cyrilzakka/clinical-trials huggingface dataset:
Hyperglycemia in Patients with Stroke and Indication of Enteral Nutrition

The purpose of this study is to evaluate the effect of a specific nutritional formula for diabetics on the development of hyperglycemia in patients with recent non-diabetic stroke who require admission and enteral nutritional support by nasogastric tube. As well as the effect on metabolic control, development of comorbidities, hospital stay, readmissions, mortality and tolerance of the formula under study.

MAIN GOAL:

To evaluate the effect on the development of hyperglycemia diagnosed as glycemia\> 126 mg / dl on an empty stomach or\> 150 mg / dl during the infusion of enteral nutrition determined by capillary glycemia during the admission of a specific formula in patients with a first episode of ischemic stroke or hemorrhagic entry into the non-diabetic HCUV stroke unit requiring enteral nutrition by nasogastric tube.

Eligibility Criteria:
Inclusion Criteria:

* Admitted for a first episode of ischemic or hemorrhagic stroke.
* Requiring total enteral nutrition by tube for at least 7 days

Exclusion Criteria:

* Contraindication to enteral nutrition
* Diabetes Mellitus
* Gastrointestinal disease: ulcer, gastritis, diarrhea, gastroparesis, vomiting, abdominal pain
* Need for admission to the ICU
* Previous neurodegenerative disease
* Antibiotherapy for 7 days prior to the inclusion visit
* Allergies or intolerances to any of the components of the formula under study
* Pregnant patients
Safety Profile Comparison of Undiluted Intracameral Moxifloxacin vs. Levofloxacin in Cataract Surgery

The goal of this randomized clinical trial study is to compare safety profile undiluted intracameral moxifloxacin vs levofloxacin during cataract surgery. The main question it aims to answer is whether moxifloxacin and levofloxacin have similar safety profile.

Participant will be randomized into two treatment arms. All participant will receive standardized treatment before, during, and after surgery and will be followed up at one day, one week, and one month after surgery.

This study aims to observe the safety profile in patient receiving cataract surgery who receives moxifloxacin and levofloxacin intracamerally during the surgery. Safety profile defined as visual acuity, intraocular pressure, corneal endothelial cell density, central corneal thickness, anterior chamber reactions, and central macular thickness. Parameters are obtained before the surgery, 1 day, 1 week, and 1 month after surgery. Subjects are randomized to two treatment arms: (1) receiving undiluted moxifloxacin 0.1 cc during surgery; (2) receiving undiluted levofloxacin 0.1 cc during surgery.

Eligibility Criteria:
Inclusion Criteria:

* Immature senile cataract in one or both eye
* Agree to be included and signed informed consent

Exclusion Criteria:

* Have a history of allergy to moxifloxacin or levofloxacin or any other antibiotics
* Other ocular comorbid such as uveitis, glaucoma, diabetic retinopathy, pseudoexfoliation, and endothelial disorders
* Ocular surgery prior to study
* Sign of infection or inflammation around the eye
* Cataract density more than grade 4 according to Lens Opacities Classification System (LOCS) III grading
* Corneal endothelial cell density \< 1500 cell/ mm2
* Anterior chamber depth \< 2.5 mm
* Diabetes mellitus type 2
The Safety and Effectiveness of Fozivudine Tidoxil in HIV-1 Infected Patients

To identify doses of fozivudine tidoxil that are well tolerated and produce measurable antiviral activity.

To identify the adverse event profile that defines the maximum tolerated dose. To characterize the single- and multiple-dose pharmacokinetics of fozivudine and its metabolites.

To correlate the adverse event profile and antiviral activity of fozivudine with pharmacokinetic parameters.

In this double-blind, dose-escalating study, patients receive fozivudine tidoxil at one of 5 dosage levels for 4 weeks and are randomized with respect to once- or twice-daily administration (cohorts 2 vs. 3 and 4 vs. 5). Within each cohort, 10 patients are randomized to the study drug and 2 to the placebo. At least 9 of the 12 patients enrolled in Cohort 1 must complete the entire 4-week course before Cohorts 2 and 3 are enrolled. At least 18 of these 24 patients must complete 2 weeks of the 4-week course before Cohorts 4 and 5 are enrolled.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

Primary and secondary prophylaxis for opportunistic infection if stable and initiated at least 3 months prior to study drug administration.

