cyrilzakka/clinical-trials huggingface dataset:
Early Palliative Care Integration in Interventional Cancer Care

A mixed methods randomized control trial assessing the impact of early palliative care incorporation in liver cancer and metastatic colorectal cancer on caregiver well-being, patient physical and psychosocial outcomes, and health services utilization.

The purpose of this project is to conduct a mixed-methods study of the impact of early integration of palliative care in interventional oncology on three outcomes of interest:

1) caregiver well-being, 2) patient physical and psychosocial outcomes, and 3) health services utilization and costs. Palliative care focuses on providing patients with serious illnesses and their families with physical, emotional, social, practical, and spiritual support. Recent trials examining the integration of palliative care in cancer care have individually shown improvement in patient symptoms and quality of life, reduction of caregiver burden, and/or health services costs. These studies, however, have not collectively analyzed these impacts.Further, a recent study shows that integrating palliative care early in lung cancer care has proven beneficial to both patients and caregivers. Given the potential of this previous body of research, the proposed study offers a comprehensive analysis of the early integration of palliative care on caregiver well-being, patient's physical and psychosocial outcomes when living with liver and metastatic colorectal cancer (mCRC), and health services utilization. This study thus broadens the scope to additional cancer types and degrees of progression.

Eligibility Criteria:
Inclusion Criteria:

- Patients over 18 years of age with a confirmed diagnosis of liver cancer or metastatic colorectal cancer requiring treatment from the IR team.

Exclusion Criteria:

- None
Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol

This is a Phase III, placebo-controlled, double-blind, randomized study in participants with ASCVD and elevated LDL-C despite maximum tolerated dose of LDL-C lowering therapies to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) inclisiran injection(s). The study will be a multicenter study in the United States.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female participants ≥18 years of age.
2. History of ASCVD (coronary heart disease \[CHD\], cardiovascular disease \[CVD\], or peripheral arterial disease \[PAD\]).
3. Serum LDL-C ≥1.8 millimole (mmol)/liter (L) (≥70 mg/dL).
4. Fasting triglyceride \<4.52 mmol/L (\<400 mg/dL) at screening.
5. Participants on statins should be receiving a maximally tolerated dose.
6. Participants not receiving statins must have documented evidence of intolerance to all doses of at least 2 different statins.
7. Subjects on lipid-lower therapies (such as a statin and/or ezetimibe) should be on a stable dose for ≥30 days before screening with no planned medication or dose change during study participation.

Exclusion Criteria:

1. New York Heart Association (NYHA) class IV heart failure.
2. Uncontrolled cardiac arrhythmia
3. Uncontrolled severe hypertension
4. Active liver disease
5. Females who are pregnant or nursing, or who are of childbearing potential and unwilling to use at least 2 methods of highly effective contraception (failure rate less than 1% per year) (for example, combined oral contraceptives, barrier methods, approved contraceptive implant, long-term injectable contraception, or intrauterine device) for the entire duration of the study. Exemptions from this criterion:

   1. Women \>2 years postmenopausal (defined as 1 year or longer since last menstrual period) and more than 55 years of age.
   2. Postmenopausal women (as defined above) and less than 55 years of age with a negative pregnancy test within 24 hours of randomization.
   3. Women who are surgically sterilized at least 3 months prior to enrollment.
6. Males who are unwilling to use an acceptable method of birth control during the entire study period (such as condom with spermicide).
7. Treatment with other investigational products or devices within 30 days or 5 half-lives of the screening visit, whichever is longer.
8. Treatment (within 90 days of screening) with monoclonal antibodies directed towards PCSK9

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Low Grade Inflammation, Gut Microbiota and Barrier Function in Elderly Humans

Cardiovascular diseases (CVD) are the main cause of death in the European Union. A large part of the aging process, including immunosenescence, is explained by an imbalance between inflammatory and anti-inflammatory networks, wich results in the low grade chronic pro-inflammatory status termed inflammaging. It can contribute to a number of age-related chronic diseases (e.g. atherosclerosis, type 2 diabetes, Alzheimer disease, osteoporosis). Prevention or delay in onset of chronic diseases can potentially benefit a large segment of the elderly population. Now it is hypothesised that a probiotic drink can reduce low-grade inflammation through improvement of the gut barrier function and gut microbiota composition in elderly people with low-grade inflammation.

