cyrilzakka/clinical-trials huggingface dataset:
Long Non Coding RNA HOTAIR and Midkine as Biomarkers in Thyroid Cancer

Thyroid cancer is the most prevalent endocrine malignancy.Papillary thyroid carcinomas and follicular thyroid carcinomas account for 95% of all thyroid cancer cases. They are clinically classified as well-differentiated thyroid carcinomas due to their biological behavior resembling normal follicular cells and good responsiveness to surgery and radioiodine therapy . However, they are usually curable when discovered at early stages, but survival rates may be reduced from 100% in stages I and II to 50% at stage IV So,early detection is the key for successful treatment and reduction of mortality.

pathological analysis by fine-needle aspiration biopsies has some limitations including difficulty in sampling small tumors, inconclusive diagnosis in up to 35% of patients and bleeding. Thus, biomarkers for diagnosis are needed.

Thyroid cancer is the most prevalent endocrine malignancy.Papillary thyroid carcinomas and follicular thyroid carcinomas account for 95% of all thyroid cancer cases. They are clinically classified as well-differentiated thyroid carcinomas due to their biological behavior resembling normal follicular cells and good responsiveness to surgery and radioiodine therapy . However, they are usually curable when discovered at early stages, but survival rates may be reduced from 100% in stages I and II to 50% at stage IV So,early detection is the key for successful treatment and reduction of mortality.

pathological analysis by fine-needle aspiration biopsies has some limitations including difficulty in sampling small tumors, inconclusive diagnosis in up to 35% of patients and bleeding. Thus, biomarkers for diagnosis are needed.

The concept of liquid biopsy was proposed in contrast to the traditional tissue biopsy which is particularly important for solid tumor diagnosis. It refers to the process of detecting genetic materials, using non-invasive method from blood or other body fluids.Long noncoding RNAs (LncRNAs) have recently been demonstrated to participate in cancer progression.HOTAIR is the type of non coding RNA that will be investigated for its ability to differentiate benign from malignant thyroid nodule Midkine a basic heparin-binding growth factor of low molecular weight, capable of exerting activities such as cell proliferation, cell migration, angiogenesis and fibrinolysis. Midkine expression is closely related with progression of tumor stage. If tumor tissues increase secretion of midkine, it becomes evident in serum.The expression of midkine gene in human tumor cells may reflect tumor formation and give clues to the biological behavior of neoplasms. Hence, the expression of midkine may serve as a tumor marker for diagnosis and follow-up.

Eligibility Criteria:
Inclusion Criteria:

* patient with thyroid mass

Exclusion Criteria:

* no other known organ malignancy no previous chemotherapy
Evaluate the Efficacy of Herbal Medicine (Shaoyao Gancao Decoction Jiawei) in Sleep-related Leg Cramps

Sleep-related leg cramps (SRLCs) are a sleep-related movement disorder whereby painful contractions of the calf or foot muscles arise at sleep onset and during sleep and awaken the patient, interrupting sleep. Application of oral administration with Chinese herbal medicine can enhance the effectiveness and efficacy in treatment of SRLCs.This study will using Shaoyao Gancao Prescription Jiawei by adding Pueraria montana, Salvia Miltiorrhiza, into Shaoyao Gancao. The study aims to evaluate the effectiveness of a Shaoyao Gancao Prescription Jiawei in relieving leg cramps.

The study will be conducted in Yan Oi Tong Mrs Shirley W K Siu Medical Centre. All participants diagnosed with sleep-related leg cramp will be screened for eligibility criteria from the general public or referred patients via daily outpatient services. This will be a prospective trial in patients with sleep-related leg cramps (SRLCs). 30 subjects will be recruited from Yan Oi Tong Mrs Shirley W K Siu Medical Centre. The medication will be taken twice daily for 28 consecutive days. Each prescription will consist of 4 herbal granules. Study follow up will be offered every 7 days till 56th day after enrolment. Daily leg cramps log will be filled in by each individual everyday from day 0 to day 56.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 60-80
2. Complain of muscular spasm and contracture of a limb with difficulty in relaxation and movement during night time, caused by wind-cold dampness chiefly involving the sinews
3. SRLCs occur at least once in the past 7 days or twice in the past 14 days
4. Visual Analogue Scale (VAS) for leg cramp ≥ 5 (0-10) at the last attack
5. Both gender but menopause or sterilization for female subjects
6. Able to fill up the VAS for leg cramp
7. Written informed consent obtained

