cyrilzakka/clinical-trials huggingface dataset:
Effectiveness and Safety Study of Early add-on of Ezetimibe With Atorvastatin in Very High-risk Patients

This study aims to confirm the effectiveness of ezetimibe add-on therapy on LDL-C levels compared to atorvastatin monotherapy, especially in very high-risk patients. We intend to lay the foundation for a standard treatment for these patients through ezetimibe add on lipid-lowering therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who are ≥ 30 years old.
2. Patients with very high-risk\*: clinical or unequivocal on imaging ASCVD. ASCVD includes previous ACS (MI or UA), stable angina, coronary revascularization (percutaneous coronary intervention (PCI), coronary artery bypass graft surgery (CABG), and other arterial revascularization procedures), stroke and transient ischaemic attack (TIA), and peripheral arterial disease (Mach F 2020).
3. Patients (a) who failed to achieve their target LDL-C goals with low and/or moderate intensity statin mono therapy for ≥ 4 weeks or (b) who are statin-naïve or have not been on a stable (unchanged) statin regimen for at least 4 weeks prior to enrollment

   * rosuvastatin \< 10 mg, atorvastatin \< 40 mg, and all dose of pitavastatin, simvastatin, lovastatin, pravastatin, and fluvastatin (Team G 2020).
4. Patients with LDL-C levels ≥ 70 mg/dL
5. Patients who are willing to maintain TLC throughout the study.
6. Patients who are willing to provide written informed consent prior to study enrollment.

Exclusion Criteria:

1. Patients with hypersensitivity to ezetimibe, atorvastatin or any of its inactive ingredients.
2. Patients with active liver disease or unexplained persistent elevations of hepatic transaminase levels. (aspartate transaminase (AST) or alanine transaminase (ALT) \> 3 x upper limit of normal (ULN)).
3. Patients who have predisposing conditions with muscle disease (i.e., rhabdomyolysis or myopathy) or neuromuscular disease.
4. Patients with myasthenia gravis.
5. Female patients who are pregnant or have a potential to be pregnant and nursing.
6. Patients who are taking glecaprevir and pibrentasvir.
7. Patients with hereditary problems of galactose intolerance, lapp lactase deficiency, or of glucose-galactose malabsorption.
8. Patients with disease known to influence serum lipids or lipoproteins excluding dyslipidemia.
9. Patients with a history of cancer within 5 years.
10. Patients whose life expectancy is less than 6 months due to their medical conditions.
11. Patients with any condition or situation that might pose a risk to the participant or interfere with participation in the study.
12. Patients who have received any investigational medicine within 12 weeks of written informed consent or are going to receive during the clinical trial period.
13. Patients who are judged to be difficult to conduct clinical trials according to the judgment of the investigator.
Efficacy of Monotherapy vs Combination Therapy of Corticosteroids With GCSF in Severe Alcoholic Hepatitis Patients.

The patients of Severe Alcoholic Hepatitis (SAH) will be included in study based on inclusion and exclusion criteria. The patients will be then randomized in 3 groups for therapy. They will receive either steroid or Granulocyte-Colony Stimulating Factor (GCSF) or both. They will be followed for atleast 90 days for improvements in symptoms and various predefined parameters. Primary outcome will be improvement in survival at 90 Days. Patients will be monitored at every follow up for disease progression and complications of therapy. The study results will be analyzed for differences in survival rate and complications in different groups to propose new therapeutic guideline in SAH patients.


Eligibility Criteria:
Inclusion Criteria:

* Severe alcoholic hepatitis patients \[Maddrey's score \> 32\] aged between 18 to 65 years.

Exclusion Criteria:

* Presence of active infections
* Acute Gastrointestinal bleed
* Hepatorenal syndrome
* Patient unwilling
* Discriminant Function \>90
* Autoimmune hepatitis
* Hepatitis B, Hepatitis C, Human immunodeficiency Virus cases
* Pregnancy
* Hemophagocytic lymphohistiocytosis (HLH)
* Hb\<8 and baseline White Blood Cell\>25000
Inspiratory Muscle Training in Obese Breast Cancer Survivors

The investigators propose a randomized controlled trial to determine the effectiveness of inspiratory muscle training in improving exercise tolerance among stage 0-III obese breast cancer survivors.

