cyrilzakka/clinical-trials huggingface dataset:
LPN in Patients With High-complex Renal Tumors

The study aims to investigate the rationale for LPN in patients with high-complexity renal tumors in terms of oncologic and functional outcomes.

From November 2009 to October 2018, 399 patients underwent LPN and 307 patients to laparoscopic radical nephrectomy (LRN). 41 patients with RENAL score ≥ 10 enrolled in LPN and 265 patients to the LRN group. Propensity score matching (matched by age, gender, clinical tumor stage, tumor size, baseline renal function, comorbidities such as diabetes mellitus (DM), hypertension (HT), coronary artery disease (CAD), and final tumor pathology of RCC) was used to reduce selection bias. Functional and oncological outcomes were compared between the two groups. After propensity score analysis, 39 patients in the LRN group were matched with 39 in the LPN group.

Eligibility Criteria:
Inclusion Criteria:

* Patients with complete data
* Patients with single renal tumor on the effected side
* Patients who approved the written consent form

Exclusion Criteria:

* Patients who not approved the written consent form
* Patients with incomplete data
* Patients with low or mild complexity renal tumors
Efficacy of Combination Immunotherapy in Patients With Metastatic Colorectal Cancer

Immunotherapy improved efficacy and survival in selective patients with metastatic colorectal cancer (mCRC), however, limited data revealed the landscape of immunotherapy efficacy. What's more, potential markers have not been comprehensively evaluated to identify responding patients to further improve efficacy.The investigators conducted a single-arm study to investigate the efficacy of combination immunotherapy in patients with mCRC, and the combined regimen is determined by the physician in charge.


Eligibility Criteria:
Inclusion Criteria:

* patients who had both baseline measurable lesion(s) and at least one post-baseline radiological disease reassessment
* patients with identified genomic status

Exclusion Criteria:

* patients who received immune monotherapy
* patients who stopped treatment for any reason without identified response assessment.
Randomized Controlled Study of Postoperative Adjuvant Therapy for Gastric Cancer Using TS-1 or TS-1+PSK

A randomized controlled study is conducted on patients with resected gastric cancer assigned to postoperative adjuvant therapy of TS-1 alone or PSK combined with TS-1, with the objective to examine or validate the outcome, QOL and prognostic factors (host and tumor factors), and explore the factors enhancing the antitumor effect of TS-1.

The 5-year survival after gastric cancer surgery remains poor as the cancer advances to stages II, IIIA, IIIB and IV. Tegafur-gimeracil-oteracil potassium (TS-1) is used as the first line treatment for advanced and recurrent gastric cancer. But TS-1 is accompanied by an adverse drug reaction of bone marrow suppression that is not readily seen in conventional oral fluoropyrimidines. Among randomized controlled trials on postoperative adjuvant chemotherapy for gastric cancer, the beneficial results of survival rates using Krestin (PSK) in combination with chemotherapy have been reported. With the objective to enhance the antitumor effect of TS-1 and to improve the QOL of patients, we have planned to validate the clinical significance of combined PSK and TS-1 therapy as postoperative adjuvant therapy for gastric cancer, using in principle the TS-1 regimen of 2-week dosing 1-week off for 6 months followed by 2-week dosing 2-week off for 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients with microscopic stage II or IIIA resectable gastric cancer
* Patients who have not received preoperative cancer therapy (radiotherapy, chemotherapy or immunotherapy)
* Patients with serum immunosuppressive acidic protein (IAP) measured within 2 weeks before surgery
* Patients with no metachronous or synchronous multiple cancer
* Patients without severe impairment of renal, hepatic and bone marrow functions
* Patients who are judged to be capable of tolerating surgery
* Patients with preoperative performance status 0 to 2
* Patients with no serious concurrent complications (such as bone marrow suppression, diarrhea and infection)
* Patients who are judged to be capable of tolerating this treatment, and who have given written informed consent to participate in this study

Exclusion Criteria:

* Patients with fresh hemorrhage from the gastrointestinal tract
* Patients with retention of body fluid necessitating treatment
* Patients with infection, intestinal palsy or intestinal occlusion
* Patients who are pregnant or hope to become pregnant during the study period
* Patients with diabetes treated by continuous use of insulin or showing poor glycemic control
* Patients with a history of ischemic heart disease
* Patients with concurrent psychiatric disease or psychotic symptoms, and judged to have difficulties participating in the study
* Patients receiving continuous administration of steroids
* Patients who have experienced serious drug allergy in the past
* Others, patients judged by the investigator or subinvestigator to be inappropriate as subject
Randomized Trial With an Observational Component of Non-operative Versus Operative Treatment for AO Type A3 Fractures

The purpose of this study is to compare surgery plus bracing versus bracing alone. Both groups are considered standard of care treatments. The goal of this study is to determine which group is a better treatment.

Patient must be between 18 and 65 years old and had an acute trauma with an AO type A3 burst fracture (a spinal injury where one of the bony parts of the spine \[vertebra\] breaks due to immediate and severe compression).

The purpose of this study is to compare surgery plus bracing versus bracing alone. Patients will be followed for 10 years. The investigators will compare patients' x-ray outcomes and clinical outcomes (i.e. how a patient is feeling and how a patient is able to do usual daily activities) as well as patients' immediate and delayed medical and surgical side effects between the 2 study arms. The goal of this study is to determine if treating patients with surgery plus bracing is better than just bracing alone.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-65 years
2. Acute trauma patient with AO Type A3.1-A3.3 fractures of T10-L2
3. Neurologically intact
4. TLICS score of 4
5. Women of childbearing potential must have a negative serum pregnancy test

Exclusion Criteria:

1. Severe poly-trauma (Injury Severity Score \>15 and/or intubation required for \> 24 hours)
2. Sepsis and/or organ failure
3. Prior instrumented arthrodesis of the thoracolumbar spine
4. Severe co-morbidities (e.g., heart, respiratory, or renal disease)
5. Recent history (\<3 years) of concomitant spinal tumor or infection
6. Greater than single level fracture involvement (other than transverse process fractures)
7. AO Type A3 fracture with associated load sharing score ≥7
8. ≥ 30 degrees regional kyphosis on standing
9. History of autoimmune (seronegative) spondyloarthropathy (i.e., ankylosing spondylitis)
10. History of osteoporosis
11. Subjects who are pregnant or plan to become pregnant in the next 24 months. Patients will be advised on the use of contraceptives during this time. Methods include abstinence or two acceptable forms including condoms with spermicide, birth control pills, injections, or an IUD.
12. Co-morbidity requiring medication that may interfere with bone or soft tissue healing (i.e., oral or parenteral glucocorticoids, NSAIDs immunosuppressive agents, methotrexate)
13. Severe morbid obesity (BMI \> 40)
14. History of metal sensitivity/foreign body sensitivity
15. History of prior laminectomy at the fracture site
16. Associated scoliotic (\> 10°) or pre-existing thoracolumbar kyphotic deformity
17. History of substance abuse (recreational drugs, prescription drugs or alcohol) that could interfere with protocol assessments and/or with the subject's ability to complete the protocol required follow-up
18. Prisoner
Effectiveness of Viscum Album Mother Tincture as an Anti-hypertensive in Essential Hypertension

To estimate the effectiveness of Viscum album Homoeopathic mother tincture in Essential Hypertension by conducting clinical trial in moderate hypertensive patients for a period of six weeks.


Eligibility Criteria:
Inclusion Criteria:

* Hypertension at the range 180-120 mm of Hg for Systole \&
* 110-80 mm of Hg for Diastole

Exclusion Criteria:

* Patients who are on ACEI / ARB for Hypertension
* Diseases in which life expectancy is less than six months
* Secondary hypertension
* CHD
* Family History of Mental Illness like Anxiety or depression.
* Nasal Congestion
Effects of Dark Chocolate on Exercise Capacity, and Mitochondrial Structure and Function

The major goal of this study is to characterize the ability of dark chocolate enriched in epicatechin (a component of dark chocolate) to improve the structural and functional features of mitochondria in two groups

1. Patients with heart failure (HF) and type 2 diabetes (DM2) and
2. Normal yet sedentary individuals with impaired baseline exercise capacity (as assessed by VO2 max)

We propose that a 3 month treatment with dark chocolate will lead to a significant improvement in exercise capacity which will be secondary to the improvement in skeletal muscle structure from epicatechin.

