cyrilzakka/clinical-trials huggingface dataset:
Prospective Cohort Study on Cognition and Cardiovascular Disease of Sedentary Behaviors in Children

The prospective cohort study is set up to address research questions dealing with sedentary lifestyle-related events mainly including cognition and cardiovascular-related disease in children .Participants aged 7-12 years old from five primary schools in Guangzhou,Guangdong province will be recruited and followed up to evaluate the risk factors of cognition and cardiovascular-related disease. Objective measurements combined with questionnaire-data-based information on a wide range of lifestyle factors and cognition were applied in this study.

There are three stages in this project.At first stage,information about socio-demographic, psychological status, physical activity,sleep and diet were collected by a multi-components questionnaire survey.The Strengths and Difficulties Questionnaire(SDQ) and Behavior Rating Inventory of Executive Function(BRIEF) were conducted at the same time. Anthropometric measurement including height, weight, waist and hip circumferences, blood pressure and fat mass were conducted.Besides,blood samples were collected to measure total cholesterol, triglycerides, high-density lipoprotein (HDL-C) and low-density lipoprotein (LDL-C).

At second stage,participants were classified for 4 subgroups as follows: Low active-high sedentary;low active-low sedentary; high active-high sedentary;high active-low sedentary by different sedentary status and physical activity levels according to the international standard. Later cardiorespiratory fitness was assessed by the 20-m shuttle run test. Accelerometer GT3X+ Actigraph with physical activity log,Combined Raven's test, a series of psychometric paradigms were measured for further studies.

At third stage,we will explore the related neuropsychological mechanism using the technology of event-related potentials (ERPs).

About 1000 participants (7-12 years old) will be prospectively followed up. The associations between sedentary lifestyle and risks for cognition and cardiovascular-related disease will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* 7-12 years old
* Children with normal intelligence measured by Raven Good vision.
* Right hand.

Exclusion Criteria:

* Children with mental health and behavioral problems in this study were found to have developmental behavior disorders, such as ADHD, ASD.
* There are serious liver and kidney diseases, cardiovascular diseases, hematologic diseases or malignant tumors.
Effects of "Comprehensive Health Promotion and Healthy Lifestyle Development" in Community-dwelling Elderly.

The World Health Organization (WHO) defines "Active Aging" as continued engagement in social, economic, cultural, spiritual, and civic activities, emphasizing the importance of participation for older adults. Personal health behaviors and habits influence both longevity and health status in later life, with healthy lifestyle development optimizing aging and enhancing well-being and quality of life.

WHO's Integrated Care for Older People (ICOPE) highlights six key indicators of physical and mental function-mobility, cognition, nutrition, vision, hearing, and depression-as critical to promoting active aging. These factors are also used to evaluate aging outcomes. Multidomain interventions are employed to address cognitive decline and dementia.

While research supports the benefits of multidomain interventions for cognitive improvement in older adults, consistent findings are lacking. Most interventions focus on exercise and cognitive training, with limited attention to other aging risk factors. Broader, more diverse interventions that actively involve older adults are needed to confirm the effects of these factors on cognitive function.

This study aims to evaluate the effects of multidomain interventions-covering exercise, cognitive training, nutrition, chronic disease management, vision and hearing care, fall prevention, psychosocial factors, and sleep-on mobility, cognition, daily functioning, and social participation in community-dwelling older adults


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 60 years old
2. Mini-Mental State Examination (MMSE) score \> 20 (Folstein et al., 1975), able to follow instructions and participate in activities
3. With self-reported or caregiver-reported memory or cognitive-related problems
4. No diagnosis of any type of dementia

Exclusion Criteria:

1. Unstable medical condition that would prevent safe participation in exercise training (e.g., myocardial infarction, heart failure, recent cardiac surgery, severe asthma, concomitant neurological disorders, or joint deformities)
2. Participation in other studies
3. Inability to provide informed consent
Effects of Orofacial Myofunctional Therapy on Mental Functioning and Overall Self-Sufficiency in Stroke Patients

This project will explore the effects of orofacial myofunctional therapy on mental functioning and overall self-sufficiency in stroke patients. The population sample will be 70 divided randomly into two groups by concealed envelop method. Then i will collect data from Physiotherapy department Wapda Hospital complex, Lahore. Group A will be treated with routine physical therapy treatment that will include EMS, Infrared and Intermittent stretching of facial muscles for 36 sessions on alternate days, each session comprise 30 minutes . Group B will receive routine physical therapy along with orofacial therapy (36 sessions on alternate days, each session comprise 45 minutes) .

