cyrilzakka/clinical-trials huggingface dataset:
Effect of CPAP in the Worsening of Renal Function in Early Stages of Chronic Kidney Disease (CKD)

Objectives: Evaluate the effect of CPAP to reduce the progression of chronic kidney disease or CKD (the decline of glomerular filtration rate is ≥ 30%) in patients with early-stage renal disease and sleep apnea syndrome (OSAS). Other objectives are; determine the prevalence of OSAS in patients with early-stage renal disease and evaluate the changes in inflamatories markers and endothelial damage, the state of KDIGO, cardiovascular events, mortality and cost-effectiveness analysis in CPAP group versus non-CPAP group patients.

Methods: A prospective, multicentric, randomized and controlled study will be carried out for 3 years. Early-stage renal disease (G1-3 KDIGO) and OSAS patients will be included. The investigators will make a respiratory polygraphy to determinate OSAS (AHI ≥15/h) and after that, the investigators randomized patients in 2 groups; CPAP group and control group (non-CPAP treatment). Patients with AHI \<15/h (non-OSAS) will be the reference group and the half of these patients, randomly chosen, will be followed up at the end of the follow up.

Statistic analysis: the investigators will analyze the differences in glomerular filtration rate before and after the treatment, comparing the percentage of patients with CKD progression for both groups. The investigators will use the chi square test with raw data and adjusted for confounding variables using intention to treat analysis with imputation of missing values.

There is a bidirectional involvement between the chronic kidney disease (CKD) and sleep apnea syndrome (OSAS). The declining of renal function, the fluid overloading and the disturbance of ventilation control could cause sleep apneas. On the other hand, the nocturnal hypoxia in patients with OSAS has been associated with changes in the renin-angiotensin system and sympathetic nervous system and production of reactive oxygen species. These findings are relationed with the deterioration of kidney function.

Eligibility Criteria:
Inclusion Criteria:

* Patients referred to the outpatient nephrology department with a diagnosis of chronic kidney disease stages G1-3 KDIGO
* Older than18 years
* Habitual snoring or observed apneas
* Scale sleep sleepiness (Epworth Test) with 11 points or lower.

Exclusion Criteria:

* Very debilitating chronic or neoplastic disease
* Respiratory failure (PaO 2 \<55 mm Hg).
* Other symptoms of suspected sleep disorder different from OSAS.
* Patients unable to perform self-administered questionnaires.
* Patients with\> 50% of central apnea or Cheyne-Stokes.
* Patients who do not sign the informed consent.
West Hertfordshire Inflammatory Bowel Disease Technology Study

A retrospective and prospective, observational, non-interventional, cohort study to develop quantitative metrics from tools used as standard of care when diagnosing, assessing and monitoring patients with inflammatory bowel disease.

Inflammatory bowel disease is a chronic inflammatory disease of the gastrointestinal tract that is without cure. It comprises two main disorders: Crohn's disease and ulcerative colitis. These conditions can lead to debilitating symptoms of abdominal pain, weight loss, diarrhoea and rectal bleeding.

The incidence of inflammatory bowel disease is increasing worldwide and is increasingly considered an emerging global disease. The prevalence of inflammatory bowel disease is currently the highest in North America and Western Europe and up to 600,000 people in the United Kingdom are thought to be affected.

The diagnosis and monitoring of inflammatory bowel disease is based on clinical, endoscopic, radiological and histological features. Endoscopy, is considered the current gold standard in inflammatory bowel disease with newer techniques being developed. There are however limitations to these methods, especially regarding the inter and intra observer variability in assessing the validated scoring systems used from the gold standard modalities.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 16 or over
* Patients with known or suspected Inflammatory Bowel Disease scheduled to undergo clinical, endoscopic or radiological assessment
* Patients with known Inflammatory Bowel Disease under ongoing clinical monitoring, who have previously undergone clinical, endoscopic or radiological assessments.
* Participant willing and able to give informed consent for participation in the study

Exclusion Criteria:

* Participant who is, or suspects that they are, pregnant at the time of assessment
* Any other cause, including significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the participant's ability to participate in the study
Evaluation of an Internet-based Intervention for Hazardous Drinkers

The purpose of this study is to determine whether the investigators internet-based intervention is effective to help hazardous drinkers reducing their alcohol consumption.


