cyrilzakka/clinical-trials huggingface dataset:
Computer Agents to Promote Walking in the Elderly

This proposal is a randomized control trial using innovative interactive health technologies to promote and sustain walking behavior among elderly patients. The technology uses an Embodied Conversational Agent (ECA), a computer character that simulates face-to-face conversation. The trial will be block randomized by literacy status and include an intensive two-month, daily contact intervention via a Tablet PC ECA in the subject's home, an automated telephone program, and then an in-clinic, kiosk-based ECA for an additional 10 months, to promote maintenance of walking behavior. The study will occur in 2 phases, a pilot phase in which 20 subjects will be enrolled for the purpose of pre- testing the intervention and all data collection instruments, and a main study phase in which an additional 264 subjects will be enrolled.


Eligibility Criteria:
Inclusion Criteria:

1. 65 years old or greater
2. English-speaking
3. Actively being cared for by a primary care provider at Boston Medical Center

Exclusion Criteria:

1. Non-ambulatory
2. Any medical condition or disorder that would limit participation in moderate intensity physical activity (such as sustained walking), including life-threatening disorders, myocardial ischemia, complex cardiac arrhythmias or significant left ventricular dysfunction, and major functional disabilities relating to gait or balance
3. Medications that would compromise patient's ability to participate
4. Had more than 2 falls in the past year (i.e. fall risk)
5. Moderate to severe dementia
6. Severe depression
7. Currently exercising, i.e., engaged regularly in moderate-intensity or more vigorous physical activity 3 or more days per week for at least 20 minutes per day
Action Observation in Children With Diplegic Cerebral Palsy

A new rehabilitative approach, called AOT, based on the discovery of mirror neuron system (MNS), has been used with promising results on the Upper Limb (UL) function in some studies in children with Cerebral Palsy (CP).

The purpose of the present trial is to provide evidence by an RCT, preceded by a pilot study, that customized and home based AOT training is an effective rehabilitation tool in children with diplegic CP (DCP) and that its effects are greater than standard care.

Both Hands Assessment (BoHA) is chosen as primary outcome measure and a sample size of 27 per group is required. The rehabilitation lasting 8 weeks will be provided at home by an ICT platform able to deliver, manage, monitor and measure a personalized AOT.

A two-arm, evaluator-blinded, randomized trial (RCT), preceded by a pilot study, will be conducted according to CONSORT guidelines. Each participant will be randomized to either:

1. Intervention group (Experimental group). Children will receive immediately the system for 8 weeks.
2. Standard care group (Control group). Children will continue standard care At the end of the project, if the study results will be positive, children enrolled in the control group will be able to have the same treatment as the experimental group, if necessary.

The system will provide an in-home, individualized, intensive treatment based on the AOT. The system will be delivered at home and the children will perform a 60-minute training session at least 5 days a week for 8 consecutive weeks (total of 40 hours).

Follow-up assessment (outcome measures) will be conducted before (T0) and post-intervention at 1 weeks (T1), and then 8 and 24 weeks after the AOT intervention/standard care (T2 and T3).

The primary endpoint will be T1. Clinical assessments will be administered by a therapist blind to group assignment in each centre. Scoring of videotaped clinical outcome measures will be performed by therapists blind to group allocation and assessment order.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of diplegic cerebral palsy (DCP) (GMFCS level I to IV - children may have been achieved an independent gait)
* age between 5 and 16 years
* MACS level I-IV
* sufficient cooperation and communicative understanding to perform assessments and participate in the intervention
* caregivers able to commit and collaborate in a rehabilitative intensive home
* subjects and parents able to commit to the intensive rehabilitation program for a period of 8 weeks.

Exclusion Criteria:

* Exclusion criteria will be uncontrolled seizures and UL botulinum injections or orthopaedic surgery in the previous 6 months or during the study period.
A Study to Test How Effective Belumosudil Tablets Are for Treating Adult Participants With Chronic Lung Allograft Dysfunction

This double-blind, randomized, placebo-controlled, multinational, multicenter, parallel-group, Phase 3, 2-arm, study will investigate the efficacy and safety of belumosudil compared with placebo, both administered on top of azithromycin and standard-of-care regimen of immunosuppression in male or female participants at least 1 year after bilateral lung transplant, who are at least 18 years of age and who have evidence of progressive CLAD despite azithromycin therapy.

