cyrilzakka/clinical-trials huggingface dataset:
Continuous MONItoring of Blood LActate and Glucose Levels Using a New Central Veinous Microdialysis Catheter Device

Continuous lactate and glucose blood levels

MAQUET Group offers a new device that gives real time blood lactate and glucose levels. It is a new central veinous catheter with a microdialysis system. It is planted in the superior vena cava. It has not yet been used and validated with a clinical purpose, and particularly in cardiac surgery.

For now, reference method for determining blood lactate and glucose levels is co oxymetry.

This new simple device could provide great fluency for determining blood lactate and glucose levels. It could allow medical teams gain time for diagnosis and treatment of both hyperlactatemia and hyperglycemia.

The primary outcome of this study was to compare blood lactate and glucose absolute measures provided with the MAQUET new device (Maquet Critical Care AB, Solna, Sweden) and with co oxymetry.

The secondary outcome of this study was to compare variations of these absolutes measures.

Eligibility Criteria:
Inclusion Criteria:

* Men or women more than 18 years old.
* Cardiac surgery.
* Central veinous catheter in superior vena cava.

Exclusion Criteria:

* Men or women less than 18 years old.
* Pregnant women.
* Central veinous catheter not in superior vena cava.
Educational Program to Improve Heart Failure Outcomes in Adults Living in Rural Areas

Heart failure patients living in rural areas usually do not have adequate access to formal heart failure management programs. This study will compare two versions of an educational intervention aimed at improving self-care management techniques among individuals with heart failure who are living in rural areas.

Heart failure is a life-threatening condition in which the heart can no longer pump enough blood to the rest of the body. It is important for individuals with heart failure to closely monitor their symptoms and seek out medical attention when appropriate. Swelling and weight gain are common heart failure symptoms that indicate excess fluid buildup in the body and worsening heart function. Closely monitoring and responding to these symptoms can be a strategic way to prevent heart failure exacerbations. However, many patients ignore symptoms and are reluctant to seek care. Specialized monitoring programs can help heart failure patients to respond more appropriately to their symptoms.

Traditionally, heart failure patients living in rural areas have had limited access to formal monitoring programs. Fluid Watchers is a program designed to help heart failure patients living in rural areas improve self-management of symptoms, specifically excess fluid buildup. The purpose of this study is to compare the effectiveness of two versions of Fluid Watchers at improving the hospitalization and death rates of individuals with heart failure who live in rural areas.

In this 2-year study, 710 participants will be randomly assigned to either the Fluid Watchers LITE program, the Fluid Watchers PLUS program, or a usual care control group. Individuals in both Fluid Watchers groups will attend a one-on-one educational session that will include heart failure counseling and information on self-monitoring and care-seeking strategies. Participants in the PLUS program will receive additional counseling, audio tapes, and follow-up telephone calls on a biweekly basis. All participants will record self-monitoring adherence and contact with healthcare providers. Outcome measures will be assessed during either clinic or home visits at study entry and Months 3, 12, and 24, and will include number of emergency department visits, number of physician visits, heart failure severity, and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized for heart failure in the 6 months prior to study entry
* Able to read and write English
* Lives independently

Exclusion Criteria:

* Current participation in a heart failure management program
* Impaired cognition
* Serious co-morbidity
Comparison of Intra-operative Radiotherapy With Post-operative Radiotherapy for Women With Ductal Carcinoma in Situ

Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation during surgery followed by external-beam radiation to the entire breast may kill more tumor cells.The clinical trial is conducting to compare the effectiveness of radiation therapy during surgery and whole-breast radiation therapy in treating women who have undergone breast-conversing surgery for Intermediate or high grade ductal carcinoma in situ breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Tumor diameter \< 5 cm
* Intermediate or high grade ductal carcinoma in situ
* Informed consent

Exclusion Criteria:

* No informed consent
* Tumor size \> 3,5 cm
* Low grade ductal carcinoma in situ
* Invasive carcinoma
* No indication for a boost
Randomized Evaluation of Strategic Intervention in Multidrug Resistant Patients With Tipranavir (RESIST)

Demonstrate the safety and efficacy of Tipranavir/Ritonavir versus an active treatment regimen in highly treatment experienced Human Immunodeficiency virus 1(HIV-1) infected patients.


