cyrilzakka/clinical-trials huggingface dataset:
Electronic Intervention to Chronic Opioid Therapy

This pilot study will attempt to apply an electronic chart intervention to improve safety for patients on chronic opioid medications.


Eligibility Criteria:
Inclusion Criteria:

* Patients prescribed long-term opioid therapy of doses greater than 90 morphine equivalent daily dose (MEDD)

Exclusion Criteria:

* Patients prescribed short-term opioid medications for acute pain (less than a 90-day supply over the past 120 days), sublingual buprenorphine, methadone maintenance for opioid use disorder or with oncology or palliative care diagnoses will be excluded.
Investigating the Effects of Exercise on Physiological Changes and Toxin Removal in Hemodialysis Patients

Hemodialysis is a life-saving treatment for end stage renal disease patients. The chief aims of hemodialysis are solute and fluid removal. Solute removal is associated with outcome of dialysis patients. Intra-dialytic exercise has been found to improve the toxin removal and it is suggested that exercise increases the cardiac output, thus increases the blood flow to lower extremities. This leads to increased toxin removal from low blood flow regions. On the other hand, exercise can possibly dilate the vasculature and decrease the compartmental resistance. In this study, the investigators aim to investigate the exercise induced physiological changes which enhances the toxin removal. This information combined with patient specific mathematical models will encourage clinicians to opt for Optimal intra-dialytic exercise protocol. On the other hand, Hemodiafiltration is widely accepted renal replacement therapy for improved toxin removal. Hence, we intend to compare the toxin removal outcome for standalone Hemodiafiltration and intra-dialytic exercise in conventional hemodialysis.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients male or female (Age \> 21 years)
* Minimum dialysis vintage of 6 months
* Stable on hemodialysis
* Minimum Hemoglobin level of 10 g/dL
* Blood access capable of delivering the blood flow rate greater than 250 mL/min
* Preserved left ventricular ejection fraction (\>50%) on prior imaging study
* Able to complete a 6min-walk-test without abnormal physiological response, excessive fatigue, or musculoskeletal discomfort

Exclusion Criteria:

* History of recurring or persistent hypotension in past 3 months
* Pregnant woman
* Severely Hypertensive patients (SBP \> 180 mmHg and/or DBP \> 115 mmHg)
* History of recent myocardial infarction or unstable angina (within past 6 months)
* Significant valvular disease, i.e. severe aortic stenosis and moderate-severe mitral regurgitation.
* Patients with end stage organ disease e.g. COPD, recent or debilitating CVA
* Patient with recent stroke (within past 6 months)
* Anemic patients
* History of known arrhythmia
* Participation in another clinical intervention trial
* Moderate to severe osteoarthritis of knee(s)
* Unable to consent
Impact of a Transitional Care Program on 30-Day Hospital Readmissions for Elderly Patients Discharged From a Short Stay Geriatric Ward

In France, it has be estimated that the hospital readmission rate within 30 days of patients aged 75 or older is 14% (IC95% \[12.0-16.7\]), nearly a quarter being avoidable. There is evidence that interventions "bridging" the transition from hospital to home involving a dedicated professional (usually nurses) would be most effective in reducing the risk of readmission, but the level of evidence of current studies is low. Our study aims to assess the impact of a program of transitional care from hospital to home for people of 75 years old or more admitted to acute care.

The study is a stepped wedge randomized cluster study. Intervention: The transition care program, involving a dedicated advanced practice nurse, will include: 1) during the patient's stay in hospital: an individualized needs-based comprehensive discharge plan and a transitional care record ; the notification of the primary care physician about inpatient care and hospital discharge; 2) the day of the discharge: specific explanations about the organization of home care provided by the transition care nurse to the patient; 3) during 4 weeks after discharge: monitoring patients and caregivers regularly through home visits and/or telephone contact,

Eligibility Criteria:
Inclusion Criteria:

* Patient hospitalized for 48 hours or more in one of the acute geriatric service participating to the study.
* Aged 75 or older.
* Leaving at home and with home as the planned discharge after the admission.
* At risk of hospital readmission emergency visit rates after discharge (if he has two or more of the following criteria (taken from the Triage Risk Screening Tool and from the 2013 French recommendation)).

