cyrilzakka/clinical-trials huggingface dataset:
China PEACE 5p-HF Study

The investigators will consecutively recruit 5000 patients hospitalized for heart failure (HF) from 50 hospitals across China and follow them up for one year, describe treatment patterns during hospitalization and the follow-ups, examine patients recovery trajectory after HF, and identify targets for care quality improvement.

This study will consecutively enroll patients with HF as the primary reason for hospitalization in 50 hospitals scattered all over China. Participants will be interviewed at baseline (i.e., during the index hospitalization for HF), and at 1, 6, and 12 months following hospital discharge. During the follow-up period, participants will be instructed to return to the hospital for interviews by site investigators. Telephone follow-ups will be conducted only when in-person interviews are not feasible.

At baseline, participants will be interviewed to collect detailed information about on demographics, socioeconomic status, cardiovascular risk factors, clinical characteristics, treatments, in-hospital outcomes, general and disease-specific quality of life, function and mental status; during the follow-ups, the investigators will collect information about clinical outcomes events, long-term treatments, function, quality of life, symptoms, and medical care during the recovery period.

The investigators will collect blood and urine samples during index hospitalization and the follow-ups.

This study will examine a series of factors that may affect patients' recovery after HF. Practical guidelines, quality evaluative system, and risk model will be established based on the findings, to improve patient outcomes in the future.

Eligibility Criteria:
* Inclusion Criteria:

  1. Patients with heart failure as the primary reason for hospitalization, including both new-onset HF or decompensation of chronic HF
  2. Aged 18 years or above
* Exclusion Criteria:

  1. Patients who have enrolled in this study
  2. Patients who usually do not live in the city/county where the index hospital locates
  3. Patients who are unable to complete interviews due to severe conditions, mental illness, or communication difficulties.
Blood Pressure Measuring Practice of Hong Kong Primary Care Doctors

Background: While office BP measurements were traditionally used to detect, diagnose and manage hypertension(HT), studies had convincingly showed that out-of-office blood pressure, including home blood pressure monitoring (HBPM) and ambulatory blood pressure monitoring (ABPM), was superior in predicting cardiovascular outcomes and death. Furthermore, some countries' guidelines suggested the use of validated automatic blood pressure machines (called automated office blood pressure monitoring (AOBP)) to screen for HT and record BP in routine HT clinical management. With difference between guidelines and various available BP measurement methods, it is not known how primary care doctors, who play the key role to detect and treat HT, are measuring BP in their daily practice.

Method: All doctors registered in the primary care directory will be mailed a questionnaire. Those who do not respond would be mailing for maximally 3 times, 2 weeks apart to enhance response rate. It is estimated that around 1500-2000 doctors will be eligible.


Eligibility Criteria:
Inclusion Criteria:

* All doctors registered in the primary care directory in Hong Kong

Exclusion Criteria:

* nil
A Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes and Inadequate Glycemic Control With Insulin Glargine, With or Without Metformin and/or SGLT-2 Inhibitor

The main purpose of this study is to determine the safety and efficacy of orforglipron. Participants will have Type 2 Diabetes (T2D) and have inadequate glycemic control with insulin glargine with or without metformin and/or SGLT-2 (sodium-glucose cotransporter-2) inhibitor. The study will last about 46 weeks and may include up to 20 visits.


Eligibility Criteria:
Inclusion Criteria:

* Have Type 2 Diabetes (T2D)
* Have HbA1c ≥7.0% \[53 mmol/mol\] to ≤10.5% \[91 mmol/mol\]
* Have been treated with stable doses of the same formulation of the following for ≥90 days prior to screening visit 1 and have maintained the same doses through randomization:

  * insulin glargine U-100 (100 U/mL) ≥0.25 U/kg/QD (units per kilogram per day) or ≥20 U/QD alone, or
  * insulin glargine U-100 (100 U/mL) ≥0.25 U/kg/QD or ≥20 U/QD in combination with
  * metformin, or
  * SGLT-2 inhibitor, or
  * both metformin and SGLT-2 inhibitor.
* Are of stable body weight (±5%) for at least 90 days prior to screening visit 1 and agree to not initiate an intensive diet or exercise program during the study with the intent of reducing body weight, other than the lifestyle and/or dietary measures for diabetes treatment.
* Have a Body Mass Index (BMI) ≥23.0 kg/m\^2 at baseline.