Randomized controlled trial (RCT) where obese participants (N=133) are randomized to 2 arms: \[i\] IMT 4 wks + Exercise 12 wks, \[ii\] SHAM 4 wks + Exercise 12 wks).

Eligibility Criteria:
Inclusion Criteria:

* completed active treatment for a Stage 0-III breast cancer diagnosis within 6 months to 5 years of enrollment.
* obese as defined by a body mass index (BMI) of 30 to 50 kg/m2
* patients who are on adjuvant endocrine therapy will be allowed to participate.
* sedentary (participating in less than 90 min of moderate intensity activity per week) and have at least one limitation in activity on the 10-question RAND-36 Physical Function Subscale to ensure some exercise intolerance

Exclusion Criteria:

* functional limitations that make independent exercise unsafe
* metastatic breast cancer
* ongoing or active infection with recent antibiotics or steroids
* Bilateral Axillary lymph node dissection (ALND) of \>5 lymph nodes on each side, which could increase risk of lymphadenopathy with repeated blood pressure measurements during exercise or if patient has been advised by their clinician to avoid repeated BP measures on both arms. Bilateral Sentinel Lymph Node Biopsy (SLNB) will be allowed.
* heart disease precluding exercise (congestive heart failure, unstable angina pectoris, cardiac arrhythmia)
* psychiatric illness/social situations that would limit compliance with study requirements
* orthopedic or neuromuscular disorders or arthritis that preclude participation in exercise
* unwilling or unable to follow protocol requirements
* pregnant or nursing
* any condition which in the investigator's opinion deems the subject an unsuitable candidate to participate in this study
* presence of provokable ECG changes suggestive of heart disease, or dangerous arrhythmias or exercise induced hypertension, etc. during the cardiopulmonary exercise test
* non-English speaking
Effects of Anke Malz on Women During Lactation

Human milk is the most optimal food to provide all infants' needs before eating solid food. However, underproduction of milk is a common and concerned problem for breastfeeding women. In this case, proper milk-making foods reveal their importance on lactation. In many European countries, ancient wisdom clams that non-alcoholic malt beverage could facilitate the secretion of breast milk. This study estimates the effects of non-alcoholic malt product during first three months of lactation.


Eligibility Criteria:
Inclusion Criteria:

* Single fetal pregnancy
* Full time birth

Exclusion Criteria:

* Any complication during pregnancy
* Smokers
* Alcohol or drug abuse
Combination of Local Therapy and Target Therapy for Brain Metastases With EGFR Mutation

The goal of this observational study is to learn about the survival benefit of local therapy combination with target therapy in lung cancer brain metastases with EGFR mutation. The main questions it aims to answer are:

* Is local therapy performed before or after target therapy would provide survival benefit ?
* What kind of local therapy combining with target therapy would provide survival benefit, neurosurgical resection or radiotherapy?


Eligibility Criteria:
Inclusion Criteria:

1. Evidence of pathological diagnosis of primary tumor.
2. Brain metastases confirmed by enhanced magnetic resonance imaging.
3. Gene test indicated that EGFR mutation.
4. Complete clinical information.

Exclusion Criteria:

1. If surgical treatment is accepted, the surgical treatment is not tumor resection, but ventricle puncture, biopsy and other non-tumor reducing surgery.
2. Patients with 2 or more types of tumors.
3. Incomplete clinical information.
Preventing Seroma Formation After Stripping Saphenous Vein in Coronary Bypass

The great saphenous vein is the most commonly used material in coronary vascular bridging operation. Coronary bypass operation to obtain the great saphenous vein is mainly through the incision open groin to ankle. This operation may damage the lymphatic, cause lymph circumfluence obstacle, cause fat liquefaction, scar formation, wound dehiscence, around hematoma and other a series of symptoms.Based on some studies and our experience that vacuum assisted closure （VAC）is effective in complex wound failures following Stripping saphenous vein, we use VAC to prevent seroma formation after Stripping saphenous vein in Coronary bypass. This study is aimed to evaluate the efficacy and economics benefits of early VAC application on postoperative complications and wound healing after Stripping saphenous vein in Coronary bypass in comparison to conventional suction drain.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Coronary heart disease patients to transplant more than 2 vascular bridge
* The thigh groin following from the saphenous vein

Exclusion Criteria:

* Subjects does not agree to participate in clinical trials
* Subjects had a injury, operation history of Thigh
* Subjects having ever received chemotherapy before the surgery
* Subjects with known hypersensitivity to components of the surgical sticky membrane
Diagnosis and Treatment of Acute Coronary Syndrome in the ED & the Impact of Rapid Bedside cTnl on Outcome.

