cyrilzakka/clinical-trials huggingface dataset:
To Evaluate The Safety and Efficacy of 'AVI' Stent Comparing With Firebird2® For Treating Coronary Revascularization

To evaluate The Safety and Efficacy of 'AVI' Stent Comparing with Firebird2® For Treating Coronary Revascularization.

The study is a Prospective, Open-lable, Multi-center, Randomized trial. 2000 primary coronary artery disease patients will be enrolled with a 1:1 randomization ratio(AVI:1000,Firebird 2:1000) at approximately 40 sites, Subject follow-up be at 30 days, 6 months, 9 months, 12 months, 2-5 years after procedure.

Eligibility Criteria:
Inclusion Criteria:

1. Patient must be at least 18 years of age.
2. Ischemic heart symptom and/or myocardial ischemia, include chronic stable/unstable coronary artery disease or acute coronary syndrome(ST elevated MI and Non-ST elevated MI)
3. At least one lesion diameter stenosis(DS) ≥70％, reference vessel diameter between ≥2.5mm, and ≤3.5mm.
4. If the subject has multiple vessel lesions, the implanted stents must be the same brand. The staged procedure only be allowed within 3 months after procedure, the implanted stent must be the same brand stent as the index procedure.
5. Subject has no CABG contraindication.
6. Subject or legal representative is informed the property of the study, understand the stipulations in the protocol, ensure the compliance and sign the ICF.

Exclusion Criteria:

1. Pregnant or nursing patients and those who plan to become pregnant up to 1 year post index procedure.
2. Subject has a tendency to bleeding or coagulation disorders, or has contraindication of antiplatelet and/or anticoagulant therapy, or can't accept the continue DAPT within 6 months.
3. Poor compliance or expectation of life less than 1 year.
4. Implanted any brand stent in the same target vessel within 1 year.
5. Left Ventricular Ejection Fraction (LVEF) of \<30％
6. Cardiogenic shock or haemodynamics abnormal, needs inotropic agents or mechanical support.
7. The subject is allergic to asprin, heparin, clopidogrel/ticlopidine, stainless steel alloy, Arsenic trioxide, sirolimus, styrene-butene-styrene or polylactic acid(PLA) polymer and contrast agent.
8. Severe tortuous and/or heavy calcification lesion.
9. Two or more proximal chronic total occlusion lesion.
10. Bifurcation lesions with double stents.
11. The subject has multi vessel lesions but can not be implanted the same brand stents
12. The subject that the investigator considers he/she was unfit to implant the AVI stents and Firebird 2 stents.
13. The subject attended other drug/device study or in the follow-up period.
The Effects of Empagliflozin on Renal Outcomes in Post Severe Acute Kidney Injury Survivors

Effects of Empagliflozin compared with placebo in post severe acute kidney injury survivors, evaluated by MAKE365.


Eligibility Criteria:
Inclusion Criteria:

* post AKI stage 2-3
* CrCl \> 20

Exclusion Criteria:

* pregnancy
* post kidney transplant
* previous use of SGLT2 Inhibitors
* history of ketoacidosis
Phase II Trial of Neo-Adjuvant Pemetrexed Plus Cisplatin Followed by Surgery and Radiation for Pleural Mesothelioma

This study aims to determine how successful the chemotherapy regimen of Pemetrexed plus cisplatin before surgery is at killing all the tumor so that none is left at the time of surgery. Following surgery, all eligible patients will receive radiation to the chest. How patients respond, whether the cancer returns and if so, where, will also be monitored.


