cyrilzakka/clinical-trials huggingface dataset:
Early Salvage Stereotactic Radiotherapy for Biochemical Failure After RP

After radical prostatectomy, 30-60% of patients will develop recurrent disease. Salvage radiotherapy, usually at 2 Gy per fraction, is the main treatment option for these patients.

The aim of the present study is to determine the 3-yr biochemical failure free survival of the stereotactic approach in 5 fractions in the context of salvage radiotherapy for biochemical failure after radical prostatectomy.

The present study aims at delivering 30 Gy to the prostatic bed in 5 fractions. At the same time, the pelvic nodes will be covered to 25 Gy, but in those patients considered at low risk of nodal involvement. In patients with evidence of macroscopic disease at the tumor bed through DCE-MRI, 40 Gy will be delivered in 5 fractions.

Selected patients will receive 6-month LHRH analogue preceded by Bicalutamide tablet 50 mg, daily, for 2 weeks to control for possible tumor flare.

Eligibility Criteria:
Inclusion Criteria:

* - Able and willing to provide informed consent;
* Pathologically proven diagnosis of prostatic adenocarcinoma;
* Biochemical failure (2 consecutive PSA rises above 0.2 ng/ml) after radical prostatectomy;
* No regional or distant metastases;
* Eastern Cooperative Oncology Group performance status 0-1

Exclusion Criteria:

* - Previous local treatment of the prostate with radiotherapy, brachytherapy, cryosurgery, high-intensity focused ultrasound or cryotherapy;
* Previous radiotherapy to the pelvis;
* Previous or current symptomatic vesicourethral anastomotic stenosis post-RP (weak stream, straining to void, hesitancy and incomplete bladder emptying);
* PSA level at sRT\> 2 ng/ml;
* (Each single) Lesion volume within the prostatic fossa at mpMR \>5 cc;
* Previous chemotherapy for malignancy in past 5 years;
* Previous androgen deprivation for biochemical failure after RP;
* Contraindication to short term AD (in case of Px)
* Presence of nodal or distant metastasis, as confirmed by magnetic resonance (MR) or PET/CT
* Pathologically positive lymph nodes (pN+) at RP;
* Serious medical comorbidities or other contraindications to radiotherapy
* Presence of active inflammatory bowel disease;
* Presence of active connective tissue disease;
* Unable or unwilling to complete quality of life questionnaires
Treatment of Burning Mouth Syndrome With Integration of Traditional Chinese Medicine and Western Medicine

This study is an open-label randomized controlled trial of the efficacy of the integration of Traditional Chinese medicine (TCM) and western medicine based on TCM syndrome differentiation. The hypothesis is (1) TCM model can identify the primary and secondary type burning mouth syndrome (BMS); (2) TCM model can identify BMS after treatment with western medicine; (3) There is a positive effect of TCM in treating BMS.

BMS patients will be classified into the primary type and secondary type according to the patients' clinical histories and laboratory examinations. The secondary BMS only includes nutritional deficiency, such as Vitamin B12, folate, iron, zinc. At first, the primary BMS patients are treated with 0.5\~1 mg clonazepam every day before sleep for 8 weeks. The secondary BMS patients are treated with vitamin B12, folate, iron and zinc according to the patient's nutritional deficiency status. Patients with no improvement or little improvement after the first stage of Western medicine management will be arranged to receive traditional Chinese medicine (TCM) therapy. All patients will receive the TCM model, including TCM doctor, automatic tongue diagnostic system (ATDS), and body constitutional questionnaire (BCQ), evaluations.

The results of this study are expected to understand whether adjuvant TCM treatment of BMS can improve treatment efficacy. The investigators will understand whether the constitution pattern may be a predictive indicator of efficacy for western BMS. The investigators will find a diagnostic indicator for the TCM model and apply it to the assessment of the prognosis of BMS patients.

