cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Effect of Streptococcus Salivarius K12 Probiotic in the Treatment of Periodontitis

Aims: The use of oral probiotics as an adjunct to the treatment of periodontal diseases is known to be beneficial in antagonizing pathogenic microflora and regulating the host immune response. The aim of this clinical study was to evaluate the clinical, microbiologic and biochemical effect of Streptococcus salivarius (S. salivarius) K12 probiotic tablet as an adjunct to scaling and root planing (SRP) treatment in stage 3 periodontitis patients.

Methods: The study included 30 systemically healthy stage 3 periodontitis patients. After non-surgical periodontal treatment, participants were randomly assigned to the test (SRP+Probiotic, n=15) or control (SRP, n=15) group. Patients in the test group used probiotic tablets once daily for 30 days. Clinical (Plaque index (PI), gingival index (GI), bleeding on probing (BOP), probing depth (PD), clinical attachment level (CAL)), microbiological (Porphyromonas gingivalis, Treponema denticola, Tannerella forsythia, Prevotella intermedia, Aggregatibacter actinomycetemcomitans, Fusobacterium nucleatum) and biochemical (IL-6, IL-8, IL-10) measurements were performed at baseline (before SRP), 30. and 90th days. Data were analyzed statistically.

Keywords: Microbiology, Periodontitis, Probiotics, Cytokines


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18-60 years,
* No systemic disease,
* No periodontal treatment in the last 6 months,
* No antibiotic therapy in the last 6 months,
* Diagnosed with stage 3 periodontitis according to the 2017 periodontal disease classification

Exclusion Criteria:

* Periodontal treatment within sixteen months,
* Smoking,
* Patients with systemic health problems such as diabetes, rheumatoid arthritis, neurological diseases, lung and kidney diseases,
* Pregnancy or lactation,
* Acute oral lesions or necrotizing ulcerative periodontitis.
Phase II Pilot Study of Octreotide, a Somatostatin Octapeptide Analog, for Gastrointestinal Hemorrhage in Hormone-Refractory Hereditary Hemorrhagic Telangiectasia and Senile Ectasia

OBJECTIVES:

I. Evaluate the efficacy of octreotide, a somatostatin octapeptide analog, in decreasing gastrointestinal bleeding in patients with hormone-refractory hereditary hemorrhagic telangiectasia or senile ectasia.

PROTOCOL OUTLINE: Patients are treated with subcutaneous injections of octreotide twice a day. The dose is adjusted based on response.

If there is no requirement for transfusions or intravenous iron for 4 weeks and the hemoglobin is greater than 10 mg/dL, therapy is continued for 1 year. If there is no decrease in bleeding after 10 weeks, the patient is removed from study.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Hereditary hemorrhagic telangiectasia or senile ectasia Refractory to or unable to tolerate hormonal therapy, i.e.: Estrogen Progesterone Danazol Gastrointestinal (GI) hemorrhage requiring transfusion within past 3 months Recurrent GI bleeding over more than 1 year At least 4 units packed RBCs transfused within past year OR intravenous iron required more than 4 times within past year No other likely source of hemorrhage determined within past year --Prior/Concurrent Therapy-- Disease hormone-refractory --Patient Characteristics-- No octreotide sensitivity
Social Networking on Mobile Phone to Improve Maternal and Neonatal Outcomes

The purpose of the study is to determine whether social networking on mobile phone in antenatal care health education is effective in the improvement of maternal and neonatal outcomes compared with usual antenatal care.

Health Education Intervention with Social Networking (HISONET) is a open-label randomized controlled trial. The objective of this study is to determine the efficacy of social networking media on mobile phone intervention in antenatal care (ANC) group-health education compared with usual ANC health education. The incidence of preterm delivery and major neonatal morbidity including respiratory distress syndrome, stillbirth and perinatal mortality in women delivering from 28 to 36 weeks' gestation are significant outcomes in a randomized prospective design. Preterm delivery occurs in approximately 9.6% as global incidence, and about 11.1% in South-Eastern Asia. Forty-four percent of child under 5 years died in neonatal period. Preterm birth is one of the three leading causes of neonatal death which 15% died from preterm birth complications such as respiratory distress syndrome, intraventricular hemorrhage, necrotizing entercolitis, and sepsis. Recent studies demonstrate that Short Message Service (SMS) on mobile phone intervention in antenatal care can increase numbers of ANC attendance to WHO recommendation of four or more visits and decrease in perinatal mortality.

