cyrilzakka/clinical-trials huggingface dataset:
New Assessment System in Measuring Symptom Distress in Cancer Patients

This trial studies how well a new assessment system (MDASI or other MD Anderson-developed PRO instrument) works in measuring symptoms and the impact on quality of life in cancer patients. Development of a new assessment system may provide more information about the common symptoms that may occur in patients due to cancer and its treatment and how the symptoms impact quality of life.

PRIMARY OBJECTIVES:

I. To examine how the MD Anderson Inventory (MD Anderson Symptom Inventory \[MDASI\]) or other MD Anderson-developed patient reported outcome (PRO) instrument performs in various sample populations including community dwelling adults and patients who have different cancer types, who have undergone various treatments, and who have different and/or more severe symptoms.

II. To evaluate the MDASI or other MD Anderson-developed PRO instrument as an estimate of functional status and quality of life.

III. To assess the impact of symptom severity on standard function and health-related quality of life measures, including both quantitative and qualitative measures (patient interviews).

IV. To assess the pattern and severity of symptoms over multiple time points in order to assay the system's responsiveness to changes due to therapy or disease.

V. To explore the utility of an interactive voice response (IVR) system in enhancing the clinical care of outpatients.

VI. To explore the effect of information from an IVR symptom assessment system on the pattern of care and development of interdisciplinary protocols.

VII. To explore the feasibility of developing symptom management pathways for patients based on these symptom and quality of life data.

OUTLINE:

Participants complete questionnaires and quality of life assessments, and may also complete interviews over 45 minutes periodically.

Eligibility Criteria:
Inclusion Criteria:

* NORMAL SAMPLES: Community dwelling adults 18 years of age or older
* PATIENT SAMPLES: Inpatients and outpatients 18 years of age or older, being followed at UT MD Anderson
* EXPERT PANEL PROFESSIONAL PARTICIPANTS: Physician or other healthcare provider with at least 5 years of experience caring for patients with the disease and/or treatment of interest, at least one publication in the last 5 years dealing with the disease and/or treatment of interest (physician only), ability to speak and read English, consent to participate
* EXPERT PANEL FAMILY CAREGIVERS PARTICIPANTS: Identification as a family caregiver by patient enrolled as expert panel participant with the disease and/or treatment of interest, 18 years of age or older, ability to speak and read English, consent to participate
* EXPERT PANEL PATIENT PARTICIPANTS: Patient with identified family caregiver participating on Expert Panel, willingness to receive packet for expert panel participation

Exclusion Criteria:

* EXPERT PANEL PATIENT PARTICIPANTS: Patient with identified family caregiver participating on expert panel, willingness to receive packet for expert panel participation
Glycemic Control and Retinal Microvascular Changes

The goal of this prospective, observational study is to compare in the association of glycemic control and retinal microvascular changes in patients with type 2 diabetes mellitus (T2DM) without diabetic retinopathy (DR).

The main question it aims to answer are:

• Do degenerative changes in retinal microvasculature or nerves depend on glycemic control even before diabetic retinopathy is detected?

Participants will receive an annual routine comprehensive examination including ultra-widefield fundus photography, spectral domain optical coherence tomography (OCT), and swept-source optical coherence tomography angiography (OCTA).


Eligibility Criteria:
Inclusion Criteria:

* The study included 30-70-year-old patients with T2DM without known DR at baseline who underwent regular screening for DR at the department of ophthalmology.
* Who underwent regular checkups for DR between January 2019 and August 2022 at Dongguk University Ilsan Hospital.
* The controls included patients without DM who presented for regular ophthalmic examination.

Exclusion Criteria:

* patients with a history of retinal or choroidal diseases (i.e., age-related macular degeneration, retinal vein occlusion, uveitis, retinal detachment, and central serous chorioretinopathy), glaucoma, or optic neuropathy
* patients with neurodegenerative diseases, such as Parkinson's disease and dementia.
Comparison of Effects of Motor, Sensory and Cognitive Exercises on Falls Prevention

Motor, sensory, and cognitive functions all contribute to balance maintenance, and age causes deterioration in these functions with associated declines in balance ability and accidental falls. Relatively speaking, the sensory and cognitive functions are "invisible" in designing falls-prevention programs. The relative proportions of training of motor, sensory, and cognitive functions, for the most efficient falls-prevention program is a practical and important issue but has not been studied yet by directly comparing their intervention effects.

