cyrilzakka/clinical-trials huggingface dataset:
Effect of Oral Health Education on Oral Health Status, Treatment Needs and Barriers to Care

Jordanian children have very poor oral hygiene parameters, and this is reflected as very high caries prevalence and poor gingival health conditions. This study will focus on children at social homes in the community in order to establish a baseline reference about their oral health status, treatment needs, and barriers to dental care. Also, to report the efficacy of oral health education using audio-visual aids and frequent motivation on oral health status, treatment needs and barriers to care among children at social homes in Jordan.

The oral health status (OHS) for children and adults is a reflection of the whole body general health status as well as the overall quality of life. Jordanian children have very poor oral hygiene parameters, and this is reflected as very high caries prevalence and poor gingival health conditions. Orphans and children who come from broken homes are suspected to have poorer oral health conditions from their peers in the public due to the different parameters that can affect their general health in whole and oral health in particular, and this could affect their quality of life. These parameters can be related to socioeconomic status, psychological and behavioral conditions, access to care and other factors. The role of tooth brushing in decreasing dental caries and enhancing the gingival health is well-established in the literature, and oral health education programs have proven to be effective in improving the oral health knowledge, attitude and behavior of children. These programs could be regarded as an effective measure to enhance the oral health status and establish good routines in childhood which is vital for optimum oral health and provision of lifelong protection against caries.

This study will focus on children at social homes in the community in order to establish a baseline reference about their oral health status, treatment needs, and barriers to dental care. Also, to report the efficacy of oral health education using audio-visual aids and frequent motivation on oral health status, treatment needs and barriers to care among children at social homes in Jordan.

Eligibility Criteria:
Inclusion Criteria:

* Healthy children living in social homes among age group specified

Exclusion Criteria:

* Children with poor behavior
Acupuncture in Menopause

The primary purpose of this study is to determine the effectiveness of acupuncture for treating vasomotor and other symptoms associated with menopause as acupuncture is generally practiced in the "real world" setting and to obtain a comprehensive assessment of use patterns and symptom relief over time. This study will allow us to determine treatment patterns recommended by practicing acupuncturists, adherence to these treatments, and the effectiveness of different treatment patterns for reducing hot flashes. Results of this study will provide meaningful information to women in terms of number and frequency of acupuncture treatments likely to be needed to reduce hot flashes.


Eligibility Criteria:
Inclusion Criteria:

* Women experiencing on average 4 Hot Flashes a day
* Women aged 45-60
* Peri or Post menopausal Women (No periods for at least 3 months)

Exclusion Criteria:

* Women who have initiated CAM or non-CAM treatments for hot flashes in the last 4 weeks
* Women who have changed their dose of a CAM or non-CAM treatments for hot flashes in the last 4 weeks
* Women who have initiated antidepressants in the last 3 months
* Women who have changed their dose of an antidepressant in the last 3 months
* Women who have had acupuncture in the last 4 weeks
* Women who have received acupuncture from one of the study acupuncturists in the last 6 months will be excluded from the study
* Women who describe their health as fair or poor are excluded from the study
* Women who have a diagnosis of Hemophilia
* Relatives and Co-Workers of the treating acupuncturists
Prevalence and Predictors of Depression in COPD

Depression adversely affects quality of life in COPD patients, associated with higher rate of exacerbations, admissions and mortality. However, local prevalence rate of depression in geriatric COPD patients remains unknown.

Though BODE index is superior to FEV1 in prediction of depression in COPD, it is unclear which domain of BODE correlates best with depression. Furthermore, with multiple confounding factors, it's ambiguous that whether frequent exacerbation is an 'independent' predictor for depression among COPD patients.

The objective of this study is i.) to study the local prevalence rate of depression in geriatric COPD patients, ii.) to identify risk factors for depression especially looking at the any independent relationship between frequent exacerbations, various domains of BODE index and depression.

