cyrilzakka/clinical-trials huggingface dataset:
Observational Study to Evaluate the Safety of DILATREND SR Cap. in Korean Patients With Essential Hypertension, Chronic Stable Angina and Congestive Heart Failure

The purpose of this study is to Evaluate the Safety of DILATREND SR Cap. in Korean Patients with Essential hypertension, Chronic stable angina and Congestive heart failure for 52 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Age 19 years or older Patients with Essential hypertension, Chronic stable angina and Congestive heart failure
2. Possible to take Dilatrend SR on the label
3. not taking Caverdilol for 6 month from Agreement date
4. Agreement with written informed consent

Exclusion Criteria:

1. Pregnancy or lactation
2. Known hypersensitivity to Carvedilol
3. Cardiogenic shock
4. Abnormality of the conduction system as Severe bradycardia(In particular, pulse \<50beats / min), 2nd degree AV block, Complete AV block, Sinus Block, Sick Sinus Syndrome
5. Cor pulmonale
6. IDDM with ketoacidosis, metabolic acidosis
7. has severe heart disease(Heart failure NYHA functional class 4)
8. Respiratory diseases as Asthma, Chronic Obstructive Pulmonary Disease
9. Secondary hypertension
10. Prinzmetal's angina
11. Acute pulmonary embolism
12. Pheochromocytoma
13. Take MAO lnhibitor(except for MAO-B)
14. Hypotension ( SBP 90mmHg or less)
15. Severe hepatic dysfunction
16. Peripheral circulatory disturbance( ex. Raynaud syndrome, intermittent claudication)
17. Has edema glottitis
18. Has heart attack with complication
19. Fluid retention or overload to required intravenous inotropes
20. Allergic rhinitis
Restricting Blood Flow in Improving Muscle Strength in Patients With Hemophilic Arthropathy

Background. The main physical sequela of patients with hemophilia is the development of a progressive, degenerative intra-articular lesion, known as hemophilic arthropathy). This sequela is manifested by chronic pain, limited range of motion, axial abnormalities, and periarticular muscle atrophy.

Objective. To assess the safety and effectiveness of an intervention through blood flow restriction, regarding the frequency of bleeding and the improvement in the perception of muscle activation and strength, functionality, joint pain, joint status and the perception of quality of life in patients with hemophilic arthropathy. knee and ankle.

Study design. Randomized, multicenter, single-blind clinical study. Method. 20patients with hemophilia A and B will be recruited in this study. Patients will be recruited in 3 regions of Spain. The dependent variables will be: bleeding frequency (self-registration), pain (measured with the visual analog scale), joint status (Hemophilia Joint Health Score scale), strength (dynamometer) and range of motion (goniometer). Three evaluations will be carried out: pre-treatment, post-treatment and after a follow-up period of 4 weeks.

Expected results. Observe the safety of blood flow restriction in hemophilia patients. To analyze the efficacy of blood flow restriction in improving muscle strength, joint pain, range of motion, and joint damage in patients with hemophilic knee and ankle arthropathy.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with hemophilia A and B
* Patients with a medical diagnosis of hemophilic ankle and knee arthropathy
* People over 18 years of age
* Patients on prophylactic or on-demand treatment regimen with FVIII / FIX concentrates

Exclusion Criteria:

* Patients with neurological or cognitive disorders that impede understanding of the test.
* Pain free patients
* Amputees, epileptics or patients with severe vision problems
* Patients who are receiving Physiotherapy treatment at the time of the study
* Patients who have not signed the informed consent document
Single and Multiple Dose Study in Japanese

This study will explore the safety, tolerability, and serum uric acid lowering effect of lesinurad in healthy Japanese males to allow comparison with the Western population.

While there is extensive clinical experience with lesinurad in the Western population, it is recognized that both intrinsic and extrinsic factors may impact the PK, PD, safety, and dose response in different ethnic populations. The purpose of this study is to explore the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) of single and multiple doses of lesinurad in healthy Japanese males, and to allow comparison of these parameters with the Western population.