This project will explore the effects of orofacial myofunctional therapy on mental functioning and overall self-sufficiency in stroke patients. The population sample will be 70 divided randomly into two groups by concealed envelop method. Then i will collect data from Physiotherapy department Wapda Hospital complex, Lahore. Group A will be treated with routine physical therapy treatment that will include EMS, Infrared and Intermittent stretching of facial muscles for 36 sessions on alternate days, each session comprise 30 minutes . Group B will receive routine physical therapy along with orofacial therapy (36 sessions on alternate days, each session comprise 45 minutes) .According to the treatment protocol, the patients participated of the OMT sessions, lasting 45 minutes each, with a weekly frequency during the first 30 days and every two weeks after this period, with no other additional therapeutic conducts5 (treatment duration = 120 days). A home exercise program was pre- scribed during each session. 10 personal activities: feeding, personal toileting, bathing, dressing and undressing, getting on and off a toilet, controlling bladder, controlling bowel, moving from wheelchair to bed and returning, walking on level surface (or propelling a wheelchair if unable to walk) and ascending and descending stairs.

Eligibility Criteria:
Inclusion Criteria:

* Both Gender
* Age (Years) 40-70
* Subacute stage of a strok

Exclusion Criteria:

- Trauma (e.g., temporal bone fracture)

* Infection
* Herpes zoster (Ramsay Hunt syndrome)
* Borreliosis (Lyme disease)
* HSV reactivation
* HIV
* Tumors (esp. parotid gland tumors)
* Pregnancy
* Diabetes mellitus
* Guillain-Barré syndrome
* Sarcoidosis
* Amyloidosis
* Stroke
A (Prospective/Pilot) Study Evaluating the Effect of Cataract Surgery on the Daily Activity Levels of Elderly Patients

To evaluate the effect of bilateral cataract surgery with intraocular lens implantation on the daily activity levels of elderly patients.

Cataract formation is a natural aging process that can be influenced by environmental factors such as exposure to ultra violet light and diet. Additionally, metabolic disorders, such as diabetes can lead to an earlier development of cataracts. As cataracts develop, a patient's vision can be affected. Reduced vision can limit activities of daily living and may even reduce a patient's mobility. When this occurs, cataract surgery should be considered to help restore a patient's vision. With the obesity and diabetic epidemic, proper diet and exercise is a major health initiative to control these diseases. If a patient's mobility is reduced as a result of poor vision - their ability to achieve adequate daily physical activity may also be effected. It is thought that improvement in vision may increase their activity levels and help combat these health issues. This study will investigate the activity level of patients before and after undergoing cataract surgery to determine how improved vision quality from removal of the natural lens inside the eye and replacement with an artificial intraocular lens effects their activity level.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing bilateral cataract extraction by phacoemulisficatin with intraocular lens implantation and a planned bilateral distance vision target or patients with bilateral cataracts who are not having cataract surgery
* Patients aged 60 years old or older
* Best corrected visual acuity worse than 20/20 in each eye (meaning 20/25 or worse)
* Non-comanged patients

Exclusion Criteria:

* Greater than 0.76 D pre-operative corneal cylinder, if having cataract surgery without a planned astigmatism correction (I.e Limbal relaxing incision or Toric intraocular lens)
* Planned implantation of a multifocal intraocular lens
* Visual field defect which may reduce mobility
* Wheel chair bound patients
* Reduced vision from an ocular disease other than cataracts
* Patients with significant dementia who are not able to fully comprehend the informed consent
Study of A Long Lasting Local Anesthestic for Hand, Wrist or Finger Surgery

The purpose of this study is to compare Exparel, a new, long-lasting numbing medication and a shorter-acting nerve block to a traditional single-shot nerve block in patients having hand, wrist or finger surgery.


