cyrilzakka/clinical-trials huggingface dataset:
Avian Influenza Studies In Lebanon

The highly pathogenic avian influenza (HPAI) H5N1 virus arrived in the Middle East in 2005 and has since established itself in local domestic birds and is now considered endemic in several Middle Eastern countries.Few studies indicate the presence of low pathogenicity avian influenza (LPAI) viruses of the H9 type among Lebanese poultry and wild birds. These studies also provide some evidence suggesting that humans exposed to these sick birds are showing elevated antibody titers against these LPAI H9 viruses.

This study will focus on the following objectives:

* To determine the seroprevalence of AI in poultry-exposed and non-exposed human populations.
* To identify risk factors associated with AI infections in occupationally-exposed poultry workers.
* To conduct nation-wide cross-sectional surveillance for AI viruses among domestic birds in low biosecurity farms and backyard flocks.

This study will examine the sera of 200 poultry-exposed adults and 50 adult controls and administer questionnaires to identify risk factors for AI infections in human beings.Study volunteers will be interviewed regarding their exposures, medical history, and behaviors using a close-ended questionnaire specifically tailored for this study. A blood sample will be collected from every participant to verify presence of antibodies against the viruses under study. All study materials are in English and Arabic. Along side the human aspect of the study, specimens will be collected from the birds that the individual handles.

This study hypothesizes that they will find evidence of previous infection with these viruses among poultry workers. Furthermore, the study team will collect animal specimens from the farms of the study volunteers and determine the types of Avian Influenza viruses that they harbour.

Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years old.
* Be willing to participate by signing a consent form, completing the study questionnaire, and providing a blood sample.

Exclusion Criteria:

* Less than 18 years old.
* Any known immunosuppressive condition or immune deficiency disease (including HIV infection), or ongoing receipt of any immunosuppressive therapy. (Note that we have chosen to exclude such populations because of their increased risk of acquiring infections, they are relatively few, and are not representative of a national sample).
* Any individual with unknown poultry exposure status, or who was exposed to poultry more than 5 years ago.
Adherence of a 1.600 mg Single Tablet 5-ASA Treatment of Ulcerative Colitis

Several oral mesalazine (5-ASA) formulations exist, but the regimes require several tablets per day. Such regimens are not ideal and can interfere with normal daily activities of patients. Non-adherence has been associated with an increase in the risk of relapse and worse disease course; leading to a decrease in quality of life, an increase in societal and personal costs, and worst case increases the risk of colorectal cancer. Recently, a new formula for 5-ASA has been approved by the Danish Medicine Agency, with a single tablet regime per day.

Primary purpose:

• To investigate whether a simplified treatment regimen for 5- ASA (1600 mg as one tablet per day \[intervention\]) improves adherence with preserved remission rates compared to conventional therapy.

Secondary purposes:

* Compare levels of endoscopic, mucosal and histological inflammation in predicting risk of relapse between the intervention group and the conventional therapy group.
* Investigate whether a simplified treatment regimen improves the disease course compared to the conventional therapy.
* To assess the correlation between different endpoints and the disease courses, with the use of clinical, endoscopic, histological, self-reported and biochemical markers.
* Improve, correlate and assess patient-reported outcomes in a prospective manner.
* To establish a biobank of cases with quiescent/mild ulcerative colitis (UC) for identification of future biomarkers.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Age between and including 18 and 60
* Diagnosed with UC according to the Copenhagen Diagnostic Criteria
* Length of disease of max. 10 years
* Stable remission on 5-ASA (defined as partial Mayo score ≤1) for at least 2 months without need for oral corticosteroids before inclusion.
* Endoscopic remission defined as Mayo Clinic Endoscopic Score \< 2
* Have had a relapse within the last 2 years

  * Defined as the need of escalation of treatment or change medical treatment.