Exclusion Criteria:

* Patient leaving in a retirement home.
* Patient hospitalized at home.
* Patient leaving at home but at 30 km (18 miles) or more from the service of his index admission
A Phase 2 Study to Evaluate the Safety and Efficacy of CTP-499 in Type 2 Diabetic Nephropathy Patients

This study is being conducted to evaluate the safety and efficacy of treatment with CTP-499 for 24 weeks in patients with chronic kidney disease, Type 2 diabetic nephropathy and who are currently receiving treatment with an angiotensin converting enzyme inhibitor (ACEI) and/or angiotensin II receptor blocker (ARB).

There are two parts to this study, each part includes double-blind treatment with either CTP-499 or placebo. Part 1 will evaluate the safety and efficacy of treatment with CTP-499 twice daily for 24 weeks. Part 2 will evaluate the effects of longer term dosing for an additional 24 weeks. Following Part 2, patients will be allowed to participate in an Open Label extension with CTP-499 for a period of an additional 48 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 years or older
* Patient diagnosed with Type 2 diabetes mellitus and chronic kidney disease
* On a stable regimen of ACE inhibitors and/or ARB drugs for a minimum of 4 weeks
* Not expected to start dialysis for one year
* Patient has blood pressure less than or equal to 145/90 mm Hg
* Patient has UACR greater than or equal to 200 mg/g if male and 300 mg/g if female but not more than 5000 mg/g
* Patient has glycosylated hemoglobin A1c less than or equal to 10.5%

Exclusion Criteria:

* Patient has concurrent condition such as uncontrolled inflammatory disease, acute infection or other unstable illnesses
* Patient has a history of allergy or sensitivity to pentoxifylline or methylxanthines
* Patient has acute, active and/or unstable renal impairment or has been hospitalized for acute renal failure within the previous year
* Patient has active malignancy or history of neoplastic disease
* Patient has a QTc interval greater than 450 milliseconds
* Patient has ALT or AST greater than 3 times the upper limit of normal or a potassium greater than or equal to 5.5mEq/L at screening
* Patient is breast feeding or pregnant
Effects of Swallowing Exercises on Patients Undergoing Radiation Treatment for Head and Neck Cancer

RATIONALE: Swallowing exercise therapy may improve the quality of life of head and neck cancer patients undergoing chemotherapy or radiation therapy.

PURPOSE: This randomized phase III trial is studying early onset of swallowing exercise therapy to see how well it works compared to late onset of swallowing exercise therapy in treating patients with head and neck cancer undergoing chemotherapy or radiation therapy.

PRIMARY OBJECTIVE:

I. To assess the difference between early and late onset swallowing exercises on swallowing quality of life in patients undergoing chemo/radiation therapy for head and neck cancer.

SECONDARY OBJECTIVE:

I. To assess the difference between early and late onset swallowing exercises on swallowing function in patients undergoing radiation therapy for head and neck cancer.

TERTIARY OBJECTIVE:

I. To assess the difference between early and late onset swallowing exercises on: individual domains of swallowing quality of life; Penetration Aspiration Scale (PAS) as assessed via FEES; diet level (Dysphagia Outcome and Severity Scale (DOSS) as assessed via FEES; feeding tube duration (days); Eating Assessment Tool (EAT); lingual strength as assessed via lingual manometry; and percent weight loss and percent weight recovery.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

Arm I (Early exercise group): Patients perform swallowing exercises comprising lingual press, head lift, breath hold, Masako swallow, high pitch e, effortful swallow, and neck stretch and massage for 2 weeks prior to beginning radiotherapy and again immediately after completion of radiotherapy.

Arm II (Late exercise group): Patients begin performing swallowing exercises as in arm I 1 month after completion of radiotherapy.

In both arms, swallowing exercises are performed twice daily, 6 days a week, for 12 months following completion of radiotherapy.