Patients must have:

* HIV-positive status.
* One HIV RNA count \> 10,000 copies/ml within 30 days prior to entry, with a second count at least 3-fold above or below the first value.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Active medical problems including chronic diarrhea and active opportunistic infections such as cryptococcosis, Pneumocystis carinii, histoplasmosis, etc..
* Malignancy for which systemic therapy or radiation therapy is expected to be required during the study.
* Any other disease or condition that would place a patient at undue risk or confound the results of the study.

Concurrent Medication:

Excluded:

Systemic therapy for malignancy.

Prior Medication:

Excluded:

* Zidovudine or any other nucleoside reverse transcriptase inhibitor.
* Immunomodulators within one month prior to study drug administration.
* Investigational drugs within 30 days prior to study drug administration.
* Systemic cytotoxic chemotherapy within 3 months prior to study drug administration.

Prior Treatment:

Excluded:

* Extended-field radiation therapy within 3 months prior to study drug administration.
* Blood transfusion within 2 weeks prior to study drug administration.
Observational Study on the Impact of Obstructive Sleep Apnea on Executive Function and Empathy Development in Children

This study aims to investigate the effects of obstructive sleep apnea (OSA) on executive function and empathy development in children aged 3-12 years. The study will compare the outcomes of different treatment approaches (surgical vs. pharmacological) in children with mild OSA and track the progression of cognitive and emotional functions over 12 months. The study will also explore potential EEG biomarkers for assessing neurological damage in OSA children.

This is a prospective observational cohort study conducted at the Sleep Center of the Respiratory Department and the Department of Child and Adolescent Healthcare, Children's Hospital of Soochow University. Children diagnosed with OSA will be divided into groups based on disease severity (mild, moderate, severe) and treatment choice (surgical or pharmacological). The study will assess executive function and empathy levels at baseline, 6 months, and 12 months post-intervention using behavioral tests, EEG, and parent-reported questionnaires. The study aims to provide evidence for treatment selection in mild OSA children and identify EEG biomarkers for neurological damage.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 3-12 years.
* Diagnosed with OSA due to adenoid and/or tonsillar hypertrophy.
* IQ ≥ 85.
* Parental consent for participation.

Exclusion Criteria:

* Other primary sleep disorders (e.g., narcolepsy, restless leg syndrome).
* Developmental delay, epilepsy, or other neurological/metabolic disorders.
* Chronic diseases or history of head trauma.
Complement 2: Blood Donations to Develop Vaccines Against Infectious Diseases

We need human blood to understand the immune response to infection and to test promising new vaccines against infectious diseases in the laboratory. One test is called the Serum Bactericidal Assay (or SBA), which is measure of how effective antibodies are at killing certain bacteria and can be an important measure of how effective a new vaccine may be.

The samples would be used in the laboratory analysis of clinical trials of vaccines used in adults and children, and some samples in pre-clinical (animal) experiments testing new vaccines before they enter human-stage testing. Most people have some form of protection against most bacteria already, so not everyone is a suitable blood donor for this laboratory test. We therefore start by taking a small blood sample and test this one before asking for more blood if we found yours suitable for the work we do.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to give informed consent for participation in the study
* Aged between 18 and 70 years
* In good health as determined by medical history and clinical judgment of the Investigators
* Able to attend the scheduled visits and to comply with all study procedures
* If found to be a suitable complement that they are willing to be approached for further donations

Exclusion Criteria:

* Body weight less than 50kgs
* Have any known or suspected impairment or alteration of immune function, resulting from, as examples:congenital or acquired immunodeficiency, receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 12 months or long-term systemic corticosteroid therapy, receipt of immunoglobulin or any blood product transfusion within the last 3 months
* Female participants who are pregnant
* Any chronic illness that could, in the opinion of the Investigators, interfere with immune function or with the donation of large volumes of blood (e.g. thrombocytopaenia or coagulopathy, malabsorption disorders, chronic anaemia)
* An individual who is on the delegation log for the study
* Planned blood donation within 4 months of undergoing testing to assess whether the individual is a suitable Complement donor
Novel Predictors of Post Spinal Hypotension in Cesarean Sections: Evaluating Jugular Vein Collapsibility Index and Shock Indices

Jugular vein collapsibility index and shock indices (Shock index, Modified Shock Index, Diastolic Shock Index) may be useful in estimating post spinal hypotension in cesarean section operations. Evaluation on the accuracy and effectiveness of these indices can contribute to the early diagnosis and management of hypotension. The main purpose of this study is to evaluate the effectiveness of shock indices in predicting the possibility of post spinal hypotension in cesarean section operations.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women between the ages of 18-45 who had a planned cesarean section and approved to participate in the study and to apply spinal anesthesia

Exclusion Criteria:

* Patients with Preeclampsia, Eclampsia, HELLP syndrome
Comparative Evaluation of Bromelain-Quercetin Gel With Chlorhexidine Gel as Subgingival Local Drug Delivery Following Scaling and Root Planing In Stage I /II and Grade B Periodontitis - Randomized Control Clinical Trail

Comparative Evaluation of Bromelain-Quercetin Gel With Chlorhexidine Gel as Subgingival Local Drug Delivery Following Scaling and Root Planing In Stage I /II and Grade B Periodontitis - Randomized Control Clinical Trail

: Periodontitis is a biofilm associated disease that induces an irreversible inflammatory state that leads to the destruction of the supporting structure of the teeth. Management of periodontal disease is through thorough removal of biofilm which is pivotal for having better oral health. Scaling and root planning (SRP) is fundamental treatment for periodontitis. Years of documented research have established that chlorhexidine digluconate (CHX), gold standard of chemical plaque control agent is safe stable and effective in preventing and controlling plaque formation. Bromelain is an extract derived from Ananas comosus (popularly known as pineapple), contains proteinases that exhibits anti-inflammatory properties, antibacterial effect against periodontopathogens. Bromelain gel has shown to have chemicomechanical method of caries removal. Quercetin present in guava have excellent antibacterial actions against periodontal pathogens, Aggregatibacter actinomycetemcomitans (Aa), Porphyromonas gingivalis (Pg), Prevotella intermedia (Pi) and Fusobacterium nucleatum (Fn). 2% Quercetin has shown to be advantageous for subgingival application after scaling and rootplaning. Bromelain-Quercetin gel has shown adjunctive effect for treatment in covid-19 patients. As there is less literature in this combination, we intend to study its effects. Individually bromelain and quercetin have been studied for treatment in oral cavity as gel form. This study will be first of its kind to check the efficacy of 2% bromelain-quercetin gel and to compare its effects with 0.2% Chlorhexidine in stage I/II and grade B periodontits.

Eligibility Criteria:
Inclusion Criteria:

* Patient with have chronic periodontitis in the age group between 30-50 years.
* Patients having ≥20 teeth.

  -.Patients with radiographic evidence of bone loss in atleast two teeth.
* Patients who are systematically healthy.
* Patients with localized pockets with probing depth of ≤ 5mm.
* Patients who are cooperative and able to attend the hospital for regular follow-up.

Exclusion Criteria:

* Patients who have received any surgical or nonsurgical therapy during past 6months
* Pregnant or lactating females.
* Use of systemic antibiotics in the past 6 months.
* Patient who are not willing to give a written informed consent
Four-hour Glycemic Kinetic Response Following 13C-enriched Oatmeal Breakfast Compared to Hot Corn Grits

The objectives of this study are to assess the 4 hr postprandial kinetics of total and exogenous glucose in response to consumption of oatmeal containing a high percentage of the viscous agent β-glucan, in comparison to a β-glucan free corn cereal that is matched by grams of available carbohydrate.