Eligibility Criteria:
Inclusion Criteria:

* patients 18 years or older having hand, wrist, or finger surgery
* ability to understand and provide informed consent
* American Society of Anesthesiologists status I-III
* presence of a responsible adult caregiver for 48-72 hours after surgery

Exclusion Criteria:

* patient refusal or inability to provide informed consent
* true allergy, not sensitivity to local anesthetics, midazolam, fentanyl, hydromorphone, propofol
* pregnancy
* hepatic or renal failure
* evidence of infection at or near the proposed needle insertion site
* any sensorimotor deficit of the upper extremity
* BMI greater than or equal to 35
* uncontrolled or severe pulmonary disease
* anticoagulant use (not aspirin or non-steroidal anti-inflammatories)
* chronic pain patients
Renal Mass Registry

Collect valuable risk factor and quality of life data from Renal Cell Carcinoma patients and harness the latest technology to organize and analyze data.

RCC is a cancer that is poorly understood. The increase in both incidence and mortality rates for RCC, coupled with the lack of effective therapies for RCC beyond surgical excision, underscore the need for a better understanding of RCC tumor biology, immunology, and epidemiology. Such improved understanding could then be directly translated into new prevention strategies as well as improved patient care. Recently, the National Cancer Institute's Kidney Cancer Progress Review Group identified as top priorities for future research the need to better understand the mechanisms underlying known risk factors for kidney cancer; and examine tumor tissue to identify predictors of patient outcome and targets for therapy. In addition, the review group stressed that the leaders in renal cancer research over the next decade would be those institutions that could enroll large numbers of patients, collect valuable risk factor and quality of life data from these patients and harness the latest technology to organize and analyze data.

Eligibility Criteria:
Inclusion:

* Patients with a renal mass or a suspected metastatic lesion from a renal primary who have been treated or are going to be studied and or treated surgically at Mayo Clinic Arizona
* Patients must be 18 years of age or older
* Patients must be capable of and willing to sign an informed consent

Exclusion:

None
Therapies for Salivary Flux Stimulation in Patients Transplanted With Hematopoietic Stem Cells

The transplantation of hematopoietic stem cells (THSC) is a therapeutic modality developed for the treatment of various diseases such as leukemia, bone marrow aplasia, lymphomas, multiple myeloma, among others. Most patients who undergo the THSC usually have oral manifestations as a result of immunosuppression achieved by chemotherapy and/or radiotherapy. The most common complications are the reduction of salivary flow, mucositis and graft-versus-host disease (GVHD). These conditions can be very debilitating and interfere with medical therapy, leading to systemic complications, affecting the prognosis and increasing the length of hospitalization of the patient and the costs of treatment. To date, there is no protocol that prevents the reduction of salivary flow and minimizes the occurrence of mucositis and GVHD in these patients. This study aims to verify the effectiveness of treatment with two sialogogues (Hyperboloid and TENS \[transcutaneous electrical stimulation\]) to restore the flow and biochemical composition of saliva in patients undergoing THSC myeloablative and non-myeloablative conditionating regime.

It will be included in the sample a total of 60 patients undergoing hematopoietic stem cell transplantation (THSC) at the Clinical Hospital. Patients will be randomly divided into four groups, each with 15 subjects: group I patients who will use only the mechanical sialogogue; group II patients who will make use of electrical sialogogue (TENS); group III patients who will make use of mechanical sialogogue associated with TENS and group IV patients who will not receive therapy (control).

The project will present the following experimental design:

1. Selection of patients to be subjected to the transplantation of hematopoietic stem cells;
2. Implementation of a reference sialometry;
3. Institution of therapy with mechanical and electrical sialogogue;
4. Clinical examination, assessment of the occurrence of mucositis and obtention of saliva samples pre- and post-THSC;
5. Qualitative analysis of saliva (turbidity, viscosity and color);
6. Biochemical analysis of saliva;
7. Statistical analysis of data.

Eligibility Criteria:
Inclusion Criteria:

* Patients submitted to THSC at Clinical Hospital of Federal University who underwent a myeloablative or a non-myeloablative conditioning regime
* Age over 16 years
* Oral mucosa intact on the first day of conditioning
* Ability to cooperate with treatment

Exclusion Criteria:

* Cases with no clinical follow up
* Patients who refuse to participate
* Patients with no ability to cooperate with treatment
Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus (SLE)

The primary objective of the study is to confirm the clinical efficacy of epratuzumab in the treatment of subjects with Systemic Lupus Erythematosus (SLE).