Eligibility Criteria:
Inclusion Criteria:

* Able to understand the study procedures, the risks involved and willing to provide written Informed Consent before the first study related activity.
* Healthy adult subjects born in Japan
* All laboratory parameters should be within normal limits or considered not clinically significant by the investigator.
* Screening serum uric acid level \>= 4.5 mg/dL.
* Subjects must be free of any clinically significant disease that requires a physician's care and/or would interfere with study evaluations or procedures.
* Subject does not have clinically relevant abnormalities in blood pressure, heart rate, body temperature, and respiratory rate, as per the Investigator's judgment.

Exclusion Criteria:

* Positive serology to Human Immunodeficiency Virus (HIV-1 and HIV-2).
* Positive test for active Hepatitis B or Hepatitis C infection.
* History of kidney stones.
* Undergone major surgery within 3 months of Day 1.
* Subject has received the last dose of an investigational drug (or treatment with a medical device) within 30 days or 5 half-lives (whichever is longer) of the investigational drug prior to Day 1 or are currently participating in another study of an investigational drug (or medical device).
* Prior exposure to lesinurad (RDEA594) or RDEA806.
Feasibility Study of At-Home EEG Monitoring for Hypersomnia

The central hypothesis is that home EEG monitoring (Dream 3 wearable) can be feasibly utilized for data capture of continuous sleep and wake measurements for the diagnostic evaluation and treatment monitoring of hypersomnia.

This clinical study is a prospective, single group assessment which will enroll patients who are prescribed a multiple sleep latency test (MSLT) at the Fontana Medical Sleep Center. Patients will be mailed an actigraph and a Dreem 3 system to undergo the following assessments:

* 1 initial in-person sleep physician encounter to discuss your sleep symptoms and review the informed consent form
* 1 week of actigraphy and Dreem 3 System monitoring. Actigraphy will be continuously monitored for 1 week to log sleep and wake periods. Dreem 3 System will be monitored for the first 5 nights and the last 2 days will be 48-hour continuous monitoring (i.e., day and night). Additionally, we will ask you to log your sleep/wake activity in a sleep diary.
* 2 consecutive in-lab sleep studies within a 24-hour period
* A few reminder telephone calls for at-home monitoring

Patients will have a follow up encounter with a physician after their in-lab visit. If a diagnosis is confirmed and treatment is initiated, the patient will be asked if they want to pursue treatment follow-up for the study. Again, patient will wear the Dreem 3 System and the actigraph during 5 nights, while keeping the actigraph on during the day, to monitor sleep/wake cycle. Then, for an additional continuous 48 hour measurement, patients will wear the Dreem 3 system and actigraph (i.e. monitoring day and night). This procedure will occur once treatment is initiated as well as 1 month and 3 months after treatment initiation.

Patients will be asked to complete various sleep and quality of life questionnaires throughout the duration of the study. Questionnaires should take approximately 10-15 minutes to complete.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be a Kaiser Permanente member
* Patients must be ≥ 6 years old.
* Patients must have an indication for Multiple Sleep Latency Test for a diagnosis of hypersomnia
* Patients are able/willing to consent and willing to undergo the electrophysiological routine assessments described in the protocol
* Patients do not meet any exclusion criteria

Exclusion Criteria:

* Patients under 6 years old.
* If a patient is taking a wake promoting medication and is unsafe to withdraw the medication during the 2 weeks prior to the in-lab Polysomnography/Multiple Sleep Latency study
* Patients suffering from mental and/or physical disorders that could interfere with the study protocol or the interpretation of the results (exclusion based on clinical judgment)
* Shift workers or patients working unusual hours will be excluded
* Patients not able to sign an informed consent form
The Psychiatric Rehabilitation Approach to Weight Loss

The primary aim of the project is to examine the efficacy of the Psychiatric Rehabilitation Weight Loss program in reduction of weight and body mass index (BMI.

The study involves 144 individuals who will be randomly assigned to the intervention group or treatment as usual group(control group). All Participants will undergo baseline assessment, assessment at week 12, week 24 and in year from baseline.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of serious mental illness,
* Age 18 - 65
* BMI \> 25
* Medication stable (there have been no changes in antipsychotic medications or mood stabilizers for the last 3 months).

