cyrilzakka/clinical-trials huggingface dataset:
Prevention of Contrast-induced Nephropathy in Patients With Acute Myocardial Infarction

OBJECTIVE: To evaluate the efficacy of prevention of contrast induced nephropathy in patients with ST segment elevation myocardial infarction treated with primary percutaneous coronary intervention.

DESIGN: Prospective study. SETTING: Three-center study Acute kidney injury was defined as a rise in creatinine \>25% from baseline Serum creatinine will be measured at baseline and each day for the following 3 days and at 30 days.

Patients will be randomised to:

1. Standard treatment
2. Standard treatment + acetylcystein for 2 days
3. Standard treatment + Sodium bicarbonate 500 ml / followed by 100 ml/h for 5 hours
4. Standard treatment + acetylcystein for 2 days + Sodium bicarbonate 500 ml / followed by 100 ml/h for 5 hours


Eligibility Criteria:
Inclusion Criteria:

* STEMI patients treated with primary PCI

Exclusion Criteria:

* Cardiogenic shock
Managing Diabetes Mindfully Study

To evaluate the feasibility of conducting a trial of a mindfulness-based stress reduction (MBSR) program for patients with diabetes (DM) on measures of HbA1c, blood pressure, perceived stress, depression, patient self-efficacy and quality of life; and to estimate the effect of a MBSR program for patients with DM. It is expected that MBSR program participants will evidence a trend toward better clinical outcome measures of HbA1c, blood pressure, and standardized measures of diabetes self-management, perceived stress, depression, self-efficacy, and quality-of-life.

Primary Objective: Evaluate the feasibility of conducting a trial of a MBSR program for patients with diabetes on measures of HbA1c, blood pressure, perceived stress, depression, patient self-efficacy and quality of life. Feasibility will be assessed via: a) the interest of patients in taking part in an MBSR program; c) the effectiveness of strategies for recruiting patients with diabetes into the study; d) rates of participant compliance with the MBSR; and, e) patient compliance with the program evaluation plan.

Estimate the effect of a MBSR program for patients with diabetes. It is expected that MBSR program participants will evidence a trend toward better clinical outcome measures of HbA1c, blood pressure, and standardized measures of diabetes self-management, perceived stress, depression, self-efficacy, and quality-of-life.

Secondary Objective: To explore the experience of people with diabetes who participate in an MBSR course through the use of semi-structured interviews.

Eligibility Criteria:
Inclusion Criteria:

* 18-80 years of age
* English speaking
* have type 2 diabetes, with 2 HbA1C values \>8 in prior 16 months
* HbA1C value of \>8 within 3 months of intervention start
* able to read course materials
* mentally intact with no history of mental illness or major depression
* reachable by phone (for phone support component)
* able to attend weekly classes
* willing to provide written informed consent

Exclusion Criteria:

* completed formal training in other mind body practices such as meditation, yoga, or tai chi within the prior year or currently have a regular ongoing practice in this area.
Effects of Tanzberger Versus Pelvic Floor Muscle Exercises on Urinary Incontinence

Randomized clinical trial (RCT) will be conducted to compare the effects of Tanzberger exercises and pelvic floor muscle training on urinary incontinence and quality of life in post_menopausal females suffering from urine incontinence in which data will be collected from Razahat Medical Centre, Lahore via International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form score (ICIQ-UI-SF) and incontinence quality of life (IQOL) Questionnaire. Sample size of 34 patients will be taken. Non_probability convenient sampling will be used. A written consent form will be taken from participants meeting inclusion criteria and will be randomly allocated into two groups through lottery method, to either the PFMs group or Tanzberger exercise group. Treatment will be given three times a week. International Consultation on Incontinence Questionnaire, Urinary Incontinence-Short Form Questionnaire and Incontinence quality of life will be used to measure quality of life. All participants in both groups will be evaluated before and after the treatment programs. Total duration of study will be six months. Data will be analyzed by using SPSS 21