Eligibility Criteria:
Inclusion Criteria:

* Positive antinuclear antibodies (ANA) at Screening (Visit 1)
* Current clinical diagnosis of Systemic Lupus Erythematosus (SLE) by American College of Rheumatology (ACR) criteria such that at least 4 of the 11 criteria are met
* Active moderate to severe SLE activity as demonstrated by the British Isles Lupus Assessment Group Index (BILAG)
* Active moderate to severe SLE disease as demonstrated by SLE disease activity index (SLEDAI) total score
* On stable SLE treatment regimen, including mandatory corticosteroids and immunosuppressants or antimalarials

Exclusion Criteria:

* Subjects who are breastfeeding, pregnant, or plan to become pregnant
* Subjects with active, severe SLE disease activity which involves the renal system
* Subjects with active, severe, neuropsychiatric SLE, defined as any neuropsychiatric element scoring BILAG level A disease.
* Subjects with the evidence of an immunosuppressive state
* Subjects who, in the opinion of the investigator, are at a particularly high risk of significant infection
* History of malignant cancer, except the following treated cancers: cervical carcinoma in situ, basal cell carcinoma, or dermatological squamous cell carcinoma.
* Subjects receiving any live vaccination within the 8 weeks prior to screening (Visit 1).
* Subjects with history of infections, including but not limited to concurrent acute or chronic viral hepatitis B or C
* Subjects with substance abuse or dependence or other relevant concurrent medical condition
* Subjects with history of thromboembolic events within 1 year of screening Visit.
* Subjects with significant hematologic abnormalities
* Subject has received treatment with other anti- B cell antibodies within 12 months prior to screening (visit 1)
* Subject use of oral anticoagulant (not including) nonsteroidal anti-inflammatory drugs (NSAIDs) within 12 weeks prior to screening (Visit 1)
* Subject has previously participated in this study or has previously received epratuzumab treatment.
A Longitudinal Study of Hermansky-Pudlak Syndrome Pulmonary Fibrosis

Hermansky-Pudlak Syndrome (HPS) is a rare genetic disease that is associated with oculocutaneous albinism, bleeding, granulomatous colitis, and pulmonary fibrosis in some subtypes, including HPS-1, HPS-2, and HPS-4. Pulmonary fibrosis causes shortness of breath and progressive decline in lung function. In HPS patients with at-risk subtypes, almost all adults eventually develop fatal pulmonary fibrosis unless they undergo lung transplantation.

The purpose of this study is to identify the earliest measurable pulmonary disease activity in individuals at-risk for HPS pulmonary fibrosis. The study also aims to develop biomarkers that will aid in understanding of the causes of HPS pulmonary fibrosis and facilitate more rapid conduct of therapeutic trials in HPS patients with mild pulmonary disease in the future.


Eligibility Criteria:
Inclusion Criteria:

* Individuals ages 12-90 years with confirmed diagnosis of HPS as defined by verification of reduced or absent platelet dense granules by electron microscopy and/or genetic diagnosis
* Ability to provide informed consent, or consent of parent/guardian and assent for minors

Exclusion Criteria:

* Status-post lung transplantation
* Perceived unsuitability for participation in the study in the opinion of the investigator
Evaluation of Gd-EOB-DTPA MRI for Detection and Characterization of Liver Nodules in Cirrhotic Patients Undergoing Liver Transplantation and Potential Impact on Transplant Eligibility

Chronic liver disease including cirrhosis is one of the most important factors in the multi-step progression of hepatocarcinogenesis, from benign regenerative nodules to early hepatocellular carcinomas (HCCs) and finally to overt HCCs. Early diagnosis of HCC, differentiation from benign hepatocellular nodules, and surgical resection of the tumor or transplantation of the liver provide the best chance for long-term survival. Several studies have evaluated MRI enhanced with superparamagnetic iron oxide, gadolinium-based contrast material, or both, for the detection and differential diagnosis of focal hepatic lesions. However, the differentiation of HCC from benign and or borderline hepatocellular nodules remains difficult, particularly in patients with cirrhosis, because of the architectural distortion of liver parenchyma and the development of cirrhotic nodules, ranging from benign regenerative nodules to overt HCC, with overlapping imaging features. Recently, gadoxetic acid (gadoliniumethoxybezyl-diethylenetriamine pentaacetic acid; Primovist®, Bayer Health Care Pharmaceuticals), a gadolinium-based paramagnetic contrast agent that produces both dynamic and liver-specific hepatobiliary MRI studies has gained widespread use. Some studies have showed that gadoxetic acid-enhanced MRI allows the accurate detection and characterization of HCC. Investigators plan to assess this in particular as it is a question of great relevance. Execution of well conducted prospective studies will also clarify inclusion of Gd-EOB-DTPA enhanced MRI as the technique of choice in evaluation of patients at risk for HCC.