Eligibility Criteria:
Inclusion Criteria:

* Patients will be clinically staged using AJCC/UICC TNM staging criteria. Eligible stages:

  1. Patients must be M0
  2. Patients with T1, T2, and T3 disease (without cardiac involvement) are eligible (T status can be established clinically and radiologically or at exploratory thoracotomy without surgical resection
  3. Patients with N0, N1,or N2 disease are eligible
* Performance status of 0 to 1 on the ECOG performance status schedule.
* No prior systemic chemotherapy and no prior intracavitary cytotoxic drugs or immunomodulators, unless given for the purpose of chemical pleurodesis
* No previous radiation therapy
* Estimated life expectancy of at least 12 weeks

Exclusion Criteria:

Patients will be excluded if they meet ANY of the following criteria:

* Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
* Have previously completed or withdrawn from this study or any other study investigating pemetrexed
* Pregnancy or breast-feeding
* Serious concomitant systemic disorders (i.e. active infection) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study
* Second active primary malignancy (except in situ carcinoma of the cervix, adequately treated non-melanomatous carcinoma of the skin, low grade (Gleason score less than or equal to 6), localized adenocarcinoma of the prostate or other malignancy treated at least 2 years previously with no evidence of recurrence
Safety Assessment of Concurrent Radiotherapy and Novel Systemic Therapy for Breast Cancer

Radiation therapy is a crucial part in the comprehensive treatment of breast cancer. In recent years, emerging systemic treatment regimens such as HER 2 inhibitors, CDK 4/6 inhibitors, PARP inhibitors, capecitabine and PD1 inhibitors have greatly improved the prognosis of breast cancer and has become the standard treatment for specific populations. A considerable number of patients require both radiotherapy and maintenance systemic therapy. However, it is not clear whether systemic therapy should be synchronized or suspended in radiotherapy，despite that previous basic research shows that some molecular drug therapy and radiotherapy has a clear synergy mechanism. There is an agent need for a definite evidence to evaluate the safety of synchronous treatment, to support clinical diagnosis and treatment and the next step of comprehensive treatment. The implementation of the new radiotherapy technology represented by IMRT takes into account the prescription dose homogenization and the minimization of normal tissue dosage, which provides a certain basis for the combination therapy. Based on the above conditions, this study intends to enroll patients between 18 and 70 years old with chest wall / breast ± lymphatic drainage area and requiring capecitabine, CDK 4/ 6 inhibitor, HER2 targeted therapy or immunotherapy. Radiation and novel systemic therapies would be delivered concurrently. The study aimed at evaluating the safety of combined treatments.


Eligibility Criteria:
Inclusion Criteria:

ECOG 0-2. Aged 18-70 years old. Pathologically diagnosed as breast cancer. Need to receive radiotherapy according to guidelines. Radiotherapy target volume included chest wall/breast with or without lymph node regions.

Need to receive one of the following therapies according to guidelines, capetabine, CDK4/6 inhibitor, PARP inhibitor , ICIs , HER2 inhibitors.

Exclusion Criteria:

Male breast cancer. Allergy to the upper medicines before. Will receive trastuzumab alone during and/or after radiotherapy. With severe other disease.
Establishment of a Prognosis Prediction Model and Scoring Criteria of Pulmonary Contusion Caused by Severe Thoracic Trauma

Pulmonary contusion caused by severe thoracic trauma is a complex disease. Some patients may be secondary to severe complications such as pulmonary infection or even acute respiratory distress syndrome. At present, there have been no reports on related studies based on Chinese population. In this study, 800 patients with pulmonary contusion will be retrospectively investigated to determine the risk factors and independent risk factors of their poor prognosis, and to construct a prognosis prediction model and scoring criteria.


Eligibility Criteria:
Inclusion Criteria:

Chinese patients aged 18 to 80 years,severe chest trauma (flail chest, more than 4 rib fractures without flail chest, multiple anterior rib fractures with sternal fractures, bilateral fractures, severely displaced sternal fractures),pulmonary contusion.

Exclusion Criteria:

Patients were excluded if they had a history of tuberculosis, heart failure,respiratory failure,severe brain injury(GSC score \< 15),loss of consciousness, spinal fracture complicated with paraplegia,abdominal trauma requiring surgical intervention,shock.
Effect of Dual Task Exercise on Cognitive and Physical Function in the Elderly With Mild Cognitive Impairment

The purpose of this study is to investigate the effect of the dual task exercise program on cognitive and physical function in the elderly with mild cognitive impairment.