Study details include:

The study duration will be up to 31 weeks for participants not entering the open-label extension (OLE) period and up to 57 weeks for participants entering the OLE period but not the long-term OLE.

The treatment duration will be up to 26 weeks for participants not entering the OLE period and up to 52 weeks for participants entering the OLE period but not the long-term OLE.

The number of visits will be up to 10 visits for participants not entering the OLE period and up to 16 visits for participants entering the OLE period but not the long-term OLE.

For participants who enter the long-term OLE, treatment and study participation will continue with visits every 12 weeks per protocol specifications.


Eligibility Criteria:
Inclusion Criteria:

* Participant ≥1 year post bilateral lung transplantation at the time of screening
* Participants presenting with CLAD Stage 1 or 2: FEV1 from \>50% to 80% of post-transplant baseline at screening and at randomization
* Participants who have received at least 8 weeks of azithromycin (≥250 mg/day, at least 3 times a week) prior to randomization

Exclusion Criteria:

* FEV1 ≤50% of the post-transplant baseline value (CLAD 3 and 4)
* Lung function decline that can be explained by non-CLAD causes including but not limited to acute lung allograft rejection (\>A1), antibody-mediated rejection, airway stenosis, or tracheobronchomalacia
A Study of Modified Stem Cells in Stable Ischemic Stroke

The primary purpose of the clinical study is to determine the safety of a modified stem cell SB623 when administered to chronic, stable ischemic stroke patients. A second purpose is to determine whether SB623 might improve stroke symptoms. Chronic, stable ischemic stroke patients must be between 6 and 60 months after their stroke, and with only this one prior stroke, and with no further improvement from physical therapy.

Chronic, stable stroke patients have no existing alternative treatments after rehabilitation therapy. SB623, a modified stem cell preparation, has been shown to improve motor function when administered in animal models of stable stroke. Safety studies in animals have shown no adverse events attributed to SB623. Patients who meet the entry criteria for this study will have regular examinations, radiological evaluations (CT, MRI, PET), and be followed for two years. Regular neurological evaluations will also be done using standard questionnaires, with occasional video recording if improvements are evident. Key entry criteria for this study, in addition to 6-60 months post-ischemic stroke, include moderately severe symptoms--e.g., difficulty standing or walking, and/or difficulty using arms or hands, and/or speech impediments.

Eligibility Criteria:
Inclusion Criteria:

* Documented history of one completed ischemic stroke in subcortical region of MCA or lenticulostriate artery with or without cortical involvement
* Between 6 and 60 months post-stroke, and having a motor neurological deficit
* No significant further improvement with physical therapy/rehabilitation
* Able and willing to undergo computed tomography (CT), magnetic resonance imaging (MRI), and positron-emission tomography (PET) scans of the head

Exclusion Criteria:

* History of more than 1 symptomatic stroke
* History of seizures
* History or presence of any other major neurological disease
* Myocardial infarction within prior 6 mos.
* Known presence of any malignancy except squamous or basal cell carcinoma of the skin
* Participation in any other investigational trial within 4 weeks of initial screening and within 7 weeks of study entry
* Contraindications to head CT, MRI, or PET
* Pregnant or lactating
Thrombus Aspiration in Patients With STEMI

This is a prospective, randomized study with blinded outcome assessment, comparing routine manual thrombus aspiration with no aspiration in patients with acute ST-segment elevation myocardial infarction (STEMI) underwent percutaneous coronary intervention (PCI).

This is a prospective, randomized study with blinded outcome assessment, comparing routine manual thrombus aspiration with no aspiration in patients with acute ST-segment elevation myocardial infarction (STEMI) underwent percutaneous coronary intervention (PCI). Patients who are diagnosed as STEMI and referred for PCI will be enrolled. They will be randomized 1:1 to either manual thrombus aspiration with PCI group or PCI alone group.The primary outcome is the composite of cardiovascular death, recurrent myocardial infarction (MI), cardiogenic shock, stroke, new or worsening NYHA class IV heart failure during 1 year follow-up. The secondary efficacy outcome are stent thrombosis, target vessel revascularization, left ventricular function and quality of life during 1 year follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-80;
* Diagnosed as STEMI for presenting symptoms or definite ECG and myocardial markers changes;
* Patients presenting with definite ECG changes indicating STEMI: ST elevation of 0.1 mV in 2 contiguous limb leads or ≥0.2 mV in 2 contiguous precordial leads;
* Referred for PCI for presenting symptoms, and the coronary angiogram (CAG) shows that the initial TIMI thrombus grade ≥2;
* Informed consent.

