cyrilzakka/clinical-trials huggingface dataset:
Radiation Therapy in Treating Patients With Stage I or Stage II Prostate Cancer

RATIONALE: Radiation therapy uses high energy x-rays to damage tumor cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of conventional radiation therapy with high-dose radiation therapy in treating men with stage I or stage II prostate cancer.

OBJECTIVES: I. Determine whether high-dose radiotherapy using conformal photons with a proton boost produces a 20% increase in the proportion of Stage I/II prostate cancer free from local failure and biochemical relapse at 5 years when compared to results of conventional-dose radiotherapy. II. Determine whether high-dose radiotherapy produces a 33% reduction in the cumulative incidence of a rising PSA (second hormone failure) following hormone therapy given at the time of first PSA/clinical failure when compared with conventional-dose radiotherapy. IV. Assess the relative rectal, bladder, and sexual morbidity of conformal photon doses of 70.2 and 79.2 Gy in these patients. V. Collect, in a prospective manner, paraffin biopsy blocks for subsequent analysis of emerging molecular pathologic predictors of outcome in three patients.

OUTLINE: Randomized study. Arm I: Radiotherapy. Boost to the prostate using high-LET protons followed by irradiation of the prostate, periprostatic tissues, and seminal vesicles using conformal photons with energies greater than 6 MV. Conventional dose. Arm II: Radiotherapy. As in Arm I. High dose.

PROJECTED ACCRUAL: There will be 390 patients accrued into this study over 3 years. An additional 3.5 years will be required for follow-up.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate Primary tumor confined to prostate TNM clinical Stages T1b-c or T2a-b No T1a No T1b-c tumor with Gleason grade 1-2/5 No Gleason grade 1-2/5 and PSA less than 4 ng/mL Nodes negative on imaging (Nx) or by surgical sampling (N0) PSA no greater than 15 ng/mL Treatment must begin within 28 days after randomization

PATIENT CHARACTERISTICS: Age: Any age Performance status: Karnofsky 70%-100% Life expectancy: Greater than 10 years Other: No major medical or psychiatric illness that precludes protocol entry No prior or concurrent second malignancy within 5 years except basal cell skin cancer

PRIOR CONCURRENT THERAPY: No prior treatment for prostate cancer
A Sample Collection Study to Validate the NEPHROCLEAR™ CCL14 Test

The objective of this sample collection study is to collect urine samples to validate the NEPHROCLEAR™ CCL14 Test in patients with KDIGO stage 2 or 3 AKI. This study is observational and will have no impact on the medical management of the subject.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females 21 years of age or older;
2. Receiving care in an intensive care unit;
3. Expected to remain in the ICU for at least 48 hours after enrollment;
4. Use of indwelling urinary catheter as standard care at the time of enrollment;
5. Subject must have acute kidney injury (KDIGO Stage 2 or Stage 3) at the time of sample collection;
6. Urine sample must be collected within 36 hours of meeting KDIGO Stage 2 criteria;
7. Written informed consent provided by patient or legally authorized representative (LAR).

Exclusion Criteria:

1. Prior kidney transplantation;
2. Comfort-measures-only status;
3. Already receiving dialysis (either acute or chronic) or in imminent need of dialysis at the time of enrollment;
4. Known infection with human immunodeficiency virus (HIV) or active hepatitis (acute or chronic);
5. Special populations, pregnant women, prisoners or institutionalized individuals.
Duke Activity Score Index in Obese Individuals

Today, obesity is a global health problem and can lead to serious health complications. Bariatric surgery is recognized as an effective treatment option to achieve long-term weight loss and health improvement in overweight or obese individuals. However, appropriate tools are needed to assess the physical activity levels of patients before and after bariatric surgery and to guide rehabilitation processes after surgery. The Duke Activity Index (DAI) is a scale used to assess activities of daily living and was developed at Duke University Medical Center. The DAI has been widely used to determine patients' physical functioning and monitor their activity levels in various health conditions and post-surgical recovery processes. The aim of this study was to evaluate the psychometric properties of the DAI and to examine whether it is an effective tool for determining physical activity levels in patients who are candidates for bariatric surgery.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index higher than 30
* No disease that may affect functional performance
* Able to adapt to the tests to be applied

Exclusion Criteria:

* Recently hospitalized due to a condition that may make it difficult to perform the test
* Inability to perform exercise tests due to neurological or musculoskeletal disorders
* Uncontrollable medical conditions (such as lung or cardiovascular disease)
* Dysfunction of the vestibular system or eyes
Right Ventricular Function and Pulmonary Hypertension in HFpEF

In patients with heart failure and preserved ejection fraction (HFpEF) right ventricular (RV) systolic and diastolic dysfunction are prognostically and functionally relevant factors but have mechanistically been neglected so far. In the present study alterations of intrinsic RV (systolic and diastolic) function, as assessed by invasive pressure volume loops, are examined in relation to tissue alterations on myocardial level and to the degree of RV afterload (pulmonary hypertension). Study aim is to gain insights into mechanisms contributing to the development of RV dysfunction and potentially identify new therapeutic targets.


Eligibility Criteria:
HFpEF

Inclusion Criteria:

* Clinical signs of heart failure
* Preserved Left ventricular (LV) Ejection Fraction (EF \>= 50%)
* Structural Heart Diseases on echocardiogram/ N terminal-pro-brain natriuretic peptide \> 125ng/l
* Elevated LV end-diastolic pressure at rest (\>15mmHg) or during exertion (\>=25mmHg)

No Heart Failure

Inclusion Criteria:

* No signs of heart failure
* Preserved Left ventricular (LV) Ejection Fraction (EF \>= 50%)
* Normal LV end-diastolic pressure at rest (=\<15mmHg) and during exertion (\<25mmHg)

Exclusion Criteria:

* Significant coronary artery stenosis at time of catheterization
* Acute coronary syndrome or cerebral insult within 1 month of examination
* more than moderate valvular diseases
* pregnancy
* contraindication to cardiac magnetic resonance imaging
Effect of Medium Chain Triglyceride Consumption on Appetite

The purpose of this study is to test the effects of medium chain triglyceride consumption, relative to long chain triglycerides, on hormones involved in appetite regulation and food intake in overweight men. We expect medium chain triglycerides to reduce appetite and food intake and to do so by increasing levels of hormones known to be involved in satiety and reduce levels of those involved in appetite.


Eligibility Criteria:
Inclusion Criteria:

* Males
* Weight stable (\<10 lb over previous 3 months)
* Overweight (body mass index 25-29.9)

Exclusion Criteria:

* Smokers
* Excessive caffeine users
* Severe health conditions
* Allergy to food products/ingredients in the study
* Taking medications known to affect energy expenditure or gastrointestinal function
Neuraxial Anesthesia and Restless Leg Syndromes in Cesarean

The restless leg syndromes is a common sensorimotor disorder of unknown cause affecting approximately 10% of the population. Different literature had different views on the association between neuraxial anesthesia and the occurrence of restless leg syndrome. Some reported that spinal anesthesia induced postoperative restless leg syndrome, but other studies showed that spinal and general anesthesia all two did not cause restless leg syndrome. A potential difference amongst these studies is that a big difference exists in surgical types. The investigators proposed that different types of surgery performed undergoing various anesthesia, and that there is a big difference in original pathophysiological condition. Therefore, the investigators hypothesized that pregnant women who have special physical states would have had an association between neuraxial anesthesia and restless leg syndrome in such patients who received selective cesarean section undergoing spinal or epidural anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Healthy pregnancy
* Selective cesarean
* Gestational age \>= 37 weeks
* Chinese

Exclusion Criteria:

* Allergic to local anesthetics
* Allergic to opioids
* History of psychosis
* Cognition malfunction
* Any organic diseases
* Original lower extremity dyskinesia and paraesthesia
* Chronic pain
* Difficult in sleep
* Drug and alcohol abuse
Efficacy and Safety Study of Varying Doses of Lanreotide Autogel in Patients With Acromegaly

The purpose of this study is to compare the effectiveness of lanreotide autogel to placebo after a single injection. Effectiveness and safety were then also assessed following four fixed-dose injections and after one year of treatment given at titrated doses.


