cyrilzakka/clinical-trials huggingface dataset:
Study to Compare the Pharmacokinetics of Fixed-Dose Combination of Mometasone + Azelastine Nasal Spray to Mometasone and Azelastine Nasal Sprays in Adolescents and Young Adults With Seasonal Allergic Rhinitis

This study will compare the PK parameters of the combination test formulation to monotherapy reference products (mometasone furoate and azelastine hydrochloride) in adolescents and young adult patients with seasonal allergic rhinitis.


Eligibility Criteria:
Inclusion Criteria:

1. Non-smoking, adolescent or young adult male and female subjects with seasonal allergic rhinitis.
2. Willing to use acceptable, effective methods of contraception.
3. Be informed of the nature of the study and give written consent (adults) / assent and consent by legal guardian(s)/parent(s) (adolescents) prior to any study procedure.

Exclusion Criteria:

1. Known history or presence of clinically significant disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
2. Known history or presence of hypersensitivity or idiosyncratic reaction to mometasone, azelastine, or any other drug substances with similar activity.
3. Unable to tolerate direct venipuncture.
4. Positive test result for HIV, Hepatitis B surface antigen, or Hepatitis C antibody.
5. Positive test result for urine drugs of abuse or urine cotinine.
6. Presence of nostril or septum piercing.
7. Use of tobacco or nicotine-containing products within 6 months prior to drug administration.
8. Females who are pregnant, breast-feeding, or have used hormonal contraceptives within 21 days (oral and transdermal) or 6 months (implanted, injected, intravaginal, or intrauterine) prior to drug administration.
9. Donation or loss of whole blood (including clinical trials) within 30 days prior to drug administration (or 56 days for ≥500 mL).
10. Participation in a clinical trial that involved administration of an investigational medicinal product within 30 days prior to drug administration, or recent participation in a clinical investigation that, in the opinion of the Investigator, would jeopardize subject safety or the integrity of the study results.
11. Received any type of live vaccine within 30 days prior to drug administration.
12. Use of medication within 30 days prior to drug administration.
13. On a special diet within 30 days prior to drug administration.
14. Have had a tattoo or body piercing within 30 days prior to drug administration.
Types of Intimate Partner Violence and Women's Health

This study uses data from 29,990 women from 12 different countries collected by the WHO multi-country study on women's health and domestic violence to capture the effect of different types, frequency and timing of IPV on self-reported health, symptoms and suicidal behaviours.

Intimate partner violence (IPV) has detrimental effects on physical and mental health, risks to children and is associated with wider societal and healthcare costs. Previous analysis of the WHO multi-country study on women's health and domestic violence found significant associations between physical and sexual IPV and self-reported ill-health, symptomatology and suicidal behaviours.

Real experience of IPV can comprise different combinations of emotional, physical and sexual abuse, and different timings and frequencies of these. A more nuanced testing of exposure to these different combinations of IPV and associations with health is needed.

This study uses data from 29,990 women from 12 different countries collected by the WHO multi-country study on women's health and domestic violence to capture the effect of different combination types, frequency and timing of IPV on self-reported health, symptoms and suicidal behaviours.

Eligibility Criteria:
Inclusion Criteria:

* The WHO report that in most sites, a representative sample of women was obtained using a two-stage cluster sampling scheme to select households and then only one woman per household was randomly selected per household for interview.

Exclusion Criteria:

-
Efficacy Analysis of Complete Laparoscopic Resection of Recurrent Hepatocellular Carcinoma

This study is aiming to evaluate the clinical efficacy of complete laparoscopic resection of recurrent hepatocellular carcinoma (HCC).

The investigators conducted a prospective study of 64 patients who were diagnosed with recurrent HCC and underwent surgical resection at the Sun Yat-sen University Cancer Center from June 2014 to November 2014; 31 patients were enrolled in the laparoscopic group and underwent complete laparoscopic resection of HCC, and 33 patients were enrolled in the control group and underwent open surgical resection. The operation time, intraoperative blood loss, shortest distance between the tumor edge and normal liver tissue, postoperative pain scores, postoperative time until the patient could walk, postoperative time until the patient could pass gas, hospital stay, and inpatient costs were compared between the two groups. The patients were followed up for one year after surgery, and the relapse-free survival was compared between the two groups.

