cyrilzakka/clinical-trials huggingface dataset:
A Virtual Reality Platform Simulating Visual Impairment for Testing of Electronic Travel Aids and Performing Orientation and Mobility Training

In this study, the study team utilize virtual reality (VR) to simulate visual impairments of different types and severity in healthy subjects. The platform implements three of the most widespread forms of visual impairment in the United States (US): age-related macular degeneration (AMD), diabetic retinopathy (DR), and glaucoma, each with three levels of severity, (mild, moderate, and severe). At present, glaucoma is further developed toward a multidimensional visual impairment simulation.

The platform is utilized: i) to provide a safe, controllable, and repeatable set of environments for development and preliminary testing of electronic travel aids (ETAs) in a variety of conditions (i.e., using the ETA to navigate in the immersed environment); and ii) to equip blind and low vision (BVI) professionals, inclusive of orientation and mobility (O\&M) instructors, with a controlled, tunable training platform for skill/capacity building, assessment, and refinement of O\&M techniques, as well as visually impaired trainees with a safe and immersive environment to improve their O\&M skills and learn novel techniques. Two sets of hypothesis-driven experiments are proposed to assess the feasibility of the platform with respect to these two objectives.


Eligibility Criteria:
Inclusion Criteria (patients with visual impairment)

1. Aged 18-80;
2. People with glaucoma of all different levels and etiologies.

Inclusion Criteria (healthy controls)

1. Aged 18-80;
2. Gender neutral: male or female.

Exclusion Criteria (patients with visual impairment \& healthy controls)

1. Significant cognitive dysfunction (score \<24 on Folsteins' Mini Mental Status Examination)
2. Previous neurological illness or psychiatric disorders, or suffer from a heart condition or other serious medical conditions
3. Significant mobility restrictions; people using walkers and wheelchairs
4. Pregnancy
5. Elderly
6. Seizures (people who previously have had a seizure, loss of awareness, or other symptom linked to an epileptic condition)
7. Interference with medical devices (the headset and controller(s) may contain magnets or components that emit radio waves, which could affect the operation of nearby electronics, including cardiac pacemakers, hearing aids, and defibrillators)
The Comparison of 50% AS Versus PFAT+ 0.05 % COE in Severe Dry Eye Syndrome

The present study aimed to evaluate and compare the efficacy of a 1 month clinical trial of 50% AS for the treatment of severe dry eye syndrom (DES) based on Schirmer's Test, tear break-up time (TBUT), fluorescein staining, and ocular surface disease index (OSDI) scores, as compared to conventional preservative-free artificial tears (PFAT) plus 0.05% COE treatment in patients with severe DES

This is an retrospective comparative study. The designation of the patient whether to use AS 8\*1 or conventional PFAT 8\*1 plus COE 2\*1 was determined randomly. Student's paired samples t-test, independent samples Student's t-test, Wilcoxon signed-rank test and Mann-Whitney U test were used to compare data. All patients responded well to both treatments after the first 1-month treatment period, based on comparison of before and after treatment OSDI scores, Schirmer's test results, TBUT values, and OXFORD scale scores.

Eligibility Criteria:
Inclusion Criteria:

* refractory to conventional treatment (those that did not respond well to entire dry eye medications containing hydroxypropyl methylellulose, carboxyl methylcellulose, polyvinyl alcohol, polyethylene glycol-propylene glycol, sodium hyaluronate, mineral oil, dextran, and carbomer artificial tears with or without preservatives)
* had low TBUT (\< 5 s) (5μL of fluorescein sodium 2% eye drops was used)
* low Schirmer's test I score without topical anesthesia ( basic+reflex secretion), positive corneal and conjunctival fluorescein staining (≥grade 1 according to the OXFORD Scale) (3) and an OSDI score \> 40 OSDI was a reliable and valid test for quantifying the severity of dry eye symptoms

Exclusion Criteria:

* active ocular infection or any other inflammation not associated with dry eye
* a severe associated ocular allergy, eyelid or eyelash abnormality
* current contact lens use, history of refractive surgery
* associated glaucoma
* current use of any type of topical eye drops other than dry eye medications
* any known graft-versus host disease
* known severe anemia (hemoglobin\<11 g/dL-1)
* medically uncontrolled significant cerebrovascular and cardiovascular disease
* pregnant and lactating patients
Oral Anti-coagulants in Fragile Patients With Percutaneous Endoscopic Gastrostomy and Atrial Fibrillation (ORIGAMI) Pilot Study

