cyrilzakka/clinical-trials huggingface dataset:
Public Title：A Study on the Registration of The Use of Feilike HeJi in Adults

Feilike HeJi is produced by Guizhou Jianxing Pharmaceutical Co. LTD. For the treatment of phlegm heat caused by lung cough phlegm yellow, bronchial asthma, bronchitis, see the syndrome of proprietary Chinese medicine (approval number: Z20025136) approved by the state and the drug from radix scutellariae, radix peucedani, radix stemonae, red gentian root of deal, phoenix tree, spreading hedyotis herb, red tube 7 flavour, with qingrejiedu, antitussive expectorant effect. In order to fully understand the safety of Feilike HeJi in clinical practice and fulfill the responsibility of production enterprises for patients, the production enterprises initiated this study to further evaluate the safety and understanding of the function characteristics of Feilike HeJi in a wide range of people, so as to guide the clinical rational drug use.


Eligibility Criteria:
Inclusion Criteria:

* All adult patients (age ≥18 years old) who use Feilike HeJi at the specified monitoring time and in the monitoring center (department) ;
* Must voluntarily participate in this study;
* Must meet ethical requirements.

Exclusion Criteria:

* NO
Computer Guided Versus Conventional TMJ Injection

This study is designed to evaluate the clinical outcomes of computer-guided sodium hyaluronate injection in superior joint space in comparison to conventional injection for treatment of intra-articular TMJ disorder.

This study aimed to reveal the superiority of computer-guided TMJ injection (if found) above the conventional method from the clinician and patient point of view.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with intra-articular TMJ disorder according to Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD).
* Patients who would not respond to conservative treatment as the first line of treatment.

Exclusion Criteria:

* Patients with polyarthritis or degenerative joint disease.
* Patients with myofascial pain.
* Previous history of minimally invasive or invasive treatment of TMJ.
* History of mandibular fracture.
* Lactating, pregnant or planning pregnancy women.
* Known hypersensitivity to hyaluronic acid or clear biocompatible photopolymer resin.
Anesthetic Component Research on VATS and NIVATS

The non-intubated video-assisted thoracic surgery (NIVATS) can avoid intubation-related complications and for a smoother postoperative recovery. Successful results are accumulating not only from anecdotal case reports of difficult and high-risk patients not suitable for an intubated general anesthesia. However, in spite of safety and feasibility, there were still three main concerns: 1. how to maintain spontaneous breathing with optimal anesthetic depth; 2. How to analyze the components of general anesthesia and regional anesthesia; 3.what's the benefits on the recovery and the risk of aspiration risk with NIVATS? The traditional monitor or methods such as BIS system, SpO2, and follow-up aspiration signs could not offer sufficient evidence to resolve the three main concerns. Recently, there have been many new methods to monitor these concerns. The density spectral array (DSA) BIS system could analyze the change of the anesthetic component. The ORI is a dimensionless index that reflects oxygenation in the moderate hyperoxic range (PaO2 100-200 mmHg).

Background: The non-intubated video-assisted thoracic surgery (NIVATS) can avoid intubation-related complications and for a smoother postoperative recovery. In recent years, investigator have completed more than 1000 NIVATS. However, the benefits on recovery including swallowing and esophageal function have nerver been demonstrated. The anesthetic components include an intravenous general anesthesia with an intraoperative nerve blocks. Monitoring and analyzing the components of anesthesia have rarely been studied. In this study, the investigator plan to do a radomized control study to demonstarte the differences between NIVATS and intubated VATS, and to investigate the differences on recovery and anesthetic components. Patients schedured for VATS operation, suitable for NIVATS will be included and randomized into NIVATS or VATS groups. DSA and Ce will be monitored throughout the surgical procedures. swalowing test, esophageal function and postoperative qustionare for food intake will be recorded, collected and analyzed.

Eligibility Criteria:
Inclusion Criteria:

* patients schedured for VATS operations, suitable for NIVATS after anesthetic evaluation

Exclusion Criteria:

-
Adjuvant Chemotherapy for High-risk Postenucleation Retinoblastoma

The purpose of this study is to determine the effect of 3 cycles of chemotherapy(CEV) in the treatment of Stage I enucleated retinoblastoma.

