cyrilzakka/clinical-trials huggingface dataset:
Phosphate Binder Switch Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis

To investigate the safety of repeated administration of KHK7791 for 52 weeks while switching from a phosphate-binding agent to KHK7791 in Hemodialysis patients with hyperphosphatemia.


Eligibility Criteria:
Inclusion Criteria:

1. Has voluntarily provided written informed consent to participate in the study.
2. Aged ≥ 20 years (expressed in completed years) at the time of providing informed consent.
3. Stable chronic renal failure patients who have undergone hemodialysis 3 times per week for at least 12 weeks until screening examination.
4. Dialysis conditions excluding dry weight, should have been unchanged during the last 2 weeks before screening examination.
5. The prescribed drug and dosage regimen should have been unchanged during the last 4 weeks before screening examination.
6. Serum phosphorus levels should be in the range of ≥ 3.5 and ≤ 7.0 mg/dL at screening examination.
7. If on any vitamin D, calcimimetics regimen, bisphosphonate,calcitonin preparations, selective estrogen receptor modulators or teriparatide preparations then the prescribed drug and dosage regimen should have been unchanged for the last 4 weeks before screening examination.
8. Kt/V urea ≥ 1.2 at the most recent test in routine medical practice before screening examination.

Exclusion Criteria:

1. Peritoneal dialysis was performed within 12 weeks before screening examination.
2. iPTH \> 600 pg/mL (should be based on the most recent value from patient's medical records before pre-enrollment)
3. History of inflammatory bowel disease (IBD) or diarrhea predominant irritable bowel syndrome
4. History of gastrectomy or enterectomy (excluding endoscopic resection and cecectomy) or having undergone gastrointestinal tract surgery within 3 months before screening examination.
5. Subjects who used anti RANKL preparations within 6 weeks before screening examination.
6. Subjects who used anti-sclerostin antibody preparations within 12 weeks before screening examination.
7. Severe heart disease, hepatic impairment, or concurrent cirrhosis.
8. Developed cerebrovascular disease or cardiovascular disease requiring hospitalization within 6 months before screening examination.
9. Uncontrollable hypertension or diabetes
10. Subjects experienced more than 3 times diarrhea or loose stool in a day at least six BSFS score more than two days in a week.
11. Scheduled for living donor kidney transplant, change in the mode of dialysis, home hemodialysis or plans to change the dialysis center (relocate to another hospital/clinic) during the study period.
12. Any diagnosis of or treatment of malignancy within 5 years before screening examination.
Rehabilitation Exercise Using Digital Healthcare System in Patients With Rotator Cuff Repair

The study aims to examine the effect of short-term rehabilitation exercise support using digital healthcare system (Uincare homeplus) in the patients with rotator cuff repair surgery. The study is a two-arm prospective randomized controlled study comparing the effect of rehabilitation exercise digital healthcare system at home with conventional brochure-based home exercise. Simple Shoulder Test (SST), Pain (using Numerical rating scale), shoulder range of motion (ROM), Disability of Arm, Shoulder and Hand (DASH), Shoulder Pain and Disability Index (SPADI), quality of life using EQ-5D will be evaluation on enrollment, 6-weeks, 12-weeks and 24-weeks after enrollment.

Rotator cuff tear is one of the most common disorders affecting shoulder pain and disabilities of daily life. It is a disorder that can be caused by trauma, overuse, inappropriate usage of shoulder as well as degenerative change, which is increasing due to enlarged geriatric population. Current method of post-operative rehabilitation is home-based self rehabilitation using brochure, combined with one or two times of education at the hospital before discharge. Patients often find difficulty in doing rehabilitation by themselves at home without supervision which resulted in decreased compliance.

With development of technologies using multi-motion sensor and AR(augmented-reality) system, the investigators have developed a digital healthcare system(Uincare Homeplus) which can supplement patients' rehabilitation at home by giving them proper instructions as well as feedback.

In this prospective randomized controlled study, the investigators aimed to compare the efficacy of the newly-developed digital healthcare system with conventional rehabilitation program.

