cyrilzakka/clinical-trials huggingface dataset:
Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 4)

The primary objective of this study was to show superiority of vilaprisan in the treatment of heavy menstrual bleeding (HMB) in subjects with uterine fibroids compared to placebo

The secondary objectives of this study were to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids


Eligibility Criteria:
Inclusion Criteria:

* Women, 18 years or older in good general health
* Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1 fibroid with largest diameter more than 30 mm and less than 120 mm
* Heavy menstrual bleeding (HMB) in at least 2 bleeding periods during the screening period each with blood loss volume of \>80.00 mL documented by the alkaline hematin (AH) method
* An endometrial biopsy performed during the screening period without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology
* Use of an acceptable non-hormonal method of contraception (ie, either male condom, cap, diaphragm or sponge, each in combination with spermicide) starting at Visit 1 until the end of the study

Exclusion Criteria:

* Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment)
* Hypersensitivity to any ingredient of the study drug
* Hemoglobin values ≤6 g/dL or any condition requiring immediate blood transfusion (subjects with hemoglobin values ≤10.9 g/dL will be recommended to use iron supplementation)
* Any diseases, conditions, or medications that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug
* Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
* Abuse of alcohol, drugs or medicines (e.g. laxatives)
* Use of other treatments that might interfere with the conduct of the study or the interpretation of results
* Undiagnosed abnormal genital bleeding
Analgesic Effect of Erector Spinae Plane Block for Renal Colic Pain

Plane blocks have become very popular in recent years with the introduction of ultrasonography into the regional anesthesia and algology practice. Erector spinae plane (ESP) block involves the injection of local anesthetics between erector spinae muscles and transverse process of vertebrae and can block the dorsal and ventral rami of thoracolumbar spinal nerves.

The aim of this study was to evaluate the analgesic efficacy of the erector spine plane block for reno-ureteral colic.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologist's physiologic state I-II patients

Exclusion Criteria:

* chronic pain
* bleeding disorders
* renal or hepatic insufficiency
* patients on chronic non-steroidal anti-inflammatory medications
Resolution of Uncertainty Through Testing

Given the high rate of delayed adoption of antenatal care (ANC), and high rates of unintended pregnancy and unsafe abortion in Uganda, research on the period of time before confirmation of pregnancy is critical to understand underlying beliefs that guide behaviors ultimately important for maternal and neonatal health (UDHS, 2011; Hussain, 2013).

Home pregnancy tests - which now cost less than 10 cents each - have the potential to facilitate FP uptake and significantly improve reproductive, maternal and child health outcomes in sub-Saharan Africa, including Uganda. These tests are easy to administer, disposable, inexpensive, and have a low false positive rate. Yet, for women living in rural areas in sub-Saharan countries, these tests are typically unavailable outside of health centers or they are prohibitively expensive.

This study will investigate women's underlying beliefs about pregnancy status and examine how providing access to home-based pregnancy tests - thus facilitating earlier resolution of uncertainty of pregnancy status - influences such beliefs and decisions to take up family planning (FP) or seek appropriate pregnancy services.

The results will inform the design of a larger study in the future.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18-35
* Live in the catchment area

Exclusion Criteria:

- Currently attending school

End Survey if

* Women in menopause
* Women with sterilization
* Women with husband/partner with sterilization
* Women who do not understand what menstrual period is
Dual Endothelin Receptor Antagonism in Large Vessel Vasculitis (DERAIL-LVV)

Large vessel vasculitis is a disease that causes damage to blood vessels. This damage to blood vessels can increase the risk of patients with LVV developing cardiovascular disease, including heart attacks and strokes. A chemical produced in the body called endothelin may contribute to this increase in cardiovascular disease risk by causing the vessels to stiffen and blood pressure to increase.

It has previously been shown that by blocking the effects of endothelin, vessel stiffness and blood pressure improve. Bosentan is a tablet that blocks the effects of endothelin. The investigators plan to assess blood vessel function in those with LVV and participants without LVV. Participants with LVV will then be given Bosentan for 6 weeks to evaluate its impact on blood vessel function.