This three-year project aims to provide evidence base for relative proportions of motor, sensory, and cognitive training when designing falls-prevention programs. The crossover randomized controlled trial (RCT) will recruit 120 community-dwelling elderly adults from local community centers. There will two experimental groups- sensory and cognitive training, one control group- motor training, each for 60 minutes per session, 3 times a week, for 16 weeks. The three groups will be trained with task-oriented design of balance exercise but focusing on different aspects, i.e., training will begin in the ICF body function level (focusing on motor, sensory, or cognitive function) in the stance position and will end in the ICF activity level (balance or mobility activities focusing on motor, sensory, or cognitive function). The primary outcome measures are rates of falls and near-falls in the ICF participation level, and the secondary measures are balance/mobility performance and risk of falling in the ICF activity level.

In Taiwan, a great amount of expense is paid to prevent falls in the community setting. Through better understanding of the comparative intervention effects between motor, sensory, and cognitive training, this project hope to be able to suggest the relative proportions of motor, sensory, and cognitive training in falls-prevention exercise design.


Eligibility Criteria:
Inclusion Criteria:

* (1) older than 60 years of age, (2) living in the community, (3) scored more than two in Mini-Cog assessment \[51\], and (4) able to walk independently or with minimal assistance in the community

Exclusion Criteria:

* (1) an injury or musculoskeletal system disorder that would hamper their ability to conduct the physical tests, (2) acute heart attack in recent 3-6 months or unstable angina, (3) uncontrolled atrial or ventricular arrhythmias, (4) aortic dissecting aneurysm, (5) severe aortic stenosis, (6) acute endocarditis/pericarditis, (7) uncontrolled blood pressure higher than 180/110 mmHg, (8) acute thromboembolism, (9) acute or severe heart failure, (10) acute or severe respiratory failure, (11) uncontrolled postural hypotension, (12) uncontrolled acute decompensated diabetes mellitus or low blood sugar, (13) any other circumstance the doctors believe prevents dosing physical activity.
Effect of Nutrition Training on Mothers' Nutrition Pattern, Breast Milk and Newborn Intestinal Microbiota

Objective: The aim of this study was to investigate the effects of nutrition Training on mothers' nutrition pattern, breast milk and newborn intestinal microbiota.

Materials and methods: The study was conducted as a non-randomized controlled experimental study. The population of the study consisted of mothers and their babies who delivered vaginally, breastfeeded their babies at the end of the second postnatal day and delivered at the maternity ward of the Malatya Training and Research Hospital Beydağı Campus. The sample of the study consisted of 120 mothers, 57 of whom were experimental and 63 of them were in the control group. In this study, a sub-sample of 15 mothers and their infants was selected and microbiota of breast milk and stool samples were examined.

In the first interview with the mothers in the experimental and control groups, Participant Identification Form, BTSKF were applied as a pre-test and stool samples of breast milk and newborn were taken. Then, the mothers in the experimental group were given nutritional education. In addition, motivational messages were sent to mothers' phones once a week. MTS in the experimental and control groups were filled with BTSKF as an intermediate test at the first month and post-test at the third month and stool samples of breast milk and newborn were collected at the mothers' own homes. During these visits, nutrition counseling was given to the mothers in the experimental group.

Nutrition is very important from intrauterine life to old age for a healthy and productive life. However, the importance of pregnancy, childbirth and breastfeeding during the special stages in which the woman is experienced in her life process increases slightly (Ho et al., 2016; Erick, 2018; Tekiner and Ungan, 2014). Healthy nutrition is a key concern for the health of the baby during pregnancy, childbirth and breastfeeding periods as well as the health of the mother (Taşkın, 2016; Samur, 2008). Intrauterine life is transmitted by placental way and in the postpartum period, breast milk is fed to the baby. Therefore, in order to ensure optimal growth and development of the baby, the mother needs adequate, regular and quality nutrition (Ho et al., 2016; Erick, 2018; Tekiner and Ungan, 2014).

