cyrilzakka/clinical-trials huggingface dataset:
The Effect of TaiChi on Ischemic Burden of Patients With Coronary Heart Disease Complicated With Renal Insufficiency

This study focuses on patients with incomplete revascularization combined with renal insufficiency. And since heart and kidney are two organs influence each other, the study take the mechanism of heart and kidney comorbidity and the risk factors of the two organs.As one of the traditional Chinese sports, Tai Chi is an aerobic exercise combineing movements with static postures, which can significantly improve the aerobic endurance of patients with coronary heart disease. In this study, a parallel, randomized controlled study method is used to quantitatively evaluate the myocardial ischemia condition by myocardial perfusion imaging indicators. This study aims to figure out whether the cardiac rehabilitation training program based on Tai Chi has a positive effect on the patients' myocardial ischemic.


Eligibility Criteria:
Inclusion Criteria:

1. 30-75 years old, all genders;
2. At least two main vessels or their main branch vessels have obvious stenosis (≥50%) according to the coronary angiography;
3. Received stent implantation and incomplete revascularization (incomplete revascularization: at least one vessel whose a diameter\> 2.0 mm and at least one lesion with a stenosis\> 50%, after PCI);
4. eGFR\<60ml/min·1.73m2;
5. Willing to be treated and followed-up during the specified time of the study;
6. Signed the informed consent approved by the Ethics Committee

Exclusion Criteria:

1. Patients with high-risks according to the exercise rehabilitation risks of patients with heart disease by AACVPR;
2. Severe cardiac insufficiency or cardiogenic shock;
3. Combined with severe ventricular arrhythmia, ICD is required;
4. Combined with severe pulmonary hypertension, chronic obstructive pulmonary disease, severe infectious disease, blood system disease, malignant tumor, severe liver damage, etc.;
5. Nervous, mental and motor system diseases;
6. Unwilling to be followed-up.
A Comparison of Beclomethasone Aqueous Spray and Aerosol Delivery Systems in Nasal Polyps

The purpose of this study is to determine if intranasal Beclomethasone delivered by aerosol or spray is more effective in treatment of nasal polyps.

Aqueous and aerosol delivery of intranasal corticosteroids has never been directly compared previously in patients with nasal polyps and it is unknown whether one is superior.

This objective of this study is to compare the efficacy of intranasal beclomethasone by two different delivery systems, aerosol and aqueous spray in patients with nasal polyps. Primary endpoint is the difference in the overall quality of life as measured by the Rhinitis Quality of Life Questionnaire. The secondary endpoint is the change in Nasal Airflow Resistance as measured by rhinomanometry.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old
* New diagnosis of nasal polyps confirmed by two physicians

Exclusion Criteria:

* Intranasal corticosteroid use within 4 weeks
* Oral corticosteroids use within 4 weeks
* Oral corticosteroid inhalation (ie for treatment of asthma or COPD) of Budesonide \>400ug daily, Fluticasone \>250ug daily, Beclomethasone \>400ug daily
* Contraindication to intranasal corticosteroid
* Inability to give informed consent
* Participation in another clinical trial
* Pregnancy (or not using effective method of contraception) or lactation
* Cystic fibrosis
Development and Validation of Multi-nuclear Magnetic Resonance Imaging and Spectroscopy for Whole Body Human Applications

The purpose of this study is to develop and refine the techniques for using magnetic resonance imaging and magnetic resonance spectroscopy to understand the composition and function of the human body


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Age 12 - 89
* Healthy (self assessed)
* Weight under 350lbs
* Able to walk 50 yards without stopping
* Able to travel to hospital for study visits
* Able to follow a 3-step command
* Able to remain in Magnetic Resonance (MR) scanner for up to 2 hours

Exclusion Criteria:

* Have internal metal medical devices, including cardiac pacemakers, aortic or cerebral aneurysm clips, artificial heart valves, ferromagnetic implants, shrapnel, wire sutures, joint replacements, bone or joint pins/rods/screws, metal fragments in your eye, or non-removable jewelry such as rings.
* Are unwilling or unable to complete the imaging procedures for the duration of the MRI scan due to claustrophobia or other reason.
* Serious mental illness that might preclude subject's ability to comply with study treatment
* Life expectancy of less than 1 year
* Are pregnant or plan on becoming pregnant in the next 8 weeks.
Adjusted Steroids Therapy in Childerens With Idiopathic Nephrotic Syndrome

The initial steroids dose for Nephrotic Syndrome is 60mg/1m2 for 6-4 weeks and the duration of the first steroid course is between 8 weeks to 6 months. The base of the initial dose for steroids Idiopathic nephrotic syndrome been put in the early 70s. In our study the investigators will adjusted the first steroids does to the response day. Our primary end point is : a lower adjusted dose is as good as the fix dose in the first year after diagnosis.

