cyrilzakka/clinical-trials huggingface dataset:
Tranilast as a Radiosensitizer in Reradiation of Nasopharyngeal Carcinoma

Nasopharyngeal carcinoma is one of the high incidence head and neck cancer in Southeast Asia. Radiotherapy is the main treatment for nasopharyngeal carcinoma, and its response rate can reach 80\~90%. However, for radiotherapy resistant patients with metastasis and recurrence, the survival prognosis decreased significantly, and the 5-year overall survival rate was only 20% - 40%. Tranilast is an anti-allergic drug, which is clinically used to treat bronchial asthma and can inhibit fibroblasts α- SMA and type I collagen expression. Through experiments in vivo and in vitro, the investigators' research group has proved that Tranilast can inhibit the activity of tumor related fibroblasts, reduce the radiotherapy resistance of nasopharyngeal carcinoma, and has the radiosensitizing effect of nasopharyngeal carcinoma. This result has been published in J exp Clin cancer res (if=11.16). The investigators plan to carry out the clinical transformation of basic research, carry out a prospective intervention phase II clinical trial, compare the objective remission rate of patients with recurrent nasopharyngeal carcinoma treated with previous radiotherapy, and explore the safety and effectiveness of using Tranilast as a radiotherapy sensitizer for radiotherapy to resist the treatment of nasopharyngeal carcinoma.


Eligibility Criteria:
Inclusion Criteria:

1. Sign informed consent
2. At least 18 years old on the date of signing the informed consent
3. Previously received standard radical radiotherapy and chemotherapy
4. Recurrent nasopharyngeal carcinoma in situ or cervical lymph nodes confirmed by pathological biopsy and imaging examination
5. After multidisciplinary consultation, there was a clear indication for surgery, and the patient was informed and refused to accept surgical treatment 6）ECOG PS：0/1

7) Laboratory examination confirmed good organ function, which should be carried out within 10 days before the first treatment.

Exclusion Criteria:

1. After evaluation, it does not meet the indications of re-radiotherapy
2. unable to take oral medication
3. Pregnancy or lactation
4. Known allergy to Tranilast
5. Patients who are judged by the researcher as unsuitable to participate in this trial
Myopia Control With Three Lever Irradiance of PBM Therapy in Children and Adults

Photobiomodulation therapy, that is, Low-level red-light technology provides a new and innovative myopia control approach. This strategy enables relatively high energies of light to be delivered at much shorter durations of exposure to induce the myopia control effect. The efficacy of the low-level red-light technology has been proven in a Chinese populationb for the recent 3 years with evidence based papers and amazing results. However, there's not yet evidence to demonstrate the relationship between the dose response effect of photobiomodulation therapy on myopia control at the different age lever.

Previous trial has demonstrated that 3-minutes per session twice a day repeated low-level red-light treatment at the irridiance of 2.3mW（2.0\~2.5mW) controlled 87.7% of refraction progression and 76.8% of axial length elongation when the time of compliance to the treatment was 75%. Retrospective analyze other irriadance of 1.2mW, 0.6mW and 0.37mW culturally diverse groups will confirm and translate this technology into a solution for myopia control globally.

Eligibility Criteria:
Inclusion Criteria:

* Myopia or near Myopia with younger age
* Without other intervention of myopia control, including atropine, Misight contact lens, special design lens to control myopia, orthokeratology and other red light devices.
* Follow-up at least once
* With baseline data of ocular parameters before the follow-up

Exclusion Criteria:

* Photophobia
* Allergy to red light
* Severe ocular progressing diseases or systemic diseases
* The data is unacceptable with reasonable explanations
Microbial Adhesion and Biofilm Formation on Denture Base Materials

Polymethylmethacrylate (PMMA) has been the material of choice for fabricating complete dentures for more than 80 years now.(1,2) As a material it is easy to handle and can be easily repaired and polished. PMMA while being a low-cost material has good esthetics. Some disadvantages of PMMA as a material are surface roughness and porosities which lead to staining, plaque accumulation and bacterial adhesion over time.

Among the various factors that can influence microbial attachment to surfaces, surface roughness, hydrophilicity and free surface energy of PMMA are most important. Carboxylate and methyl ester groups found in PMMA make it a very hydrophilic material with a large amount of free surface energy. Despite the influence of the chemical composition, processing methods play the most important role in developing surface roughness.

