cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Wen Xin Granules for the Treatment of Unstable Angina Pectoris

This is a double-blind, randomized placebo-controlled trial which aims to evaluate the efficacy and safety of Wen Xin granule in patients with unstable angina pectoris.

Coronary heart disease has remained the leading cause of death worldwide over the past decades. Unstable angina is a clinical syndrome intermediate in severity between stable angina and acute myocardial infarction with high morbidity and mortality. Standard drug therapy and invasive revascularization are effective in decreasing progression to infarction, reducing symptoms and multiple hospitalizations, in most cases without a decrease in the long-term mortality rate. However, there are still many patients with persistence or recurrence of angina despite standard medical therapy and/or revascularization. Wen Xin granule, as a Chinese herbal medicine has shown great effect in patients with unstable angina in our clinical. However, there is still insufficient evidence on his specific efficacy and safety. Therefor, we'd like to evaluate the efficacy and safety of Wen Xin granule in patients with unstable angina through this multi-center, double-blind, randomized placebo-controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* aged between 35 and 75 years of age;
* diagnosed with CAD through coronary arteriography, clinically diagnosed with UAP in low or medium risk;
* belong to Yang deficiency and blood stasis syndrome according to TCM, and give written informed consent.
* For the diagnostic criteria of UAP, the investigators will refer to 2014 AHA/ACC Guidelines for the Diagnosis and Management of Non-ST-Elevation Acute Coronary Syndromes.
* For the TCM diagnostic criteria, the investigators will refer to Guidelines for Clinical Research into New Traditional Chinese Medicine Drugs for Chest Obstruction (2002 edition).

Exclusion Criteria:

* chest pain caused by congenital heart diseases, valvular heart disease, severe neurosis, or arrhythmia
* with New York Heart Association class III or IV heart failure, in acute phase of cerebral infarction;
* with uncontrolled hypertension (systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>95 mmHg in the resting state)
* with uncontrolled hyperglycemia or diabetic complications, with mental and neurological abnormalities or dysgnosia;
* female patients in pregnancy or lactation;
* by participating in other clinical trials.
Proteinuria During Acute Pyelonephritis In Pregnancy

The purpose of this research study is to compare the amount of protein excreted by the kidneys in a 24-hour period between patients who have a kidney infection and those who do not have a kidney infection.

Preeclampsia is a pregnancy-unique disorder that is cured only with delivery of the baby, even if the pregnancy is premature. Defined by both blood pressure and proteinuria criteria, diagnosis is often obscured by renal processes like systemic lupus erythematosus or nephrotic syndrome that increase urinary protein spillage. Proteinuria is defined as a total protein urinary excretion exceeding 300 mg in a 24-hour urine collection in pregnancy. This is suggested to be double the protein excretion in the non-pregnancy population at 150 mg/day. A mean 24-hour urine protein excretion of 204.3 mg (± 92.5) was found in the non-hypertensive pregnant population.

Physiological changes in pregnancy predispose patients to urinary tract infections; ureteral compression by the gravid uterus, progesterone-mediated slowing of ureteral peristalsis and decreased bladder tone, and mechanical compression of the bladder contribute to impaired clearance of bacteria from the urinary tract. Indeed, acute cystitis complicates 2-4% of all pregnancies. While it has been said that urinary tract infections increase proteinuria, it is unknown how much protein spillage should be expected in the general or the pregnant populations. Hence a patient with pyelonephritis may obscure the diagnosis of preeclampsia if she spills urinary protein from her infection.

The purpose of this study is to compare the mean of 24-hour urine protein in pregnant patients with and without acute pyelonephritis.

The importance of this study will be to determine if urine protein excretion is in fact increased in the setting of pyelonephritis. This will allow for reliable evaluation of urine protein during the work up for preeclampsia in those women also found having a kidney infection.

Eligibility Criteria:
Inclusion Criteria:

* Women ≥ 18 years old admitted at Miller Children and Women's Hospital Long Beach Memorial Medical Center
* Gestational age between 20 weeks and 0 days to 41 weeks and 0 days
* Singleton pregnancy
* Pyelonephritis group:

meeting 2 out of 3 criteria:

1. Fever \> 100.4
2. Costovertebral angle tenderness
3. Positive urine culture - without pyelonephritis group: without acute cystitis and pyelonephritis

Positive culture defined as: quantitative count of ≥ 100,000 CFU/mL or single catheterized urine specimen with quantitative count of 100 CFU/mL.