About 90% of the patients will response to steroid therapy. The initial steroid dose is between 2mg/kg or 60mg/1m2 for 6-4 weeks and the duration of the first steroid course is between 8 weeks to 6 months. The bases of this treatment have been put in the early 70s. Since then most of the study were focused on the duration of the therapy with a results that 8-12 weeks course is as good as 6 month. Studies have showed no difference in response rate between 2mg/kg to 60m2' although the difference in the dose in young children can rich to 25%. Other retrospective analysis been show that patients who response in the first 7-9 days tend to have lass relapses than other patients. In our nephrology clinic the investigators there is ongoing clinical study on low doses of steroid therapy for relapse of nephritic syndrome with good results.

Eligibility Criteria:
Inclusion Criteria:

* Children who recently have been diagnosed with nephrotic syndrome.

Exclusion Criteria:

* Children with nephrotic syndrome that can not be treated with steroids.
Efficacy of VR Distraction During Local Anesthesia in Children

The aim of this study is to compare between active distraction (video game) and passive distraction (cartoon video) using a Virtual Reality ( VR ) device, in reducing injection pain and anxiety associated with local anesthesia in children.

This comparative study is a double blinded controlled randomized clinical trial which includes 82 healthy 6-10 years old children with positive and definitely positive behavior according to Frankl Rating Scale with no known allergy to local anesthesia, no emergency dental treatment, no previous treatment from the same researcher and no previous experience in using the Virtual Reality ( VR ) device.

the participants will be allocated and treated at department of pediatric dentistry, faculty of dentistry, Tishreen university and a written consent will be obtained from the parents.

The random-numbers table will be used to divide 82 participants in to two groups:

1. The active distraction group, which will be receiving the injection of local anesthesia while using the VR device with a video game and a Play Station 4 ( PS4 ) controller.
2. The passive distraction group, which will be receiving the injection of local anesthesia while using VR device watching a cartoon video.

All the participants will receive an inferior alveolar nerve block with semi supine position.

Eligibility Criteria:
Inclusion Criteria:

* healthy children need a simple treatment for temporary teeth in the mandibular jaw
* children with positive and definitely positive behavior according to frankl behavior classification
* children with no known allergy to local anesthesia
* children with no previous treatment from the same researcher
* children with no previous experience in using the VR device

Exclusion Criteria:

* children with negative and definitely negative behavior according to frankl behavior classification
* children with known allergy to local anesthesia
* children with emergency dental treatment in the mandibular jaw
* children with previous treatment from the same researcher
Non-interventional, Real Life Study on Satisfaction With LNG-IUS in Spanish Young Women (18-30 Years Old) With Different Parity Status and Menstrual Bleeding Pattern

The aim of this non-interventional study (NIS) is to assess, under real-life conditions, woman's satisfaction with Levonogestrel IntraUterine System (LNG-IUS) in a young (18-30 years old (y.o.)) Spanish population taking into account their parity status.

Furthermore, the study is aimed to evaluate the impact of: menstrual bleeding pattern and satisfaction with it at baseline, LNG-IUS chosen, previously used contraceptive method and reasons for change to/ choice of a LNG-IUS on overall satisfaction with LNG-IUS use.


