cyrilzakka/clinical-trials huggingface dataset:
Mindfulness-based Lifestyle Modification Programme for Caregivers of People With Neurodegenerative Disorders

Over 80% of caregivers for individuals with neurodegenerative diseases (ND) engage in significant risk behaviors, particularly physical inactivity, which increases the risk of cardiometabolic diseases (CMD) by 30% and reduces life expectancy by 4-8 years. Despite the health benefits of maintaining healthy behaviors, awareness of behavioral risk management among healthcare professionals and the public is low, and research on this topic for ND caregivers is limited. Given that physical activity (PA) is the most prevalent modifiable risk factor, timely intervention is essential.

International guidelines prioritize PA as a key strategy for caregiver health. However, existing PA interventions often struggle with low compliance due to the physical and emotional challenges caregivers face. Our research group actively explores the health-regulating and enhancing effects of integrative mind-body modalities, particularly mindfulness, which may promote and sustain healthy behaviors by improving attentional regulation and psychological flexibility. Mindfulness-based lifestyle modification might help caregivers better manage physical discomfort, stress, and self-limiting beliefs, thereby supporting sustained PA.

The World Health Organization advocates for non-communicable disease (NCD) prevention through brief lifestyle interventions, such as ecological momentary interventions (EMI), which use mobile messaging (e.g., WhatsApp) to deliver personalized health content. This method is particularly valuable for caregivers who find it difficult to access traditional services due to their responsibilities.

This randomized clinical trial aims to evaluate the effects and acceptability of an EMI-enhanced "Brief and Blended Mindfulness-based Lifestyle Counselling Programme" (B-Mindful-Life) compared to brief lifestyle education for increasing PA among Chinese ND caregivers. The primary outcome will measure the change in accelerometer-determined, 10-minute bout moderate-to-vigorous physical activity (MVPA) over a 7-day period from baseline to post-intervention.


Eligibility Criteria:
Inclusion Criteria:

* adults who self-identify as the primary caregivers of ND patients for ≥3 months,
* experience of at least moderate stress as indicated by a PSS score ≥14,
* have a mobile device (e.g., smartphone, tablet, and laptop) with Internet access, and
* able to read and communicate in Chinese and give written consent

Exclusion Criteria:

* a self-reported exercise regimen of great than 150 minutes/week of MVPA (according to the American College of Sports Medicine guidelines),
* have received (within the past 6 months) or are receiving other physical and/or psychosocial interventions,
* pregnancy or within 6 months of postpartum,
* contraindications (e.g., current diagnosis of psychiatric illness according to the DSM IV-TR, DSM-V, or ICD-10) or severe comorbidities (e.g., severe hearing/vision/cognitive impairment) that might limit full participation.
Iron Supplementation in Hip/Knee Surgery

Randomized controlled trial to evaluate the efficacy of oral iron supplementation in reducing the prevalence of preoperative anemia in a cohort of 82 patients undergoing elective prosthetic hip or knee surgery.


Eligibility Criteria:
Inclusion Criteria:

* Males and females
* ASA 1, 2, or 3
* No neuropsychiatric conditions
* Acceptance of informed consent
* Elective prosthetic hip or knee surgery

Exclusion Criteria:

* ASA 4
* Present or past neuropsychiatric conditions
* Hip or knee revision surgery
* Use of iron as dietary supplement
* Known erythrocytosis
* Incompatible hypersensitivities
* Iron metabolism disorders
* Lymphoproliferative disorders
A Study of Ibandronate (Bondronat) in Participants With Malignant Bone Disease

This study will assess the efficacy and safety of ibandronate (Bondronat), administered intravenously (IV) or orally (PO), in participants with malignant bone disease and moderate to severe pain. Participants will be randomized to receive ibandronate either as a 6-mg IV infusion every 3 to 4 weeks or a 50-mg tablet PO daily. Pain response and Karnofsky Performance Index (KPI) will be measured at intervals throughout the study. The anticipated time on study treatment is 4 months and the target sample size is 150 individuals.