This study is a multi-centers, cross-sectional study, conducted in Kwong Wah Hospital and Wong Tai Sin Hospital, Hong Kong SAR. Age and comorbidity-matched COPD and control subjects were recruited from clinics. Depressive symptoms were measured by a validated Chinese version of Geriatric Depression Scale short form (GDS - 15 items) with 2 cut-off points. A score of 8 or above was considered significant depressive symptoms while the cut off score of 5 or above was for patients with mild depressive symptoms. Prevalence rates of depressive symptoms were measured in both COPD and control groups. Predictors for depression (GDS = or\> 8) were determined using univariate and multivariate analysis.

Eligibility Criteria:
Inclusion Criteria:

* aged 60 or above,
* with stable COPD suggested clinically and
* post-bronchodilator spirometry FEV1/FVC ratio \<0.7.

Exclusion Criteria:

* Patients were excluded if they had co-existing pulmonary diseases like active pulmonary tuberculosis, interstitial lung diseases etc;
* if they were too demented or physically incapacitated to participate e.g wheelchair-bound for bedbound.
A Retrospective Epidemiological Study on Pneumococcal Infection in Children in Ministry of Health Hospital at EHSA Region in the Eastern Province

The purpose of this study is to establish retrospectively the incidence rates of invasive pneumococcal disease in children aged less than 5 years. The investigators allocate the El Hasa region for the study because it has higher incidence of sickle cell anemia. The study will include data from 2003 to 2007(before introduction of the vaccine) and then for 2008 and 2009 (after introduction of the vaccine).

Data will be collected from patents files or records for 5 years before the introduction of the vaccine and for 2 years after the introduction of the vaccine. We assigned 4 doctors in each hospital to carry and supervise the work.

Eligibility Criteria:
Inclusion Criteria:

* Invasive pneumococcal disease
* Children under 5 years
* Children lived in Elhasa region

Exclusion Criteria:

* Children above 5 years
* No invasive pneumococcal disease
Empirical Comperative Study Of Variation Blood Level Antibody Vitamin D at Different Groups Of Patients Compared Healthy Peoples

The aim of this study is to detect antibodies to vitamin D in the serum at Different Groups of patients and healthy volunteer. A second goal is to find the relation between Vitamin D Antibody and Vitamin D level.

Vitamin D and its metabolites have a significant role in the calcium homeostasis and bone metabolism. Vitamin D deficiency as measured by serum 25(OH)D below 20 ng/mL (50 nmol/L) may contribute to the development of osteoporosis and Osteomalacia.

Several studies have clearly demonstrated that low 25(OH)D levels are associated with more comorbidities, higher estimated cardiovascular risk and autoimmune diseases.

Exposure to the ultraviolet (UV) rays in sunlight is the major source of vitamin D. other sources are dairy products enriched with vitamin D.

Vitamin D deficiency can result from inadequate exposure to sunlight, malabsorption including inflammatory bowel disease, celiac disease and patients undergone resection of the small intestine and inadequate intake of dairy products enriched with vitamin D.

Another possible explanation for vitamin D deficiency is the presence of neutralizing autoantibodies to vitamin D.

The aim of this study is to detect antibodies to vitamin D in the serum at Different Groups of patients and healthy volunteer

At least 64 Blood samples of Patients and healthy volunteer will be tested for the presence of auto-antibodies using an ELISA reader.

The result will compare antibody-positive and antibody-negative individuals with respect of serum 25(OH)D level and other variables and to find the relation between Vitamin D Antibody and Vitamin D level.

Eligibility Criteria:
Inclusion Criteria:

1. Patients treated in Meir Medical Center
2. Data on serum vitamin D values
3. 18 years old
4. Both sexes
5. Patient hereby declare that he\\she agree to participate the clinical trial

Exclusion Criteria:

1. Patient refuses to sign Informed Consent.
2. Patients without vitamin D values
TDF VS LAM + ADV in LAM + ADV Treated LAM-resistant CHB Patients With Undetectable Hepatitis B Virus DNA

This study will provide a rationale for switch from lamivudine plus adefovir to tenofovir monotherapy in Lamivudine plus Adefovir Treated Lamivudine-resistant chronic hepatitis B patients with Undetectable Hepatitis B Virus DNA

Recently, in Korea, long-term medication of antiviral agents and their resulting resistance expression have been the most serious cause of failure to treat chronic hepatitis B. Exp.

