cyrilzakka/clinical-trials huggingface dataset:
A More Engaging Visual Field Test to Increase Use and Reliability in Pediatrics

The majority of young children do not think that visual field (VF) testing of peripheral vision is similar to a game; therefore, it is not surprising that they have difficulty maintaining attention during VF testing and thus the test reliability suffers as a consequence. Poor VF reliability has been a longstanding, major issue since it leads to an increased number of tests and/or longer duration of time needed to determine when there are true vision losses. Providers are less likely to obtain VF tests in children since the results are of doubtful value and challenging to interpret when they are inconsistent. Effectively this means that children with untreated, slowly progressive eye diseases may go undiagnosed and incur greater visual losses. The investigators aim to create a prototype device that the investigators hypothesize will make VF testing more engaging for young children, thus increasing their attention and consistency of their responses to the test stimuli, which in turn should improve VF reliability. The components include a microdisplay video screen (1.5" diameter) as the fixation target (instead of the standard LED light) displaying video clips of popular cartoon characters, and audio clips of impersonated cartoon character voices presented by the test operator to provide instructional feedback based on the child's performance during testing. Improved VF reliability from the investigators intervention would translate to improved diagnosis and care for young childrens' peripheral vision loss through widespread implementation of the investigators innovative, affordable and readily adoptable system at eye care providers' offices.


Eligibility Criteria:
Inclusion Criteria:

* Ages 5-8
* Seen previously in the clinics at Nova Southeastern University's The Eye Care Institute with a diagnosis for glaucoma suspect or optic nerve abnormalities
* Able and willing to complete VF testing at 2 study visits about a week apart
* Provide informed consent

Exclusion Criteria:

* History of having previously completed a VF test using Humphrey static perimetry
* Inability to understand study or communicate responses (cognitive impairment)
* Unable to understand, read and speak English fluently
Seroquel on Glucose Metabolism

The purpose of this study is to determine whether six months treatment with the antipsychotic medicine Seroquel (quetiapine) may affect the schizophrenic patient's glucose metabolism


Eligibility Criteria:
Inclusion Criteria:

* In- or outpatients with schizophrenia, 18-65 years old, requiring a change in treatment due to insufficient efficacy or tolerability and giving signed informed consent.

Exclusion Criteria:

* Known diabetes mellitus, high HbA1c, fasting plasma glucose and/or high 2h glucose-OGTT.
* Previous use of atypicals (3 months) or other medications that might influence glucose metabolism
* Contraindications or non-responsiveness for any of the treatments or other safety issues
* Expected non-compliance to treatment and/or study procedures
Amygdala TIS for Depression

The current investigation employs a directed neuromodulation technique, specifically targeting the right amygdala, to ascertain its therapeutic efficacy in managing depressive episodes. The intervention's safety and efficacy will be evaluated using an assessment incorporating depressive symptomatology, cognitive abilities, and daily functions.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be aged between 18 and 65, with no gender restrictions;
* A diagnosis of depression made by the study physician based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-5);
* HAMD-17 score of 17 or higher;
* Participants must not have changed their antidepressant medication regimen from 30 days prior to signing the informed consent form through the duration of the experiment;
* Eligible individuals or their authorized representatives must demonstrate, as assessed by the study physician, a comprehensive understanding of the study's objectives and procedures, be capable of adhering to the requirements set forth in the study protocol and provide their signature on the informed consent form.

Exclusion Criteria:

* Eligible participants must not have a history of psychiatric disorders such as schizophrenia, as judged by the investigator, which may impact the evaluation of the study's efficacy;
* Participants must not have a history of seizures or prior episodes of epilepsy;
* The presence of metallic foreign objects within the cranial structure or metallic cardiac implants;
* Participants must not have a diagnosis of organic brain disease nor a history of significant cranial trauma or neurosurgical intervention;
* Participants received electroconvulsive therapy or other physical therapies (such as transcranial magnetic stimulation therapy);
* The researcher evaluated the individual's mental state and determined it to present a significant risk of suicidal ideation or behavior;
* Pregnant or breastfeeding;
* Participants who are concurrently engaged in other clinical interventional trials;
* Participants presenting with other circumstances that the investigator deems unsuitable for the intervention being studied.
Durvalumab With or Without Olaparib as Maintenance Therapy After First-Line Treatment of Advanced and Recurrent Endometrial Cancer

A study to assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.