Cardiovascular diseases (CVD) are the main cause of death in the European Union. A large part of the aging process, including immunosenescence, is explained by an imbalance between inflammatory and anti-inflammatory networks, wich results in the low grade chronic pro-inflammatory status termed inflammaging. It can contribute to a number of age-related chronic diseases (e.g. atherosclerosis, type 2 diabetes, Alzheimer disease, osteoporosis). Prevention or delay in onset of chronic diseases can potentially benefit a large segment of the elderly population. Now it is hypothesised that a probiotic drink can reduce low-grade inflammation through improvement of the gut barrier function and gut microbiota composition in elderly people with low-grade inflammation.

Eligibility Criteria:
Inclusion Criteria:

* Men \>65 years of age.
* Body mass index: 22-34,9 kg/m²
* non-smokers

Intervention trial:

* hsCRP \> 1 mg/L (Screening blood test)
* normal blood count (Screening blood test)
* normal ALAT, ASAT and serum creatinine levels (Screening blood test)

Exclusion Criteria:

* any major non-organic disease, including malign diseases (haematological, inflammatory, metabolic,)
* any major organ disease, including neoplastic diseases.
* intake of antibiotics within the last 6 weeks
* chronic therapy with analgetics (incl. acetylsalicylic acid)
* chronic therapy with proton pump inhibitors
* regular intake of probiotic bacteria products within the last 3 weeks
* chronic anti-inflammatory therapy with NSARs or previous therapy within the last 20 days
* subjects with expected non-compliance to protocol guidelines
* subjects that participate in other trials
Study on the Efficacy of Phenytoin in the Prophylaxis of Seizures of Patients With Pneumococcal Meningitis at Least 50 Yrs Old.

To evaluate the efficacy of the prophylaxis with phenytoin in the prevention of seizures in patients with pneumococcal meningitis. Hypothesis: Administration of prophylactic phenytoin will reduce the incidence of seizures in patients with pneumococcal meningitis older than 50 yrs.

Background: Bacterial meningitis has still a high morbi-mortality despite the global improvement in therapy.

Among complications, the presence of seizures may contribute to increase the morbi-mortality. Prophylactic phenytoin is used in clinical practice in high risk patients but this use is variable because there are not controlled clinical trials demonstrating efficacy along with antibiotics and corticosteorids. Pneumococcal episodes are associated to a higher number of seizures and a higher mortality especially in elderly patients.

Objectives: To evaluate the efficacy of the prophylaxis with phenytoin in the prevention of seizures in patients with pneumococcal meningitis. Hypothesis: Administration of prophylactic phenytoin will reduce the incidence of seizures in patients with pneumococcal meningitis older than 50 yrs.

Methodology: Multicentre, randomized, double blind placebo controlled clinical trial. Patients will be included mostly from hospitals from REIPI and CAIBER and randomly assigned to receive phenytoin or placebo.

Sample size has been estimated in 61 patients per group. Antibiotic therapy and ICP prophylaxis will be standardized in all centres. Phenytoin administration will be maintained during antibiotic therapy. End point will be incidence of seizures during hospital stay and overall mortality will be a secondary end-point. Followup visits at 1 and 3 month will be performed.

Eligibility Criteria:
Inclusion Criteria:

Adult patients \> or = 50 years old.

Diagnosed of pneumococcal meningitis due to clinical characteristics plus a positive CSF Gram stain and/or a detection of pneumococcal antigen or PCR

or

Suspected pneumococcal meningitis since it is an episode related to otitis, pneumonia, sinusitis or pericranial fistula or in patients with known risk factors such as myeloma or splenectomy.