This study will be a phase Ⅲ open label interventional case series. Patients with Stage I enucleated retinoblastoma will receive 3 cycles of chemotherapy(CEV) oon a monthly basis. Patients will be followed for 60 months.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent and comply with study assessments for the full duration of the study.
* Definite pathology signs of retinoblastoma, Stage I base on International Retinoblastoma Staging System.
* Received enucleation in the study eye.
* Monocular retinoblastoma.

Exclusion Criteria:

* Any previous disease in the study eye.
* Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals).
* History of chemical intervention for retinoblastoma in the study eye.
Prospective Treatment Algorithm Guiding Repair of Severe Ischemic Mitral Regurgitation

Ischemic mitral regurgitation is a disease where the mitral valve is regurgitant, or leaking, as a result of changes in the muscle of the heart caused by coronary artery disease Ischemic mitral regurgitation, or IMR, is normally treated by repairing or replacing the mitral valve. Currently, we don't have very strong evidence showing which patients might benefit from mitral valve repair and which might benefit from replacement, and surgeons tend to repair or replace valves based on their preference or experience. Some surgeons, including Dr. Vincent Chan, the Principal Investigator, believe that the decision to repair or replace the valve should be based on specific measurements of the mitral valve. This study will randomly assign patients to receive either the current standard of care for ischemic mitral regurgitation, which is valve repair or replacement based on the surgeon's preference, or to have their treatment decided by a set of criteria called an algorithm. This algorithm will assign patients with certain mitral valve measurements to repair, and others to replacement. Patients will be followed for 12 months after surgery, to compare whether patients whose treatment was decided by the algorithm did better than patients whose treatment was decided by surgeon preference.


Eligibility Criteria:
Inclusion Criteria:

* Severe ischemic mitral valve regurgitation

  * 18 years of age, and able to provide informed consent.

Exclusion Criteria:

* Mixed mitral valve pathology
* Acute ischemic mitral regurgitation
Non-surgical Treatment of Knee Osteoarthritis - a Comparison of Effects in 2200 Patients

The purpose of this study is to assess whether radiographic osteoarthritis severity (OA; Kellgren-Lawrence scale) is associated with self-reported improvement in pain after non-surgical treatments (physiotherapy, pain killers, injection, other treatments).

The hypothesis is that radiographic OA severity is inversely associated with self-reported improvement.


Eligibility Criteria:
Inclusion Criteria:

* Not eligible for at total knee arthroplasty

Exclusion Criteria:

* Ipsilateral knee arthroplasty
Predictive Value of HAS-BLED and CHA2DS2-Vasc Scores After PCI

To assess the predictive value of two scoring systems, namely HAS-BLED and CHA2DS2-VASc scores, to be linked with bleeding events and recurrence of chest pain and other measures of clinical outcome of percutaneous coronary intervention. The investigators aim to provide evidence for local guidelines of optimum options suited to our population

Dual-antiplatelet therapy (DAPT) with aspirin and an inhibitor of the platelet P2Y12 receptor is necessary to prevent stent-related thrombotic complications after percutaneous coronary intervention (PCI). (1) Although continuation of DAPT confers substantial and durable benefits that extend beyond the local stented segment, bleeding risk also increases with continued exposure to antiplatelet therapy. (2) Current guidelines give fixed duration of DAPT after coronary intervention but many patients still having early stent thrombosis despite this fixed policy, while others, on the contrary, suffer minor and major bleeding events. These clinical situations should raise the possibility of individualizing therapy. (5) The rationale of this study is to find a new method to tailor the optimal duration of DAPT for each patient by balancing long-term risks for both coronary thrombosis and major bleeding (MB).

The HAS-BLED (hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly, drugs/alcohol concomitantly) score has long been used to predict bleeding events in patients on anticoagulation therapy. (3) Also, the CHA2DS2-VASc (congestive heart failure, hypertension, ≥75 years, diabetes, stroke/transient ischemic attack or thromboembolism, vascular disease, elderly, sex) score is a well-established system for prediction of thrombo-embolic events in patients with atrial fibrillation. (4) The aim of the present study is to evaluate the predictive ability of these 2 scoring tools when applied to patients undergoing PCI.