Eligibility Criteria:
Inclusion Criteria:

Patients meeting the following criteria will be eligible for participation in th is study:

1. Human Immunodeficiency virus 1 (HIV-1) infected males or females \>=18 years of age.
2. Screening genotypic resistance report indicating both of the following: at least one primary protease Inhibitor (PI) mutation at the following sites:

30N, 46I/L, 48V, 50V, 82A/F/L/T, 84V or 90M, and no more than two protease mutations on codons 33, 82, 84, or 90.

3. At least 3 consecutive months experience taking antiretrovirals (ARVs) from each of the classes of nucleoside reverse transcriptase inhibitors(NRTI(s)), non-nucleoside reverse transcriptase inhibitors(NNRTI(s)), and protease inhibitors (PIs) at some point in treatment history,with at least 2 protease inhibitor (PI)-based regimens, one of which must be the current regimen, and current protease inhibitor (PI)-based antiretroviral (ARV) medication regimen for at least 3 months prior to randomization.

4. Human Immunodeficiency Virus 1 (HIV-1) viral load \>=1,000 copies/mL at screening.

Exclusion criteria:

Patients with any of the following criteria are excluded from participation in t he study:

1. Antiretroviral (ARV) medication naïve.
2. Patients on recent drug holiday, defined as off antiretroviral (ARV) medications for at least 7 consecutive days within the last 3 months.
3. alanine aminotransferase (ALT) \>=3.0x upper limit of normal (ULN) and aspartate aminotransferase(AST) \>=2.5x upper limit of normal (ULN) (\>=Division of AIDS(DAIDS) Grade 1) at either screening visit.
Blood Pressure Variability and Cardiovascular Disease Events in Patients With Hypertension

Cardiovascular Disease (CV) including stroke is the leading cause of death in Malaysia Hypertension is a major contributor to this. Prevalence of hypertension in Malaysia is high (42%) in adults age 30 years or older. Besides the actual blood pressure (BP) level recently, blood pressure variability (BPV) has been recognized as an independent and strong predictor of CV events especially strokes. However, data on the BP variability and its relationship to CV events is very limited in Asia, particularly in Malaysia. Hence the investigators aim to study BPV and its relationship to CV events in treated hypertensive patients

This will be a cross-sectional study on patients with hypertension. The 10-year retrospective data on BP, treatment, biochemical changes, kidney function and CV events will be extracted from patient records.

Eligible patients who have given written informed consent will be given a questionnaire capturing data of their socio-demographic status, weight, height and BP measured.

Those agreeable to measure their own BP at home 3 times a day for a week will be loaned a BP device to measure their own BP at home. The home BP readings will be recorded onto a provided form and returned to the investigators.

Data will be analysed to

1. determine BPV of the clinic visit-to-visit BPV (long tem BPV)
2. determine the day to day BPV (short term BPV)
3. examine the BPV to CV events, kidney function, cognition
4. determine the prevalence of white coat and masked hypertension
5. determine the level of control of BP
6. examine the relationship of ownership of home BP devices to control and satisfaction of treatment

Eligibility Criteria:
Inclusion Criteria:

* Patients on treatment for hypertension of at least 3 years
* Patients who consent to the study

Exclusion Criteria:

* those unable to give consent
* recent (less than 6 months) of cardiovascular events (stroke, heart attack, heart failure)
* patients on dialysis
* patients with end stage kidney failure
Feasibility Study of Supine Breast MRI : Comparison With Prone MRI and Comfort Assessment

The aim of the present study was to determine the prone-to-supine displacement of breast lesions using preoperative prone MRI and supine second-look ultrasound data


Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria were being a woman with breast lesions whose assessment involved breast MRI and ultrasound at our institution. There were no exclusion criteria.