Social networking on mobile phone has been increasingly used in daily life of both healthcare personnel and women who attend ANC clinic. However, there is lack of evidence that demonstrates the effect of social networking on mobile phone to improve maternal and neonatal outcomes. LINE, a mobile application, is a popular one of many social networking applications. So, health education through LINE of antenatal women about serious complications such as labor pain, bleeding, water breaking and fewer fetal movement during pregnancy may encourage them to come to the hospital as early as possible. Early diagnosis of premature labor provides early management and better maternal and neonatal outcomes. So, a randomized controlled trial should be conducted to answer these questions.

Eligibility Criteria:
Inclusion Criteria:

* women who attend antenatal care clinic and have intention to deliver at the study hospital.
* Thai race
* participant or husband or relatives is an owner of mobile phone with social networking application

Exclusion Criteria:

* participant is known by other one in different study arm (contamination)
* cannot be assess on wel-being about privacy, delivery failure and misinterpretation of media via social network after complete study
Anastrozole Administration in Elderly Hypogonadal Men

The purpose of the study is to assess the effects of sustained aromatase inhibitor therapy to reduce estrogen levels in elderly men with mild hypogonadism (a decreased level of sex hormones).

It has long been accepted that aging in men is associated with a slow, steady decline in gonadal androgen (male sex hormone) production. Several studies have explored androgen replacement, but the safety and efficacy of testosterone administration remains controversial. Aromatase inhibitors may provide a particularly useful way to restore normal androgen production in aging men.

This study will recruit 150 male volunteers, 60 years of age or older, to be randomized to receive either anastrozole or a placebo for 24 months. Six visits are planned over the 96-week treatment period.

Eligibility Criteria:
Inclusion Criteria:

* Men ages 60 and older
* Serum testosterone between 150-300 ng/dL
* Symptoms suggestive of androgen deficiency
Dietary Intervention of Stress-Induced Neurovegetative Disorders With a Specific Amino Acid Composition (asn01)

Psychosocial stress leads to altered neuroendocrine functions, such as serotonergic dysfunction, as well as alterations of the autonomic nervous system and the hypothalamic-pituitary-adrenal (HPA) axis activity resulting in an imbalance between inhibitory and excitatory neurotransmitters. Clinical consequences include, inter alia, neurovegetative disorders, higher resting heart rate, hypertension, depressive symptoms, sleep disturbances, irregular body-weight changes, and insulin resistance. Poor dietary intake of the essential amino acid L-tryptophane as a precursor to 5-hydroxytryptamine (HT, serotonin) increases sensitivity to stress.

It is therefore the investigators hypothesis that daily oral administration of an amino acid mixture (dosage 3.8 g/day) with micronutrients specifically designed to decrease neurovegetative disorders will target these neuroendocrine and metabolic alterations in adults with psychosocial stress. The principal endpoints will be a decrease in points in the psychological-neurological questionnaire (PNF).


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-65 Years
* Psychological-Neurological Questionnaire (PNF): 30 - 50 Points

Exclusion Criteria:

* Age: \< 18 and \> 65 Years
* Psychological neurological questionnaire (PNF): \< 30 and \> 50 Points
* Resting heart rate: \< 70/min
* Supplementation with dietary supplements or drugs which contains amino acids, vitamins and other micronutrients
* Therapy with antipsychotic drugs such as tranquilizer, antidepressants
* acute and chronic diarrhea
* Psychological-neurological or psychiatric therapy
Clinical Epidemiology Cohort Study for Patient Living With HIV

This is a retrospective observational cohort study for the patient living with HIV aiming to understand more in disease progress, resistant mutation, comorbidity, and common coinfection.


