cyrilzakka/clinical-trials huggingface dataset:
SYMPHONY-PE Study for Treatment of Pulmonary Embolism

Evaluation of the Safety and Efficacy of the Symphony Thrombectomy System in the Treatment of Pulmonary Embolism

SYMPHONY-PE is a pivotal study intended to assess the safety and efficacy of the Symphony Thrombectomy System to treat subjects with acute pulmonary embolism.

Eligibility Criteria:
Inclusion Criteria:

1. CTA evidence of acute PE within ≤14 days
2. Clinical signs and symptoms consistent with acute PE.
3. Systolic BP ≥90 mmHg with evidence of dilated RV with an RV/LV ratio \>0.9 (based on Investigator's assessment of RV/LV ratio)
4. Stable heart rate \<130 BPM prior to procedure
5. Subject is between 18 and 80 years of age
6. Subject is willing to sign an IRB-approved informed consent form
7. Subject is willing and able to comply with protocol follow-up

Exclusion Criteria:

1. Thrombolytic use within 14 days of baseline CTA
2. International Normalized Ratio (INR) \>3
3. Platelets \<100,000/µL
4. Kidney dysfunction as confirmed by serum creatinine \>1.8 mg/dL or GFR \<45 mL/min
5. Hematocrit \<28% or hemoglobin \<9 g/dL
6. Systolic BP \<90 mmHg for 15 min or requirement of inotropic support to maintain systolic BP ≥90 mmHg any time after admission
7. Experienced cardiac arrest
8. Has left bundle branch block
9. Known bleeding diathesis or coagulation disorder
10. Presence of intracardiac lead in the right ventricle or right atrium
11. Presence of intracardiac thrombus
12. Major trauma within the past 14 days
13. Cardiovascular or pulmonary surgery within last 7 days
14. Known serious, uncontrolled sensitivity to radiographic agents
15. Contraindication to anticoagulants, i.e., heparin or alternative
16. Patient on extracorporeal membrane oxygenation (ECMO)
17. Cancer requiring active chemotherapy
18. Heparin-induced thrombocytopenia (HIT)
19. Pulmonary hypertension with peak pulmonary artery pressure \>70 mmHg by right heart catheterization.
20. History of chronic severe pulmonary hypertension, and/or chronic left heart disease with left ventricular ejection fraction ≤30%
21. Life expectancy \<90 days as determined by investigator
22. Pregnant or nursing
23. COVID-19 positive at hospital admission
24. Current participation in another investigational study
25. Evidence such as imaging or other that suggests the subject is not appropriate for this procedure (e.g., target vessel size is too small to accommodate 16F or 24F catheters).
Elective Simultaneous Modulated Accelerated Brain Radiation Therapy for NSCLCs With Limited Brain Metastases

Brain metastases are the most common intracranial tumors in adults. Whole-brain radiation therapy (WBI) increases the median survival of patients with brain metastases up to 3-6 months, but WBI can lead to the decline of cognition and quality of life, with short local control time. The use of SIB(simultaneous integrated boost) technology can increase the local control rate. Hippocampus avoidance can effectively reduce the cognitive impairment caused by WBI.This study was designed to evaluate the safety and efficacy of selective brain radiotherapy (EBI)(based on SIB and hippocampus, inner ear avoidance )in NSCLCs with limited brain metastases.

In this prospective phase 1 study evaluating the safety and efficacy of selective brain radiotherapy in NSCLCs with limited brain metastases, patients will received selective brain radiotherapy based on SIB and hippocampus, inner ear avoidance.

Prescription dose: Gross tumor (PGTV) 40-50 Gy/10 fractions/2 weeks + EBI (PCTV) 30 Gy/10 fractions/2 weeks.

OARs dose limits: Hippocampus D100%≤10Gy, Dmax≤17Gy,Inner ear: Dmean ≤15Gy. All patients were observed and recorded daily for acute radiation impairment during radiotherapy. Follow-up every 2 months will be performed after radiotherapy.

The primary endpoint:Acute and chronic radiation response, QOL in patients, vestibular function,neurocognitive function based on mini-mental state examination(MMSE) questionnaires, hearing.

The secondary endpoint included:objective response rate (ORR);intracranial progression-free survival (iPFS); OS (defined as the time from study beginning to death from any cause).