Eligibility Criteria:
Inclusion Criteria:

* a. Patients with liver cirrhosis enlisted for liver transplantation with high probability of undergoing transplantation within the ensuing 12 months

  b. Patients who are diagnosed or suspected with HCC and listed for liver transplant surgery with priority MELD (Model for End-Stage Liver Disease) points based on the cancer diagnosis, regardless of whether they have or have not received pre-transplant treatments (incl. RFA, TACE, and XRT)

  c. Subjects must be able to undergo MRI

Exclusion Criteria:

* a. GFR \<30 mL/min/1.73 m2

  b. Elevated bilirubin (\>3mg/dl)

  c. Pregnant and/or nursing women

  d. Contraindications to MRI such as pacemaker or ferromagnetic implants

  e. Hypersensitivity to Primovist or to any ingredient in the formulation or component of the container

  f. Younger than 18 years of age
Study of Chiglitazar Compare With Sitagliptin in Type 2 Diabetes Patients

The purpose of this study is to evaluate the efficacy and safety of Chiglitazar, compare with Sitagliptin.

The efficacy and safety will be compared between Chiglitazar and Sitagliptin after treatment of 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Meet the WHO Diagnostic Criteria for Type 2 Diabetes (published on 1999);
2. HbA1c≥ 7.5% and ≤ 10.0% after control of diet and exercises;
3. Male and female,age between 18 and 70 years;
4. BMI between 18.5-35kg/m2;
5. Willing to be assigned to any treatment arm and sign inform consent.

Exclusion Criteria:

1. Type 1 diabetes;
2. Treated by oral or injective antidiabetic drug before screening, including insulin and herb;
3. Fasting plasma glucose \> 13.3 mmol/L (240 mg/dL);
4. Resistant hypertension \[blood pressure above the goal despite adherence to at least 3 optimally dosed antihypertensive medications (including diuretic) of different classes,or blood pressure is controlled to below the goal by at least different classes of drugs\];
5. Plasma triglyceride \> 500 mg/dL (5.65 mmol/L);
6. Is treating by fibrates;
7. History of diabetic ketoacidosis,diabetic hyperglycemic hyperosmolar syndrome,lactic acidosis, diabetic hypoglycemia; or is currently combined with retinopathy, diabetic nephropathy and diabetic neuropathy;
8. Had transient ischemic attack,cerebrovascular accident or unstable angina in the past 6 months;
9. History of myocardial infarction or had conducted coronary angioplasty or coronary artery bypass graft surgery;
10. Had or is having pancreatic diseases;
11. Heart failure (NYHA classification Stage III or IV), or left ventricular hypertrophy indicated by ECG;
12. Hepatic diseases such as hepatocirrhosis, active hepatitis,aspartate aminotransferase or alanine aminotransferase \> 2.5 fold of the upper limit of the normal range;
13. Kidney diseases or serum creatinine exceed the normal range: male \> 133 μmol/L or female \>108 μmol/L;
14. Had malignancy in the past 5 years, not including basal cell carcinoma;
15. Had or is currently receiving treatment that can alter blood glucose metabolism, including but not limited to diuretic,hormone (corticotropin or steroids),beta blockers;
16. Have the diseases that can alter blood glucose metabolism, including but not limited to active hepatitis, hyperthyroidism,or adrenal tumors;
17. Edema with unknown reason;
18. Alcohol or drug addiction;
19. Had participated other drugs' clinical trials in the 3 months before screening;
20. Pregnant or lactic women; or women of childbearing age who are not able to or is not willing to conduct contraception;
21. Any condition that make investigator consider the subject is not suitable to participate the trial.