Exclusion Criteria:

1. Known mental disorder 2. Known serious organic disease including severe coronary function impairment, post-stroke depression and dementia, and auto-immune diseases 3. Known history of renal or liver function impairment; 4. Patients whose blood tests show exclusion criteria 5. Currently taking anticoagulant or antiplatelet 6. Any contraindications for taking herb confirmed by investigator

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Diet in the Management of Acromegaly

Impact of low carbohydrate and low gluten diet on acromegaly progression, symptoms, complications, and treatment outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of acromegaly.

Exclusion Criteria:

* Diet restrictions.
Impact of Polymorphism on Pulmonary Pressure in Subjects With Pulmonary Hypertension of Different Cause

Pulmonary Hypertension (PH) is a disease that is characterized by vasoconstriction of small vessels of the lung. Many cases do have proliferation of endothelial cells within these vessels. A possible influence of polymorphisms of genes relevant for inflammatory and endothelial processes is suspected.

Especially patients with chronic heart failure can develope PH. The reasons therefore are lacking.

The researchers investigate different polymorphism and the influence of these on pulmonary artery pressure (measured invasively) in patients with congestive heart failure (CHF) and patients with primary pulmonary hypertension.

The study consists of 3 arms-patients with CHF and PH, patients with CHF without PH and patients without CHF and PH.

The PH measurement is due to routine catheterization, thereafter we measure different vasoactive polymorphism.

Eligibility Criteria:
Inclusion Criteria:

* CHF with or without pulmonary hypertension or
* patients with normal LVEF and pulmonary hypertension
* right heart catheterization due to routine
* informed consent

Exclusion Criteria:

* no right heart catheterization
* no informed consent
* elevated pulmonary pressure due to valve diseases or congenital heart disease
Pulmonary Artery Denervation in Patients With Atrial Fibrillation and Group 2 of Pulmonary Hypertension

The goal of the study is to compare efficacy and safety of the pulmonary artery denervation procedure combined with atrial fibrillation ablation versus atrial fibrillation ablation alone in patients with paroxysmal and persistent atrial fibrillation and group 2 of the pulmonary hypertension


Eligibility Criteria:
Inclusion Criteria:

* Mean pulmonary artery pressure \> 25 mm Hg and pulmonary artery wedge pressure \> 15 mm Hg by right heart catheterization
* Paroxysmal or persistent atrial fibrillation
* NYHA II-III
* BNP \> 105 pg/ml
* Indications for catheter ablation of atrial fibrillation according guidelines
* LVEF \> 50%

Exclusion Criteria:

* Group 1,3,4 of the pulmonary hypertension
* Left atrium diameter \> 6 cm
* Planned open heart surgery procedure
* Previous heart valve surgery
* Severe aortic, pulmonary, tricuspid or mitral, valves regurgitation
* Thrombus in the left heart chambers
Core Stability Training in Multiple Sclerosis

The primary purpose of this study is to determine whether a 12 week Pilates based core stability training programme is effective in improving balance, mobility and balance confidence in ambulant individuals with Multiple Sclerosis (MS).

The primary purpose of this study is to determine whether a 12 week Pilates based core stability training programme is effective in improving balance, mobility and balance confidence in ambulant individuals with Multiple Sclerosis (MS). The secondary aim is to determine the relative effectiveness of this 12 week Pilates based core stability training programme compared to a standardised physiotherapy exercise programme. Finally we intend to explore the underlying mechanisms of change associated with these exercise interventions by directly measuring changes in muscle thickness and activation in the deep abdominal core stabilising muscles of a sub-set of participants.