The flavanol epicatechin (which is derived from cocoa and has no known toxicity in humans) has been shown in clinical trials to increase levels of nitric oxide (NO) as assessed by flow-mediated dilation (FMD) in the brachial artery and measurements of circulating NO in plasma. NO is thought to be an activator of PGC-1 alpha \[PPAR (peroxisome proliferator-activated receptor) alpha coactivator 1\] which stimulates mitochondrial biogenesis. In both patients with heart failure and diabetes there is nitric oxide deficiency and mitochondrial dysfunction. In our proposed double-blinded placebo controlled clinical trial, we will test the hypothesis that chronic administration of epicatechin to patients with both heart failure and diabetes will increase levels of NO and PGC-1 alpha leading to increased mitochondrial biogenesis and improved mitochondrial function. We believe similar changes will occur in sedentary individuals.

In a preliminary study with 5 patients with heart failure and diabetes (conducted under UCSD IRB protocol number #090688) we have shown that epicatechin enriched dark chocolate improves mitochondrial structure (Taub PR, Ramirez-Sanchez I, Ciaraldi TP, et al. Alterations in Skeletal Muscle Indicators of Mitochondrial Structure and Biogenesis in Patients with Type 2 Diabetes and Heart Failure: Effects of Epicatechin Rich Cocoa. Clin Transl Sci. 2011;5(1):43-47.)

Eligibility Criteria:
Healthy, sedentary individuals:

Inclusion Criteria:

* Healthy, inactive individuals
* BMI 27-32

Exclusion Criteria:

* Smoking or quit smoking less than 1 year prior to enrollment
* Currently taking Coumadin or Pradaxa.

Heart failure and diabetes patients:

Inclusion Criteria:

* Medically diagnosed with heart failure and diabetes
* No significant HbA1C fluctuations in past 6 months

Exclusion Criteria:

* Currently taking Insulin
* Currently taking Coumadin or Pradaxa.
* Smoking or quit smoking less than 1 year prior to enrollment
Effect of Erugliflozin On Liver Fat, Liver Fibrosis and Glycemic Control in Type II DM Patients With NASH/NAFLD

Open-label, prospective, single-arm, multicenter study to determine effects of Ertugliflozin on liver fat, liver fibrosis \& glycemic control in subjects with Type 2 Diabetes Mellitus (T2DM) with Non-Alcoholic Fatty Liver Disease (NAFLD)/Non-Alcoholic Steatohepatitis (NASH)


Eligibility Criteria:
Inclusion Criteria:

* Patient able to provide written informed consent
* Adult males \& females between 18 to 65 years
* SGLT2i and insulin naïve patients
* BMI \>23 Kg/m2
* HbA1C % ≥ 6.5 to 10
* Documented hepatic steatosis or fatty liver disease on Ultrasound
* Patient with Type II Diabetes Mellitus

Exclusion Criteria:

* History of use of SGLT 2 inhibitors or Glucagon-like peptide (GLP) 1 agonist or insulin; 3 months prior to enrollment in the study.
* Pioglitazone use in the past 6 months
* History of vitamin E use (400mg twice daily) 3 months prior to enrollment in the study.
* History of anti-obesity medication or weight loss procedure (bariatric surgery) use within 3 months prior to enrollment in the study.
* History of uncontrolled Endocrine disorder (for example uncontrolled hypothyroidism, or that requires frequent dose adjustment, or Cushing's syndrome)
* History of liver disease including viral hepatitis, auto-immune hepatitis, liver cirrhosis, hepatocellular carcinoma and/or HIV
* History of recurrent UTIs and mycotic infection.
* Severely ill patients (who have high grade fever, sepsis or acute infection)
* Pregnant woman, lactating woman or planning pregnancy during study duration
* History of Drug-induced liver disease (e.g. amiodarone, valproate, tamoxifen, methotrexate, steroids (including homeopathic medicines).
* History of active substance abuse (cannabinoid-derived substances like heroin, cocaine, amphetamines) based on history and/or laboratory tests
* Alcohol intake 10 - 30 g/day (three drinks per day) within the previous year
* Active substance abuse such as acetaminophen over-use, hashish, tobacco products, heroin, cocaine or amphetamines.
* Severe hepatic impairment ( AST \& ALT levels \> 3 times upper limit normal
Evaluating the Effects of Nitroglycerin on Heart Function and Urinary Output in Patients with Acute Heart Failure