This Phase III study will assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.

Target patient population: Adult female patients with histologically confirmed diagnosis of epithelial endometrial carcinoma (excluding sarcomas): newly diagnosed Stage III, newly diagnosed Stage IV, or recurrent endometrial cancer

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years at the time of screening and female.
* Histologically confirmed diagnosis of epithelial endometrial carcinoma. All histologies, including carcinosarcomas, will be allowed. Sarcomas will not be allowed.
* Patient must have endometrial cancer in one of the following categories:

  1. Newly diagnosed Stage III disease (measurable disease per RECIST 1.1 following surgery or diagnostic biopsy),
  2. Newly diagnosed Stage IV disease (with or without disease following surgery or diagnostic biopsy)
  3. Recurrence of disease (measurable or non-measurable disease per RECIST 1.1) where the potential for cure by surgery alone or in combination is poor.
* Naïve to first line systemic anti-cancer treatment. For patients with recurrent disease only, prior systemic anti-cancer treatment is allowed only if it was administered in the adjuvant setting and there is at least 12 months from date of last dose of systemic anti-cancer treatment administered to date of subsequent relapse
* FPPE tumor sample must be available for MMR evaluation.
* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days of starting study treatment.

Exclusion Criteria:

* History of leptomeningeal carcinomatosis.
* Brain metastases or spinal cord compression.
* Prior treatment with PARP inhibitors.
* Any prior exposure to immune-mediated therapy, including (but not limited to) other anti CTLA-4, anti-PD-1, anti-PD-L1, or anti-programmed-cell-death ligand 2 (anti-PD-L2) antibodies, excluding therapeutic anticancer vaccines.
Safety of Anticoagulant Therapy After Endoscopic Treatment

The investigators aimed to verify the efficacy and safety of nadroparin calcium warfarin sequential (NWS) anticoagulation therapy after endoscopic therapy in PVT patients with cirrhosis and AVB.

Acute variceal bleeding is one of the most serious complications of liver cirrhosis and is associated with significant morbidity and mortality. Portal vein thrombosis (PVT) aggravates portal hypertension and worsens hemorrhage, which Increases the risk of endoscopic therapy, and PVT has been shown to be associated with a longer time to variceal eradication, a higher risk of variceal relapse and rebleeding. So, PVT should be treated earlier. Data regarding the safety and initiation time of anticoagulant therapy in PVT patients with variceal bleeding after endoscopic therapy is lacking. Aim of this study is to verify the efficacy and safety of NWS anticoagulation therapy in PVT patients with cirrhosis and AVB after endoscopic therapy and further to explored the appropriate initiation time of NWS anticoagulation therapy after EVL in these patients.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of cirrhosis
* Portal hypertension with esophageal and gastric varices
* diagnosis of PVT by imaging examination
* undergo endoscopic therapy

Exclusion Criteria:

* older than 75 years
* uncontrolled active bleeding
* hepatocellular carcinoma or other extrahepatic malignancy
* on-going or received antithrombotic/thrombolytic treatment
* previous treatment with TIPSS
* cavernous transformation of the portal vein
* platelet count lower than 10\*10 \^ 9/L, creatinine more than 170 μmol/L
* Budd-Chiari syndrome
* pregnancy or breast-feeding period
* severe cardiopulmonary diseases, severe systemic infection or sepsis
* inability to sign informed consent
Evaluation of the Nonmotor Symptomatology of Parkinsonian Patients Treated With Two Strategies Related to Apomorphine Pump Therapy in French Hospitals

There is currently no consensus on the adequate concomitant treatment to apomorphine pump in Parkinson's disease (PD). In practice, some centers withdraw all dopaminergic agonists when initiating apomorphine pump therapy, whereas others combine the two. To date, there has been no study led to determine the best strategy for efficiently treating motor and nonmotor symptoms, as well as improving patients' quality of life (QoL). This preliminary study, entitled AGAPO, aims at identifying significant differences in patients' evolution (nonmotor symptoms and quality of life), over a course of 6 months, depending on the two strategies adopted in French centers (apomorphine pump with or without dopaminergic agonists), through the Non Motor Symptoms Scale (NMSS, Chaudhuri et al, 2017).