Eligibility Criteria:
Inclusion

* Written informed consent must be obtained from all participants prior to beginning therapy (participants should have the ability to understand be willing to sign a written informed consent document)
* Individuals with oropharyngeal, hypopharyngeal, or laryngeal cancer of Stages I-IV undergoing radiation and chemo therapies at Wake Forest Baptist Medical Center
* Participants will have surgically received no more than selective neck dissection and tumor biopsy (participants who have undergone primary tumor resection or radical neck dissection will not be eligible)
* Participants must have completed a minimum of third grade education in order to answer questions of the quality of life survey
* Participants must be willing to participate in the swallowing exercise program

Exclusion

* Medical history of cerebrovascular accident, Parkinson's disease, any type of dementia, myasthenia gravis, or amyotrophic lateral sclerosis
* Previous radiation treatment for head/neck cancer
* Swallowing problem of etiology other than current lesion
* Pregnant women are not anticipated in the patient population, but would be excluded from participation in the study
Precision of Optical Diagnosis in Polyps Between 5-15 mm and Its Implications on Surveillance. A Prospective, Multicenter Study.

This study evaluates the ability of endoscopists to perform a complete optical diagnosis of colorectal polyps between 5 and 15 mm, and the impact of the only endoscopic diagnosis on the follow-up program for those patients. This is a prospective study in which we compare the diagnosis regarding size and histology made by the endoscopist versus de pathologic diagnosis.

Background: Optical diagnosis of colonic polyps is an attractive possibility and a common practice. However, recommendations and the main decision concerning patients' management still rely on histological diagnosis, with controversial results in previous studies, usually designed to analyze the accuracy of this diagnosis in the setting of a 'resect and discard' or 'diagnose and leave' strategy. However, little has been studied on this diagnosis on polyps of about 10 mm, the threshold for the consideration as a high risk adenoma, that need a 3 year colonoscopy, or, in case of a smaller adenoma, with a recommended revision in 5 years. Some studies have addressed the accuracy when estimating the polyp size, and others the histology by means of virtual or optical chromoendoscopy, but no one has studied both parameters, that are the two pillars in which a revision program for the patient is decided.

Hypothesis: Our main purpose is to determine the accuracy of the complete optical diagnosis as made by the endoscopist in the endoscopy room, in order to give recommendations immediately after the colonoscopy, with no need of further histological analyses.

Aims:

* To establish endoscopist accuracy, in different hospital settings, to predict size and histology of polyps between 5 and 15 mm and whether follow-up recommedations based on this diagnosis are accurate enough, when compared to the pathologic diagnosis.
* To evaluate accuracy of the optical size estimation by the endoscopist, with respect to the measurement after resection and by the pathologist (after formaline fixation).
* To analyze the rate of sessile serrated adenoma not diagnosed by the endoscopista on site.
* To determine the proportion of incomplete resection and complications with different resection techniques.
* To follow-up patients with high risk adenoma with the aim to establish the best follow-up schedule for those patients, and clarify this topic, still subjected to uncertainty.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-80 years
* Colorectal polyps with an estimated size (endoscopist estimation) between 5 and 15 mm.
* Consent to be included in the protocol.

Exclusion Criteria:

* Polyps sized \<5 mm or \>15 mm
* Polyps that cannot be resected.
* Polys that cannot be sent for pathologic study.
* Peacemeal resection.
* Polyposis syndromes with a previous histologic diagnosis.
* Patients do not consent to participate in the study.
Comparing KIM to TVT Exact Sling

To assess to the non-inferiority of the retropubic Neomedic Knotless Incontinence Mesh (KIM) sling compared to the Gynecare Tension-free Vaginal Tape (TVT) Exact sling.

Participants: Women 21 years or older with a diagnosis of stress urinary incontinence (SUI) or mixed urinary incontinence (MUI) with objective evidence of SUI planning surgery for stress urinary incontinence.

Procedures (methods): Patients will be randomized to receive either the Gynecare TVT Exact sling or the retropubic Neomedic KIM sling. Patients will be followed for 1 year postoperatively.