Eligibility Criteria:
Inclusion Criteria:

* Being literate,
* Being within 48 hours after delivery,
* No disease / complications in mother and newborn,
* Delivery at term (according to the first day of the last menstrual period).

Exclusion Criteria:

• A mother's inability to breastfeed her baby for a variety of reasons, either short or long term (mastitis, abscess).
Effects of Blood Flow Restriction Training on Exercises in Healthy Individuals.

Partial restriction of blood flow to working muscles during exercise is proven to increase muscle mass and strength even with low-intensity of exercise. Blood Flow Restriction Training (BFRT) is also beneficial to improve the maximum rate of oxygen consumption (VO2max), bone health, and vascular health. Recent studies focus on its effects beyond the musculoskeletal system. Post-exercise hypotension is a known acute physiological response that happens after intense exercise. Early studies demonstrated BFRT might amplify the acute hypotensive effects with low intensity of exercise. However, it's not clear what type of exercise would help to lower blood pressure when it is combined with BFRT.

Partial restriction of blood flow to working muscles during exercise is proven to increase muscle mass and strength even with low-intensity of exercise. Blood Flow Restriction Training (BFRT) is also beneficial to improve the maximum rate of oxygen consumption (VO2max), bone health, and vascular health. Recent studies focus on its effects beyond the musculoskeletal system. Post-exercise hypotension is a known acute physiological response that happens after intense exercise. Early studies demonstrated BFRT might amplify the acute hypotensive effects with low intensity of exercise. However, it's not clear what type of exercise would help to lower blood pressure when it is combined with BFRT. Considering BFRT, it's safe to implement among hypertensive individuals as per recent studies. It's still unclear what type of exercise would benefit maximum in reducing blood pressure while using it along BFR. The study aims to determine whether BFRT can influence BP, MAP, HR, and muscle girth differently while doing resisted exercises and aerobic exercise. Understanding the effects of BFRT on these parameters can provide valuable insights for optimizing exercise protocols and improving overall health outcomes. In general, this study can also add to the increasing amount of studies about the possible advantages and drawbacks of BFRT, and provide guidance on how to design exercise programs for people with borderline hypertension or in those with early phase of hypertension.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults of both gender, between the ages of 18 and 35 years
* Adults who are not participating in any regular exercise/fitness programmes for the last three months

Exclusion Criteria:

* Adults with previous history of cardiovascular diseases, or with pathological changes in ECG
* Adults with concomitant illness such as diabetes, hypertension, or kidney diseases
* Chronic smokers or alcoholics
* Those with recent history of injury to lower limbs or with implants in lower limbs
An Exploratory Study of Naltrexone Plus Aripiprazole for Alcohol Dependence

The principal aim of this exploratory study is to examine whether the addition of aripiprazole to naltrexone will enhance efficacy over naltrexone alone in a 16-week randomized, placebo-controlled clinical trial, in which all subjects will be provided medical management as delivered in the COMBINE Study (Anton et al, 2006). To test whether medication treatment will reduce drinking compared to placebo treatment alone in the context of medical management and whether naltrexone plus aripiprazole will reduce drinking compared to naltrexone treatment alone in the context of medical management.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 70
2. Subjects will meet criteria for primary alcohol dependence operationalized as follows:

   A. Meets the DSM IV criteria for alcohol dependence including loss of control over drinking (criterion 3) B. Has not had more than one previous inpatient medical detoxification
3. Consumes, on average, at least 10 standard drinks per drinking day for men and 8 drinks per day for women in the 90 days pre-screening (to select an appropriately heavy drinking population)
4. Able to maintain sobriety for four days (with or without the aid of alcohol detoxification medications) as determined by self report, collateral report, and breathalyzer measurements
5. Able to read and understand questionnaires and informed consent
6. Lives within approximately 50 miles of the study site -

Exclusion Criteria:

1. Currently meets DSM IV criteria for any other psychoactive substance dependency disorder except nicotine dependence
2. Ever abused opiates
3. Any psychoactive substance abuse, except marijuana and nicotine, within the last 30 days as evidenced by subject report, collateral report, or urine drug screen
4. Meets DSM IV criteria for current axis I disorders of major depression, panic disorder, obsessive compulsive disorder, post traumatic stress syndrome, bipolar affective disorder, schizophrenia, or any other psychotic disorder or organic mental disorder
5. Meets DSM IV current criteria for dissociative disorder or eating disorders
6. Has current suicidal ideation or homicidal ideation
7. Need for maintenance or acute treatment with any psychoactive medication including anti-seizure medications
8. Current use of disulfiram
9. Clinically significant medical problems such as cardiovascular, renal, GI, or endocrine problem that would impair participation or limit medication ingestion
10. Hepatocellular disease indicated by elevations of SGPT (ALT) and SGOT (AST) of at least 3.0 times normal at screening and/or after 5 days abstinence
11. Sexually active female of child-bearing potential who is pregnant (by urine HCG), nursing, or who is not using a reliable form of birth control
12. Has current charges pending for a violent crime (not including DUI-related offenses)
13. Does not have a stable living situation and a reliable source of collateral reporting
14. Has taken an opiate antagonist drug in the last month
15. Has taken aripiprazole in the last month or has experienced adverse effects from it at any time in the past
Effects of an Exercise Program in Women Over 60 yr. With HFpEF and Sarcopenia on Functional Capacity and Quality of Life

This prospective study will randomize (1:1) women with heart failure with preserved ejection fraction (HFpEF) and sarcopenia to receive standard management alone or a combined 12-week supervised exercise program (combining aerobic and strength exercise) carried out in a single centre.

After randomization, patients will be clinically evaluated. The primary endpoint (peakVO2) will be assessed by cardiopulmonary exercise testing (CPET) at 12 weeks. Women over 60 with HFpEF, functional class NYHA class II-III, and sarcopenia criteria will be enrolled. A sample size estimation \[alfa: 0.05, power: 80%, a 20% loss rate, and at least a delta change of mean peakVO2: +1.9 mL/kg/min (SD±2)\] of 40 patients (20 per arm) would be necessary to test our hypothesis.

Heart failure with preserved ejection fraction (HFpEF) is a highly prevalent clinical entity that predominantly affects women, whose incidence has increased in the last decade and has a complex and multifactorial pathophysiology. Sarcopenia, a prevalent concurrent condition, appears to be associated with reduced muscle strength and reduced maximal functional capacity.

Supervised training programs in patients with heart failure with reduced ejection fraction and sarcopenia have improved functional capacity. However, the researchers do not have evidence about the effects of a supervised training program on patients with HFpEF and sarcopenia, mainly when affecting women older than 60. This work aims to evaluate the effect of a 12-week supervised exercise program in patients with HFpEF and sarcopenia on maximal functional capacity evaluated by peak oxygen consumption (peakVO2).

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with heart failure with preserved ejection fraction according to 2021 ESC guidelines for Heart Failure, with N-terminal pro-B-type natriuretic peptide (NT-proBNP) \>125 pg/mL, inthe last month.
* Stable symptomatic heart failure patients (New York Heart Association functional class II-III) during the last month.
* Age ≥ 60 years old.
* The participant is willing to give informed consent to participate in the study.
* SARC-F score ≥4 points.

Exclusion Criteria:

* Inability to perform a valid baseline cardiopulmonary exercise test.
* Cardiac pacemaker.
* Significant primary moderate-to-severe valve disease.
* Effort angina or signs of ischemia during CPET.
* Primary cardiomyopathies.
* Cardiac transplantation.
* Any other comorbidity with a life expectancy of less than one year.
Comparison of Two New Generation Dressings in Intensive Care (ADVANCED)

Intravascular devices in intensive care units are often associated to complications. The investigators estimate that 23.5% of catheters placed and used in intensive care are subject to at least one complication; the investigators goal is to demonstrate the effectiveness of the new Tegaderm ™ IV Advanced dressings to achieve a decrease of 35% in the number of complications associated with intravascular catheters in intensive care.

randomized controlled trial of 2 intravascular dressings in Intensive care unit

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years with a central venous catheter, an arterial catheter, a hemodialysis catheter, a Swan Ganz catheter or a peripheral catheter inserted in the ICU or within the 24 before their arrival at the ICU in another ICU setting.
* Patients benefiting from the social security protection.