The recruitment period will be 24 months. The duration of the study will be 6 months for each patient due to adjustments of apomorphine pump parameters and oral medication as well time needed for motor and nonmotor changes to develop and influence QoL.

This study will be done without any modification of the planned treatment plan for each patient included. The treatments are administered in accordance with their marketing authorization and according to the usual practices of each center. No additional visits are expected.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged = or \> 18 years,
* Idiopathic PD (According to British Brain Bank Criteria) without any other known or suspected cause of symptoms,
* Indicated for apomorphine pump therapy and according to the centers' practice, treatment with apomorphine pump association with dopamine agonists or apomorphine pump therapy alone
* Presence of fluctuations for \> 3 years,
* Patients covered with social insurance.
* Written informed consent

Exclusion Criteria:

* Neurological (other than Parkinson's disease) or severe psychiatric history (depression, schizophrenia, addiction, bipolar disorder, anxiety and depressive disorders);
* Severe neurocognitive disorders (DSM-V)
* History of use of apomorphine pump treatment or deep brain stimulation or lesional surgery for PD or intrajejunal L-Dopa;
* History or current drug or alcohol abuse or dependencies;
* History of impulse control disorders;
* Adults legally protected (under judicial protection, guardianship or supervision), persons deprived of their liberty;
* Inability to understand the information given on the study, to express informed consent.
Autonomic Dysfunction in Temporal Lobe Epilepsy and SUDEP

The study aimed at detection of autonomic dysfunction among cases with temporal lobe epilepsy; using different electrophysiological techniques.

Moreover, it aimed at finding any correlation between electrophysiological tests and SUDEP risk.

Temporal lobe epilepsy (TLE) is the commonest focal form of epilepsy; representing 60% of all epilepsies . It has two major subtypes; neocortical (nTLE) and mesial (mTLE), each with different presentations.

Its diagnosis depends on detailed clinical history, neurological examination as well as neurophysiological (including EEG), and neuroimaging diagnostic tests which are mandatory in localizing the pathology.

Intimate connection between epileptic networks and the autonomic nervous system had been revealed. Seizures could affect autonomic functions whether directly through activation of cortical autonomic centers or indirectly through the released catecholamines.

The SUDEP is considered as one of the most serious complications of epilepsy and second most common cause of death from neurological diseases after stroke. Autonomic dysfunction could have a potential role in the pathophysiology of sudden unexpected death of epileptic patients (SUDEP).

Attention has been focused on biomarkers that could assist in the detection and early stratification of SUDEP risk. Such biomarkers include neurophysiological tests, imaging findings, laboratory findings.

Among the introduced neurophysiological biomarkers are electroencephalogram (EEG), sympathetic skin response (SSR) and heart rate variability (HRV).

The HRV is considered as simple, sensitive index of cardiovagal function. Reduced heart rate variability (HRV) is a strong predictor of sudden death in patients with heart disease.

The electrodermal activity (EDA )or SSR is referred as the most popular used test for assessment the sudomotor function . The EDA had been proven to be a reliable biomarker for detecting generalized tonic-clonic seizures (GTCs) through a wearable device.