Urinary Incontinence is defined by the International Continence Society (ICS) as the involuntary loss of urine through urethra which is distressing and disabling condition mainly affecting the social and psychological well-being of an individual. Due to the embarrassing nature of incontinence, it is both underreported and under diagnosed. It affects women's quality of life. Tanzberger technique using Swiss ball strengthen levator ani muscles which play role in closing urethra. Pelvic floor muscle exercises are safe and efficient treatment option to treat urinary incontinence and improves quality of life. The significance of this study is, PMFs training and Tanzberger exercises will be executed in comparison to treat post-menopausal women who are facing with unhygienic and social embarrassing health disorder of Urinary Incontinence.

Eligibility Criteria:
Inclusion Criteria:

* Age between 45 to 60 years.
* Postmenopausal Females
* Diagnosed patients of urinary incontinence

Exclusion Criteria:

* Delivery with any complication.
* Females have any history of diabetes, hypertension, neurological, or any chronic illness.
* Any pelvic or abdominal surgery
* Disc herniation or spine fracture.
LUMIERE on the FETUS

Congenital anomalies are a major public health problem. They affect 2-3% of births, around 20,000 new cases per year in France, of which 15% are cared for in Ile de France. These congenital anomalies are a major cause of morbidity, infant mortality and disability. They are also a major cause of death during the infant period (22% of deaths during the first year of life: source CépiDC Inserm 2010). The detection, accurate diagnosis and accurate prognosis, particularly functional, of these congenital anomalies are still difficult in the current monitoring of pregnancy, which is based primarily on ultrasound. The use and development of modern imaging techniques is now essential to enable doctors to better see and better examine the fetus. Alongside ultrasound, Magnetic Resonance Imaging (MRI) is a technique that has undergone significant development in recent years. MRI must allow the effective anatomical and functional evaluation of the main fetal organs and could in particular be interesting in several situations in which it has not yet been sufficiently evaluated and is not yet performed in clinical routine.

The inclusion will take place from 16WF to 36WG, within the framework of one of the 4 clinical subgroups of patients envisaged.

The standardized anatomic and functional MRI examination will in all cases last less than 45 minutes and will be based on sequences already used in clinical practice.

Clinical, biological, and ultrasound data will be collected prospectively and used for the usual management of the patient. For the purposes of the study, these data will be secondarily anonymized and analyzed in connection with the MRI data and the perinatal outcome to meet the specific objectives.

The lost-to-follow-up bias will be limited by the simplicity of the proposed perinatal surveillance, which does not differ from the surveillance usually recommended for these pregnancies

Eligibility Criteria:
Inclusion Criteria:

* patient ≥ 18 years
* Single or twin pregnancy
* gestational age≥ 16 WG and ≤ 36 WG based on cranio-caudal length (LCC) dating
* Collection of the patient's consent

Exclusion Criteria:

contraindication to MRI

* multiple pregnancies \> 2
* subsequent follow-up impossible
* maternal condition contraindicates continuation of pregnancy
* patient having to have an MRI examination as part of the normal clinical follow-up of her pregnancy (identified or strongly suspected echocardiographic abnormality on ultrasound, diaphragmatic dome hernia, CMV fetal infection, antecedent brain abnormality in siblings, STT operated)
A Study of Pyrotinib Plus Vinorelbine in Patients With Brain Metastases From HER2-positive Metastatic Breast Cancer

Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER1, HER2 and HER4 receptors. This study is a single-arm, prospective, open label clinical study of pyrotinib plus vinorelbine as the therapy of brain metastases from HER2-positive metastatic breast cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Age18-75 years.
2. ECOG performance status ≤2.
3. Histologically confirmed HER2 positive advanced breast cancer.
4. Prior to anthracyclines and taxanes (neoadjuvant, adjuvant and metastatic setting). Received ≤4 regimes in metastatic setting. Prior to trastuzumab is allowed.
5. Not received whole brain radiotherapy (WBRT) or recurrence after WBRT.
6. Controlled CNS symptoms (headache, dizziness, lethargy, nausea etc.).
7. Patients with CNS metastasis; at least one CNS metastases with a longest diameter ≥1 cm and a diameter perpendicular to the longest diameter should be ≥0.5 cm;
8. Signed the informed consent form prior to patient entry.

