cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetics and Pharmacodynamics of Apixaban in Subjects on Hemodialysis

The purpose of this study is to assess the pharmacokinetics of a single oral dose of 5 mg Apixaban in subjects with normal renal function and subjects with end stage renal disease (ESRD) maintained with hemodialysis.

Primary Purpose : To provide a clear understanding of the pharmacokinetics of Apixaban in subjects with ESRD and to determine the effect of hemodialysis on Apixaban pharmacokinetics .

Eligibility Criteria:
Inclusion Criteria:

* The signed informed consent form.
* Subjects with normal renal function classified based on calculated creatinine clearance (CLCr) determined by the cockcroft-gault calculation.
* Eligible subjects with ESRD that is maintained with chronic and stable hemodialysis.

Exclusion Criteria:

* Any history of abnormal bleeding or coagulation disorders including those in a first degree relative under 50 years of age.
* History of significant head injury within the last two years.
* Any gastrointestinal surgery that could impact the absorption of study drug.
* Not expected to continue the hemodialysis treatment for the duration of the study.
* INR, PT, or aPTT above the upper limit of normal, unless agreed upon between the investigator and BMS medical monitor.
* History of allergy to Apixaban or Factor Xa inhibitors.
Evaluation of Parents' Knowledge About Infant Teething

Many children may have general disorders such as sleep disorders, lack of appetite, fever, diarrhea, vomiting, coughing and respiratory problems during tooth eruption.These symptoms usually occur in6-36 monthchildren. The emergent symptoms don't affect not only children but also parents try to find solutions to these symptoms. Parents' knowledge level and their way trying finda solution to these symptoms may differ.

The aim of this study is to evaluate the perceptions of parents towards the teething signs and symptoms of their children aged 6-36 months-old.As a result of the research, it is aimed to organize educational programs for families by increasing the knowledge level of parents about teething symptoms.

The study is being carried out in Istanbul University Department of Pediatric Dentistry, period between September 2021 - August 2022 following the ethics committee approval 2021/34. Patient parents are informed about the study and the written informed consents are obtained from parents of all participants included in the study. The questionnaireis conducted face-to-face. Parents with children between 6-36 months-oldwho has been applying to the Department of Pedodontics at Istanbul University Faculty of Dentistry are asked to complete the questionnaire consisting of 55 questions.

Questionnaire:

8 questions to find out the sociodemographic characteristics, 6 questions to find out the characteristics of the baby 6 questions to find out the general knowledge about children's teething 23 questions to find outthe teething symptoms that are seen in their babies 3 questions to find out the timing of the symptoms 9 questions to find out the parents practices in managing teething problems. Questionnaire responses are being recorded. The answers will be evaluated with statistical analyses. Detailed analyses of responses will be carried out according to sociodemographic characteristics, family structures and educational levels of parents.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study
* Parents who have 6-36 months old child
* Presence of parents who can adequately answer the questionnaire questions

Exclusion Criteria:

* Not willing to participte in the study
* Parents with no children for the specific age group
* In case of not being able to answer the questionnaire questions from the parents
Antibody Persistence to REVAXIS or DT Polio and Immune Response to TETRAVAC-ACELLULAIRE

PRIMARY OBJECTIVES

* To describe in 11 to 13-year-old children previously vaccinated with either REVAXIS or DT Polio at 6 years of age the antibody persistence against diphtheria, tetanus, and poliovirus types 1, 2 and 3
* To describe one month after a booster dose of TETRAVAC-ACELLULAIRE the immune responses against diphtheria, tetanus, and poliovirus types 1, 2 and 3

SECONDARY OBJECTIVES

* To describe other parameters of the antibody persistence against diphtheria, tetanus and poliomyelitis antigens
* To describe other parameters of the immune responses to diphtheria, tetanus and poliomyelitis antigens one month after a booster dose of TETRAVAC-ACELLULAIRE
* To describe the safety profile of a booster dose of TETRAVAC-ACELLULAIRE


Eligibility Criteria:
Inclusion Criteria:

* Healthy child 11 to 13 years of age previously vaccinated in Study F05-TdI-301

Exclusion Criteria:

* Immunization against diphtheria, tetanus, pertussis and/or poliomyelitis beyond Study F05-TdI-301
* Previous clinical or bacteriological diagnosis of diphtheria, tetanus, pertussis or poliomyelitis
* Known or suspected immune dysfunction
* Receipt of medications / vaccination that may interfere with study assessments
* Known true hypersensitivity to any of the vaccine components or to a vaccine containing the same substances
* Known personal history of encephalopathy, seizure disorder or progressive, evolving or unstable neurological condition
* Thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection
* Any medical condition that might interfere with the evaluation of the study objectives
* Febrile illness
Treatment Patterns in Metastatic Prostate Cancer

This study will evaluate treatment patterns, mortality, healthcare resource utilization, and costs in patients with prostate cancer with bone metastases (primary objectives). Additionally, this study will evaluate opioid/analgesic use among lines of therapy in this patient population (secondary objective). The study is descriptive in nature and is meant to provide a greater understanding of the patterns of therapy observed in real-world clinical practice (in the absence of clear guideline recommendations with regards to treatment sequencing), to contribute to a greater understanding of the major cost drivers (thus better-informing payers), and to examine real-world mortality in such patients.


Eligibility Criteria:
Inclusion Criteria:

- Subjects with at least one claim with a primary diagnosis of prostate cancer (International Classification of Diseases(ICD) Clinical Modification (CM)185.xx )and any of the below on same day or after the prostate cancer claim:

* At least one inpatient claim with a primary or secondary diagnosis indicating bone metastases (ICD 9 CM 198.5 or Healthcare Common Procedure Coding System (HCPCS) code for a treatment indicative of bone metastases OR
* At least two outpatient claims with a primary or secondary diagnosis indicating bone metastases (ICD 9 CM 198.5 or HCPCS code for a treatment indicative of bone metastases, with a minimum of 30 days between claims.

Exclusion Criteria:

* Subjects with a diagnosis of a cancer other than prostate cancer - defined as the presence of one inpatient or two outpatient claims with a primary or secondary diagnosis of malignant neoplasms (ICD-9-CM 140.xx-171.xx, 174.xx-184.xx,186.xx-195.xx,200.xx-209.3x, 230.xx-239.xx) - in the 12-month pre-index period.
* Subjects with any claim for a primary or secondary diagnosis indicating bone metastases (ICD-9-CM 198.5) or any treatment indicative of bone metastases in the 12-month pre-index period.
* Patients who had a SRE in the 12-month pre-index period.
* Subjects without continuous enrollment for at least 12 months before the index date.
* Subjects without continuous eligibility for at least 6 months after the index date.
* Subjects that are female.
* Subjects that have negative costs.
* Subjects that are less than 45 years of age on the index date.
Maintenance Treatment of Renal Anemia in Dialysis Subjects

The purpose of this study is to evaluate the efficacy and safety of molidustat in comparison to darbepoetin alfa in dialysis subjects with renal anemia who are treated with Erythropoiesis-Stimulating Agents (ESAs).


Eligibility Criteria:
Inclusion Criteria:

* Subject with ESKD (end-stage kidney disease) on regular dialysis (including, hemodiafiltration, hemofiltration, hemodialysis, and other modalities except for peritoneal dialysis) weekly or more than weekly for at least 12 weeks prior to randomization
* Body weight (after dialysis) \> 40 and ≤ 160 kg at screening
* Male or female subject ≥ 20 years of age at screening
* At least one kidney
* Treated with weekly or bi-weekly dose of darbepoetin alfa, monthly or bi-weekly dose of epoetin beta pegol, OR weekly, biweekly, twice or three times per week dose of epoetin alfa/beta, and having had no more than one dose change within 8 weeks prior to randomization
* Mean screening Hb level ≥ 9.5 and \< 12.0 g/dL (mean of all central laboratory Hb levels before dialysis \[at least 2 measurements must be taken ≥ 2 days apart\] during the screening period, AND all Hb level must be measured by the central laboratory, AND the difference between the lowest level and highest level is \< 1.2 g/dL), with the last screening Hb level measurement within 14 days prior to randomization
* Ferritin ≥ 100 ng/mL or transferrin saturation ≥ 20% at screening
* Serum folate level and serum vitamin B12 level above lower limit of normal (LLN) at screening