Exclusion Criteria:

* Evidence of infectious diarrhoea (i.e. pathogenic viruses, bacteria or Clostridium difficile toxin in stool culture) within the last month
* On immunomodulators, including methotrexate
* On any biological therapy
* Any previous abdominal surgery related to UC
* Any chronic infections (e.g. HBV, HCV, HIV)
* Any severe concomitant cardiovascular, autoimmune, hematologic, hepatic, renal, endocrine, oncologic or psychiatric disorder, which in the opinion of the investigator might have an influence on the patient's compliance or the interpretation of the results
* Well-founded doubt about the patient's cooperation, e.g., because of addiction to alcohol or drugs in the opinion of the investigators.
* Participation in another clinical trial within the last 30 days, or simultaneous participation in another clinical trial.
* Any previous documented allergic reaction to tested the medical drugs
Orodental Hygiene in Children With Special Needs

This clinical trial aims to learn about the general oral hygiene status of children with special needs and test the effect of hygiene education on their oral and dental hygiene. The main questions it aims to answer are:

* What is the general oral hygiene status of children with special needs?
* Does brushing education and dietary guidance to parents improve oral and dental hygiene in children with special needs? Participants will receive a complete oral and dental examination. Following this examination parents/legal guardians will be educated about the maintenance of oral and dental hygiene and dietary guidance will be provided. Patients will be evaluated one year after the education

One hundred and thirty children with special needs who are being rehabilitated at three rehabilitation centers (Maviel, Sirinler and Ugurlu Kalpler Rehabilitation Centers) in Kilis will undergo a complete oral and dental examination at which their oral bacteria (str. mutans) levels, PUFA and plaque indexes (indices that measure oral health) will be recorded. The parents/legal guardians of the children will be educated about dental hygiene toothbrushing and dietary habits leading to caries. After a year, the examination and assessments will be repeated. The change in oral hygiene indices will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Children with special needs
* Aged between 6-12 years

Exclusion Criteria:

* Refusal
* Being unable to complete oral examination due to lack of cooperation
Impact of Clomiphene Citrate Administration During the Early Luteal Phase on Endocrine Profile in IVF Cycles

The purpose of this study is to evaluate the effect on LH levels of the 5-day CC administration during luteal phase in oocyte donors, to investigate whether the CC corrects the suppressed LH levels in the luteal phase and whether it prolongs the luteal phase in the agonist triggered antagonist cycles.


Eligibility Criteria:
Inclusion Criteria:

* Oocyte donors
* 18-35 years old
* BMI 18-29 Kg/m2
* Normal basal hormonal levels
* No contraceptive pill

Exclusion Criteria:

* Polycystic ovarian syndrome (PCOS)
* Previous participation in the study
Stretching Versus Walking From Reducing Blood Pressure

High blood pressure is a leading risk factor for cardiovascular disease. Traditionally, one of the ways to treat or prevent high blood pressure is to prescribe aerobic exercise training (i.e.brisk walking). Previous studies have shown that stretching is also very effective for reducing blood pressure. This is an exciting possibility because if stretching is more effective, it would change the way exercise is prescribed to people with elevated blood pressure. This study will now assess 20 individuals in a supervised stretching or walking program five days per week for 8 weeks to determine for certain whether stretching is superior for reducing blood pressure. This research will contribute to recommendations about the most effective exercise programs for reducing blood pressure and risk of cardiovascular disease.

The study hypothesis is that stretching (flexibility training) will be superior to brisk walking for reducing blood pressure.

This is a parallel-group randomised trial. Twenty participants (aged 18 and older) with borderline or stage-1 hypertension (systolic blood pressure between 130 and 159 mmHg OR diastolic blood pressure between 85 and 99 mmHg) will be randomised to walking or stretching groups. Each group will do 30 minutes of exercise, five days per week. Exercise sessions will be supervised three days per week with participants doing exercise sessions on their own two days per week. Exercise sessions involve either brisk walking or stretching. The stretching exercises will involve stretching all major muscle groups. The main outcome is 24-hour blood pressure which will be assessed at baseline, after four weeks, and after eight weeks. Other outcomes will be assessed at baseline and eight weeks and include: Body weight, height, waist circumference, resting heart rate, physical activity levels (questionnaire), diet (questionnaire), maximal distance walked in six minutes. All participants will be counselled on how to follow the DASH eating plan, which involves reducing dietary salt intake.