Large vessel vasculitis (LVV) is an autoimmune disease characterised by inflammatory damage to the blood vessels. Although symptoms initially are non-specific, complications such as vessel stenosis can lead to heart failure and stroke. While current immunosuppressive treatments have improved short-term outcomes, they have not led to improvements in long-term outcomes. Patients with LVV remain at an increased risk of developing cardiovascular disease, the underlying mechanisms of which are not yet fully understood.

The inflammatory damage to blood vessels in LVV can result in endothelial dysfunction. Endothelin-1 (ET-1) is a potent vasoconstrictor produced by the endothelium. In endothelial dysfunction, excess ET-1 production causes raised blood pressure, increased arterial stiffness and reduced fibrinolytic capacity. Previous research has demonstrated that short-term blockade of endothelin receptors improves arterial stiffness and fibrinolytic capacity.

The investigators will conduct a cross-sectional, case-control study comparing endothelial function in patients with LVV with sex-, age-, and cardiovascular disease risk factor-matched control participants. This will be followed by an open-label study involving 6 weeks of treatment with Bosentan (a dual endothelin receptor antagonist) within the LVV group to assess whether this drug can improve endothelial function. Assessment of endothelial function will be carried out by forearm plethysmography which is the gold standard.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of large vessel vasculitis that has been in remission for ≥ 6 months.

Exclusion Criteria:

* Age \<18 years
* Active LVV
* Any organ transplant recipients
* A requirement for any medications that are contra-indicated whilst taking Bosentan
* Congestive cardiac failure
* Patients not medically fit to attend study visits
* Patients without mental capacity or willingness to provide informed consent
* History of multiple and/or severe (clinical judgement as determined by the Investigator) allergic reactions to drugs, including the study drug, or food
* Patients who are pregnant or breast feeding, or those who plan to become pregnant during the study
* Participation in another clinical trial for 28 days before or 90 days after the study period
An Evaluation of Concordance of Smartwatch ECG and One Clinical ECG and Comparison of The Two ECGS in Terms of Predictive Risks

The participant is being asked to take part in this trial, because the participant is a survivor of childhood cancer.

Primary Objective

To evaluate remote cardiomyopathy prediction via smartwatch and one clinical ECG and assess the concordance of the two ECGs in terms of predicted risk.

Secondary Objective

To build a novel predictive model solely on smartwatch ECG to predict risk for cardiomyopathy.

The proposed study is looking to compare the 30 second ECG read from a smartwatch to the clinical ECG during a SJLIFE scheduled ECG appointment.

Eligibility Criteria:
Inclusion Criteria:

* SJLIFE participant and 22 years of age or older at time of enrollment
* Participant or legal guardian is able and willing to give informed consent
* At least 5 years after childhood cancer diagnosis

Exclusion Criteria:

* Been diagnosed with cardiomyopathy on previous SJLIFE ECG
* Currently on heart medication
Evaluation of LBL-003 Phase I Study in Patients With Advanced Malignancies

This study is a single-arm, dose-escalation phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of LBL-003 injection in patients with advanced malignant tumors.

The purpose of the single-dose escalation study of LBL-003 in subjects with advanced malignant tumors was to evaluate the safety and tolerability of monotherapy to determine the MTD (or MAD) and to determine the clinically recommended dose of LBL-003 monotherapy.

All subjects in this study underwent pharmacokinetic (PK) and pharmacodynamic (PD) studies. The dosing frequency of LBL-003 is once every 2 weeks (Q2W), and the subsequent dosing frequency is adjusted according to the obtained PK and tolerability results.

This study is expected to enroll 17-36 patients with solid tumors who have no standard treatment or have treatment failure with standard treatment or are not suitable for standard treatment at this stage.