Midurethral slings (MUS) are recognized as a minimally invasive treatment of SUI. The retropubic route of MUS placement has a cure rate of 89.1% with long term subjective cure rates ranging from 51-88%. The Neomedic Knotless Incontinence Mesh (KIM) sling is a tension-free macroporous monofilament polypropylene knotless mesh designed to be resistant to elongation and deformation over time. The KIM sling also offers a reusable trocar, which results in less waste and cost- savings. KIM sling trocars are available for the retropubic route or trans-obturator (TOT) route.

While studies have been performed comparing the TOT approach of the KIM sling to other slings, no studies have been performed to date with the retropubic (RP) approach. The RP and TOT approaches to MUS have been shown to be equivalent in the treatment of SUI. Since the same mesh material of the KIM sling is used for both the TOT and RP approach, it can be hypothesis that the RP route would show similar treatment success rates.

A type 1 macroporous (\> 75um) polypropylene mesh is the most appropriate material for vaginal implantation. However, literature has suggested that the design and weave of synthetic mesh material can also have a significant effect on efficacy and safety; therefore, the novel design of the KIM may be beneficial to reduce complications. If there is similar efficacy with the RP approach of the KIM sling to the TVT Exact, there will be benefit of reduced costs and the potential for less complications. With this study, the objective is to show non-inferiority of the KIM sling to the Gynecare TVT Exact.

Eligibility Criteria:
Inclusion Criteria:

* Women greater than or equal to 21 years based on medical chart review
* Diagnosis of SUI or mixed urinary incontinence based on medical chart review
* Objective evidence of SUI as indicated by positive cough stress test or urodynamic stress incontinence during urodynamic testing within the last year prior to enrollment. Medical chart will be reviewed.
* Planning surgery for SUI with/without pelvic organ prolapse (POP) surgery

Exclusion Criteria:

* Current pregnancy, desire for future childbearing, less than or equal to 12 months postpartum at the time of enrollment
* Prior history of surgery for SUI based on medical chart review
* Bladder capacity \<200 mL on Urodynamic testing or post-void residual (PVR) \>150 mL on urodynamic testing or bladder scan.
* Non-ambulatory
* Current genitourinary fistula or urethral diverticulum based on pre-operative exam in the medical chart.
Maternal and Infant Health and Breast Milk Study in South China

The purpose of this study was to investigate the nutrients in breast milk of Chinese mothers and its related factors, as well as exploring the early development of infants.

Breast milk contains a variety of nutrients that are beneficial to the early development of infants, such as lipids, Vitamins and so on. At present, the level of these nutrients in milk and infant formula are lower and which are present in a different form from that in breast milk. Therefore, this study was designed to investigate the level of nutrients in breast milk of Chinese mothers and learn about its related factors, as well as exploring the relationships between these nutrients and the early development of infants.

Eligibility Criteria:
Inclusion Criteria:

* age 20-45 years
* natural delivery, singleton pregnancy
* healthy term infants（at 37-42 weeks of pregnancy）
* don't smoke and drink
* self-evaluation as physical health
* breastfeeding at least until three months of age
* Apgar score \> 8
* sign informed consent

Exclusion Criteria:

* suffering from mastitis
* gestational diabetes, hypertension and other metabolic diseases
* AIDS, tuberculosis and other acute or chronic infectious diseases
* severe heart and kidney diseases
* mental system diseases
* cancer and other malignant consumptive disease
* take drugs that affect nutrient metabolism
* infants with congenital and genetic diseases
* with lactation contraindications
* don't agree to sign informed consent
Effect of Transcranial Direct Current Stimulation on the Voice

The goal of this clinical trial is to verify the effect on the voice of transcranial direct current stimulation (tDCS) in vocally healthy non-singers. The main question it aims to answer is: What is the brain area in which tDCS promotes better vocal performance in vocally healthy individuals? Each participants received anodal tDCS applied at an intensity of 2 mA for a duration of 20 minutes for tDCS stimulations in different areas with a 7-day washout period between stimulations. Vocal assessments was conducted before and after the intervention. The targeted places were the primary motor cortex (M1), primary somatosensory cortex (S1), Cerebellum, and dorsolateral prefrontal cortex (DLPFC).