Exclusion Criteria:

* New York Heart Association (NYHA) Class III or IV congestive heart failure
* History of cardio- (cerebro-) vascular events (e.g., unstable angina, myocardial infarction, stroke, pulmonary thromboembolism, and acute limb ischemia) within 6 months prior to randomization
* Sustained, poorly controlled arterial hypertension (defined as systolic BP (blood pressure) ≥ 180mmHg or diastolic BP ≥ 110mmHg) or hypotension (defined as systolic BP \< 90mmHg) at randomization
* Proliferative choroidal or retinal disease, such as neovascular agerelated macular degeneration or proliferative diabetic retinopathy requiring invasive treatment (e.g., intraocular injections or laser photocoagulation) at screening
Dynamics of the Upper and Lower Airway Respiratory Microbiomes Associated With Severe Infant Asthma

Nature of potential dysbiosis, interrelation of the different microbiomes of the respiratory tract, and potential role of the immune system in the pathogenesis of severe asthma in infants, and its evolution under treatment.

Exploring and understanding these data is to improve patient care and discover new therapeutic targets.

The aim is to open up prospects for therapeutic studies, such as the use of azithromycin as an immunomodulator in infant asthma, the results of which are discordant.


Eligibility Criteria:
Inclusion Criteria:

* Infants less than 24 months old
* Follow-up by a pneumo-pediatrician for severe asthma in infants
* Requiring etiological investigations and assessment of severity in day hospitalization, including bronchial fibroscopy (HAS 2009)
* Parent informed of the research and having signed consent

Exclusion Criteria:

* Prematurity \<32 WA
* Congenital heart disease with significant left to right shunt
* Chronic respiratory disease other than infant asthma (cystic fibrosis, bronchiolitis obliterans)
* Antibiotic therapy in progress or administered the seven days preceding the date of inclusion (day hospitalization)
* Refusal of bronchial fibroscopy
Investigating the Effects of Altering Portion Size Reduction Awareness on Compensatory Eating Behaviour

The present study aims to investigate whether energy intake is reduced when participants consume a reduced portion size (15% compared to the 'control' portion), and also to see whether awareness of this reduction affects energy intake.

In the present study, all participants will participate in two sessions - the baseline session and the experimental session. In the baseline session, participants will be given ad libitum access to a lunch meal (followed by ad libitum access to dessert), and ad libitum access to a dinner meal (followed by ad libitum access to dessert). Then, after a washout period of between 1-6 weeks, participants will return to complete the experimental session, where they will be randomised to one of three conditions:

Condition 1 (control condition): The same as the baseline condition except that the lunch will be of a fixed portion which participants must consume all of - this portion size will be the same amount of food as was consumed in the ad libitum lunch meal in the baseline session (participants will be told that the amount of food served is the same as the amount they consumed in the baseline session).

Condition 2 (reduced aware condition): The same as the baseline condition except that the lunch will be of a fixed portion which participants must consume all of - this portion size will be 15% less than the amount of food consumed in the ad libitum lunch meal in the baseline session (participants will be told that the amount of food served has been reduced from the amount they consumed in the baseline session).

Condition 3 (reduced unaware condition): The same as the baseline condition except that the lunch will be of a fixed portion which participants must consume all of - this portion size will be 15% less than the amount of food consumed in the ad libitum lunch meal in the baseline session (participants will be told that the amount of food served is the same as the amount they consumed in the baseline session).