Eligibility Criteria:
Inclusion Criteria:

* Adults at least 18 years of age
* Malignant bone disease due to multiple myeloma or cancer of the lung, prostate, gastrointestinal (GI) tract, ovary, or bladder
* Bone pain defined as a Brief Pain Inventory (BPI) most acute pain score greater than or equal to 4
* Radiologically confirmed bone disease disease

Exclusion Criteria:

* Previous treatment with ibandronate (Bondronat) within previous 2 months
* Severely impaired renal function
* Known brain metastases
Exhaled Air Temperature (TAE) As A Marker Of Airway Inflammation In Asthma

The goals : to develop and computerize equipment for measuring ITAE , compare the results with TAEP Itae study the possible relationship between different markers of inflammation: sputum eosinophils , FeNO , the ITAE and TAEP and see the influence spirometry or a bronchodilator in measuring the ITAE .

It has designed a line of work studying the following aspects :

1. Comparison with TAEP ITAE in a group of healthy and stable asthmatics 60 patients , 30 asthma and 30 volunteers .

Two . Study of the relationship between the number of eosinophils in sputum, FeNO , the ITAE and TAEP , 30 patients randomly FeNO , the ITAE and TAEP be measured.

Three . ITAE measurement before and after the spirometry test , 20 patients , in stable phase will be measured before and after the ITAE spirometry .

April . ITAE baseline measurement and after administration of 400 micrograms of salbutamol , 20 patients diagnosed with asthma , phase stable , they measure the ITAE before and fifteen minutes after administration of salbutamol .

May . Measurement in patients Itae a bronchial provocation test with methacholine was performed , 20 patients were measured and baseline Itae after administration of methacholine .

6. Measuring Itae in patients during an asthma exacerbation and stable phase , 20 patients during an exacerbation , the ITAE be measured. Already in clinically stable measurement is repeated.

The goals : to develop and computerize equipment for measuring ITAE , compare the results with TAEP Itae study the possible relationship between different markers of inflammation: sputum eosinophils , FeNO , the ITAE and TAEP and see the influence spirometry or a bronchodilator in measuring the ITAE .

It has designed a line of work studying the following aspects :

1. Comparison with TAEP ITAE in a group of healthy and stable asthmatics 60 patients , 30 asthma and 30 volunteers .

Two . Study of the relationship between the number of eosinophils in sputum, FeNO , the ITAE and TAEP , 30 patients randomly FeNO , the ITAE and TAEP be measured.

Three . ITAE measurement before and after the spirometry test , 20 patients , in stable phase will be measured before and after the ITAE spirometry .

April . ITAE baseline measurement and after administration of 400 micrograms of salbutamol , 20 patients diagnosed with asthma , phase stable , they measure the ITAE before and fifteen minutes after administration of salbutamol .

May . Measurement in patients Itae a bronchial provocation test with methacholine was performed , 20 patients were measured and baseline Itae after administration of methacholine .

6. Measuring Itae in patients during an asthma exacerbation and stable phase , 20 patients during an exacerbation , the ITAE be measured. Already in clinically stable measurement is repeated.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with asthma

Exclusion Criteria:

* Patients unable to perform the maneuver the measurement of the TAE
Post-Market Registry in Europe and US for the Use of VascuCelTM

This is a post-market, multi-centre, open-label registry designed to collect prospective safety and performance data on the use of VascuCel in patients who require great vessel reconstruction, peripheral vascular reconstruction or suture line buttressing. This registry will collect safety and performance data up to 2 years following implantation.

Post-market, prospective, multi-centre, open-label, registry designed to collect prospective safety and performance data on the use of VascuCel in patients with vascular disorders and in accordance with local standard of care. The Registry has been designed to collect data up to 2 years following implantation. The VascuCel Registry will collect data on the use of the VascuCel, for the following major indications:

* Great vessel reconstruction
* Peripheral vascular reconstruction

As suture line buttressing is a procedure that does not consistently use tissue, data on this indication will only be included if available. Data will be prospectively collected by the sites on registry-specific electronic case report forms (eCRFs). The primary endpoints will assess device's safety and performance through measures and images obtained via the facility's standard of care at the respective registry site. Additional data will also be collected from the implant procedure to assess user (surgeon) satisfaction with the devices' handling and performance.