Eligibility Criteria:
Inclusion Criteria:

1. Participants who signed the informed consent
2. The clinical diagnosis was primary or secondary type BMS patient
3. ≥ 20-year-old
4. Female
5. Willing to take Traditional Chinese Medicine

Exclusion Criteria:

1. History of an angiotensin-converting enzyme inhibitor (ACEI) taking
2. Autoimmune disease
3. Poor kidney function
4. Unwilling to take Traditional Chinese Medicine
5. Male
6. Participants who have been treated with TCM or Acupuncture within a month
7. Participants who have been treated with medicine for burning mouth syndrome
Prospective Study on Primary Aldosteronism in Resistant Hypertension

Prevalence of primary aldosteronism (PA) in resistant hypertension is not clear. In addition, emerging evidence supports the role of elevated serum aldosterone in promoting cardiovascular disease, independently from high blood pressure (BP) levels, but current data on this issue are heterogeneous.

PA is the most frequent form of secondary hypertension, with a prevalence that increases with the severity of hypertension. The wide variation of the reported PA prevalence is due to different study design and population. Very few data derive from well designed prospective study. Additional problems in the interpretation of study results are the different diagnostic cut-off used in various centers and the low diffusion of the adrenal vein sampling, that has a central role in the PA diagnosis.

Resistant hypertension (RH) is a condition of insufficient BP control, despite appropriate lifestyle measures and treatment with at least 3 drugs at full dose, including a diuretic, in patients whose adherence to therapy has been confirmed. The primary aim of our study is define prospectively the prevalence of PA in RH.

Moreover, emerging evidence supports the crucial role of elevated serum aldosterone in promoting cardiovascular disease, independently from high BP levels. Aldosterone improves oxidative stress, inflammation, impairs insulin metabolic signaling, reduced endothelial-mediated vasorelaxation and is associated to cardiovascular and renal abnormalities. However, current data on the contribution of PA on cardiometabolic complications have heterogeneous results.

The secondary outcome of our study is to investigate prospectively the association of PA with cardiometabolic complications in a cohort of patients with RH.

Eligibility Criteria:
Inclusion Criteria:

* age over 18 and under 80 years old;
* diagnosis of resistant hypertension defined as: uncontrolled blood pressure at ambulatory blood pressure measurement (ABPM), despite the use of at least 3 antihypertensive drugs at full dose, including a diuretic.

Exclusion Criteria:

* age under 18 or over 80 years old;
* pseudo-resistant hypertension (poor medication adherence, high salt intake);
* previous cardiovascular disease;
* insulin treated diabetes mellitus;
* other than primary aldosteronism cause of secondary hypertension (obstructive sleep apnea, renal artery stenosis, pheochromocytoma/paraganglioma, primary hyperparathyroidism, autonomous cortisol secretion or over hypercortisolism);
* liver cirrhosis;
* chronic heart failure;
* known malignant neoplasm;
* chronic disease with major organ involvement;
* excessive alcohol ingestion;
* current steroids assumption;
* use of sympathomimetic drugs;
* use of contraceptives.
Electroacupuncture Versus Fast-track Perioperative Program for Laparoscopic Colorectal Surgery

Background: Our previous study demonstrated that electroacupuncture at Zusanli, Sanyinjiao, Hegu, and Zhigou reduces the duration of postoperative ileus and hospital stay after laparoscopic colorectal surgery within a traditional perioperative care setting. Recent evidence also suggested that a 'fast-track' perioperative program may help accelerate recovery after colorectal surgery. As electroacupuncture is simpler to implement and less labor intensive, it may be the preferred adjunct therapy if it is proven to be noninferior to fast-track program in reducing the duration of postoperative ileus and hospital stay after laparoscopic colorectal surgery.

Objectives: To compare the efficacy of electroacupuncture and fast-track program in reducing the duration of postoperative ileus and hospital stay after laparoscopic colorectal surgery.

Design: Prospective, randomized, noninferiority trial.

Subjects: One hundred sixty-four consecutive patients undergoing elective laparoscopic resection of colonic and upper rectal cancer will be recruited.

Interventions: Patients will be randomly allocated to receive either: (A) electroacupuncture with traditional perioperative care; or (B) fast-track program without acupuncture.

Outcome measures: Primary outcome: time to defecation. Secondary outcomes: duration of hospital stay, time of first passing flatus, time to resume diet, pain scores, analgesic requirement, morbidity, and medical costs.