PMMA for dentures may be processed by conventional techniques like compression moulding or injection moulding with the conventional pack and press technique being considered the 'gold standard' when it comes to processing methods as it has successfully withstood the test of time. With the advent of technology CAD/CAM milling is now being used to mill dentures from pre-polymerized blocks of acrylic resin. At the same time 3D printing/Rapid prototyping technology is also being used to print denture bases with acrylic resins. Both these technologies eliminate the need for conventional flasking and processing methods. The rapid prototyping technique involves serial apposition of resin layers on a custom designed support structure. These layers are hardened by curing with either visible light, UV Light, heat or laser depending upon the technique used. This process is repeated until the designed structure is completely formed. The milling or subtractive technique on the other hand uses pre-polymerized commercially manufactured PMMA blanks (Pucks) which are made under high pressure. This technique allows for the material to have superior mechanical properties.

In reviewing the literature, no clinical studies were performed to compare which method of PMMA denture construction can reduce the amount of microbial colonization while there are a lot of invitro studies was performed.

Eligibility Criteria:
Inclusion Criteria:

* Completely edentulous populations.
* Good physical and mental health.
* No systemic disease

Exclusion Criteria:

* Partially edentulous populations.
* Patients with smoking more than 10 citrates day.
* Patients with systemic diseases.
* Patients undergrown radiotherapy.
Fresh Frozen Plasma as a Substitute for Albumin in Patients Receiving a Large Volume Paracentesis

Large volume paracentesis with albumin administration is the standard of care for patients with refractory ascites complicating end-stage liver disease. However, the use of albumin is frequently limited due to expense and occasional short supply. The goal of this study is to demonstrate if the administration of fresh frozen plasma (FFP) is as effective as albumin for volume expansion at the time of a large volume paracentesis.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older
2. Cirrhosis of the liver based on biopsy or clinical and radiographic criteria
3. Ability to provide informed consent (Grade 0 to 1 HE)
4. Grade 3 ascites or refractory ascites
5. Ascites requiring frequent large volume paracentesis of at least 5 liters at least once a month
6. No diuretic use

Exclusion Criteria:

1. Inability to obtain informed consent
2. Age less than 18
3. Hepatic Encephalopathy Grade \> 1
4. Septic shock
5. Active infection
6. Respiratory failure
7. Heart failure with reduced ejection fraction of ≤ 50%
8. Moderate or severe pulmonary hypertension
9. History of stroke
10. Unstable coronary artery disease
11. Chronic kidney disease (GFR \<60)
12. GI bleed within 2 weeks
13. Any licorice within 2 weeks of starting the study
14. Any Beta Blocker use within the last 2 weeks
15. Any diuretic use within 2 weeks
16. Absence of paracentesis within 2 weeks
17. Absence of volume expanders within 2 weeks
18. INR \> 1.7
Evaluation of the Zilver Vascular Stent in the Iliac Arteries (ZIPS)

The purpose of this study is to assess the ability of a vascular stent to maintain an open iliac (leg) artery. The Zilver Vascular Stent is made of nitinol, a flexible metal with a long history of use in medical devices. The stent self-expands once inside the artery where it is intended to hold the vessel wall open. Within a few weeks, a layer of cells will grow over the stent helping to hold it in place.


Eligibility Criteria:
Inclusion Criteria:

* Patient has documented stenotic or occluded atherosclerotic lesions of the external iliac or common iliac artery.
* Patient has a de novo or restenotic lesion(s) with no prior stent in the target lesion.
* Patient has given informed consent.

Exclusion Criteria:

* Patient is less than 50 years of age
* Patient is participating in another investigational drug or device study.
* Patient has multiple lesions (ipsilateral or in the aorta) that would require a staged procedure.
* Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
* Patient has a known hypersensitivity or contraindication to aspirin, clopidogrel, nitinol, or contrast dye that cannot be adequately premedicated.
* Patient is pregnant or breast-feeding.
Role of Computed Tomography in Evaluation of Different Causes of Intestinal Obstruction Correlated With Operative Findings

Intestinal obstruction is a common clinical problem that occurs secondary to mechanical or functional obstruction of the intestine, preventing normal transit of its contents. It is a frequent cause of hospitalization and represents 15-20% of surgical admissions for acute abdominal pain .

The underlying aetiology of large bowel obstructions (LBOs) is age dependent, but in adulthood, the most common cause is colonic cancer (50-60%), typically in the sigmoid. The second most common cause in adults is acute diverticulitis (involving the sigmoid colon). Together, obstructing tumors and acute diverticulitis account for 90% of all causes of LBO.

