cyrilzakka/clinical-trials huggingface dataset:
Observation of Recovery of Foveal Cone Microstructures After Macular Hole Surgery

The objective is to determine whether a recovery of the microstructures of the foveal photoreceptors after macular hole (MH) closure is correlated with the best-corrected visual acuity (BCVA) is determined.

Macular hole patients were evaluated by spectral domain optical coherence tomography (SD-OCT) to determine the integrity of the microstructures of the foveal photoreceptors. The inner segment/outer segment (IS/OS) junction, the external limiting membrane (ELM), and the cone outer segment tips (COST) line were determined preoperatively, and at 1, 3, 6, 9, and 12 months after the MH surgery. The correlation between the integrity of the foveal photoreceptor microstructures and the best-corrected visual acuity (BCVA) was determined.

Eligibility Criteria:
Inclusion Criteria:

* The patients had undergone surgery from March 2008 to August 2009 at Kyorin Eye Center
* Idiopathic macular hole patients with either a Stage 2, 3, or 4 according to the Gass classification

Exclusion Criteria:

* The presence of other retinal diseases including a treated rhegmatogenous retinal detachment, diabetic retinopathy
* High myopia with an axial length \> 27.0 mm or refractive error \> -8.0 diopters
* The patients followed for less than 6 months postoperatively
Short Duration Levetiracetam to Extended Course for Seizure Prophylaxis After aSAH

Our primary objective is to compare two treatment options for prevention of seizures following a subarachnoid hemorrhage and determine if a short-course regimen of levetiracetam is as efficacious in the prevention of in-hospital seizures when compared to an extended course.

This is a prospective, single-center, randomized, controlled trial. Patients admitted with spontaneous SAH (and meet enrollment criteria) will be randomized to either levetiracetam 1000 mg twice daily for 3 days or levetiracetam 1000mg twice daily until hospital discharge.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>18 years of age
2. Diagnosis of spontaneous SAH

Exclusion Criteria:

1. SAH secondary to trauma or arteriovenous malformation
2. Early death (defined as death within 3 days of presentation)
3. Known allergy to levetiracetam
4. Know seizure history on chronic AEDs
5. Pregnancy
6. Current incarceration
Sensorimotor Rhythm Brain-Computer Interface Switch to Operate Assistive Technology

The purpose of this research is to develop tools to help people who are paralyzed. These tools are called brain-computer interfaces (BCIs). BCIs would allow a person to use brain signals to operate technology. Specifically this project's goal is to design a BCI to operate a switch.

The investigators want to make a BCI that can be used to operate commercially available technologies for communication, environmental control or computer access. The BCI would replace a switch to let people operate these technologies without moving. However, investigators need people to test the BCI so they can determine how effective it is in replacing a switch.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Able to read text on a computer screen
* Able to understand and remember instructions concerning participation

Exclusion Criteria:

* Unable to give informed consent
* Unable to understand and follow instructions
* Have abnormal tone or uncontrolled movements in the head-and-neck that would interfere with EEG recordings
* Known to have photosensitive epilepsy
* Open head lesions or sores
Controlled Sedation for Cataract Surgery

This study evaluates the surgeon and patient´s satisfaction who undergoes cataract surgery using either dexmedetomidine or remifentanil as sedation

This is a double blind, randomized study which evaluates surgeon and patient´s satisfaction whom undergoes cataract surgery. The surgery was done under local anesthesia and sedation.

Eligibility Criteria:
Inclusion Criteria:

* subject has cataract,
* subject older than 18 years,
* local anesthesia and sedation.

Exclusion Criteria:

* general anesthesia,
* history of consumption of sedatives.
Physical Therapy in the Intensive Care Unit: A Comparative Study of Three Asian Countries

This descriptive-comparative study has explored and presented an overview of the extent of PT practice in the ICU in JP, PH, and TW. Specifically, the socio-demographic and ICU-related profiles of physical therapists (PTs) in Japan (JP), Philippines (PH), and Taiwan (TW) were presented, with the inclusion of the common PT interventions and challenges encountered in delivering PT services in the ICU in the said countries.