Statistical analyses: All outcomes will be assessed with a group x time ANOVA with alpha level of 0.05. LSD post-hoc tests will be done when necessary to identify differences between pairs of means.

Eligibility Criteria:
Inclusion Criteria:

* Systolic blood pressure between 130 and 159 mmHg OR diastolic blood pressure between 85 and 99 mmHg

Exclusion Criteria:

* Individuals will be excluded if they have taken blood pressure medications within the past six months unless they are on a stable dose of medication and have not reach target blood pressure levels (i.e. systolic blood pressure below 130 mmHg and diastolic blood pressure below 85 mmHg)
Effects of Berberine Hydrochloride and Bifidobacterium in Prediabetes Prevention and Treatment

The aim of this study is to assess the beneficial effects of Bifidobacterium and Berberine Hydrochloride on lowering glucose and delaying progress to diabetes in patients with prediabetes and to detect the potential mechanism.

Gut microbiota may play an important role in patients with prediabetes. Berberine, which is usually used as an antibiotic drug, has been reported a potential glucose-lowering effect in vitro and in vivo studies. Bifidobacterium, as a familiar probiotics, can modulate gut microbiota and improve glucose and lipid metabolism in animal experiments. Therefore, the aim of this study is to assess the beneficial effects of Bifidobacterium and Berberine Hydrochloride on lowering glucose and delaying progress to diabetes in patients with prediabetes and to detect the potential mechanism.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any trial-related activities
* Male or female between 18 and 70 years of age
* 19≤Body mass index(BMI)≤30kg/m2
* No participate in any clinical trial at least 3 months
* Fasting blood glucose(FBG)\<7.0mmol/L and 2-hour postprandial blood glucose(2hPBG)\<11.1mmol/L
* Females in child-bearing period should be given birth control
* No severe disease about heart, lung and kidney
* Ability and willingness to adhere to the protocol including performance of self-monitored blood glucose (SMBG) profiles according to the protocol;
* Subject is likely to comply with the Investigators instruction.

Exclusion Criteria:

* Type 2 diabetes mellitus or type 1 diabetes mellitus
* Females of childbearing potential who are pregnant，breastfeeding or intend to become pregnant or are not using adequate contraceptive methods
* Impaired liver function, defined as Aspartate aminotransferase(AST) or Alanine transaminase(ALT)\> 2 times upper limit of normal (central laboratory)
* Impaired renal function, defined as serum-creatinine≥133μmol/L
* Uncontrolled treated/untreated severe hypertension (systolic blood pressure≥160mmHg and /or diastolic blood pressure≥95mmHg)
* Chronic gastrointestinal diseases
* Cancer and medical history of cancer (except basal cell skin cancer or squamous cell skin cancer)
* Any clinically significant disease or disorder, which in the Investigator's opinion could interfere with the results of the trial
* Mental incapacity, psychiatric disorder, unwillingness or language barriers precluding adequate understanding or co-operation, including subjects not able to read and write
* Previous participation in this trial. Participation is defined as randomized. Re-screening of screening failures is allowed only once within the limits of the recruitment period
* Known or suspected hypersensitivity to trial products or related products
* Known or suspected abuse of alcohol, narcotics or illicit drugs.
Assessing Pain by the painDETECT Questionnaire (PDQ)

Prospective cohort study using drug survival rates to assess the predictive value of the PDQ when used to classify patients into a non-neuropathic pain phenotype group (score \<13) or a neuropathic pain phenotype group (score ≥13)

The original painDETECT questionnaire (PDQ) DANBIO study was a survey among all DANBIO users having an arthritis diagnosis 'Pain and pain mechanisms in patients with inflammatory arthritis: A Danish nationwide cross-sectional DANBIO registry survey'. The PDQ was implemented onto the DANBIO touch screens for a period of 6 months in 2013-14 and data from more than 7000 individual patients were collected. The overall background for the study was that central pain mechanisms may be prominent in subsets of patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and other spondyloarthritis (SpA). The study showed that approximately 50 % of patients experienced significant pain levels and that a high PDQ score was associated with higher levels of pain and DAS28 but not with markers of inflammatory activity such as CRP and swollen joint count. Furthermore, indications of more frequent bio-switch in the PDQ groups showing neuropathic pain features were found.