The primary outcome in this study will be time to discharge for low-risk patients and therapeutic turnaround time for patients with NSTEMI or unstable angina.

Phase IV prospective, randomized (1:1), parallel-group trial utilizing concurrent controls. Assess the reduction in time taken to dispostion or discharge patients. Assess the ability of POC testing to satisfy guidelines for a 30 minute turn around time of results. Assess and differences in clinical decision-making for other diagnostic procedures including nuclear imaging, echo, and stress treadmill, disposition from the ED, time to catherterization lab, PCI, and CafBG based on the cardiac troponinn results from the bedside analyzer and the central lab instrument.Assess the difference for in-hospital and 30 day post hospital discharge cardiac events including all-cause and cardiac-specific deaths, CHF, cardiomyopathy, and atrial and ventricular arrhythmia, beween the bedside analyzer and the central lab instrument. Assess the differences in hospital care costs for the hospitalization period, and assess direct medical and indirect productivity costs in the 30 day post hospital discharge period to patients who are diagnosed, using the bedside cTnl test and the central lab cTn tests, and subsequently treated as per the guidelines.

Eligibility Criteria:
Patient must be 21 years old or older with chest pain or other symptoms that lead to drawing cardiac biomarkers.
Evaluation of a New Cardiac Pacemaker

An evaluation of a safety and performance of a new cardiac pacemaker


Eligibility Criteria:
Inclusion Criteria:

* Subject must have one of the following clinical indications:

  1. Chronic atrial fibrillation with 2 or 3° AV or bifascicular bundle branch block (BBB block) ; or
  2. Normal sinus rhythm with 2 or 3° AV or BBB block and a low level of physical activity or short expected lifespan (but at least one year); or
  3. Sinus bradycardia with infrequent pauses or unexplained syncope with EP findings; and
* Subject ≥18 years of age;
* Subject has life expectancy of at least one year;
* Subject is not enrolled in another clinical investigation;
* Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams;
* Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the EC;
* If female, for 3 months post-operative, subject will actively practice a contraception method, or will practice abstinence, or is surgically sterilized, or is postmenopausal.

Exclusion Criteria:

* Pacemaker dependent;
* Known pacemaker syndrome, have retrograde VA conduction or suffer a drop in arterial blood pressure with the onset of ventricular pacing;
* Hypersensitivity to \< 1 mg of dexamethasone sodium phosphate;
* Mechanical tricuspid valve prosthesis;
* Pre-existing pulmonary arterial (PA) hypertension or significant physiologically-impairing lung disease;
* Pre-existing pacing or defibrillation leads;
* Current implantation of an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT);
* Presence of implanted vena cava filter;
* Presence of implanted leadless cardiac pacemaker;
* Pregnant or breastfeeding.
The Exopulse Mollii Suit Study - a Database for Routine Follow-up of Clinical Outcomes

The objective is to explore the potential short and long-term impact of the Exopulse Mollii Suit on subjects with CP, MS, stroke, SCI or other neurological disorders which may cause such types of symptoms, and to identify high responders among the sub-categories of the diagnoses. The primary endpoint will be improvement on the Berg/Pediatric Balance Scale (BBS) as a measurement of balance and risk of falls.

The registry is designed to demonstrate the impact of Exopulse Mollii Suit on improvement and relaxation of muscles, muscle activation, local blood circulation and chronic pain relief.

The subjects will serve as their own control and the data will be collected before, during and after the treatment period. As the electrical stimulation from the suit usually is above the level of sensation, the study participant cannot be blinded to the treatment.

To prevent bias, multiple investigators will be collecting the data and only standardized and validated methods will be used. All investigators will be trained on the measurements prior to the registry start.

Additionally, all investigators are trained and certified in the Exopulse method, and the generic stimulation settings are selected according to a standardized matrix based on the subjects' age and level of impairment.

