protection during intercourse with women of child-bearing potential while taking study treatment.

Other protocol-defined inclusion/exclusion criteria may apply.
Impact of an Operating Room Nurse Pre-operative Dialogue in Patients Undergoing Major Visceral Surgery

Single-center, open label, randomized controlled trial of a preoperative nursing dialogue in patient undergoing major visceral surgery aiming in evaluating its impact on patients' anxiety, satisfaction and early postoperative outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing elective major visceral surgery
* Hospitalization the day before surgery
* Sufficient command of French language

Exclusion Criteria:

* emergency procedures (after unplanned admission)
* inability to obtain informed consent or refusal
* inability to follow intervention
A Phase 3 Trial of MM120 for Generalized Anxiety Disorder (Voyage)

A Phase 3 Double-blind, Placebo-controlled Study (Part A) with an Open-label Extension (Part B) Evaluating MM120 Compared to Placebo in Generalized Anxiety Disorder - Voyage

The study will enroll up to 200 participants aged 18 to 74 years, inclusive with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) confirmed primary diagnosis of GAD and a minimum HAM-A total score of at least 20 at Screening and Baseline without clinically relevant medical or psychiatric history.

The study consists of a 12-week randomized, double-blind, single-dose administration period evaluating MM120 versus placebo, followed by a 40-week extension phase with the opportunity for open-label treatment. During this phase, participants will be monitored and evaluated for potential treatment with MM120 based on pre-specified safety and symptom severity criteria.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of GAD per DSM-5
2. Male or female aged 18 to 74
3. HAM-A Total Score ≥20

Exclusion Criteria:

1. Certain psychiatric disorders (other than generalized anxiety disorder)
2. First degree relative with or lifetime history of a psychotic disorder or bipolar disorder
3. Current diagnosis of alcohol or substance use disorder (excluding nicotine and caffeine)
4. Any clinically significant unstable illness
Racing and Crowded Thoughts in Mood Disorders

Racing thoughts relate to subjective acceleration of thinking which has been essentially associated with manic episodes in bipolar disorder. Qualitatively, the phenomenology of racing thoughts in major depression seems to differ from rumination and pure manic racing thoughts: thoughts of all kinds accumulate in the patient's head. Recent qualitative evidence is consistent with the existence of these two kinds of "thought overactivity" related to mood disorders. In order to evaluate this and better understand the psychopathological and cognitive mechanisms that underlie thought overactivity in mood disorders, we have created a 34-item self-questionnaire - the Racing and Crowded Thoughts Questionnaire (RCTQ) and a number of neuropsychological tasks (time perception, cognitive flexibility). Also, given the relationship between mood disorders and creativity, it is likely that thought overactivity is related to increased creativity. We aim at evaluating this relationship through the French version of the Cognitive Processes Associated with Creativity scale (CPAC).


Eligibility Criteria:
Inclusion Criteria:

* Bipolar disorder or depressive disorder
* 18 -65 years old

Exclusion Criteria:

* neurological conditions or sequelae
* substance abuse in the last 10 months
* schizophrenia
* ADHD
* Borderline personality disorder
* Pregnant women- Subjects under legal supervision
Does Cranioplasty Reduce Disability in Cases With Post Traumatic Skull Bone Defects

Background: The percentage of permanent infirmities following traumatic cranial bone cranial bone defects following trauma for restoration of function and cosmoses. This study designed to evaluate the influence of cranioplasty as a method of skull repair on work capability of the patients and their employability.

Methods: The authors compared the work capability and employment of 35 patients with traumatic cranial bone defects after head trauma treated in the Neurosurgery Department of Assiut University Hospitals, Egypt from January 2013 to January 2018 before and after cranioplasty.

Cranioplasty is surgical repair of a cranial bone defect, important to cover defects following skull trauma for restoration of function, cosmoses and protective effects. Cranioplasty is the surgical procedure in which the autologous skull, synthetic materials (titanium, methyl methacrylate, polyetheretherketone implants, hydroxyapatite, and bioceramics are used to repair the skull defect

Eligibility Criteria:
Inclusion Criteria:

• Patients with traumatic skull bone defects

Exclusion Criteria:

• Patients were not working before trauma
Association Between Non-alcoholic Fatty Liver Disease and Iron Status

The investigators hypothesize that low iron storages protects from and down-grades non-alcoholic fatty liver disease.