Conclusions: This study will determine if electroacupuncture is noninferior to fast-track program in reducing the duration of postoperative ileus and hospital stay after laparoscopic colorectal surgery. Electroacupuncture may be the preferred perioperative adjunct therapy to laparoscopic colorectal surgery because it is simpler to implement and less labor intensive than fast-track program.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients undergoing elective laparoscopic resection of colonic and upper rectal cancer
* Age of patients between 18 and 80 years
* Patients with American Society of Anesthesiologists (ASA) grading I-II
* Patients with no severe physical disability
* Patients who require no assistance with the activities of daily living
* Informed consent available

Exclusion Criteria:

* Patients undergoing laparoscopic low anterior resection with total mesorectal excision, abdominoperineal resection, or total/proctocolectomy
* Patients with planned stoma creation
* Patients undergoing emergency surgery
* Patients with evidence of peritoneal carcinomatosis
* Patients with previous history of midline laparotomy
* Patients who are expected to receive epidural opioids for postoperative pain management
* Patients with cardiac pacemaker
* Patients who are allergic to the acupuncture needles
Infectious Diseases and Movement Program: Study of the Effects of Physical Activity on HIV Infection

exercise and physical activity can have an anti-inflammatory effect, while there is evidence that a sedentary lifestyle could be the basis for the development of systemic inflammation and increased cardiovascular risk. The primary objective is to assess whether regular physical activity is able to induce a decrease in systemic immune-activation in HIV positive patients.

Many studies document that exercise and physical activity can have an anti-inflammatory effect, while there is evidence that a sedentary lifestyle could be the basis for the development of systemic inflammation and increased cardiovascular risk. This occurs because a sedentary lifestyle leads to the accumulation of visceral fat, and this is accompanied by an increase in adipokine release and infiltration of adipose tissue by the pro-inflammatory immune cells. Furthermore, the imbalance between immune processes and metabolic processes is associated with the development of insulin resistance, atherosclerosis and neurodegeneration.

The primary objective is to assess whether regular physical activity is able to induce a decrease in systemic immune-activation in HIV positive patients.

To evaluate this hypothesis, the following parameters will be analyzed: evaluation of immune-activation levels, of metabolic parameters, of cardiac function, of immuno-virological set-up, of dietary intake and of physical performance indices in HIV-positive patients with a sedentary lifestyle; these data will be compared with the values measured in the same HIV positive population with a sedentary lifestyle after three months of regular physical activity.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18-60 years
2. Patients who have signed informed consent
3. HIV positive patients
4. Patients who have performed a sports medical examination with ECG and are suitable for non-competitive physical activity.

Exclusion Criteria:

1. Anemia, pregnancy or any other contraindication to blood sampling and sports activity
2. Patients suffering from cardiomyopathies and ischemic heart disease
Childhood Obesity Treatment - Telephone Coaching vc Usual Care

This study evaluates if usual physical care visits to an outpatient pediatric clinic can be replaced with more frequent and shorter Telephone coaching Contacts during 18 months.

In this randomized controlled study, patients at age 5 to 14 and enrolled in obesity treatment, were randomized to either usual care according to regular routine or to telephone consultation.The randomization was done at the start of individual treatment and lasted for 18 months. We also studied working time required for the Health care, and the families' experience of the Telephone coaching.

Eligibility Criteria:
Inclusion Criteria:

* Children 5 to 14 years old who were patients at the outpatient pediatric centre
* All families after that the parents had attended at least 4 of 7 meetings in a parental/education group.

Exclusion Criteria:

* Obesity related syndromes
* Non-Swedish speaking families
Geriatric Communication Skills Training Program for Oncology Clinicians

The purpose of this study is to learn more about the effects of a training program designed to help doctors communicate better with older patients and their caregivers.


Eligibility Criteria:
Inclusion Criteria:

Clinician Eligibility

* MSK medical oncology Health Care Professionals (HCP) - specifically identified as Attendings, fellows, or Advance Practice Professional (APP) - either a Nurse Practitioner (NP) or Physician Assistant (PA) from GI, GU Oncology, Lymphoma, Bone Marrow Transplant or Geriatrics Service (five services with a large number of geriatric patients)
* Willingness to be audio-recorded as per self-report
* Clinician has individual clinic consultations with patients in the target population: 65 years of age and over, English speaking, and patients who have had a new visit within the last 6 months.