Exclusion Criteria:

* Chronic hypertension
* Pre-gestational diabetes
* Autoimmune disorders
* Preexisting renal disease
* Multiple gestation
* Vaginal bleeding
* Preeclampsia
* Hospital admission \> 3 days
Sleep Apnea Video Education for CPAP (SAVE-CPAP)

The purpose of this study is to determine how satisfied patients are when undergoing an overnight polysomnogram (sleep study), what their knowledge about sleep apnea is, and what factors affect obstructive sleep apnea (OSA) treatment use.

The effects of educational interventions on subject compliance, satisfaction, and knowledge of their condition will be examined through the use of video vs pamphlet and MD vs staff contact for follow-up visit reminder.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged \> 18 years of age who are referred to the University of Chicago sleep laboratory for split-night polysomnography by a non-sleep physician and who have a consultation appointment with a sleep physician following the appointment
* Have not had prior contact with a sleep physician or prior exposure to CPAP therapy.

Exclusion Criteria: Subjects will be excluded for any of the following characteristics: -Non-English speaking

* Illiterate
* Sleep study is negative for sleep apnea (apnea-hypopnea index \< 5 events/hr)
* Subject does not undergo CPAP titration during the in-laboratory polysomnogram
* Subject does not have a working telephone number
* Poor eyesight or hearing
* Dementia
Routine Maternal Leg Movements During the Second Stage and the Rate of Operative Deliveries

Cesarean delivery rates have risen in the US in a dramatic fashion from less than 5% in the 1960 to 32.7% by 2013 with stable rate around 32-33% in the last five years , cesarean delivery is associated with increased maternal morbidity and mortality, Labor arrest is the most common indication for cesarean delivery, Maternal position during the second stage of labor has been suggested to affect the risk of instrumental vaginal delivery. A Cochrane review of position in the second stage of labor in women without epidural showed a reduction in instrumental vaginal delivery in the upright group, although the quality of the included trials was reported to be generally poor, A Cochrane review of position in the second stage of labour for women with epidural analgesia was published in 2017, This review included trials that compared upright with recumbent positions and suggested no effect.

No prior studies examined whether maternal legs movement during the second stage of labor has any effect on the rate of operative deliveries.

A randomized controlled trial to determine whether routine maternal leg movement during the second stage of labor decreases the rate of operative deliveries (instrumental delivery of cesarean section )

Eligibility Criteria:
Inclusion Criteria:

•Women who had a low risk pregnancy followed by an uncomplicated vaginal delivery, instrumental delivery or cesarean section.

Exclusion Criteria:

•Women who had a high risk pregnancy ((IUGR, hypertension disorders of pregnancy, maternal cardiovascular or respiratory illness).
Test-retest Correlation in Isokinetic Shoulder Testing

This study is a prospective, monocentric interventional clinical study in 30 healthy volunteers.

The aim is to objectively assess shoulder external and internal rotation strength using a Cybex dynamometer in a specific position (seated with the arm at 45° abduction and 30° elevation).

The investigator would like here to determine the reproducibility of measurements in this precise evaluation position, but also to determine reference values in healthy subjects.

The results of this study will enable us to improve our management and establish a database for comparison with pathological subjects.


Eligibility Criteria:
Inclusion Criteria:

* Student of the Montpellier School of Physical Therapy
* Adult having received informed information about the study and signed the consent form

Exclusion Criteria:

* Any history of shoulder pathology in the year preceding the tests.
Leveraging mHealth Messaging to Promote Adherence in Teens With CKD

The overall goal of this study is to develop and test effectively framed mobile health (mHealth) messages to promote medication adherence in teens with chronic kidney disease (CKD).