Included in the socio-demographic variables are the respondents' sex, age, highest educational attainment, PT work experience, and hospital affiliation. As to the ICU-related variables, it includes the respondents' ICU work experience, the types of ICU where respondents primarily work, the hiring department they belong to, the status of ICU posting, the duration of ICU posting, the daily ICU stay of the respondents, their engagement in on-call ICU PT services, the usual source of ICU patient referral, the number of daily ICU patients, the ratio of PT to ICU patients, and the level of participation in ICU-related PT training. Furthermore, different interventions that are commonly implemented and challenges that are commonly encountered in ICU PT service delivery in Japan, Philippines, and Taiwan were also investigated.

Physical therapy (PT) is proven beneficial among critically ill patients. However, there is an extent to the practice of PT in the intensive care unit (ICU) which differs between countries. With this, the extent of PT practice in the ICU in three Asian countries, namely Japan (JP), Philippines (PH), and Taiwan (TW), was determined and compared by specifically determining the socio-demographic and ICU-related profile of physical therapists (PTs) who have worked in the ICU.

Eligibility Criteria:
Inclusion Criteria:

* Physical therapists who:

  1. are currently residing or working in Japan, Philippines, and Taiwan;
  2. are working, or have worked in an ICU in JP, PH, or TW, and have provided PT services to critically ill patients regardless of age, sex, nationality/race, and years of work experience (in general);
  3. have an active e-mail address; and
  4. provided informed consent

Exclusion Criteria:

* Physical therapists who are:

  1. newly hired (or rotated) PTs with ICU duty but have not yet handled any ICU patient; and
  2. licensed PTs from JP, PH, and TW but are based and/or are working abroad.
Efficacy and Safety of Cevira® in Patients With Cervical Histologic High-grade Squamous Intraepithelial Lesions (HSIL)

A double blind, prospective, randomized, placebo controlled, multi-center phase 3 study to evaluate efficacy and safety of Cevira® in patients with cervical histologic high-grade squamous intraepithelial lesions (HSIL).

To evaluate the efficacy and safety of Cevira® compared to placebo in treatment of patients with cervical histologic HSIL.A total of 384 subjects will be enrolled globally, among which, 300 subjects of them will be enrolled in China.

Eligibility Criteria:
Inclusion Criteria:

1. Biopsy-confirmed HSIL histology determined by a panel of 3 pathologists from a central laboratory in each region (China, US, and Europe);
2. Adequate colposcopy including:

   1. visualization of entire cervical transformation zone including the squamocolumnar junction
   2. visualization of entire lesion margin
3. Colposcopically visible lesion after biopsy, before treatment (Note: To ensure a colposcopically visible lesion after biopsy, the lesion should cover approximately 15% of the uterine cervix before biopsy)
4. Average sized uterine cervix suitable for application of the Cevira® device
5. Use of adequate birth control until completion of the 6 month assessment visit
6. Age 18 or older (Note: Patients aged 18-20 should not be actively recruited)
7. Signed written informed consent

Exclusion Criteria:

1. Biopsy-confirmed HSIL (CIN3) histology with a total lesion area covering more than half of the uterine cervix area
2. Invasive cervical cancer
3. Adenocarcinoma in situ, or other glandular intraepithelial lesions
4. Lesion(s) extending to the cervical canal (as clinically indicated and whether to perform endocervical curettage \[ECC\] test at the discretion of the investigators)
5. Lesion(s) extending to the vaginal vault
6. Current severe pelvic inflammatory disease, severe cervicitis, or other severe gynecological infection as per colposcopy and clinical examination
7. Vaginal bleeding at time of treatment at the discretion of the investigator
8. Pregnancy
9. Nursing
10. Childbirth or miscarriage within six weeks of enrolment
11. Patients who previously received surgical treatment, have incomplete cervical structure and have recurrent HSIL; or patients who received other treatment after the confirmed diagnosis of HSIL
12. History of toxic shock syndrome
13. Known or suspected porphyria
14. Known allergy to hexaminolevulinate or similar compounds (e.g. methyl aminolevulinate or aminolevulinic acid)
15. Known allergy to silicone
16. Use of heart pacemaker
17. Participation in other therapeutic clinical trials using investigational agents either concurrently or within the last 30 days
18. Patients that in the investigator's opinion are not suitable for participation
19. Patient is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the study
Clinical Trial of Orthokeratology Lens (MCOK-01)