Eligibility Criteria:
Inclusion Criteria:

* Patient who had rotator cuff repair surgery
* Patient who is discharged to home after surgery

Exclusion Criteria:

* Patient who has previous history of shoulder surgery on the affected shoulder
* Patient who has severe neurological deficit or infection on the affected shoulder
* Patient who has severe comorbidities (Ex: uncontrolled diabetes mellitus or rheumatoid arthritis) that inhibit affected shoulder rehabilitation
* Patient who cannot participate rehabilitation program
Is the 6-Minute Walking Test Combined With an IMU Useful in Stroke Rehabilitation Assessment?

This Observational study aims at the evaluation of stroke subjects with an inertial measurement unit (IMU) during the execution of a 6-Minute Walking test, to evaluate the associations between the kinematic parameters retrieved trough an IMU and the classical outcome scales. Moreover compare the stroke subjects with age-matched healthy subjects, and detect the differences of gait kinematic.


Eligibility Criteria:
Stroke Group

Inclusion Criteria:

* Age \>= 18;
* Mini-Mental State Examination ≥ 24;
* Ability to provide written informed consent and to understand the test instructions;
* Presence of a single stroke.

Exclusion Criteria:

* More than one stroke;

  . Stroke area other than the cerebral cortex;
* Concomitant neurological disease and pathology of the locomotor system.

Healthy Group

Inclusion Criteria:

- Volunteers with age similar to the Stroke group subjects

Exclusion Criteria:

- Any disease that could affect the performance in terms of metres walked and quality of gait.
Sleep Duration and Cardiovascular Health

This is a cross-sectional study with an optional intervention that will examine how extreme sleep durations relate to cardiovascular health, physical activity, and sleep quality by studying three groups of participants: short sleepers (≤ 6 hrs), long sleepers (≥ 9 hrs), and average duration sleepers (7-8 hrs). The optional intervention asks participants to maintain an 8-hour per night regular sleep schedule for one week.

PRIMARY OBJECTIVES:

1. To test the hypothesis that vascular endothelial function in the brachial artery, and other associated cardiovascular risk markers are impaired in short sleepers and long sleepers as compared to the control group of average duration sleepers.

To test the hypothesis that the optional intervention to maintain an 8-hour per night sleep schedule will alleviate vascular endothelial function impairment.

OUTLINE:

Participants will measure sleep, physical activity, and blood pressure with at-home devices before coming in for one in-lab visit, where they will have vascular function and blood markers measured, as well as an optional CT scan to measure calcium in the coronary arteries. An optional intervention may occur after this: Participants will continue the at-home measures while maintaining a chosen regular 8-hour per night sleep schedule, before coming in for a second in-lab visit with all same measures except for CT scan.

Eligibility Criteria:
Inclusion Criteria:

* Men and women ages 25-65y
* Lean and overweight (BMI 18.5-40 kg/m2)
* No acute, chronic, or debilitating medical conditions
* No prescription/non-prescription medications or drugs of abuse
* Current non-smoker (tobacco and marijuana)
* Persons who fit all the above criteria and are suitable based on a medical history and health habits questionnaire, and additional sleep and health profiling questionnaires may be eligible to participate.

Exclusion Criteria:

* Persons with any acute, chronic, or debilitating medical condition except pre-hypertension will be excluded.
* Persons with any symptoms of acute or active illness (e.g. fever, leukocytosis) will be excluded.
* Persons with a history of severe psychiatric illness or psychiatric disorders will be excluded.
* Persons with a history of regular night/or rotating shift work in the past year, or who have traveled more than three time zones during the one month prior to the study will be excluded.
* Pregnant women, decisionally impaired adults, and prisoners will be excluded.
Nutritional Assessment Tool in Childhood Chronic Liver Disease

Study Cohort:

All Children (Age: 3 months- 18 years, corrected age upto 2 years for preterm children) with Chronic Liver Disease attending Pediatric Hepatology Out Patient Department/In Patient Department


Eligibility Criteria:
Inclusion Criteria:

1. Children from age of 3 months- 18 years (corrected age upto 2 years for preterm children)
2. Chronic liver disease.

Exclusion Criteria:

1. Any metabolic or endocrinal diseases independently affecting nutritional status
2. Refusal to give written informed consent to participate in the study
Recruitment and Engagement in Care to Impact Practice Enhancement (RECIPE) for Sickle Cell Disease