Eligibility Criteria:
Inclusion Criteria:

* documentation of a diagnosis of active acromegaly based on either of the following definitions:

  1. the patient has never received somatostatin analog nor dopaminergic agonist or had previously received this medication but had stopped more than 3 months before visit 1 and had a mean growth hormone (GH)level \>5ng/mL at visit 1; or
  2. the patient was receiving treatment with a somatostatin analog (other than lanreotide autogel) or a dopaminergic agonist at visit 1, had a mean GH \>3ng/mL at visit 2 (or visit 2a) and had at least a 100% increase in mean GH levels between visit 1 and visit 2 (or visit 2a)

Exclusion Criteria:

* receipt of radiotherapy for acromegaly within 3 years
* pituitary surgery within 3 months prior to visit 1
* prior receipt of lanreotide autogel or GH antagonist
* anticipated need for pituitary surgery (adenomectomy) or radiotherapy during the study period
* known hypersensitivity to any of the test materials or related compounds
* clinically significant renal or hepatic abnormalities
10 Vs.15 mcg Norepinephrine Bolus in Severe Maternal Hypotension During Cesarean Delivery

Data regarding the optimum dose of norepinephrine for management of severe maternal hypotension is lacking. A previous report showed that the use of 10-mcg norepinephrine bolus was not superior to the 5-mcg bolus in the management of severe hypotension in addition the incidence of reactive bradycardia and hypertension was comparable in the two doses. Therefore, we hypothesize that using a higher dose of norepinephrine (15 mcg) would increase the success rate of management of severe hypotensive episode.

Upon arrival to the operating room, the patient will be in supine position with left uterine displacement using a wedge below the right buttock. Routine monitoring will be applied (electrocardiography, pulse oximetry, and non-invasive blood pressure monitor). An 18G-cannula will be inserted, and the patients will receive 10 mg metoclopramide. Baseline heart rate and systolic blood pressure will be recorded as the average of three consecutive readings with 2-minutes interval.

Lactated Ringer's solution will be infused at rate of 15 mL/Kg over 10 minutes as a co-load; spinal anesthesia will be achieved by injecting 10 mg of hyperbaric bupivacaine and 20 mcg fentanyl into the subarachnoid space at L3-L4 or L4-L5 interspace using 25G spinal needle.

After subarachnoid block, mothers will be placed in the supine position with left-lateral tilt.

Block success will be assessed after 5 minutes from intrathecal injection of local anesthetic; and will be confirmed if sensory block level is at T4.

The patient would receive the study drug only if she developed severe post-spinal hypotension (defined as systolic blood pressure ≤60% of the baseline reading) as her first hypotensive episode. The management of the hypotensive episode will be considered successful if the systolic blood pressure is \> 80% of the baseline within 2 mins of the bolus. If the bolus failed, norepinephrine bolus of 5 mcg will be given.

Any other hypotensive episode (systolic blood pressure \<80% of baseline) will be managed with norepinephrine bolus of 5 mcg.

Intraoperative bradycardia (defined as heart rate less than 55 bpm) will be managed by IV atropine bolus (0.5 mg) will be administered.

Fluid administration will be continued up to a maximum of 1.5 liters. An oxytocin bolus (1 IU) will be delivered over five seconds after delivery then infused at a rate of 2.5-7.5 IU/hour.

Eligibility Criteria:
Inclusion Criteria:

* full-term singleton pregnant women
* American society of anesthesiologist II, scheduled for elective cesarean delivery,

Exclusion Criteria:

* Patients with uncontrolled cardiac morbidities (patients with tight valvular lesion, impaired contractility with ejection fraction \< 50%, heart block, and arrhythmias),
* hypertensive disorders of pregnancy,
* peripartum bleeding,
* coagulation disorders (patients with INR \>1.4 and or platelet count \< 80000 /dL) or any contraindication to regional anesthesia,
* baseline systolic blood pressure (SBP) \< 100 mmHg
The Effect of Early Switching From Intravenous to Oral Antibiotics Therapy

To date, many studies showed the great benefits of switching from IV to PO antibiotics in some infectious diseases, especially skin and soft tissue, urinary tract, respiratory tract, gallbladder, and biliary tract infection. Higher level of evidence is necessary to confirm the benefit of early switching protocol in infectious condition management. Therefore, we conducted a clinical trial to investigate the effectiveness and cost of IV-to-PO antibiotic switch therapy in some surgical infection conditions.

Introduction: The benefit of early switching from intravenous (IV) to oral (PO)was raising from the last decade. This randomized clinical trial was to evaluate the effect of early switching from IV to PO antibiotics on the outcome of surgical patients at a public hospital.