A prospective, multicenter, randomized, controlled clinical trial of orthokeratology lens

The test product is the orthokeratology lens, and the control product is a commercially available orthokeratology lens. The number of enrolled subjects is 390, and clinical observation is performed for 12 months.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with myopia and myopic astigmatism
2. Those who are not willing to wear glasses in daily life
3. Fully understand of the purpose of the clinical trial and agree to sign the informed consent form to participate in clinical trials, based on his/her willingness
4. Those who can visit the institution on scheduled dates
5. Those who can receive guidance and tests as required by the investigator
6. Those who fully understand and follow the instructions of the lenses for this clinical trial

Exclusion Criteria:

\<At screening\>

1. Best corrected vision acuity of less than 0.8 with spectacles
2. Subjective refraction test shows spherical power greater than -6.00D，less than -0.50D or astigmatism greater than 1.5D
3. Patients in need of treatment for eye disease other than refractive error (excluding those receiving artificial tears eye drops due to the wearing of corneal contact lenses)
4. The medical history of intraocular surgery that may affect the effect of wearing the lens for this clinical trial (those with corneal transplantation, Retinal detachment, etc.)
5. The medical history of refractive corneal surgery
6. Those in need of a strength out of the scope of lens for this clinical trial
7. Having eye allergic diseases that may cause disorders in wearing the lenses for this clinical trial
8. All Corneal abnormalities including keratoconus, corneal dystrophy, previous history of ocular herpes infections, acute dry eyes, low corneal endothelial cell counts.
9. Pregnant (judgment according to her known information) or those who plan to become pregnant during clinical trial, or those who are breast feeding
10. Those who are participating in other clinical trials or have participated in other clinical trial in the past 30 days
11. Prior experience with use of rigid lenses within the previous 3 weeks or use of soft lenses within the previous 3 days
12. Prior experience with myopia control treatment (e.g. atropine, orthokeratology, multifocal soft contact lenses)
13. Minor/adult subjects who lack mental capacity
14. Other not suitable for this clinical trial at investigator's discretion \<At the beginning of the wearing\>

(1) Those who are determined to be unable to obtain good centralized positioning even though changing strength (2) Pregnancy confirmed (3) Those who are difficult in continuing the clinical trial at investigator's discretion
Broccoli Ileo Study

Epidemiological and experimental studies have indicated that the consumption of diets rich in cruciferous vegetables such as broccoli has a range of beneficial effects on human health. These effects are usually attributed to naturally-occurring glucosinolates and their breakdown products, isothiocyanates, in cruciferous vegetables. One of these compounds, sulforaphane, the hydrolysis product of glucoraphanin, the main glucosinolate in broccoli has been reported to have bactericidal activity against H. pylori and other human pathogens. The investigators have recently shown that adding mustard seeds, which contain a more resilient form of this enzyme, to processed broccoli actually increased the formation of sulforaphane and minimised production of another biologically-inactive form. Experimental studies by the investigators have shown that sulforaphane can inhibit growth of a number of enteric pathogens including salmonella and E. coli which exert their effects in the small intestine. Currently the bioavailability, stability and bioactivity of sulforaphane in the small intestine of a human following consumption of broccoli is not known.