Exclusion Criteria:

* Patients under 18 years of age,
* Patients having known allergy or sensitivity to adhesive dressing materials
NonNarcotic Pain Control in Percutaneous Needle Tenotomy of Elbow

This study is a double-blind, randomized controlled trial comparing the effectiveness of oral acetaminophen, diclofenac, and tramadol in reducing the consumption of narcotic doses (primary outcome) and minimizing patients' exposure to narcotics (secondary outcome) following an ultrasound-guided percutaneous needle tenotomy procedure on the lateral elbow.

Tramadol is currently the standard post-procedure medication. Acetaminophen will be prescribed (1000 mg) and should be taken every 8 hours if pain is present. Tylenol should be the first taken for pain. If pain persist, the study kit containing the blinded, pain-controlled capsules will be taken second. Both diclofenac potassium (50mg) and tramadol (50mg) will be provided in identical-looking capsules and randomly assigned to patients in sealed packets by a physician, ensuring the double-blind nature of the study and be instructed to use every 8 hours as needed for pain If pain is still not adequately controlled an hour after taking the blinded study pack, a rescue medication, consisting of tramadol 50mg capsules, will also be supplied to the NSAID group in sealed packets while rescue medication of oral diclofenac will be provided to the opioid group. These medications will be administered immediately after the tenotomy procedure to all participants. The primary endpoint of the study will be the total count of tramadol doses taken by each group at the 10 day (± 4 days) postoperative follow-up. Pill counts from sealed packages and the use of rescue narcotics will be verified during the in-person visit at 10 days (± 4 days) .

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female, aged 18-65 years
* Percutaneous Needle Tenotomy of Lateral Elbow Procedure
* Ability to take oral medication and willingness to participate in a 2-week follow-up pill counts
* Musculoskeletal ultrasound or MRI with diagnosis of tendinosis of the common extensor tendon of the elbow

Exclusion Criteria:

* • Any full thickness common extensor tendon tear of the elbow

  * Prior history of elbow surgery
  * Symptomatic cervical radiculopathy
  * Concurrent symptoms of the medial elbow
  * Treatment with another investigational drug or other intervention concurrently or previously that would interfere with postoperative pain control
  * Psychiatric illness that impedes evaluation of pain and/or narcotics use
  * No history of inflammatory arthritis, diabetes, chronic regional pain syndrome, connective tissue disease, fibromyalgia or autoimmune disease
  * No contraindications to NSAIDs or Opioids
Clinical Evaluation of a Test for Monitoring Patients Diagnosed With Chronic Myeloid Leukemia (CML)

The objective of this study is to establish the performance of an assay that detects mRNA transcript levels in patients diagnosed with CML. The study is conducted at locations within the United States. Testing is performed on peripheral blood specimens provided by eligible enrolled patients. Results from this study will not be used for patient management decisions.


Eligibility Criteria:
Inclusion Criteria:

* prospective specimens:

  * Patient is at least 18 years of age
  * Patient has provided documented informed consent as required by the reviewing IRB. Experimental Bill of Rights will also be documented for all subjects enrolled in applicable states.
  * Patient has been diagnosed with CML.
  * Patient consents to provide at least 12 mL of peripheral blood for study purposes
* frozen specimens:

  * Specimen is from a subject diagnosed with CML
  * Specimen meets the manufacturer's criteria to support testing by both diagnostic assays

Exclusion Criteria:

* prospective specimens:

  * Patient is considered to be of insufficient health to supply the required volume of peripheral blood by his/her health care provider
  * Patient has been previously enrolled
* frozen specimens: • Specimen previously enrolled