Eligibility Criteria:
Inclusion Criteria:

histologically or cytologically confirmed NSCLC with MRI confirmed new brain metastases a life expectancy of at least 3 months; adequate organ function according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0.

Exclusion Criteria:

radiologically or pathologically confirmed metastases in the spinal cord or meninges obvious hernia formation risk previously received brain surgery or radiotherapy a history or presence of poorly controlled systemic diseases pregnant patients
the Regulation of Phosphorus Homeostasis by Dietary Phosphorus Intake in Normal Men

The investigators have conducted the study about the effects of normal diet and low-phosphorus diet on phosphorus homeostasis in healthy subjects, now this study is designed to explore further about the effect of high-phosphorus diet on phosphorus homeostasis.

Serum phosphate concentrations are not only associated with cardiovascular and all-cause mortality in chronic kidney disease (CKD) patients, but also associated with the mortality in community population. Thus, maintaining normal serum phosphate and reducing postprandial fluctuation of serum phosphate are essential for healthy people.

The investigators have conducted a study about the effects of normal diet (phosphorus 1500mg) and low-phosphorus diet (phosphorus 500mg) on phosphorus homeostasis in healthy men. The results showed low-phosphorus diet could significantly reduce serum phosphorus and urine phosphorus level compared to normal diet. However, the levels of serum FGF23 and a-klotho were not different between these two groups.Thus, the investigators want to further explore the effects of high-phosphorus diet (phosphorus 2300mg)on phosphorus homeostasis in healthy men.

Therefore, the investigators plan to conduct a crossover clinical study to evaluate the phosphorus homeostasis modulated by native normal diet, restricted phosphorus diet, high phosphorus diet and then to explore the underlying mechanisms.

Eligibility Criteria:
Inclusion Criteria:

* Men aged 18-45 years
* Healthy volunteers: no history of chronic diseases; no active symptoms or physical signs; negative results of electrocardiogram and chest X-ray; biochemical indicators of regular medical examination are within 95%-105% of normal range.
* Willingness to sign the consent form approved by an Institutional Review Board and comply with the study protocol.
* Body mass index ranged within 18.5-24 kg/m2.

Exclusion Criteria:

* Current history of drug or alcohol abuse as assessed by the principal Investigator.
* Subject has blood donations or blood loss more than 300ml within three months
* Allergic to more than two foods or drugs.
* Subject has psycho-disability or body disability.
* Subject has a condition that in the judgment of the Principal Investigator could potentially pose a health risk to the patient while involved in the study.
* Subject has participated in the other clinical trials at the same time.
Expression of AMP-activated Protein Kinase (AMPK) Protein in Lung Adenocarcinoma

AMP-activated protein kinase (AMPK) is an evolutionally conserved protein kinase that serves as an energy guardian to help cells adapt to various metabolic stress including hypoxia. Because the role of AMPK in cancers has not been fully elucidated, in this study we investigated the expression and activation of AMPK in lung adenocarcinoma (LADC) cells and tissue.


Eligibility Criteria:
Inclusion Criteria:

* Lung cancer received operation lobectomy in CMUH

Exclusion Criteria:

* History of uremia, other malignant disease, and liver cirrhosis
* History of pneumonia and pulmonary tuberculosis
* History of long period of medications.
Study of the Intraocular Pressure (IOP)-Lowering Efficacy of Azopt 1.0% Compared to Timolol 0.5% in Patients With Glaucoma or Ocular Hypertension

This is a multiple-dose study of the IOP-lowering efficacy of Azopt (brinzolamide) 1.0% compared to timolol 0.5% when added to a prostaglandin analogue (PGA) as adjunctive therapy over a 24 hour period in patients with glaucoma or ocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Primary open angle glaucoma or ocular hypertension patients

Exclusion Criteria:

* Women of childbearing potential
* History of bronchial asthma, or severe chronic obstructive pulmonary disease
* Presence of acute glaucoma
Telehealth Following Orthopaedic Procedures

This study aims to evaluate the quality of care provided by a home-based teleheath program as a safe and acceptable alternative to an in-person office visit as determined by satisfaction with the program and the amount of further medical management required by the patients.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects over 18 and under 75 years of age undergoing elective primary orthopaedic surgery at Thomas Jefferson University Hospital, Rothman Orthopaedic Specialty Hospital or Methodist Hospital who have the capability to utilize a telecommunications platform (computer, tablet or similar device at home with a webcam, microphone and access to high-speed internet).