Adhesions are the most common cause of small bowel obstruction (SBO) , For practical purposes, they do not tend to cause LBO.Other causes which cause symptoms that are mimic intestinal obstruction as in bowel ischemia that mainly caused by mesenteric vessels occlusion (adynamic obstruction).

Computed tomography (CT) has become a mainstay in diagnosing bowel obstruction. This is because the management of obstruction has dramatically changed with a decrease in the proportion of patients who need surgery Multi Detector Computed Tomography scanners provide a huge gain in performance that can be used to reduce the scan time, reduce section collimation, or to increase scan length surgery.

Diagnosis of intestinal obstruction is established by patient history and clinical findings include abdominal distension, acute abdominal pain, vomiting and inability to pass stools or flatus .

The role of CT in diagnosing intestinal obstruction has been expanding by determining presence, degree, level and cause (extrinsic lesions, intrinsic lesions, intussusception, intraluminal lesions) of obstruction and in identifying any associated strangulation, and also it has an important role in diagnosing the mesenteric vessels obstruction by thrombi by injection of IV contrast media which causes adynamic bowel obstruction .


Eligibility Criteria:
Inclusion Criteria:

* Any age group and gender presented by manifestations of acute intestinal obstruction.

Exclusion Criteria:

* Pregnant women.
BCI Post-stroke Neurorehabilitation

The goal is to evaluate the potential of a EEG based BCI (Brain-Computer-Interface) connected to a non-invasive pneumatic glove for rehabilitation of hand-movements post-stroke.

Brain computer interfaces (BCI) encompasses the usage of the brain signals to compensate for lost physical function. The current protocol evaluates the therapeutic potential of a EEG based driven BCI that is connected to a non-invasive pneumatic glove for rehabilitation of hand flexion/extension post-stroke. The system non-invasive, portable and low-cost. The utility and usability of the system will be investigated at two levels. First by means of questionnaires for patients and therapist and second by means of in depth analysis of the EEG signals during intended, imagined and passive driven hand movements in relation to no movement at all and the capacity of the BCI to distinguish between these conditions.

Eligibility Criteria:
Inclusion Criteria:

* \> 6 months post-stroke (chronic), unilateral
* \> 18 yrs
* little to no hand movement
* spasticity \< 3 on modified Ashworth Scale

Exclusion Criteria:

* major cognitive deficits (Folstein mini mental status \> 23
* strong hemi-neglect (Catherine Bergego scale \> 15/30)
Targeted Evaluation, Action, & Monitoring of Traumatic Brain Injury

TEAM-TBI (Targeted Evaluation, Action, and Monitoring of Traumatic Brain Injury) is a research study that brings together TBI patients, advanced evaluation methods, and experts in a multi-faceted study to address the heterogeneity of TBI and to evaluate the effects self-help strategies might have on TBI outcomes.

TEAM-TBI (Targeted Evaluation, Action, and Monitoring of Traumatic Brain Injury) proposes a new approach to clinical trials in TBI that will:

* Evolve diagnostic technology \& treatment
* Improve self-help strategies
* Lower cost and speed for delivery of effective strategies

The TEAM-TBI program proposes an innovative new approach to TBI clinical trials to overcome the limitations of past efforts and achieve long-awaited breakthroughs for TBI survivors. The study will involve a comprehensive 3-4 day intake evaluation, followed by a variety of remotely performed tasks during a 1-6 month follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* 18-60 years of age
* Fluent in English
* Documented history of TBI or blast exposure since 2001

Exclusion Criteria:

* Inability to have MRI
* Pregnancy
* History of TIA within last 6 months.
* Presently involved in open litigation
Safety and Efficacy Study for AKB-6548 in Participants With Chronic Kidney Disease and Anemia

The purpose of this study is to evaluate the safety, pharmacodynamics and pharmacokinetics of repeat doses of orally administered AKB-6548 in pre-dialysis participants with anemia.