All participants provided written informed consent before study participation. A total of 12 community-dwelling participants were randomized either to the exercise group or to the control group.

The exercise group underwent 8-week, 3 times a week, 60-minute group exercise sessions, which were comprised of moderate-to-high intensity exercise and simultaneous cognitive tasks. They also performed moderate-intensity home aerobic exercises for at least 60 minutes per week. The control group performed 60-minute light intensity home exercise, 4 times a week for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* a score on the Korean Montreal Cognitive Assessment (MoCA-K) of 25 points or below
* aged 65 or more
* no physical or medical problem which impairs moderate to vigorous physical activity

Exclusion Criteria:

* uncontrolled or unstable cardiovascular disease
* malignancy affecting general condition
* musculoskeletal problems affecting motor performance
* speech and hearing impairment
* other organic brain diseases
Evaluation Study of Ultrasound Bladder Scanner for Monitoring Bladder Function

The purpose of this study is to evaluate a novel ultrasound bladder scanning device designed particularly for children in children with bladder dysfunction.

A continuous precise monitoring of bladder volume is of great impotence in many nephro-urological diseases in children.

Some children suffer from bladder dysfunctions that necessitate bladder emptying by catheterization. The bladder catheterizations are at present performed at fixed time intervals and are not based on the amount of urine in the bladder.

In order to avoid overfilling of the bladder, the interval between the emptying is set with a safety margin. This leads to at least some needless catheterizations and hereby discomfort for the children. A portable bladder monitor could possible give a measurement of the degreed of bladder filling and hereby minimize the number of catheterizations needed.

Another group of children suffers from daytime urinary incontinence as a result of overactive bladder syndrome. Home recordings of fluid intake and micturations are used for diagnosing the cause of the decease however; a portable bladder monitor system would possibly give a more true reflection of the bladder function.

With a prevalence of about 10 % nocturnal enuresis is the most common nephro-urological disorder of childhood. In this group of children a portable bladder monitor may enable a more precise measure of bladder function. In addition to this the monitor may be used as a alarm device in the treatment of the disorder.

The portable ultrasound bladder scanner tested has been designed particularly for children.

Hypothesis:

* The bladder volume estimated by the portable ultrasound bladder scanner is concordant with "true" bladder volume measured by catheterization in children.
* The portable ultrasound bladder scanner can be used for continuous non-invasive monitoring of bladder volume during natural fill in children with bladder dysfunction.

  30 children that suffer from bladder dysfunction and perform bladder emptying by catheterization will be recruited from the Center of Child Incontinence, Skejby University Hospital, Aarhus, Denmark.

Eligibility Criteria:
Inclusion Criteria:

* Age between 4-16 yrs
* Dependent on bladder emptying by catheterization
* Informed consent

Exclusion Criteria:

* Wounds, scar tissue or staples in the suprapubic area
* Severe urinary incontinence
Effect of Surgical Therapy on RANKL/OPG (Osteoprotegerin) System

In the present clinical study including chronic, aggressive periodontitis and healthy individuals, the investigators aimed to determine the RANKL, osteoprotegrin (OPG), Interleukin-1 (IL-1β), IL-10, IL-1β levels in gingival crevicular fluid(GCF) before and after surgical periodontal treatment and search out the relationship of clinical parameters with these cytokine levels.


Eligibility Criteria:
Inclusion Criteria:

* Chronic periodontitis having at least 5mm or more probing depth and aggressive periodontitis patients.

Exclusion Criteria:

* Any known systemic disorder, used antibiotics and/or anti-inflammatory medications, had periodontal treatment in the last 3 months and all of them were non smokers. Subjects who were lactating and pregnant were also excluded.
PROximal Protection VErsus NON-Protection in Carotid Artery Stenting

To compare the incidence of new ischemic brain injury detected with magnetic resonance imaging (MRI) after carotid artery stenting in patients treated with and without proximal cerebral protection (Gore Flow Reversal System).

Primary Objective:

The purpose of this study is to compare the rate of new ischemic brain injury detectable on MRI after carotid artery stenting between patients treated with proximal cerebral protection (Gore Flow Reversal System) and without cerebral protection.