Eligibility Criteria:
Inclusion Criteria:

* Definite diagnosis of MS, according to McDonald's criteria
* Aged 18 years or over
* Able to walk independently with or without use of intermittent or constant unilateral assistance such as walking stick or orthotic brace

Exclusion Criteria:

* In relapse or relapse in previous three months
* Any medical condition contra-indicating participation in core stability exercises
* Score \< 6 on the Abbreviated Mental Test, as an indicator of those whose cognitive difficulties could interfere with the informed consent process, or the ability to fully engage in the exercise programme.
* Current or recent (within past 6 months) participation in core stability exercises
* Current involvement in another interventional research study
Neurodevelopmental Outcomes of Preterm Infants Treated for Pain Management With Repeated Doses of Sucrose 24%

The purpose of this study is to determine the effect of sucrose 24% for pain prevention on preterm infants. Our hypothesis is that repeated doses of sucrose 24%, given prior to painful procedure,do not impair neurodevelopmental outcomes of preterm infants

preterm infants born at 27-33 weeks gestational age at Sheba Medical Center will be recruited for this study. Prior to invasive procedure infants will be treated with pacifier and swaddling as recommended by the American Academy of Pediatrics and Canadian Pediatric Society.

Group 1.Will be treated with Sucrose 24% 0.1-0.5ml on the anterior pat of the tongue 1-3 min prior to invasive procedure.

Group 2. Similar to group 1 but breast milk or formula will replace Sucrose.

Number of invasive procedures/day will be documented

General Movements by Prechtel will be used for developmental assessment at 2,4,6 weeks after birth and at 14-16 weeks corrected age

Griffiths developmental scales (GMDS) will be used at 40 weeks, 14-16 weeks corrected age, and 3-6 month corrected age

Eligibility Criteria:
Inclusion Criteria:

* preterm infants born at SMC

Exclusion Criteria:

* need for intubation
* surgery
* need for sedation
* abnormal head ultrasound
* genetic abnormalities
* necrotizing enterocolitis
* other painful conditions other than routine blood exams
Efficacy and Safety of Fenofibrate Added on to Atorvastatin Compared With Atorvastatin

The purpose of this study is to evaluate the efficacy and safety of Atorvastatin and Fenofibrate compared with atorvastatin monotherapy in mixed hypercholesterolemic patients.

Multi center, randomized, double-blind, parallel-group, therapeutic confirmatory study

Primary Outcome Measure:

The mean percent change of Non-HDL Cholesterol \[Time Frame: from baseline at week 8\]

Secondary Outcome Measures:

The achievement rate of LDL-C\<100mg/dl, Non-HDL-C\<130mg/dl \[Time Frame: from baseline at week 8\] The mean percent change of LDL-C, HDL-C, TG, TC, Apo-AI, Apo-B \[Time Frame: from baseline at week 4, 8\] The mean percent change of Non-LDL-C/HDL-C, TC/HDL-C, LDL-C/HDL-C, Apo-B/Apo-AI \[Time Frame: from baseline at week 4, 8\] The mean percent change of Fibrinogen, hs-CRP \[Time Frame: from baseline at week 4, 8\] Safety evaluation \[Time Frame: Treatment period and Extension period\]

Eligibility Criteria:
Inclusion Criteria:

* \>19 years old
* High risk patient to Coronary Heart Disease (applied to 1 or more CHD risk factor listed below)

  1. Patient with Coronary Heart Disease
  2. Patient with carotid artery disease, peripheral blood vessel disease, abdominal aneurysm
  3. Patient with diabetes(HbA1C≤9.0%)
  4. 10-year risk of CHD \>20%(by Framingham 10-year risk score calculation)
* At Visit 1(Screening)

  1. 100mg/dl≥LDL-C, 150mg/dl≤TG≤500mg/dl

     * 4weeks of Atorvastatin 20mg monotherapy run-in period
  2. LDL-C\<100mg/dl, 150mg/dl≤TG≤500mg/dl

     * If treated with Atorvastatin 20mg monotherapy 4weeks prior to this study
* At Visit 2(After 4weeks of Atorvastatin monotherapy run-in period)

  * LDL\<100mg/dl, 150mg/dl≤TG≤500mg/dl

Exclusion Criteria:

* Patients with acute artery disease within 3 months
* Patients with congestive heart failure(NYHA class III\~IV) or uncontrolled arrhythmia within 6 months
* Patients with uncontrolled hypertension(SBP\>160mmHg or DBP\>95mmHg)
* TSH\>1.5X ULN
* Patients with myopathy, rhabdomyolysis or CK\>2X ULN
* Hypersensitive to Atorvastatin and/or Fenofibrate or had photoallergy or phototoxicity during fibrate and/or ketoprofen treatment
* Serum Creatinine\>2.5mg/dl, AST or ALT \> 2X ULN
* History of drug or alcohol abuse within 6 months
* History of GI tract surgery or disability to drug absorption
* Women with pregnant, breast-feeding
* Patients with gallbladder disease
* Patients with biliary cirrhosis
* Patients with pancreatitis(acute pancreatitis is excluded due to severe hypertriglyceridemia)
* Patients treated with any investigational drugs within 4 weeks at the time consents are obtained
* History of malignant tumor including leukemia, lymphoma within 5 years
* Patients must be treated with medications prohibited for concomitant use during study period
* Not eligible to participate for the study at the discretion of investigator
Effectiveness and Safety of a Digitally Based Multidomain Intervention for Mild Cognitive Impairment

This study is designed to evaluate the preliminary effectiveness and safety of a digitally based multidomain intervention in patients with MCI. In addition, a portion of cognitively normal subjects and caregivers of patients with MCI will also be recruited as an exploratory cohort. We hope that the digital platform will improve the overall cognition and quality of life in patients with MCI.

3 groups of participants will be recruited. For the participants in the MCI (group A) and cognitively normal subjects (group B), they will be provided with a digital tablet and a wearable device. The digital tablet will be pre-loaded with 10 modules, 1 module per week (1 hour) for 10 weeks to be completed at home. The wearable device will be used to track and collect physiological data.

For the caregivers of the patients with MCI (group C), they will be asked to complete a questionnaire during screening visit and follow-up visit, and to use the caregiver app during the intervention period.

Eligibility Criteria:
Patients with MCI Thirty (30) patients with MCI of the amnestic type (single or multi domain) will be recruited. MCI will be diagnosed using the Petersen's criteria and/or the NIA-AA criteria by cognitive neurologists.

Inclusion criteria:

1. Either male or female aged between 50 and 70 years (inclusive)
2. Diagnosis of amnestic MCI using the Petersen's criteria and/or the NIA-AA criteria
3. Clinical Dementia Rating (CDR) score of 0.5 and Mini-Mental State Examination (MMSE) \>24
4. Education \>6 years
5. Literate in English
6. Basic proficiency in using web-based applications/mobile platforms
7. Willing to give informed consent

Exclusion criteria:

1. Significant hearing or visual impairment
2. Significant systemic, neurological or psychiatric illness such as end stage renal failure, Parkinson's disease or major depression.
3. Participation in any pharmacological or non-pharmacological (interventional) clinical trial in the preceding 12 weeks

Cognitively Normal Subjects Ten (10) cognitively normal subjects will be recruited.

Inclusion criteria:

1. Either male or female aged between 50 and 70 years (inclusive)
2. CDR of 0 and MMSE \> 27
3. Education \>6 years
4. Literate in English
5. Basic proficiency in using web-based applications/mobile platforms
6. Willing to give informed consent

Exclusion criteria:

1. Significant hearing or visual impairment
2. Significant systemic, neurological or psychiatric illness such as end stage renal failure, Parkinson's disease or major depression.
3. Participation in any pharmacological or non-pharmacological clinical trial in the preceding 12 weeks

Caregivers of Patients with MCI Fifteen (15) caregivers of the 30 patients with MCI will be recruited.

Inclusion criteria:

1. Either male or female aged ≥21 years
2. Is the spouse or child of the patient and must spend at least 2 hours per week with the patient.
3. Must be healthy and not suffering from any serious systemic, neurological or psychiatric illness.
4. Literate in English
5. Willing to give informed consent Exclusion criteria: NA
The Mechanisms of Underlying Accelerated Repetitive Transcranial Magnetic Stimulation for Treatment-resistant Depression

In this project, the investigators evaluate an accelerated schedule of repetitive transcranial magnetic stimulation for treatment-resistant depression. The investigators focuse on participants' brain activity and blood markers (Reelin, Apoer2, NMDAR, BDNF, exosomes and so on) to deepen the understanding of the mechanism of accelerated rTMS for treatment-resistant depression.

