cyrilzakka/clinical-trials huggingface dataset:
Clinical and Economic Burden of Bleeding Events in Patients in the UK With Non-valvular Atrial Fibrillation Treated With Vitamin k Antagonists

The purpose of the study is to estimate the impact of bleeding events in patients in the UK with non-valvular atrial fibrillation (NVAF) treated with vitamin K antagonists (VKA).


Eligibility Criteria:
Inclusion Criteria:-

For the CPRD-HES cohort, patients will be included if they meet these criteria:

* Have CPRD data linked to HES
* Have an AF diagnosis (based on Read codes from CPRD or ICD-10 codes from HES) and have been treated with VKA during the study period

  -≥18 years old at index date
* CPRD acceptability quality criteria are present.

For the CPRD cohort, patients will be included if they meet the following criteria:

* Have an Atrial Fibrillation (AF) diagnosis (based on Read codes from CPRD) and have been treated with VKAs during the study period
* ≥18 years old at index date
* CPRD acceptability quality criteria are present.

Exclusion Criteria:

For the two cohorts of interest, patients will be excluded if they meet the following criteria:

* Fewer than 12 months of computerised data available prior to the index date (in order to provide a minimum amount of computerised history and to avoid issues associated with updating records when a patient joins a practice). The date of start of computerized records will be the latter of the patient's date of registration with the practice or the practice's Up-to-Standard (UTS) date (when the practice is deemed to be contributing data of adequate quality)
* The practice is not UTS, or the patient is deemed "unacceptable" according to CPRD's quality criteria
* There is evidence of valvular disease, repair, or replacement before (ie, up to 12 months prior to the index date) or during the study period
* There are records of Novel anticoagulant (NOAC)
Measuring Analgesic Interventions

It is generally recognized that pain assessment and management especially in newborns, children and other nonverbal populations is an unmet need. According to the American Medical Association, "the pediatric population is at risk of inadequate pain management, with age-related factors affecting pain management in children. Children are often given minimal or no analgesia for procedures that would routinely be treated aggressively in adults. Although much is now known about pain management in children, it has not been widely or effectively translated into routine clinical practice". These two factors combine to emphasize the necessity for an objective tool to quantify pain and monitor the effectiveness of analgesia, especially during treatments. Further, it is reported that many patients require a combination of treatments, and it is often necessary to test a variety of treatments before the personal match for treatment is found. The method in place to change the care on a subjective basis is difficult, time consuming, and not easily individualized. This pilot study is part of an ongoing effort to develop a method to objectively assess response to specific analgesic interventions. It specifically aims to discern the impact of analgesic interventions on sensory nerve fiber sensitivity in a diverse patient population.


Eligibility Criteria:
Inclusion Criteria:

1. The subject is 7 to 21 years of age
2. The subject is receiving an analgesic intervention in the Children's National Medical Center Pain Clinic
3. The subject is willing and able to provide written informed assent/parental consent to the study participation.

Exclusion Criteria:

1. Eye pathology precluding pupillometry
2. Patients who are actively using opioids (history of use acceptable). Rationale: opioids constrict the pupil, and therefore concomitant opioid use would bias our results.
3. Subjects who are or may be pregnant
Evaluation of C13 Breath Test for Upper Gastrointestinal Bleeding in Patients Who Need Double Antiplatelet After PCI

Hp infection is closely related to upper gastrointestinal bleeding in patients who need dual-antiplatelet after PCI. Taking anti-Hp treatment has the effect of reducing bleeding risk. Thus, we propose a scientific hypothesis: the C13 breath test may be used to assess the risk of upper gastrointestinal bleeding in patients who need dual- antiplatelet after PCI.

Our study is to retrospectively analyze the clinical data of 1606 patients of acute myocardial infarction who need dual- antiplatelet after PCI.The diagnostic criteria for upper gastrointestinal bleeding is: 1.symptoms: digestive discomfort, such as abdominal pain, nausea, belching, acid reflux, etc.;2.mainly based on endoscopy examination, endoscopic examination showed that the stomach or duodenum showed spotted, linear or diffuse bleeding;3.the fecal examination:melena, tar-like stool, hematemesis, fecal occult blood, etc.The study was divided into two groups according to whether the C13 breath test was performed, and the C13 breath test component was the positive anti-HP treatment group and the non-anti-HP treatment group.And then compare the upper gastrointestinal bleeding rates of the above groups.