Secondary Objective:

Impact of MRI-morphology of atherosclerotic plaque to the rate of new hyperintense diffusion weighted imaging (DWI) lesion on the post-treatment scan and to the rate of ipsilateral stroke or death.

Eligibility Criteria:
Inclusion Criteria:

* Male and female ≥ 18 years old;
* Suitable/Eligible for carotid artery revascularization;
* Significant artery stenosis in symptomatic patients defined as ≥ 50% of the artery diameter (%DS) or asymptomatic ≥ 80 %DS by angiography. Symptomatic is defined as a carotid artery stenosis associated with ipsilateral transient ischemic attack (TIA), amaurosis fugax, ischemic stroke or retinal infarction within 6 months prior to enrollment.
* Adequate clinical conditions to perform DW-MRI.
* Ability of the individual to understand the character and the consequences of clinical trial.
* Signed and dated informed consent provided before the beginning of any intervention.
* Negative pregnancy test (serum or urine) and contraception use for any woman of childbearing age. Systematic contraceptives (oral, implant, injection) and dia-phragm or condoms with spermicidal are considered reliable. Women who have undergone bilateral oophorectomy or/and hysterectomy or women status post-menopausal for at least two years are eligible for this trial.

Exclusion Criteria:

* Intracranial hemorrhage, hemorrhagic stroke, or stroke with mass effect demonstrated on CT scan or MRI within 30 days of the index procedure.
* Persisting ischemic stroke (defined as either a score \> 15 on the NIH stroke scale, a Rankin score \> 3 or a Barthel score \< 60 measured within one week prior to study entry).
* Intracranial mass lesion (i.e., abscess, tumor, or other infection).
* peripheral vascular, supra-aortic or internal carotid artery tortuosity precluding the use of catheter-based techniques required for successful results.
* Lactation.
* Arterio-venous malformation in the territory of the target carotid artery.
* Any disease or medication that affects local hemostasis,
* Participation in other clinical trials during the present clinical trial or within the last month.
* Medical or psychological condition that would not permit completion of the trial or signing of informed consent.
Menopausal Treatment Using Relaxation Exercises (MaTURE)

Hot flashes occur in as many as two thirds of U.S. women during menopause and are severe enough to require treatment in 20%. Although postmenopausal hormone therapy is effective in suppressing hot flashes, it is associated with increased risk for a variety of serious adverse effects. There is an urgent need for alternative treatments that are effective, safe, and easy to use. In this study, the investigators will compare two different types of behavioral relaxation therapies, paced respiration and music therapy, for treatment of menopausal hot flashes. Effects on frequency of hot flashes, other symptom and quality-of-life outcomes associated with hot flashes, and physiologic measures of sympathetic/parasympathetic activity will be examined.


Eligibility Criteria:
Inclusion Criteria

1. Women aged 40 through 59 years at the time of screening.
2. Perinenopausal or postmenopausal.
3. Adequate adherence to study procedures during a 1-week run-in.
4. At least 4 hot flashes per 24 hours recorded by a hot flash monitor and diary.
5. Capable of understanding study procedures and giving informed consent.
6. Willing to refrain from using other treatments for hot flashes during the study period.

Exclusion criteria

1. Pregnant or breastfeeding in the past year.
2. Current or recent use of medications known to affect hot flashes.
3. Resting blood pressure less than 100/60.
4. Spontaneous resting breathing rate less than 10 breaths/minute.
5. Chronic medical therapy for pulmonary disease.
6. Known sensitivity to adhesives.
7. Cardiac pacemaker or implanted defibrillator.
8. No access to a telephone.
9. Plans to move out of the area or travel by airplane in ways that would interfere with the study.
10. Inability to sign an informed consent, participate in interviews, or understand and complete questionnaires in English.
11. Report conditions that, in the judgment of the investigators, render potential participants unlikely to follow the protocol.
12. Participation in another research study involving investigational drugs or devices.
"Tunnel" Flap vs Trapezoidal Flap for Lateral Sinus Lift