In particular, the annual resistance rate to lamivudine currently widely being used in Korea amounts to about 15 to 20 percents and the rate is expected to reach 70 to 80 percent in four to five years.

The guidelines by the American Association for the Study of Liver Disease (AASLD) and the European Association for the Study of the Liver (EASL) recommend a combination therapy with adefovir or tenofovir for patients with lamivudine resistant HBV .

In Korea, however, in case of combined prescription of lamivudine and adefovir, only one of them is covered by the health insurance and therefore many patients are difficult to continue treatment due to their economic conditions.

Tenofovir that has been developed most recently and will be placed on sale sooner or later in Korea has strong antiviral effects, causes little or no emergence of resistant viruses, and is known to have lower nephrotoxicity than adefovir.

In particular, several papers reported that tenofovir has effective and sustaining antiviral effects in patients who had other antiviral agents resistant HBV as well as those who received initial treatment. This shows that patients only with lamivudine resistant HBV can be treated only with tenofovir without a combination therapy and when they have low levels of HBV DNA, treatment is relatively effective despite their resistance to adefovir.

Therefore, it is considered that tenofovir switching therapy in patients with undetectable HBV DNA after lamivudine plus adefovir combination therapy to maintain their virus response.

The results of this study will provide a rationale for switch from lamivudine plus adefovir to tenofovir monotherapy in such patients.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged 18 or older
* The CHB patients (both HBeAg-positive and - negative) who have at least 6 months undetectable HBV DNA (serum HBV DNA ≤ 20 IU/mL) after lamivudine plus adefovir combination therapy.

Exclusion Criteria:

* Patients with decompensated liver disease
* Patients with HCV, HDV or HIV
* Patients with HCC
* Serum ALT \> 2x ULN level
* Serum creatinine \> 2.0mg/dL
* Pregnant or lactating women
* Women who have a plan for pregnancy within the three coming years
* Patients who have uncontrolled severe concomitant diseases- severe cardiovascular diseases and other infection
* Those who have no capabilities to understand and sign an informed consent
Safety, Pharmacokinetics and Efficacy of KBSA301 in Severe Pneumonia (S. Aureus)

The objectives of this study are to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical outcome of patients who have severe pneumonia caused by Staphylococcus aureus (S. aureus) after a single intravenous administration of KBSA301 in addition of standard of care antibiotic treatment.

S. aureus is a leading cause of bloodstream, skin, soft tissue, and lower respiratory tract infections worldwide. The frequencies of both nosocomial and community-acquired S. aureus infections have increased steadily over the years and the treatment of these infections has become more challenging due to the emergence of multi-drug resistant strains (e.g. methicillin-resistant Staphylococcus aureus).

S. aureus has several virulence factors that contribute to the pathogenesis of the infection. Amongst them, alpha-toxin that is involved in the pathogenesis of pneumonia, as it leads to apoptosis and cell lysis, in particular lymphocytes, macrophages, alveolar epithelial cells, pulmonary endothelium, and thrombocytes.

In spite of preventive measures for S. aureus infections and current medical treatment (mostly antibiotic therapy, alone or in combination), there is a clear unmet medical need in the clinic for additional treatment options. Passive immunotherapy with monoclonal antibodies may improve treatment options for severe and life-threatening infections like those caused by S. aureus.

