cyrilzakka/clinical-trials huggingface dataset:
Prevalence and Predictors of Esophageal Thermal Lesions in High-power-Short-duration Ablation of Atrial Fibrillation

Patients with documented atrial fibrillation who were referred to our clinic for catheter ablation will undergo standard HPSD ablation and subsequent esophagoscopy.

After esophagoscopy patients will be followed up for one month in the form of a telephone follow-up.

The primary endpoint of the study assessed by esophagoscopy performed on the day after the index catheter ablaton is the incidence of esophageal thermal lesions.

Secondary endpoints include:

1. The size of the esophageal thermal lesions.
2. The severity of esophageal thermal lesions.


Eligibility Criteria:
Inclusion Criteria:

* Atrial fibrillation documented in the 12-lead ECG
* Indication for catheter ablation in accordance with currentn ESC guidelines

Exclusion Criteria:

* Pregnancy
* Women of childbearing potential without a negative pregnancy test within 48 hours prior to ablation procedure
* Known intracardiac or other thrombi
* Contraindication to anticoagulation
* Contraindication to esophagoscopy: diseases and deformities of the cervical spine, esophageal varices
Serous Endometrial Intraepithelial Carcinoma (SEIC): Prospective Registration Study

Background: Serous endometrial intra-epithelial carcinoma (SEIC) is a rare condition affecting the lining of the uterus. It's a pre-cancerous change that might lead to cancer if not treated. Doctors aren't sure of the best way to manage it because it's so uncommon. A previous study looked at past cases in the Netherlands from 2012 to 2020. This study found that none of the 23 women with SEIC had their cancer spread during surgery, and none had a recurrence in the following three years. This suggests that a simpler surgery might be safe for patients with SEIC.

Methods: Information on disease details from patients who agree to participate in our study will be collected. All participants will fill out online forms and health questionnaires at several points: when they join the study, and again at six months, two years, and five years after their diagnosis. During the years after diagnosis, various details like health status, test results, treatments will be checked in the electronic medical record.

Results: This study is just starting, with the first patients expected to join on January 1, 2025.

Conclusion: A large international study is created to track SEIC patients over time. This will help us learn more about the condition and improve treatment strategies.


Eligibility Criteria:
Inclusion Criteria:

* Serous endometrial intra-epithelial carcinoma (SEIC).
* Women older than 18 years of age.
* Women with understanding of Dutch or English language in reading and writing.

Exclusion Criteria:

* Diagnosis with a different type of endometrial neoplasm or invasive carcinoma.
* Previous and/or current treatment for another malignancy (\<2 year before diagnosis of SEIC).
Sympathetic Innervation of the Heart and Cardiac Resynchronization Therapy(CRT)

The purpose of this study is to assess whether baseline sympathetic innervation in patients with chronic heart failure (CHF) is predictive for response to cardiac resynchronization therapy (CRT). And to assess whether response to CRT coincides with restoration of regional sympathetic innervation.


Eligibility Criteria:
Inclusion Criteria:

* Indication for CRT
* Stable optimal medication
* Non ischemic cardiomyopathy

Exclusion Criteria:

* Age less then 18 years
* Previous CRT
* Clinically relevant valvular heart disease or coronary artery disease
* Acute or chronic infection
* Untreated clinical hypo- or hyperthyroidism or \< 3 months euthyroidism
* Uncontrolled hypertension, defined as a systolic blood pressure \> 160 mm Hg and/or a diastolic blood pressure \> 95 mm Hg
* A concurrent medical condition (i.e. alcohol or drug abuse or a severe progressive extra cardiac disease or M. Parkinson) or is unlikely to comply with the protocol
* Participation to a previous protocol involving radioactivity in the past year
* Pregnancy
Survey on PD Patients With Depressive Symptoms

The primary objective of this investigation is to conduct a 12-week prospective survey in PD patients with depressive symptoms treated with BI Sifrol Tablets (hereinafter referred to as this drug) in the routine clinical settings to determine the following items related to the safety and efficacy.

i. Adverse drug reaction symptoms, incidence, and severity ii. Motor capacity during the investigation iii. Depressive symptoms during the investigation


Eligibility Criteria:
Inclusion criteria:

\*\*PD patients with depressive symptoms Patients who have not received pramipexole hydrochloride hydrate preparations within 1 month before survey entrance.