Compelling evidences support the safety of direct oral anticoagulants (DOAC) compared to Vitamin K antagonists (VKA) in patients with non-valvular atrial fibrillation. The 2018 EHRA/ESC practical guide on the use of non-vitamin K antagonist oral anticoagulants stated that "data have shown that administration in a crushed form (e.g. via a nasogastric tube), does not alter the bioavailability for apixaban, rivaroxaban, and edoxaban". However, at the moment, there are no evidences supporting unequivocally the use of DOAC via PEG.

The purpose of this study is to evaluate the safety and efficacy of Edoxaban administered through PEG in patients with an indication of anticoagulation according to the current clinical practice.

Several studies support the safety of direct oral anticoagulants (DOAC) compared to Vitamin K antagonists (VKA) in patients with non-valvular atrial fibrillation.

The 2018 EHRA/ESC practical guide on the use of non-vitamin K antagonist oral anticoagulants affirmed that "data have shown that administration in a crushed form (e.g. via a nasogastric tube), does not alter the bioavailability for apixaban, rivaroxaban, and edoxaban". However, at the moment, there are no evidences supporting unequivocally the use of DOAC via Percutaneous endoscopic gastrostomy (PEG).

PEG is a method developed throughout the early 1980s for patients who need long-term enteral nutrition due to neurodegenerative, neuromuscular and oncological diseases. This class of patients is expected to increase significantly in the next decade.

Several studies have proven the safety of DOAC compared to VKA even recommending to prefer DOAC over VKA wherever possible in the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation. However, there is no evidence to support unequivocally the use of DOAC in patients fed PEG.

The purpose of this study is to evaluate the safety and efficacy of Edoxaban administered through PEG in patients with an indication of anticoagulation according to the current clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Patients with PEG and indication for treatment with long-term oral anticoagulant therapy
* Patients with Atrial Fibrillation

Exclusion Criteria:

* Children under 18 years old.
* Life expectancy \<30 days.
* Lack of informed consent.
Anastrozole in Patients With Pulmonary Arterial Hypertension

The main purpose of this clinical trial is to study the safety and efficacy of anastrozole in adults diagnosed with pulmonary arterial hypertension (PAH). The study will evaluate how well the drug is tolerated. The study will also evaluate if anastrozole effects estradiol (E2) hormone levels, a sex hormone, and improves the function of the lower right chamber of the heart (right ventricle).


Eligibility Criteria:
Inclusion Criteria:

* Previous documentation of mean pulmonary artery pressure \> 25 mm Hg with a pulmonary capillary wedge pressure (or left ventricular end-diastolic pressure) \< 16 mm Hg and PVR \> 3 WU at any time before study entry.
* Diagnosis of PAH which is idiopathic, heritable, drug- or toxin-induced, or associated with connective tissue disease, congenital heart disease, portal hypertension, or HIV infection.
* Most recent pulmonary function tests with FEV1/FVC \>50% AND either a) total lung capacity \> 70% predicted or b) total lung capacity between 60% and 70% predicted with no more than mild interstitial lung disease on computerized tomography scan of the chest
* Ability to perform six minute walk testing without limitations in musculoskeletal function or coordination.
* If female, post-menopausal state, defined as:
* \> 50 years old AND
* a) have not menstruated during the preceding 12 months OR
* b) have follicle-stimulating hormone (FSH) levels (\> 40 IU/L) OR
* \< 50 years and FSH (\> 40 IU/L) OR
* having had a bilateral oophorectomy
* Informed consent

Exclusion Criteria:

* Treatment with estrogen or anti-hormone therapy (tamoxifen, fulvestrant, etc.)
* WHO Class IV functional status
* History of breast cancer
* Clinically significant untreated sleep apnea
* Left-sided valvular disease (more than moderate mitral valve stenosis or insufficiency or aortic stenosis or insufficiency), pulmonary artery or valve stenosis, or ejection fraction \< 45% on echocardiography
* Initiation of PAH therapy (prostacyclin analogues, endothelin-1 receptor antagonists, phosphodiesterase-5 inhibitors) within three months of enrollment; the dose must be stable for at least 3 months prior to Baseline Visit
* Hormone therapy
* Hospitalized or acutely ill
* Renal failure (creatinine \> 2.0)
* Child-Pugh Class C cirrhosis
* Current or recent (\< 6 months) chronic heavy alcohol consumption
* Current use of another investigational drug (non-FDA approved) for PAH
* Enrollment in a clinical trial within one month of screening
* Age \< 18
Pilot Study of Patient Navigation to Promote Smoking Cessation

Cigarette smoking is a highly significant health threat, responsible for more than 430,000 deaths each year. Low-income persons and racial/ethnic minorities are at particularly high risk, smoking at greater rates and having greater tobacco-related morbidity and mortality than other persons. Yet poor and minority smokers are less likely to receive advice to stop smoking or to use tobacco cessation services. Using non-physician members of the health care team as patient navigators to connect low-income and minority smokers to evidence-based tobacco treatment services is a promising approach because 1) many primary care providers (PCPs) are unable to provide counseling to patients who smoke due to time constraints; 2) minority patients may be less aware of smoking cessation resources and may have misconceptions about tobacco dependence treatments; and 3) as primary care practices are redesigned as medical homes, non-physician members of the health care team will increasingly be taking on tasks previously performed by PCPs. Patient navigators are lay persons from the community, working as paid employees, who are trained to guide patients through the health care system to receive services. Information on the efficacy of patient navigation to connect vulnerable patients to smoking cessation services is needed.

The investigators will implement a patient navigation-based intervention in the primary care setting to promote engagement of low-income and minority patients in smoking cessation treatment. To test our intervention, the investigators will conduct a pilot randomized control trial (RCT), randomizing 240 patients to the intervention condition (patient navigation) or an enhanced traditional care (ETC) control condition. The investigators will perform follow-up at three months following the start of the intervention, with a primary outcome of engagement in smoking cessation treatment.


Eligibility Criteria:
Inclusion Criteria:

1. age \> 18 years
2. smoked cigarettes in the past week
3. have a scheduled visit with a PCP
4. telephone access
5. English speaking
6. able and willing to participate in the study protocol and provide informed consent.

Exclusion Criteria:

1. planning to move out of the area within the next 6 months
2. cognitive impairments that preclude participation in study activities.
3. severe illness or distress
4. inability to read/understand English
5. actively using evidence-based smoking cessation treatment, and
6. transient residence or lack of a telephone for follow-up assessments.
Radiomics Signature of Hepatic Venous Pressure Gradient (rHVPG) With CT Angiography (CHESS1701)

This is a prospective, multi-center diagnostic trial conducted at 5 high-volume liver centers in China designed to determine the diagnostic performance of radiomics-based hepatic venous pressure gradient (rHVPG) (investigational technology) by CT angiography (CTA) for noninvasive assessment of the clinically significant portal hypertension (CSPH) in patients with cirrhosis. Direct hepatic venous pressure gradient (HVPG) measurement by means of catheterization of a hepatic vein with a balloon catheter is the gold-standard method to assess the presence of CSPH, which is defined as HVPG≥10 mmHg.

This is a prospective, multi-center diagnostic trial conducted at 5 high-volume liver centers (302 Hospital of PLA; Beijing Shijitan Hospital; The Third Xiangya Hospital of Central South University; Beijing Youan Hospital; Xingtai People's Hospital) in China designed to determine the diagnostic performance of radiomics-based hepatic venous pressure gradient (rHVPG) (investigational technology) by CT angiography (CTA) for noninvasive assessment of the clinically significant portal hypertension (CSPH) in patients with cirrhosis. Direct hepatic venous pressure gradient (HVPG) measurement by means of catheterization of a hepatic vein with a balloon catheter is the gold-standard method to assess the presence of CSPH, which is defined as HVPG≥10 mmHg.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Patients providing written informed consent
* Patients with cirrhosis and scheduled to undergo clinically-indicated invasive HVPG measurement by means of catheterization of a hepatic vein with a balloon catheter
* Has undergone \> 64 multi-detector row CT within 14 days prior to hepatic vein catheterization
* No hepatic-portal vein interventional therapy between the CT and hepatic vein catheterization