The aim of the study is to show the association between the severity of Non-alcoholic fatty liver disease to low iron status.

Patients that will pass a CT scan that includes the abdomen will be asked to participate at our study. These patients will be divided into two groups - with and w/o fatty liver. The severity of fatty liver will be determined using the CT scan (as well as other parameters, such as the size of subcutaneous fat layer). Within 72 hours from the scan, a venous blood test will be taken from the enrolled patients (together with a BMI calculation and a blood pressure measurements). In the blood test we will examine liver functions, iron status etc.

This is a preliminary study that will aid in planning future strategies to treat or even prevent fatty liver (one of the epidemics of our century).

Eligibility Criteria:
Inclusion Criteria:

* age\>18
* BMI\>25

Exclusion Criteria:

* pregnancy
* unable to sign an informed consent (legally)
* known solid/hematological malignancy
* hemoglobinopathy or myelodysplastic disease (not including G6PD deficiency)
* active or carrier of viral hepatitis
* treated a drug the cause fatty liver (eg. amiodarone, tetracyclin, HAART, steroid treatment \> 3 months)
* consumption of \> 120g ethanol per week
* primary liver disease (eg. glycogen storage disease)
* CRP\>20
* acute intoxication
* surgery in previous 7 days
Intraoperative Mitomycin C, Amniotic Membrane Transplantation and Conjunctival Autograft for Primary Pterygium

The purpose of this randomized multi-center clinical trial is to compare the efficacy and safety of intraoperative mitomycin C(MMC),amniotic membrane transplantation(AMT) and Conjunctival Autograft(CAG) for primary pterygium surgery. The investigators will also evaluate particular risk factors related to pterygium recurrence.

Patients with primary pterygium will be randomly assigned to undertake pterygium excision followed by intraoperative mitomycin C application,amniotic membrane transplantation or conjunctival autograft in five clinical centers. Multi-center collaboration and quality monitoring will be based on a website designed for this study. The patients will be followed at least 12 months. Corneal Recurrence as the primary outcome measure, is considered as a fibrovascular ingrowth beyond the limbus with conjunctival drag.

Eligibility Criteria:
Inclusion Criteria:

* Primary pterygium
* Willingness to participate in research project and to attend research follow-up
* Adults (age 18 to 80 years old)
* Patients must not meet any of the following exclusion criteria

Exclusion Criteria:

* Pregnant,breast-feeding women or patients with poor general health
* Patients with significant ocular or lid pathology, such as Sjogren's Syndrome, infection, exposure keratitis, glaucoma, active uveitis, retinal detachment and trauma
* Patients with previous surgery on ocular surface, such as trabeculectomy, strabismus surgery
* Patients with allergy to intraoperative or postoperative drugs, such as mitomycin C, tobramycin or local anesthetics
Using MRI in Patients With Non-dystrophic Myotonia to Access Muscle Contractility

The aim of this project is (1) to investigate whether or not structural muscle abnormalities could be a consequence of the disorder and (2) to provide further clinical description of this rare phenotype. To do so, the investigators will (1) use Dixon MRI to quantify fatty infiltration in muscle tissue and compare it to muscle strength measurements from isometric dynamometry in order to access contractility and (2) describe the myotonic phenotype with simple squeeze test and questionnaires.

Non-dystrophic myotonias are rare genetic diseases in which the membrane excitability is altered by mutations in genes encoding muscle ion channels.

Patients suffer from myotonic stiffness, pain, fatigue and sometimes paralysis. Non-dystrophic myotonia is distinct from myotonic dystrophies with the absence of muscle degeneration.

Paramyotonica congenita is characterzied by paradoxial myotonia, which, in contrast to the more common myotonia congenita, is myotonic stiffness that worsens with activity. Typically, the first few contractions seem normal, whereas repetition leads to severe stiffness. Our hypophysis is that these patient might also suffer from muscle degeneration.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age
* Diagnosed with non-dystrophic myotonia

Exclusion Criteria:

* MRI contraindications
Transcranial Alternating Current Stimulation for Hand Function Recovery

tACS has the potential to directly induce cortical alterations in the intrinsic neural oscillation at specific frequencies, and the brain could mirror the induced frequencies of the external source of oscillations from the stimulation. Hence, tACS with matching stimulation frequency could be an effective means of enhancing brain oscillatory activity to potentially induce synaptic plasticity for restoration of damaged brain functions. However from the existing studies of applying tACS over the M1 in healthy and diseased brains, there is a wide range of applied stimulation frequencies and varied neuromodulation effects on motor behavior or cortical excitability at different frequencies. In this proposal, subject-specific stimulation frequency and latency will be identified.