Methods: Patients admitted for a therapeutic antibiotic to orthopedic and general surgery conditions were randomly assigned to three groups: control (non-switching), early switching (within 48-72 hours), and late switching (after 72 hours). The rate of effectiveness of each arm, length of hospital stay, length of IV antibiotics, and cost were recorded prospectively.

Eligibility Criteria:
Inclusion Criteria:

* on the second day of IV antibiotic
* no difficulties on taking oral medication
* clinical improvement

Exclusion Criteria:

* n/a
Evaluation of an Individually Tailored Digital Service to Promote Healthy and Sustainable Behaviors and Well-being

The goal of this quasi-experimental observational study is to evaluate the impact of an individually tailored digital service aimed to support healthy habits on well-being, lifestyle behaviors, and mental health among the adult population. The main questions it aims to answer are:

I) Is a digital service developed to personalize support for healthy habits effective in improving well-being compared to a control group in the general population after 6 months? II) Does the digital service improve dietary and physical activity habits, mental health, and well-being among users across 24 months? III) Are sociodemographic factors associated with achieving the self-identified goals and improvements in dietary and physical activity habits, mental health, and well-being? IV) Do the intended mediators (engagement with the service, improved motivation, improved self-efficacy, and reduced barriers) mediate the effects of the digital service on achieving the self-identified goal, improved dietary and physical activity habits, mental health, and well-being? V) How is the pattern of user engagement across 24 months?

Participants are users of the mobile phone application LongLife Active®. Researchers will compare with individuals in the general population to see if the digital service is effective in improving well-being, dietary and physical activity habits, and mental health.

LongLife Active is an individually tailored digital service supporting healthy habits that is based on behavioral research evidence, supported by artificial intelligence and co-developed.

Eligibility Criteria:
Inclusion Criteria (intervention arms):

* adults ≥18 years
* siging up for the service LongLife Active using BankID for identification
* consent to the research study

Inclusion Criteria (controls):

* adults ≥18 years
* consent to the research study

Exclusion Criteria (intervention arms):

* individuals who are discharged from the app due to refracting the terms of the service
* subjects scoring \>70 on well-being will be excluded from the primary analyses

Exclusion Criteria (controls):

* age ≤ 17 years.
* is currently using a digital product or any other kind of support for behavior change
* is found to be a user of LongLife Active.
* subjects scoring \>70 on well-being will be excluded from the primary analyses
Textbook Outcome in Adrenal Neoplasms

BACKGROUND:

Textbook outcome (TO) is a multidimensional quality management tool that uses a set of traditional surgical measures to reflect an "ideal" surgical result for a particular pathology. The aim of the present study is to record the rate of TO in patients undergoing elective surgery for adrenal neoplasms.

MATERIAL AND METHODS:

Retrospective study of all patients undergoing scheduled adrenal neoplasms surgery at a Spanish university hospital from September January 2010 to December 2022. Emergency surgeries were excluded. The variables included in the definition of TO were: R0 resection, no Clavien-Dindo ≥IIIa complications, no prolonged stay, no readmissions, and no mortality in the first 30 days.

The main objective of this study is to analyse the achievement of TO in a series of patients undergoing scheduled adrenal neoplasms resection at the Doctor Balmis General University Hospital in Alicante, Spain. The investigators compare the group of patients who achieve a TO result with the group of patients who do not. A univariable and multivariable analysis will be carry out in order to indentified the variables associated with TO.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective adrenal resection were eligible for the study

Exclusion Criteria:

* Age under 18 years
* Emergency surgery
* Resections of other organs in the same surgery.
The Efficacy of Platelets Rich Plasma for Ovarian Rejuvenation

In recent years, an increased approach has appeared in the use of autologous blood products to assist tissue and organ healing. Application of platelet rich plasma (PRP) has emerged as a potential solution for infertile women with poor ovarian reserve in reproductive specialty.

Quantitative and qualitative functional improvement of ovarian function has been reported in several studies after using autologous PRP in a reproductive field. Ovarian rejuvenation, stimulating the ovaries to produce new eggs after injecting PRP, can offer hope for renewed fertility to women with poor reserve volume, advanced maternal age, or either naturally occurring or premature menopause. But, these encouraging results should be supported by several new studies.

