cyrilzakka/clinical-trials huggingface dataset:
Low-dose CT-based Method for Detection of Subclinical Anthracycline-induced Cardiotoxicity

Prospective single arm study to evaluate a low-dose CT-based protocol for early detection of myocardial dysfunction in 50 cancer patients undergoing anthracycline-based chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. Ability to understand and the willingness to sign a written informed consent.
2. 18-75 year old patients with newly-diagnosed cancer scheduled to undergo anthracycline-based chemotherapy (minimum of 200 mg/m2 of doxorubicin or equivalent) at UCSD Medical Center.
3. Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

   • A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
   * Has not undergone a hysterectomy or bilateral oophorectomy; or
   * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
4. Women of child-bearing potential must have a negative pregnancy test during the screening period.

Exclusion Criteria:

1. Prior chemotherapy with anthracycline;
2. Persistent tachycardia (heart rate\>90);
3. LVEF\<53% or history of cardiomyopathy or decompensated heart failure;
4. Baseline GLS below lower limit of normal (normal range varies depending on age and gender (23)) or inability to obtain meaningful strain data due to poor quality of Echocardiographic images;
5. Known unrevascularized coronary artery disease, myocardial infarction within 30 days of enrollment;
6. Moderate or severe valvular heart disease;
7. Prior allergy or intolerance to iodinated contrast;
8. Renal failure (GFR\<30, creatinine \>1.5);
9. Cancer involvement of the heart.
Safety and Efficacy of Different Oral Doses of BAY94-8862 in Japanese Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Nephropathy (ARTS-DN Japan)

This study will be conducted in Japanese subjects with type 2 diabetes mellitus and the clinical diagnosis of Diabetic Nephropathy( DN) using a multi-center, randomized, adaptive, double-blind, placebo-controlled, parallel-group design.

Primary objective of the study is investigate the change of Urinary Albumin to Creatine Ratio (UACR) after treatment with different oral doses of BAY94-8862 given once daily from baseline to Visit 8 (Day 90)


Eligibility Criteria:
Inclusion Criteria:

* Japanese subjects with type 2 diabetes mellitus and a clinical diagnosis of DN (Diabetic Nephropathy) treated with at least the minimal recommended dose of an Angiotensin Converting Enzyme Inhibitor (ACEI) and/or Angiotensin Receptor Blocker (ARB)
* Subjects with a clinical diagnosis of Diabetic Nephropathy (DN) based on at least 1 of the following criteria:

  * Persistent very high albuminuria defined as Urinary Albumin to Creatine Ratio (UACR) of \>/=300 mg/g (\>/=34 mg/mmol) in 2 out of 3 first morning void samples and estimated glomerular filtration rate (eGFR) \>/=30 mL/min/1.73 m2 but \<90 mL/min/1.73 m2 Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) or
  * Persistent high albuminuria defined as UACR of \>/=30 mg/g but \<300 mg/g (\>/=3.4 mg/mmol but \<34 mg/mmol) in 2 out of 3 first morning void samples and eGFR\>/=30 mL/min/1.73 m2 but \<90 mL/min/1.73 m2 (CKD-EPI)
* Serum potassium \</=4.8 mmol/L at both the run-in visit and the screening visit

Exclusion Criteria:

* Non-diabetic renal disease (confirmed by biopsy)
* Known bilateral clinically relevant renal artery stenosis (\>75%)
* Glycated hemoglobin(HbA1c) \>12% at the run-in visit or the screening visit
* UACR \>3000 mg/g (339 mg/mmol) in any of the urinary first morning void samples at the run-in visit or screening visit
* Hypertension with mean sitting systolic blood pressure (SBP) \>/=180 mmHg or mean sitting diastolic blood pressure (DBP) \>/=110 mmHg at the run-in visit or mean sitting SBP \>/=160 mmHg or mean sitting DBP \>/=100 mmHg at the screening visit
* Subjects with a clinical diagnosis of heart failure with reduced ejection fraction (HFrEF) and persistent symptoms (New York Heart Association class II-IV) at the run-in visit
* Concomitant therapy with eplerenone, spironolactone, any renin inhibitor, or potassium-sparing diuretic
Individualized Deliberate Practice on a Virtual Reality Simulator

Training on simulated models in a surgical skills laboratory has been shown to improve technical performance in the operating room. Currently described simulation-based curricula consist of trainees practicing the same tasks until expert proficiency is reached. It has yet to be investigated whether individualized deliberate practice, where curricula tasks vary depending on prior levels of technical proficiency, would translate to the operating room.