Exclusion Criteria:

-
Mindfulness-based Educational Intervention on Anxiety, Depression, Stress and Quality of Life on Menopausal Woman

Mindfulness-based educational intervention is a structured program that incorporates principles of mindfulness to help individuals develop greater awareness and acceptance of their thoughts, feelings, and bodily sensations. The intervention typically includes mindfulness meditation practices, cognitive-behavioral techniques, and educational components about stress management and emotional regulation. By fostering a non-judgmental and present-focused attitude, participants learn to manage their symptoms more effectively and improve their overall quality of life.

Menopause is a significant transitional phase in a woman's life, often accompanied by various physical, emotional, and psychological challenges. Common issues during menopause include anxiety, depression, stress, and a decreased quality of life. Addressing these concerns holistically is crucial for improving overall well-being. Mindfulness-based educational interventions have gained recognition for their effectiveness in enhancing mental health and quality of life by promoting awareness and acceptance of present experiences. This study investigates the impact of a mindfulness-based educational intervention on anxiety, depression, stress, and quality of life in menopausal women.

Eligibility Criteria:
Inclusion Criteria:

* in age of menopause

Exclusion Criteria:

* age of menarche
* older than 70 years old
Improving Balance in Frail Elderly

The objective of this pilot study is to estimate, for a frail elderly population, the extent to which balance improves following a Core-Strength training program in comparison to a Stretch \& Strength program. A secondary objective is to explore the impact of core strength training on urinary incontinence.

Participants will be randomized to one of the two exercise groups, Core-Strength training group or the Stretch \& Strength group. The exercises will consist of 15-20 minute session for every day they attend the GDH. Measures will be made at admission, after 6 weeks of the program and at discharge if more than past 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* elderly persons attending the geriatric day hospital at the royal victoria hospital

Exclusion Criteria:

* persons who are not medically fit to participate in the Geriatric day hospital physiotherapy component.
* the individuals at high risk for falls
Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Q.3

It has been found that in some cases, when a person with Diabetes Mellitus has an episode of low blood sugar,or hypoglycemia, and then later exercises, he or she is vulnerable to another bout of hypoglycemia during that exercise. The purpose of this study is to determine what factors during the previous bout of hypoglycemia might cause another bout of hypoglycemia while exercising later.

The SPECIFIC AIM of the study outlined in this proposal is to determine if hypoglycemia blunts counterregulatory responses during subsequent exercise in Type 1 Diabetes Mellitus due to physiologic increases in plasma cortisol.

Eligibility Criteria:
Inclusion Criteria:

* Males and females with Type 1 Diabetes Mellitus will be studied. Subjects recruited will be 18-50 years, with an HBA1c less than 9.5%, who have been diagnosed with diabetes for \>5 years, with no clinical evidence of diabetic tissue complications.

Exclusion Criteria:

* Subjects with known prior cardiac events will be excluded from the study. Additional exclusion criteria:

  1. all medical students (Vanderbilt policy)
  2. prior or current history of poor health
  3. abnormal results following blood and physical examination
  4. pregnancy
Overactive Bladder (OAB) Drink Advice Study

The researchers want to investigate how fluid intake influences the symptoms of OAB. The researchers will recruit 45 patients with OAB and randomize them (blind) in 3 groups (low/normal/high fluid intake). Patients will follow this drink pattern for 2-5 days, while filling in an standard micturation diary for 2 days. This micturation diary is coupled to: collection of multiple urine samples, urine pH measurements, and a Perception of Intensity of Urgency Scale (PPIUS) scoring table. All this is collected by the patients themselves. Urine samples will be analysed for osmolality by the clinical chemistry department.