Eligibility Criteria:
Inclusion Criteria:

* The diagnosis of patients with coronary heart disease is based on the diagnostic criteria of ACA/AHA,the diagnostic criteria for upper gastrointestinal bleeding refer to the guidelines for the diagnosis and treatment of acute non-variceal upper gastrointestinal bleeding.
* In the hospital, all patientsI were treated with clopidogrel 300 mg or ticagrelor 180 mg before surgery, and C13 breath test was performed after surgery.
* All patients were treated with dual- antiplatelet.
* The clinical data of the included subjects were complete.

Exclusion Criteria:

* Patients with previous liver and kidney disease, Cr greater than 150 μmol / L, AST or ALT increased more than 2 times the normal value of patients.
* Patient with history of cerebrovascular disease.
* Patients with active gastrointestinal bleeding disease due to cirrhosis or other reasons before PCI.
* Patients with abnormal coagulation.
* Diabetic patients, diagnostic criteria for anemia: 8th edition of internal medicine, adult males with Hb less than 120g / L or RBC less than 4 × 10\^12 / L, adult women with Hb less than 105g / L or RBC than 3.5 × 10\^12 / L.
* Patients with incomplete medical records;7.Patient with pregnant.
* Patients with malignant tumors
Evaluation of the Long Term Follow up of the Efficacy of OC-01 Nasal Spray on Signs and Symptoms of Dry Eye Disease

The objective of this safety long-term follow-up study was to evaluate the safety of OC-01 Nasal Spray at 6 months and 12 months post treatment in the OPP-002 study (NCT03636061).

Study OPP-002-01 was a long-term follow-up study of those subjects who had previously participated in the OPP-002 study (NCT03636061). The OPP-002 study is a Phase 2, multicenter, randomized, double-masked, placebo-controlled study designed to evaluate the safety and efficacy of OC-01 nasal spray in adult participants with dry eye disease.

The first scheduled visit occurs 6 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study. The second scheduled visit occurs 12 months after the first treatment of OC-01 nasal spray/placebo in the OPP-002 study.

Eligibility Criteria:
Inclusion Criteria:

1. Have been enrolled in the OPP-002 study
2. Have received at least one dose of the study drug/placebo in OPP-002 study
3. Completed the OPP-002 study to Visit 5
4. Have provided verbal and written informed consent

Exclusion Criteria:

1. Have discontinued prior to Visit 5 in the OPP-002 study.
Infection Control for Severe Acute Respiratory Syndrome Coronavirus 2

The investigators aim to develop expert consensus statements on infection control management of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in intensive care units (ICU).

The COVID-19 pandemic has resulted in a considerable change in the infection control protocols in the hospitals, especially ICU. The ICU management of these patients requires robust infection control measures in order to prevent cross-transmission of SARS-CoV-2 (to healthcare workers (HCWs) and other patients) and hospital acquired bacterial or fungal infections. The understanding of epidemiological characteristics of SARS-CoV-2 and pathophysiology of coronavirus disease 2019 (COVID-19) along with evidence on transmission of SARS-COV-2 in controlled healthcare-setting is still evolving. The mode of transmission of SARS-CoV-2 is airborne, through droplets or fomites. Respiratory interventions performed in these patients in ICU, such as non-invasive ventilation, high flow nasal oxygen or tracheal intubation are considered to be aerosol generating procedures and may lead to airborne transmission of SARS-CoV-2. In the absence of the robust evidence, there are no specific recommendations available on infection control of SARS-CoV-2 in ICU.

The objective of this study is to achieve consensus statements on the infection control management of SARS-CoV-2 in ICU.