Patient Eligibility

* MSK patients 65 years of age and over as per EMR
* English speaking as per EMR
* Being seen by one of the consented HCPs as per the HCP and/or electronic medical record (EMR)
* Willingness to be audio-recorded as per self-report
* Patient had their first visit with the clinician within the last 6 months

Caregiver Eligibility

* English speaking as per EMR
* Accompanying an MSK patient being seen by one of the consented HCPs as per the HCP and/or EMR

Exclusion Criteria:

* N/A
Treatment of Parkinson's Disease With Eliprodil

Patients with Parkinson's disease are missing the chemical neurotransmitter dopamine. This occurs as a result of destructive changes in an area of the brain responsible for making dopamine, the basal ganglia. Patients with the disease experience, rigid muscles, stooped posture, and a shuffling-type walk (gait).

In this study researchers plan to evaluate the effectiveness of the drug eliprodil for the treatment of Parkinson's Disease. Eliprodil works by blocking special receptors (NMDA) that are associated with the symptoms of Parkinson's Disease.

The objectives of this study are to evaluate the acute effects of the NR2B subtype-selective NMDA antagonist eliprodil on levodopa-associated motor response complications in patients with advanced Parkinson's Disease (PD).

Eligibility Criteria:
All patients will carry a diagnosis of idiopathic Parkinson's Disease based on the presence of a characteristic clinical history and neurologic findings. Most will have relatively advanced disease with associated motor response complications.

Males and females between the ages of 18-75.

No presence or history of any medical condition that can reasonably be expected to subject the patient to unwarranted risk.

No patients with baseline QTc prolongation (greater than 440 msec).

No pregnant women nor those not practicing effective means of birth control.
Breakfast Training Based on PENDER's Health Promotion Model (HPM)

Nutrition of school-age children is very important. Children at this age need to eat three main meals and at least one snack every day. Breakfast, among the main meals, is an important component of a healthy diet and is vital for healthy and normal development, especially in children and adolescents. T.R. According to TÜBER prepared by the Ministry of Health, the most frequently skipped meal among school-age children is breakfast. It is necessary to raise awareness in parents and children about regular breakfast consumption and frequency and to instill healthy lifestyle behaviors. It is aimed to regulate breakfast consumption and frequency in parents and children with a web-based training based on PENDER Health Promotion Model (HGM).

Before starting the study, students and parents will be informed in writing and verbally. Then, a pre-test will be applied with the specified data collection tools to students and parents who agree to participate in the research. Then, a 6-week web-based training on breakfast consumption based on PENDER's Health Promotion Model will be given. After the training, a post-test will be applied with data collection tools. Then the pre-test and post-test data will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* • Being a 7th grade student of secondary school,

  * Not having a chronic disease
  * Students who voluntarily agreed to participate in the research and received consent from their parents.

Exclusion Criteria:

* • Not being a 7th grade student of secondary school,

  * Having a chronic disease
  * Students who do not agree to participate in the research voluntarily and whose parents\&#39; consent cannot be obtained
Comparison Between PECS BLOCK 2 vs ESP BLOCK in Ocnologic Breast Surgery

The study aims to compare the efficacy of the two operating blocks PECS2 and ESP by measuring postoperative opioid consumption and, secondarily, to compare (between PECS and ESP) postoperative opioid consumption between surgery with/without axillary cavity dissection and with/without implantation of prosthesis or expansion

Breast cancer is the most frequent type of cancer in the female population. Early detection is the most effective tool for improving prognosis, and the surgical approach plays a central role in the treatment of this disease. However, many are the psychophysical implications that patients face: among the main ones is postoperative and chronic pain, a symptom that greatly worsens the quality of life.

In the last decade it has been witnessed an important development of locoregional anesthesia techniques in all surgeries. In breast surgery, particularly mastectomy, the following locoregional anesthesia techniques are referred to as the Gold Standard:

1. PVB (Paravertebral Block)
2. PECS2 BLOCK (or modified PECS). For the same purposes, ESP Block (Erector Spinae Plane Block) has been applied experimentally, which has already shown its effectiveness in breast surgery in several trials.