Exclusion Criteria:

* Previous history of myocardiopathy, valvular heart disease or severe heart failure;
* Severe hepatic or renal dysfunction;
* Life expectancy less than 1 year;
* Prior PCI or CABG;
* Contraindications of using anticoagulation or antiplatelet drugs.
Topo-guided LASIK and Photorefractive Keratectomy vs Wavefront LASIK and Photorefractive Keratectomy

This study evaluates the difference in results between eyes that have been treated wavefront optimized laser vision correction (either LASIK or Photorefractive Keratectomy) compared to eyes treated with topography-guided laser vision correction (either LASIK or Photorefractive Keratectomy). Each participant will receive wavefront optimized correction in one eye and topography-guided correction in the other.

Participants will have an in depth discussion with our refractive surgery coordinator regarding refractive surgery. Patients will choose LASIK or Photorefractive Keratectomy surgery based on our standard pre-operative discussion that is provided to all patients. As is standard for laser refractive candidates, the advantages and disadvantages of LASIK and Photorefractive Keratectomy compared to the other refractive surgical options will be discussed. Following patient selection of their preferred type of refractive procedure they will be randomized as discussed below, and only patients who elect for LASIK or Photorefractive Keratectomy will be included in our study.

Prior to surgery, one eye from each patient will be randomly assigned to receive either Wavefront optimized or Topography Guided treatment. Each patient in the study will have a fellow eye enrolled in the other treatment group. Patients will either receive LASIK treatment or Photorefractive Keratectomy treatment in both eyes but the eyes will be randomized to topography guided or wavefront optimized forms of treatment.

Eligibility Criteria:
Inclusion Criteria:

* All subjects who are deemed suitable candidates for laser refractive surgery after routine refractive surgery screening will be considered eligible for participation in this study.

Subjects must be at least 21 years of age and not pregnant or nursing (due to fluctuations in visual parameters during pregnancy)

Exclusion Criteria:

* Any patient who is not a suitable candidate for LASIK or PRK will not be included.
Flare Measurements in Human Radiation Therapy Patients

This is a longitudinal Feasibility Study of a novel non-invasive device in assessing radiation dose exposure in humans. All patients receiving whole body irradiation therapy and meeting all other inclusion/exclusion criteria will receive ocular flare meter measurements and slit-lamp examinations on up to eleven occasions starting prior to the first fractional dose of irradiation.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be scheduled to receive whole body irradiation in a dose range from 1.5 to 12Gy.
* Subjects must not have received ocular surgery for at least three months prior to study enrolment.
* Subjects must not have a history of uveitis.
* Subjects must have at least one eye free of cataracts
* Subject age must be greater than 18 years
* Subjects must have the ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

* Inability to give informed consent
* Cataracts in both eyes
* Subject has received ocular surgery within the prior three months
* Subject has a history of uveitis
Short Term Effects of Anodal Cerebellar vs Anodal Cerebral Transcranial Direct Current Stimulation in Stroke Patients

To compare the effect of anodal cerebellar Transcranial Direct Current Stimulation (tDCS) vs anodal cerebral tDCS on balance, mobility and cognition in stroke patients in stroke patients


Eligibility Criteria:
Inclusion Criteria:

* ability to give written consent.
* Able to walk unassisted
* Functional status allowing the participants to participate in the balance training.
* Score 6 or above on Johns Hopkins fall risk assessment tool

Exclusion Criteria:

* Neurological diseases, such as Parkinson, Alzheimer
* Any history of psychological illnesses
* Receipt of electrotherapy that might affect the nervous system in the two weeks prior to the study
* Cerebellar disorders
* use of any sedative medicines in the two days prior to the study
* any symptoms of amnesia and depression;
* Memory disorders with scores below 21 on the Mini Mental Status Examination test
* Any signs of severe motor disorders in the lower extremity which cause any movement limitation or deformity
* Any signs of radiculopathy or root lumbar spinal cord involvement
* Any visual or auditory impairment, or vertigo reports
* Use of a heart rate regulator
* Any structural deformities in the lower extremities or the spine
* Any abnormalities in the vestibular system
* History of recent fracture
* Inability to move without assistance
Efficacy and Safety of MCO-010 Optogenetic Therapy in Adults With Retinitis Pigmentosa [RESTORE]

The purpose of the study is to evaluate the safety and efficacy of a single intravitreal injection of virally-carried Multi-Characteristic Opsin (MCO-010).

This multicenter, randomized, double-masked, sham-controlled, dose-ranging study will evaluate 2 dose levels of MCO-010 in up to 18 subjects with retinitis pigmentosa (9 per dose). An additional nine subjects will receive sham injection. Subjects with a confirmed diagnosis of Advanced Retinitis Pigmentosa (RP) based on clinical examination, dilated fundus examination, and genetic testing will be considered for participation in this study. All subjects will continue to be assessed for 100 weeks following treatment with MCO-010.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Able to comprehend and give informed consent.
3. Confirmed diagnosis of Advanced Retinitis Pigmentosa (RP) based on clinical examination, dilated fundus examination, and genetic testing.
4. Best-Corrected (Freiburg) Visual Acuity worse than 1.9 LogMAR (Snellen equivalent 20/1600) in the study eye and no better than 1.6 LogMAR (Snellen equivalent 20/800) in the fellow eye during screening.

Exclusion Criteria:

Subjects are excluded from the study if any of the following criteria apply:

1. Prior participation in gene therapy program
2. Pre-existing conditions in the study eye such as glaucoma, diseases affecting the optic nerve causing significant visual field loss, active uveitis, corneal or lenticular opacities).
3. Presence of any complicating systemic diseases such as malignancies whose treatment could affect central nervous system function.
4. Active ocular inflammation or recurrent history of idiopathic or autoimmune associated uveitis.
5. Having received retinal prothesis (such as ARGUS-II) or any gene or stem cell therapy (ocular or non-ocular).
Evaluation of Two Versions of a Digital Problem Solving Tool for the General Public Specific for the COVID-19 Pandemic

A digital problem solving tool was tailored to people in the general public with practical or emotional problems during COVID-19. Content analysis were used to account for the types of problems participants used the tool to solve. Participants were randomized to one of two versions of the problem solving tool, a simple and a more advanced graphical interface. These versions were compared on participant-rated usability, credibility and the level of actual interaction with the tool.


Eligibility Criteria:
Inclusion Criteria:

* can use the Swedish language
* access to, and knowledge how to use, a digital internet-capable device

Exclusion Criteria:

* under 16 years
* no practical or emotional problems during pandemic
Nosocomial Bacterial and Fungal Chest Infections in Cirrhotic Patients

Hospital acquired chest Infections are common complications in hospitalized cirrhotic patients. Infectious complications are the most common cause of mortality in cirrhotic patients with bronchopneumonia early antibiotic treatment at the base of culture and sensitivity is an optimal therapeutic approach in cirrhotics with nosocomial pneumonia Intensive care unit acquired pneumonia is the leading infection in critically ill patients and a major cause of morbidity and mortality despite recent major advances in antimicrobial therapy, supportive care, and the use of a broad range of preventive measures

Aim of the work

1. To estimate the frequency and risk factors of nosocomial chest infections in cirrhotic patients .
2. To determine the causative pathogens of nosocomial chest infections in patients with cirrhosis including fungal infections in order to establish our local empirical antimicrobial protocol.
3. To define the impact of nosocomial chest infections on survival of our patients.
4. To develop an effective and continuous surveillance program and infection control measures to reduce the burden of these infections as well as morbidity , mortality , hospital stay ,hospital cost and to achieve quality of care .
5. To motivate pharmaceutical companies to create a new umbrella coverage of antimicrobials through the ongoing knowledge of the changes in microbial resistance pattern inside hospitals