Exclusion Criteria:

* Current or history of eating disorder
* Pregnant or breast feeding
* Uncontrolled HTN
* Severe coronary artery disease
* Severe valvular disease
* Uncontrolled diabetes
* Sustained arrhythmia
* Insulin using severe physical limitations
* Severe Lung Disorders
* Diagnosis of MR or dementia
A Study to Evaluate the Effect of Ustekinumab on Cytochrome P450 Enzyme Activities Following Induction and Maintenance Dosing in Participants With Active Crohn's Disease or Ulcerative Colitis

The purpose of this study is to evaluate the potential effects of an intravenous (IV) induction and subcutaneous (SC) maintenance administration of ustekinumab on the pharmacokinetic (PK) of a cocktail of representative probe substrates of cytochrome P450 (CYP) enzymes (CYP3A4, CYP2C9, CYP2C19, CYP2D6, and CYP1A2) in participants with Active Crohn's disease (CD) or Ulcerative Colitis (UC).


Eligibility Criteria:
Inclusion Criteria For Crohn's Disease (CD) Participants

* Participant must have a body weight in the range of 45 to 110 kilogram (kg) inclusive and have a body mass index (BMI) of 18 to 35 kilogram per meter square (kg/m\^2) inclusive
* Have had moderate to severe CD or fistulizing CD of at least 3 months duration, with colitis, ileitis, or ileocolitis, confirmed at any time in the past by histology, and/or endoscopy

For Healthy Volunteers

* Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening
* Healthy on the basis of clinical laboratory tests performed at screening and Day-1
* If a woman of childbearing potential, she must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test at screening; and a negative urine pregnancy test at Day -1

Exclusion Criteria For CD Participants

* Has complications of CD such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation that might be anticipated to require surgery in the next 3 months, could preclude the use of the Crohn's Disease Activity Index (CDAI) to assess response to therapy, would possibly confound the ability to assess the effect of treatment with ustekinumab, or would alter the absorption of the probe cocktail
* Currently has or is suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks prior to baseline, or 8 weeks prior to baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery. Participants with active fistulas may be included if there is no anticipation of a need for surgery and there are currently no abscesses identified

For Healthy Volunteers Participants

* Has an abnormal C-reactive protein (CRP) greater than (\>) 2\* upper limit of normal (ULN)
* Has had major surgery (example, requiring general anesthesia) within 8 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during the time the participant is in screening or is expected to participate in the study (5 weeks)
* Is pregnant, nursing, or planning a pregnancy (both men and women) during the study
A Retrospective, Observational, Multicentre, Study to Evaluate the Safety and Performance of POLYPATCH ® Vascular Patch

POLYPATCH® study is RWE multicentre study which examine short and long-term outcomes of using POLYPATCH® when exposed to a larger and more varied population.

All data will be retrieved from medical charts for each patient from time of surgery (considered as baseline of study) until a maximum of 3 years after surgery.

A minimum of 250 up to a maximum of 300 subjects will be evaluated from 3 to 8 different sites. At least 100 subjects will be evaluated in carotid location and at least 100 in femoral location.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who did receive POLYPATCH® at least one year ago for vascular angioplasty
* Subjects ≥ 18 years old

Exclusion Criteria:

* None
Neural Effects of Mindfulness Training on Attention

The purpose of this study is to examine behavioral and neural changes resulting from Mindfulness Meditation Training (MMT), and to use this knowledge in advancing our understanding of the mechanisms of attention.

Mindfulness Meditation Training (MMT) has been used successfully to decrease stress, pain, and adverse health symptoms in a varied subject population. MMT has been described as "paying attention in a particular way." Although attention is a key component of meditation, little is known about the cognitive and neural changes within the human attention system that result from MMT. In this study, we examine the effects of MMT on the human attention system using neurobehavioral measures. Here MMT comprises participation in a Mindfulness-Based-Stress-Reduction (MBSR) course, while the comparison group participates in a nutrition education course, both 8 weeks long. We compare the performance and neural activity of these groups both before and after participation in the course.