Exclusion Criteria:

1. Subjects who are unable to access the telemedicine platform or who are uncomfortable with following up in this fashion
2. Subjects who are unable or unwilling to provide post-operative radiographs electronically or who are unable or unwilling to obtain them
3. Subjects with workman's compensation or automotive claims or other ongoing litigation
4. Subjects that are unable or unwilling to consent for enrollment
5. Patients under the age of 18 years
6. Pregnant or breastfeeding women
7. Patients undergoing surgery for tumor, trauma or infection or who require revision or staged procedures
8. Patients without English-language proficiency
9. Patients with unforeseen intra-operative or perioperative complications
Effects of Antenatal Education on Fear of Birth, Depression, Anxiety, Childbirth Self-efficacy, and Mode of Delivery in Primiparous Pregnant Women

Background: Caesarean delivery rates are quite high, especially in primipara, in Turkey. Fear of birth, low childbirth self-efficacy, and psychological factors may be among the primary causes. Since antenatal educations are not universal and there are differences in educational contents, there is not sufficient evidence on this topic in international studies.

Objective: To investigate the effects of antenatal education on birth fear, depression, anxiety, stress, childbirth self-efficacy, and mode of delivery in primiparous pregnant women.

Background: Caesarean delivery rates are quite high, especially in primipara, in Turkey. Fear of birth, low childbirth self-efficacy, and psychological factors may be among the primary causes. Since antenatal educations are not universal and there are differences in educational contents, there is not sufficient evidence on this topic in international studies.

Objective: To investigate the effects of antenatal education on birth fear, depression, anxiety, stress, childbirth self-efficacy, and mode of delivery in primiparous pregnant women.

Design: A single-blind, prospective, randomized controlled trial. Setting and Participants: The study was conducted in a province in Central Anatolia region in Turkey, and the data were collected between April 2019 and September 2019. Randomized block assignment was used to assign 120 primiparous pregnant women to either the antenatal education group (n = 60) or the control group (n = 60). At the end of the study, 112 women were evaluated.

Measurements: Those in the antenatal education group received two-hour (240 min) educational sessions, twice a week, for 4 weeks. Data were collected by demographic and labor outcomes information form, The Wijma Delivery Expectancy/Experience Questionnaire (Version A and B), Childbirth Self-Efficacy Inventory, and the Depression, Anxiety and Stress Scale.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women (between 20 and 32 gestation weeks),
* Healthy,
* Nulliparous with singleton pregnancies,
* Older than 18 years.
* Involved giving birth at full term,
* Having a healthy newborn (born at 38-42 weeks of gestation)

Exclusion Criteria:

* Women taking medication for a diagnosed mental illness (e.g., antidepressants, antianxiety or antipsychotic medication),
* Women with complicated or high- risk pregnancies,
* Anticipating or experiencing a perinatal death (e.g., congenital abnormality incompatible) or stillbirth,
* Having experienced no postnatal complications (hemorrhage, puerperal infection, mastitis, thromboembolic disease or postpartum psychiatric disorder).
OCT Vibrography for Biomechanical Properties of Tissues

The overall goal of this study is to develop OCT Vibrography (aka OCT elastography) as a novel tool for measuring biomechanical properties of human tissues in vivo.

The overall goal of this study is to develop OCT Vibrography (aka OCT elastography) as a novel tool for measuring biomechanical properties of human tissues in vivo. The investigators aim to establish baseline data in healthy subjects, compare elastic moduli in different tissue types, and measure differences in elastic moduli between keratoconus and normal eyes. If successful, this project will provide useful, previously inaccessible elastic parameters and advance the investigators' understanding of the relationship between the bulk mechanical properties and the microstructure of the human tissue in vivo. This information can ultimately be used to improve the diagnosis and treatment of keratoconus, inflammatory skin diseases, and inflammatory gingiva diseases. More broadly, the technologies developed in this project will have relevance to other potential applications beyond the tissues in this research study.