This randomized controlled trial effectively demonstrates that deliberate practice on a virtual reality simulator results in an improvement in technical skills in a real clinical situation. This enhances the feasibility of implementing simulation-based curricula into residency training programs, and consequently has the potential to improve patient safety.


Eligibility Criteria:
Inclusion Criteria:

* post graduate year 1 and 2 surgical residents
* performed less than 10 laparoscopic cholecystectomies as the primary surgeon

Exclusion Criteria:

* n/a
Effect of Chinese Traditional Medicine for Post Revascularization Treatment of Coronary Artery Disease

The purpose of this study is to built the standard of Chinese Traditional Medicine test for Post percutaneous coronary artery intervention and coronary artery bypass graft，also for acute coronary syndrome，according to the multi-site、random large sample test.


Eligibility Criteria:
Inclusion Criteria:

* age40～75
* angina or CAD patient
* deficiency of heart-QI and blockage of phlegm and blood stasis in chinese medicine
* 1 week after operation，or 1week after drainage tube extraction for CABG
* sign a informed consent

Exclusion Criteria:

* severe cardia failure
* severe renal inadequacy
* complicating with malignant tumor,reactive alimentary tract hemorrhage and haematological systemic disorder etc.
* psychotic
* pregnant,lactation
The Relative Bioavailability Study of Two Ropinirole 0.25 mg Tablets Under Fed Conditions

The purpose of this study is to compare relative bioavailability of the test formulation of ropinirole hydrochloride 0.25 mg tablets (Manufactured and distributed by TEVA Pharmaceuticals USA) with the already approved formulation REQUIP® (ropinirole hydrochloride) 0.25 mg tablets (GlaxoSmithKline) under fed conditions in healthy, adult subjects.

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Eligibility Criteria:
Inclusion Criteria:

* Males and females, 18 to 45 years of age (inclusive), with a body mass index (BMI) of 19-30 kg/m² inclusive and weighing at least 120 lbs.
* Sitting (at least 5 minutes) blood pressure of at least 100/70 and sitting pulse of at least 60 b.p.m.
* Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.
* Signed and dated informed consent form, which meets all criteria of current FDA regulations.
* If female and of child bearing potential, subjects must be prepared to abstain from sexual intercourse or use a reliable barrier method of contraception (e.g. condom with spermicide, IUD) during the duration of the study. Female subjects who have used oral contraceptives within 14 days or injected or implanted hormonal contraceptives within 180 days of dosing will not be allowed to participate.

Exclusion Criteria:

* If female, pregnant, lactating, or likely to become pregnant during the study.
* History of allergy or sensitivity to ropinirole or other dopamine agonists (e.g. Corolpam®, Dostinex®, Mirapex®, Permax®, Symmetrel®) or history of any drug hypersensitivity or intolerance which, in the opinion of the investigator, would compromise the safety of the subject or the study.
* History of dizziness, lightheadedness or fainting upon standing.
* Significant history or current evidence of chronic infectious disease, system disorders, organ dysfunction, hyper/hypotension, arrhythmia, tachycardia, seizure disorder or glaucoma.
* Presence of gastrointestinal disease or history of malabsorption within the last year.
* History of psychiatric disorders occurring within the last two years that required hospitalization or medication.
* Presence of a medical condition requiring regular treatment with prescription drugs.
* Use of pharmacologic agents known to significantly induce or inhibit drug metabolizing enzymes within 30 days prior to dosing.
* Receipt of any drug as part of a research study within 30 days prior to dosing.
* Drug or alcohol addiction requiring treatment in the past 12 months.
* Donation or significant loss of whole blood (480 ml or more) within 30 days or plasma within 14 days prior to dosing.
* Positive test results for HIC, Hepatitis B surface antigen or Hepatitis C antibody.
* Positive test results for drugs of abuse at screening.
* Positive serum pregnancy test.
* Tobacco user within 90 days of the first study dose.
* Unable, or unwilling to tolerate multiple venipunctures.
* Difficulty fasting or eating the standard meals that will be provided.
Trabeculectomy With MMC and I Stent in Uveitic Glaucoma and POAG : Outcomes and Prognostic Factors