Eligibility Criteria:
Inclusion Criteria:

* Men and women (all races and ethnicities) between 18 and 40 years old
* Women of childbearing age with a negative pregnancy test within 48 hours of scanning
* In good health
* Right-handed
* Normal or corrected-to-normal vision
* English as a first language
* Able to understand and provide signed informed consent
* No history of metal in their body or other reasons why they could not undergo an Magnetic Resonance Imaging
* No history of ischemic or hemorrhagic stroke, encephalopathy or encephalitis, minimal-cognitive impairment or dementia, movement disorder such as Parkinson's disease, head trauma causing loss of consciousness, cancer involving the central nervous system

Exclusion Criteria:

* Pregnant or breast-feeding women
* Individuals with implanted metal or electronic devices that would prevent them from MRI scanning.
* Individuals with a history of neurologic dysfunction that would prevent performance on attentional tasks including: history of transient ischemic attacks, history of cerebral infarction, history of Binswanger's disease (or a history of hypertensive encephalopathy), history of intracranial hemorrhage, history of head trauma with loss of consciousness, history of encephalitis, history of extended exposure to any known neurotoxin, history of acquired cognitive impairment, history of normal pressure hydrocephalus, history of a cancer metastatic to the central nervous system, history of Parkinson's or other basal ganglia disease, history of Guillain-Barré syndrome or chronic or relapsing polyneuropathy
A Controlled Trial of Growth Hormone in Phelan-McDermid Syndrome and Idiopathic Autism

This clinical trial will use growth hormone as a novel treatment for Phelan-McDermid syndrome (PMS) and idiopathic autism. A double-blind, placebo-controlled crossover trial design will be used in 30 children with idiopathic autism and 15 children with PMS to evaluate the the effects of growth hormone on visual evoked potentials (VEPs), socialization, language, and repetitive behaviors. The researchers expect to provide evidence for the feasibility of using VEPs in PMS, and to show support for growth hormone in ameliorating clinical symptoms of ASD.

This study will show that select electrophysiological markers in PMS are relevant to iASD and predictive of treatment response with growth hormone. The long-term goal is to optimize treatment selection in iASD by establishing biological signature(s) derived from PMS. The expected outcome is to establish the feasibility of electrophysiological biomarkers for use in clinical trials in PMS and iASD, demonstrate efficacy of growth hormone in PMS and iASD, and to define a biological profile that will mark a subset of patients with iASD likely to show clinical response to growth hormone.

The study will enroll 45 children (15 PMS; 30 iASD; age 2-12 years) and administer growth hormone/placebo as once daily subcutaneous injection for 12 weeks at standard doses. The study team will monitor baseline anthropometric measures, laboratory parameters for growth, IGF-1 levels, and bone age throughout the study. Evaluations will include validated behavioral scales. Visual evoked potentials (VEPs) will be used as biomarkers of visual sensory reactivity.

Growth Hormone is approved by the FDA for the treatment of children with short stature due to primary growth hormone deficiency, among several other indications. It is being used off-label in the current study and is not FDA approved for use in PMS or ASD.

Eligibility Criteria:
Inclusion Criteria:

* Children between 2 and 12 years of age
* Open epiphyses on bone age x ray
* Must be on stable medication and psychosocial treatment regimens for at least three months prior to enrollment, assuming the concomitant medication is safe for use with Growth Hormone
* No prior use of Growth Hormone or IGF-1
* ASD group: Meet DSM-5 criteria for Autism Spectrum Disorder confirmed by the Autism Diagnostic Interview-Revised (ADI-R) and the Autism Diagnostic Observation Schedule, Second Edition (ADOS-2); absence of known pathogenic copy number variants
* PMS group: Known pathogenic deletions or mutations in SHANK3 gene diagnosed by array CGH and/or direct sequencing

Exclusion Criteria:

* Closed epiphyses
* Active or suspected neoplasia
* Intracranial hypertension
* Hepatic insufficiency
* Renal insufficiency
* Cardiomegaly/valvulopathy
* History of allergy to growth hormone or any component of the formulation (mecasermin)
* Patients with comorbid conditions who are deemed too medically compromised to tolerate the risk of experimental treatment with growth hormone (including severe obesity, sleep apnea, and various acute health conditions)
* Visual problems that preclude the use of VEP
Evaluation of Ultrasensitive Chromosomal Aneuploidy Detection for Detecting Minimal Residual Disease in Multiple Myeloma

Despite the significantly higher complete remission rates and improved survival achieved over the last decade，multiple myeloma (MM) patients continue to relapse due to persistence of minimal residual disease (MRD). Currently, numerous studies have evaluated the prognostic value of MRD by detecting immunophenotypic and immunoglobulin (Ig) gene rearrangements from bone marrow aspiration samples. Here the investigators intend to study the clinical utility of Ultrasensitive Chromosomal Aneuploidy Detection (UCAD) as an MRD assay, which is based on plasma cell-free DNA(cfDNA) low-coverage whole-genome sequencing. UCAD is non-invasive and applicable for tumors with high heterogeneity and extramedullary invasions.