Eligibility Criteria:
Inclusion Criteria:

* United Kingdom (UK) residents able to visit laboratory on campus in Liverpool, aged ≥ 18
* Body Mass Index (BMI) between 18.5 and 32.5 kg/m2
* Proficiency in English language
* Self-report willingness to eat each of the test foods

Exclusion Criteria:

* Current medication use which affects appetite
* Pregnant
* Currently or previously diagnosed with an eating disorder
* Currently on a diet
* Have any food allergies or intolerances
* Are vegan
Comparison of SITA-Standard Compared to SITA-Fast Visual Fields.

This study will compare SITA-Standard and SITA-Fast tests in patients newly referred to the glaucoma screening clinic at the RD\&E hospital.

This study will compare SITA-Standard and SITA-Fast tests in patients newly referred to the glaucoma screening clinic at the RD\&E hospital. In addition to standard care (SITA-Fast) each person who agrees to take part in the trial will undertake one extra visual field test (SITA-Standard). By comparing the results of the two types of visual field test the investigators aim to provide information on which of the two tests is more specific for glaucoma and which test is better tolerated by patients. The investigators anticipate that this study will generate sufficient data to support a grant application for a longitudinal study to examine the relative merits of different visual field tests in patients with glaucoma and those suspected of developing the disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old attending the West of England Eye Unit Glaucoma Service who have been newly referred for suspected glaucoma.

Exclusion Criteria:

* 1. Patients who are unable to perform visual field tests. 2. Patients who are unable to have a full glaucoma assessment. 3. Patients who have undertaken visual field tests in hospital eye departments in the last 2 years.
High Intensity Interval Training After Stroke

The purpose of this study is to examine if high intensity interval training after stroke is more effective than standard care to increase maximal oxygen uptake, reduce known risk factors for recurrent stroke and improve function.

Stroke is a leading cause of adult disability. Well designed studies have shown that the majority of the stroke population have low aerobic capacity and many are inactive. This is negative for their health and well-being. Physical inactivity may increase their risk of having recurrent stroke.

The optimal training mode and intensity to improve aerobic capacity after stroke are not clear. High intensity interval training (ie. 90-95% of peak heart rate) has been proven to be more beneficial than moderate and low intensity exercise in order to improve maximal oxygen uptake in patients with cardiac disease. The response from this training on aerobic capacity and physical function in the stroke population are not known.

Eligibility Criteria:
Inclusion Criteria:

* Approved informed consent
* Independent walking \> 2 minutes
* First episode of stroke (ischemic or hemorrhagic)
* Minimum 3 months post-stroke
* Living in the community and able to travel to assessment and training site
* Approval to participate from the study's responsible medical doctor
* Modified Rankin Scale 0-3

Exclusion Criteria:

* Impaired cognitive function to give valid informed consent to participate
* Instability of cardiac conditions (ie. serious rhythm disorder, valve malfunction)
* Other conditions where test of maximal oxygen uptake is contraindicated
* Poorly controlled hypertension (\>180/100), measured at rest
* \> 5 years post stroke
* Subarachnoid hemorrhage
* Participating in other ongoing intervention study
* Other serious illness influencing testing of cardiorespiratory fitness and function at 1 year follow-up
Stopping Cavities Study: Diammine Silver Fluoride

This study is being conducted to test whether the use of diammine silver fluoride (also called silver diamine fluoride) hardens the cavity sufficiently so that it arrests.

Phase III RCT with two arms: (1) 38% diammine silver fluoride; (2) distilled fluoride free water. Subjects are 200 preschool children in good general health with untreated tooth decay. Intervention is topical application of the study drug to the open cavity. Primary outcome is caries activity at 14-21 days.