The goal of this observational study is to help us understand more about the best ways to help individuals living with Sickle Cell Disease (SCD) get the best care. The main question it aims to answer is: How to find individuals unaffiliated from SCD specialist care use three distinct pathways? Once unaffiliated individuals are found using the pathways, Investigators will employ linkage coordinators (trained staff) to engage these patients in care. Participants will be asked to fill out an assessment survey which will cover areas such as previous and current treatment, clinic and hospital experience, pain, and quality of life. Participants will also be given the option of participation in a 1-hour long interview how they feel about treatment for sickle cell disease including clinic experience, pain, and quality of life?

The goal of RECIPE (Recruitment and Engagement in Care to Impact Practice Enhancement) for Sickle Cell Disease is to find unaffiliated patients with SCD using three distinct pathways (Community, Hospital, Surveillance) engage them in care using linkage coordinators (LCs; a successful method adapted from HIV care), and understand the contextual factors and implementation support needed to ensure these methodologies can be further scaled up at a national level. This study is significant because information about unaffiliated patients with SCD who are not actively engaged in the health system has not been systematically collected and studied in the past. Information comes only from experienced clinicians, community groups, patient advocates, and word of mouth. The lack of data about this population is problematic because current implementation studies focus on the barriers related to affiliated patients, with no known strategies identified to engage unaffiliated patients. No previous studies have evaluated the best methods for locating and then engaging and maintaining unaffiliated patients in specialty SCD care. This study will contribute to the literature by optimizing different pathways for finding unaffiliated patients, as well as providing evidence on what may work best in different clinical care settings and among different patients to address barriers to care in hard-to-reach populations.

Eligibility Criteria:
Inclusion Criteria:

* Persons must be \>/= 18 years of age
* Persons must have confirmed SCD
* Persons not seen by a SCD specialist \> 1 year +/- 3 months
* Literacy in English will be required of the consenting patient or parent/guardian

Exclusion Criteria:

* Persons \< 18 years of age
* Persons that are unable to provide informed consent and do not have a designated care-giver that can consent on his/her behalf
* Persons with sickle cell trait (as per hemoglobin electrophoresis)
* Persons seen by a SCD specialist \< 1 year +/1 3 months
Device-related Central Nervous System Infections in Adult Intensive Care Units in Brazil

Resistant microorganisms are public health problems because they affect the treatment of infectious diseases and the survival of patients. Neurosurgical procedures with placement of intracranial pressure monitoring and external ventricular drainage devices are related to increased morbidity and mortality. In Brazil, there are several multicenter studies demonstrating the prevalence and types of resistant microorganisms, however, there is a lack of data related to central nervous system infections associated with invasive devices, which can have a direct impact on prevention and treatment policies.

Neurosurgical procedures with placement of devices are related to increased morbidity and mortality. A study shows that the incidence of device-related central nervous system infection can reach 27%. A meta-analysis published in 2015, which included 35 studies, showed an incidence of 11.4 per 1000 catheters-day.

This is a prospective cohort study, including adult patients, in the ICUs of hospitals participating in the IMPACTO MR Platform, who have a catheter device for monitoring intracranial pressure or external ventricular shunt, with infection densities and microbiological profile being evaluated; risk factors; clinical management; costs involved and short- and long-term clinical outcomes

Eligibility Criteria:
Inclusion Criteria:

* All patients over 18 years of age admitted to the ICU in the selected hospitals during the study period, using intracranial pressure monitoring catheters and/or external ventricular shunt.

Exclusion Criteria:

* Diagnosis of brain death.
The Effects of Aerobic Exercise Training on Vascular, Cardiac and Cerebral Vascular Function in COPD

The primary cause of chronic obstructive pulmonary disease is smoking, which can lead to inflammation in the lungs and blood vessels that can lead to secondary problems such as blood vessel disease, high blood pressure and heart disease. Aerobic exercise training has been shown to reduce the risk of heart and brain disease; however, it is currently unknown whether exercise training can have the same affect in patients with COPD. The aim of this study is to investigate how eight weeks of aerobic exercise training improves blood vessel and heart function and brain blood flow in patients with COPD.