Exclusion Criteria:

* Prior transjugular intrahepatic portosystem stent-shunt surgery
* Prior devascularization operation
* Has received a liver transplant
* Patients with known anaphylactic allergy to iodinated contrast
* Pregnancy or unknown pregnancy status
* Patient requires an emergent procedure
* Any active, serious, life-threatening disease
* Inability to adhere to study procedures
Patella Fracture : A Randomized Controlled Trial

This is a multi-centre, randomized controlled trial comparing operative and non operative treatment for displaced patella fractures in elderly, low-demand patients.

Patients with a displaced patellar fracture who meet the inclusion criteria and provide consent will be randomized to one of the two treatment arms. One group (Group A) will receive standardized non-operative treatment with immediate weight-bearing as tolerated in a knee immobilizer and early ROM exercises begun at 2 weeks post injury. The other group (Group B) will receive ORIF of their displaced patellar fracture with a standardized post-operative protocol.

Post-operative rehabilitation will be standardized across both groups. Patients will be weight bearing as tolerated immediately in a removable knee immobilizer, with progressive range-of-motion exercises begun at two weeks following surgery or randomization. The knee immobilizer will be used full-time (with the exception of removal for physiotherapy and bathing) for 6 weeks after surgery or randomization. At six weeks post-treatment, patients will be allowed to perform active extension and will initiate progressive strengthening exercises of the extensor mechanism.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients 65 years of age or older and ambulatory prior to injury (with or without walking aids).
* Closed fracture of the patella displaced by 5 mm or greater (Displacement will be determined by measuring the widest displacement on any x-ray view with the knee in full extension).
* The patient scores between 3 and 6 on the Clinical Frailty Scale. This score corresponds to a low-demand patient who is ambulatory and functionally independent
* Within 14 days of injury, the patient is able to perform a straight leg raise with less than 30 degrees of extensor lag.
* Able to read and understand the study consent form document.
* Willing and able to sign consent, follow the study protocol and attend follow-up visits.

Exclusion Criteria:

* Associated extremity injuries or polytrauma injuries that would otherwise require surgery or interfere substantially with rehabilitation or outcome in the opinion of the investigator.
* Neurovascular injuries at the level of the knee requiring surgery.
* Pathologic fractures.
* Periprosthetic fractures, or other knee surgery which would contra-indicate inclusion in the study (e.g. previous patella ORIF or previous surgery involving patella such as patella tendon or quads repair).
* Medical contra-indication to surgery.
* Likely problems, in the judgment of the investigators, with maintaining follow-up (e.g. patients with no fixed address, intellectually challenged patients without adequate support, etc.).
A Study of Axl Inhibitor FC084CSA in Patients With Advanced Malignant Solid Tumors

This is a phase I clinical study to evaluate safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of Axl inhibitor FC084CSA in patients with advanced malignant solid tumors who have failed standard anti-cancer treatment.

FC084CSA accelerated doses at 100mg QD, and then started the conventional "3+3" design from 200mg QD.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 to 75 years old male and female.
2. Patients with advanced malignant solid tumors who have failed standard treatments.
3. According to RECIST 1.1, there is at least one measurable lesion.
4. ECOG performance status 0-1.
5. Laboratory examination should meet: ① Blood routine: hemoglobin (HGB) ≥85 g/L, neutrophil count (ANC) ≥1.5×10\^9/L, platelet count ( PLT) ≥75×10\^9/L; ②Blood biochemistry: total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0×ULN, serum creatinine ( Cr)≤1.5×ULN or calculate the creatinine clearance ≥50 mL/min according to the Cockcroft-Gault formula method.