The whole process of this study will be done in the form of three-four rounds of Google Forms-based Delphi surveys. The survey questionnaire, will be prepared by the investigators after systematic search of available literature and concern areas in the infection control of SARS-CoV-2 in ICU. The objective is to achieve consensus statements on the infection control management of SARS-CoV-2 in ICU.

The survey questionnaire is divided into five sections: 1.Design and engineering 2.Health-care workers and visitors 3. Personal protective equipment 4. Patient and procedures 5. Disinfection and sterilisation.

The majority of these questionnaire statements are to be rated on Likert scale and others have multiple choices. The participating experts comments and feedback will be collected through comment section after each question in round one. All the subsequent surveys will be iterative and the experts can give their opinion in each round using either open text or directly to steering group of investigators.

Eligibility Criteria:
Inclusion criteria for participants Health care professionals involved in the management of COVID-19 patients with publications and expertise in infectious disease, infection control, sepsis, respiratory failure or public health.

Exclusion Criteria:

* Those who do not accept the invitation or not meeting any of the inclusion criteria.
Preliminary Clinical Study on the Effect of L-ornithine on the Efficacy of Ustekinumab in Patients With Crohn's Disease

The goal of this clinical trial is to evaluate the effect of supplementing L-ornithine compared to the control group on the efficacy of Ustekinumab in patients with Crohn's disease, and to summarize the role of supplementing L-ornithine in the treatment of CD patients.

Participants will be randomized into two groups: the L-ornithine supplementation group and the control group. The patients in the L-ornithine supplementation group received oral ornithine capsules for 8 weeks. The control group did not receive additional intervention. Follow up once a week, and after the study, patients will come to the hospital to finish the evaluation indicators.

The goal of this clinical trial is to evaluate the effect of supplementing L-ornithine compared to the control group on the efficacy of Ustekinumab in patients with Crohn's disease, and to summarize the role of supplementing L-ornithine in the treatment of CD patients.

Participants will be randomized into two groups: the L-ornithine supplementation group and the control group. Patients in the L-ornithine supplementation group take oral ornithine capsules twice a day, three capsules per time, for 8 weeks, each containing 500mg of L-ornithine. The control group did not receive additional intervention. Follow up once a week, and after the study, patients will come to the hospital to finish the evaluation indicators.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old, ≤ 75 years old;
2. Patients clinically diagnosed with Crohn's disease shall refer to the Chinese Guidelines for the Diagnosis and Treatment of Crohn's Disease (Guangzhou, 2023) for diagnostic criteria;
3. Patients receiving treatment with Ustekinumab;
4. Agree to participate in this study and sign an informed consent form.

Exclusion Criteria:

Participants who meet any of the following criteria are not eligible for inclusion in this study.

1. Patients with ALT or AST exceeding the normal upper limit by more than twice, and TBIL exceeding the normal upper limit by more than twice;
2. Patients with creatinine clearance rate less than 60ml/min;
3. Patients with severe active infections in the intestines or other areas that require the use of antibiotics or antiviral drugs;
4. Patients with intestinal tuberculosis, other chronic intestinal infectious diseases, and intestinal malignant tumors;
5. Pregnant and lactating women;
6. The fasting blood glucose of patients with diabetes or screening period exceeds 7.0mmol/L or glycosylated hemoglobin exceeds 6.5%;
7. Merge patients with severe mental illness, drug use, alcohol abuse, etc. who are unable to cooperate with the study;
8. Have participated in any other clinical research within the first month prior to enrollment;
9. The researcher determined that any other disease or condition is not suitable for patients participating in this study.
A Study of LY3295668 Erbumine in Participants With Breast Cancer That Has Spread to Other Parts of the Body

The reason for this study is to determine the recommended phase 2 dose of the study drug LY3295668 erbumine in participants with breast cancer that has spread to other parts of the body.