Eligibility Criteria:
Inclusion Criteria:

* OAB patients

Exclusion Criteria:

* benign prostatic hyperplasia
* neurogenic detrusor overactivity
* urine tract infection
* anticholinergics
* intravesical botulin toxin
* cardiac failure
* renal insufficiency
* sacral neurostimulation
* percutaneous neurostimulation
The Role of Genetic Factors in the Development of Idiopathic Osteoarthritis of the Knee in the Kazakh Population

The purpose of this study is to identify genetic determinants of susceptibility to idiopathic osteoarthritis of the knee . It will assist in predicting individual risks of disease progression and would help to clarify pathophysiologic mechanisms of idiopathic osteoarthritis of the knee


Eligibility Criteria:
Inclusion Criteria:

1. Patients with bilateral idiopathic gonarthrosis aged 18 to 65 years;
2. Representatives of the Kazakh ethnic group up to the 3rd generation;
3. Hereditary history of arthrosis;
4. Persons who are able and willing to provide written informed consent;

Exclusion Criteria:

1. Patients with bilateral idiopathic gonarthrosis under 18 years of age and over 65 years of age;
2. Representatives of other ethnic groups;
3. Representatives of the Kazakh ethnic group less than 3 generations;
4. No family history of bilateral idiopathic gonarthrosis;
5. Patients with an acute period of the inflammatory process (laboratory and clinical signs);
6. Persons who, in the opinion of the researcher, are mentally or legally incapacitated, which prevents obtaining informed consent;
7. Pregnant or lactating women;
8. Tuberculosis of any localization in the active phase and in history;
9. Severe and decompensated diseases of the liver and kidneys, cardiovascular system;
10. Severe and decompensated course of endocrine diseases;
11. Autoimmune diseases;
12. Systemic diseases;
13. Oncological diseases;
Neoadjuvant Chemo (Gemcitabine and Cisplatin) With Radical Cystectomy or Radiotherapy in Patients With Bladder Cancer

The purpose of this study is to evaluate efficacy of gemcitabine and cisplatin combined with either radical cystectomy or radiotherapy in the treatment of bladder cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically proven urothelial carcinoma of the urinary bladder in stage T2b-T3, N0/Nx, M0.
* Patients must have measurable disease. Response assessment will be evaluated according to RECIST criteria. Measurable lesions with clearly defined margins will be evaluated by X-Ray, Transvesical Ultrasound, CT-Scan or MRI, cystoscopy.
* Lesions serving as measurable disease must have the longest diameter of greater than or equal to 20 mm as measured with conventional techniques or greater than or equal 10 mm with spiral CT scan. Lesions measured by physical examination must have a longest diameter of greater than or equal 20 mm.

Exclusion Criteria:

* Patients with prior or concomitant malignant diseases (other than appropriately treated basal cell carcinoma of the skin or carcinoma of the cervix)
* PSA greater than 5.0 ng/mL
* Concurrent administration of any other tumor therapy, including radiotherapy, cytotoxic chemotherapy, immunotherapy, molecular target therapy.
Multicomponent Exercise Program on the Intrinsic Capacity (ICOPE) of Community-dwelling Older Adults in Primary Care

A three-branch multi-center randomized clinical trial to be conducted in 6 public Primary Care centers located in the city of Madrid (Spain). A total of 180 older adults (\>=70 years old) presenting with declines in the intrinsic capacity (IC) locomotion domain will be recruited in the participating centers. They will be randomized in a 1:1:1 ratio to a center-based supervised Vivifrail multicomponent exercise (MCE) program, a home-based non-supervised Vivifrail MCE program, or to a control group. The intervention consists of thrice-a-week exercise sessions encompassing strength, aerobic, flexibility, and balance and gait training tailored to the individual's baseline functional ability. IC will be assessed through its operational domains following ICOPE guidelines at baseline and 6 and 12 weeks after the start of the intervention. Secondarily, effects on frailty status and health-related quality of life will be evaluated.