Eligibility Criteria:
Inclusion Criteria:

1. Both male and female aged 18-75 years (including borderline values) at the time of signing the informed consent form;
2. ECOG score: 0-1;
3. Agree to follow the study treatment plan and visit plan, voluntarily enrolls, and signs the written informed consent.
4. Subjects with advanced malignant solid tumors confirmed by histology or cytology have failed the standard treatment or have no standard treatment protocol or are not suitable for standard treatment at this stage.
5. Subjects should have at least one evaluable lesion as defined by RECIST V1.1;
6. Subjects are expected to survive at least 12 weeks;

Exclusion Criteria:

1. History of immunodeficiency, including positive HIV antibody test results；
2. Active hepatitis (hepatitis B or C)；
3. having undergone major surgery or still in the recovery phase of an earlier surgery within 4 weeks before the first administration;
4. Women during pregnancy or lactation;
5. The investigator's assessment that there may be other factors affecting compliance among participants or that some may not be suitable for inclusion in this study.
Synergic Effects of Physical Activity and Probiotic on Gut Immune System and Quality of Life of Breast Cancer Survivors.

Physical exercise along with gut microbiota improvement -because of probiotic intake- can improve the quality of life and immune system in breast cancer survivors. This is achieved because exercise improves the muscle mass in cancer patients (often reduced by treatment and/or inactivity), together with the gut microbiota improvement, this stimulates the inmune system function, improving the quality of life of these patients.

The aim of this study is to determine the effects of physical exercise together with the supplementation of a probiotic on gut microbiota balance, the gut immune system and quality of life (intended as functional and muscular capacity, physical qualities and emotional state) in breast cancer survivors .

A randomized controlled pilot study has been designed in three parallel groups. Breast cancer survivors will be randomly assigned to each of the 3 groups: a) probiotic supplementation + supervised combined physical exercise (PEF), b) probiotic supplementation and habitual sedentary lifestyle (P), and c) control group will follow their usual lifestyle and will receive a placebo (C).

The exercise intervention will last 12 weeks. It will include three weekly sessions of programmed physical exercise of \~ 60 min duration (combined training). The exercise program will be individualized and will follow the rules of the world reference institutions for aerobic training. Each session will be held in a qualified fitness center and it will be supervised and individualized for each subject by professional experts .The two supplemented groups will take 3 capsules (Lactobacillus rhamnosus, Lactobacillus paracasei, Lactobacillus acidophilus, Bifidobacterium bifidum) a day (at night before bedtime) for 12 weeks.

The variables gut microbiota, fecal levels of immunoglobulin A, cardiorespiratory capacity, anthropometry variables, lifestyle, muscular capacity, quality of life, anxiety, depression and stress levels will be analized at the beginning (baseline dose) and after 12 weeks of intervention.

Eligibility Criteria:
Inclusion Criteria:

* Breast Cancer Survivors
* \<18 aged.
* No chemotherapy treatment or that at least three months have passed after the last chemotherapy treatment before the beginning of the study.
* Breast cancer status: I-IV status.
* ECOG scale: 0-1.
* Normal weight.

Exclusion Criteria:

* Extreme Diet.
* Exercise practice (at least at the doses recommended by WHO)
* Presence of heart disease
* Uncontrolled blood hypertension: (\>160/90 mmHg).
* Uncontrolled metabolic disease
* Infectious chronic disease
* Uncontrolled pain
* Pregnancy or breast feeding
* Gastrointestinal disease
* Alcoholism
* Any condition that contraindicates the exercise practice in survivors cancer (fractures risk, severe leukopenia , low platelet count)
* Antibiotics intake during the study.
Evaluation of Posterior Capsule Opacification in Eyes With Diabetes Mellitus

To compare the development of posterior capsule opacification (PCO) between eyes with and without a history of diabetes mellitus (DM) after single-piece hydrophobic acrylic intraocular lens (IOL) implantation 4 years postoperatively.Diabetes mellitus would not increase the incidence of PCO at 4 years.

There is a paucity of available literature that prospectively evaluates the development of PCO with the single-piece hydrophobic acrylic IOL implantation in diabetic versus non-diabetic eyes on a long-term basis. Therefore, this study was designed to compare the degree of PCO after cataract surgery between diabetic and age-matched non-diabetic patients. This prospective, observational case control study comprised patients who underwent phacoemulsification .The patients were asked to return for postoperative follow-up visits at 1 month, 1 year and 4 years.

the digital images were analyzed for PCO .

Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus was defined as glycosylated haemoglobin (Hb A1c ) levels of 6% or more ,
* use of diabetic medication (oral hypoglycemic agents, insulin injection or diet restriction), or a physician's diagnosis of diabetes.
* Patients with uncomplicated age-related cataract who were otherwise healthy constituted the controls (n=75 eyes).

Exclusion Criteria:

* patients with glaucoma,
* high myopia (axial length \> 27.0 mm),
* pseudoexfoliation,
* traumatic cataract,
* subluxated cataract,
* previous ocular surgeries,
* allergy to dilating drops.
Ultrasound Guided Fallopian Tube Catheterization During Hysterosalpingo-foam Sonography (HyFoSy)

Investigate a novel ultrasound guided transcervical fallopian tube catheterization during hysterosalpingo-foam sonography in the treatment of proximal tubal obstruction.

Tubal catheterization is usually reserved for infertility treatment in selected cases of proximal tubal occlusion. As the incidence of this condition is limited to approximately 10-20% of women with mechanical infertility, the hitherto published data concerning the best therapeutic approach for these patients is scarce.

Hysterolaparoscopy with dye instillation is considered the gold standard for comprehensive evaluation of the female reproductive organs. Moreover, while the gold standard for evaluation of the uterine cavity is diagnostic hysteroscopy and hydrosonography, tubal patency may be validated by either hystrosalpingography, or ultrasonic evaluation using Echovist-200. However, interpretation of the passage of contrast medium into the proximal portion of the tube remains somewhat uncertain.

Since hysterolaparoscopy with dye instillation, is an expensive and an invasive procedure, with potentially life-threatening risks, the search for a safer and less invasive techniques is still ongoing. In 2012, Hysterosalpingo-Foam Sonography was introduced as a new technique for assessing fallopian tube patency. During the exam, the passage of a hyper-echogenic foam composed of a mixture of gel and purified water can be visualized as it progresses from the uterine cavity through the fallopian tubes into the peritoneal cavity. Hysterosalpingo-foam sonography is a promising alternative for laparoscopy and hysterosalpingography with regard to accuracy and effectiveness and has been suggested as a first step test of tubal assessment since it is relatively safe, non (embryo-) toxic and non-invasive.

In the present report the investigators aim to perform an ultrasound guided transcervical fallopian tube catheterization during hysterosalpingo-foam sonographyin the treatment of proximal tubal obstruction. This "one stop - shop" procedure combines uterine cavity investigation and assessment of tubal patency, with the concomitant advantage of therapeutic tubal re-canalization.

Eligibility Criteria:
Inclusion Criteria:

• uni or/and bilateral proximal tubal occlusion.

Exclusion Criteria:

* ongoing pregnancy
* positive Human Chorionic Gonadotropin test
* active pelvic inflammatory disease
* vaginal bleeding
* presence of distal tubal occlusion
Predicting Resting Energy Expenditure in Critically Ill Patients by Measuring Lean Body Mass by US

The study aims to correlate Lean Body Mass (LBM) Evaluated by Musculoskeletal Ultrasound with Resting Energy Expenditure (REE) measured by Indirect Calorimetry and to generate a predictive equation of REE based on LBM, in addition to identifying other factors that may affect REE such as age, gender, and severity scores.

Caloric needs in critically-ill patients fluctuate significantly over the course of the disease which might expose patients to either malnutrition or overfeeding.Malnutrition is associated with deterioration of lean body mass (LBM), poor wound healing, increased risk of nosocomial infection, and weakened respiratory muscles. On the other hand overfeeding in medically compromised patients can promote lipogenesis, hyperglycemia, and exacerbation of respiratory failure. Many factors may affect the resting energy expenditure (REE) through manipulation of oxygen consumption (VO2). One of the strongest determinants of REE is the LBM.

