cyrilzakka/clinical-trials huggingface dataset:
The Effect of Renal Impairment on the Pharmacokinetics of Oral Treprostinil

This is a single-center, open-label, single-dose evaluation of 1 mg UT-15C SR pharmacokinetics, safety, and tolerability in subjects with normal, mild, moderate and end stage renal disease (ESRD; on dialysis).

Subjects in the ESRD group will receive 2 doses of UT-15C SR, separated by 14 days. One dose will be given 4 hours prior to dialysis, the other dose will be given at the end of dialysis.

Pharmacokinetic samples will be taken immediately prior to dosing and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 24, 30, 36, 42 and 48 hours post dose. Additionally, subjects with ESRD will have a sample taken at 60 hrs post dose.


Eligibility Criteria:
Male and female volunteers with ESRD (requiring dialysis), moderate (creatinine clearance; CrCL = 30-50 mL/min), mild (CrCL = 50-80 mL/min) and normal renal function (control group; (CrCL \>80 mL/min)) may be enrolled. Eligible subject will be 18-79 years of age with a BMI between 18 - 40 kg/m2 and not taking chronic nonsteroidal antiinflammatory drugs (NSAIDs)
Virtual Reality Intervention Alleviates Dyspnea in Patients Recovering From COVID Pneumonia

The present COVID-19 Virtual Reality (COVVR) clinical study is performed to test the hypothesis that an immersive virtual reality (iVR)-based Digital Therapeutics (DTx), would alleviate dyspnea by improving breathing comfort in patients recovering from COVID-19 pneumonia presenting with persistent dyspnea. We will further evaluate participants' perceived awareness of and agency over their breathing movements. Finally, we will track patients' perceived benefits related to the iVR intervention and the feasibility of using COVVR in the clinic or at home.

Persistent dyspnea is the experience of breathlessness that persists despite optimal treatment of the underlying pathophysiology, and results in physical, psychosocial disability for the patient. As observed for SARS-CoV and MERS-CoV patients, a significant portion of COVID-19 patients present with persistent respiratory physiological impairment and persistent breathlessness that may not be addressed with conventional respiratory treatment such as oxygen, bronchodilators, diuretics or non-invasive ventilation.

Previous research on respiration-related feedback in Virtual Reality (VR) has demonstrated strong and replicable effects of VR feedback over one's perceived sense of agency and control over one's virtually embodied respiration. Based on these studies, the VR intervention evaluated here aims to alleviate symptoms of perceived breathlessness.

This within-subject study will compare breathing comfort as well as breathing discomfort, prior, during, and after a VR intervention that provides embodied visual feedback of participants' on-going respiration. Primary outcomes include subjective reports from participants (breathing comfort and breathing discomfort) and the intervention's clinical feasibility. Secondary outcomes include subjective ratings on perceived embodiment and sense of agency, as well as changes in respiration rate and variability.

Eligibility Criteria:
Inclusion Criteria:

* Recovering from COVID-19 pneumonia confirmed by RT-PCR for SARS-CoV-2
* Presented with persistent dyspnea with a self-rated intensity of five or higher (out of ten) on a visual analog dyspnea scale. ( "Do you have difficulty breathing?" "On a scale of 0 to 10, with 0 being no difficulty to breathe and 10 being the worst difficulty to breathe that you can imagine, where do you rank?".) This dyspnea rating will only used as an inclusion criterion and not as an outcome.
* Being able to give consent
* Being able to understand and speak French or English

Exclusion Criteria:

* Any unstable respiratory, neurological, and cardiac conditions
* Any psychiatric illness
* Montreal Cognitive Assessment (MoCA) score below 25.
Epidemiology of Depression, Anxiety, and Cognitive Impairment

Many older adults have undetected health problems and lack basic prevention measures. Failure to identify and treat these conditions can lead to unnecessary morbidity and mortality and a decreased quality of life. Traditional screening and intervention programs, usually based in primary care providers' offices, have been insufficient, particularly in medically underserved populations. Alternate sites for screening and intervention have begun to receive attention and may hold promise.