Eligibility Criteria:
Inclusion Criteria:

* patient has signed the informed consent
* patient is a candidate for treatment with VascuCel per approved device indications.

Exclusion Criteria:

* no study specific exclusion criteria; patients treated per standard clinical practice
AZD6244 vs. Capecitabine (Xeloda®) in Patients With Advanced or Metastatic Pancreatic Cancer, Who Have Failed First Line Gemcitabine Therapy

The purpose of this study is to assess the efficacy and safety of AZD6244 (ARRY-142886)versus capecitabine in patients with advanced or metastatic pancreatic cancer who have failed first-line therapy with gemcitabine. Following baseline assessments, a minimum of 64 patients in approximately 5-6 centers from the US will be treated with either AZD6244 or capecitabine. Treatment will be continued for as long as the patients receive clinical benefit. The status of all patients will be checked (whether they are still taking treatment or not) approximately 3 months after the last patient has entered the study.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed with pancreatic cancer
* Have failed first line gemcitabine therapy

Exclusion Criteria:

* Previous therapy with EGFR inhibitor, MEK inhibitor or capecitabine.
* Any recent surgery, unhealed surgical incision or severe condition such as uncontrolled cardiac disease or chronic gastrointestinal diseases.
Edwards EVOQUE Eos MISCEND Study

Study to evaluate the safety and performance of the Edwards EVOQUE Eos mitral valve replacement system

The study is a multi-center, prospective, single-arm, and non-randomized study designed to evaluate the safety and performance of the Edwards EVOQUE Eos mitral valve replacement system.

Eligibility Criteria:
Inclusion Criteria:

* Clinically significant, symptomatic mitral regurgitation
* High risk for open-heart surgery
* Meets anatomical criteria

Exclusion Criteria:

* Unsuitable anatomy
* Patient is inoperable
Indicators of Quality Care and Services for Adults With Acute Ischemic Stroke in Different Types of Hospitals in Quebec : Research Protocol

The goal of this study is to describe the performance of care and services offered to people hospitalized with ischemic stroke. More specifically, this study aims to answer the following questions:

* Is stroke care and service delivered to the population optimally?
* Are these services equitable, regardless of the hospital where the patient is hospitalized?
* Are all patients treated in the same way, regardless of individual characteristics such as age, sex or risk factors?

An evaluation of the quality of practices will be carried out on the health records of patients hospitalized in different hospital centers in Quebec such as a subspecialized center, a regional center and a center in a remote region. An in-depth analysis will also be conducted to determine whether certain individual patient characteristics may influence how they are managed during a stroke.


Eligibility Criteria:
Inclusion Criteria:

- Adults 18 years old or over with ischemic stroke requiring hospitalization in an acute care unit or special stroke unit

Exclusion Criteria:

* Adults with hemorrhagic stroke
A Randomized Phase II Study of Concurrent Chemoradiation With Every 3 Week of Cisplatin vs With Weekly Cisplatin in Locally Advanced Nasopharyngeal Carcinoma

The study try to show the weekly cisplatin based CCRT is not inferior to 3-weekly cisplabe based CCRT in terms of 3-yr progression free survival rate in advanced nasopharyngeal carcinoma


Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed nasopharyngeal carcinoma age of 18 years or over stage II \~ IVb no history of chemotherapy, radiotherapy, or immunotherapy for NPC with measurable lesion based on RECIST 1.1 ECOG PS 0 \~2 good organ function (liver, renal, hematologic)

Exclusion Criteria:

* active infectious disease requiring antibiotics uncontrolled heart disease pregnancy and on feeding state history of other malignancy within 5 years before enrollment, except for well treated non-melanomatous skin cancer, in situ cervical cancer, thyroid cancer
Evaluation of Neoadjuvant Therapy Efficacy and Postoperative Pathological Indicators in Esophageal Cancer Using CT and Multimodal MRI