Eligibility Criteria:
Inclusion Criteria:

* all patients undergoing PCI

Exclusion Criteria:

* Those who had undergone unexpected immediate CABG
Efficiency of Two Dimensional High Definition vs Three Dimensional Endoscopic Systems in Transanal Endoscopic Surgery

Introduction: The usual surgical technique for large adenomatous tumors and rectal cancer is anterior resection of the rectum or abdominoperineal resection. These techniques are associated with high mortality and morbidity and with genitourinary dysfunctions.

To solve these problems, transanal endoscopic microsurgery (TEM) was designed. Through its 3-D vision system using a rectoscope, this procedure allows access to rectal tumors located up to 20 cm from the anal verge. It is associated with minimal morbidity and has few repercussions for anal continence.

The use of 2-D high definition cameras and screens obtains images of a similar quality to 3-D images. This means that from the surgical point of view the procedure known as TEO (transanal endoscopic operation) seems as practicable as classic TEM.

Main aim: To assess the effectiveness of 2-D high definition vision systems (TEO) versus conventional 3-D (TEM) in endoscopic surgery of rectal tumors, with respect to surgical facility, postoperative morbidity, quality of the surgical specimens, and cost.

Design: Prospective, controlled, randomized study of the efficacy of the use of 2-D high definition endoscopic systems versus 3-D (TEM) in transanal endoscopic surgery.

Disease studied: Rectal adenomas and adenocarcinomas "in situ" suitable for local surgery.

Main variable evaluated: Cost per procedure assuming similar surgical efficacy and equal postoperative morbidity.

Study population and total number of patients: Patients diagnosed with rectal tumor treated with curative intent (rectal adenomas and adenocarcinomas "in situ"). The total sample calculated for the trial was 36 patients, 18 in each group (TEO and TEM).

Timing and expected finish date: After approval by the CEIC, the expected date for the inclusion of the first patient was August 2010. The study is expected to last 18-24 months.


Eligibility Criteria:
Inclusion Criteria:

* Patients of either sex older than 18 years
* Rectal tumor identified as rectal adenoma by multifocal biopsy using colonoscopy, with endorectal ultrasound and magnetic resonance imaging findings of non-invasive tumor.
* Size of the tumor between 2 and 6 cm in maximum diameter.
* Tumor location, lower edge at least 2 cm from the anal verge, and upper edge at least 15 cm from the anal verge.
* ASA score more than III.
* intervention was performed under general anesthesia

Exclusion Criteria:

* Invasive adenocarcinoma shown in the final pathology study. "in situ" or intraepithelial adenocarcinomas are not excluded .
* Pregnant patients
* Patients with liver cirrhosis or blood dyscrasia.
* Patients who can not be administered under general anesthesia.
* Patients on antiplatelet or anticoagulation therapy who have not been properly prepared for surgery.
* Presence of two or more transanal endoscopic excisions in the same procedure.
* Informed consent not signed.
Intraocular Pressure Reduction With the Bimatoprost/Timolol Fixed Combination

The purpose of this study is to examine the ocular hypotensive effect of Bimatoprost and the potential additional effect of the Bimatoprost/Timolol fixed combination in eyes with ocular hypertension, primary open angle glaucoma or exfoliation glaucoma.


Eligibility Criteria:
Inclusion Criteria:

* Primary open angle glaucoma
* Exfoliation glaucoma
* Ocular hypertension

Exclusion Criteria:

* Younger than 18 years old
* Inability to understand and/or follow study requirements
* Women of childbearing potential not using reliable birth control, pregnant or lactating women
* History of chronic obstructive pulmonary disease, heart failure, 2nd or 3rd AV block
* Anticipated modification of treatment for systemic hypertension during the study period
* History of ocular herpes, corneal scarring, conventional or laser surgery or macular pathology
* History of allergy, poor tolerability or poor response to study medication
* Best corrected visual acuity less than 0.4
* Significant visual field defect (MD\<15.0 dB)
The Effect of Transcutaneous Electrical Nerve Stimulation on People With Muscle Fatigue Due to Training, Sports

The objective is to assess if TENS will improve the muscle recovery rate from post-exercise fatigue.