Eligibility Criteria:
Inclusion Criteria:

* Subject is 18-45 years of age.
* Subject has a body mass index (BMI) between 18.5 and 29.9 kg/m2, inclusive at screening (visit 1).
* Subject has normal fasting serum glucose (\<6.5 mmol/L capillary corresponding to whole blood glucose \<5.8 mmol/L) at beginning of each visit.
* Subject has no health conditions that would prevent him from fulfilling the study requirements as judged by the Investigator on the basis of medical history.
* Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator.

Exclusion Criteria:

* Failure to meet any one of the inclusion criteria.
* Failure to comply with pre-visit instructions on diet and physical activity.
* Known history of clinically important medical conditions, such as any major trauma or surgical event within 3 months of screening, AIDS, cancer, hepatitis, endocrine (including Type 1 and Type 2 diabetes mellitus), cardiovascular (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), pulmonary, biliary, or GI disorders.
* Subject using medications or supplements known to influence carbohydrate or lipid metabolism, including, but not limited to adrenergic blocks, diuretics, thiazolidinediones, metformin, statins, and systemic corticosteroids within 4 weeks of the screening visit.
* Subject who cannot or will not comply with the experimental procedures or does not follow GI Labs safety guidelines.
* Subject has a known intolerance, sensitivity or allergy to any ingredients in the study products.
* Subject has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
Immunogenicity & Safety Study of Combined/Separate Vaccine(s) Against Common Diseases in Infants (2,4,6 Months of Age).

This study will evaluate the immunogenicity of the co-administration of different combinations of DTPa, IPV, hepatitis B, Hib and Men C vaccines during the first year of life.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female infant between, \& including, 0 \& 7 days of age at the time of the inclusion. Born after a normal gestation period (between 36 \& 42 weeks).
* Written informed consent obtained from the parent/guardian of the subject.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) or planned use during the study period.
* Administration of immunosuppressants or other immune-modifying drugs from birth.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
* Administration / planned administration of a vaccine not foreseen by the study protocol during the period starting from birth and ending 30 days after the last dose except BCG vaccination if given before the 30-day period preceding the administration of the 1st dose of Infanrix penta™ or Infanrix hexa™ in combination with a meningococcal C vaccine.
* Evidence of previous or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B, meningococcal C and Hib disease.
* Evidence of previous diphtheria, tetanus, pertussis, polio, hepatitis B, meningococcal C and Hib vaccination.
A Study of SHR6390 in Combination With Fulvestrant in Patients With HR Positive and HER2 Negative Advanced Breast Cancer

This is a phase III clinical trial to evaluate the efficacy and safety of SHR6390 in combination with Fulvestrant versus placebo combined with Fulvesrant in Patients who have HR positive and HER2 negative recurrent/metastatic breast cancer and have received prior endocrine therapy are eligible for study.


Eligibility Criteria:
Inclusion Criteria:

1. Has the pathologically-confirmed diagnosis of locally recurrent or metastatic, hormone-receptor positive, HER2 negative Breast Cancer.
2. Age: 18 - 75 years old, postmenopausal women or prepostmenopausal women
3. Received prior endocrine therapy
4. One previous line of chemotherapy for advanced/metastatic disease is allowed in addition to endocrine therapy.
5. Eastern Cooperative Oncology Group \[ECOG\] 0-1

Exclusion Criteria:

1. Patients who received prior treatment with any CDK4/6 inhibitor, everolimus or fulvestant.
2. Clinically significant cardiovascular and cerebrovascular diseases,including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, Congestive heart failure (New York heart association (NYHA) class \> 2), or ventricular arrhythmia which need medical intervention.
Effectiveness of Testosterone Undecanoate to Improve Sexual Function in Postmenopausal Women

Additional testosterone undecanoate can improve female sexual function in postmenopausal women which one aspects of quality of life. The dose adjustment can reduce incidence of adverse effects and low cost of treatment with effective outcome.