1. determine whether cataract surgery has a major effect on outcomes of trabeculectomy with MMC or not.
2. Success rates of trabeculectomy with MMC in Queen Elizabeth hospital.
3. recurrence rate of uveitis after glaucoma surgery

1. determine different success rates of trabeculectomy with MMC undergone in QE hospital, UK.
2. determine different complications and effect of cataract surgery on the outcome of glaucoma surgery

Eligibility Criteria:
Inclusion Criteria:

* Fesh trabeculectomy surgeries

Exclusion Criteria:

* recurrent surgeries
Efficacy of Quetiapine in Generalised Social Anxiety Disorder

This trial will explore the efficacy of quetiapine in Social Anxiety Disorder, generalized type. The following elements of response will be tested: number of responders to treatment, time to response, effect size as measured with the LSAS


Eligibility Criteria:
Inclusion Criteria:

* Written Confirmed Consent,
* All patients meet the DSM IV criteria for generalized social anxiety disorder,
* A score ≥ 60 on the LSAS,
* male and female aged between 18 and 65 years

Exclusion Criteria:

* Presence of any primary axis I diagnosis other than social anxiety disorder according to DSM-IV,
* alcohol and/or substance abuse according to DSM-IV criteria within the last 12 months,
* any personality disorder as the primary diagnosis, with the exception of avoidant personality disorder,
* patients at risk of suicide
To Evaluate the Immunogenicity and Safety of Sarilumab Administered as Monotherapy in Patients With Rheumatoid Arthritis (RA)

Primary Objective:

To evaluate the immunogenicity of sarilumab administered as monotherapy.

Secondary Objectives:

* To evaluate the other safety aspects of sarilumab administered as monotherapy.
* To assess the exposure of sarilumab administered as monotherapy.

Total study duration was up to 34 weeks: Up to 4-week screening period, 24-week open-label treatment phase, 6-week post-treatment observation. After completion of the treatment phase of this study, participants were eligible to enter a long term safety study (LTS11210 - SARIL-RA-EXTEND) for continuous treatment with sarilumab (SAR153191 \[REGN88\]).

Eligibility Criteria:
Inclusion criteria:

* Diagnosis of rheumatoid arthritis (RA) ≥ 3 months.
* Moderately to severely active rheumatoid arthritis.
* Participants who per investigator judgment were incomplete responders to at least 12 weeks of an adequate dose of continuous treatment with or who were intolerant of one or a combination of non-biologic disease modifying anti-rheumatic drugs (DMARDs).

Exclusion criteria:

* Participants \< 18 years of age.
* Past history of, or current, autoimmune or inflammatory systemic or localized joint disease(s) other than RA.
* History of juvenile idiopathic arthritis or arthritis onset prior to age 16.
* Severe active systemic RA, including but not limited to vasculitis, pulmonary fibrosis, and/or Felty's syndrome.
* Prior treatment with any biologic anti-interleukin 6 (IL-6) or IL-6 receptor (IL-6R) antagonist therapies.
* Treatment with prednisone \> 10 mg or equivalent per day, or change in dosage within 4 weeks prior to randomization.
* New treatment with or dose-adjustment of on-going nonsteroidal anti-inflammatory drug (NSAIDs) or cyclooxygenase-2 (COX-2) inhibitors within 4 weeks prior to randomization, except for the use of low-dose acetylsalicylic acid for cardiovascular diseases.
* Use of parenteral glucocorticoids or intra-articular glucocorticoids injection within 4 weeks prior to randomization.
* Prior treatment with a Janus kinase (JAK) inhibitor (tofacitinib).
* New treatment or dose-adjustment to on-going medication for dyslipidemia, such as statin, within 6 weeks prior to randomization.
* Participation in any clinical research study evaluating another investigational drug or therapy within 5 half-lives or 60 days of first dose of study drug administration, whichever is longer.
* Participants with a history of malignancy other than adequately-treated carcinoma in-situ of the cervix, non-metastatic squamous cell or basal cell carcinoma of the skin, within 5 years prior to the randomization visit. Non-malignant lymphoproliferative disorders are also excluded.
* Participants with active tuberculosis or untreated latent tuberculosis infection.
* Pregnant or breast feeding women.