Eligibility Criteria:
Inclusion Criteria:

1. recurrent HCC after open surgery
2. recurrent HCC located in any part of the left lateral lobe or the diaphragm side of the right lobe and near the surface of the liver, which resulted in an easier operation
3. no significant surgical contraindications
4. no major vessel or bile duct tumor invasion and metastasis
5. grade A or B liver function or grade C liver function that recovered to grade A after liver-protective treatment;
6. the patient and his/her family was willing to undergo laparoscopic resection.

Exclusion Criteria:

1. major vessel or bile duct tumor invasion
2. recurrent HCC located in the right liver parenchyma and near secondary vessels and bile ducts, resulting in a difficult operation
3. grade C liver function
4. significant surgical contraindications
5. the patient and his/her family declined laparoscopic hepatectomy.
Positron Emission Tomography (PET) Study

The primary purpose is to study the occupancy at the α4β2 neuronal nicotinic receptor's (NNRs) and to determine the relation between plasma concentration of AZD1446 and the occupancy at α4β2 NNRs.


Eligibility Criteria:
Inclusion Criteria:

* Physically healthy volunteers
* Body weight between 50 to 100 kg and body mass index (BMI) between 19 and 30 kg/m2

Exclusion Criteria:

* History of any clinically significant disease or disorder
* History of severe allergy/hypersensitivity reactions
* Participation in a PET examination as part of a scientific study during the past twelve months
Economic Burden of Knee Osteoarthritis in Talavera de la Reina Health Area.

This is a descriptive retrospective study of individuals affected with knee osteoarthritis. The aim of this study is to describe the sociodemographic and clinical characteristics of individuals diagnosed with knee osteoarthritis within a specific health area, as well as to assess the economic impact of this condition on the healthcare system. To achieve this, medical records will be reviewed, and the following data will be collected:

Sociodemographic and clinical participant data. Healthcare resource use. Clinical burden. Up to 400 subjects will be enrolled in the Talavera de la Reina Health Area (Toledo, Spain).

This is a multicenter, observational, retrospective study focusing on individuals diagnosed with knee osteoarthritis. This study will be conducted in the Talavera de la Reina Health Area (Toledo, Spain). Participants will be identified through the codes assigned in the electronic database associated with knee osteoarthritis.

Data will be collected from the initial radiologic diagnostic moment to December 31, 2019. For each participant enrolled, data from medical records will be collected and entered onto an electronic case report form (REDCap).

The sociodemographic and clinical data related to the pathology will be collected, including age, weight, height, duration of the condition, and occupational activity.

The following data will be considered as direct healthcare costs: the number of visits in primary and specialized care, diagnostic tests, surgical interventions, and emergencies at both health centers and hospitals. In addition, pharmacotherapy, rehabilitation number of sessions, and work absences (temporary and permanent) will be registered.

For cost estimation, a prevalence-based approach and a bottom-up estimation will be employed in the monetary valuation of healthcare resources, utilizing official sources.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years old.
* Diagnosed with unilateral or bilateral knee osteoarthritis according to the clinical criteria of the American College of Rheumatology.
* Radiographic imaging diagnosis based on the Kellgren \& Lawrence (K-L) classification.

Exclusion Criteria:

* No available X-ray.
* Pre-existing neurological diseases before the diagnostic date (stroke, Parkinson's, multiple sclerosis, ALS).
* Connective tissue disorders (Ehlers-Danlos, Marfan). Secondary cause of osteoarthritis or severe osteoarthritis (ACL tears, severe traumas, infections, or sepsis).
* Inflammatory arthropathy (any type of arthritis).
* Genetic disorders with a higher risk of developing arthropathies (Down syndrome).
Memantine and Constraint-Induced Language Therapy in Chronic Poststroke Aphasia:A Randomized Controlled Trial

* Aphasia, the loss or impairment of language caused by brain damage, is one of the most devastating cognitive impairments of stroke. Aphasia can be treated with combination of speech-language therapy and drugs. Conventional speech-language therapy in chronic aphasic subjects is of little help and several drugs have been studied with limited success. Therefore other therapeutic strategies are warranted.
* Recent data suggest that drugs (memantine) acting on the brain chemical glutamate may help the recovery of cognitive deficits, included language, in subjects with vascular dementia. The present study examines the safety profile and efficacy of memantine paired with intensive language therapy in subjects with stroke-related chronic aphasia (more than 1 yr. of evolution).