Exclusion Criteria:

* Have New York Heart Association functional classification III-IV congestive heart failure.
* Have had any of the following cardiovascular conditions within 60 days prior to baseline.

  * acute myocardial infarction
  * cerebrovascular accident (stroke), or
  * hospitalization for congestive heart failure.
* Have acute or chronic hepatitis, including a history of autoimmune hepatitis, signs or symptoms of any other liver disease other than nonalcoholic fatty liver disease
* Have had chronic or acute pancreatitis any time.
An Efficacy, Safety, and Tolerability Study of VX-880 in Participants With Type 1 Diabetes With a Kidney Transplant

This study will evaluate the efficacy, safety, and tolerability of VX-880 in participants with Type 1 Diabetes (TID) with a kidney transplant.


Eligibility Criteria:
Key Inclusion Criteria:

* Clinical history of T1D with greater than or equal to (≥)5 years of insulin dependence
* Taking a stable immunosuppression regimen of tacrolimus and mycophenolate mofetil, mycophenolate sodium, or sirolimus for at least 4 weeks
* Consistent use of continuous glucose monitor (CGM) for at least 4 weeks before Screening and willingness to use CGM for the duration of the study

Key Exclusion Criteria:

* Prior islet cell transplant, organ transplant (other than kidney transplant) or cell therapy
* Participants had greater than (\>)1 kidney transplant procedure

Other protocol defined Inclusion/Exclusion criteria may apply.
Comparison of Gated Blood-pool SPECT and Echocardiogram for Ventricular Function

To compare the calculated biventricular ejection fraction from cadmium-zinc-telluride (CZT) single photon emission computed tomography (SPECT) with planar equilibrium radionuclide angiography (ERNA), first-pass radionuclide ventriculography (FP-RNV) and echocardiogram.

To evaluate the feasibility of using CZT SPECT as an "all-in-one" technique to provide information on both left ventricular ejection fraction (LVEF) and right ventricular ejection fraction (RVEF) derived from a single examination and compare with the values from traditional planar ERNA, FP-RNV and echocardiography.

Eligibility Criteria:
Inclusion Criteria:

* Patients underwent transthoracic echocardiogram and resting cardiac function within interval of 90 days of each other

Exclusion Criteria:

* Pregnancy
Study Evaluating the Impact of Electronic Surveys on Patient-physician Communication and Quality of Life in Breast Cancer Patients

PRO-COM Project: Randomized-controlled study evaluating the impact of electronic patient reported outcome (ePRO) surveys on patient-physician communication and quality of life in patients with advanced breast cancer


Eligibility Criteria:
Inclusion Criteria:

* Stage IV breast cancer
* Start of a systemic anti cancer therapy: chemotherapy -/+ antibody therapy 1st until 3rd line (palliative), endocrine therapy or other therapy without limit
* Estimated life expectancy of minimum six months
* Signed informed consent
* No cognitive or speech impairments
A Study of LY900014 Formulations in Healthy Participants

This study evaluated four test formulations of a glucose lowering drug (LY900014) administered by injection under the skin of the abdomen. The study was conducted in healthy people to investigate how the human body handles LY900014 and the effect of LY900014 on blood sugar levels. Side effects and tolerability were documented. The study was to be conducted in two parts (Part A and Part B) to achieve its objectives. Each part of the study was to last for about 11 to 12 weeks, including screening and follow up. Screening was required within 28 days prior to entering into either study Part A or Part B. Part B was not executed because no suitable formulation was identified.