Eligibility Criteria:
Key Inclusion Criteria:

* 18 to 79 years of age, inclusive
* Chronic Kidney Disease Stage 3 or Stage 4
* Hemoglobin (Hgb) \< 10.5 g/dl
* TSAT \> 20% and CBC indicating normocytic red blood cell morphology

Key Exclusion Criteria:

* BMI \> 40
* Red blood cell transfusion within 12 weeks.
* Androgen therapy within the previous 21 days prior to study dosing
* Therapy with any approved or experimental erythropoiesis stimulating agent (ESA) within the 10 weeks prior to the Screening visit
* Participants meeting the criteria of ESA resistance within the previous 4 months
* Individual doses of intravenous iron of 250 mg or larger within the past 21 days
* AST or ALT \>1.8x ULN.
* Alkaline phosphatase \>2x ULN.
* Total bilirubin \>1.5x ULN.
* Uncontrolled hypertension
* New York Heart Association Class III or IV congestive heart failure
* Myocardial infarction, acute coronary syndrome, or stroke within 6 months prior to dosing
Chidamide, Azacitidine Combined With GM Regimen for Relapsed and Refractory DLBCL Patients

To evaluate the efficacy and safety of CAGM regimen in R/R DLBCL patients and to provide a safe and more effective approach for R/R DLBCL patients.

The study will start with an initial 2 cycles of induction therapy with CAGM containing chidamide, azacitidine, obinutuzumab and mitoxantrone liposome, orelabrutinib and rituximab，following imaging examinations to evaluate response rates. For patients feasible to CAR-T/ASCT, sequential CAR-T/ASCT treatment was given. For patients who were unable to undergo CAR-T/ASCT, 4 cycles of CAGM immunochemotherapy were carried out. Efficacy and safety of CAGM regimen in R/R DLBCL will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years.
2. At least one measurable lesion，measurable lymph nodes or masses of at least 15 millimeter (mm).
3. Histopathologically confirmed DLBCL.
4. Diseases refractory to first-line treatment (including CD20 monoclonal antibody and anthracycline) or relapsed after the last treatment.
5. Life expectancy \> 3 months.
6. Appropriate organ function: Cardiac function: cardiac ejection fraction ≥50%; Liver function: alanine aminotransferase and aspartate aminotransferase ≤3 times the upper limit of normal; Renal function: serum creatinine clearance ≥30 mL/min; Lung function: SPO2\>91% without oxygen;
7. Adequate bone marrow reserve: Hemoglobin ≥8 g/dL; Platelet count ≥75×10\^9/L; Absolute neutrophil value ≥1.0×10\^9/L; Platelet count ≥50×10\^9/L, absolute neutrophil value ≥0.75×10\^9/L if there is bone marrow invasion.
8. The patient has the ability to understand and is willing to provide written informed consent.
9. Agreement to practice birth control from the time of enrollment until the follow-up period of the study.

Exclusion Criteria:

1. Severe liver and kidney dysfunction (alanine aminotransferase, bilirubin, creatinine \> 3 times the upper limit of normal);
2. Structural heart disease, leading to clinical symptoms or abnormal cardiac function (NYHA ≥ grade 2);
3. Uncontrolled active infection;
4. Concurrent presence of other tumors requiring treatment or intervention;
5. Current or expected need for systemic corticosteroid therapy;
6. Pregnant or lactating women.
7. Other psychological conditions that prevent patients from participating in the research or signing the informed consent.
8. In the investigator's judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or does not meet the requirements for participation in the study.
Traditional Chinese Medicine in the Treatment of Patients With Hyperuricemia.

To testify the efficacy and safety of traditional Chinese formulae, "Wu-Ling San" and "Yin-Chen Wu-Ling San" for patients with hyperuricemia.

The prevalence of hyperuricemia and gout is increasing in Taiwan. It is probably contributed by adapting to Western diet and lifestyle. Previous studies have demonstrated the relationship between hyperuricemia with hypertension, metabolic syndrome, cardiovascular disease and chronic renal disease. While Western medicine shows promising effects in treating hyperuricemia and gout, we are searching for an alternative in traditional Chinese medicine with both safety and efficacy in treating hyperuricemia.

We conducted a randomized double-blinded placebo-controlled clinical trial in adults with hyperuricemia. Sixty patients with serum uric acid level more than 8 mg/dl were enrolled. Patients were then randomized into three arms: Traditional Chinese Medicine formulae: "Wu-Ling San", "Yin-Chen Wu-Ling San" or placebo for 4 weeks. Efficacy and safety were evaluated at Week 2, 4 and 8. Primary endpoint was the serum uric acid\<6 mg/dL at Week 4. Secondary endpoints were the differences between groups in serum uric acid at Week 2 and 8, serum SGPT, SGOT, creatinine, total cholesterol, triglycerides, HDL, LDL, fasting blood glucose, body weight, blood pressures and frequency of gouty attack at Week 4.