The emergency department (ED) is the entry point for access to medical and social services for many patients and has the potential to serve as a site to identify older adults with unmet needs. However, we do not know the prevalence of depression and cognitive impairment and how they differ by mode of arrival of the patient to the ED. Second, a question remains as to the validity of screening patients during an acute illness. Upon completion, this study will describe the epidemiology of the population of older adults presenting to the ED.

Many older adults have undetected health problems and lack basic prevention measures. Failure to identify and treat these conditions can lead to unnecessary morbidity and mortality and a decreased quality of life. Traditional screening and intervention programs, usually based in primary care providers' offices, have been insufficient, particularly in medically underserved populations. Alternate sites for screening and intervention have begun to receive attention and may hold promise.

The emergency department (ED) is the entry point for access to medical and social services for many patients and has the potential to serve as a site to identify older adults with unmet needs. However, we do not know the prevalence of depression and cognitive impairment and how they differ by mode of arrival of the patient to the ED. Second, a question remains as to the validity of screening patients during an acute illness. This study aims to:

1. Compare the prevalence of depression and cognitive impairment among patients who arrive at the ED by EMS, as compared to those arriving via other means.
2. Evaluate the reliability of screening patients for depression and cognitive impairment during an acute illness and after the illness.
3. To evaluate correlates of depression, anxiety and suicidal ideation. Upon completion, this study will describe the epidemiology of the population of older adults presenting to the ED.

Eligibility Criteria:
Inclusion Criteria:

* Age 60 and older
* Arrival at ED

Exclusion Criteria:

* Institutionalized
Translational Obesity Research

The proposed project takes an innovative approach to childhood obesity prevention, for which there currently no evidence-based programs, and for which results of current trials have produced mainly short-term or disappointing effects. The aim of this project is to adapt and revise parts of two nationally recognized programs for drug prevention for use with children in grades 4-6 with the express purpose of obesity prevention. The current study will attempt to promote emotion regulation, neuro-cognitive function, and social competence in order to prevent obesity. A total of 24 elementary schools from two of the largest districts in Orange County will be randomly assigned to either the obesity prevention program or control group (N=1587) 4th grade students and their parents). A cohort of students will be followed from the 4th through 6th grades. Intervention students will be administered the Pathways obesity prevention program by trained teachers. The population is ethnically diverse (36% white, 57% Hispanic, 6%Asian; 48% on free/reduced lunch programs). Self-report measures, BMI, and waist circumference will be administered at the beginning of 4th grade, and at end of 4th , 5th , and 6th grade. Teacher, administrative, and parent surveys will be administered on the same schedule to measure school environment. Program implementation will be measured by teacher self-report and research staff observations. Data will be analyzed with statistical approaches that capture effects of school and classroom, test the theoretical model of change, and evaluate developmental trends in mediators and outcomes across the three grades. Findings should be generalizable to most elementary schools, and will be used to develop evidence-based program standards for childhood obesity prevention.


Eligibility Criteria:
Inclusion Criteria:

* 4th grade students at participating schools

Exclusion Criteria:

* None
Clinical Performance and Safety Investigation of ENDOmetrial Washing MEdical DEvice Forielle

This is a multicenter, prospective randomized controlled, interventional investigation to assess the safety and clinical performance of Forielle, a medical device for endometrial washing, in restoring favorable endometrial condition to implantation after Controlled Ovarian Stimulation (COS) during Assisted Reproductive Technique (ART).


Eligibility Criteria:
Inclusion Criteria:

* All infertile women treated with intracytoplasmic sperm injection (ICSI)/Fertilization in Vitro and Embryo Transfer (FIVET)
* Less than or equal to (\<=) 1 previous failed embryo transfer
* Eumenorrheic normo-gonadotropic women
* Basal follicle-stimulating hormone (FSH) \<=12 International unit per liter (IU/L)
* Anti-mullerian hormone (AMH) greater than (\>) 1.1 nanogram per milliliter (ng/mL)
* Ovarian Reserve: number of antral follicles 2 millimeter (mm) between 6 \<= antral follicle count (AFC) \<= 16
* Follicles \> 16 mm at the triggering day between 5-14
* Body Mass Index (BMI) between 18 \<= BMI \<= 27 kilogram per meter square (kg/m\^2)
* Indication for Fresh Embryo transfer
* Normal uterine cavity on ultrasound exam (e.g., no presence of hydrosalpinx)
* Undergoing Assisted Reproductive Technique (ART) and oocyte maturation by human chorionic gonadotropin (HCG) triggering
* Progesterone (P4) serum level at the HCG triggering day \<= 1.5 ng/mL (Day O/Randomization)
* Estradiol (E2) \<= 3000 picogram/milliliter (pg/mL) at the human chorionic gonadotropin (HCG) triggering day (Day 0/Randomization)
* Subjects must have read and signed the Informed Consent Form prior to study-specific-procedures not part of standard of care
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Clinically significant systemic disease (such as diabetes, metabolic syndrome, immunological diseases, diagnosed thrombophilia, porphyria, or any other medical condition requiring the use of low-molecular weight heparin therapy)
* Polycystic ovary syndrome (PCOS) according to Rotterdam Consensus Criteria (European Society of Human Reproduction and Embryology \[ESHRE\]/American Society for Reproductive Medicine \[ASRM\], 2003)
* Poor ovarian response (POR) according to the European Society of Human Reproduction and Embryology (ESHRE) Criteria
* RIF (repeated implantation failure), defined as greater than or equals to (\>=) 2 previous failed embryo transfers
* Endometriosis III-IV stage or adenomyosis
* Clinically significant findings on exam or ultrasound, such as salpingitis, hydrosalpynx or evidence of ovarian cysts
* Known hypersensitivity to any of the components of the solution
* Known hypersensitivity to vaginal progesterone or its excipients
* Other protocol defined exclusion criteria could apply
Proof of Concept, Twice Daily Applications of LEO 124249 Ointment in the Treatment of Chronic Hand Eczema

To compare the efficacy of twice daily applications of LEO 124249 ointment with LEO 124249 ointment vehicle for up to 8 weeks in the treatment of subjects with chronic hand eczema.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of chronic hand eczema with or without atopic etiology/background with a history of not adequately controlled disease activity with cutaneously applied steroid
* Physician's Global Assessment of disease severity graded as at least mild at Visit 1
* In overall good health including well controlled diseases

Exclusion Criteria:

* Systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine, azathioprine), retinoids (e.g. alitretinoin) or corticosteroids within 6 weeks prior to randomization (inhaled or intra-nasal steroids corresponding to up to 1 mg prednisone for asthma or rhinitis may be used).
* PUVA (Psoralen Ultraviolet A) or UVB (Ultraviolet B) therapy on the hands within 4 weeks prior to randomization
* Cutaneously applied treatment with immunomodulators (pimecrolimus, tacrolimus) or corticosteroids on the hands within 2 weeks prior to randomization.
* Use of systemic antibiotics or cutaneously applied antibiotics on the hands within 2 weeks prior to randomization
* Concurrent skin diseases on the hands
* Current diagnosis of exfoliative dermatitis
* Significant clinical infection (impetiginized hand eczema) on the hands which requires antibiotic treatment
* A marked abnormal ECG at baseline
* Known hepatic dysfunction or hepatic dysfunction tested at Screening
* Current participation in any other interventional clinical trial
A Study to Compare a New Drug for Type 2 Diabetes to Placebo and to a Treatment Already Available for Type 2 Diabetes

The main purpose of this study is to compare the safety and effectiveness of the study drug known as LY2944876 to exenatide extended-release and placebo in participants with type 2 diabetes mellitus. All drugs will be given by an injection under the skin. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry. Participants' involvement in the study is expected to last about 30 weeks.

The study will include a 12 week blinded treatment period, where neither the participant nor the investigator will know to which treatment each individual is assigned. Thereafter follows a 12 week period where participants and the investigator will know which treatment they are assigned to. Participants' on LY2944876 and on exenatide extended-release continue treatment in this period, those who received placebo will be followed without treatment.