Frontal midline theta activity was studied using quantitative EEG (QEEG); that confirmed the presence of interactive relationships between activities of the peripheral autonomic system and the cortical network. The QEEG technique had been introduced in the thirties of the last century. Yet, it had not been applied before on epileptic patients to assess either the central autonomic function or the SUDEP risk and thus, this is considered as the first study to address such issue.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed as temporal lobe epilepsy(TLE) depending on clinical semiology and EEG temporal inter-ictal epileptiform discharges

Exclusion Criteria:

* Any identifiable disease that could affect autonomic nervous system function including diabetic patients.
* Any drug that could affect autonomic nervous system function including oral contraceptives
The Stroke Vision App: A Screening Tool for Visual Stroke

Visual impairment can affect up to 70% of stroke survivors, but many do not have their vision adequately assessed in hospital. An unidentified visual defect can cause significant problems for recovery and quality of life. The Stroke Vision app (an application currently scaled for a 10" Android tablet) has been developed to act as a screening tool for visual problems in stroke survivors; to help identify visual problems earlier and thereby improve rehabilitation outcomes. The app includes a suite of tests for assessing the patient's acuity, their visual fields and to aid in the identification of visual neglect / inattention. Furthermore, it includes educational information on visual stroke in order to better educate staff, patients and their carers. This study seeks to validate the novel digital assessments included in the Stroke Vision app against the current methods used for screening (clinical examination by confrontation field testing). Both screening measures will be compared with the gold standard methods for visual assessments, Octopus perimetry for fields and paper-based methods for visuospatial neglect


Eligibility Criteria:
Inclusion Criteria:

* All patients referred to Visual Stroke Orthoptic Clinics
* All patients with stroke or stroke-like visual problems (for example, but not limited to bitemporal hemianopia caused by pituitary adenoma) referred to the neuro-ophthalmology clinics.
* Consent Provided

Exclusion Criteria:

* No spoken English
* Unable to provide consent
* Profound cortical blindness
Effects of Intracoronary Prourokinase on the Coronary Flow During Primary Percutaneous Coronary Intervention for Acute Myocardial Infarction

The purpose of this study is to determine whether intracoronary selective thrombolysis are more effective than tirofiban on the coronary flow during primary percutaneous coronary intervention for the acute myocardial infarction.


Eligibility Criteria:
Inclusion Criteria:

* ST-segment elevation AMI within 12 hours of symptom onset

Exclusion Criteria:

* Contraindications to thrombolysis or PCI
* Patients administered a fibrinolytic agent before PCI
* Patients enrolled in clinical trials
A Study of the Effect of ONO-8539 on Oesophageal Pain Hypersensitivity in Patients With Non-erosive Reflux Disease

A random controlled study to investigate the effect of a new drug, ONO-8539, on oesophageal pain hypersensitivity in patients with gastric reflux disease

This is a Randomised, Double-blind, Placebo-controlled, Two-period Crossover Study to Investigate the Effect of ONO-8539 on Oesophageal Pain Hypersensitivity in Patients With Non-erosive Reflux Disease

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects aged 18-70 years inclusive with confirmed GERD and normal oesophageal mucosa will be enrolled in this study. Subjects demonstrate moderate intensity heartburn while being on a stable dose of proton pump inhibitor and demonstrate oesophageal hypersensitivity following distal oesophageal acid perfusion.

Exclusion Criteria:

* Subjects will be excluded if they have a motility disorder, are not able to tolerate study procedures or have had GI surgery or have a condition that would affect the study results. Subjects with functional heartburn, acute GI symptoms, endoscopic or manometric abnormality or a protocol-specified cardiovascular condition will not be enrolled.
Older People, New Needs, and Possible Solutions. A Pilot Study on Peer-to-peer Digital Education

"Older people, new needs, and possible solutions: A pilot study on peer-to-peer digital education" aims to create a digital literacy protocol targeted specifically to older people, providing them with the digital skills needed to age healthily and actively in a changing social context. Specifically, the main goal is to pilot (by designing, implementing, and evaluating) a peer-to-peer digital literacy course, whereby older educators teach less digitally savvy older people how to use smartphone daily utility apps, such as e-Gov, home banking, etc.

To evaluate the effect of the intervention on participants, smartphone usage patterns are measured before, during, and after the course. Then, the impact of the course on participants' perception of well-being is assessed as well.