This study aims to predict the efficacy of different types of neoadjuvant therapy and related postoperative pathological indicators in patients with esophageal cancer based on imaging parameters from CT and multimodal MRI, as well as clinical indicators collected before and after neoadjuvant treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Consecutive patients with histopathological diagnosis of esophageal cancer.
2. Patients underwent neoadjuvant therapy before radical surgery for esophageal cancer: neoadjuvant chemotherapy, neoadjuvant chemoradiotherapy, neoadjuvant chemotherapy plus immunotherapy, neoadjuvant chemoradiotherapy plus immunotherapy.
3. All patients underwent CT and multimodal MRI examinations before and after neoadjuvant therapy.
4. The preoperative clinical data and postoperative pathological data are complete.

Exclusion Criteria:

1. Patients with other primary malignant tumors or previous anti-tumor treatment.
2. CT and MRI images with poor quality.
Functional Capacity in Children with Chronic Kidney Disease

The aim of our study is to assess the functional capacity of children with chronic kidney disease using various tests.


Eligibility Criteria:
Inclusion Criteria:

* Having been diagnosed with chronic kidney disease
* Being clinically stable
* Being between 6-18 years old
* Volunteering to participate in the research

Exclusion Criteria:

* Having a musculoskelatal disease that may affect functional capacity measurement
* Having a cognitive problem
Combination Chemotherapy Following Surgery in Treating Women With Early Stage Breast Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective following surgery for breast cancer.

PURPOSE: Randomized phase III trial to study the effectiveness of combination chemotherapy consisting of cyclophosphamide, methotrexate, and fluorouracil with or without epirubicin in treating women who have early stage breast cancer.

OBJECTIVES: I. Compare the effects of 4 courses of epirubicin followed by 4 courses of cyclophosphamide/methotrexate/fluorouracil (CMF) versus 8 courses of CMF as adjuvant chemotherapy in women with node positive early breast cancer, as measured by overall and event free survival from the date or randomization. II. Compare the effects of 4 courses of epirubicin followed by 4 courses of CMF with 8 courses of CMF as adjuvant chemotherapy in these patients, as measured by acute and chronic toxicities. III. Compare the effects of 4 courses of epirubicin followed by 4 courses of CMF versus 8 courses of CMF as adjuvant chemotherapy in these patients, as measured by quality of life.

OUTLINE: This is a randomized, multicenter study. Patients are randomized into 2 treatment arms within 4 weeks of surgery. Treatment begins within 6 weeks of surgery. One treatment arm receives 8 courses of cyclophosphamide/methotrexate/fluorouracil (CMF) given intravenously (IV) every 3 weeks. The other arm receives 4 courses of epirubicin followed by 4 courses of CMF given IV every 3 weeks. Patients are followed annually for 10 years.

PROJECTED ACCRUAL: A total of 1,000 patients will be accrued over 3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed, early stage, unilateral invasive breast cancer of TNM stages T0 - T3, N0-1, M0, i.e., Histologically proven axillary node metastases OR Lymph node negative Not locally advanced If supraclavicular node is enlarged or suspicious of metastasis, negative biopsy for supraclavicular node metastases required No evidence of any other metastases clinically or on routine staging investigations No past history of pure in situ carcinoma in either breast Primary tumor is completely excised

PATIENT CHARACTERISTICS: Age: Not specified Sex: Female Performance status: Not specified Hematopoietic: Neutrophil count greater than 2,000/mm3 Platelet count greater than 100,000/mm3 No evidence of sepsis Hepatic: Adequate hepatic function Bilirubin normal AST/ALT normal Renal: Adequate renal function Creatinine less than 1.2 mg/dL Cardiovascular: No clinically significant cardiovascular disease Other: No prior or concurrent other malignancy except adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Prior tamoxifen allowed Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics
Influence of Closed Suction Drainage After Total Knee Replacement.

The aim of the study will be to compare functional outcomes, basic morphology results, number of blood transfusions, costs of hospitalization, and inflammation factors, following total knee replacement (with use of one type of endoprosthesis) comparing use of closed suction drainage (CSD). Use of closed suction drainage may have influence on patients functional outcome.