Eligibility Criteria:
Inclusion Criteria:

* Patient living with HIV receiving follow-up in Kaohsiung VGH

Exclusion Criteria:

* not applicable
Effectiveness of Phenylefrine in Prevention of Hypotension During Spinal Anesthesia for Cesarean Delivery

Hypotension in patients who are taken to surgery, is a very frequent complication, when the spinal anesthetical technique is used, associating this with significant adverse effects that can lead to morbidity specially in the obstetric patient. The objective of the study is determine if the phenylephrine used of prophylactic form, achieved to prevent the appearance of hypotension in obstetric patients led to Caesarea under spinal anesthesia.

Worldwide, the caesarean section is one of the surgical procedures most frequently performed, representing a challenge to the anesthesiologist, who must administer anesthesia to the mother with minimal effects in the newborn. For this reason, spinal anesthesia emerges as an important option in the management of the obstetrical patient who is going to be taken to Caesarea. The hypotension, is one of the most frequent events adverse associated to this technical anesthetic, represented a risk of complications both, in the mother as in the fetus, by this reason the anesthesiologist must implement different strategies to treat it when this be present. From there arises the necessity of establishing if the phenylephrine, a drug used to treat hypotension, when is administed prophylactically, allows to avoid this effect. We designed a randomized clinical trial in elderly patients over 18 years who are taken to Caesarea, where they formed two groups of patients, one that will administer a prophylactic infusion of phenylephrine compared with placebo, assessing the incidence of hypotension in the two groups and the adverse events most commonly associated with this.

Eligibility Criteria:
Inclusion Criteria:

* pregnant subjects who are to be delivered to cesarean section under subarachnoid anesthesia
* Gestational age \>37 weeks

Exclusion Criteria:

Pregnant subjects with:

* Hipertensive disorders in pregnancy
* Acute fetal distress
* Evidence of placental dysfunction
* History of cardiovascular or cerebrovascular diseases
* hypersensitivity to phenylephrine
* Rejection of the patient
Use of Hyperpolarized Xenon Gas for Lung Imaging in Children and Adults

The goal of this study is to evaluate the usefulness of hyperpolarized (HP) 129Xe (xenon) gas MRI for regional assessment of lung function in a normal population of children and adults and in adults and also in children with respiratory compromise due to a variety of diseases.

Hyperpolarized 129Xe will be produced, by trained staff, using a polarizer housed at Cincinnati Children's Hospital Medical Center. Individual imaging sessions will be done on a single day and will involve administration of (maximum) 1 liter doses (less for children) for up to four MRI scans. Subject will inhale hyperpolarized xenon gas and hold breath for up to 16 seconds during the MRI scans. In addition to 129 Xe MRI, a series of anatomical conventional proton MR images may also be collected. Follow up phone calls will be done one day and 30 days from the MRI date.

Eligibility Criteria:
Inclusion Criteria:

* Ages 6 and up
* Participant must be able to hold breath for up to 16 seconds

Exclusion Criteria:

* History of heart defect
* Pregnancy or positive pregnancy test
* History of uncontrolled asthma defined for this study as requiring use of rescue inhaler ≥ 2 times in past month
* Symptoms of respiratory infection (loose or productive cough or wheeze), chest tightness, or sinus infection within past week
* Baseline oximetry at MRI visit of less than 95% on room air or less than 95% on a previously prescribed dosage of oxygen delivered by nasal cannula
* Participant is claustrophobic and unable to tolerate the imaging.
* Standard MRI exclusions (metal, implants)
Study to Characterize Demographics, Compliance, Tolerability and Safety in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis Prescribed Adalimumab (Humira®) as Part of Routine Clinical Care

The primary objective of this post-marketing observational study was to obtain data on the characteristics (patient age/gender; disease type, severity and duration; disease specific treatment history; current concomitant medications; other relevant medical history) of patients prescribed adalimumab (Humira®) for rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PsA) as part of routine clinical care in Russia.

This is a non-interventional, observational study in which adalimumab is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication. No data currently exist that characterize patient types and adalimumab administration within the Russian population. Further, it is important to characterize the compliance, acceptability of patient self-injection, tolerability and safety profile of this therapy option with the routine clinical care.