* The efficacy of drugs that act on glutamate such as the N-methyl-D-aspartic acid (NMDA) receptor antagonist memantine requires to be explored in this population. The rationale for using memantine in post-stroke aphasia comes from recent studies on vascular dementia. Data extracted from a recent Cochrane review of randomized controlled trials of memantine in different types of dementia (vascular dementia, Alzheimer's disease, mixed dementia) reveal, after 6 weeks of treatment, beneficial effects on cognition (including language), activities of daily living, behavior and global scales as well as in the global impression of change.
* Recovery from aphasia is possible even in severe cases. While speech-language therapy remains as the mainstay treatment of aphasia, its effectiveness has not been conclusively proved. This has motivated the planning of more rational therapies (e.g., constraint-induced language therapy \[Pulvermüller et al., 2001; 32: 1621-1626\]).
* In addition, the neural correlates of improvement of language function can now be readily detectable with event-related potentials. This is a noninvasive technique that can detect in real time functional brain changes during recovery promoted by the combined action of memantine and constraint-induced language therapy.
* The aim of the present study is to assess the efficacy, safety profile, and functional correlates of memantine paired with massed language therapy in a sample of patients with chronic poststroke aphasia.

Eligibility Criteria:
Inclusion Criteria:

* Chronic aphasia of more than one year duration
* Must be able to complete protocol

Exclusion Criteria:

* Dementia
* Major psychiatric illness
* Severe global aphasia (precludes participation in constraint-induced language therapy)
Study of Risk Factors for Developing Inhalation Pneumonia After Inhalation

Inhalation pneumonia (PI) is common in clinical practice but is rarely studied. For example, there are no data on the incidence of pneumonia after inhalation and risk factors or protective factors to develop one since it is known that anyone who inhaled does not necessarily develop an IP. There is no data on the benefit of treating inhalation by antibiotic therapy pre-emptively although this practice is common. In this context, this observational study wishes to take stock of the situation on the subject in order to determine what actions to implement to prevent IP.


Eligibility Criteria:
Inclusion Criteria:

* In intensive care: Any intubated patient who presented:
* It is a coma with GCS ≤ 12 without VAS protection, whatever the duration
* Either a proven inhalation, defined by the presence in the VAS of gastric fluid or food
* Either a suspected inhalation, defined by the extrahospital anamnesis
* In medicine :
* Any wrong way (defined by a reflex cough when taking food)
* Coma without intubation, regardless of duration or depth

Exclusion Criteria:

* Patients with VAP
Adipokines as Predictors of Foot Function, Pain, and Disability in Patients With Rheumatoid Arthritis

Significant increase in the levels of serum adiponectin, ADA, and hsCRP was reported in all RA patients compared to controls.

Compared to patients with early RA, the increase in these markers significantly correlated with disease activity (DAS-ESR), lower f-BMD, radiographic scoring, pain, FFI, and functional limitations in patients with established RA.

Adiponectin showed a negative correlation with serum levels of both ADA and hsCRP. By using ROC curve analysis, optimal cut-off values of adiponectin (28.8 µg/ml), ADA (27.3 IU/L), and hsCRP (1.6 mg/L) could be used to estimate early RA in 45 % of the patients. Similarly, using cut-off values of adiponectin (32.8 µg/ml), ADA (26.1 IU/L ml), and hsCRP (2.5 mg/L), established RA could be predicted in 55 % of patients with 98-99% accuracy.

The present study attempts to evaluate the efficacy of adiponectin, ADA, and foot bone mineral density (fBMD) as predictors of the disease progression in patients with rheumatoid arthritis. A total of 80 RA patients and eighty age and sex-matched healthy controls were included in this study.