Eligibility Criteria:
Inclusion Criteria:

* Participant must have hormone receptor positive and HER2 negative metastatic breast cancer
* Participant must have progressed on at least 1 line of endocrine therapy and 1 cyclin dependent kinase (CDK)4/6 inhibitor
* Participant must be able and willing to undergo mandatory tumor biopsy
* Participant must have normal organ function
* Participant must be able to swallow capsules

Exclusion Criteria:

* Participant must not have had prior chemotherapy for mBC. Chemotherapy in the adjuvant/neoadjuvant setting is permitted
* Participant must not be currently enrolled in a clinical study
* Participant must not have another serious medical condition
* Participant must not have previously received an aurora kinase inhibitor
Study to Assess the Safety and Efficacy of BOL-303242-X Ophthalmic Suspension in Dry Eye Syndrome

The objective of this study is to identify the concentration and daily dosing frequency of BOL-303242-X ophthalmic suspension in treating dry eye syndrome over a 12 week dosing period.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have a diagnosis of dry eye disease.
* Intraocular pressure (IOP) ≤28 mmHg with no IOP lowering medications.
* Subjects who are willing and able to refrain from using contact lenses during the study.

Exclusion Criteria:

* Subjects with known hypersensitivity or contraindication to any component of the study medication.
* Subjects who are expected to require concurrent treatment with ophthalmic medications (prescription or over the counter).
* Subjects who are expected to require treatment with corticosteroids during the study.
* Subjects who have used topical or systemic isotretinoin, cyclosporine, or retinoid therapies within 30 days prior to the screening visit.
* Subjects who have undergone any type of ocular surgery within three months prior to screening.
* Lacrimal punctal occlusion (plugs or cautery) within 2 months of Screening Visit.
* Subjects with a history or presence of chronic generalized systemic or ocular disease that the Investigator feels might increase the risk to the subject or confound the result of the study.
Impact of Bariatric Surgery on Women Fertility

Obesity is a multifactorial risk factor for subfertility, in relation to chronic hormonal change induced by adipose tissue. This prospective cohort study aims to evaluate the impact of bariatric surgery induced weight loss on women fertility.

Females undergoing sleeve gastrectomy will be assessed for improvement of fertility indicators

Eligibility Criteria:
Inclusion Criteria:

* Age from 20-40 years.
* BMI \>35 kg/m2

Exclusion Criteria:

* Women with medical endocrinal disorders as DM, thyroid, hyperprolactinaemia, etc.
* Women using any hormonal treatment or fertility drugs like oral contraceptive pills and/or metformin.
* Women have any surgical complication intra-operatively or post operatively.
* Women refused to participate in the study.
Effects of Nateglinide on Postprandial Glucose Excursion by Restoring Early Phase Insulin Secretion

A 3-week, multi-center, open-label, randomized, active-control, parallel-group study to compare effects of Nateglinide and Acarbose on postprandial glucose fluctuation in Chinese drug-naive patients type 2 diabetes mellitus (T2DM). In this study, participants in different groups took Nateglinide at a dose of 120 mg orally three times daily for up to 3 weeks or Acarbose at a dose of 50 mg three times daily for up to 3 weeks, respectively.


Eligibility Criteria:
Inclusion criteria

1. Patients must give written informed consent before any assessment is performed.
2. Male, non-fertile female or female of childbearing potential using a medically approved birth control method based on local regulations.
3. Drug naïve type 2 diabetes patients, defined as who neither take consecutive anti-hyperglycemic drug treatment more than 3 months anytime, nor any anti-hyperglycemic drug treatment in 4 weeks prior to visit 1.
4. Age in the range of 18-75 years inclusive.
5. HbA1c in the range of \> 6.5 to ≤9.0% at Visit 1.

Exclusion criteria

1. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (\>5 mIU/mL).
2. With known hypersensitivity to Nateglinide, Acarbose or any of the excipients.
3. A history of,

   1. type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g., Cushing's syndrome and acromegaly.
   2. acute metabolic diabetic complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months.
   3. Torsades de pointes, sustained and clinically relevant ventricular tachycardia or ventricular fibrillation.
   4. percutaneous coronary intervention within the past 3 months.
   5. any of the following within the past 6 months: myocardial infarction (MI), coronary artery bypass surgery, unstable angina, or stroke.
4. Evidence of significant diabetic complications, e.g., symptomatic autonomic neuropathy or gastroparesis.
5. Acute infections which may affect blood glucose control within 4 weeks prior to visit 1.
6. Congestive heart failure requiring pharmacologic treatment. mg/dL (123μmol/L)
Combination Study Of S-555739/Cetirizine HCl In Adult Patients With Seasonal Allergic Rhinitis

The primary objective of the study was to examine the efficacy and safety of S-555739/cetirizine HCl compared with the individual components and placebo.