Eligibility Criteria:
Group 1:

Inclusion criteria:

• Subjects with healthy eyes (age 18 - 75, N = 50)

Exclusion criteria:

* Subjects with history of eye diseases, and previous eye surgeries.
* Subjects with diabetes, glaucoma family history
* Subjects allergic to anesthetic eyedrop, especially proparacaine
* Subjects with severe allergy
* Subjects who have difficulty biting
* Subjects who have recurrent corneal erosion

Group 2:

Inclusion criteria:

• Subjects with healthy skin (age 18 - 75, N = 10)

Exclusion criteria:

• Subjects with open cuts/sores on the skin, skin infection, or any contagious skin condition

Group 3:

Inclusion criteria:

• Subjects with healthy gingiva (age 18 - 75, N = 10)

Exclusion criteria:

• Subjects with open cuts/sores on the gingiva, gingiva infection, or any contagious gingiva condition

Group 4:

Inclusion criteria:

• Mild or moderate keratoconus subjects (age 18 - 40, N = 20)

Exclusion criteria:

• Subjects with K-max above 60 diopters (Pentacam imaging) are excluded
Preoperative Optimization of Diabetic Patients

Diabetic patients, as part of preoperative evaluation, should have glycated hemoglobin (HbA1C) measured. HbA1C provides information on longterm glucose control. There is a suggestion in the literature that elevated A1C levels predict a higher rate of postoperative adverse events, including infections, myocardial infarction, and mortality. It is unclear whether chronic glycemia, as reflected in raised HbA1C level, is the risk factor for adverse perioperative events or whether it is a surrogate measure for poor perioperative glucose management. Conversely, in a retrospective analysis of 431,480 surgeries perioperative glucose was predictive of increased 30-day mortality, but that HbA1C was a less useful predictor of this measure. In our experience of at the University of Alberta Preadmission Clinic there is significant variability with respect to whether diabetic patients have a valid HbA1C measurement i.e. within 3 months of surgery. If a valid measurement is present, there is also considerable variability with respect to diabetes control.

Purpose: The purpose of this study to retrospectively determine the incidence of diabetes in the surgical population and what proportion of diabetic patients have a valid HbA1C. Hypothesis: A valid (measured within 3 months of surgery) HbA1C measurement is frequently missing prior to surgery and when present has a high chance of being higher than normal.

Objectives:

Perform a retrospective analysis of all surgeries in Alberta from November 2019 to the present time looking for the following:

Primary outcomes:

1. Determine the incidence of diabetes in the surgical population and describe the demographics and clinical charcteristics of patients
2. Determine the incidence of valid HbA1C in diabetic patients presenting for surgery
3. Determine long-term diabetes control through assessment of HbA1C values in diabetic patients presenting for surgery

Secondary outcomes:

1. Determine association between HbA1C and post-operative length of stay
2. Determine association between HbA1C and in hospital mortality Design: This study will be a population-based, retrospective observational cohort study. Setting: Alberta Hospitals Participants: Adults with diabetes having surgery in Alberta since November 2019 Descriptive statistics will be tabulated according to HbA1C status and Univariate comparisons of means, medians and proportions will be performed to evaluate the association of independent variables with primary and secondary outcomes. Normally distributed continuous data will be reported as means with standard deviations (SD). Non-normally distributed continuous data will be reported as medians with interquartile ranges (IQR). Categorical variables will be compared using Chi-square test for independence

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or greater
* Having any surgical procedure at any hospital in Alberta

Exclusion Criteria:
Mobilization Protocol for Knee Arthroplasty Patients

This randomized controlled study evaluates the effect of mobilization protocol applied to knee arthroplasty patients on anxiety level, pain, mobility and functional status.

In the study, 68 knee arthroplasty patients were randomly assigned to the study and control groups. The mobilization protocol was applied to the study group (34). The mobilization protocol starts on the day of the operation and is completed on the day of discharge. The patient is mobilized within the first 24 hours after surgery. Mobilization protocol includes six levels. Level 1: Repositioning should occur every two hours. Level 2: Range of motion (PROM) should occur at least three times a day. Level 3: The head of bed (HOB) \>30 degrees. Duration goal: 5-15 minutes. HOB 65≥ degrees with patient sit in the bed. Duration goal: 5-15 minutes. Progress to level 4. Level 4: HOB 65≥ degrees with legs in dependent position (recliner chair). Duration goal: 5-15 minutes. Progress to level 5. Level 5: Stand/pivot/step to chair. Sitting in chair. Duration goal: 5-15 minutes. Progress to level 6. Level 6: Patient is able to ambulate at least three times a day. No intervention was applied to the control group. The primary outcome of the study is the effect of mobilization protocol on the state anxiety level, pain, mobility and physical function of knee arthroplasty patients. The results collected before the mobilization protocol, postoperative first day, second day, the discharged day and the 3rd week after discharge.