Eligibility Criteria:
Inclusion Criteria:

* patients who diagnosed with Rheumatoid arthritis according to American Rheumatology Association criteria and radiographic analysis for at least 10 years previously were randomly involved in this study
* Not receiving any drugs affecting the data obtained
* had Normal daily diets

Exclusion Criteria:

* Subjects with obvious ischemic heart disease (angina, myocardial infarction, and lead electrocardiogram abnormalities),
* HCV, HBV, chronic liver and kidney diseases, hypothyroidism.
* Drugs (diuretics; oral contraceptives).
Relationship Between Oxytocin Level, Trust, and Attachment in Individuals With Borderline Personality Disorder

We aim to assess the baseline oxytocin levels in individuals with borderline personality disorder and correlate those levels with social behavior, and compare the results with controls.

Primary Hypothesis (H1):

There is a significant difference in trust-related behavior as measured by oxytocin (OXT) levels between borderline personality disorder (BPD) patients and healthy controls.

Secondary Hypotheses:

H2: The trust-related behavior in BPD patients is significantly influenced by their level of emotional sensitivity. Specifically, higher emotional sensitivity in BPD patients is associated with lower trust-related behavior and vice-versa.

H3: There is a significant correlation between trust-related behavior and childhood trauma in BPD patients. BPD patients with higher levels of reported childhood trauma will exhibit lower trust-related behavior compared to those with lower levels of trauma.

H4: Trust-related behavior in BPD patients varies depending on their attachment styles. Specifically, BPD patients with insecure attachment styles will exhibit lower trust-related behavior compared to those with secure attachment styles.

H5: There is a significant correlation between trust-related behavior and BPD severity. Patients with more severe BPD symptoms will exhibit lower trust-related behavior compared to those with less severe symptoms.

H6: The levels of OXT in BPD patients will significantly correlate with their reported levels of emotional sensitivity, childhood trauma, attachment styles, and BPD severity.

These hypotheses aim to address the complexities surrounding the modulation of trust-related behavior by oxytocin in BPD patients, taking into account various factors like emotional sensitivity, childhood adversity, attachment styles, and BPD severity. By testing these hypotheses, the study aims to provide a comprehensive understanding of the interplay between these factors in influencing trust-related behavior in BPD patients.


Eligibility Criteria:
Inclusion Criteria:

* Individuals with borderline personality disorder will qualify as cases
* controls will be age, gender matched individuals without any psychiatric/mental health concerns

Exclusion Criteria:

* for all: pregnancy, hormonal or neurological disorders, and any kind of regular medication
* additional exclusion criteria for cases: a lifetime diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or significant neurological disease, current alcohol/ drug dependence
* for controls: MacLEan screening instrument for BPD will be used at the time of screening to exclude BPD diagnosis in controls
Effects of Prednisolone and Pentoxifylline on the Regulation of Urea Synthesis in Alcoholic Hepatitis

Loss of total mass of muscles (catabolism) is a serious clinical problem in patients with alcoholic hepatitis. The liver might play an important role in this stress-catabolism by increasing the production of urea during the inflammatory process.

The purpose of this study is to examine the regulation of urea synthesis in patients with alcoholic hepatitis and to study the effect of the anti-inflammatory drugs prednisolone and pentoxifylline on this regulation.


Eligibility Criteria:
Inclusion Criteria:

* Alcoholic hepatitis (alcohol intake (\> 40g/day in 6 months), bilirubin \> 80 μmol/l)

Exclusion Criteria:

* Severe bacterial infections
* Other chronical inflammatory diseases
* Cancer
* Other catabolic diseases
* Treatment with prednisolone or pentoxifylline within the last 8 weeks
Two- Dimensional Speckle Tracking Echocardiography After Primary Percutaneous Coronary Intervention

ST-segment elevation myocardial infarction (STEMI) is a major cause of morbidity and mortality worldwide. In spite of decrease in acute and long-term mortality following STEMI in parallel with more use of reperfusion therapy, such as primary percutaneous coronary intervention (PPCI), modern antithrombotic therapy, and secondary prevention, mortality remains considerable. Reduced EF is a well-known predictor of increased short and long term major adverse cardiovascular events MACE :( heart failure, stroke and death)