Eligibility Criteria:
Inclusion Criteria:

* serum uric acid \> 8 mg/dL

Exclusion Criteria:

* 1. gout attack within 2 weeks before baseline 2. drug for control urine acid must be stable dose within 2 weeks before baseline (e.g.allopurinol、benzbromarone、probenecid、sulfinpyrazone) 3. subject taking the drug involved azathioprine、aspirin (\>325 mg)、atorvastatin、fenofibrate、losartan、thiazide、systemic corticosteroid、estrogen、oral contraceptive pills 4. serum creatinine \> 3.0 mg/dL 5. GPT \> 100 mg/dL 6. Pregnant or breast-feeding women 7. Chemotherapy or radiation therapy in cancer patients
The Effect of Enhanced External Counter Pulsation on Left Ventricular Systolic and Diastolic Function

Enhanced external counter pulsation (EECP) is a procedure performed on patients with ischemic heart disease. The treatment improves physical capacity and relieves angina pectoris. It is suitable for patients with persistent angina pectoris despite and for patients not amendable for coronary revascularization. Some studies demonstrate a relationship between diastolic and systolic blood pressure ratio (d/s ratio) and the effect of EECP.

The aim of the investigators study is to understand the effect of EECP on left ventricular systolic and diastolic function assessed by trans-thoracic echocardiography (TTE).

Hypothesis: EECP improves left ventricular systolic and diastolic function. There is a relationship between d/s ratio and aortic arterial stiffness EECP improves left ventricular diastolic function Standard TTE would be performed prior the EECP procedure, which lasts 60 min., and repeated every 15 minutes. Moreover the investigators would measure pulse wave velocity, a measure of aortic arterial stiffness, in order to investigate the relationship between the d/s ratio and arterial stiffness.

The patients would be recruited among former study patients who have undergone EECP before. 20 patients with the best acoustic conditions would be selected and invited to enroll into the study.


Eligibility Criteria:
Inclusion Criteria:

* Angina pectoris, CCS-class 2-4
* Reversal ischemia
* Pathological coronary angiogram without the possibility of revascularization
* Sinus rhythm

Exclusion Criteria:

* Cancer
* Dementia
* Pregnancy
* Blood pressure \> 180/110
* Severe valvular disease
* Ejection fraction \< 25%
* Acute coronary syndrome the last 3 months
* History of aortic aneurism
* Pacemaker
* Diabetes mellitus
* Cardiac arrythmia that prevents the EECP procedure
* Bleeding
* Active venous thrombosis
Regulation of Lipid Metabolism in Guangzhou Individuals With Dyslipidemia by Red Yeast Rice, Phytosterol Esters and Lycopene

The objective of this study is to evaluate the effect of using red yeast rice, phytosterol esters and lycopene in combination for 12 weeks on improving the glycolipid metabolism of Guangzhou individuals with dyslipidemia. Our hypothesis is that when compared with placebo, red yeast rice, phytosterol esters and lycopene together as supplements would lead to greater improvements in lipid metabolism (including lipid profiles and parameters ) in participants after 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Age: 30-50 years old.
2. Non-obese individuals: 18.5 ≤ BMI \< 28.
3. Total cholesterol levels ranging from marginal increase to increase: 6.2\> TC ≥ 5.2 mmol/L (200 mg/dL).

Exclusion Criteria:

1. Currently being pregnant or breast-feeding or planning to become pregnant.
2. Having severe complications of diabetes mellitus as well as any forms of cardiovascular diseases, tumor, liver diseases and kidney diseases.
3. History (past 3 months) of intake of lipid-lowering or anti-diabetic health care products.
4. Having hemorrhagic diathesis (high bleeding tendencies) or currently taking aspirin.
5. Unwilling/unable to draw blood due to physical/personal reasons.
6. History (past 1 month) of surgery.
7. History (past 1 month) of large amounts of oral or intravenous treatment of glucocorticoids (such as prednisone, methylprednisone, betamethasone, beclomethasone propionate, Dubossone, prednisone, hydrocodesone, dexamethasone).
8. History (past 2 weeks) of taking supplements containing red yeast rice, phytosterol ester or lycopene.
9. Unqualified outcomes of safety measures at baseline.