The total follow-up for each participant was planned to be 12 months, with approximately 6 follow-up visits occurring at average intervals of 2-3 months. However, since this was an observational study, follow-up was performed according to routine clinical practice; for 127 participants the follow-up period consisted of more than 12 months and the maximum observation period lasted 18.2 months. Follow-up visits were designated sequential visit numbers (Visit 1-6), regardless of the time point at which they occurred.

Eligibility Criteria:
Inclusion Criteria:

Patients for whom adalimumab therapy is indicated according to product label and who meet the following criteria:

* Patients who are newly prescribed adalimumab therapy (no prior history of treatment with adalimumab) including patients with infliximab treatment history.
* Patients who completed Abbott sponsored interventional trials and are continuing treatment with commercial adalimumab thereafter.

Exclusion Criteria:

The following patients will not be included in the study:

* Patients who are being treated or will be treated with drugs at risk of interactions with adalimumab.
* Hypersensitivity to adalimumab
* Pregnancy
* Lactation
* Age below 18
* Infectious diseases including tuberculosis
* Patients currently participating in another clinical trial.
Drug Interaction Study of GBT440 With Caffeine, S-warfarin, Omeprazole, and Midazolam in Healthy Subjects

The purpose of this study to evaluate the effect of concomitant administration of GBT440 on caffeine (a CYP1A2 probe substrate), S warfarin (a CYP2C9 probe substrate), omeprazole (a CYP2C19 probe substrate), and midazolam (a CYP3A4 probe substrate) plasma concentrations.


Eligibility Criteria:
Inclusion Criteria:

* Subject is a female of non-childbearing potential or male, who is healthy, nonsmoking, and 18 to 55 years old, inclusive, at screening
* Male subjects agree to use contraception
* Willing and able to give written informed consent

Exclusion Criteria:

* Evidence or history of clinically significant metabolic, allergic, dermatological, hepatic, renal,hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
* History of hypersensitivity or allergy to drugs, foods, or other substances
* History or presence of abnormal electrocardiogram or hypertension
* History of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or any history of drug abuse or addiction within 1 year of screening
* Participated in another clinical trial of an investigational drug within 30 days (or 5 half-lives of the investigational drug, whichever is longer) prior to Screening
"Evaluation of Static and Dynamic Postural Balance in Children With Thoracic Hyperkyphosis"

The purpose of our study; is to investigate how balance parameters are affected in comparison with healthy children in children with thoracic hyperkyphosis and to examine the relationship of these results with muscle strength, shortness-flexibility, pain, range of motion, functional status, physical activity level and quality of life. The hypothesis of the study is that children with thoracic hyperkyphosis have impaired balance compared to their healthy peers. With this finding, it can be ensured that clinical evaluations and treatment strategies for balance in children with hyperkifosis are included in the treatment plan. 31 children with thoracic hyperkyphosis were included in the evaluation group, and 31 children with normal physiological curves were included in the control group. Participants were evaluated once by the physical therapist.

The study was included chidren with hyperkyphosis at the İstanbul University-Cerrahpaşa, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation. G\*Power 3.1.9.2 program was used to calculate the sample size. Due to the absence of MCID value for the Biodex Balance System in the literature while sample size calculation, the average values for males and females are 3.83 and 3.05 based on the "Overall Stability Index" based on the dominant side from a similar study conducted with healthy young adults; standard deviation values were placed in the formula as 1.03 and 1.13 (σ). (power=80%, α=0.05, significance level 2-tailed, and effect size d = 0.73). A total of 62 cases were decided to be included in the study, with 31 individuals per group. Participants were evaluated once by the physical therapist. Evaluation consist of demographic information form, Biodex Balance System, visual analog scale, "Hand-held" dynamometer, range of motion, pektoralis minor muscle flexibility, triple-hop distance test, 20-m sprint test, Physical Activity Questionnaire for Children, Pediatric Quality of Life Inventory, functional reach test and occiput-wall distance. SPSS (Statistical Package for Social Sciences) 22 statistical program was used for the statistical analysis of the data. Normality was assessed using the Shapiro-Wilk test. The "Chi-Square Test" was used to compare the difference between groups for categorical variables such as gender, dominant side, and educational status. The statistical analysis for group comparisons was performed using the "Mann-Whitney U Test" for non-parametric samples. Correlation analysis between the data was done with "Spearmann r Test". In all tests, a significance level of 0.05 (5%) was used.