Exclusion Criteria:

To have seizures prior to arrive to the hospital or the inclusion in the study.

Pregnancy or breastfeeding.

To have conduction abnormalities in ECG.

History of allergy or intolerance to phenytoin.

Patients with meningitis as a complication of neurosurgical procedures.

Epileptic patients taking usually anticonvulsivants.

Refusal by the patient or family to participate and/or to sign the informed consent.
Using Technology to Improve Physical Activity Levels Among Postmenopausal Women (The Active & Aware Study)

Women who are overweight or do not exercise are at higher risk for breast cancer after menopause. This study will test a new electronic device that measures the body's movement and works alongside a website to help women increase their physical activity level. If effective, this system could be tested in larger studies aiming to reduce breast cancer risk by reducing or preventing obesity.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Postmenopausal
* BMI \>= 25.0 kg/m2
* Physically inactive
* Internet user with regular access to high-speed internet
* Willing and able to complete study requirements

Exclusion Criteria:

* History of invasive breast cancer
* Medical contraindication to exercise
* Medical problem or other issue that would interfere with intervention
* Current participation in another physical activity study
Anastrozole Biphosphonate Study in Postmenopausal Women With Hormone-Receptor-Positive Early Breast Cancer

The purpose of this study is to evaluate safety parameters of anastrozole with regard to its potential effects on postmenopausal bone loss and on lipid profiles. This trial is conducted to investigate the effects of risedronate on BMD and on bone metabolism in postmenopausal women using anastrozole as adjuvant therapy for hormone-receptor-positive early breast cancer and who are high or moderate risk of fragility fracture. It is also conducted to determine the effects of anastrozole on bone mineral density (BMD) and on bone metabolism in women at low risk of fragility fracture.


Eligibility Criteria:
Inclusion Criteria:

* Women defined as Postmenopausal
* Histologically proven operable invasive breast cancer
* Hormone-receptor-positive breast cancer

Exclusion Criteria:

* Clinical evidence of metastatic disease
* Bilateral hip fractures or bilateral hip prosthesis
* Receiving or received in last 12 months hormonal therapy for breast cancer, bisphosphonate therapy, oestrogens
* Malabsorption syndrome
Correlation of Berg Balance Scale, Time up and Go and Dynamic Gait Index Scale in Elderly

This study will find a correlation Between Berg Balance scale, Time up and Go and Dynamic Gait Index Scale in community Dwelling Ambulatory Elderly. It will be comparative cross sectional survey that will be evaluate which scale is best one for quick screening of elderly. This study will be completed within the time duration of 6 month. Convenient sampling technique will be used to collect the data. 125 sample size will be taken, in this study to find the correlation between Berg Balance scales. Time up and Go and Dynamic Gait index scale in community dwelling ambulatory elderly. In this study all subjects perform Mini-mental state examination test to meet the inclusion criteria of the study it will be above than 25 than all subjects perform Berg Balance test, Time up and Go test and Dynamic Gait Index test then interpret their values to find the best one scale for screening of elderly. . In this study subjects included will be living independently in the community and also those who walk without any aid. Those subjects who are diagnosed with neuromuscular condition, cardiorespiratory condition, cognitive impairment and having uncorrected auditory and visual deficit will be excluded from this study. In this study we will check the static, proactive part of the dynamic balance, their gait impairments and also the risk of fall of elder population. Pearson correlation Data will be analyzed on SPSS 25.


Eligibility Criteria:
Inclusion Criteria:

65 or above 65 years old. Both male and Females. Living independently in the community. Walking without any aid. Minimental state examination score more than 25

Exclusion Criteria:

Diagnosed neuromuscular condition. Diagnosed cardiorespiratory conditions. Diagnosed cognitive impairment. Uncorrected visual and auditory deficit
The Effects of Lactobacillus Plantarum on Cortisol, IgA and Alpha-amylase Levels in Human Saliva During Stress

In the present study the main goal has been to clarify the effect of the probiotic bacteria Lactobacillus plantarum 299v on the salivary cortisol level in young adults under examination stress. Salivary IgA from minor glands and in whole human saliva was measured as alternative marker of stress. The hypothesis was that the levels of cortisol would be reduced or stabilized in the test group in comparison to the placebo group where the cortisol levels were expected to increase due to the examination-induced stress. By contrast, the salivary IgA levels were expected to increase in the test group in comparison to the placebo group.