To assess the effect of broccoli phytochemicals in vivo 20 participants who have previously had an ileostomy (removal of colon, \> 1.5 years post operative) will be fed 200 ml of broccoli soup/control in a randomised double blind crossover design and collect the ileal fluid before (0 hr) and after (4 hr) the feeding. The ileal fluid collected from participants will have undergone in vivo digestion, allowing analysis of the chemical composition and bioactivity of the ileal fluid. The hypothesis to be tested is that consumption of cooked broccoli plus myrosinase from mustard seeds will result in high levels of sulforaphane in ileostomy fluid, sufficient to suppress growth of enteric pathogens. This study will be used to assess whether previous observations on the in vitro antibacterial activity of broccoli are relevant in vivo.


Eligibility Criteria:
Inclusion Criteria:

* undergone an ileostomy and be more than 1.5 year post-operative
* non smoking

Exclusion Criteria:

* not undergone an ileostomy and/or is less than 1.5 year post-operative
* smoker.
Montelukast in Pediatric Allergic Asthma (0476-336)(COMPLETED)

This is a 3-week study to evaluate FEV1 following treatment with drugs in persistent asthma which is also active during allergy seasons in pediatric patients with seasonal aeroallergen sensitivity.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients, ages 6 to 14 years, with persistent asthma that is also active during allergy season
* Patients must demonstrate positive skin prick tests to seasonally relevant geographic aeroallergens

Exclusion Criteria:

* Patient cannot have any other acute or chronic pulmonary disorder
Fingolimod in COVID-19

Although immune-inflammatory treatment is not routinely recommended to be used for SARS-CoV-2 pneumonia, according to the pathological findings of pulmonary oedema and hyaline membrane formation, timely and appropriate use of immune modulator together with ventilator support should be considered for the severe patients to prevent ARDS development. The sphingosine-1-phosphate receptor regulators Fingolimod (FTY720) is an effective immunology modulator which has been widely used in multiple sclerosis.The aim of this study was to determine whether the efficacy of fingolimod for a novel coronavirus disease (COVID-19).


Eligibility Criteria:
Inclusion Criteria:

* The patients who were diagnosed with the common type of NCP (including severe risk factors) and severe cases of new coronavirus pneumonia;
* Aged 18 to 85 years;
* Patients or authorized family members volunteered to participate in this study and signed informed consent.

Exclusion Criteria:

* Patients with any history of bradyarrhythmia or atrioventricular blocks
* Patients who are participating in other drug clinical trials;
* Pregnant or lactating women;
* ALT / AST\> 5 ULN, neutrophils \<0.5, platelets less than 50;
* Definite diagnosis of rheumatic immune-related diseases;
* Long-term oral anti-rejection or immunomodulatory drugs;
* Patients with active pulmonary tuberculosis, with definite bacterial and fungal infections.
COMPARISON OF SILODOSIN AND TAMSULOSIN IN MEDICAL EXPULSIVE THERAPY OF DISTAL URETERIC CALCULI

to compare efficacy and safety of Silodosin and Tamsulosin in Medical expulsive therapy of Distal Ureteric Calculi.

to compare efficacy and safety of Silodosin and Tamsulosin in Medical expulsive therapy of Distal Ureteric Calculi in our local setup to find out the optimal drug which promptly and quickly cures the disease thus enabling the person to return to routine activity with less adverse effects.

Eligibility Criteria:
Inclusion Criteria:

* symptomatic, unilateral, single, uncomplicated Distal Ureteric Calculi of \<10 mm in size (on plain CT KUB)

Exclusion Criteria:

* solitary kidney, bilateral ureteric stones, UTI, renal impairment, high-grade hydronephrosis (Grades 3 and 4), any history of previous endoscopic or surgical interventions, pregnancy, diabetes mellitus,
Platform for Medical Information Extraction From Incomplete Data

In order to perform research smoothly, the process of information extraction is required for translating data in clinical text into available format for analysis and statistic. In medical research, the problem of missing data occurs frequently. It is important to develop the method with better imputation performance in the stability and accuracy. The purposes of this project are to provide the data integration and extraction methods for handling the structured and unstructured data sources in more efficient ways, to provide the validation scheme for facilitating the data reviewing of extracted results produced by information extraction modules, to increase the quality of clinical data by comparing the data from different data sources and correcting data errors and inconsistent, to handle the clinical data with the properties of time series and incompleteness, to increase accuracy of data analysis and increase quality of health care by improving the completeness and correctness of clinical data, to provide flexibility of methods in the platform. In the project, the disease topic is focused on the liver cancer patients' clinical data and we hope the methods in the projects can be extended to handle other diseases by replacing these knowledge models in the future.