Eligibility Criteria:
Inclusion Criteria:

* Hemiparesis subsequent to first-ever unilateral stroke for more than 6 months;
* MCP and PIP finger joints can be extended to 180° passively;
* Sufficient cognition to follow the experimental instructions

Exclusion Criteria:

* Severe hand spasticity or hand deformity;
* History of alcohol or drug abuse or epilepsy;
* Bilateral brain infarcts;
* Severe cognitive deficits;
* Comprehensive aphasia;
* Contraindications to tACS and MRI
Do You Arthroscopic Repair for Subscapularis Tendon Tear, Which Accounts for More Than Half of the 1st Facet? Or do You Perform Debridement?

The purpose of this study was to randomly classify the upper third of the subscapularis in 1/2 of the rupture patients as preoperative group (arthroscopic and arthroscopic debridement group) and the difference between clinical and clinical scores.

The degree of rupture that is an adaptation of arthroscopic surgery is now known to be about one-third to one-half of a rupture. However, the most controversial case is the one-third to one-half of the upper tear attached to the tendinous portion of the subscapularis. Currently, debridement or repair is under way. But evidence-based studies are lacking and no clear treatment guidelines are available.

Eligibility Criteria:
Inclusion Criteria:

* Subscapularis tendon tear from more than 1/2 to entire of 1st facet found during routine arthroscopy with 70 degree scope
* Isolated or combined with Supraspinatus and/or Infraspinatus tear (SS/IS tear less than 3 cm)
* Combined biceps lesion
* Combined acromial clavicle (AC) arthritis

Exclusion Criteria:

* Revision case or previous surgical history of the index shoulder
* Any open surgery, including open repair of the subscapularis tendon
* Compensation case
* Combined severe arthritis of the glenohumeral joint
* Patient who selects one's own surgical method, i.e. not randomized
* Infection, tumor, etc
Escalation Antifungal Prophylaxis for Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

This is single arm study to evaluate an escalation anti-fungal prophylaxis protocol for patients undergoing allogeneic stem cell transplantation. For all patients without documented proven or probable invasive fungal disease (IFD), patients will receive fluconazole during the treatment in the laminar air flow units (LAF). After discharged from LAF units, patients will receive anti-mold prophylaxis in case of haplo-identical or HLA-matched unrelated donor transplantation to d+100 without active acute GVHD (aGVHD). In case of active aGVHD, the prophylaxis treatment will be extended until recovery of aGVHD and tapering of immunosuppression. In case of HLA-matched sibling donor, fluconazole will be continued to d+100 and anti-mold prophylaxis will be given in case of active aGVHD.

Based on CAESAR study, the IFD incidence increased significantly in patients with unrelated donor or hallo-donor HSCT after patients being discharged from LAF units. The overall incidence of IFD in patients with HLA-matched sibling donor remain low unless in patients with active aGVHD. In this single-arm prospective study, we plan to evaluate the feasibility and effect of an escalation anti-fungal prophylaxis protocol for patients undergoing allogeneic stem cell transplantation. For all patients without documented proven or probable invasive fungal disease (IFD), patients will receive fluconazole during the treatment in the laminar air flow units (LAF). After discharged from LAF units, patients will receive anti-mold prophylaxis in case of haplo-identical or HLA-matched unrelated donor transplantation to d+100 without active acute GVHD (aGVHD). In case of active aGVHD, the prophylaxis treatment will be extended until recovery of aGVHD and tapering of immunosuppression. In case of HLA-matched sibling donor, fluconazole will be continued to d+100 and anti-mold prophylaxis will be given in case of active aGVHD.