This study aims to pilot, by designing, implementing, and evaluating, a digital peer education course for older people, focusing specifically on the use of smartphones and daily utility apps. The course has been co-designed with AUSER MB, a non-profit organization involved in active aging, and the peer tutors. It is structured in ten 90-minute classes covering topics such as emails, online accounts, app downloads, e-Gov apps, healthcare apps, mobility and payment apps, etc. The 30 participants, divided into three groups, have been selected among the 65+ year-old people attending the computer classes already offered by AUSER MB and having a personal smartphone, as a very basic set of digital skills and familiarity with digital devices was necessary for the slightly more advanced topics covered by the course.

In addition to piloting the course and aiming to define a protocol that could be replicated in other similar contexts, this study aims to measure the effect of the course on participants' digital skills and their perceived well-being. To do so, the investigators adopted a mixed methods approach, employing digital methods by collecting and analyzing data on participants' smartphone use (i.e., log data on smartphone use before/during/after the intervention), a quasi-experiment collecting information on course participants' well-being before/after the course attendance using a questionnaire survey, and ethnographic observation conducted during the course, observing interactions between subjects during the course.

The study is part of the project "ACTIVE ageing in changing societies. Older people's social and digital resources in pandemic and post-pandemic Italy (ACTIVE-IT)", funded by the Italian Fondazione Cariplo

Eligibility Criteria:
Inclusion Criteria:

* 65 years old or older
* personal smartphone

Exclusion Criteria:

* N/A
Efficacy of Osteopathic Manipulation on Breathing Mechanics in a Healthy Population: A Randomized Controlled Study

This study focused on improving breathing mechanics by using various osteopathic manipulative therapy (OMT) techniques. The investigators randomly assigned participants to a control group who received sham treatment and a treatment group who received OMT. The investigators measured variable pre- and post- treatment on both groups. The investigators observed an improvement in breathing mechanics in the treatment group.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers from Touro College of Osteopathic Medicine (TouroCOM), including students and staff, were recruited as subjects of this study. Any participant with recent or past medical history of obstructive or restrictive lung disorders, recent trauma, or illnesses, and/or chest abnormalities were excluded from the study.

Exclusion Criteria:

* Certain study results were excluded on the basis of abnormal baseline measurements, including but not limited to, heart rate, oxygen saturation, respiratory rate, improper spirometer use, technique and/or high variance among the repeated measurements obtained for each participant.
Dry Blood Spot Screening Test for Biliary Atresia（DBS-SCReBA）

Our study aims to develop a screening test for biliary atresia (BA) using dry blood spot to improve patient survival by early diagnosis. Newborn screening dry blood spot will be examined for the direct bilirubin (DB), γ-GT or matrix metalloproteinase-7 (MMP-7) levels. These findings will promote early diagnosis for BA and hence improve the survival.

BA accounts for approximately 60% of the liver transplantations in infants younger than 1 year of age. The diagnosis of BA remains a clinical challenge because affected neonates have signs, symptoms, and serum liver biochemistry that are also seen in those with other causes of neonatal cholestasis.

The success of the Kasai procedure is varied, but a good outcome is correlated with an early diagnosis. Unfortunately, most BA are usually identified later and the average age at surgery is about 60 days. To address this problem, some research groups screen infants for the pale stools or measure bilirubin level in the serum. However, these screening programs have not yet to be implemented because of several reasons. Recently, the relative abundance of serum MMP-7 was suggested to have discriminatory features for infants with BA. Nevertheless, whether the level of MMP-7 elevates in newborn dry blood spot of BA is still undefined. In this study, we will explore a screening strategy based on DB, γ-GT or MMP-7 measurement in newborn screening blood spot, and identify whether DB , γ-GT or MMP-7 measurement in the newborn period could be sensitive and specific for BA.

Eligibility Criteria:
Inclusion Criteria:

* Neonates born in Shanghai

Exclusion Criteria:

* Subjects who do not agree with study protocol
* Subjects who join other clinical trials