This study aimed to estimate the efficacy of trans-vaginal ovarian injection with PRP in rejuvenates ovaries in woman with poor ovarian reserve, and to assess any association of some women variables (age, menstrual status, parity, BMI) as predicting factors in success of ovarian injection with PRP.

Eligibility Criteria:
Inclusion Criteria:

1. Menopause or peri-menopause under the age of 50.
2. Premature ovarian insufficiency which is ovarian failure before the age of 40.
3. Woman with primary ovarian failure of any cause.

Exclusion Criteria:

1. A previous injection with any medication, plasma, or PRP
2. Invisible or difficult access ovaries.
3. Medical disease or unfit for anesthesia patient.
Ranolazine in Ischemic Cardiomyopathy

Patients with ischemic cardiomyopathy may continue to experience persistent chest pain and shortness of breath despite conventional medical therapy and/or revascularization. The purpose of this study is to determine the efficacy of taking Ranexa versus placebo in patients with ischemic (due to blockages) cardiomyopathy treated with optimal conventional medical therapy and/or percutaneous revascularization.


Eligibility Criteria:
Inclusion Criteria:

1. Ischemic cardiomyopathy patients on optimal medical treatment. Optimal medical treatment is defined as the continued symptoms of chest pain or dyspnea despite treatment with 2 antiischemic agents (beta blockers, CCB or nitrates). Unless contraindicated, all cardiomyopathy patients should be treated with a beta blocker and an ACEI/ARB.
2. Anginal chest pain or dyspnea
3. Documentation of non treatable or optimally treated coronary artery disease
4. Ejection Fraction of less than or equal to 40%

Exclusion Criteria:

1. Less than 18 years of age
2. Pregnant or breast feeding
3. Patients with non ischemic cardiomyopathy
Evaluate a Saw Bone Training Protocol in Using Tactile Sensation to Classify Bone Quality During Implant Surgery

Bone quality is one of the major factors influencing the dental implant survival rate. Bone quality is believed to have effects on initial implant stability and success of osseointegration. Different implant designs and surgical protocols were developed for improving the survival rate in different bone quality. Although bone quality can be partly diagnosed by radiographic images, lots of experienced surgeons also evaluate bone quality with tactile sensation when they drill the bone. However, variations in evaluation of bone density maybe exist among different surgeons. For less experienced dentists, it is difficult to diagnose bone quality with tactile sensation in the beginning. This purpose of this study is to evaluate a training protocol in using tactile sensation to classify bone quality during implant surgery. Saw bones of variant densities are used as training materials. The outcomes before and after training will be compared. The effect of training frequency before surgery will also be evaluated.

Twenty-five dentists will be enrolled into the study. Tests will be performed using visual analog scale to score bone quality of test blocks.

Eligibility Criteria:
Inclusion Criteria:

* Certified dentist with implant surgery experience less than 10 implants.

Exclusion Criteria:

* Age exceed the limits
* Implant surgery experience more or equal to 10 implants
Patient Satisfaction With the Management of a Stopped Pregnancy in the First Trimester

The clinical practice recommendations highlight the fact that the patient's choice concerning the management of her aborted pregnancy in the first trimester should be privileged, after clear and appropriate information on the available treatments, in order to improve his experience and reduce the negative psychological symptoms that can generate an alteration in the quality of life, in the aftermath of the loss of pregnancy.

The present study will describe the efficacy, satisfaction and tolerance of patients benefiting from medical treatment with Mifégyne® and MisoOne® versus those benefiting from surgical treatment by endo-uterine aspiration for the management of a pregnancy stopped during the first trimester at the Toulouse University Hospital


Eligibility Criteria:
Inclusion Criteria:

* Any adult patient presenting to the gynecological emergency department of the Paule de Viguier Hospital in Toulouse for whom a diagnosis of an arrested pregnancy in the first trimester is made
* Whose cranio-caudal length of the embryo measured by ultrasound is less than 25 mm or having a clear egg
* Having agreed to the study (written or verbal) after clear and fair information
* Who understands and reads French

Exclusion Criteria:

* Medical contraindication to treatment with Mifégyne® or MisoOne®
* Hemodynamically unstable patient requiring urgent surgical treatment.
* Protected adult patient (guardianship, curatorship, safeguard of justice)