Eligibility Criteria:
Inclusion Criteria:

* No phobia of electrical stimulation
* No pain or anti-inflammatory medication will be taken during study
* English speaking

Exclusion Criteria:

* Pregnancy
* Diabetes Mellitus
* Neuropathy
* Smoker
* Uncontrolled Hypertension
* Past surgery in the region to be treated by TENS or had received an intra-articular corticosteroid or hyaluronic acid injection within 6 months prior to enrollment
* Rhumatoid Arthritis (RA) in the area to be treated by TENS
* Allergic to tape/electrodes
* Dementia
* History of knee joint replacement or tibial osteotomy
* Undergoing physical therapy
* Any major joint pain (e.g., back, hip, or ankle) that could limit functional ability
* Contraindications to TENS such as having a pacemakers, dermatological conditions, and abnormal sensation of the lower extremity.
The Feasibility Usability and Effectiveness of Fully Immersive Horticultural-based Virtual Reality Cognitive Training for Community-dwelling Elderly

The pilot study will be a novel investigation of the usability and feasibility of leisure activities-based fully immersive VR cognitive training systems for cognitive training. We will recruit healthy aged individuals and occupational therapists for usability plus feasibility evaluation and perform the comparison of the effect with the developed VR intervention on psychological, daily life function and quality of life outcomes in populations experiencing cognitive decline. The fully-immersive VR system applied with horticultural therapy will be conducted in cognitive training and it was equipped with a headset and a pair of controllers for motion estimation and monitoring in a virtual environment. The findings of the research will effectively lead to advancement of the fully immersive leisure-based virtual reality cognitive training for elderly with cognitive decline.


Eligibility Criteria:
Inclusion Criteria:

* Occupational therapists

  1. Have clinical experience for more than one year
* Healthy aged Individuals:

  1. An initial MoCA scores ≧ 20
  2. age between 60 to 85
  3. ability to follow instructions and perform tasks
  4. willing to provide written informed consent

Exclusion Criteria:

* Occupational therapists

  1. History of severe dizziness or epilepsy
  2. Unstable physical conditions accompanied by neurological or other orthopedic diseases may affect immersive VR experience
  3. Recent diagnosis of psychiatric disorders
* Healthy aged individuals:

  1. An initial MoCA scores lower than 20
  2. History of psychiatric disorders, major perceptual (visual or auditory) impairments, migraine or epilepsy, motion-sickness sensitive, unable to provide informed written consent due to severe cognitive impairment

\[Effect study\]

Inclusion Criteria:

1. An initial MoCA scores ≧ 20
2. age between 60 to 85
3. ability to follow instructions and perform tasks
4. willing to provide written informed consent

Exclusion Criteria:

1. An initial MoCA scores lower than 20
2. History of psychiatric disorders, major perceptual (visual or auditory) impairments, migraine or epilepsy, motion-sickness sensitive, unable to provide informed written consent due to severe cognitive impairment
Incidence of Sleep-disordered Breathing and Upper Airway Collapsibility in Postpartum Patients and Its Intervention

The investigators hypothesized that sleeping in a 45 degrees elevated body position decreases the likelihood of upper airway vulnerability to collapse early after delivery. Furthermore, the investigators want to elucidate the anatomical and physiological risk factors that contribute in the upper airway obstruction in post-partum patients.

After obtaining study consent, each patient underwent measurements of upper airway cross-sectional area (CSA) during daytime within 48 h after delivery. The minimum upper airway CSA was measured using acoustic pharyngometry (Eccovision Acoustic Pharyngometry; Sleep Group Solutions, Inc) in sitting, 45° elevated, and nonelevated upper body position. This method has been previously used and validated in pregnant women.

In the patients who further gave consent for the sleep study, polysomnography (PSG) was performed throughout the entire study night. Within a crossover design, patients were randomly assigned to receive first either nonelevated or 45° elevated upper body position. Position was changed after 3.5 h by a member of the team.