Hypertension is a risk factor for chronic kidney disease (CKD) progression. Only 77% of adolescents with CKD are adherent to antihypertensive medications despite evidence that adherence slows disease progression. Mobile health (mHealth) applications show promise for improving adherence but most are not designed within health-promotion frameworks, only send medication reminders, use unreliable outcome measures, and/or have small effects on adherence. Nonadherence is a public health problem that may benefit from using health communication strategies to advance beyond reminders and improve mHealth efficacy. Highly effective health messages modify perceptions, attitudes, and skills to facilitate behavioral change; inappropriately framed messages (e.g., use of fear appeals) may have unintended, negative effects on health behaviors (i.e., reduce adherence). For adolescents with CKD, framing mHealth messages to motivate adherence may be a key factor in preventing disease progression; however, there has been little research to guide the use of this approach. Hence, the current study aims to develop and test effectively framed mobile health (mHealth) messages to promote medication adherence in teens with CKD.

Prior to study recruitment, the intervention messages will be developed by the research team and key stakeholders before testing in this pilot randomized controlled trial (RCT). Adolescents/young adults with CKD will be invited to participate in the pilot RCT to evaluate the intervention messages versus an active control condition; the primary outcome is antihypertensive medication adherence and secondary outcomes are participants' responses to surveys.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents/young adults aged 11-21 years
* Physician diagnosis of CKD stage 1-4
* Currently prescribed an antihypertensive medication and anticipate staying on an antihypertensive through the study duration (switching medication classes is permitted)
* Must have daily access to a Wi-Fi-enabled electronic device (e.g. iOS, Android 4.2 or higher, phone, tablet, computer) to receive private health information.

Exclusion Criteria:

* Adolescents/young adults who are on dialysis or had a kidney transplant
* Sibling participating in the study, unable to comprehend spoken English
* Cognitive delay precluding completion of study procedures
* And prescribed a liquid form of an antihypertensive medication (cannot be monitored).
Reliability and Validation of New Manual Dynamometer to Measure Lower Limb Strength

INTRODUCTION: There are several ways to assess muscle strength: not only subjective ways, but also high standard equipment, such as isokinetic dynamometers. These, however, are expensive, and require extensive training. Over the years, manual dynamometers were produced, portable equipment that simplify its use. Among them, a national equipment was developed, but its reliability and validation are yet to be confirmed, compared to equipment already used, such as the Lafayette®. OBJECTIVE: Assess the reliability of a new manual dynamometer - Medeor® device (SP Tech model) -, in relation to the gold standard, Lafayette® device (model 01165), already validated, in the evaluation of muscle strength of the knee and hip groups. METHODS: A total of 26 recruits of both sexes were selected. Muscle strength was measured by Lafayette® and Medeor® dynamometers in the following groups: knee flexors and extensors; flexors, extensors, abductors, adductors, hips internal and external rotators. Each data was collected 3 times, and then the average was calculated.

Keywords: Muscle Strength; Muscle Strength Dynamometer; Lower Extremity.

Eligibility Criteria:
Inclusion Criteria:

* 20-40 year
* both sex
* Healthy

Exclusion Criteria:

* individual who practiced physical activity,
* cognitive disability
* osteomioarticular diseases in lower limb and/or spine
* rheumatic or cardiorespiratory disease
Study to Assess Speed of Onset and Durability of Effectiveness of Upadacitinib in Adult Participants With Moderate to Severe Crohn's Disease (CD) in Real World Clinical Practice.

Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will assess how safe and effective upadacitinib is in treating moderately to severely active CD in real world. Speed of onset and durability of effectiveness will be assessed.

Upadacitinib is a drug approved for the treatment of CD. All study participants will receive upadacitinib as prescribed by their study doctor in accordance with approved local label. Approximately 1200 participants will be enrolled in approximately 230 sites across the world.

Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 3 years.

There is expected to be no additional burden for participants in this trial. Study visits may be conducted on-site or virtually as per standard of care.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of moderate-to-severe crohn's disease (CD).
* Participants initiating upadacitinib at the clinician's discretion as part of their routine clinical care; the decision to administer upadacitinib must be made prior to and independent of recruitment into the study.
* Participants prescribed upadacitinib in accordance with the approved local label.
* Able to understand and communicate with the investigator and comply with the requirements of the study.
* Willing to continue with study documentation after cessation of upadacitinib.
* Willing and able to participate in the collection of PRO data via a cloud-based application on their personal or provided mobile phone or website app.