Eligibility Criteria:
Inclusion Criteria:

* adults
* studying at the University in Lund
* participation in ongoing examination period

Exclusion Criteria:

* pregnancy
* intake of antibiotics
* medication with cortisone during the study period
Investigating the Role of Energy Balance Modification on Health Responses in Chronic Lymphocytic Leukaemia

This randomised control clinical trial aims to investigate the effects of exercise training and diet on physical and functional fitness and immunological and metabolic changes in adults with chronic lymphocytic leukaemia. Investigators will randomise participants to either 12 weeks of supervised/semi-supervised exercise only, exercise + nutritional guidance, or no exercise.

This study aims to perform a randomised control trial of exercise or exercise plus nutritional guidance on the physiological and immunological health of adults diagnosed with chronic lymphocytic leukaemia (CLL). Recruited participants will be randomised to either 12 weeks of an exercise-only program, an exercise-plus nutritional guidance program or a no-exercise control group. Fasting blood samples collected at Baseline and 12 weeks will measure absolute CLL cell counts, immune function, and inflammatory and metabolic biomarkers. A series of physical fitness assessments will be assessed at baseline and 12 weeks to determine physiologic reserve and resilience against external stressors. Additionally, participants will be asked to return 12 weeks after completing the intervention to assess the legacy effects of the intervention on the same physiological and blood-based biomarkers of health.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of CLL (including small lymphocytic leukaemia) as per the International Workshop on CLL Guidelines.
* Male or female ≥ 18 years of age
* Able to walk on a treadmill or cycle on an ergometer
* Pass the Physical Activity Readiness Questionnaires (PAR-Q and PAR-Q+)

Exclusion Criteria:

* Corticosteroid therapy initiated less than 7 days before study entry. Prednisone 10mg or less or equivalent is allowed. Topical or inhaled corticosteroids are permitted.
* Secondary malignancy within 3 years of study enrollment requiring intervention except for adequately treated basal, squamous cell carcinoma or non-melanomatous skin cancer, carcinoma in situ of the cervix, superficial bladder cancer not treated with intravesical chemotherapy or BCG within 6 months, localised prostate cancer and PSA stable.
* Absolute contraindications to exercise: Recent (\<6 months) acute cardiac event unstable angina, uncontrolled dysrhythmias causing symptoms or hemodynamic compromise, symptomatic aortic stenosis, uncontrolled symptomatic heart failure, acute pulmonary embolus, acute myocarditis or pericarditis, suspected or known dissecting aneurism and acute systemic infection.
* Significant orthopaedic limitations, musculoskeletal disease and/or injury. Due to the nature of the study, persons with known joint, muscle or other orthopaedic limitations that restrict physical activity may be excluded.
* Type I diabetes mellitus or uncontrolled Type II diabetes mellitus, or chronic obstructive pulmonary disease
* Uncontrolled blood pressure (≥180/90) at rest
* Known concurrent HIV, Hepatitis B or Hepatitis C
* Unable to comply with other study requirements
A Trial of Ligation Plus Nadolol Versus Nadolol Alone in the Prophylaxis of First Variceal Bleeding in Cirrhosis

The value of banding ligation plus beta blocker in the prophylaxis of first episodes of variceal bleeding has not yet been evaluated. This study was conducted to compare the efficacy and safety of banding ligation plus nadolol versus nadolol in the prophylaxis of first bleeding in cirrhotic patients with high-risk esophageal varices.