Eligibility Criteria:
Inclusion Criteria:

* Men or women with diabetes mellitus Type 2
* Have screening HbA1c ≥7.0% and ≤10.5% either on diet and exercise alone or on a stable dose of metformin (≥1000 mg/day) for 3 months prior to screening
* Have body mass index (BMI) ≥23 and ≤45 kilograms per meter squared at screening

Exclusion Criteria:

* Women of child bearing potential
* Participants who have used thiazolidinediones within 3 months prior to screening, or any other drugs for treatment of hyperglycemia (except metformin) within the prior 2 months
* Participants who have used insulin for diabetic control for more than 6 consecutive days within the prior year
* Participants with impaired renal function (serum creatinine \>124 micromole per liter (µmol/L) \[1.4 milligrams per deciliter (mg/dL)\] in women, \>133 µmol/L \[1.5 mg/dL\] in men)
Cardiovascular Events in Patients With CAD During Emergent Endoscopy for Upper Gastrointestinal Bleeding

Background:

Upper gastrointestinal (GI) bleeding, a common disorder encountered at emergency room, may cause hypotension and tachycardia that may in turn result in myocardial ischemia in patients with coronary artery disease (CAD). An emergent endoscopy with hemostasis is the mainstay of management. However, endoscopy itself may result in myocardial ischemia. Whether myocardial ischemia and arrhythmia occurs more frequently during emergent endoscopy in patients with CAD remains unknown.

Objective:

To determine whether the risk of myocardial ischemia and arrhythmia is increased during emergent endoscopy in patients with CAD.

Method:

Adult patients with documented CAD undergoing emergent endoscopy due to UGI bleeding are included. Adult patients without CAD undergoing emergent endoscopy due to UGI bleeding were included as the control group. The expected case numbers were 50 patients in each group. Patients with terminal illness, pregnancy, active lung disease requiring ventilator support are excluded. Before endoscopy, symptoms of myocardial ischemia, blood pressure, heart rate, O2 saturation, hemogram, baseline 12-lead EKG, and cardiac enzyme are obtained. All patients are monitored with Holter EKG since 10 minutes before endoscopy to 2 hours after the procedure. Blood pressure, heart rate, and O2 saturation are closely monitored during the procedure. Endoscopy is performed by experienced endoscopist and endoscopic hemostasis is done according to the types of lesions. The duration of endoscopy, types of endoscopic hemostasis, and blood pressure are recorded. After endoscopy, symptoms of myocardial ischemia, blood pressure, heart rate, O2 saturation, hemogram, baseline 12-lead EKG, and cardiac enzyme are checked again.

Keywords: Emergent endoscopy, coronary artery disease, cardiovascular events

Expected Result and Implication If myocardial ischemia is not increased in CAD patients undergoing emergent endoscopy, then this technique can be used safely in this group of patients. If myocardial ischemia occurs more frequently in CAD patients undergoing emergent endoscopy, we can try to analyze factors associated with increased risk, such as duration of endoscopy, severity of anemia, or drugs used for endoscopic hemostasis. Then we can try to avoid these predisposing factors and increase the safety of emergent endoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with documented CAD undergoing emergent endoscopy due to UGI bleeding are included.
* Adult patients without CAD undergoing emergent endoscopy due to UGI bleeding were included as the control group.

Exclusion Criteria:

* Acute coronary syndrome before enrollment
* Unable to receive upper endoscopy
Ureteroscopic Laser Modality on Total Lasing Time and Total Energy in Patients With Large, Dense Renal Calculi

This study will examine the effects of ureteroscopic lasing technique (dusting, fragmentation and a hybrid approach) on total lasing time and total energy in patients with a large renal calculi burden of single or multiple stones with the sum of its longest diameters between 10-20 mm and having mean Hounsfield units of 1000 or more.

This study will examine the effects of ureteroscopic lasing technique (dusting, fragmentation and a hybrid approach) on total lasing time and total energy in patients with a large renal calculi burden of single or multiple stones with the sum of its longest diameters between 10-20 mm and having mean Hounsfield units of 1000 or more. Additionally, we will observe the impact of these parameters on total operative time.