By comparing postoperative opioid consumption between the two groups of patients, divided into PECS Block and ESP Block, the study aims to identify which anesthesia block is most effective in order to improve the care of patients undergoing mastectomy.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing mastectomy exclusively for breast cancer
* Presence of written informed consent to the trial

Exclusion Criteria:

* Bilateral breast surgery
* Previous drug use
* Chronic opioid and minor opioid therapy
* BMI \>40
* Allergy or contraindications to taking Paracetamol and Toradol
* Inability to use PCA (Patient Controlled Analgesia)
* Intraoperative opioid administration
* Patients with neuropathy
Study Evaluating the Safety and Efficacy of Tigecycline in Hospitalized Patients With cIAI

In light of tigecycline's activity against these resistant bacteria, tigecycline may represent a viable new therapy for complicated intra-abdominal infections.

To evaluate the efficacy and safety of tigecycline to treat complicated intra-abdominal infections in hospitalized patients. Both the clinical response profile and the microbiological response profile will be assessed. The primary endpoint will be clinical response within the microbiological evaluable population at the test-of-cure assessment.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized male or female patients greater than or equal to 18 years of age.
* Patients must be a candidate for or have had a laparotomy, or laparoscopy of an intra-abdominal abscess.
* Patients with a complicated intra-abdominal infection such as:

  * an intra-abdominal abscess;
  * an intra-abdominal abscess (including liver and spleen) that develops in a post-operative patient after receiving \> 48 hours and less than or equal to 5 days of a non-study antibiotic. An intra-abdominal culture must be obtained from the infected site.
  * appendicitis complicated by perforation (grossly visible) and abscess and/or periappendiceal abscess;
  * perforated diverticulitis complicated by abscess formation or fecal contamination;
  * complicated cholecystitis with evidence of perforation or empyema;
  * perforation of the large or small intestine with abscess, or fecal contamination;
  * purulent peritonitis or peritonitis associated with fecal contamination;
  * gastric or duodenal ulcer perforation with symptoms lasting at least 24 hours prior to operation;
  * traumatic bowel perforation with symptoms lasting at least 12 hours prior to operation.

Exclusion Criteria:

* Patients with any concomitant condition that, in the opinion of the investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy or follow-up visits could be completed.
* Active or treated leukemia or systemic malignancy that required treatment with chemotherapy, immunotherapy, radiation therapy or antineoplastic therapy within the past 3 months, or any metastatic malignancy to the abdomen with life expectancy less than 6 months.
* Anticipated length of antibiotic therapy less than 5 days.
ABVN Phase 2-Studying the Effect of Stimulation on the Auricular Branch of the Vagal Nerve

The purpose of this study is to find out if we can gain access to the vagus nerve which is largely an internal nerve that controls stomach function. We hope to gain access to the internal vagus nerve by electrically stimulating the nerve around the external ear. If we can do this then we hope that this will help our treatment of patients with nausea and vomiting and disordered stomach function

Subjects will undergo transcutaneous stimulation of the auricular branch of the vagus nerve and also undergo blood draw before, after stimulation and later a third draw after a period of no stimulation. Healthy subjects will also undergo vagal maneuver using the Multi Array Electrodes (MEA). Gastroparetic subjects will also undergo vagal maneuver using either the regular EKG electrodes or the MEA electrodes.

Subjects will also complete health history questionnaires.

Eligibility Criteria:
Inclusion Criteria healthy volunteers

* Healthy volunteers with no gastric symptoms or conditions (except due to COVID 19)
* Aged 18-80 years
* Willing to have electrodes placed in the external ear (ABVN arm)
* Willing to perform vagal activity maneuver (Vagal arm)
* Willing to have 1 tablespoon (15 ml) of blood drawn at 3 time points

Inclusion Criteria gastroparesis subjects

* Gastroparesis subjects with a confirmed diagnosis of gastroparesis from a GI physician
* Have a formal diagnosis of gastroparesis or are seeing the GI physician for symptoms related to gastroparesis
* Aged 18-80 years
* Willing to have electrodes placed in the external ear (ABVN arm)
* Willing to perform vagal activity maneuver (Vagal arm)
* Willing to have 1 tablespoon (15 ml) of blood drawn at 3 time points

Exclusion Criteria:

* Unable to provide consent
* Pregnant females
* Prisoners