Exclusion Criteria:

1. Not recovered from the adverse reactions caused by previous anti-tumor treatments (≥CTCAE grade 1).
2. Received anti-tumor therapy within 4 weeks before enrollment.
3. Participated in other clinical trials within 4 weeks before enrollment and used clinical investigational drugs during this period.
4. Have undergone surgery within 4 weeks before enrollment, and the investigator believes that the patient's state has not recovered to the point where the study can be started.
5. Patients with ascites (ascites), pleural effusion (pleural effusion) or pericardial effusion that cannot be controlled by drainage or other methods.
6. Central nervous system metastases with clinical symptoms.
7. With any situations that the researcher considers inappropriate to participate in this research.
A Study of Absorption-Distribution-Metabolism-Excretion (ADME) of [14C]IMP4297 to China Healthy Male Subjects

A Phase I, Open-label Study of Absorption-Distribution-Metabolism-Excretion (ADME) of \[14C\]IMP4297 Following a Single Oral Dose to China Healthy Male Subjects

Study design A Phase I, single-center, open-label, single arm study is designed to evaluate Absorption-Distribution-Metabolism-Excretion (ADME) of \[14C\]IMP4297 Following a Single Oral Dose to China Healthy Male Subjects.

6-8 subjects are planned to be enrolled (at least 6 subjects complete the study)

Eligibility Criteria:
Inclusion Criteria:

* Volunteers must meet all of the following inclusion criteria to be included in the study:

  1. Volunteers must fully understand the objective, nature, methods and possible adverse reactions of the trial, volunteer to be volunteers, and sign an informed consent form before the start of any study procedures, and at the same time guarantee that the volunteers will personally participate in the study during any procedures.
  2. Chinese healthy male volunteers aged between 18 and 55 (including cut-off values) at the time of screening.
  3. Volunteers with a body mass index (BMI) of 18.0-28.0 kg/m2 (including cut-off values), and a body weight of ≥ 50.0 kg.

Exclusion Criteria:

* Volunteers who meet any of the following criteria cannot be included in this study:

  1. Diseases with abnormal clinical manifestations that need to be excluded, including but not limited to diseases of the nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism and bones.
  2. A history of allergic diseases (including drug allergies and food allergies, etc.).
  3. A history of any gastrointestinal diseases that will affect drug absorption such as dysphagia, irritable bowel syndrome, and inflammatory bowel disease; active hemorrhoids or perianal diseases accompanied by regular/current blood in the stool; habitual constipation or diarrhea.
  4. Those who have undergone surgery within 3 months before screening, or who plan to undergo surgery during the study period, and those who have undergone surgery that will affect drug absorption, metabolism, or excretion.
  5. Those who cannot tolerate venipuncture, and those who have a history of needke sickness and blood phobia.
Reliability and Validity of Modified Postural Assessment Scale for Stroke Patients and the Application of This Scale on Early Detection of Patients With Stroke at High Risk of Falls

The purposes of this study are to investigate the reliability and validity of the modified Postural Assessment Scale for Stroke Patients (mPASS) and its applications in early detection of fall-prone patients.

The intraclass correlation coefficient will be used to examine the intra-rater reliability, inter-rater reliability, and the Cronbach's alpha will be used to examine the internal consistency of the 16 items of mPASS.

Due to the impaired balance function, patients with stroke show high incidence of falls. Impaired postural stability has been shown as one of the primary risk factors of falls in these patients. Research has shown that patients who have moderate level of mobility and stability are more likely to fall than those who have very good or very poor mobility and stability. Therefore, there is an urgent need for physical therapists, who are used to play an important role in improving balance function of patients with stroke, to be able to early detect stroke patients who are at high risk of falls, and to implement fall prevention training and education on these patients. However, to date, there is not any clinical assessment scale that can be used for early detection of fall-prone stroke patients.

Eligibility Criteria:
Inclusion Criteria:

* between 30 and 80 years old
* first onset or recurrent stroke as a result of a single cerebral vascular accident (ischemic or hemorrhage stroke)
* ever received medical or rehabilitation therapies at National Taiwan University Hospital
* being willing to take the clinical assessments and accept the vedio record

Exclusion Criteria:

* having unstable vital sign, unconsciousness, or having serious cognitive, perception, and language impairment, and being unable to follow the order of the experimenter
* having other neurological diseases(ex. Parkinson's disease or cerebellar disease etc.), or moderate to severe neuromuscular or musculoskeletal disorders, or disorders from systematic diseases those will influence the balance performance other than stroke