Eligibility Criteria:
Inclusion Criteria:

* Women in childbearing age, between 18-30 years old.
* Women who have chosen a LNG-IUS as contraceptive method, after been adequately counselled by the physician about all contraceptive possible options.
* Women who have chosen a LNG-IUS mainly for contraceptive reasons, not due to heavy menstrual bleeding.
* Women with no desire to conceive for at least within the next 12 months.
* Women capable of reading and writing

Exclusion Criteria:

* Women whose main reason to use a LNG-IUS is not a contraceptive reason.
* Women with contraindication for LNG-IUS.
* Women with previous experience with a IUS.
* Women who have been diagnosed with heavy menstrual bleeding.
* Women with degenerative or other kind of diseases that could directly negatively impact their daily life.
* Women who have undergone a hysterectomy or irreversible contraceptive method.
* Women participating in a clinical trial.
* Women with a mental illness and unable to make decisions and follow instructions.
* Women with amenorrhea
* Women with clinical history of severe dysmenorrhea
* Women with concomitant medication that may lead changes in bleeding pattern (e.g. antiplatelets and/or anticoagulants)
Efficacy and Safety of LC-Z300-01 in Chinese With Type 2 Diabetes

This trial is conducted in China. The aim of the trial is to investigate the efficacy and safety of an Bamboo cane polysaccharide (oral LC-Z300-01) in subjects with type 2 diabetes.

This trial is conducted in China. The aim of the trial is to investigate the efficacy and safety of an Bamboo cane polysaccharide (oral LC-Z300-01) in subjects with type 2 diabetes.

Considering the rights and interests, the trial is divided into two phases. The first phase is a double-blind group, in which subjects are randomly assigned to the blank control group, the low-dose experimental group, and the high-dose experimental group to observe the changes in glycosylated hemoglobin and CGMS compared with the baseline, as well as safety events.

The second phase is an open-label group, in which the three groups are willing to freely enter the high-dose experimental group and further observe recovery and safety.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, age reach and over 18 years at the time of signing informed consent,
* Body mass index (BMI) between 18.0 and 35.0 kg/m\^2 (both inclusive),
* Type 2 diabetes mellitus (as diagnosed clinically) before screening.
* hemoglobin A1c of 7.5 - 9.0% (both inclusive) as assessed by central laboratory on the day of screening,
* Treated with stable doses of oral antidiabetic drugs (OADs) , insulin or glucagon-like peptide-1 (GLP-1) receptor agonists (exenatide, liraglutide, etc.) within 3 months prior to screening;

Exclusion Criteria:

* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method,
* Anticipated initiation or change in concomitant medication (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or systemic corticosteroids),
* Any episodes (as declared by the participant or in the medical records) of diabetic ketoacidosis within 90 days before screening,
* Presence or history of pancreatitis (acute or chronic) within 180 days before screening,
* Any of the following: Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days before screening.

Chronic heart failure classified as being in New York Heart Association Class IV at screening,

* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days before screening or in the period between screening and randomisation. Pharmacological pupil dilation is a requirement unless using a digital fundus photography camera specified for non dilated examination.
Fasted Evening Exercise: Performance and Compensatory Eating

This study will compare the appetite, energy intake, and exercise performance responses to a bout of exercise completed in the evening after an extended period of fasting with a similar bout of exercise completed in the evening and the morning, after consuming a carbohydrate-containing meal.

Regular exercise is known to be a successful strategy for improving several facets of health and maintaining body weight. However, many people are not engaging in enough exercise, and some may not be achieving maximum benefits from the exercise that they already do. Performing exercise in the overnight fasted state has been shown to reduce energy intake over the course of a single day, without any compensatory reductions in free-living energy expenditure. Despite these promising findings, it is likely that not every member of the population is logistically able to perform exercise in the morning due to various work, family and social commitments, and exercise in the evening may be a logical alternative for these individuals. Whether the beneficial effects of overnight fasted exercise can be observed at an alternative time of the day (i.e. the evening) is unknown.

Therefore, the investigators are interested in examining the compensatory appetite and energy intake responses following a bout of evening exercise performed after an extended (7 hour) period of fasting. Exercise performance will also be assessed as a marker of voluntary energy expenditure, which if reduced, has the potential to compensate for the reduced energy balance induced by fasted exercise.

Eligibility Criteria:
Inclusion Criteria:

* Non-smokers.
* Have maintained a stable weight for 6 months (self-reported).
* No history of gastric, digestive, cardiovascular or renal disease (self-reported).
* Female specific: must be using a monophasic, low dose combined OCP (containing less than 50μg oestradiol and a synthetic progestin) OR females with regular menstrual cycles (self-reported).

