cyrilzakka/clinical-trials huggingface dataset:
A Trial Investigating the Efficacy and Safety of Insulin Detemir Versus Insulin NPH in Combination With Metformin and Diet/Exercise in Children and Adolescents With Type 2 Diabetes Insufficiently Controlled on Metformin With or Without Other Oral Antidiabetic Drug(s) With or Without Basal Insulin

This trial is conducted globally. The aim of the trial is to investigate the efficacy and safety of insulin detemir versus insulin Neutral Protamine Hagedorn (NPH) in combination with the maximum tolerated dose of metformin and diet/exercise on glycaemic control in children and adolescents with type 2 diabetes insufficiently controlled on the maximum tolerated dose of metformin with or without other oral antidiabetic drug(s) with or without basal insulin.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent from the subject or a legally acceptable representative (LAR) and child assent from the subject obtained before any trial-related activities.Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
* Male or female, above or equal to 10 years and below or equal to 17 years at the time of signing informed consent/assent
* Diagnosis of type 2 diabetes mellitus at least 3 months prior to screening
* Treated with the maximum tolerated stable dose of metformin for at least 3 months prior to screening or have documented complete metformin intolerance
* HbA1c (glycosylated haemoglobin) above or equal to 7.0% and below or equal to 10.5% (above or equal to 53 mmol/mol and below or equal to 91 mmol/mol) at screening

Exclusion Criteria:

* Maturity onset diabetes of the young (MODY)
* Fasting C-peptide at screening below 0.6 ng/mL
* Impaired liver function defined as alanine aminotransferase (ALT) above or equal to 2.5 times upper normal limit
* Known proliferative retinopathy or maculopathy requiring acute treatment as judged by the investigator
* Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 3 months before the day of screening
A Study of Apalutamide in Participants With Severe Hepatic Impairment Compared With Participants With Normal Hepatic Function

The purpose of this study is to characterize the single-dose pharmacokinetic (PK) of apalutamide in participants with severe hepatic impairment relative to participants with normal hepatic function.


Eligibility Criteria:
Inclusion Criteria:

* Participants must not have hepatic encephalopathy greater than or equal to (\>=) Grade 3 (for participants with severe hepatic impairment) where the participant lacks the capacity to provide informed consent as judged by the investigator. Mild or moderate hepatic encephalopathy that would not impede informed consent in the investigator's judgment is permitted
* Participants with normal hepatic function must be in good health with no clinically significant findings from medical history, physical examination, vital signs, and laboratory evaluation, unless deemed not clinically significant by the investigator
* Participants with normal hepatic function must have serum creatinine within normal limits and Creatinine Clearance (CrCL) greater than (\>) 60 milliliter per minute per 1.73 meter square (mL/min/1.73 m\^2) as calculated per Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine Equation
* Participants with severe hepatic impairment must have a total Child-Pugh score of 10 to 15 inclusive, as determined by the investigator during screening and on Day -1 prior to study drug administration. Source documents to substantiate the clinical diagnosis (for example, ultrasonography, liver biopsy, liver/spleen scan, laboratory results or clinical findings), and medical history will be reviewed and signed by the investigator
* Participants with severe hepatic impairment must have CrCL \>= 45 mL/min/1.73 m\^2 as calculated per CKD-EPI Creatinine Equation

Exclusion Criteria:

* Use of thyroid hormone replacement therapy
* Participants with normal hepatic function with presence of sexual dysfunction (abnormal libido, erectile dysfunction, etc.) or any medical condition that would affect sexual function
* Participants with normal hepatic function who have Hepatitis A immunoglobulin M positivity, Hepatitis B surface antigen (HBsAg) positivity, positive serology for Hepatitis B or Hepatitis C antibodies. Hepatitis B surface antibody positivity is not exclusionary if participant can provide evidence of Hepatitis B vaccination
* Participants with severe hepatic impairment who have acute or exacerbating hepatitis, fluctuating or rapidly deteriorating hepatic function as indicated by widely varying or worsening of clinical and/or laboratory signs of hepatic impairment in the judgment of either the investigator or the sponsor's medical monitor
* Participants with severe hepatic impairment previously diagnosed with hepatocellular carcinoma
Interferon Alpha Lozenges Plus Oseltamivir for Influenza Treatment

This study aims to evaluate the safety and effect of interferon-alpha lozenges when used in combination with oseltamivir (Tamiflu) to treat influenza.