Eligibility Criteria:
Inclusion Criteria:

* Alcohol Use Disorders Identification Test (AUDIT) score from 6 (female) or 7 (male) to 12
Guidewire for Chronic Total Occlusion

Under the circumstances that appropriate first-choice guidewires for percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) have yet to be established, the objective of this study is to determine appropriate first-choice guidewires. G-FORCE study is a prospective multicenter randomized study between normal (distal tip size 0.014 inch) and slender (distal tip size 0.010 inch or less) guidewires. Primary end point is lesion penetration rate of the first choice guidewire.

Background. Although the success rate of PCI for CTO is yet to reach a satisfactory level, prognoses have been improved in successful cases. The greatest challenge is the passage of the guidewire and a variety of new approaches including a parallel wire technique and a retrograde approach have been reported. However, the fundamental question of what type of guidewire is the most appropriate as a first-choice guidewire has not been answered.Tapered guidewires have recently been reported to be useful for CTO lesions. In addition, a multicenter prospective registry indicates the effectiveness of 0.010-inch guidewires (PIKACHU registry, personal communication). Its mechanism is associated with micro-channels ranging from 100 to 300 μm in size in CTO lesions. If 250 μm micro-channels are present in 60% of CTO lesions, a 0.010-inch (equivalent to 250 μm) guidewire theoretically can pass through the lesion at the probability of 60%, and this assumption consists with the findings of the PIKACHU study. This idea also suggests that a 0.014-inch (350 μm) guidewire is unlikely to pass through lesions.

Based on the above, a hypothesis has been formulated that a guidewire with a small tip should be selected as a first-choice guidewire for CTO lesions. In this study, patients will be prospectively randomized to slender guidewires or standard 0.014-inch guidewires to determine appropriate first-choice guidewires.

Objective. To determine appropriate first-choice guidewires.

Design. Prospective multicenter randomized controlled trial

Methods. The first choice guidewire to treat CTO lesion was randomly assigned to normal group (distal tip size 0.014 inch) or slender group (distal tip size 0.010 inch or less). The primary passage must be performed with antegrade approach.

Primary endpoint. Lesion penetration rate of a first-choice guidewire

Power calculation. The PIKACHU registry indicates a 0.010 guidewire passes through a lesion with a success rate of 60%. Assuming the penetration rate of a 0.014 guidewire is 40%, a necessary number of patients would be 260 for a two-sided test with 90% power and significance level of 0.05. Assuming the dropout rate is approximately 10%, the target sample size would be 290 patients.

Eligibility Criteria:
Inclusion Criteria:

* Chronic total occlusion (CTO) lesion in native coronary artery
* De novo lesion
* Elective procedure

Exclusion Criteria:

* No indication of PCI
* Prior failed lesion
* Restenotic or in-stent restenotic lesion
* Vein or arterial grafts
* Younger than 20 years old
* Pregnant woman
* Patients who gave no informed consent
Cardiovascular Risk in General Practice in France: Cardiovascular Risk Week

The purpose of this study is to evaluate the proportion of patients which present a high cardiovascular risk estimated by the SCORE scale, in general practice consultations of the 7 French regions (Paris area, North-East, Paris basin, West, South-West, South- East, Mediterranean area)

MC MD

Eligibility Criteria:
Inclusion Criteria:

* Without any personal history of coronary disease
* Non treated with lipid-lowering agents
* Lipid test = 1 year old
* Presenting at least one cardiovascular risk
* Visiting their General Practitioner

Exclusion Criteria:
Rapid Evaluation of Pandemic H1N1 Influenza Vaccine in Adults Receiving Seasonal Influenza Vaccine