Re-assessments during scheduled visits are part of normal routine and use. The decision whether the subjects will be enrolled in the registry is separated from the subject's decision to use the device.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with CP, MS, stroke, spinal cord injury or other neurologic disorder that may cause such type of symptoms.
* Diagnosed \>6 months prior to inclusion in case of MS, stroke, or SCI
* Give written informed consent
* Cognitively able to understand and follow verbal and/or written instructions
* A minimum age of 2 years

Exclusion Criteria:

* Any of the contraindications listed in the instructions for use of the Exopulse Mollii Suit
* Being introduced to any new medication affecting the neuromuscular activity during the study period
* Using botulinum toxin \<3 month before or during the study period
* Subjects \<100 cm and \<13 kg
* Subjects \>205 cm and \>115 kg
Dietary Fiber and Hyperkalemia in Dialysis Patients

To analyze the dietary nutrition and dietary fiber (DF) intake of maintenance hemodialysis (MHD) patients, and explore the effect of dietary nutrition and DF intake balance on the nutritional status and pre-dialysis hyperkalemia of MHD patients.

A total of 100 MHD patients were retrospectively enrolled, including 67 males and 33 females. The daily diet was recorded by 3-day dietary recording method. The daily average dietary nutritional intake and DF intake of MHD patients were calculated by professional software. Dietary guidance and analysis were conducted according to the Expert Consensus on Nutrition in Chronic Kidney Disease (2005) and the Dietary Guidelines for Chinese Residents (2016). Of the 100 patients, 37 had hyperkalemia (serum potassium \> 5.5 mmol/L) before dialysis.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old; undergoing hemodialysis at least 3months; with a certain level of education; with complete behavioral ability

Exclusion Criteria:

* In the acute phase of acute cardiovascular disease, acute cerebrovascular disease, and acute digestive system disease；Anorexia, long-term malnutrition, or dietary disorders；poor compliance；
Effects of Acupuncture at ST36 and PC6 on Blood Pressure and Endothelial Dysfunction in Hypertensive Patients

This is randomised, controlled study about effects of acupuncture on blood pressure and endothelial dysfunction in stage I hypertension patient without medication. Subject will receive 8 weeks of either acupuncture or sham acupuncture, measuring FMD and blood test before and after treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients age 18-70 diagnosed stage I hypertension ( JNC-7) without taking hypertensive medication

Exclusion Criteria:

* Secondary hypertension
* DM
* History of cardiovascular disease
* Taking hypertensive medication
* Taking hyperlipidemic medication
* Smoking
* Pregnancy or feeding woman
* Cannot follow indication or there is no agreement of patient and conservator
* Investigator decide Inappropriate to trial
Feasibility Study of Neoadjuvant Chemotherapy Modified FOLFOX6 for Resectable Liver Metastases of Colorectal Cancers

The purpose of this study is to evaluate the safety of liver resection for metastatic, resectable lesions from colorectal cancers after systemic chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically diagnosed as colorectal adenocarcinomas, including cecal, appendiceal, and anal canal cancers.
2. Liver lesions are measurable by spiral CT or SPIO-MRI scans.
3. Extrahepatic lesions include lung metastases which can be resected curatively.
4. Curative resection for metastatic lesions can be performed with residual hepatic functions preserved.
5. No prior treatment histories for liver lesions, including L-OHP regimens, hepatectomy, hepatic arterial infusion, MCT, or RFA
6. No evidence of chronic hepatic diseases which affect systemic chemotherapy and/or surgical resection
7. Performance status (ECOG): 0-1
8. Vital organ functions, including hematopoietic, cardiac, respiratory and renal functions, are preserved.

Exclusion Criteria:

Excluded are cases with conditions as below:

1. Peritoneal or pleural fluid retention to be drained.
2. Multiple malignancies to be treated.
3. Peripheral neural disturbances.
4. Active infectious diseases.
5. Severe watery diarrhea.
6. Mental disturbances.
7. Treatment history of continuous, oral or intravenous steroid therapy.
8. Previous history of ischemic heart diseases.
9. Coexistent severe diseases including pulmonary fibrosis, interstitial pneumonia, ileus, uncontrollable diabetes, cardiac dysfunction, hepatic failure, or renal failure.
10. Pregnant.
11. Previous history of severe drug-induced allergy.
Béa Applicator and Béa Cervical Cap Safety and Usability Study

This is a Clinical Study Designed to Validate the Usability and Safety of the Over-the-counter (OTC) Béa Applicator and Béa Cervical Cap Device in a Home Use Environment.