This study aims to understand how nitroglycerin affects patients with acute heart failure, a condition where the heart struggles to pump blood effectively, leading to fluid buildup and breathing difficulties. Nitroglycerin relaxes blood vessels to ease the heart's workload and may help reduce fluid buildup. The investigators hypothesize that nitroglycerin can increase blood flow from the heart and promote urine production, which may reduce congestion in AHF patients. By studying heart function, blood volume, and fluid levels during treatment, the goal is to identify which patients may benefit most from nitroglycerin therapy.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Clinical diagnosis of AHF requiring hospitalization
* Systolic blood pressure ≥85 mmHg
* Echocardiographic signs of cardiac dysfunction, by at least one of

  * Left ventricular ejection fraction ≤45%
  * Abnormal left ventricular filling with dilatation of the left atrium
  * Elevated filling pressures (systolic pulmonary artery pressure\>30, dilated vena cava inferior or E/é\>10)
  * Significant left-sided heart valve disease

Exclusion Criteria:

* Ongoing ventricular taky- or brady-arrythmias or supraventricular arrhythmias with heart rate \> 180 or \< 40 bpm.
* Retinopathy or intraocular lens implantation (contraindication to Valsalva maneuver)
* Recent myocardial infarction or thromboembolic events.
* Intake of sildenafil or vardenafil withing 24 h and tadalafil within 48 h.
* Absolute contraindication for vasodilation using nitroglycerin as assessed by treating physician
* Intravenous administration of furosemide within 2 hours of baseline measurements
Impact of a Virtual Reality-based Mindfulness Program on Clinician Wellness

Burnout shares symptoms with anxiety and depression. While there is no single intervention for burnout, there are validated interventions (which are amenable to virtual reality (VR)) for anxiety and depression. UMassMemorial data from the Professional Well-Being Academic Consortium show that MD burnout and distress has increased since 2020. The investigators believe providing clinicians with a unique tool (VR) will be a feasible and efficacious way to tackle distress. It is known that only 1% of our MDs have done mindfulness training but nearly 50% are interested in doing so. Therefore, a self-administrable, interactive mindfulness program delivered over VR has great potential to reach clinicians who want to practice a more active form of mindfulness at a time convenient to them. The results of the study will provide preliminary evidence to determine if a take-home VR mindfulness program decreases clinician stress.

Cohorts 1 will be the intervention group Cohorts 2 will be the controls. Study endpoints include results from the following questionnaires:

1. PROMIS - Short Form Anxiety (8 questions)
2. PROMIS - Short Form Depression (8 questions)
3. Perceived Stress Scale (10 questions)
4. Connor-Davidson Brief Resilience Scale (10 questions)
5. System Usability Scale (10 questions)

The intervention is a 12-week mindfulness-based VR intervention.

Cohort 1 will complete the questionnaires 1-4 at baseline (just before the intervention). They will be sent twice weekly reminders to use the VR for the duration of the 12-week intervention. After 12 weeks Cohort 1 will retake questionnaires 1-4 and take questionnaire 5, while Cohort 2 will then take questionnaires 1-4 and be provided the VR headsets. After another 12 weeks, Cohort 1 will take questionnaires 1-4 and be done with the study, while Cohort 2 will take questionnaires 1-5. After 12 more weeks, Cohort 2 will take questionnaires 1-4 and be done with the study.

Eligibility Criteria:
Inclusion Criteria:

* physician or APP employed by the Medical Group

Exclusion Criteria:

* Not willing to receive 2 texts per week
Zilver® Flex™ Vascular Stent Study

This study is intended to evaluate the long-term effectiveness of treatment of de novo or restenotic lesions of the above-the-knee femoropopliteal artery using the Zilver® Flex™ Vascular Stent which has received the CE mark for commercial use. The study is designed as a single arm non-randomized post-approval study.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are at least 18 years old and have at least 1 stenotic atherosclerotic lesion of the above-the-knee femoropopliteal artery may be considered for enrollment.
* To be enrolled in the study, the lesion must be the appropriate size and and no prior stent in the target vessel may be present.