Eligibility Criteria:
Inclusion Criteria:

* History and diagnosis of seasonal allergic rhinitis by skin prick test
* Have nasal symptom scores as defined by the study protocol
* Able to comply with study procedures

Exclusion Criteria:

* Any nasal disease or abnormality, active respiratory tract infections within the past 2 weeks, or recent nasal surgery or sinus surgery at Screening
* Use of any prohibited concomitant drugs or therapies
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of RO7079901 and the Combination of RO7079901 With Meropenem in Adult Healthy Volunteers

This is a randomized, double-blind, placebo-controlled, multiple-ascending dose (MAD) study that will evaluate the safety, tolerability and pharmacokinetics (PK) of RO7079901 and the combination of RO7079901 with meropenem in healthy volunteers. The study will consist of three parts (Part I, II, and III). At each dose level/cohort, a total of 8 healthy volunteers will be randomized to receive active study drug or placebo in a 3:1 ratio.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or healthy female of non-childbearing-potential
* A Body Mass Index (BMI) between 18.0 and 30.0 kilograms per square meter (kg/m\^2) (inclusive) and a body weight of at least 45 kilograms (kg) at screening
* Negative urine drug and alcohol screen (barbiturates, benzodiazepines, methadone, amphetamines, methamphetamines, opiates, cocaine, cannabinoids, cotinine, and alcohol)
* Non-smokers, or former smokers, who have not smoked for at least 60 days prior to screening

Exclusion Criteria:

* Known history of any significant hypersensitivity or severe allergic reaction to any beta-lactam antibiotics (e.g., cephalosporins, penicillins, carbapenems, or monobactams)
* History of any severe antibiotic-associated superinfections like Clostridium difficile colitis and/or frequent fungal vaginal infections
* Concurrent or history of clinically significant cardiovascular, hepatic, renal, endocrine, gastrointestinal, respiratory, psychiatric, neurologic, and/or hematological disorders
* A history or presence of malignancy (with the exception of successfully treated basal cell carcinoma); seizures, brain lesions or other significant neurological diseases
* Donation of blood (or loss of blood) greater than 500 milliliters (mL) within three months before screening
* History of Gilbert syndrome
* Any clinically significant concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the healthy volunteer in this study
* Positive test at screening of any of the following: Hepatitis A Virus Immunoglobulin M Antibody (HAV IgM Ab), Hepatitis B Surface Antigen (HBsAg), Hepatitis C Virus Ribonucleic Acid or Hepatitis C Virus Antibody (HCV RNA or HCVAb), or Human Immunodeficiency Virus Antibody (HIV Ab)
Long-term Benefit of Aortic Stent-graft in Patients With Distal Aortic Dissection

Background: Aortic stent-graft is useful to occlude intimal tear and prevent further dilatation of the false lumen in patients with aortic dissection. The long-term benefit of aortic stent-graft in patients with uncomplicated distal aortic dissection has not been well demonstrated, especially in patients at high risk of aneurysmal change and death.

Purpose: The purpose of the study is to evaluate long-term clinical benefit of stent-graft insertion performed just after the acute phase into the descending thoracic aorta in patients with distal aortic dissection and at high risk of aneurysmal change of the dissected aorta.


Eligibility Criteria:
Inclusion Criteria:

* Uncomplicated distal aortic dissection
* Initial false lumen diameter \>= 22 mm

Exclusion Criteria:

* Old age (\> 75 years old)
* Other comorbidity or malignancy with life expectancy \< 5 years
* Complicated dissection requiring aortic surgery or intervention
* Sudden death in acute phase
* Marfan syndrome