The purpose of this study is to assess the safety and effectiveness (immune response) to a licensed H1N12009 influenza vaccine in adults when given at the same time or prior to the seasonal influenza vaccine. The study will enroll 300 adults (ages 20-59 years). Participants will be randomized into 2 groups. One group will receive one dose of a licensed H1N1 vaccine and one dose of the seasonal influenza vaccine at the same time; the second group will receive the seasonal influenza vaccine 3 weeks after receiving the licensed H1N12009 influenza vaccine. Study procedures include: medical history, blood samples and completing a memory aid. Participants will be involved in study related procedures for approximately 3-6 weeks depending upon the group assignment.

The objectives of this study are two-fold:

1. To evaluate the safety and immunogenicity of H1N12009 influenza vaccine in a convenience sample of adults, soon after the pandemic vaccine becomes available so as to inform the subsequent use of vaccine in public programs.
2. To evaluate the compatibility of co-administered H1N12009 pandemic vaccine and seasonal TIV vaccine in the same group of subjects, as the option of co-administration would be useful for public programs.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Adults 20-59 years of age

Exclusion Criteria:

* Allergies to eggs, thimerosal, gentamicin sulphate, neomycin
* Life-threatening reaction to previous Flu vaccine
* Bleeding disorder
* Pregnancy
* Receipt of blood or blood products in past 3 months
* Chronic illness
* Compromised immune system
* Previous lab-confirmed H1N12009 infection
* Receipt of H1N12009 vaccine
* Receipt of Seasonal Influenza vaccine since March 2009
Gestational Metabolic Abnormalities and Maternal and Infant Nutrition and Health

Childhood obesity is on the rise and is a major risk factor for type 2 diabetes later in life. Recent evidence indicates that abnormalities that increase risk for diabetes may be initiated early in infancy. Since the offspring of women with diabetes have an increased long-term risk for obesity and type 2 diabetes, the impact of maternal metabolic abnormalities on early nutrition and infant metabolic trajectories is of considerable interest. The purpose of the study is to investigate the impact of maternal nutrition and metabolic abnormalities in pregnancy on human milk and subsequently on infant health over the first year of life.

The current investigation is a prospective study conducted within ongoing cohort studies of women and their offspring. Pregnant women attending outpatient obstetrics clinics in Toronto, Canada are recruited. The overall study protocol includes four study visits between the second half of pregnancy and the first year of infant's life and interim phone call interviews:

* Pregnant women undergo an oral glucose tolerance test at an expected average of 30 weeks of gestation and complete medical and lifestyle questionnaires including food frequency questionnaires.
* Infant birth anthropometry measurements and human milk samples are collected at an expected average of 3 days postpartum. The timing of onset of lactogenesis II is asked at 3d, 5d, 7d postpartum or until the event occurrence up to day 7.
* At 3 months postpartum, follow-up assessments including infant anthropometry, medical and lifestyle questionnaires and human milk sample collection are completed.
* Interim telephone interviews are conducted at 6 weeks and 5, 7, 9 months postpartum to characterize infant feeding and supplementation behaviors.
* At 12 months postpartum, infant anthropometric assessments are conducted.

Eligibility Criteria:
Inclusion Criteria:

* singleton or twin pregnancy
* aged 20 years or older at the time of recruitment
* intention to breastfeed

Exclusion Criteria:

* pre-existing diabetes
May Metformin be Used in Renal Failure?

The study is to treat metformin dose-escalation diabetic subjects of all stages of renal failure (stages 1-5) and compare their rates of erythrocyte metformin (best reflections of a possible accumulation than those of plasma) to the therapeutic range. A number of 12 patients by stage is considered, 60 patients in total.