Exclusion Criteria:

1. Participated in other drug clinical trials within 4 weeks before the start of the study;
2. Received radiotherapy, chemotherapy, surgery and target therapy within 4 weeks before the start of the study;
3. Received endocrine therapy within 7 days before the start of the study;
4. Suitable for surgical resection;
5. Accompanied by rapid progress of organ invasion;
6. Factors influencing the usage of oral administration (such as unable to swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction etc.).
7. Prior to pyrotinib or vinorelbine or anti-HER2 TKI drugs;
8. Allergies to any compounds of experimental drugs;
9. CNS disorders or mental disorders, history of clear neurological or mental disorders, including epilepsy or dementia;
10. Other malignancies within 5 years, except cured in-situ of uterine cervix carcinoma , skin basal cell carcinoma and squamous-cell carcinoma.
11. Any other situations judged by investigator as not suitable for participating in this study.
Endometrial Preparation Before Operative Hysteroscopy in Premenopausal Women

The presence of a thin endometrium has an important role in allowing the best conditions for hysteroscopic surgery. The aim of this study is to evaluate the efficacy of a 21 day administration of 2 mg of dienogest versus ulipristal acetate 5 mg, in rapid endometrial preparation to operative hysteroscopy.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis at office hysteroscopy of symptomatic submucous myomas with intramural development (G1 and G2)

Exclusion Criteria:

* pregnancy
* other hormonal therapy in the previous 8 weeks
* hepatic or renal impairment
* any medical condition that would increase the surgical risk
* refusal or unable to sign written consent
Translating Research Into Practice for Postpartum Depression

This is a study to assess the impact of introducing screening and planned follow up for postpartum depression. All women ages 18 to 45 who speak English or Spanish who come to the enrolled community family medicine offices will either be given usual care or screened using the Edinburgh Postnatal Depression Screening tool. If the EDPS score is high the women will be given the PHQ-9 to more clearly identify the specific likelihood of being depressed. Women who are determined to be depressed will be treated with medication or counseling based on the preference of the women and their physicians. Women will be followed through nurse initiated phone calls and visits to the physicians office.

Outcomes include the level of depression symptoms, measure of comfort with parenting, and satisfaction with partner relationships comparing baseline levels with those at 6 and 12 months from the usual care and intervention sites. These data will be collected by questionnaire. In addition, with the women's permission, medical records will be reviewed.

A randomized controlled trial of screening and management of postpartum depression that includes a second phase assessing the maintenance of the intervention in the original intervention sites and a switch from usual care to intervention in the control sites.

Planned enrollment includes 29 family medicine practices and 3000 women over a period of four years. All follow up and management is initiated within the family medicine practices to improve generalizability and likelihood for dissemination.

In addition to the patient centered outcomes, exploratory analyses will look at the uptake and degree of implementation and maintenance of the intervention based on characteristics of the practice including size, location, affiliation with larger group, type of practice and whether or not the practice is a community health center or residency practice.

Eligibility Criteria:
Inclusion Criteria:

* 5 to 12 weeks postpartum
* Able to speak and read English or Spanish

  * 18 to 45 years of age

Exclusion Criteria:

* Significant cognitive impairment and unable to answer screening questions
Effect of Nano Care Gold on Marginal Integrity of Resin Composite

The aim of this study to detect the effect of Nano Care Gold on marginal integrity of resin composite restoration

This study will be divided into 3 groups (control, Nano Care Gold, Chlorhexidine). Both materials will be used as a surface pre-treatment. Their effect on marginal integrity will be evaluated through evaluation of marginal adaptation, marginal staining, post-operative sensitivity. The follow up period is one year

Eligibility Criteria:
Inclusion Criteria:

* (1) Patients with at least two class II cavities (2) 17-50 years old (3) Males or females (4) Good or hygiene (5) Good general health (6) Cooperative patients (7) Subjects who signed the informed consent

Exclusion Criteria:

1. Patients younger than 17 years or older than 50 years old
2. Pregnant females
3. Disabilities
4. Systemic disease or severe medical complications
5. Heavy smoking
6. Lack of compliance
Agility Training on Physical Performance, Cognitive Function and Brain Activities in Elderly

Agility comprised of cognitive and physical functions, which influences whole-body movement with change of speed and direction. Agility training is widely used in athletes, and recent studies have begun to apply it into the elderly. Agility training is multidimensional and highly functional, which makes it possible to provide more efficient training in limited time. In elderly, the decrement of cognitive function, muscle strength in the upper and lower limbs, the percentage of body fat, body flexibility and endurance caused by aging will make it difficult for the elderly to perform movements. Therefore, it is essential to explore whether agility training can achieve the improvement of the physical function and cognitive function in elderly, and to find the relationship between the two functions and brain activity. Method: This study will recruit 60 participants, and randomly allocate to control group and agility training. The training groups will have 8 weeks of training, 2 times a week, 45 minutes of training each time. Assessment will be performed before and after intervention in 1-week, and with 1-month follow-up. Assessment including agility ability, physical function, cognitive function, brain activity, and functional assessment scales.


Eligibility Criteria:
Inclusion Criteria:

1. older than 65 years old
2. score of Mini-Mental State Examination (MMSE) ≥ 24
3. able to walk independently for more than 30 meters without assistive aids
4. able to follow orders

Exclusion Criteria:

1. poorly controlled or unstable systematic disease
2. has a history of central nervous system disease
3. currently taking antidepressants, anti-anxiety, or other psychiatric drugs that may affect blood flow in the brain
4. has other medical conditions for which exercise is contraindicated; (5) subjects with achromatopsia.
PREvention of Atrial Fibrillation in patientS Undergoing thorAcic surGEry for Lung Cancer

The aim of this study is to assess whether prophylactic treatment with metoprolol or losartan is able to reduce the incidence of atrial fibrillation (AF) in patients undergoing thoracic surgery for lung cancer, showing elevated plasma levels in NT probrain natriuretic peptide (NT-proBNP), measured in the perioperative period.

Postoperative atrial fibrillation is one of the most common complication after thoracic surgery for lung cancer, with an incidence ranging from 8 to 20% after lobectomy and up to 42% after pneumonectomy.

In a recent study we demonstrated that a high perioperative plasma levels of NT-proBNP is able to identify patients at risk for AF (incidence of 65%).

It has also been demonstrated that the renin-angiotensin system may play an important role in the pathophysiology of atrial fibrillation and that angiotensin converting enzyme inhibitors (ACEI) and angiotensin II receptor blockers (ARBs) are able to prevent atrial fibrillation in patients with heart failure, after myocardial infarction, in hypertensive patients and after electrical cardioversion.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes with age ≥ 18 years
* Thoracic surgery for lung cancer
* Evidence of elevated perioperative NT-proBNP
* Written informed consent

Exclusion Criteria:

* Hypersensitivity and / or intolerance to metoprolol or losartan
* History of heart failure
* Left ventricular ejection fraction \<50% measured by echocardiographic techniques (Simpson rule)
* Permanent atrial fibrillation
* Antiarrhythmic therapy
* Current therapy with beta-blockers, angiotensin II receptor blockers and angiotensin-converting enzyme inhibitors
* Systolic blood pressure \<95 mmHg
* Pregnant and lactating women

Additional exclusion criteria for therapy with beta-blocker:

* History of sick sinus syndrome, evidence of AV-block grade II or greater
* Heart rate \<65 b / m
* History of bronchial asthma, severe bronchopneumopathy, evidence of bronchospasm
Acupuncture-assisted-anesthesia to Improve Postoperative Outcome After Digestive Surgery in Elderly Patients

The investigators assume that transcutaneous electric acupoint stimulation (TEAS) pretreatment may activate the endogenous protective mechanism, as a result protect the patients against subsequent surgical stress pregnancy. And TEAS may induce the production of endogenous analgesic transmitters, so develop an anesthetic-sparing effect. The investigators believe this intervention will reduce the subsequent incidence, duration and severity of organ dysfunction, possibly reducing the morbidity, even mortality. So in this study, the investigators hypothesize that TEAS before anesthesia and during surgery would decrease the morbidity and mortality of postoperative complications in 30 days after digestive surgery in elderly patients .