Eligibility Criteria:
Inclusion Criteria:

* ST elevation myocardial infarction patients after primary percutaneous coronary intervention

Exclusion Criteria:

* Previous myocardial infarction.
* Sever or haemodynamically significant (associated with chamber dilation) valvular heart diseases.
* Previous heart failure.
* Previous cerebrovascular strokes.
* Atrial fibrillation.
* Severe comorbidities as severe renal impairment, hepatic or respiratory failure.
* Bad equality views which affects accurate speckle tracking imaging.
ACU-TENS on Pain and Stress Reduction Before and During TUGOR

Objectives: To demonstrate the use of acupuncture-type transcutaneous electrical nerve stimulation (acu-TENS) during transvaginal ultrasound-guided oocyte retrieval (TUGOR) will reduce 50% of the intensity of pain experienced by women.

Hypothesis to be tested: Does the use of acu-TENS reduce 50% of pain in TUGOR? Design and subjects: A prospective randomized control trial will be carried out at the Department of Obstetrics and Gynaecology, Prince of Wales Hospital. 144 women undergoing TUGOR will be randomized to receive acu-TENS or sham acu-TENS for pain control during TUGOR.

Study instruments: During the TUGOR procedure, ultrasound of the pelvis will be performed by Aloka ProSound SSD-3500SX device (Japan). Each follicle will be pierced using a single lumen ovum aspiration needle or a double lumen ovum aspiration catheter (COOK Medical, UK) under ultrasound guidance. Acu-TENS will be done using MTR+ Myolito Multifunctional Stimulator.

Main outcome measures: Primary outcome is the pain score before and during TUGOR. Secondary outcomes include (1) other pain level parameters including pain control satisfaction, surgeon's assessment of the patient co-operation score and patient intraoperative pain; (2) stress and anxiety levels, Stait Trait Anxiety Inventory, General Health Questionnaire, Beck Depression Inventory, and saliva cortisol; (3) patient's satisfaction measured by Client Satisfaction Questionnaire and satisfaction score on pain control; (4) difficulty in retrieving oocytes; (5) IVF parameters; (6) safety profile; and (7) bias assessment.

Data analysis: Data analysis will be performed using Statistical Packages of Social Sciences for Windows.

Expected results: The investigators expect that acu-TENS will reduce 50% of pain in TUGOR.


Eligibility Criteria:
Inclusion Criteria:

* Women undergoing IVF-ET cycles are to be recruited from the Assisted Reproduction Technology unit in the Prince of Wales Hospital

Exclusion Criteria:

* Patient not eligible for acu-TENS
* Patient with severe cardiac and respiratory disease history
* Smoker or drinker
* Refuse or incompetence for informed consent
Intermittent Exercise Among Students

Evaluate the effectiveness of intermittency anaerobic exercise interventions among the students with high risk of cardiometabolic .


Eligibility Criteria:
Inclusion Criterias:

* Male: Waist-to-height ratio≥0.463
* Female： Waist-to-height ratio≥0.469
* Students with cardiometabolic risk factors include elevated BP, dyslipidaemia, elevated fasting blood glucose (FBG) and central obesity.

Exclusion Criterias:

* Participates with severe disease conditions include cardiac insufficiency, respiratory system relate diseases, immunodeficiency or severe malnutrition, ect
* Taking or having taken weight-loss drugs
* Participates unsuitable or improper to participate the study
Study on Short Chain Fatty Acids Concentration in Breast Milk and Its Correlation With the Maternal Diet

The purpose of this study is to determine whether the acetate, butyrate and propionate concentration in breast milk and to evaluate the possible correlation of these concentrations with maternal diet.


Eligibility Criteria:
Inclusion Criteria:

* parturients women at term hospitalized in the Department of Obstetrics, Gynecology and Pathophysiology of Human Reproduction, "Federico II" University of Naples.

Exclusion Criteria:

* infections,
* diabetes and other chronic diseases at the level of each organ or system,
* diseases of pregnancy.
* antibiotics, prebiotics, probiotics and synbiotics in the 30 days prior to the first observation.