Exclusion Criteria:

* Have an unusual eating pattern (i.e., extended fasting periods \>8h other than overnight - self-reported).
* Severe food allergies, dislike or intolerance of study foods or drinks.
* Currently undergoing a lifestyle intervention (structured diet or exercise)
* Diagnosis of a condition or currently undergoing treatment therapy known to affect glucose or lipid metabolism (e.g., type-2 diabetes, taking statins), or contraindications to exercise.
* Use of medication or supplements that may affect hormone concentrations.
* Excessive alcohol consumption (\>14 units/week).
* Intensive training schedule (\>10 hours/week).
* Having received a positive COVID-19 test in the 6-month period prior to participation.
* Female specific: currently pregnant or breastfeeding, the use of any hormonal contraception, and the self-reporting of short (\<24 d), long (\>35 d), or irregular menstrual cycles.
Paclitaxel (Albumin-bound) Combined With Radiotherapy for the Treatment of Early Stage Nasopharyngeal Carcinoma

This trial is a prospective, parallel controlled, randomized, open, multi-center phase III clinical trial. The trial will enroll 364 patients with nasopharyngeal carcinoma who are staged T1-2N0-1M0 (except T1N0M0) (UICC 8th edition) . This experiment was participated by multiple centers of Nanjing Gulou Hospital, Jiangsu Provincial People's Hospital, Jiangsu Cancer Hospital, Nanjing Military Region General Hospital, Jiangsu Provincial Hospital of Traditional Chinese Medicine, and Zhongda Hospital. Each center competes for admission of cases.

The subjects will be randomly assigned (using the random number table method according to the order of entry) to the experimental group to receive albumin-bound paclitaxel combined with IMRT concurrent radiotherapy, or the control group to receive cisplatin combined with IMRT concurrent radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Differentiated non-keratinizing carcinoma and undifferentiated non-keratinizing carcinoma confirmed by pathology;
* The staging is T1-2N0-1M0 (except T1N0M0) (UICC 8th edition);
* Initial treatment patients who have not received anti-tumor therapy;
* No history of other malignant tumors;
* Male or female, aged 18 to 70 years old;
* Liver and kidney function: total bilirubin ≤ upper limit of normal (ULN); AST and ALT ≤ 2.5 times ULN; alkaline phosphatase ≤ 5 times ULN; creatinine clearance ≥ 80 mL/min;
* Neutrophil count (ANC) ≥2×109/L, platelet count ≥100×109/L and hemoglobin ≥9 g/dL;
* No serious heart, lung, liver, kidney and other important organ dysfunction;
* Karnofsky score ≥70 points;
* Sign the informed consent form;
* Able to follow research protocols and follow-up procedures.

Exclusion Criteria:

* Anti-tumor treatment has been performed, including chemotherapy, radiotherapy, and surgery;
* Find distant metastases before treatment;
* Women who are pregnant or breastfeeding;
* Disagree to sign the informed consent form;
* Patients who cannot cooperate with regular follow-up due to psychological, social, family and geographic reasons;
* Simultaneously accept experimental treatment of other clinical research (in the treatment period of clinical research);
* Known to be allergic to possible chemotherapy drugs;
* Patients with other malignant tumors;
* Accompanied by severe uncontrollable infections or medical diseases, including autoimmune diseases;
* Major organ dysfunction, such as decompensated heart, lung, kidney, and liver failure, cannot tolerate radiotherapy and chemotherapy;
* Laboratory examination: total bilirubin\>upper limit of normal (ULN); AST and/or ALT\>1.5 times ULN and accompanied by alkaline phosphatase\>2.5 times ULN;
* Any uncertain factors that affect patient safety or compliance.
A Study of TACI（Transmembrane Activator and Calcium-modulator and Cyclophilin Ligand (CAML) Interactor）-Antibody Fusion Protein Injection (RC18) in Subjects With Systemic Myasthenia Gravis

The purpose of this study is to initially observe the safety and effectivity of RC18 in Participants with systemic myasthenia gravis.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntarily signed informed consent ;
2. Patient diagnosed with systemic myasthenia gravis according to The following conditions.
3. Seropositive at screening for AChR（Acetylcholine receptor）-Ab or MuSK（Muscle specific tyrosine kinase）-Ab;
4. MGFA（Myasthenia Gravis Foundation of America） Clinical classification Ⅱ-IIIb;
5. QMG score≥8,and QMG score\>2 in four or more items;
6. Maintained any one of the stable standard treatment programs in the trial protocol.