Eligibility Criteria:
Inclusion Criteria:

* patients undergo allogeneic HSCT
* Conditioning regimens: myelo-ablative, reduced toxicity
* No proven or probable IFD before HSCT
* No allergy to fluconazole, voriconazle and posaconazole
* Inform consent given

Exclusion Criteria:

* Imparied liver function with (AST or ALT\>3ULN, TBil \>2ULN)
Infliximab, Regulatory T Cells, IL2 and Crohn's Disease

Crohn's disease is an inflammatory (swelling and soreness) disorder of the digestive tract. Affected patients suffer from abdominal pains, diarrhea (sometimes bloody), weight loss. It is a lifelong disease with frequent flares during the course of the disease. Crohn's disease is mostly treated with medications, sometimes surgery is needed. Infliximab is a medication for treating severe Crohn's disease. This medicine is effective by blocking special substance (tumor necrosis factor) released from certain white blood cells in the body. Infliximab is given via a vessel at week 0, 2, 6 initially, then every 2 monthly for maintenance. However, some of patients with Crohn's disease do not respond infliximab. Currently there is no test to reveal which patients will respond to treatment. This study aims to analyze and compare particular subgroup of white cells and its products during and after infliximab treatment which may determine the responsiveness to infliximab treatment.

All patients will have chest x-ray and pregnancy test (if female) prior to infliximab treatment.

There will be total 5 study visits. At each visit, body weight will be measured, abdominal exam will be performed , 2 tablespoonful of blood will be drawn, stool will be collected, a questionnaire will be completed.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed or exacerbating CD (Moderate to severe CD).
* The diagnosis of moderate to severe CD will be confirmed by previous endoscopy and biopsy.
* Have the capacity to understand and sign an informed consent form.
Role of Patient Selection for Pancreatic Resections

Pancreatic surgery is complicated and risky, especially for pancreatic cancer. It's been noticed that having these surgeries done at specialized centers can lead to better outcomes and survival rates. However, factors like patient selection and hospital conditions also play an important role. Some studies show that more surgeries done at a hospital might not always mean better results, as the type of patients and procedures can vary. To understand this better, the present study compared outcomes and patient characteristics between high-volume pancreatic centers and others.

The study utilized German nationwide administrative data (diagnosis-related group statistics) spanning from 2010 to 2018. Persons who underwent pancreatic resections during this period were included, with exclusions for certain criteria like underage and type of procedure. Various factors including patient demographics, diagnoses, procedures, and comorbidities were analyzed to assess in-hospital mortality rates. High-volume pancreatic centers (HVPCs) were identified as those performing at least 50 procedures annually. Statistical analyses included comparing crude and adjusted mortality rates and assessing patient characteristics between HVPCs and non-HVPCs. Models were adjusted for multiple variables, and methods like the Cochran-Armitage trend test and mixed models were employed. Additionally, the study investigated how differences in patient characteristics between HVPCs and non-HVPCs affected mortality rates.

Eligibility Criteria:
Inclusion Criteria:

* partial or total pancreatic resections between 2010 and 2018

Exclusion Criteria:

* childhood (\<18 years)
* subjects with a pancreatic transplantation procedure
* missing information on age or gender
Study of Peri-Articular Anaesthetic for Replacement of the Knee

The clinical and cost effectiveness of peri-articular liposomal bupivacaine plus bupivacaine hydrochloride compared with bupivacaine hydrochloride alone for post-operative recovery after knee replacement surgery: A multi-centre, patient-blinded, randomised controlled trial.

The trial design is a patient-blinded multi-centre, active comparator, randomised controlled two-arm parallel group superiority trial of liposomal bupivacaine plus bupivacaine hydrochloride versus bupivacaine alone for post-operative pain in patients undergoing knee replacement surgery.

Patients will be randomised in a 1:1 ratio. The randomised controlled trial (RCT) design is robust and reduces any potential bias. Patients will be blinded as to which treatment they receive. Blinding of patients is possible as they will be under general anaesthetic for their knee replacement surgery at the time of the drug administration. Blinding of surgeons, who administer the medication and outcome assessors was not necessary as the primary outcome is a patient reported outcome measure.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral primary knee replacement, including both total knee replacement (TKR) or unicompartmental knee replacement (UKR), for end stage osteoarthritis
* American Society of Anaesthesiologists (ASA) Grade I to III
* Participant is willing and able consent for themselves
* Male or Female, aged 18 years or above
* In the Investigator's opinion, is able and willing to comply with all trial requirements

Exclusion Criteria:

* Allergy or intolerance to amide type local anaesthetics
* Objective evidence of nerve damage in the affected lower limb.
* Rheumatoid arthritis
* Any other significant disease, disorder or condition which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the results of the trial, or the participant's ability to participate in the trial.
* Participants who have participated in another research trial involving an investigational product in the past 6 months.
* Participants who have significant cognitive impairment or language issues
* Contra-lateral knee replacement within the trial or within 12 months prior to randomisation