Eligibility Criteria:
Inclusion Criteria:

* All cirrhotic patients , decompensated , child pug score B or C ,may have Hepatocellular carcinoma , other comorbidities may present as (Diabetius mellitus , Hypertension , Heart disease and renal impairment ) , both sex and with clinical suspicion of chest infections acquired after 48 hours of admission

Exclusion Criteria:

* Patients have any chronic chest disease
* Patients have severe immunosuppression (neutropenia after chemotherapy or hematopoietic transplant, drug-induced immunosuppression in solid-organ transplant or cytotoxic therapy, and HIV-related disorders.
NASVAC Phase-III Trial in Chronic Hepatitis B (CHB) Patients

The general objective of the present clinical trial is to compare the therapeutic efficacy of a combination therapeutic vaccine containing hepatitis B surface antigen (HBsAg) and hepatitis B core antigen (HBcAg) \[later called NASVAC\] with a commonly used antiviral drug, pegylated interferon in patients with chronic hepatitis B (CHB).

To collect and assess data on the therapeutic potential of the NASVAC in CHB patients regarding:

Reduction of the serum HBV DNA levels. Reduction in the levels of alanine aminotransferase (ALT) Clearance of hepatitis B e antigen (HBeAg) Negativation or lowering of HBsAg Anti-HBsAg/anti-HBeAg seroconversion

An additional objective of this study is to reconfirm the safety of NASVAC in CHB patients that has previously been shown by us in Phase I-II clinical trial in CHB patients.

Eligibility Criteria:
Inclusion Criteria:

* HBsAg+ serology for more than 6 months before the beginning of the treatment.

In the last six months, according to HBeAg serostatus, for:

* HBeAg (-) patients, with a) baseline HBV DNA ≥ 103 and b) raised serum ALT (x \>1 ULN) or significant hepatic necroinflammation and/or fibrosis (HAI-NI\>4 and/or HAI-F \>2) or liver stiffness \>7.2 KPa.
* HBeAg (+) patients, with a) baseline HBV DNA ≥ 104 and b) and raised serum ALT (x \>1.5 ULN) or significant hepatic necroinflammation and or fibrosis (HAI-NI\>4 and/or HAI-F \>2) or liver stiffness \>7.2 KPa.
* Patients of both sex from 18 to 60 years-old
* No specific hepatitis B treatment at least for 6 months previous to the inclusion
* Voluntary signed informed consent to participate in the trial

Exclusion Criteria:

* Condition of HBV asymptomatic carrier or cirrhosis or patients with primary hepatocellular carcinoma
* Positive serological markers for hepatitis C
* Positive serological markers for HIV
* Previous specific anti-hepatitis B treatment in the last 6 months.
* Critically ill patient history of heart or renal failure, hypertension, hyperthyroidism, epilepsy, immunodeficiency diseases, malignancies or any non-controlled systemic disease.
* Pregnancy or nursing women. Women in fertile age without any contraceptive methods.
* Known severe allergic conditions (degree III or IV asthma, urticaria, dermatitis, bronchitis, etc. or hypersensitivity to any of the ingredients present in the preparation).
* Severe psychiatric dysfunction or another limitation that prevents the patient's consent.
* History of Autoimmune diseases (such as SLE, rheumatoid arthritis, multiple sclerosis, non controlled diabetes mellitus type 1)
* History of other hepatic diseases of different etiology (such as alcoholism, autoimmune hepatitis, drug induced hepatitis, Wilson's diseases, hemochromatosis)
* History of immune suppressive disorder or administration of immune suppressive-immune modulator drugs (including steroids) during or in the 6 months previous to the study.
* Very high transaminase levels at the beginning of treatment (ALT over 500 U/L) suggesting a not stable disease with risk for patient's health or acute flares over 15 times the upper limit of normality.
L-arginine Effects on Chronic Hypertension in Pregnancy

The purpose of this study is to evaluate the effects of oral L-arginine administration on pregnant women at second trimester of gestation with chronic hypertension, respect with placebo.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women between 18-20 weeks of gestation with chronic hypertension

Exclusion Criteria:

* Other maternal or fetal systemic disease