This study might bring new evidence around the ICOPE recommendation on the Vivifrail MCE for the management of IC locomotion declines in Primary Care for the first time. Gaining insight on exercise interventions for IC promotion/maintenance will reinforce current recommendations and contribute to the development of real-world strategies for healthy aging promotion.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥70 years old
* Attending participating primary care centers
* Pre-frailty or frailty according to Fried's criteria
* SPPB \<10
* Barthel Index Score ≥60
* Being able to communicate and ambulate with or without technical aids
* Relative/caregiver willingness to supervise the exercise (if needed)

Exclusion Criteria:

* Major cognitive disorder according to the Diagnostic and Statistical Manual of Mental Disorders V criteria or the Global Deterioration Scale by Reisberg (GDS\>4)
* Physically active individuals (moderate-to-vigorous physical activity greater than 150 minutes per week according current physical activity guidelines for older adults) or those already participating in structured physical exercise programs
* Diagnosis of a terminal illness/life expectancy ≤3months
* Lack of possibility of follow-up
* Institutionalized or awaiting institutionalization
* Any contraindications for physical exercise or testing procedures, including but not limited to: myocardial infarction in the past 6 months; unstable angina pectoris; uncontrolled arrhythmia; unstable cardiovascular disease or other unstable medical condition; uncontrolled arterial hypertension; recent pulmonary thromboembolism; upper or lower extremity fracture in the past 3 months
Web-Based Self-Monitoring Activity-Restriction and Relaxation Training Program for Kids With Mild Traumatic Brain Injury

SMART is an interactive web-based program that will allow youth with mild traumatic brain injuries (mTBI) to monitor their symptoms and receive education on problem-solving and coping strategies. This study will evaluate the effectiveness of SMART as a means of improving symptom-management, coping skills, and general well-being during recovery from mTBI. Half of participants will receive the SMART intervention, while half will receive usual care.


Eligibility Criteria:
Inclusion Criteria:

* 11-18 years old
* Sustained mTBI within the past week

Exclusion Criteria:

* Patient and/or family do not speak and read English
* Patient and/or family do not have Internet access
* Patient experiencing more severe brain injury (Glasgow coma score \<13)
* Patient with more than one moderate extracranial injury
* Patients with non-mTBI reasons for altered mental status
* Patients with severe pre-existing neurologic or cognitive disorders or other disorders that may impair ability to participate in the intervention.
Yoga and Mindfulness for Chronic Low Back Pain: A Randomized Controlled Trial

Chronic low back pain (CLBP) is a leading cause of disability, significantly impacting quality of life and work productivity. Traditional treatments often provide limited relief, necessitating alternative approaches. This multicenter, parallel-arm, randomized controlled trial (RCT) aims to evaluate the efficacy of Sphinx Pose Yoga Therapy (Yoga), Mindfulness-Based Stress Reduction (MBSR), and their combination in managing CLBP among healthcare providers (HCPs).

Participants will be randomly assigned to one of four groups:

Group A (Yoga Therapy): Sphinx Pose Yoga therapy, practiced three times per week.

Group B (MBSR): Weekly mindfulness meditation, body scan, and gentle stretching.

Group C (Usual Care): Standard treatment guidelines as per The Back Book. Group D (Combined Yoga \& MBSR): Integrated approach, practiced twice per week. The study will assess pain intensity, functional disability, quality of life, physiological markers, mental health, and heart rate variability. Outcomes will be measured at baseline (Week 0), post-intervention (Week 12), and follow-up (Week 24). The trial aims to determine whether Yoga, MBSR, or their combination provides superior benefits over usual care in CLBP management.


Eligibility Criteria:
Inclusion Criteria:

* Both genders between 25 to 45 years of age.
* Subjects having low back pain complaints and have visited the healthcare provider in recent days.
* Numerical Pain Rating (NPR) scale score ≥ 2 for their pain intensity.
* Roland Morris Disability Questionnaire subject's score should be ≥ 4.
* Fear Avoidance Beliefs Questionnaire (FABQ) work subscale score must be \< 19.

Exclusion Criteria:

* Subjects with high risk for physical injuries during exercise.
* Pregnant and/or lactating females.
* Subjects with musculoskeletal disorders.