Chronic obstructive pulmonary disease (COPD) is a treatable respiratory condition that is only partially reversible. The primary cause of COPD is smoking which leads to airway inflammation and oxidative damage to the lungs, which has been linked to the development and progression of the disease. The inflammation is not isolated to the lungs as patients with COPD also have systemic inflammation that has been linked to a number of cardiovascular comorbidities such as endothelial dysfunction, cardiovascular disease and stroke. Evidence demonstrates that COPD patients have a greater incidence of vascular dysfunction and adverse vascular remodeling, which worsens with disease severity. In fact, patients with COPD are at 35 times greater risk of developing cardiovascular disease and stroke than healthy aged matched individuals. In healthy individuals and a number of chronic conditions, aerobic exercise training is well established to reduce the risk of cardiovascular and cerebrovascular disease. The benefits of exercise are likely through improvements in endothelial function, systemic inflammation, and cardiac and cerebral vascular function. However, whether exercise training can have the same effects in a chronic inflammatory condition like COPD has not been studied. The purpose of this study is to determine the effectiveness of an 8 week aerobic exercise training program in patient's chronic obstructive pulmonary disease as determined by improvements in endothelial function, systemic inflammation and cardiac and cerebral vascular function.

Eligibility Criteria:
Inclusion Criteria:

* Non-smokers (\>6 months);
* Forced expiratory volume in one second/ forced vital capacity (FEV1/FVC) \< 0.7 and FEV1/FVC \<lower limit of normal
* Stable (\>3 months exacerbation free)

Exclusion Criteria:

* On supplemental oxygen;
* Known cardiac or cerebral vascular disease, diabetes, obstructive sleep apnea;
* Uncontrolled hypertension;
* BMI \>30kg/m2
* Currently performing pulmonary rehabilitation or structured exercise training;
* Desaturate during exercise (SpO2\<85%)
* Cardiovascular contraindications to exercise in the incremental test used for screening
A Prospective, Randomized Comparison of Drainage Techniques After One- or Two-Level Open Posterior Lumbar Decompression or Decompression and Fusion

This project is being done to understand if a drain reduces recovery problems after surgery, such as infection or the need for more surgery.

The primary objective is to prospectively evaluate drains used in lumbar spine surgery in patients undergoing one- or two-level open posterior lumbar decompression or decompression and fusion for the relative risk of return to the operating room within 90 days.

Eligibility Criteria:
Inclusion Criteria:

* One or two-level open spinal decompression or decompression and fusion for the treatment of lumbar stenosis and/or spondylolisthesis

Exclusion Criteria:

* Infection, tumor, or trauma
* Prior lumbar fusion surgery
* Lumbar fusion surgery at more than 2 levels
* Anterior lumbar surgery
* Perioperative anticoagulation treatment
* Intraoperative incidental durotomy
* Intraoperative or postoperative cerebrospinal fluid leakage
* Intraoperative EBL greater than one liter
Expression of Markers Related to Mitochondrial Functionality in Carcinoma of the Urinary Bladder: Comparative Retrospective Analysis Between Recurrent Tumors ("Non-responders") and Non-recurrent Tumors ("Responders") After Intravesical Treatment With Chemotherapy or Immunotherapy

Retrospective monocentric study evaluating different immunohistochemical phenotypes related to mitochondrial functions with treatment outcomes

About 80% of newly diagnosed patients have non-muscle-invasive bladder cancer (NMIBC), including papillary lesions confined to the urothelium (stage Ta) or invading the lamina propria (stage T1), and carcinoma in situ (CIS). These tumors show low progression rates, but high recurrence. In particular, patients with multifocal high-grade urothelial carcinoma have a high risk of both recurrence (∼70% after 1 yr) and progression (5% after 1 yr). Initial NMIBC management is a transurethral resection of bladder tumor (TURBT), followed by adjuvant intravesical treatment with the chemotherapeutic agent Mitomycin C (MMC) or the immunotherapy Bacillus Calmette-Guérin (BCG). However, these therapies lead to variable clinical responses and patients recur shortly after surgery. Despite both therapies have been used for decades in the treatment of NMIBC, at the moment it is not possible to predict after initial staging which patients will benefit from them since neither resistance mechanisms nor genetic markers associated to relapse have been identified yet.