Eligibility Criteria:
Inclusion Criteria:

* fever \>=38C
* one or more respiratory symptoms (e.g. cough, rhinorrhea or sore throat) plus one or more constitutional symptoms (e.g. chills, headache, malaise and myalgias)of \< 48 hours' duration
* body weight \> 40 kg
* positive for influenza A (nasal swab rapid test)

Exclusion Criteria:

* pregnancy/lactation
* history of depression or psychiatric disorders
* history of conditions that could complicate flu infection, such as chronic pulmonary, cardiac, renal, or metabolic disorders
* use of immunosuppressive therapy
* HIV infection
A Study to Assess the Anti-viral Activity, Safety, Tolerability and Pharmacokinetics of TMC435350 in Participants Infected With Hepatitis C-Virus (HCV)

The purpose of this study is to assess anti-viral activity (inhibition of viral growth) of TMC435350 in genotype 2,3,4,5 and 6 hepatitis C virus infected participants who have never received treatment for their hepatitis C infection.

This is an open-label (all people know the identity of the intervention) study to assess the antiviral activity, safety, tolerability and pharmacokinetics (explores what the body does to the medication) of TMC435350 hereafter referred to as TMC435. Approximately 40 participants will be divided in 5 groups as per the genotype (8 participants each group). The study will include a screening phase (up to 6 weeks), treatment phase (7 days) and a follow-up phase (30-35 days after the last dose of study medication). Safety evaluations will include assessment of adverse events, clinical laboratory tests and cardiovascular safety.

Eligibility Criteria:
Inclusion Criteria:

* Participants with documented chronic genotype 2, 3, 4, 5 or 6 hepatitis C virus (HCV) infection
* Participants who have never received treatment for their HCV infection
* Participants with either no cirrhosis or up to Child Pugh A liver disease
* Participants with plasma HCV genotype level of more than or equal to 100, 000 IU/mL at screening

Exclusion Criteria:

* Evidence of Child Pugh B or C liver disease at screening, decompensated liver disease defined as prior or current history of ascities, hepatic encephalopathy, esophageal or gastric varices
* Participants with diagnosed or suspected hepatocellular carcinoma
* Participants coinfected with human immunodeficiency virus type 1 or 2, or hepatitis A or B virus infection or active tuberculosis at screening
* Participants with any active clinically significant disease, or medical history or physical examination or electrocardiogram findings during screening
Investigating the Effects of Different Incision Types on Aesthetic Outcomes and Incision-related Complications After Breast Reconstruction Surgery

1. DATA COLLECTION: About 300 cases of female patients who underwent breast reconstruction at Hubei Cancer Hospital(HBCH) between February 2013 and June 2023 were retrospectively collected. The incision was defined as the mastectomy incision and was grouped by the commonly used inframammary fold incision, lateral chest wall incision, circumareolar incision, and radial incision. The incidence of postoperative incision-related complications was recorded for different incision types;
2. DATA ORGANIZATION: Patients were divided into subgroups based on history of previous breast surgery, location and size of the lump, retention of the nipple-areola complex, timing of reconstruction, and type of the implant. The correlation of each subgroup with incision design is discussed;
3. FOLLOW-UP: Collected cases were followed up by telephone to complete the Breast-Q questionnaire (aesthetic score);
4. DATA ANALYSIS: The incidence of postoperative incision-related complications and aesthetic scores for different incision types were statistically analyzed.


Eligibility Criteria:
Inclusion Criteria:

1. total mastectomy
2. implant and/or autologous breast reconstruction.