Eligibility Criteria:
Inclusion Criteria:

Volunteering to participate in research

Being 18 years or older

Having unilateral elective knee arthroplasty surgery

Having DA surgery for the first time

It is the absence of an obstacle to communicating cognitively, emotionally and verbally.

Exclusion Criteria:

Patients who initially agreed to participate in the study but wished to leave later were excluded from the study.

In the event of a complication affecting the mobilization of the patient during the intraoperative and post-operative period, the patient is excluded from the study.

He was excluded from the study due to the development of a cognitive, emotional and verbal barrier to communication after the surgery.
An Open, Randomized, Multicentre, Phase II Pilot Study

The objective of this study is to evaluate efficacy, safety and quality of life adjuvant docetaxel-cisplatin chemotherapy versus no adjuvant treatment in patients with completely resected NSCLC Stage I-II.

Open multicentre, centrally randomized, two-arm parallel-group, phase II pilot-study. Duration of the Treatment : Arm A - will be 4-6 cycles Docetaxel 75mg/m2 and Cisplatin 75mg/m2 on day 1 every 21 days.

Arm B untreated control group - best supportive care. A follow-up check-up examination will be performed every 3 months for a total of three years.

Eligibility Criteria:
Inclusion Criteria:

* histologically documented NSCLC stage I-II
* Complete resection of tumor amd resection margins microscopically tumor free.
* Surgical procedure: According to necessity for oncology radicality a lobectomy, bilobectomy or pneumectomy will be performed with either radical mediastinal lymphadenectomy or complete sampling of all relevant lymph node areas.
* Randomization within 60 days after surgical required.
* Initial work-up
* General Conditions: 19-70 years, WHO performance status 0-2, adequate hematological function, adequate renal and hepatic function, negative pregnancy test.

Exclusion Criteria:

* NSCLC stage II-IV, SCLC or alveolar carcinoma
* Clinical evidence of CNS metastases
* pregnant and lactating patients
* past or concurrent history of malignancies other than NSCLC,except for curatively treated non melanoma of the skin or in situ cervical carcinoma or other curatively treated cancer with no evidence of disease for at least five years.
* prior or concurrent antitumor therapy for NSCLC other than surgery.
* Concomitant participation in clinical studies of non-approved experimental agents or procedures.
* major complications after surgery
* serious concomitant medical conditions
* psychological,familial, sociological or geographical conditions which do not permit compliance with the study protocol
Alcohol Brief Intervention Plus Personalized Mobile Chat-based Intervention for High-risk Drinking University Students

The aims of this pilot study are:

1. To examine the factors associated with alcohol drinking and alcohol use disorder
2. To examine the effect of face-to-face alcohol brief intervention on drinking reduction
3. To examine the effect of a continuous interactive chat-based intervention via "WhatsApp" on drinking reduction
4. To explore the perception of face-to-face alcohol brief intervention
5. To explore the perception of continuous interactive chat-based intervention via instant messaging mobile application "WhatsApp"

According to the Department of Health, majority of people in Hong Kong started to develop drinking habit at 18-21 years of age in 2014/2015. Amongst them, 16.8% had scored higher than 3 in the Alcohol Use Disorders Identification Test for Consumption (AUDIT-C) (an abbreviated version of the Alcohol Use Disorders Identification Test, or AUDIT, designed by the World Health Organization(WHO)), while 3.5% had even scored 8 or above in the test. With higher prevalence to begin drinking within 18 and 23 years old, university students could have established higher tendency of harmful drinking and alcohol dependence as compared with other age groups. Therefore, early interventions such as the evidence-based Alcohol Brief Intervention (ABI) suggested by the WHO are particularly needed to target university drinkers who are 5% more likely to develop higher frequency of drinking in later of their lives compared with other age groups.

Eligibility Criteria:
Inclusion Criteria:

* Hong Kong resident aged 18 to 26 inclusive
* Scored 5-19 inclusive in the Alcohol Use Disorder Identification Test (AUDIT)
* Able to communicate in Chinese and read Chinese
* Using a phone with instant messaging mobile application "WhatsApp" installed for communication

Exclusion Criteria:

* Students with communication barrier (either physically or cognitively)
* Currently participating in other alcohol treatment services or clinics.