Eligibility Criteria:
Inclusion Criteria:

* Adults between the ages of 18-80.
* Any gender, race or ethnicity may be included- these factors play a small, if any role on renal calculi formation and ability to withstand procedure.
* Must be suitable for a flexible ureteroscopy as determined by the MD
* Large renal calculi burden of single or multiple stones with the sum of its longest diameters between 10-20 mm
* An average stone density of at least 1000 Hounsfield units.

Exclusion Criteria:

* Those with a stone burden less than 10mm or more than 20mm.
* Those with an average stone density below 1000 Hounsfield units.
* Patients who are dependent on mandatory anticoagulation therapies and cannot stop for surgery
* Patients that cannot undergo ureteral access sheath placement
* Patients with abnormal anatomy such as horseshoe kidney
* Patients with a history of:

  * Ipsilateral upper urinary tract reconstructive procedures on the side of the renal calculi
  * Ipsilateral ureteral strictures
  * Prior radiotherapy of the abdomen or pelvis
  * Neurogenic bladder
  * Spinal cord injuries
  * Those who are pregnant
  * Currently being treated for infection or cancer
Polish Survey on the Efficacy of the Hypercholesterolemia Treatment

The purpose of the survey is to evaluate the efficacy of treatment of hypercholesterolemia in Polish patients who are currently on lipid- lowering pharmacological therapy . Efficient treatment is defined as achievement of the LDL cholesterol level goals according to the European Society of Cardiology 2007 guidlines.


Eligibility Criteria:
Inclusion Criteria:

* Patients on lipid lowering drug treatment
* Lipid lowering drug treatment lasting at least 3 months
* No lipid lowering drug/dose change for a minimum 6 weeks prior to enrolment to the study

Exclusion Criteria:

* Lack of patient's signed informed consent form
* Lack of the blood sample taken for lipid profile and glucose within 10 days before or after assessment of the patient
Non-interventional Study on Oral Contraception Not Containing Ethinylestradiol (EE) to Assess Continuation Rates and Satisfaction

Prospective, non-interventional, multi-center study. Each subject will be followed for up to twelve months during the treatment with oral hormonal contraceptives(Qlaira ® or a Progestin Only Pill). For each subject demographic data and medical history will be documented at Visit 1: (Baseline). Bleeding profile, subjective assessment of study treatment (satisfaction and wellbeing) and adverse events including unintended pregnancies will be documented at Visit 2 (Month 3-5) and Visit 3 (Month 6-12). Data audit/monitoring will be done.


Eligibility Criteria:
Inclusion Criteria:

* Women between 18-50 years
* Women who used ethinylestradiol containing oral contraceptives for at least the three preceding months before the study
* Women who decided to start Qlaira® or a Progestin Only Pill. The prescription of the hormonal contraceptive is made at the discretion of the attending physician and has to be documented

Exclusion Criteria:

* Contraindications and warnings of the respective Summary of Product Characteristics (Qlaira® or Progestin Only Pill)
* Women who are breast-feeding
Outcomes of Disposable Distal Attachment Device (Endocuff and Transparent Plastic Cap) Assisted Colonoscopy

The purpose of the study is to compare the efficacy of device assisted colonoscopy (DAC) with standard colonoscopy (SC) in detecting adenomas in a randomized fashion.


Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing first screening colonoscopy
2. Patients undergoing subsequent surveillance colonoscopies with known history of prior colon polyps detected on prior screening colonoscopies.
3. Ability to provide informed consent.

Exclusion Criteria:

1. Previous surgical resection of any part of the colon
2. history of colon cancer
3. history of inflammatory bowel disease
4. use of antiplatelet agents or anti-coagulants that precluded removal of polyps
5. Poor general condition
6. History of polyposis syndrome or hereditary nonpolyposis colorectal cancer
7. Inability to give informed consent.
Prevalence of Renal Failure and Risk Factors in an Unreferred Healthy Population

Blood sample is taken for measurement of serum creatinine, cystatin C, clone V haemoglobin, cholesterol, urine acid, glycemia and CRP.

The medical file is gathered. There will be searched for an association between renal function and cardiovascular risk factors and risk factors by exposition to toxic substantia during work.


Eligibility Criteria:
Inclusion Criteria:

* 20-55 years
* Male and female subjects