In a preliminary analysis, the invesitigators found that low expression of several proteins involved in mitochondrial functions correlate with a worst prognosis in bladder cancer patients. The aim of this study is to detect markers of mitochondrial dysfunction by immunohistochemistry in recurrent tumors ("non-responders") and non-recurrent tumors ("responders") after intravesical treatment with chemotherapy or immunotherapy, and determine the prognostic relevance of these different markers.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years of age at diagnosis
* Histologically confirmed NMIBC urothelial carcinoma of the urinary bladder (pTa, pT1, CIS)
* Primary NMIBC or not treated secondary NMIBC, after a primary non-invasive malignancy
* Patients underwent TURBT for NMIBC at Humanitas between 2000 and 2019
* Patients that received intravesical instillations with either MMC or BCG after TURBT at Humanitas between 2000 and 2019
* Written informed consent to research purpose
* For non-recurrent tumors ("responders"):

  * Patient treated with adjuvant MMC or BCG that did not experience recurrence for at least 42 months after TURBT
  * Patients are tumor-free at the moment of the analysis
* For recurrent tumors ("non-responders"):

  * Patient treated with adjuvant MMC or BCG that experienced recurrence in the first 24 months after TURBT.

Exclusion Criteria:

* Previous malignancies other that bladder cancer
* Patients with a history of treated bladder cancer recurrences
Evaluation of Phenotypic and Genetic Properties in Male Subjects Affected By Hypohidrotic Ectodermal Dysplasia (ECP-012)

The study proposes to enroll male subjects affected by Hypohidrotic Ectodermal Dysplasia (XLHED). The sweat duct images will be acquired with a CE marked skin-imaging device and the sweat rate will be measured using a CE marked pilocarpine iontophoresis and collection system. The technologies for both imaging of sweat ducts and the measurement of maximal sweat rate have been used safely and without adverse events in our prior studies involving HED/XLHED subjects. Furthermore, this study will assess the feasibility of developing a non-invasive screening tool that will enable detection of clinical signs of XLHED based on an analysis of a two dimensional frontal photograph.

The study proposes to enroll male subjects affected by XLHED (determined by genetic testing and restricted to age \> 1 yr). The sweat duct images will be acquired with a CE marked skin-imaging device and the sweat rate will be measured using a CE marked pilocarpine iontophoresis and collection system. The technologies for both imaging of sweat ducts and the measurement of maximal sweat rate have been used safely and without adverse events in our prior studies involving HED/XLHED subjects. Furthermore, this study will assess the feasibility of developing a non-invasive screening tool that will enable detection of clinical signs of XLHED based on an analysis of a two dimensional frontal photograph.

Eligibility Criteria:
Inclusion Criteria:

Subjects must meet all of the following criteria to be enrolled in this study.

* Attending the 2012 Spanish Association for those Affected by Ectodermal Dysplasia Annual Reunion;
* One year of age or greater;
* Conform to one of the following requirements for providing informed consent/assent:

  * If more than 18 years of age, subjects must provide signed informed consent;
  * If less than 18 years of age and it is determined that the subject is capable of providing assent, both the assent of the subject and consent of the parent(s) or guardian of that subject must be granted. Under this condition, both parents of the subject should give their permission, unless 1 parent is deceased, unknown, incompetent, or not available;
  * If the subject is incapable of providing assent, the consent of the parent(s) or guardian of the subject must be granted. Under this condition, both parents should give their consent, unless 1 parent is deceased, unknown, incompetent, or not available.
* Can provide documentation of genetic testing results positive for an EDA gene mutation /deletion;
* As described in Section 3.2 above, subjects must meet one of the following criteria:

  * Documented diagnosis of XLHED confirmed via genetic testing;
  * Unaffected male controls.

Exclusion Criteria:

* Known hypersensitivity to pilocarpine or pilocarpine-like muscarinic agonists;
* Presence of pacemakers;
* Subjects who are not able or are not willing to comply with the procedures of this protocol;
* Subjects with any major medical problem that will prevent them from participating in this study.