The aim of this study is to examine the association between drug retention of biological DMARDs (bDMARDs) and the PDQ pain classification categories (i.e. non-neuropathic vs. neuropathic features) and to investigate whether this categorization is predictive of drug retention and changes in clinical outcomes over a 5-year period.

Eligibility Criteria:
Inclusion Criteria:

* Registered in DANBIO
* Having inflammatory arthritis (Specific diagnoses include RA, PsA and other SpA)
* At time of the PDQ assessment and up to 4 months thereafter being on ongoing bDMARDs treatment or on switch of bDMARD treatment.

Exclusion Criteria:

- Missing answer to PDQ
The Circadian Rhythm of Urine Output in Healthy Infants

The purpose of this study is to describe the 24-hour urine output including the urinary excretion of hormones, electrolytes and other osmotically active substances in healthy children age 0 to 3 years old.

The purpose of this study is to describe the 24-hour urine output including the urinary excretion of hormones, electrolytes and other osmotically active substances in healthy children age 0 to 3 years old.

Eligibility Criteria:
Inclusion Criteria:

* Healthy children, free of medication

Exclusion Criteria:

* History of urinary diseases
Safety and Pharmacokinetic Characteristics of HD203 Liq. in Healthy Subjects

The purpose of this study is compare the safety and pharmacokinetic characteristics of HD203 liquid with those of etanercept (enbrel) prefilled injection after subcutaneous injection.

A randomized, double-blind, single-dosing, crossover study to compare the safety and pharmacokinetic characteristics of HD203 Liquid 25 mg with those of Enbrel Prefilled® injection 25 mg after subcutaneous injection.

Eligibility Criteria:
Inclusion Criteria:

* 20 to 40 years of healthy volunteers
* Weight over 55kg
* Subject who signed on ICF

Exclusion Criteria:

* Subject who had been treated with Etanercept before
Effect of GEMS-H on Locomotor Function in Adults

The purpose of this study is to investigate the effect of training with the Gait Enhancing and Motivating System-Hip (GEMS-H) vs. training without the GEMS-H on locomotor function in adults. The investigator hypothesizes that long-term GEMS-H use would improve locomotor function. Specifically, individuals in the GEMS-H group will show faster gait speed compared to those in the control group.

The GEMS-H is a hip-type assist device developed by Samsung Electronics. The GEMS-H is worn around the waist and fastened at the waist and thighs by a set of belts with velcro to assist motion at the hip joints. The device weighs 2.1kg, and has 2 brushless direct current motors running on a rechargeable lithium ion battery. The normal operation time for the device is 2 hours. It is controlled through a custom built application on a hand held tablet.

The purpose of this study is to investigate the effect of training with the Gait Enhancing and Motivating System-Hip (GEMS-H) vs. training without the GEMS-H on locomotor function in adults. The investigator hypothesizes that long-term GEMS-H use would improve locomotor function. Specifically, individuals in the GEMS-H group will show faster gait speed compared to those in the control group.

Participants will be scheduled for 18 sessions of training (randomly placed either in GEMS-H training group or traditional training group without the GEM-H) plus 5 sessions of testing (pre-training, mid-test after the 9 sessions of training, post-training, 1 month follow-up and 3 month follow-up after the 18 sessions training completed).