Eligibility Criteria:
Inclusion Criteria:

* Adult male or female patients ≥ 18 years and ≤ 70 years of age
* Severe pneumonia caused by S. aureus (either methicillin-resistant or methicillin-sensitive) managed in an ICU
* APACHE II of ≤30 at the time of diagnosis
* Identification of S. aureus
* Written informed consent provided by the patient, the relatives or the designated trusted person and/or according to local guidelines

Exclusion Criteria:

* Women of child bearing potential are excluded from the participation from the study unless they have a negative pregnancy test at baseline and during the course of the study. Postmenopausal women or females that have been surgically sterilized are allowed to participate.
* Hypersensitivity to excipients or to any prescribed medication
* Severe neutropenia, lymphoma or anticipated chemotherapy
* Patients who have long-term tracheostomy
* Current or recent investigational drug (within 30 days of enrollment, or 5 half-lives of the investigational compound, whichever is longer)
* Presence of meningitis, endocarditis, or osteomyelitis
* Acquired immune deficiency syndrome (AIDS) with cluster of differentiation 4 (CD4) count \<200 cells/ml
* Known bronchial obstruction or a history of post-obstructive pneumonia.
* Active primary lung cancer or another malignancy metastatic to the lungs
* Cystic fibrosis, known or suspected Pneumocystis jiroveci pneumonia, or known or suspected active tuberculosis
* Immunosuppressive therapy
* Liver function deficiency
* Moribund clinical condition
A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)

This is a phase 3, open-label extension study to assess the long-term safety of KarXT for the treatment of mania or mania with mixed features in Bipolar-I disorder (BP-I)

The primary objective of the study is to evaluate the long-term safety and tolerability of KarXT in the treatment of participants with mania or mania with mixed features associated with BP-I.


Eligibility Criteria:
Inclusion Criteria:

* Participants who participated in double-blind placebo-controlled study (CN0120036 or CN0120037):

  a. Participants must have completed treatment period of parent study.
* De novo participants who did not participate in double-blind placebo-controlled studies:

  1. Participants must have primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation based on DSM-5-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI, v7.0.2), with symptoms of mania or mixed mania.
  2. Participants must have Young Mania Rating Scale (YMRS) score of ≥ 14 at Screening and at baseline.
  3. Participants must have CGI-BP score of ≥ 3 at Screening and at baseline.
  4. Participants does not require hospitalization for acute mania.

Exclusion Criteria:

* Participants who participated in double-blind placebo-controlled study (CN0120036 or CN0120037):

  a. Discontinuation from any KarXT parent studies.
* De novo participants who did not participate in double-blind placebo-controlled studies:

  1. All participants with a risk for suicidal behavior at baseline as determined by Investigator's clinical assessment or history of suicidal behavior as assessed on C-SSRS.
  2. Participants must not have primary diagnosis of BP-I with rapid cycling (ie, ≥ 4 distinct mood episodes in one year).
  3. Participants must not have any primary DSM-5-TR disorder other than BP-I with mania or mania with mixed features within 12 months before Screening (confirmed using MINI version 7.0.2 at Screening), including BP-I with depression, (previous 3 months only), Bipolar-II disorder, major depressive disorder, and primary psychotic disorder, with the exception of mild anxiety disorders.
  4. Individual has a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before Screening (confirmed using MINI version 7.0.2 at Screening), or current use as determined by urine toxicology screen or alcohol test.
  5. Participants must not have history of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months.
  6. Participants must not have history or high risk of urinary retention, gastric retention, or untreated narrow-angle glaucoma.
  7. Other protocol-defined Inclusion/Exclusion criteria apply.
Autonomic Monitoring in Neurocardiogenic Syncope

This is a prospective observational pilot study of suitability of autonomic monitoring via the VU-AMS device for prediction of neurocardiogenic syncope (NCS) in children referred to cardiopulmonary exercise testing (CPET) for a diagnosis of syncope. The study population is children referred for CPET to evaluate for neurocardiogenic syncope. The purpose is to describe autonomic function during rest and exercise and determine the positive predictive value of autonomic function measurements against the gold standard for diagnosis of neurocardiogenic syncope, the CPET. Children presenting for CPET with chest pain or who are status post orthotopic heart transplantation will serve as positive and negative controls respectively.