The above information is not intended to contain all considerations relevant to a Participant's potential participation in a clinical trial.
The Analysis of Factors Causing Indwelling Urinary Catheter-related Infections in ICU Patients and Their Nursing Strategies

To explore the analysis of factors causing indwelling urinary catheter-related infections in ICU patients and their nursing strategies, and to provide reference for clinical nursing work. 291 patients with indwelling urinary catheters in the second area of ICU of our hospital from January 1, 2023 to September 30, 2023 were selected as research subjects. They were divided into infection group and non-infection group according to the presence or absence of urinary tract infection. Non-infection group The first group consisted of patients without urinary tract infection (278 cases), and the infection group consisted of patients with urinary tract infection (13 cases). A retrospective analysis method was used to analyze the causes of catheter-related urinary tract infection and the infecting bacteria of the two groups of patients. A single factor analysis was performed on various factors and other related factors, and corresponding nursing strategies were summarized and proposed.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 14 years
* Patients with indwelling urinary tube during hospitalization
* Length of stay in ICU \> 48h
* Complete hospitalization data

Exclusion Criteria:

* Had urinary tract infection before hospitalization
* Indwelling catheter \< 72h
* Severe liver and kidney failure and death within 48 hours of admission
Study to Improve Outcomes in Aortic Stenosis

Multi-centre, multi-national, observational, prospective registry in four central full access centres in Germany (2), France (1) and the United Kingdom (1) and up to two satellites per hub (smaller hospitals / office based cardiologists (OBC) without access to surgical and percutaneous aortic valve (AV) interventions).

The hypothesis is that the management of patients with severe AS will differ between sites with on-site access to all treatment modes and those without such facilities.

Data from existing studies indicate that the treatment pathways for patients with severe aortic stenosis with or without symptoms are insufficiently defined. This lack of definition can contribute both to delay in treatment and inappropriate treatment decisions. While this has been confirmed in hospitals with a full complement of treatment modalities for severe aortic stenosis, including surgery and percutaneous options, it is not known whether delay in treatment or appropriateness of treatment decisions are better or worse in smaller hospitals without equivalent on-site access.

The aim of this study is to delineate the case load of patients with aortic stenosis, outline the management of these patients and determine appropriateness in participating centres with and without on-site access to surgery and percutaneous treatment.

Eligibility Criteria:
Inclusion Criteria:

* age over 18 years
* identified on echocardiography with severe aortic stenosis, defined as at least one of:
* aortic valve area \< 1 cm2
* indexed valve area \< 0.6 cm2/m2
* maximum jet velocity \> 4.0 m/sec
* mean transvalvular gradient \> 40 mmHg

Exclusion Criteria:

* non-severe aortic stenosis
* previous aortic valve repair
The Effect of Portion Sizes on Mood

The purpose of this study is to investigate whether different portion sizes will effect overall mood.

The objective of this investigation is to determine whether participants will have a change in mood based on the portion size of foods served. The specific aims of the study are:

1. Determine the effect of increasing portion sizes on mood.
2. Determine the effect of decreasing portion sizes on mood.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-35
* have a body mass index of 18.5 and 24.9 kg/m\^2
* be an unrestrained eater( scoring less than 12 on the Three Factor Eating Questionnaire)
* Report Being a non-smoker

Exclusion Criteria:

* currently pregnant or nursing
* report being an athlete in training
* currently taking any medications that affect appetite or food intake
* Have a medical condition affecting eating or are currently following a therapeutic diet
* Report disliking foods used in the investigation
* Report having allergies to foods used in the investigation
Micronet Covered Stent in in Arterial Locations Beyond the Carotid Bifurcation - FLOW-Guard Study

Prospective observational study of MicroNet covered stent implantation in the elevated risk peripheral lesions (high lesion load, thrombus containing, highly calcified).