Exclusion Criteria:

* Any contraindication to upadacitinib.
* Previously exposure to upadacitinib in a clinical trial.
* Currently participating in interventional research (not including non-interventional study, post-marketing observational study (PMOS) , or registry participation).
* Initiation of upadacitinib prior to enrollment.
Individualized Prevention Strategy for High Risk Patients in Cardiovascular Disease: Prospective Cohort Study (Cardiovascular and Metabolic Disease Etiology Research Center - HIgh Risk Cohort) CMERC-HI

Set the prospective cohort (CMERC-HI) to study the known and novel etiologies and related factors for predicting clinical outcomes in Korean patients with high risk cardiovascular disease.


Eligibility Criteria:
Inclusion Criteria:

* high risk hypertension patients a. eGFR \> 60 with one of target organ damages b. eGFR \<= 60
* diabetes mellitus with microalbumin ration (AC ratio \>= 30mg/g)
* anuric ESRD patients on dialysis
* the relatives of acute myocardial infarction patients under 55 years old (men)/ 65 years old (women)
* atherosclerotic cardiovascular disease (abdominal aorta diameter ≥3 cm or ankle-brachial index \<0.9, or carotid plaque or carotid intima-media thickness ≥0.9 mm, or asymptomatic old cerebrovascular accident, or \>30% stenosis in at least one major coronary artery)
* rheumatoid arthritis patients aged \> 40 years on MTX and steroid therapy
* atrial fibrillation patients with CHADS-VASc Score ≥ 1
* kidney transplant recipient at \> 3 months after transplantation

Exclusion Criteria:

* acute myocardial infarction, acute coronary syndrome patients, symptomatic coronary artery disease or history of these diseases
* symptomatic peripheral artery disease, heart failure and history of these diseases
* desired life time under 6 months due to non-cardiovascular disease (e.g. cancer, sepsis)
* women with pregnancy or on nursing
* history of contrast allergy and related side effects
* within the first three months after transplantation
* acute renal allograft rejection
The Eshre Study Into The Evaluation of Oocyte Euploidy by Microarray Analysis

A pragmatic, multicentre, randomized double-blind controlled trial with an intention-to-treat analysis, of the use of preimplantation genetic screening (PGS) for aneuploidy by means of microarray comparative genomic hybridization (CGH) for the chromosomal analysis of the polar bodies (PB) of oocytes collected after ovarian stimulation for in vitro fertilization (IVF), and with the intention to assess the genetic competence of oocytes of advanced biological age, and the effect of this technique on reproductive outcome.


Eligibility Criteria:
Inclusion Criteria:

* infertility as an indication for IVF or ICSI;
* patients between their 36th and 41st birthdays (at time of signing ICF i.e. max 40years and 364days at the day of signing the informed consent);
* BMI range 18 to 30 kgs per m2;
* patients prepared to accept transfer of up to two embryos;
* absence of any type of genetic abnormality in the patient's personal and family history;
* normal karyotype (optional)

Exclusion Criteria:

* treatment involving donor oocytes (donor sperm is allowed subject to local practice and regulations and provided karyotype of the sperm donor is available and normal);
* menstrual irregularity (\<24 and \>35 days);
* three or more previous failed IVF or ICSI cycles, with the present partner. (Definition of a failed cycle: 'absence of a clinical pregnancy relating to a treatment with embryo transfer resulting from oocyte retrieval for the current intended pregnancy and with the current partner; the transfers include transfers of fresh and frozen within this treatment; clinical pregnancy is defined as the presence of a gestational sac at the earliest ultrasound and includes early clinical miscarriage, late miscarriage and clinically confirmed extrauterine pregnancy, and excludes preclinical miscarriage (biochemical pregnancy); -
* three or more clinical miscarriages;
* poor response in any previous cycle;
* low ovarian reserve (At least one of the following two features must be present: (1) a previous poor ovarian response (≤ 3 oocytes with a conventional stimulation 119 protocol); (2) an abnormal ovarian reserve test (i.e. AFC \< 5 follicles or AMH \< 0,5 ng/mL)\* (adapted from Ferraretti et al., 2011);
* cycles requiring surgical sperm recovery procedures;
* total asthenozoospermia and/or globozoospermia.
* any type of genetic abnormality or family history of genetic abnormality in subject or partner
Safety Study of Airway Clearance Techniques in Infants.