In this project, the investigator evaluate an accelerated schedule of repetitive transcranial magnetic stimulation for treatment-resistant depression. Patients were included in two groups and received an accelerated stimulation or sham treatment. The changes of neuroimaging and biomarkers at baseline, 5 days after treatment and 1 month after treatment are evaluated. The investigators focuse on participants' brain activity and blood markers (Reelin, Apoer2, NMDAR, BDNF, exosomes and so on) to deepen the understanding of the mechanism of accelerated rTMS for treatment-resistant depression.

Eligibility Criteria:
Inclusion Criteria:

1. The current episode met the DSM-5 diagnostic criteria for major depression in patients with first-episode or relapsed unmedicated depression without psychotic symptoms.
2. 24-item Hamilton Depression Scale (HAMD-24) ≥ 20.
3. Age 18-45 years, regardless of gender.
4. Right-handedness.
5. Han Chinese.
6. Signed a written informed consent, willing to participate in the study and be evaluated.

Exclusion Criteria:

1. Co-morbid other mental disorders, including: schizophrenia, mental retardation, substance dependence, etc.
2. Patients with metal objects in the body or with other contraindications to MRI scanning
3. Patients with severe or unstable somatic diseases
4. Women during pregnancy or lactation, and women of childbearing age with positive urine HCG test results during the screening period
5. Other conditions that, in the opinion of the investigator, exist that make participation in this clinical trial inappropriate.
Influence of Exceptional Patient Characteristics on Everolimus Exposure

A study to determine whether everolimus pharmacokinetics in elderly and obese patients is different compared to control patients.

Furthermore the investigators will investigate the relation between metabolic response assessed with \[18F\] Fluorodeoxyglucose-Positron Emission Tomography (FDG-PET) and everolimus exposure and clinical benefit.

The investigators will explore whether dose escalation in patients who are hypothetically underexposed will result in an increase in metabolic response.


Eligibility Criteria:
Inclusion Criteria:

* Adult women (≥ 18 years of age) with metastatic or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy.
* Histological or cytological confirmation of estrogen-receptor positive (ER+) breast cancer
* Postmenopausal women
* Radiological or clinical evidence of recurrence or progression on last systemic therapy prior to enrollment.
* Progression following a non-steroidal aromatase inhibitor
* Falling into one of the following categories

  * elderly patients (age ≥ 70 years and BMI \< 30 kg/m2); or
  * obese patients (BMI ≥ 30 kg/m2 and age \< 70 years); or
  * control patients (BMI \< 30 kg/m2 and age \< 70 years);
* Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 x ULN
* Adequate renal function: calculated creatinine clearance, as estimated by GFR using the MDRD formula, is ≥ 30ml/min/1.73m2
* Performance status ECOG 0 - 2 (Karnofsky index: 60 - 100)
* Patient is willing and able to sign the Informed Consent Form prior to screening evaluations

Exclusion Criteria:

* Patients aged ≥ 70 years AND BMI ≥ 30 kg/m2
* HER2-overexpressing patients by local laboratory testing (IHC 3+ staining or in situ hybridization positive).
* Previous treatment with exemestane or mTOR inhibitors. Except for the treatment with exemestane in the adjuvant setting.
* Known hypersensitivity to mTOR inhibitors, e.g. sirolimus (rapamycin).
* Patients with a known history of HIV seropositivity.
* Any severe and / or uncontrolled medical conditions such as:

  * Unstable angina pectoris, serious uncontrolled cardiac arrhythmia
  * Patients with severe hepatic impairment (Child-Pugh A/B/C)
  * Uncontrolled diabetes mellitus
  * Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drugs (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome)
* Patients who test positive for hepatitis B or C
* Patients being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A within the last 5 days prior to enrollment
* History of non-compliance to medical regimens
* Patients unwilling to or unable to comply with the protocol