Eligibility Criteria:
Inclusion Criteria:

* Overtly healthy male or a female (not pregnant and agreeable to take birth control measures until one month after study completion)
* Have a body mass index (BMI) of 18.5 to 30 kilogram per square meter (kg/m\^2), inclusive, at screening
* Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study
* Are nonsmokers, have not smoked for at least 2 months prior to entering the study, and agree not to smoke (cigars, cigarettes, or pipes) or use smokeless tobacco for the duration of the study

Exclusion Criteria:

* Are currently participating in or completed a clinical trial within the last 30 days from a clinical trial or any other type of medical research judged to be incompatible with this study
* Have previously participated or withdrawn from this study
* Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
Combined Dry Powder Tobramycin and Nebulized Colistin Inhalation in CF Patients

To assess whether the inhalative combination of Tobramycin/Colistin is more effective in reducing Pseudomonas colony forming units (CFUs) and improvement of lung function than Colistin in mono-therapy.

Cystic fibrosis (CF), the most common autosomal recessive disorder in Western countries, is caused by mutations of the cystic fibrosis transmembrane conductance regulator molecule (CFTR) and affects approximately 40.000 patients in Europe. The majority of CF patients develop chronic pulmonary infections with Pseudomonas aeruginosa. These are normally treated with single antibiotics, administered orally, intravenously or inhalatively. Once the infection becomes chronic, eradication of the pathogen is not any more possible due to biofilm formation of the pathogen and increasing resistance. However, inhalative antibiotic combination therapy might be more efficient than single antibiotic therapy in chronically infected CF patients. This notion is supported by previous in vitro and animal studies using Tobramycin/Colistin combination therapy. Importantly, a pilot study in five CF patients who inhaled consecutively Colistin and Tobramycin solutions for 4 week, revealed a decrease of log10 2.52 ± 2.5 cfu of P. aeruginosa in sputum specimens during the course of the treatment compared to baseline values (p=0.027). The treatment was shown to be safe and well tolerated. However, forced expiratory volume in 1 sec (FEV1) did not differ significantly.

Taking advantage of the new development of dry powder inhalation (DPI) antibiotics, specifically TOBI© Podhaler, a larger randomised trial has been performed in which the combined TOBI© Podhaler and Colistin treatment is compared to the monotherapy with Colistin.

Eligibility Criteria:
Inclusion Criteria:

1. Cystic Fibrosis is verified;
2. Patient is 12 years or older;
3. FEV1 is higher than 25% and lower than 100%;
4. The patients' lung is colonised with P. aeruginosa chronically (≥6 months);
5. P. aeruginosa must be sensitive for Tobramycin or Colistin;
6. Pretreated with Colistin \>2 months;
7. Last i.v. antibiotic treatment ≥2 weeks;
8. Informed consent is given by patients/legal representatives

Exclusion Criteria:

1. Clinical deterioration is present (exacerbation symptoms);
2. Last Tobramycin inhalation treatment ≤ 2 weeks;
3. Renal dysfunction (creatinine \<1.5 fold of normal, glomerular filtration rate (GFR) \<80%) at baseline
4. auditoria or vestibular dysfunction, hearing loss
5. Intolerances against Tobramycin, Colistin or Polymyxin B
6. Myasthenia gravis
7. Porphyria
8. Pregnancy and nursing
Electroencephalogram Dynamics in Children During Different Levels of Anesthetic Depth

As part of the clinical routine of the Department of Anesthesiology and Intensive Care Medicine CVK/CCM in the Charité - University Medicine Berlin intraoperative electroencephalography data and clinical routine data are recorded and evaluated in surgical children and adolescents according to different age groups.


Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents undergoing surgery procedure

Exclusion Criteria:

* Neurosurgery
* Pre-existing neurological conditions
Increased Inflammation-resolving Activity by Omega-3 Monoglycerides in Peripheral Blood Mononuclear Cells (PBMC).

The purpose of this biological study is to provide Dr. Samuel Fortin's laboratory with a continuous supply of blood mononuclear cells (PBMCs) so that he can pursue research on the potential beneficial effects of monoglyceride omega-3 fatty acids on the resolution of inflammation.

The biological activity of omega-3 fatty acids requires selective oxidation by lipoxygenase (LOX) enzymes in the human body to form SPM (Specialized Pro-resolving Mediators). The formulations based on omega-3 monoglyceride (MAG-Omega-3) currently marketed by SCF Pharma have been optimized so as not to interfere with this natural metabolism process in the human body. It has already been shown that the antiproliferative activity of docosapentaenoic acid (or omega-3 ADP) can be increased tenfold when it is pre-metabolized using a LOX enzyme from soybean (C. Morin et al. PLEFA (2013) 203-213). This antiproliferative potential may play a key role in the mechanisms of inflammation resolution.