Recently, non-invasive brain stimulation (NIBS) techniques , including transcranial direct current stimulation (tDCS), have been employed to enhance vocal skills. tDCS can be used to temporarily and reversibly modulate brain functions and is an increasingly popular tool for investigating the relationships between the brain and behavior . The aim of the present study is investigate the effect of tDCS applied to different areas on the voice of vocally healthy non-singers. This is a randomized crossover clinical trial, approved by the Research Ethics Committee of the Federal University of Pernambuco, number 5,758,856. Vocally healthy people from the city of Recife and its Metropolitan Region, aged between 18 and 45 years, participated in the study.Each participant underwent four tDCS stimulations in different areas with a 7-day washout period between stimulations to study their vocal assessments before and after tDCS. The targeted places were the primary motor cortex (M1), primary somatosensory cortex (S1), Cerebellum, and dorsolateral prefrontal cortex (DLPFC). All participants were subjected to voice acessments analysis immediately before and after tDCS application in each area. Data normality will be analyzed using the Shapiro-Wilk test, rejecting the hypothesis of normal distribution when p\<0.05. ANOVA will be applied to design repeated measures in case of normality and in the existence of asymmetric data, Friedmann's ANOVA will be used for repeated measures. For the comparison of values before and after application of the technique and between modes of execution of the technique (with and without non-invasive neuromodulation), tests will be applied for related and independent samples, respectively, with a significance level of 5%

Eligibility Criteria:
Inclusion Criteria:

* Non-singers with healthy voice

Exclusion Criteria:

* Smokers
* Those who present signs and symptoms of laryngeal, pharyngeal or respiratory diseases at the time of collection
* Volunteers who make regular use of neuroactive drugs
* Those who have metallic implants or a pacemaker
* People that have any history of seizures or epilepsy
The Effect of Reiki on Symptom Control and Quality of Life in Breast Cancer Patients

The aim of this study is to examine the effect of Reiki on symptom control and quality of life in breast cancer patients.

Breast cancer is the world's second most common type of cancer, the most frequently diagnosed cancer in women, and the leading cause of cancer death. Energy therapies have an essential place in complementary and alternative treatments that are commonly used in breast cancer patients. Reiki, practiced by trained practitioners, is performed by activating the body's energy centers, including blood and lymph circulation, and stimulating the nervous system, thus providing energy circulation and providing mental-physical relaxation, positively affecting health. The effect of Reiki on cancer patients has been shown in studies that it can relieve pain, reduce anxiety and depression, improve quality of life and reduce fatigue.

In this study, women with stage 3 and 4 metastatic breast cancer who were diagnosed with breast cancer for at least 3 months and received at least two cycles of chemotherapy in the outpatient chemotherapy unit of the Medical Oncology outpatient clinic of a training and research hospital will be included. It is aimed to reach a total of 52 women who meet the inclusion criteria and agreed to participate in the study between February 1, 2023, and July 30, 2023. Patient Descriptive Information Form, Edmonton Symptom Diagnosis Scale (ESTO), and European Association for Cancer Research and Treatment BR23 Quality of Life Scale (EORTC-QLQ-BR232) preliminary tests will be applied to all women. Patients will be randomized 1:1 into groups by a single therapist according to the block randomization method. Under the guidance of a researcher holding a Usui Reiki Master \& Teacher degree, a total of 26 patients in the intervention group will be given a short 30-minute application to energy centers by researchers with a second-degree Reiki practitioner. On the second and on third days, 30 minutes of short Reiki will be done remotely. No treatment will be applied to 26 patients in the control group. Post-tests will be applied to all patients 3 days and 10 days after they were included in the study.

Eligibility Criteria:
Inclusion Criteria:

* Women with at least 3 months of breast cancer diagnosis, at least two cycles of chemotherapy, and stage 3 and 4 metastatic breast cancer.

Exclusion Criteria:

* Those who have difficulty in responding to the data collection form to be used in the research and have problems in understanding and communicating Turkish,
* Those who refuse to answer the Reiki application and data collection tools,
* Those who want to leave the research while the research is continuing,
* Those who received any supplementary application in the last 6 months will be excluded from the study.