Exclusion Criteria:

1. No total mastectomy
2. loss of data or loss of follow-up
3. fatal cases
Penetration of Cefazolin Into Hepatic Cysts

Hepatic cysts are fluid-filled cavities located in the liver parenchyma. They are usually asymptomatic, but can cause mass-related symptoms as abdominal pain, dyspnea and nausea. Aspiration sclerotherapy is indicated in patients with a dominant hepatic cyst to alleviate symptoms by draining the hepatic cyst to reduce cyst diameter. Spontaneous cyst infection, or following aspiration sclerotherapy, presents a severe complication of hepatic cystic disease requiring frequent hospitalization, long-term antibiotic treatment, and in some invasive therapies. Evidence that antibiotics are able to reach adequate intracystic concentration is however lacking. To prevent procedure-related cyst infection in patients receiving aspiration sclerotherapy, cefazolin prophylaxis is given as standard of care. In this study we want to assess the hepatic cyst penetration capacity of cefazolin by comparing serum and cyst fluid concentrations of cefazolin. We hypothesize that cefazolin is able to penetrate hepatic cysts, with treatment naïve cyst allowing a better penetration, reducing the risk of developing cyst infection following aspiration sclerotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Indication for aspiration and sclerotherapy
* Providing informed consent

Exclusion Criteria:

* Presence of an arteriovenous fistula, history of mastectomy or lymph node dissection at both extremities
* Signs of phlebitis, defined as localized skin redness and swelling, at both extremities
* History of cephalosporin and/or penicillin allergy consisting of IgE-mediated reactions as anaphylaxis, angioedema, urticaria.
* Any current or prior medical condition that may interfere with the conduct of the study or the evaluation of its results in the opinion of the investigator.
Real-Time Myocardial Perfusion Echocardiography in the ICU

This study is being done to find out if and how much the use of RTMPE improves a provider's confidence in the diagnosis they assign. This is important because the use of RTMPE may decrease the need for any additional invasive testing.

The finding of elevated troponins and regional wall motion abnormalities on echocardiography in the absence of other signs of acute coronary syndrome among the intensive care population creates a diagnostic challenge for evaluation. Sometimes these ill patients undergo invasive coronary angiography to rule out acute thrombosis. Real-Time Myocardial Perfusion Echocardiography (RTMPE) is a safe and accurate imaging modality to assess perfusion and can be performed in the resting state at the bedside in the intensive care unit (ICU) to help stratify the likelihood intracoronary thrombosis as the etiology for abnormal troponins and/or echocardiography. The primary aim of this study is to evaluate the impact of RTMPE on providers' diagnostic confidence using a 5-point Likert scale for patients that receive a standard transthoracic echocardiogram (TTE) compared to patients that receive RTMPE. The RTMPE to assess perfusion will be added to the standard transthoracic echocardiogram in approximately 24 patients undergoing evaluation of myocardial ischemia in medical or surgical ICUs. The caring provider will complete a web-based survey regarding their confidence in the diagnosis prior to and after the study in both groups. The images will be interpreted by an experienced cardiologist and results will be made available in the medical record. The difference in diagnostic confidence scores will be analyzed using the Wilcoxon signed-rank test. The secondary aims are to assess the management and outcomes in both groups.

Eligibility Criteria:
Inclusion Criteria:

1. Adults age ≥ 18 years
2. Located in a designated ICU
3. TTE ordered by the primary care team
4. Significant delta in troponin trend
5. Concern for myocardial ischemia
6. Women of child-bearing potential must have a clinical negative pregnancy test result
7. Experienced sonographer available to complete RTMPE portion of the exam
8. Provider willing to complete the study survey

Exclusion Criteria:

1. Adults \< 18 years
2. Contraindication to echo contrast administration
3. Location other than an ICU
4. No significant delta in troponin trend
Efficacy of Besifloxacin Ophthalmic Suspension in the Treatment of Bacterial Conjunctivitis

This study is being conducted to evaluate the clinical and microbial efficacy of besifloxacin ophthalmic suspension compared with vehicle in the treatment of bacterial conjunctivitis. This study was conducted as a phase IIb study and continued with further enrollment as a phase III study.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who are at least one year of age.
* Subjects who have a clinical diagnosis of acute bacterial conjunctivitis.
* Subjects who are willing to discontinue contact lens wear for the duration of the study.