Exclusion Criteria:

* Patient is \< 18 years of age.
* Patient is pregnant or breast-feeding.
* Patient is simultaneously participating in an investigational drug or device study. The patient must have completed the follow-up phase for the primary endpoint of any previous study at least 30 days prior to enrollment in this study.
* Patient has had previous stenting of the target vessel.
* Patient has a medical condition or disorder that would limit life expectancy to less than 1 year or that may cause noncompliance with the protocol or confound the data analysis.
* Patient in whom antiplatelet and/or anticoagulant therapy is contraindicated.
* Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
* Patient has known hypersensitivity or contraindication to aspirin, antiplatelet medication, contrast dye, or nitinol that, in the opinion of the investigator, cannot be adequately premedicated.
Measuring hCG Levels in Pregnant Women

This study seeks to assess trends in hCG between the 9th and 12th weeks of gestation. Women presenting at prenatal care at the study site who are 70 days gestation or less will be offered participation in the study. 75 consenting women will be asked to provide urine for an MLPT and to have blood drawn for hCG serum testing at 56-63 days, 64-70 days, and 71-77 days' gestation, and 75 consenting women will be asked to provide urine for an MLPT and to have blood drawn for hCG serum testing at 64-70 days, 71-77 days, and 78-84 days' gestation.

Women presenting at the study site for a prenatal visit, and who are ≤ 70 days' gestation, will be offered participation in the study. Efforts will also be made to recruit patients through physician or treating health care professional referral and advertisements. One hundred and fifty consenting women will be enrolled. Up to three additional study visits will be scheduled: At the enrollment, if an ultrasound-confirmed gestational age is not available in the woman's medical record, a transvaginal ultrasound will be performed. If the woman is 56-63 days gestation on the day of enrollment, she will be asked to return weekly until she reaches 71-77 days. If the woman is 64-70 days gestation, she will be asked to return weekly until she reaches 78-84 days. If the woman is less than 56 days gestation, she will be asked to return for the three research visits at the appropriate time to provide the urine samples and blood draws. Women will have one visit during each of their three assigned gestational age weeks. At each visit, women will provide a urine sample for an MLPT and have a blood draw to measure serum hCG.

Eligibility Criteria:
Inclusion Criteria:

* Intrauterine pregnancy \<= 70 days' gestation
* Be in general good health
* English speaking competency
* Be willing and able to sign consent forms
* Agree to comply with the study procedures, including returning for three study visits that each involve a blood draw and urine pregnancy test for measuring hCG

Exclusion Criteria:

* Women less than 18 years of age.
* Any women not meeting the inclusion criteria listed above will be excluded from participating in the trial.
A Liquid Biopsy Diagnostic Techniques for Endometriosis

To evaluate the diagnostic efficiency of circulating endometrial cell detection method using microfluidic chip as an non-invasive method for diagnosis in endometriosis.

Endometriosis is a chronic condition, characterized by the presence of functional endometrial glands and interstitium in extrauterine ectopia. Ectopic endometrial tissue responds to estradiol and other hormones similar to normal endometrium. Endometriosis is one of the most common benign gynaecological conditions, affecting up to 5 to 10 percent of women of reproductive age. In addition to severe dysmenorrhea or pelvic pain, decreased fertility is a common clinical manifestation of internal heterogeneity, with up to 40 percent of patients associated with infertility . Currently, laparoscopy is the gold standard for diagnosis. However, the actual time to diagnosis in patients with internal dysmorphia is delayed by an average of 4 to 11 years, resulting in a large number of patients with moderate to severe (stage III to IV) at diagnosis. Recently, the exploration of efficient and cost-effective non-invasive diagnostic solutions has been a hot button issue.

Eligibility Criteria:
Inclusion Criteria:

• Surgically and pathologically verified patients with or without endometriosis

Exclusion Criteria:

* suspicion of malignancy
* pregnancy
* acute infection
* Lack of ability to sign informed consent forms on their own