Open-label, non randomized, single arm observational study. Jagiellonian University Medical College research project.

Peripheral artery stents in routine use (both balloon expandable and self-expendable) do not sufficiently prevent distal embolization. They might induce a "cheese-grater" effect - a consequence of their single layer design with uncovered space between stent struts.

Aim of the study is to evaluate short and long term safety and efficacy of MicroNet covered stent implantation in the high risk lesions beyond the carotid bifurcation. Treatment eligibility will be evaluated by a Vascular Team process (angiologist, vascular surgeon, cardiologist). Optimal pharmacotherapy will be administered according to the current guidelines.

Symptomatic and asymptomatic patients with peripheral artery disease requiring endovascular treatment for high risk stenosis (soft plaque, highly calcific plaque) per Vascular Team assessment.

A group of 30-50 consecutive patients meeting inclusion and exclusion criteria will be enrolled.

Eligibility Criteria:
General

Inclusion Criteria:

* Patients older than 18 years, eligible for peripheral artery stenting after Vascular Team evaluation, according to local standards
* Written, informed consent to participate
* Agreement to attend protocol required (standard) follow up visits and examinations

Exclusion Criteria:

* Life expectancy \<1 year (e.g. active neoplastic disease).
* Chronic kidney disease with creatinine \> 3.0 mg/dL.
* Myocardial infarction in 72 hours proceeding the stenting procedure (if possible, postponing the procedure)
* Pregnancy (positive pregnancy test)
* Coagulopathy.
* History of uncontrolled contrast media intolerance

Angiographic

Inclusion Criteria:

* De novo lesion in major arteries or grafts connecting arteries
* Stenosis eligible for endovascular treatment per Vascular Team evaluation (according to current standards and guidelines)
* High risk morphology stenosis (per 2 independent, experienced operators)

Exclusion Criteria:

* Chronic total occlusion not amenable to re-canalization
* Stent in the target vessel/lesion
* Anatomic variants precluding stent implantation
* Mobile (free-floating) plaque elements in aorta or arteries proximal to target lesion
CLDN18.2 Targeting PET Imaging in Patients With Gastrointestinal Tumors

The objective of the study is to constrcut a noninvasive approach 124I-18B10(10L) PET/CT to detect the CLDN18.2 expression of tumor lesions in patients with gastrointestinal tumors and to identify patients benefiting from CLDN18.2 targeting treatment.


Eligibility Criteria:
Inclusion Criteria:

* 1. Aged \>18 years old; ECOG 0 or 1;
* 2. Patients with Gastrointestinal tumors;
* 3. Has at least one measurable target lesion according to Response Evaluation Criteria in Solid Tumors (RECIST V1.1);
* 4. life expectancy \>=12 weeks.

Exclusion Criteria:

* 1. Significant hepatic or renal dysfunction;
* 2. Is pregnant or ready to pregnant;
* 3. Cannot keep their states for half an hour;
* 4. Refusal to join the clinical study;
* 5. Suffering from claustrophobia or other mental diseases;
* 6. Any other situation that researchers think it is not suitable to participate in the experiment.
Evaluation of Immunogenicity, Reactogenicity and Safety of HBV-MPL Vaccine vs Engerix™-B, in Haemodialysis Patients

This trial is designed to evaluate the immunogenicity, reactogenicity and safety of an MPL-adjuvanted recombinant hepatitis B vaccine in comparison with those of Engerix™-B in haemodialysis patients with or without previous vaccination against hepatitis B

At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham

Eligibility Criteria:
Inclusion Criteria:

* Dialysis patients
* A medical examination including physical examination and medical history as well as serological screening established acceptability for enrollment into the study.
* Age: from 18 years onwards
* Seronegative for anti- hepatitis antibodies

Exclusion Criteria:

* History of persistent hepatic, cardiac or respiratory disease
* Any acute disease at the moment of entry into the study
* Chronic alcohol consumption
* Hepatomegaly, right upper quadrant pain or tenderness
* Any treatment with coticosteroids or immunomodulating drugs
* Known hypersensitivity to any component of the vaccine
* Simultaneous participation in any other clinical trial