Eligibility Criteria:
Inclusion Criteria:

* Nyvad criteria 3
* Active carious lesion

Exclusion Criteria:

* Allergy to silver
* Stomatitis or oral ulcerative condition
* Weight less than 15 kg
A Multi-center Real-world Efficacy and Safety of Trastuzumab-deruxtecan in Advanced Gastric Cancer

* Institutions will be selected
* This study aims to collect real-world data, targeting patients who started treatment with Enhertu from September 2022, for clinical data collection
* Among patients treated with Enhertu, those who have passed away or are no longer visiting due to hospice care will have their clinical data collected without consent until August 19, 2024
* For patients who are scheduled to receive Enhertu treatment, are currently undergoing treatment, or have previously undergone treatment but experienced disease progression and are now receiving subsequent chemotherapy (i.e., patients with newly added data after registration)
* Efficacy evaluation

* Institutions will be selected through the Gastric Cancer Subcommittee of the Korean Cancer Study Group.
* This study aims to collect real-world data, targeting patients who started treatment with trastuzumab-deruxtecan from September 2022, for clinical data collection.
* Among patients treated with trastuzumab-deruxtecan, those who have passed away or are no longer visiting due to hospice care will have their clinical data collected without consent until August 19, 2024.
* For patients who are scheduled to receive Enhertu treatment, are currently undergoing treatment, or have previously undergone treatment but experienced disease progression and are now receiving subsequent chemotherapy (i.e., patients with newly added data after registration), data will be collected with consent until March 31, 2027.
* Efficacy evaluation will include overall survival (OS), progression-free survival (PFS), and tumor response rate (TRR)

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 19 years or older.
* Patients with pathologically confirmed metastatic, recurrent, or unresectable gastric/gastroesophageal adenocarcinoma.
* Patients whose tumor tissue shows HER2 immunohistochemistry (IHC) results of 3+ or 2+ with in-situ hybridization (ISH) positivity.
* Patients who received Trastuzumab Deruxtecan as third-line or later treatment.

Exclusion Criteria:

* Patients with HER2-negative gastric cancer.
* Patients who did not provide consent to participate in the study.
* Patients who received Trastuzumab Deruxtecan as first-line or second-line treatment as part of a clinical trial.
Physical Activity and Sports for People With Special Needs

Purpose of this study was to assess the balance level of highly qualified amputee football players in relation to their sports level, training experience, position on the pitch, as well as the type of amputation/dysfunction and disability experience.

The participants were presented with the procedure of the study and informed that they could resign from their participation in the study at any stage. All participants were given the written informed consent form after the detailed written and oral explanation of the risk and benefits resulting from participation in this study Static balance was assessed using AMTI AccuSway stabilographic platform (ACS Model). The study participants performed the single 10 second left- or right-leg stance with eyes open (EO), and single 10 second left- or right-leg stance with eyes closed (EC) (depending on leg amputation). If the first attempt was not successful, study participants were able to do the second attempt. The tests were conducted on a match-free day, approximately 2 hours after a meal, in a sports outfit, in a specially designated room.

Eligibility Criteria:
Inclusion Criteria:

* participant of European Amputte Football Championschip
* field player (leg amputation or leg dysfunction)
* written consent form

Exclusion Criteria:

* goalkeeper
* injury
* tiredness
* refusal
Expanded Treatment Protocol (ETP) of Ruxolitinib in Patients With Polycythemia Vera Who Were Hydroxyurea Resistant or Intolerant and for Whom no Treatment Alternatives Was Available.

The purpose of this open-label, single arm, multi-center Expanded Treatment Protocol (ETP) was to provide early access to ruxolitinib and evaluate safety information in patients with polycythemia vera (PV) who were hydroxyurea (HU) resistant or intolerant and who had no other standard treatment option, nor did they qualify for another clinical study for PV


Eligibility Criteria:
Inclusion Criteria:

•Confirmed diagnosis of PV according to the 2008 World Health Organization criteria, palpable spleen, Resistant to or intolerant of hydroxyurea, ECOG performance status of 0, 1 or 2; did not have access to a comparable or satisfactory alternative treatment

Exclusion Criteria:

•Inadequate liver or renal function, Significant bacterial, fungal, parasitic, or viral infection requiring treatment, Active malignancy within the past 5 years, except treated cervical intraepithelial neoplasia, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin, with no evidence for recurrence in the past 3 years., Women who were pregnant or nursing.