Eligibility Criteria:
Inclusion Criteria:

* Parent/Legal guardian able to provide informed consent
* Verbal participant assent
* Undergoing clinically indicated CPET.
* Diagnosis of either syncope, chest pain/dyspnea or status post OHT
* Participant willing and able to participate in study procedures
* Age 7-24 years

Exclusion Criteria:

* Participant unwilling or unable to participate
* Contraindication to adhesive placement, eg, epidermolysis bullosa
* Cancellation of the subject's planned CPET procedure.
* Tracheostomy tube presence (this will prevent proper placement of impedance cardiogram lead)
Study to Investigate the Efficacy of Symbicort® SMART.

The primary objective of this study is to compare the efficacy of Symbicort SMART (Symbicort Turbuhaler 160/4.5μg, one inhalation twice daily plus as needed) with Symbicort Turbuhaler 160/4.5μg, one inhalation twice daily plus terbutaline Turbuhaler 0.4 mg as needed, as asthma therapy


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of asthma according to the Global Initiative for Asthma guidelines (GINA) 2007 with a documented history of at least 6 months duration.
* Reversible airway obstruction, defined as an increase in FEV1 ≥12% relative to baseline for all patients 15-30 minutes after inhalation of in total 2 x 0.4 mg terbutaline Turbuhaler
* Prescribed use of inhaled glucocorticoid steroid (GCS) (any brand) for at least 12 weeks.

Exclusion Criteria:

* Respiratory infection affecting the asthma, as judged by the investigator, within 4 weeks.
* Intake of oral, rectal or parenteral GCS within 4 weeks and/or depot parenteral GCS within 12 weeks.
Misoprostol Versus Oxytocin for Induction of Labour in Parturients With Spontaneous Rupture of Fetal Membranes at Term

Intravenous oxytocin titration has a prime position as a choice agent for induction of labour following term PROM as it has been shown to be efficacious for such purpose. Recent evidence however has shown that misoprostol is associated with better outcomes and merits evaluation in our environment. This study compared the efficacy of misoprostol and oxytocin for induction of labour in parturients with term Prelabour Ruptuture of Membranes.

Induction of labour for term premature rupture of fetal membranes (PROM) is associated with greater maternal satisfaction and lower risk of maternal infection compared with expectant management. The ideal method of induction of labour for term PROM is a subject of controversy. Intravenous oxytocin titration has a prime position as a choice agent for induction of labour following term PROM as it has been shown to be efficacious for such purpose. Recent evidence however has shown that misoprostol is associated with better outcomes and merits evaluation in our environment.

This study compared the efficacy of misoprostol and oxytocin for induction of labour in parturients with term PROM. This was a double blind randomized controlled trial on the efficacy of sublingual misoprostol versus oxytocin titration in women with term PROM at the Alex Ekwueme Federal University Teaching Hospital Abakaliki (AEFUTHA) and Mile 4 Hospital Abakaliki. 240 Participants were divided into two groups of 120 participants each. Group A received 25 mcg of sublingual misoprostol and titration of 500 ml of Ringer's lactate solution as placebo with 5ml of sterile water injected into it while group B underwent immediate induction of labour with titration of 5 units of oxytocin in a 500 ml of Ringer's lactate solution and received one tablet of 100mg Vitamin C as placebo. The primary outcome measure was the mean induction delivery interval. The secondary outcome measures were Caesarean section rate, the incidence of uterine hyper-stimulation, tachysystole or hypertonus, APGAR scores at the first and fifth minute and NICU admission. Data analysis was done using statistical Package for Social Science (IBM SPSS) software (version 20, Chicago IL, USA). Continuous variables were presented as mean and standard deviation (Mean ± SD), while categorical variables were presented as numbers and percentages. Categorical variables were analyzed using Chi-square while means were compared using T-test. A difference with a P value of \<0.05 was considered significant.

Eligibility Criteria:
Inclusion Criteria:

* signed informed consent
* singleton pregnancy at term
* prelabour rupture of membranes
* not having contraction
* Bishop scoe 5 or less

Exclusion Criteria:

* prelabour rupture of membranes at less than term
* declined consent
* contraindication for vaginal delivery
* multiple gestation
* medical conditions co-existing with pregnancy
* grand multiparous parturients
* previous caesarean section scar
* already having contractions
* has intrauterine foetal death
* bishop sore \>5