Because of the increasing adoption of Electronic Medical Record (EMR) systems, the data access of EMR is more and more convenient. However, there still have difficulties in analyzing all the clinical data directly due to a large number of records using the narrative format. In order to perform research smoothly, the process of information extraction is required for translating data in clinical text into available format for analysis and statistic. In medical research, the problem of missing data occurs frequently. It is important to develop the method with better imputation performance in the stability and accuracy. The purposes of this project are to provide the data integration and extraction methods for handling the structured and unstructured data sources in more efficient ways, to provide the validation scheme for facilitating the data reviewing of extracted results produced by information extraction modules, to increase the quality of clinical data by comparing the data from different data sources and correcting data errors and inconsistent, to handle the clinical data with the properties of time series and incompleteness, to increase accuracy of data analysis and increase quality of health care by improving the completeness and correctness of clinical data, to provide flexibility of methods in the platform. In the project, the disease topic is focused on the liver cancer patients' clinical data and we hope the methods in the projects can be extended to handle other diseases by replacing these knowledge models in the future.

Eligibility Criteria:
Patients with liver cancer
Unreamed Intramedullary Tibial Nailing in Treatment of Open IIIa Diaphyseal Tibial Fractures in Adults

To study the incidence of non union of Unreamed intramedullary nailing in type IIIa Open diaphyseal fractures of the tibia as a primary outcome and the incidence of complications and clinical and functional outcome as a secondary outcome .

Tibia is one of the most common bones to sustain open injury because of its superficial nature.Concerns over the high rates of malunion, nonunion, and deep infection have resulted in the development of aggressive treatment protocols including emergent wound exploration, thorough irrigation and debridement, bony stabilization, judicious antibiotic therapy, repeated wound debridements, and early soft-tissue coverage. However, there is still controversy regarding the optimal method of skeletal stabilization. High rates of pin tract infections, poor patient compliance, and malunion rates of 20% and greater have limited the use of external fixators as a definitive form of fixation.Despite initial encouraging results, plate fixation of open tibial fractures has been associated with implant failures, nonunions, and deep infection rates as high as 35%.6As a result, locked intramedullary nailing has become the standard treatment for open tibia fractures enabling axial alignment, early weight bearing, and immediate knee and ankle motion. Despite this, the complications including a high incidence of local bony necrosis and sepsis that occur following reamed intramedullary nails have led some to discourage the use of this method of skeletal stabilization in open tibia fractures.intramedullary tibial nail insertion without reaming has the advantage of minimal endosteal blood supply disruption and thus supposed to have increased union rate and reduction of infection rate .

Sanders et al 11 reported on the treatment of 64 patients with open tibial shaft fractures using unreamed interlocked intramedullary nails. All but 1 of the fractures healed with excellent alignment and an overall chronic infection rate of 4%.other studies reported similar results .12 type and timing of fixation were important determinants of infection , with people who received intramedullary nailing within 24 h having the lowest risk of infection .UTN significantly reduced the incidence rates of superficial infection and malunion compared with EF, suggesting that it is likely a safe and effective alternative to EF for treating open tibial fractures. however patients' postoperative weight bearing should be controlled to avoid hardware failure.

Here,our purpose is to investigate the outcome of Unreamed intramedullary nail in open diaphyseal fractures of the tibia in our setup .

Eligibility Criteria:
Inclusion Criteria:

1. Open grade IIIa diaphyseal tibial fractures .
2. Skeletaly mature patients .

Exclusion Criteria:

1. late presentation and open infected fractures .
2. Associated intraarticular fractures of proximal /distal tibia.