We now want to develop a new line of high performance products by pre-metabolizing MAG-Omega-3 in the form of SPM monoglycerides (MAG-SPM) using the LOX enzyme from soy. The potential for resolving inflammation by MAG-SPM can be measured by cell proliferation assays. To perform these tests, cells of the PBMC type must be isolated from the blood of donors and maintained in culture in the presence of an inflammatory agent (LPS) which induces their proliferation (C. Morin et al. European Journal of Pharmacology 807 (2017)) 205-211). Next, the reduction in proliferation induced by MAG-SPM is quantified and then compared with that of cells not treated with MAG-SPM. This type of test requires a large amount of fresh cells, and therefore, a source of blood sample supply.

This research project is divided into two parts: 1) A protocol for collecting blood samples; 2) A cell proliferation test protocol to demonstrate the activity of MAG-SPM in the resolution of inflammation. This protocol covers the first part of this research project.

Eligibility Criteria:
Inclusion Criteria:

* Participant aged of at least 18 years old.

Exclusion Criteria:

* Participant who use omega-3 supplements and / or anti-inflammatory medication such as, but not limited to - Aspirin, Ibuprofen (Motrin, Advil), Celecoxib (Celebrex), diclofenac (Cambia, Cataflam, Voltaren ) within 7 days of day 1 of the study.
Medical Clowning: Needs Assessment and Implication for Hospitalized Children With Cancer/Blood Disease

Hospitalized children who undergo painful procedures are more susceptible than others to experiencing iatrogenic effects, such as anxiety, pain, and severe stress. Clowns in clinical setting have been found to be effective in reducing children's experiences of these effects during hospitalization and before procedures. This article provides an overview of clowning in health care settings; reviews major studies conducted on clowning for hospitalized children, discussing evidence that clown interventions decrease pain and distress in pediatric patients; and concludes with a discussion of health care clowning as a profession.


Eligibility Criteria:
Inclusion Criteria:

* aged 4-18 children with cancer/blood disease and parents of children aged 0-18 years with cancer/blood disease

Exclusion Criteria:

* older than aged 18
A Study of ARRY-334543 in Patients With Advanced Cancer

This is a Phase 1 study during which patients with advanced solid tumors will receive investigational study drug ARRY-334543.

This study has 2 parts. In the first part, patients will receive increasing doses of study drug (2 dosing schedules will be evaluated) in order to achieve the highest dose possible that will not cause unacceptable side effects. Approximately 70 patients from the US and Canada will be enrolled in Part 1 (Completed).

In the second part of the study, patients will receive the best dose(s) and schedule(s) of study drug determined from the first part of the study and will be followed to see what side effects the study drug causes and what effectiveness it has, if any, in treating the cancer. Approximately 40 patients from the US and Canada will be enrolled in Part 2 (Completed).


Eligibility Criteria:
Key Inclusion Criteria (Part 2):

* Histologically or cytologically confirmed diagnosis of ErbB2+ breast cancer, pancreatic, squamous cell head and neck, hepatocellular, hepatobiliary, glioblastoma, ovarian, prostate, upper GI, colorectal, non small cell lung, or bladder cancer or other relevant cancers if approved in advance by the Sponsor.
* Measurable disease (at least 1 target lesion) according to modified RECIST.
* Failed at least one previous therapeutic regimen and either no longer a candidate for standard therapy, has no standard therapy available, or chooses not to pursue standard therapy.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
* Must consent to allow the Sponsor access to an archival histological specimen or to have a pre-dose tumor biopsy.
* Additional criteria exist.