Exclusion Criteria:

1. Combined autoimmune diseases, such as systemic lupus erythematosus,rheumatoid arthritis, systemic sclerosis and so on,except for hypothyroidism and hyperthyroidism;
2. Abnormal laboratory parameters need to be excluded, including but not limited to:
3. Immunosuppressive agents except agents of standard treatment programs were used within one month prior to randomization.;
4. Use of biological agents for targeted therapy within 6 months prior to randomization;
5. Intravenous immunoglobulin therapy or plasma exchange therapy within 2 months before randomization;
6. Active infection during screening(For example,herpes zoster,HIV antibody positive,active tuberculosis,etc);
7. Currently suffering from active hepatitis or severe liver lesions and history;
8. Diabetics with poor blood sugar control:HbAlc\>9.0% or FBG≥11.1mmol/L;
9. Currently having a thymic tumor ,or had a thymectomy within 6 months prior to screening;
10. Received live vaccines within 3 months before randomization,or scheduled to administer vaccine during the trial;
11. Malignant tumor patients;
12. Allergic to human biological preparations;
13. Have participated in any clinical trial within 28 days before randomization,or in 5 times half-life period of the drugs of any clinical trial(taking the longer time).
14. Pregnant , lactating women and men or women who have birth plans during the research;
15. Having alcohol or drug abuse that affect the experimental conditions;
16. Investigator considers candidates not appropriating for the study.
Efficacy of Unstable Shoes for Instability and Lumbopelvic Pain

During pregnancy, pregnant women adopt an atypical pattern position with the intention to maintain stability and balance.These postural changes can cause instability at the level of the sacroiliac joint with painful condition during pregnancy and postpartum.

40 % of women have postpartum lumbopelvic instability. In 17 % of cases the lumbopelvic pain is perpetuated.

Another alteration influenced by the gestational status and progress of labor is urinary incontinence (UI).

The mechanism developed by Masai Barefoot Technology (MBT) provides an unstable base. Some studies reviewed, indicate that this shoe increases muscle activity, contributes to the decrease of joint overload and thereby, decreases pain.

Objective To compare the efficacy of shoes with unstable sole MBT®, over the use of conventional sports shoes, in primiparous women with lumbopelvic postpartum pain.

Material and Methods Randomized clinical trial. 24 postpartum women from the Gynecology Service of the Hospital Universitario Madrid Chiron were included in the study.

The subjects were randomly divided into experimental and control group.


Eligibility Criteria:
Inclusion Criteria:

Primparous women.

* Postpartum, between 8-12 weeks after the date of delivery.
* With lumbopelvic pain and positive diagnostic tests of sacroiliac pain
* Women with ambulation ability.

Exclusion Criteria:

* Presence of vaginal prolapses.
* Be receiving another treatment for the alteration that concerns us, pharmacological or any other type of therapy.
* Neuromuscular alterations.
Study to Assess the Safety & Reactogenicity of GSK Biologicals' dTpa Vaccine (Boostrix) When Given at 6-8 Years of Age.

This study will evaluate the safety and reactogenicity of booster dose of GSK Biologicals' dTpa vaccine (Boostrix) in Chinese children at 6-8 years of age.


Eligibility Criteria:
Inclusion Criteria:

* A male or female between, and including, 6-8 years of age at the time of vaccination,
* Written informed consent obtained from the parent or guardian of the subject,
* Subjects who have received a total of 4 doses of DTP vaccine in the first 2 years of life,

Exclusion Criteria:

* subjects who have received previous DTP booster vaccination since administration of the fourth dose of vaccine in second year of life can not participate
* Subjects with history of diphtheria, pertussis or tetanus diseases can not participate
Mi-RNA and COVID-19

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the cause of coronavirus disease 2019 (COVID-19), induces a spectrum of clinical conditions ranging from asymptomatic infection to life threatening severe disease, characterized by respiratory failure, shock and multi-organ dysfunction requiring admission in the intensive care unit (ICU).

The aim of the present study is to analyze miRNAs associated with SARS-CoV-2 infection, disease severity and mortality.


Eligibility Criteria:
Inclusion Criteria:

* 18 years
* diagnosis of SARS-CoV-2 infection confirmed by molecular testing on nasopharyngeal swabs

Exclusion Criteria:

* pregnant women