Exclusion Criteria:

* Subjects who have any uncontrolled systemic disease or debilitating disease.
* Subjects with known sensitivity or contraindications to besifloxacin, fluoroquinolones or any ingredients in study drugs.
* Subjects who are expected to require treatment with any disallowed medications.
High-concentration Small-volume Versus Low-concentration Large-volume Iodine Solution for Esophageal Chromoendoscopy

This clinical trial aims to test the participants' tolerance for different concentration iodine solutions during esophageal chromoendoscopy. The main question it aims to answer is:

Under the same iodine dosage, do the participants have the same tolerance for 1% and 5% iodine solutions? Participants will be asked to score based on pain and discomfort and describe symptoms and corresponding location at 5 minutes (only for unanesthetized participants) and 30 minutes after chromoendoscopy.

Lugol's iodine chromoendoscopy is the commonly used method for detecting and diagnosing esophageal squamous cell carcinoma. However, iodine can induce mucosal irritation and has been commonly associated with adverse retrosternal symptoms, including retrosternal pain and/or heartburn. The existing research shows that spraying iodine solution neutralizers (Sodium thiosulfate solution, N-acetylcysteine, and vitamin C solution) after esophageal iodine chromoendoscopy can alleviate patient discomfort. However, a recent study has shown that excessive iodine concentration or excessive dosage of iodine can still increase patient discomfort even under spraying an iodine solution neutralizer. It is currently unclear whether the factors affecting patient tolerance are the iodine solution concentration or the total dosage of iodine used. Therefore, the multicenter randomized controlled trial will compare the patient's tolerance for the 1% and 5% iodine solutions under the same iodine dosage conditions. The trial will help determine the specific reasons influencing patient tolerance. Participants will be asked to score based on pain and discomfort and describe symptoms and corresponding location at 5 minutes (only for unanesthetized participants) and 30 minutes after chromoendoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing esophageal Lugol's iodine chromoendoscopy.
* Age ≥ 18

Exclusion Criteria:

* Patients allergic to iodine or with hyperthyroidism;
* Patients with esophageal varices, esophageal ulcer or other conditions inadvisable for Lugol chromoendoscopy;
* Patients with severe gastroesophageal reflux disease or reflux symptoms which may interfered with the outcome measures of current study;
* Patients with postoperative esophageal stenosis affecting endoscopic observation;
* Patients who could not cooperate with the observation and data collection including patients with mental disorders, severe neurosis, dysgnosia or communication disorder;
* Patients with advanced-stage tumors;
* Patients after upper gastrointestinal surgery;
* Patients who do not agree to sign informed consent forms or follow the trial requirement.
Improving Coordination and Transitions of Care in Stroke Patients

This study will examine if the attending nurse model will enhance critical patient-centered elements of care that will in turn improve patient education and shared decision-making, medication adherence, stroke-related health literacy, and reduce early readmissions to ultimately yield improved patient quality of life. Our primary objective is to determine whether the attending nurse model of care improves stroke patients' health at 7 days, 30 days, and 90 days after hospital discharge as assessed through questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years of age
* Admission to the Hospital of the University of Pennsylvania Vascular Neurology service
* Incident or recurrent:
* Ischemic stroke: focal neurological deficit of likely ischemic vascular origin
* Intracerebral hemorrhage: blood seen on initial head CT
* Transient Ischemic attack: focal neurological deficit of likely ischemic vascular origin that has clinically resolved

Exclusion Criteria:

* Pregnancy
* Comfort or hospice care
* Severe dementia prior to stroke
* Non-communicative and have no family/social support
Prophylactic Pyloric Balloon Dilatation During Ivor Lewis Oesophagectomy