Eligibility Criteria:
Inclusion Criteria:

* Diabetic patients not treated with metformin, no treatment diabetic or have been treated but poorly balanced (HbA1c\> 7%) and an applicant building with metformin; at any stage renal stable (stages 1-5 according to the classification MDRD)
* Patients aged 18 to 80 years;
* Patients with an assessment of renal function dating back more than 3 months;
* Patients whose renal function is stable, on the criterion of the absence of fluctuation over 30% of renal function of creatinine clearance in the last three months, a reference to renal function at least 3 months from the balance sheet inclusion is necessary.

Exclusion Criteria:

* Patient over 80 years
* Patients incapacitated adults (protected under guardianship)
* No previous reference creatinine;
* Fluctuation over 30% of renal function (creatinine clearance) in the three months;
* Reduction in BMI of more than 5% during the last 3 months;
* Severe hepatic impairment (Child stage\> A);
* No reference to liver stages 3-5
* Patients to be an X-ray with injection of contrast.
The Effect of Electric Ride-On Cars Use During Transport to the Operating Theatre

The aim of our study was to evaluate the effect of the use of a electric ride-on car during transport to the operating theatre on preoperative anxiety in children undergoing elective ambulatory surgery. As a distraction method, children in the experimental group will be introduced to the operating theatre with a electric ride-on car. Yale Modified Preoperative Anxiety Scale Child Form will be used to evaluate anxiety. The sample size was determined as 118 as a result of power analysis. 59 children will be included in the experimental group and 59 children in the control group.

Translated with DeepL.com (free version)


Eligibility Criteria:
Inclusion Criteria:

* Being between 2-10 years old,
* Less than 35 kg (according to the manufacturer's instructions for ride-on battery cars),
* To undergo elective surgery,
* Volunteering to participate in the study.

Exclusion Criteria:

* having cognitive or physical disabilities that may prevent riding a electric ride-on car
* premedication before surgery
Pharmacokinetics Study of AMG 423 in Healthy Subjects and Subjects With Various Degrees of Renal Insufficiency

A phase 1, open-label study in subjects with normal renal function and subjects with various degrees of renal insufficiency, including patients with end-stage renal disease (ESRD) requiring hemodialysis. The primary objective is to evaluate the single-dose PK of AMG 423 in subjects with various degrees of renal insufficiency, including patients with end-stage renal disease requiring hemodialysis.

This study was conducted by Amgen as the IND holder, with Cytokinetics as a collaborator. Due to the termination of the collaboration agreement between Amgen and Cytokinetics in May 2021 and subsequent transfer of the omecamtiv mecarbil IND from Amgen to Cytokinetics, Cytokinetics is now listed as the sponsor.

Eligibility Criteria:
Inclusion Criteria:

* Men or women ≥18 years of age
* Laboratory test values (clinical chemistry and hematology)within normal limits, (other than test values out of the normal range for subjects with CKD \[groups 1 and 3 through 5\]), or clinically acceptable to the investigator and sponsor at screening and day -3
* Free of any clinically significant disease or condition(s) (other than that consistent with CKD for subjects in groups 1 and 3 through 5) that require a physician's care and/or would interfere with the evaluations, procedures, or participation in the study per the investigator's discretion;

Exclusion Criteria:

* Subjects whose second MDRD eGFR result during the screening period is not within 10% of the first eGFR result
* Subjects who have received a functioning renal transplant within the past year
* Subjects with ESRD who do not have a functioning hemodialysis access
* Subjects with hemodynamic instability during hemodialysis
* Subjects whose renal insufficiency is due to active autoimmune renal disease
* Subjects with renal insufficiency or ESRD requiring hemodialysis and Troponin I \> upper limit of normal (ULN) at screening or day -3
* Subjects with history of heart disease or unstable angina within the last 3 months
* Subjects with uncontrolled diabetes (Hb1Ac \> 8%) and/or subjects who are able but unwilling to adhere to the required fasting intervals
Discovery and Validation of Proteogenomic Biomarker Panels in Liver Transplant Recipients

The main focus of this study is to develop blood and/or urine tests that will help to detect early signs of rejection in people who have had a liver transplant. Researchers will examine blood, urine, and tissue samples and try to identify markers for certain conditions such as rejection, response to therapy, and scarring of the liver. Additionally, researchers would like to identify biomarkers that can detect damage to the native kidneys before blood levels of creatinine rises. By studying gene expression, researchers hope to be able to diagnose these conditions earlier and improve liver survival.