Patients with primary knee osteoarthritis will be included in a randomized controlled trial and assigned to total knee arthroplasty with or without closed suction drainage. Subjects will be evaluated preoperatively, 1-day, 3-, 6- and 12-month postoperatively.

Change in morphology results will be measured by comparing preoperative and postoperative levels of haematocrite, haemoglobin, erythrocytes, and platelets.

Change in the number of blood transfusions will be measured by analyzing the number of needed transfusion of packed red blood cells in the postoperative period during stay in the hospital.

Change in levels of inflammation factors will be measured by analyzing the level of C-reactive protein in first and third day postoperatively.

Change in body temperature wille be measured daily by analyzing body temperature from day of the surgery until the day of discharge from the hospital

Presence of haematoma will be evaluated daily in the postoperative period by clinical examination.

Change in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Pain Score will be measured from baseline (can be measured anytime to a maximum of one month before surgery) 3,6 and 12 months post-operatively

Change in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Function Score will be measured from baseline (can be measured anytime to a maximum of one month before surgery) 3,6 and 12 months post-operatively

Costs of hospitalization will be measured by comparing cost of hospitalization between two analyzed groups

Eligibility Criteria:
Inclusion Criteria:

* patient's consent for anticipation in the study
* arthroplasty in one knee

Exclusion Criteria:

* patient's lack of consent for anticipation in the study
* haematological diseases
* reoperations in the area of endoprosthesis
* medical history of any surgical intervention on the lower limb
A Multi-Center Protocol for Obtaining and Storing Human Samples for Immediate or Future Microbial, Immune, or Host-Microbe Scientific Study

The intent of this protocol is to salvage human-related material that is normally destined for destruction, so it can be used in infection-related scientific studies. This clinical material can be studied in order to better understand the molecular, cellular, or ecological components of the infected or potentially infected tissue or device.

The samples can include material such as wound debridement, removed orthopedic implants, removed catheters or shunts, excised tonsils, amputated tissue, sputum, stool, or other excretions. The samples can be cultured for microbes, examined using microscopy, or analyzed using molecular techniques. The studies can examine microbes or the host's response to microbes by examining the nucleic acids (e.g. 16S DNA, mRNA), proteins, or other metabolites.

Eligibility Criteria:
Inclusion Criteria:

1. The Subject must be 18 years of age or older
2. The Subject must be mentally competent as determined by the Investigator, or have a Legally Authorized Representative.

Exclusion Criteria:

1. The Subject may not be currently incarcerated.
2. The Subject may not be knowingly pregnant.
3. The Subject may not be institutionalized.
4. The Subject may not be an employee or student of the investigator or sponsor.
The Salivary Microbiome in Children With Type 1 Diabetes Mellitus

Aims: To profile the oral microbiome of children with type 1 diabetes mellitus, and to compare it to healthy children while taking into account other aspects of the oral environment.

Research: exploring the differences between oral microflora of children with type 1 diabetes mellitus and control healthy children using salivary microbiome. The investigators will furthermore intend to analyze the differences of salivary flow rate, pH, glucose, calcium, inorganic phosphate and urea between the two groups.

Saliva from 50 children ages 5 to 15 years old who had been diagnosed with type 1 diabetes mellitus and are followed at the Pediatric Endocrinology Clinic, Hadassah University Hospital Mt. Scopus and Ein Kerem, Jerusalem, Isreal, will be compared to 50 healthy children, preferably their siblings, matched in age and gender. Each patient or their legal guardian will sign an informed consent to participate in the study. The investigators will request a permission to access the medical records of the patients. Data will be collected from patient medical history. The investigators will measure salivary flow rate, pH and glucose, salivary Calcium, inorganic phosphate and urea and perform microbiome analysis and 16S rRNA gene-based analysis comparing children with diabetes to healthy children.

Eligibility Criteria:
Inclusion Criteria:

• Children with type 1 diabetes mellitus

Exclusion Criteria:

* Children Unable to give saliva sample
* Children On antibacterial medicaments