Female participants will undergo a baseline physical assessment performed by a physician at the study site. The participants will then be given the Béa Applicator and Béa Cervical Cap device with accompanying instructions and a semen collection pot. The participants will return home to use the device as per the Instruction for Use (IFU). The Béa Cervical Cap will remain in place for a minimum of 4 hours and a maximum of 6 hours. At the follow-up assessment, the investigator will investigate all primary objectives via a physical exam or via questioning the participant.

Eligibility Criteria:
Inclusion Criteria:

* People who are able to and for whom it is medically safe to conceive
* Heterosexual couples and individuals, of any race or ethnicity, who are sexually active
* 18 - 40 years of age
* Trying to conceive
* Signed Informed Consent
* Approximately nineteen per cent (19%) of participants will present with a retroverted uterus as found in the general female population.

Exclusion Criteria:

* Vaginal prolapse (female)
* Hysterectomy (female)
* Erectile dysfunction (male)
* Diagnosis and/or treatment of vaginitis or sexually transmitted infection (STI) within the last month
* Colposcopy with biopsy surgery within the last three (3) months (female)
* Treatment for dysplasia surgery within the previous three (3) months (female)
* Vaginal/cervical surgery within the last three (3) months (female)
* Current pregnancy (female)
* Unable to read and understand English, as assessed by REALM
* Presence of noticeable lesions, open sores, viral warts, and any other genital abnormalities (female \& male)
Orbital Radiotherapy in Grave's Ophthalmopathy 1 Week vs 2 Weeks (OraGO-1 Trial)

Thyroid ophthalmopathy, also known as thyroid eye disease or Graves' ophthalmopathy, is a condition characterized by inflammation and swelling of the tissues around the eyes, often accompanied by protrusion of the eyeballs. This condition can lead to significant discomfort, visual disturbances, and in severe cases, permanent vision loss.

Primary treatment modalities are intravenous methylprednisolone (IVMP) and other medications for patients with moderate to severe and active thyroid eye disease. In addition, external beam radiation therapy (ERT) is an another treatment option in combination with IVMP.

Radiation therapy delivers targeted doses of ionizing radiation to the affected orbital tissues, effectively reducing inflammation. This approach is particularly beneficial for patients who may not respond adequately to steroid therapy alone or those who experience recurrent disease flares.

This study will test the efficacy of a shortened treatment regimen comprising 5 sessions of ERT to a standard protocol of 10 treatments. The primary aim is to ascertain the effectiveness of shorted radiation treatment while improving patients' quality of life.

The research methodology of this study involves comparing the standard protocol of 10 radiation treatments with a modified approach comprising 5 treatments of daily External Beam Radiation Therapy (ERT).

The primary objective of this investigation is to assess whether reducing the number of radiation treatments while maintaining the effectiveness of the therapy can lead to improvements in the quality of life for patients with thyroid ophthalmopathy.

By comparing these two treatment regimens, researchers aim to evaluate the efficacy and safety of the abbreviated radiation schedule in managing the symptoms and progression of the disease.

Participants enrolled in the study will be randomized into two groups: one receiving the standard 10 treatments and the other receiving the modified 5-treatment regimen of daily ERT. Throughout the study period, participants will undergo comprehensive assessments to monitor changes in symptoms, vision, and quality of life. These evaluations will include ophthalmic examinations, imaging studies, and patient-reported outcome measures to capture both objective and subjective measures of treatment response.

Eligibility Criteria:
Inclusion Criteria:

* Patient with active moderate to severe thyroid eye disease with a CAS \> 4 with/ without diplopia before starting IVMP
* Patient with poor response to 3 doses of IVMP (CAS drop \< 1) หรือ CAS score \> 3 after 3 doses of IVMP
* Patients with diplopia after 3 doses of IVMP
* Patients with Graves' Ophthalmopathy who have maintained euthyroidism
* Non-pregnant adults (aged 35 years or older)

Exclusion Criteria:

* Individuals with severe hypertension or diabetic retinopathy