The goal of this clinical trial is to evaluate the efficacy of the lateral sinus lift procedure using the tunnel technique flap in comparison to the traditional lateral sinus lift in partially or totally edentulous patients with loss of teeth in the maxillary premolar or molar areas and severe alveolar atrophy. The primary questions it aims to answer are:

1. Is the tunnel flap technique more suitable for lateral sinus lift than the trapezoidal flap technique in terms of post-operative symptoms?
2. Is the tunnel technique safer and more effective than the trapezoidal flap technique in terms of complication rate and the effectiveness of bone grafting?

Participants will undergo the lateral sinus lift procedure using the tunnel technique, which involves making a vertical anterior incision. Patients will receive follow-up care, including phone contact the day after the procedure to detect any issues, and they will keep a diary during the week after surgery to record visual analog scale (VAS) pain values and analgesics taken. Follow-up surgical visits will be scheduled for suture removal and at 30 days after suture removal. After 6 months, dental implants will be inserted, and prosthetic rehabilitation will take place 6 months later. Implants will be monitored for up to 12 months after prosthetic rehabilitation.

Researchers will compare the outcomes of tunnel flap technique lateral sinus lift with the trapezoidal flap sinus lift.


Eligibility Criteria:
Inclusion Criteria:

* edentulous or partly edentulous patients with a unilateral loss of teeth in the maxillary premolar or molar areas
* severe alveolar atrophy and a residual severe alveolar ridge height up to 3 mm

Exclusion Criteria:

* severe illness
* head and neck radiation therapy
* chemotherapy
* antiresorptive therapy
* uncontrolled diabetes
* uncontrolled periodontal disease
* smoking \>10 cigarettes per day
* facial or neck inflammatory or oncologic diseases
* obliteration of sinus ostium and osteomeatal complex
Use of Optune TTF With Radiation as an Alternative for Elderly Patients With Primary CNS Lymphoma

This study will compare the overall survival (OS) time of elderly patients who would not tolerate standard chemotherapy for PCNSL treated with WBXRT together with Optune-TTF to those treated with whole-brain radiotherapy alone.

Standard treatment of primary central nervous system lymphoma (PCNSL) for patients with good performance status involves high-dose methotrexate-based chemotherapy regimens and whole-brain radiation therapy (WBXRT). Although up to 20% of patients with PCNSL are 80 years of age or older, little data exist with regard to optimal treatment of this patient population and they often do not qualify for clinical trials. In addition, elderly patients have a poorer rate of complete and partial response and increased risk of toxicity when treated with standard chemotherapy regimens. Though a consensus does not exist, radiotherapy alone is often used in these patients to minimize toxic effects of more aggressive chemotherapies.

The Optune TTF device has proven effective in treating high-grade gliomas and is currently being investigated to treat meningiomas and metastatic lesions in the brain as well as other tumor types elsewhere in the body. It is generally well tolerated with no known systemic side effects, producing only an occasional local skin reaction. The mechanism of action is independent of tumor type and therefore may be effective in treating lymphoma as well.


Eligibility Criteria:
Inclusion Criteria:

* Histological de novo diagnosis of PCNSL
* Tumor located in the supra-tentorial brain region
* Karnofsky performance score of 70 or above
* Ineligible for chemotherapy due to age or other co-morbidities
* Life expectancy of at least 3 months
* Patient has a caretaker willing to assist with study compliance
* Patient is able to provide written consent on their own behalf

Exclusion Criteria:

* Second or subsequent recurrence of PCNSL
* Patient wishes to receive systemic treatment
* Implanted electronic medical device in the brain (deep brain stimulator, vagus nerve stimulator, programmable shunt, etc.)
* Skull defect without replacement
* Prior radiation, surgery, or chemotherapy for PCNSL within the 4 weeks prior to enrollment
* Patient unable to comply with Optune device treatment or the study follow- up schedule
* Active participation in another therapeutic clinical trial
* Patient unable to provide written consent on their own behalf