In multiple myeloma, Minimal Residual Disease (MRD) refers to myeloma cells that are present in the bone marrow after a clinical response has been measured and the patient is in remission. A patient who tests "MRD negative" after treatment for myeloma has less than one myeloma cell per million bone marrow cells. Data from recent clinical trials suggest that patients with such a low level of disease may be less likely to experience a relapse of their condition than patients with higher levels. In recent years, MRD testing is now be applied in the management of patients receiving standard therapies for the disease.

Chromosomal instability(CIN) results from errors in chromosome segregation during mitosis, leading to structural and numerical chromosomal abnormalities. It will generate genomic heterogeneity that acts as a substrate for natural selection. Furthermore, it is proved that tumors with aneuploidies and polyploidy resulting from whole-genome doubling are related with metastasis, treatment resistance, and decreased overall survival. It is estimated that 60%-80% of human tumors exhibit chromosomal abnormalities suggestive of CIN. CIN positively correlates with tumor stage and is enriched in relapsed as well as metastatic tumor specimens. Due to the ubiquity of CIN in cancer cells and cancer cell releasing DNA into peripheral blood (PB) when apoptosis, it is a potentially non-invasive way to detect CIN in PB cfDNA from the MM patients to character MRD level. UCAD is a new method to detecting CIN in the DNA sample from patients, including extracting cfDNA from PB, analyzing DNA by low-coverage whole-genome sequencing, processing the data by bio-information techniques, and finally optimizing the management of MM patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients new diagnosed with MM and with the curative effect at least VGPR.
* Male or female patients aged \>= 18 years.
* Participants signed informed consent form.

Exclusion Criteria:

* Age under 18 years
* Individuals unwilling to sign the consent form or unwilling to provide PB for test or unwilling to provide the medical record.
* Individuals unwilling to participate in this trial.
Smoking Cessation Interventions in Stroke Patients

The primary objective of the present randomized controlled trial is to compare the effectiveness of three anti-smoking interventions of different intensities. It has been hypothesised that early follow-up visits facilitate post-stroke smoking cessation in patients hospitalized because of first-ever ischemic stroke.

BACKGROUND: It is well known, that continued smoking after stroke increases the risk of death and stroke recurrence within a few years after the first stroke. Searching for more efficient methods of antismoking interventions is therefore justified.

OBJECTIVES: The primary objective of the present study is to compare the effectiveness of three anti-smoking interventions of different intensities.

DESIGN: Randomized, controlled trial.

METHODS: Study participants will be recruited among patients of neurological clinics of Institute of Psychiatry and Neurology, hospitalized because of their first in a lifetime ischemic stroke. All stroke patients will be screened regarding their smoking status. The subjects will be patients smoking cigarettes immediately before their first-ever stroke, able to understand the research protocol procedures and able to cooperate during the investigation.

Antismoking interventions will be based on the "5A's" method. Study participants will be randomized to one of three interventions differing in follow-up intensity.

Eligibility Criteria:
Inclusion Criteria:

* Patients smoking immediately prior to stroke
* The first in the lifetime ischemic stroke
* Ability to understand the research protocol procedures and cooperation during the investigation
* Reported availability of and declaration to participate in follow-up
* Informed consent to participate in the study

Exclusion Criteria:

* Severe stroke
* Stroke onset more than 3 weeks before admission
* History of previous stroke with clinical symptoms
* Hemorrhagic stroke
* Diagnosis of dementia or presence of other neurological disease (Parkinson's disease, amyotrophic lateral sclerosis, multiple sclerosis, Huntington's chorea, a previous subarachnoid haemorrhage, meningitis, cerebral trauma in an interview)