A measurement of muscle mass and changes in muscle mass could thus provide an index of LBM in critically ill patients. At present, computerized tomography, magnetic resonance imaging and dual-energy X-ray absorptiometry (DXA) are widely used as reference methods for evaluating LBM in vivo. However, these methods are impractical in critically ill patients. More practically, ultrasound scanning is a simple, portable, safe, and a low-patient burden technique. Several studies found that the use of ultrasound can be a good estimate to LBM.

Indirect calorimetry remains the accepted standard for determining the REE in the critically ill. Indirect calorimetry measures oxygen consumption(VO2) and carbon dioxide excretion (VCO2 ) (both in mL/min), which are used to calculate the respiratory quotient and the resting energy expenditure. Although, the measured LBM has been shown as an important determinant of REE, there was no previous study tested the relationship between estimated LBM by ultrasound-based muscle thickness measurement and REE.

Eligibility Criteria:
Inclusion Criteria:

- Patient requiring ventilatory support \> 24 hours

Exclusion Criteria:

* Patient who will require FIO2 more than 0.6.
* Air leak from the chest tube.
* Patient with body temperature \> 39oC.
* Patients with known endocrine dysfunction.
* Patients on parenteral nutrition
OneTouch® Verio™Pro+ Blood Glucose Monitoring System Clinical Accuracy Study in China

The evaluation will determine professional clinical accuracy comparing the OneTouch® Verio™Pro+ blood glucose results with the YSI 2300 analyzer. "Professional Clinical Accuracy" is defined as accuracy of the system when used by a trained healthcare professional.


Eligibility Criteria:
Inclusion Criteria:

* Subject is at least 18 years of age.
* Subject has been diagnosed with diabetes mellitus (type 1 or type 2 diabetes)
* Subject agrees to sign two (2) copies each of the Subject Informed Consent Form and to follow the procedures of the study.
* Subject agrees to allow the HCP to perform finger stick for blood glucose test by the meter and the YSI instrument. Up to one retry of finger stick will be needed in the event of insufficient blood collected or test failure.
* Subject agrees to allow the HCP to perform venous puncture for blood glucose test by the meter and the YSI instrument, and for haematocrit (HCT) test. Up to one retry of venous puncture will be needed in the event of insufficient blood collected or test failure.
* Subject agrees to provide demographic and medical history information and give access to medical records where appropriate.

Exclusion Criteria:

* Subject is currently working for, has previously worked for, or has an immediate family member working for a company manufacturing and/or marketing blood glucose monitoring products.
* Subject has already participated in this study.
* Subject is known pregnant
Impact of a Novel Heart Failure Medication Decision Aid

A modified Zelen design randomised controlled trial over 6 months period is designed to investigate the influence of a heart failure medication decision aid prior to clinic session on shared decision making and its long term effect. Participants are randomised to either the decision aid arm or the usual care arm.

A novel heart failure (HF) medication decision aid (DA) has been constructed, taking into account the needs of both patients and clinicians. Developed with a focus on brevity, this single-page DA is designed to offer patients a quick and concise overview of the information they desire about their medication ahead of their clinic session. It encompasses personalised cost information, considering the subsidies available in Singapore. The aim of the DA is to improve the communication between clinicians and HF patients. The conduct of this randomized controlled trial (RCT) is to study the effectiveness of the HF DA in the real-world setting.

Patients are randomized to either the DA arm or the usual care (UC) arm. In the DA group, patients will be provided with a DA featuring duration and frequency of use, benefits, side effect and cost information about angiotensin receptor neprilysin inhibitor and angiotensin-converting enzyme inhibitor medications. These patients will then be tasked to choose a preferred medication and reflect on which attribute holds the most significance for them. The preferred medication will be communicated to the clinicians during the clinic session. For the UC arm, clinicians will manage the encounter as per current usual routine.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with heart failure with reduced ejection fraction (HFrEF)
* Singaporean nationality

Exclusion Criteria:

* Patient is currently on Medifund OR have Medical Claims Pro-ration System (MCPS)
* Pregnant
* Age 21 years and below
* Incapable of personally giving consent
* Unable to speak and read English or Chinese