Eligibility Criteria:
Inclusion Criteria:

* Subjects undergoing primary deceased-donor or living donor liver transplantation;
* Subject must be able to understand and provide informed consent.

Exclusion Criteria:

* Need for combined organ transplantation;
* Previous solid organ and/or islet cell transplantation;
* Infection with HIV;
* Allergy to iodine;
* Inability or unwillingness of a participant to comply with study protocol;
* Any condition that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements.
Lifestyle Modification Program for Lung Cancer Patients - Physical Activity Preference

Lung cancer is the leading cause of deaths in the world. Engagement in physical activity can provide important benefits for cancer patients. The current study is a cross-sectional questionnaire survey and in-depth interview to understand the physical activity preferences of patients with lung cancer. This process could help to develop a lifestyle modification program based on our patients' needs and preferences.

Lung cancer is one of the most common cancer globally and locally. Patients with lung cancer are in a uniquely difficult situation in their disease, comorbidities, and treatment that may lead to worsened symptoms and many negative health consequences, including fatigue, irritability, and impaired daytime functioning.

Physical activity (PA) is defined as 'any bodily movement produced by skeletal muscle that results in energy expenditure'. Several health benefits of increased PA have been reported for people with cancer. PA plays a critical role across the cancer trajectory, from prevention through to post-diagnosis and has been proposed as an alternative for improving physical and psychosocial health outcomes, reducing cancer recurrence, and cancer-specific and all-cause mortality. However, most of the findings were predominantly in breast and colorectal cancers. The PA dosage required to attain health benefits across these cancer groups is not uniform, nor is it clear whether the results can be applied to other groups of people with cancer.

The current study includes a cross-sectional questionnaire survey and an in-depth interview. It aims to understand the current physical activity practice and preference of patients with lung cancer, which could help to develop a lifestyle modification program based on our patients' needs and preferences.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years and above;
* Diagnosis with non-small cell lung cancer
* General condition stable, either is undergoing or finished treatment
* Able to speak and read Chinese
* Able to complete the self-administered questionnaire
* Mental, cognitive and physically fit for joining the trial as determined by the clinician or responsible investigator

Exclusion Criteria:

* Mentally unfit for answering questionnaire
* Unable to give informed consent
Xarelto Evidence in Real Life of Patients' Preference and Satisfaction Study

The main objective of the study is to assess preferences of Non Valvular Atrial Fibrillation (NVAF) patients towards different options of an anticoagulation treatment.

Patient preferences for anticoagulant treatment attributes (convenience attributes only), based on a Discrete Choice Experiment(DCE) interview will be elicited and the impact of switching from Vitamin K Antagonist(VKA) to Xarelto® on Atrial Fibrilation(AF) patient treatment satisfaction will be documented, measured by score differences of the Anti-Clot Treatment Scale (ACTS) score in patients switching from VKA to Rivaroxaban.


Eligibility Criteria:
Inclusion Criteria:

* Female and male patients ≥ 20 years of age (legal age limit in Taiwan) with a confirmed diagnosis of AF (non-valvular).
* Treatment with VKA for at least 6 weeks.
* Decision to initiate treatment with Rivaroxaban has been made as per investigator's routine treatment practice.
* Written informed consent of the patient.
* Wilingness and capability to conduct two F2F interviews.

Exclusion Criteria:

* Contraindications to the use of Rivaroxaban as outlined in the local product information .
* Concomitant treatment with any other anticoagulants.
* Participation in another study (clinical intervention/observational) within the 3 months prior to enrollment.
* Patients participating in an investigational program with interventions outside of routine clinical practice.