Research Question:

" Does oral testosterone undecanoate improve sexual problem in postmenopausal women? " Type Research:Clinical research

Study design:

Randomized double-blinded placebo controlled trial

Eligibility Criteria:
Inclusion Criteria:

* postmenopausal women with age between 40-60 years
* Women complain about her sexual problem and her score of Female Sexual Function Index ≤ 26.5

Exclusion Criteria:

* women with previous use of hormonal replacement or anti-psychiatric drugs within 3 months
* women with history of or present premalignancies/malignancies
* women present with liver disease or abnormal liver enzyme
* women with active cardiovascular, cerebrovascular or thromboembolic disorders
* women with Present psychiatric disease
* Partner have sexual dysfunction
Escitalopram in Depressive Patients With Acute Coronary Artery Syndrome

This study aimed to evaluate the efficacy and safety of escitalopram in the treatment of depressive patients with acute coronary artery syndrome (CAS).

Depression is common in patients with acute CAS and increases cardiac morbidity and mortality. However, there are a few limited data available regarding the effects and safety of antidepressants for treating depression in patients with acute CAS. This study aims to investigate whether escitalopram might be an effective treatment option for these patients.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18\~85
* Diagnosed as acute CAS (unstable angina or acute myocardial infarction) and being conducted coronary angiography
* Beck Depression Inventory \> 10 and major or minor depressive disorder by the DSM-IV criteria
* With ability to complete various questionnaires
* Can understand the objective of the study and sign informed consent

Exclusion Criteria:

* Occurrence of acute CAS while the patient was hospitalized for another reason, except for CAS
* Current CAS developed less than 3 months after coronary artery bypass graft procedure
* Uncontrolled hypertension (systolic BP \> 180mmHg or diastolic BP \> 100mmHg)
* Resting heart rate \< 40/min
* Severe physical illnesses threatening life or interfering with the recovery from CAS
* Persistent clinically significant laboratory abnormalities
* Concomitant use of class I antiarrhythmic medications; reserpine, guanethidine, clonidine, or methyldopa; anticonvulsants or neuroleptics
* History of neuropsychiatric illnesses such as dementia, Parkinson's disease, brain tumor, psychoses, alcoholism, and other substance dependence
* Pregnancy
Effect of Itraconazole on the Pharmacokinetics of Apatinib

he primary purpose of this study is to investigate potential pharmacokinetic interaction in healthy volunteers when apatinib is administered in combination with itraconazole. Secondary objective is evaluating the safety and tolerability of apatinib alone and when co-administered with itraconazole.


Eligibility Criteria:
Inclusion Criteria:

* female of non-childbearing potential or male;
* age 18-45 years;
* body mass index 19-24 kg/m2 with total body weight;

Exclusion Criteria:

* clinically signiWcant medical or surgical conditions with the potential to interfere with the absorption, distribution, metabolism or excretion of the study drugs;
* history of alcohol abuse; smoker;
* electrocardiogram(ECG) abnormality;
* blood pressure \>140/90 mmHg;
* treatment with an investigational drug or any known CYP450 enzyme inducing/-inhibiting agents or herbal supplements within 14 days prior to first dose of study medication;
* Subjects were to abstain from using prescription and non-prescription drugs (other than acetaminophen as deemed necessary), vitamins and dietary supplements within 14 days prior to the first dose of study medication and throughout the study.
Phase 2 Extension Trial in Patients With Relapsing-Remitting Multiple Sclerosis (RRMS)

The objective of this active-drug Extension Study is to evaluate the continuing safety and efficacy of ONO-4641 (MSC2430913A) in subjects with relapsing-remitting multiple sclerosis (RRMS) who have completed an initial 26-week Core Study (ONO-4641POU006 \[NCT01081782\]).


Eligibility Criteria:
Inclusion Criteria:

* Completed 26 weeks of double-blind phase of Study ONO-4641POU006

Exclusion Criteria:

* Presence of any dermatological abnormalities during Study ONO-4641POU006 that could increase the risk of the patient developing a skin cancer