Eligibility Criteria:
Inclusion Criteria:

* Age: 19 - 84 years
* No history of central nervous system related disease

Exclusion Criteria:

* Difficulty in walking due to conditions such as poor vision or fractures
* Height is less than 140cm or more than 185cm.
* Body mass index (BMI) greater than 35.
* Difficulty understanding and participating in the study such as those with cognitive problems or dementia.
* Subject who is at risk of falling during walking due to severe dizziness
Teicoplanin Prophylaxis for Total Hip or Knee Arthroplasty

This is a prospective, open-label, randomized clinical trial where patients were administered prophylaxis for total hip or knee arthroplasty either with teicoplanin or with other antibiotics. The study is aiming to evaluate any differences between these two different strategies of antimicrobial prophylaxis in the occurrence of surgical site infections

This is a prospective, open-label, randomized clinical trial where patients were administered prophylaxis for total hip or knee arthroplasty either with a single dose of teicoplanin or with multiple doses of other antibiotics according to the habits of the attending physicians aiming to evaluate any differences between these two different strategies of antimicrobial prophylaxis in the occurrence of surgical site infections

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted for total hip arthroplasty
* Patients admitted for total knee arthroplasty

Exclusion Criteria:

* Revision arthroplasty
* History of any infection within the preceding two months
* History of an operation in the same hip or knee for other causes
* Known history of allergy to the studied drug
* Pregnancy or lactation
* Any antibiotic therapy in the week before operation.
Non-interventional Study With Ra-223 Dichloride Assessing Overall Survival and Effectiveness Predictors for mCRPC Patients in a Real Life Setting in Germany

This observational prospective single arm cohort study is designed to assess overall survival, symptomatic skeletal event free survival and quality of life of metastatic Castration Resistant Prostate Cancer (mCRPC) patients receiving Radium- 223 under real life conditions. In addition, time to next tumor treatment (TTNT), mobility, quality of life and selfcare, independence in activities of daily living and safety will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Male patients diagnosed with castration resistant adenocarcinoma of the prostate (CRPC) with symptomatic bone metastases without known visceral metastases
* Decision to initiate treatment with Radium-223 was made as per investigator's routine treatment practice

Exclusion Criteria:

-Patients participating in an investigational program with interventions outside of routine clinical practice and also in all non-interventional studies focusing on Radium- 223-dichloride.
Nerve and Plane Block Data Collection Study for the Development of Artificial Intelligence-assisted Software

The primary objective of this observational study is to acquire ultrasound images (raw data) from nerve and plane block regions to develop artificial intelligence-guided nerve block software (Nerveblox). The study aims to acquire raw ultrasound video from 200 volunteers' planned nerve and plane block regions. These participants will undergo ultrasound scans administered by expert clinicians proficient in these techniques in their clinical practice. The data collection devices utilized in this study are FDA-cleared general-purpose ultrasound devices.

Ultrasound-guided nerve and plane blocks have facilitated regional anesthesia by providing clinicians with real-time imaging capabilities for precise needle placement and application of local anesthetics. These techniques involve the use of ultrasound technology to visualize nerves and surrounding anatomical structures, allowing for accurate identification and targeting of specific nerve pathways. Additionally, the integration of artificial intelligence (AI) into ultrasound-guided nerve blocks offers further enhancements to this practice. AI algorithms can assist clinicians in image interpretation, needle localization, and decision-making, streamlining procedural workflows and reducing the risk of complications. The sponsor, Smart Alfa Teknoloji San. Ve Tic. A.Ş., located in Ankara, Turkey, aims to collect data from planned regions of volunteers to develop artificial intelligence-supported nerve block software (Nerveblox). The gathered data will be utilized for training, validation, and test processes of the AI algorithm.

The study methodology encompasses the following components:

* A cohort of 200 volunteers, evenly distributed by gender (100 male, 100 female), will have their demographic data (BMI, gender, age) documented.
* Each scan from one volunteer is expected to take 30 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Male at least 18 years of age
* Female at least 18 years of age
* Health volunteers
* Able to confirm and sign the Informed Consent Form before enrolment the study

Exclusion Criteria:

* Male below 18 years of age
* Female below 18 years of age
* Unwilling to participate or unable to sign an informed consent form
* Inability to lie flat
* Anatomical deformity in the area to be scanned for nerve and plane blocks