Eligibility Criteria:
Inclusion Criteria:

1. Postpartum mothers within 48 hours of delivery in a major academic teaching hospital.
2. Age over 18 years.
3. Admitted to the Massachusetts General Hospital OB service for the delivery.
4. Interventions will be randomly assigned to the patients enrolled in this study

Exclusion Criteria:

1. Age under 18 years.
2. History of pre-existing pulmonary and cardiac diseases, including bronchial asthma, cystic fibrosis, chronic obstructive lung disease, neck and chest tumors (thyroid, mediastinal, etc.), irradiation to the neck and/or chest, and congenital airway deformities, other critically-ill conditions.
Safety Study of Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody in Lupus Nephritis

The purpose of this study is to determine the safety and tolerability of Anti-MIF Antibody in subjects with lupus nephritis.


Eligibility Criteria:
Inclusion Criteria:

* Signed and dated written informed consent obtained from the subject
* Males and females of age 18 years and older at the time of screening
* Established diagnosis of systemic lupus erythematosus (SLE) according to the American College of Rheumatology classification criteria
* Documented renal biopsy evidence of proliferative glomerulonephritis prior to screening
* Urine protein-to-creatinine ratio \> 0.5 (mg/mg)

Exclusion Criteria:

* Any significant health problem other than lupus or lupus nephritis
HELIX, a Double-masked Study of SYL1001 in Patients With Moderate to Severe Dry Eye Disease (DED)

The purpose of this study is to determine whether SYL1001 ophthalmic solution is safe and effective in the treatment of signs and symptoms of Dry Eye Disease.


Eligibility Criteria:
Inclusion Criteria:

* Both genders
* ≥ 18 years old
* Give written informed consent to participate in the study after having been informed of the study design, objectives and possible derived risks
* Common symptoms of persistent, daily, moderate to severe dry eye lasting more than six months.
* Use of artificial tears
* VAS scale for eye discomfort/pain between 30 - 80
* CFS ≥ 2 and ≤ 4 on the Oxford scale
* TBUT \< 10 seconds
* Hyperemia score ≥ 1 (McMonnies scale)
* Schirmer's test without anesthesia ≥ 2 and \< 10 mm/5min in the eye
* Corrected visual acuity ≥ 0.7 logMAR

Exclusion Criteria:

* Pregnant or breastfeeding females or those with a positive pregnancy test.
* Females of childbearing potential who will not use a medically acceptable contraceptive method from selection and during the whole study.
* Current relevant disease, including respiratory disease, cardiovascular, endocrine, neurological, haematological, renal, neoplasic, hepatopathy, gastrointestinal distress, hypertension, or infectious acute processes.
* Past history of a chronic o recurring condition that could interfere with study according to the investigator's judgement.
* Concomitant use of other drugs with analgesic activity by any route of administration at the enrolment period.
* Changes in any ocular and/or systemic concomitant medication one month prior to the study commencement and during the study development.
* Changes on the preestablished artificial tears dosage 15 days prior to the study commencement and during the study development.
* Cyclosporine treatment initiation or changes in cyclosporine dosage or dosing regimen during the 6 months prior to enrolment.
* Previous history of drug hypersensitivity.
* Use of contact lenses
* Case history of drug or alcohol abuse or dependence.
* Relevant abnormal laboratory results as judged by the investigator
* Previous refractive surgery
* Participation in a clinical trial within 2 months before the enrolment visit
* Relevant ocular pathology judged by the investigator.
Mechanisms and Reversibility of Heart Failure Associated With Diabetes

Patients with diabetes have a higher incidence of heart failure and worse outcomes than normoglycaemic subjects. Basic science research has suggested many mechanisms for this observation including endothelial dysfunction, abnormal calcium handling, fibrosis and activation of the renin-angiotensin-aldosterone system (RAAS), but clinical data are lacking. In this study the investigators will investigate the relationship between diabetes and heart failure by exploring the correlation between microvascular dysfunction and cardiac magnetic resonance (CMR) markers of left ventricular (LV) hypertrophy, cardiac dysfunction and fibrosis. The investigators also propose to see if this relationship is independent of blood pressure and markers of RAAS activity. This could have important clinical ramifications in type 2 diabetes by increasing the indications for treatment with RAAS inhibition or making a case for lower blood pressure targets.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes

Exclusion Criteria:

* Known cardiac or renal disease
* Uncontrolled hypertension
* Treatment with ACEi/ARB
* Treatment with insulin
* Contraindication to CMR