Patients older than 65 years old are at higher risk of postoperative morbidity and mortality. With the increasing number of old patients scheduled for digestive surgery, exploring methods to decrease postoperative morbidity is very important. Noninvasive methods may be easier to clinically use. Transcutaneous electric acupoint stimulation (TEAS)has been proved to decrease need for general anesthetics during anesthesia, and to alleviate systemic inflammatory response. Considering the morbidity and mortality after surgery is closely related to use of anesthetics and inflammatory response,TEAS may be a good selection for improving postoperative outcomes.Among the postoperative complications, pulmonary complication and systemic inflammatory response syndrome is with higher incidence, so we will focus on these two complications in our study.

Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent
* Age ≥65 years of age
* Elective digestive surgery under general anesthesia

Exclusion Criteria:

* ASA(American Society of Anesthesiologists) status\> Ⅲ
* Patients undergoing surgery within 12 h of admission to hospital
* Patients undergoing surgery of the chest
* Patients suffered from neurologic disorder or impaired mental state
* Patients with contraindications to the use of electro-acupuncture, such as skin damage or infection at the acupoints
* Patients with experience of transcutaneous electrical stimulation treatment
Mirena Efficiency and Tolerability During the First Year of Use

In this trial the efficacy and safety of Mirena was investigated during the first year of use


Eligibility Criteria:
Inclusion Criteria:

* Women aged 25 to 39 years who sought effective contraception during the post-partum period (i.e. insertion of the device between 6 and 12 weeks after parturition).

Exclusion Criteria:

* Standard exclusion criteria for use of intrauterine hormone devices
The Real World Study of BTK Inhibitor in the Treatment of Chronic Lymphocytic Leukemia in China

This is a Multicenter, Retrospective Real-world Study of Zanubrutinib in the Treatment of Chronic Lymphocytic Leukemia in China


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged ≥18 years old
2. Must have a confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL) requiring treatment (iwCLL \[International Workshop on Chronic Lymphocytic Leukemia\] criteria)；
3. Treatment-naïve OR Refractory Recurrence CLL patients who were initiated on BTK inhibitor;
4. Prior or current use of BTK inhibitor for ≥3 months
5. At least one follow-up was recorded during BTK inhibitor treatment
Heart Rate Variability Change After Liver Transplantation

Cirrhotic cardiomyopathy describes a hyperdynamic state with the presentation of high cardiac output and low systemic vascular resistance. And the latent heart failure becomes obvious under physiologic and pharmacologic stress. The goal of our study is to assess the effects of liver transplantation on the heart rate variability in patients with end stage liver disease.


Eligibility Criteria:
Inclusion Criteria:

* Age:18-70y/o receiving liver transplantation

Exclusion Criteria:

* History of cardiovascular disease
Association of Genetic Polymorphism and Acute Kidney Injury After Liver Transplantation

Some of the liver transplantation recipients experience postoperative acute kidney injury due to various causes including genetic factors. Prevention of postoperative acute kidney injury is essential for postoperative care in liver transplantation recipients. The aim of this study is to investigate the relationship between gene polymorphisms which have been known to be associated with postoperative acute kidney injury, and the occurrence of acute kidney injury after liver transplantation.


Eligibility Criteria:
Inclusion Criteria:

1) adult patients scheduled for liver transplantation

Exclusion Criteria:

1. Patients on dialysis
2. patients not able to read, or understand the consent form
3. ethnicity, other than asian
4. patients refusal