Currently, endoscopic variceal ligation (EVL) has replaced EIS as the endoscopic treatment of choice for management of bleeding esophageal varices. The advantages of EVL include requiring fewer treatment sessions to achieve variceal obliteration, lower rebleeding rates and fewer complications (5-9). Controlled studies that compared EVL with beta-blocker in the prevention of first variceal bleeding suggested that EVL was at least equal to beta-blockers in the prophylaxis of first variceal bleeding. However, portal pressure may be elevated after repeated EVL. Hence the combination of nadolol and EVL is a reasonable approach to prevent the first episode of variceal bleeding.

Eligibility Criteria:
Inclusion Criteria:

1. the cause of portal hypertension was cirrhosis
2. the degree of esophageal varices was F2 (moderate varices) or more, associated with any of red color signs (red wale markings, cherry red spots or hematocystic spots)
3. no history of hemorrhage from esophageal varices
4. no current treatment with beta-blockers
5. cirrhosis was based on results of liver biopsy, or clinical and biochemical examinations and image studies

Exclusion Criteria:

1. age greater than 75 years old or younger than 20 years old
2. association with malignancy, uremia or other serious medical illness which may reduce the life expectancy
3. presence of refractory ascites, hepatic encephalopathy or marked jaundice (serum bilirubin \> 10 mg/dl)
4. history of shunt operation, transjugular intrahepatic portosystemic stent shunt or endoscopic therapy (EIS or EVL)
5. had contraindications to beta-blockers, such as asthma, heart failure, complete atrioventricular block, hypotension ( systolic blood pressure \< 90 mmHg), pulse rate \< 60/ min
6. unable to cooperate
EffectiVenEss of a Rehabilitation Treatment With Nordic Walking in obEse or oveRweight Patients

Nordic Walking (NW) is a biomechanically correct walking technique that originated in Finland in the 1930s as an off-season training method for cross-country skiers. In the NW, the use of special sticks is combined with "conventional" walking: this involves a greater caloric expenditure, with an energy consumption higher by 20-30% compared to walking without sticks, and also toning of the upper part of the body, in particular triceps, shoulders and back, and the involvement of about 90% of the body's muscles, while maintaining a reduced load on ligaments and joints (Baek \& Ha, 2021). The NW acts simultaneously and effectively on different components of fitness: coordination, endurance, strength, and mobility. It does not require sudden accelerations and is based on a technique that is easy to learn (with the help of an instructor), especially as regards maintaining correct posture. Finally, in addition to the cardiovascular benefits, NW has also been shown to effectively reduce the risk of falls in the elderly. The study is a single-center, randomized controlled trial (RCT), with a three-parallel-arm design, open-label. The primary objective is to evaluate the efficacy (in terms of cardiovascular performance), safety, and adherence (in terms of dropout rate) to the exercise prescription after 6 and 12 months follow-up of a 3-month NW intervention compared with standard rehabilitation training (SR, 3 months) in obese/overweight diabetic patients with cardiovascular (CV) complications. The study will enroll in parallel a control group that can access only generic cardiological counseling with a prescription for unsupervised home exercise.


Eligibility Criteria:
Inclusion Criteria:

- overweight \[Body Mass Index (BMI) ≥ 27 kg/m2\] or obese (BMI ≥30 kg/m2) adult patients with diabetes mellitus and with a recent cardiovascular event and/or coronary revascularization in the previous three months

Exclusion Criteria:

* inability to walk independently and constantly;
* acute joint or spine pathologies that make movement impossible;
* the presence of dementia as approved by consultation of the patient's medical record and/or administration of the Montreal Cognitive Assessment (MOCA) test ≤ 15.5 (Nasreddine et al., 2005);
* chemotherapy 6 months before surgery;
* advanced renal failure;
* acute cardiovascular event \< 3 months (unstable angina, AMI with FE \<40%, arrhythmias, valvular disease, intracerebral/subdural haemorrhage, uncontrolled AI);
* home oxygen therapy and Non-Invasive Ventilation (NIV) \[excluding Continuous Positive Airway Pressure (CPAP)\].