This is a feasibility study to assess recruitment for a randomised control trial comparing prophylactic pyloric ballon dilatation versus control group (no intervention) in Ivor-Lewis Oesophagectomy

The Ivor Lewis gastro-oesophagectomy is a complex operation that is performed to treat cancer of the oesophagus (food pipe) whereby most of the oesophagus and upper stomach are removed and the remaining stomach is brought into the chest and joined to the remaining oesophagus. In order to reduce the burden of complications of the procedure, research has been conducted in search of methods to improve the procedure and outcomes after the operation. Delayed gastric emptying (how quickly food empties out of your stomach into your small bowel) is a common problem after this operation (20% of patients). The situation can lead to a feeling of being full up, loss of appetite and nausea. Rarely, in severe cases patients may vomit or food going into lung causing a chest infection or develop a leak from the operative joint which can prolong hospital stay by an average of 5 days. Treatment currently is uncertain, as is the scale of problem (how common it is) and there is no standard definition for delayed gastric emptying (there is no agreed standard way to describe slow emptying of food from the stomach into the small bowel by experts). There is a theory that the problem might be caused due to the outlet of the stomach (pylorus) narrowing down. Prevention of the problem is also uncertain.

In order to investigate prevention of the problem, the study will involve randomising patients during the oesophagectomy to either dilatation (stretching) of the pylorus with a balloon, or not, and completion of an abbreviated quality of life questionnaire (8 multiple choice questions).

During the oesophagectomy, all patients routinely have endoscopy (camera test of the gullet and stomach) to assess the tumour. It is during this part of the operation that you will be randomised to either the balloon group or no intervention. The questionnaire is to assess your quality of life, in terms of delayed gastric emptying, at different points after the operation.

Preoperative endoscopic pyloric balloon dilatation with 20 mm has been shown to decrease incidence of DGE (only 18.3 % of the intervention group developed DGE compared to 37.5% in the non-intervention group (Hadzijusufovic et al., 2019). This however was a cohort study, and the main issue was that the intervention group had 115 patients whilst the non-dilatation group had 24 patients (tumour could not be passed with the scope). There aren't currently any published randomised control trials that looked at intra-operative endoscopic pyloric dilatation and how this relates to incidence of DGE.

Eligibility Criteria:
Inclusion Criteria:

* All patients over the age of 18 undergoing Ivor Lewis oesophagectomy in Derriford.

Exclusion Criteria

* Patient declined to participate.
* Impassable stricture at endoscopy.
* Patient is unable to give consent.
Glenohumeral Internal Rotation Deficit in Non-pitcher Overhead Athletic Athletes: Case Series Analysis of Athletes

In this observational case series the investigators would like to investigate wether or not the strenuous activity exerted on over head athletic athletes (ie. javelin throwers, discus throwers) may incite injury on their shoulders.

The investigators understood that these athletes had to perform repeated throwing motions and yet reports on their effects are very limited. This condition in the long run may contribute to injury and affecting performance of the athletes.

The investigators found that these relationships have not been looked at closely by others and largely overshadowed by athletes in other fields; such injury patterns had been described in details in baseball pitchers but not in other athletes.

Description of protocol:

In this study, the investigators would recruit athletes from the national athletics federation training in our city.

Data collection:

History taking:

* complaints of shoulder stiffness
* need for prolonged warm-up
* pain
* discomfort relating to the shoulders

Physical examination:

* Bilateral shoulder range of motion (internal and external rotation)
* Posterior shoulder flexibility test (denotes internal rotation deficit)
* Scapular malpositioning, inferior medial border prominence, coracoid pain and malposition and dyskinesis of scapular movement (SICK) scapula rating

Notes: measurements are taken by at least two investigators separately and compared to ensure accuracy.

Results are presented in a table and analysed.

Eligibility Criteria:
Inclusion Criteria:

* Performed overhead throwing motions in their athletic skills
* Athletes have competed in regional and national level
* Undergoing active training

Exclusion Criteria:

* Apparent anatomical deformity
* Sustaining injury(ies)