Eligibility Criteria:
Inclusion Criteria:

* Thoracic kyphosis angle: ≥ 45˚ (Cobb)
* Age between 9-18 years
* Volunteering to participate in the study
* Not physiotherapy
* Not cest tretment

Exclusion Criteria:

* Spinal surgery history
* Vision and hearing impairment
* Difficulty in detecting commands given
* Lower extremity affect that may affect balance
* Systemic disorder associated with balance
* Neurological influence
* \> 20˚ (Cobb) scoliosis deformity
Efficacy Study of LIQUICURE™ to Treat Toe Nail Fungus

There is a major clinical need for an inexpensive topically-applied product that can inhibit the growth of the dermatophytes that cause nail fungus. Chesson Labs has developed LIQUICURE with a longer drying/curing time that will allow better nail penetration or adsorption. Though the product may have inherent antimicrobial activity, the product does not contain a drug or antimicrobial agent.

Consistent use of LIQUICURE as described will clear fungal nail infection. Clearing of nail fungal infection is defined by negative dermatophyte culture and visual improvement in nail characteristics within six months, with few, if any product-related adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Nail fungal infection of at least one great toe \[per visual assessment, positive KOH preparation, and positive dermatophyte culture\]
* Subjects who have target toenail showing 20-65% involvement as judged by the clinical investigator
* 2 mm of clear nail proximally on great toenail / no lunula involvement
* Subject must be physically able to reach toes to clean them and apply product
* Subject is willing to discontinue use of other nail fungus treatment products and nail cosmetic products for duration of this study
* Subject is willing and available to return for study follow up
* Ability of the subject or legal representative to understand and provide signed consent for participating in the study
* Negative urine pregnancy test for women of child bearing age
* Females must be post menopausal or must agree to use approved contraceptives (actions, devices or medications to prevent or reduce the likelihood of pregnancy) throughout the study (Note: abstinence is NOT an accepted form of contraception)

Exclusion Criteria:

* Known hypersensitivity or allergy to the product materials
* Negative KOH preparation or dermatophyte culture
* Thickness of nail greater than 3 mm
* Enrollment in another investigational drug or product protocol that would interfere with this study
* Continuation or use of other topical or pharmaceutical treatments for the condition; a wash-out period of at least four weeks after discontinuation of a topical product or 180 days after discontinuation of an oral product for treatment of nail fungus is required
* Chronic disease, including: diabetes, psoriasis, immune deficiency, severe foot injury, chronic vascular disease or any other condition that would decrease circulation to the extremities at the discretion of the investigator Pregnant or nursing females
* Investigators, Chesson personnel, or Chesson Scientific Advisory Board members or their immediate family
Gastroesophageal Varices in Cavernoma

Myeloproliferative neoplasms (MPNs), including polycythemia vera, essential thrombocythemia, and primary myelofibrosis, may lead to gastroesophageal varices. The quality of life, morbidity, and mortality of MPN patients mainly depend on disease-related symptoms, thromboembolic and hemorrhagic complications. Previous studies have shown that JAK2 V617F has a prominent role in vascular risk and MPN-associated gastroesophageal varices. Portal vein thrombosis and portal cavernoma frequently occur in the MPN population and the management of gastroesophageal varices in these patients are sometimes technically difficult. The aim of this study is to investigate the the characteristics of patients with gastroesophageal varices and portal caver cavernoma with or without JAK2 mutation.


Eligibility Criteria:
Inclusion Criteria:

* male or female patients aged 18-75
* diagnosed as portal hypertension and portal cavernoma by contrast-enhanced computed tomography
* underwent JAK2 mutation test

Exclusion Criteria:

* combined known etiologies of chronic liver disease, including hepatitis, primary biliary cirrhosis, schistosomiasis, and non-alcoholic fatty liver disease.
* other factors judged by the investigator that may affect the safety of the subject or the compliance of the trial. Such as serious illnesses (including mental illness) that require combined treatment, serious laboratory abnormalities, or other family or social factors.