Key Exclusion Criteria (Part 2):

* Uncontrolled or symptomatic brain metastases (if a patient has brain metastases and is on steroids, the steroid dose must be stable for at least 30 days).
* Use of an investigational medication or device within 30 days prior to first dose of study drug.
* Major surgery within 30 days prior to first dose of study drug.
* Radiotherapy or chemotherapy within 28 days prior to first dose of study drug (not including palliative radiotherapy at focal sites).
* Pregnancy or lactation.
* Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or hepatitis C. Of note, if a patient has hepatocellular carcinoma, then they may be enrolled even if they are positive for hepatitis B and/or hepatitis C.
* Additional criteria exist.
Serum Metabolomics Study of Traditional Chinese Medicine Formula （Shen Qi Tiao Ti Formula） Intervention to Polycystic Ovary Syndrome

Polycystic ovary syndrome (PCOS) is a most common, heterogeneous, complex endocrinopathy disease.Traditional Chinese medicine (TCM) has been used in the treatment of PCOS for many years. However, the mechanism underlying TCM remains obscure and challenging.In the present study, a metabolomics approach based on ultra-high-performance liquid chromatography (UPLC) coupled with linear ion trap Orbi-trap mass spectrometer (LTQ Orbi-trap MS) is used to investigate serum metabolic changes of TCM intervention to PCOS.


Eligibility Criteria:
Inclusion Criteria:

* PCOS diagnostic criteria: According to the diagnostic criteria revised by the European Society of Human Reproduction and Embryology and the American Society for Reproductive Medicine at the Rotterdam in 2003, PCOS patients can be diagnosed if two of the three criteria are present after excluding congenial adrenal hyperplasia, Cushing's syndrome, androgen secreting tumors, or other related disorders. The three criteria are (1) oligo- and/or anovulation; (2) clinical and/or biochemical signs of hyperandrogenism (clinical manifestations of hyperandrogenism include presence of acne, hirsutism, and androgenic alopecia); (3) polycystic ovaries by ultrasound examination: presence of 12 or more follicles in each ovary measuring 2-9 mm on diameter and/or ovarian volume\>10 ml.
* Age between 14 and 40 years.
* 2 years after menarche

Exclusion Criteria:

* Administration of other medications known to affect reproductive function or metabolism within the past three months, including oral contraceptives, Gonadotropin-releasing hormone (GnRH) agonists and antagonists, anti androgens, gonadotropins, anti-obesity drugs, Chinese herbal medicines, anti diabetic drugs such as metformin and thiazolidinediones, somatostatin, diazoxide, and calcium channel blockers.
* Patients with other endocrine disorders including 21-hydroxylase deficiency, hyperprolactinemia, uncorrected thyroid disease, suspected Cushing's syndrome.
* Patients with known severe organ dysfunction or mental illness.
Clopidogrel Monotherapy in Patients With High Bleeding Risk

The goal of this research is to show that a shorter duration of two antiplatelet medications (compared to the standard of care) is safe and effective while reducing the risk of bleeding complications. Bleeding complications can cause significant problems (hospitalizations, need for blood transfusions, and even death) for patients on antiplatelet medications after coronary stents. Researchers hope to show that reducing the time on two antiplatelet agents in patients at high risk for these bleeding complications will reduce the number of bleeding events while not causing any increase in cardiovascular complications (heart attack, stent malfunction, death).


Eligibility Criteria:
Inclusion Criteria:

* Informed consent in adults
* Successful percutaneous coronary intervention (PCI) \[no non-fatal myocardial infarction (MI)/stroke/repeat target revascularization/bleeding/acute kidney injury\].
* Academic research consortium-high bleeding risk (ARC-HBR) score ≥ 4.

Exclusion Criteria:

* Chronic use of warfarin or direct oral anticoagulant (DOAC).
* Unsuccessful PCI (see above).
* Lesions with angiographic thrombus.
* Prior PCI within 6 months.
* Planned PCI or surgical intervention to treat any cardiac or noncardiac condition within 6 months.
* High risk lesion/stent characteristics (\> 50% unprotected left main disease, bifurcation disease requiring 2 stents technique, rotational atherectomy.
* Vein graft.
* Unprotected left main intervention or history of definite stent thrombosis.
* Women of child-bearing age unless negative pregnancy test is done.
* Life expectancy \< 1 year.
* Known drug/alcohol dependence.
* Assessment that the patient will not be compliant with the study protocol.