The purpose of this study is to determine whether three airway clearance techniques ( Bouncing, Assisted Autogenic Drainage ( AAD) and bouncing and AAD) provoke or aggravate gastro-esophageal reflux in infants under the age of 1 year.


Eligibility Criteria:
Inclusion Criteria:

* infants \< 1 year
* acid reflux monitoring

Exclusion Criteria:

* gestational age \<24 w
* anti-reflux medication
* Nissen fundoplication
* no parental consent
The COPENHAGEN Puberty Study

By clinical examinations and withdrawing of blood samples from a large number of healthy Danish children, this study will reveal if age of pubertal onset is declining. Furthermore, the extensive normative data will provide detailed insight into normal ranges and individual changes of anthropometrics and hormone levels in healthy children during childhood and adolescence.

The COPENHAGEN Puberty Study is a combined cross sectional and longitudinal study of healthy Danish children.

All children will be thoroughly examined and blood- and urine samples will be collected at every visit. The families fill out questionaires.

Physical examination: Height; sitting-height; weight; circumference of waist, hip, arm; measurement of fatfolds (biceps, triceps, flank, subscapularis); voice-break (yes/no), blood pressure; pubertal staging according to Tanners classification: breast development (B1-B5), genitalia development boys (G1-G5), pubic hair development (PH1-PH5), axillary hair (yes/no), sweat (yes/no), acne (yes/no

Urine sample: For measurement of FSH, LH and endocrine disrupters.

Blood sample: For measurement of hormone levels (FSH, LH, estradiol, SHBG, testosterone, DHEAS, androstenedione, inhibin A, inhibin B, Insl3, kisspeptin, ghrelin, leptin, IGF-1, IGFBP3, TSH, T4, Free T4, T3, HbA1C, calcium-ion, PTH, phosphate, 25-OH-vitamine D, AMH), endocrine disrupters (PCB´s, dioxines, parabens, phthalates), isolation of DNA and RNA to evaluate relevant polymorphisms.

Questionaire: regarding information of previous growth and health.

Eligibility Criteria:
Inclusion Criteria:

* all children accepting to participate were included

Exclusion Criteria:

* no children were excluded from examination or blood sampling. In case of chronic diseases, medical treatment, or ethnicity the children may be excluded from specific final data analysis.
Transient Osteoporosis of Pregnancy: A Possible Peptide Mediator

Transient osteoporosis of pregnancy (TOoP) is uncommonly encountered in orthopedic and obstetric practice, with most reports consisting of single cases.

This rare condition consists of significant osteoporosis affecting the hips and spine, causing significant morbidity, and putting young female patients at risk for vertebral and femoral neck fractures.

The pathogenesis of transient osteoporosis of pregnancy is unknown, with various theories as to its etiology.

Recently, a number of reports have described elevated levels of PTHrP in patients with transient osteoporosis in pregnancy and of the postpartum period Our goal in this study is to assess the role of PTHrP in transient osteoporosis of pregnancy


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed consent
Efficacy and Safety of HE10 for Dry Eye Syndrome

The purpose of this study is to evaluate the efficacy and safety of HE10 eye drop for the patients with moderate to severe dry eye syndrome.

This study is to compare the efficacy and safety of HE10 and Restasis for patients with moderate to severe dry eye syndrome in multi-center, double-blind, randomized, active comparator-controlled, parallel design, non-inferiority Phase III clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Corneal staining score of ≥2(Oxford grade)
* Schirmer test score (without anesthesia) \< 10 mm/5 min in either eye
* Tear break-up time is 10 seconds or less
* Screening both eyes, the corrected visual acuity is 0.2 or more

Exclusion Criteria:

* Current or recent patients used dry eye syndrome medications (topical or systemic) that may affect the status
* The patients with systemic or ocular disorders affected the test result
* Being treated with systemic steroid
* History of eyeball surgical operation within 3 months of screening visit
* Wearing contact lenses within 2 weeks of screening visit
* Be a use or used punctual plug within 1 month of screening vist
* Use of cyclosporine eye drop within 3 weeks
* Pregnancy or Breastfeeding
* Intraocular pressure \> 25 mmHg
* Abnormal eyelid function : Disorders of the eyelids or eyelashes