Exclusion criteria:

* PD patients with the past history of suicidal attempt, suicidal ideation or tendency
* PD patients with suicidal ideation
* PD patients with the past history of suicidal tendency
Phase 2a Study to Evaluate Safety and Explore Efficacy of J2H-1702 for NASH

The study aims to evaluate the safety of J2H-1702 compared to the placebo and explore the efficacy of J2H-1702 at Week 12 timepoint after administration compared to baseline in patients with NASH.

Subjects will be randomized to the study group 1 (J2H-1702 A mg), study group 2 (J2H-1702 B mg), study group 3 (J2H-1702 C mg), or control group (placebo of J2H-1702) in a 1:1:1:1 ratio and administered the investigational product (IP) for 12 weeks. After the IP administration, the safety and efficacy will be evaluated at V4, V8 and V12 (end of treatment, EOT).

Eligibility Criteria:
Inclusion Criteria:

1. A subject aged ≥19 years to ≤75 years
2. Meeting all of the following criteria:

   * Screening MRI-PDFF with ≥8% steatosis
   * Screening MRE with liver stiffness ≥2.5 kPa
   * ALT or AST ≤250 IU/L at screening
3. Willing to maintain the same lifestyle (exercise, alcohol consumption, diet, etc.) during the study
4. Voluntarily provide written consent to participate in the study

Exclusion Criteria:

1. A subject who has past or current history of liver diseases
2. A subject who has the following medical or surgical history

   * Severe cardiac diseases, Malignant tumors, Clinically significant hypersensitivity reaction to any drugs containing components of the 11β-HSD1 inhibitor or same class
3. A subject who has the following concomitant diseases

   * liver disease, uncontrolled hypertension, uncontrolled DM, etc.
4. A subject who has taken the following medications

   * Systemic glucocorticoids, NSAIDs, any medication that may induce fatty liver disease, etc.
5. A subject who has taken IP of another study
6. A subject who does not agree with appropriate methods of contraception
Safety and Efficacy of Azelaic Acid Foam, 15% in Papulopustular Rosacea

This study will investigate the safety and efficacy of a new formulation of an existing medication for the treatment of papulopustular rosacea. The study will test the active ingredient plus foam against foam alone.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* Diagnosis of papulopustular rosacea (IGA score of moderate or severe) with a minimum of 12 and maximum of 50 inflammatory lesions (papules and/or pustules) and persistent erythema with or without telangiectasia
* Free of any clinically significant disease which could interfere with the study
* Willingness to follow all study procedures
* Male or female patient at least 18 years of age

Exclusion Criteria:

* Subjects known to be non-responders to azelaic acid
* Presence of dermatoses that might interfere with the rosacea diagnosis or the evaluation of treatment results
* Ocular rosacea, phymatous rosacea
* Any condition or therapy that in the opinion of the investigator may pose a risk to the patient of interfere with any evaluation in the study
* Facial laser surgery in the 6 weeks prior to the study
* Topical or systemic use of prescription or non-prescription medications to treat rosacea
* Use of any agent other than the investigational drugs to treat rosacea during the study
* Expected use or change in dose in the 90 days prior to the study of beta-blockers, vasodilators, NSAIDs, hormonal treatment or drugs causing acneiform eruptions
* Known hypersensitivity to any ingredients of the investigational product formulation
* Alcohol or drug abuse
* Incapability of giving fully informed consent
* Subject is dependent person, i.e., a relative/family member of the investigator and/or is a member of the investigator's staff
* Participation in another clinical research study within the last 4 weeks before randomization in this study
Effect of Probiotics and Prebiotics in Renal Function in Septic Acute Kidney Injury Patients

Septic acute kidney injury is a condition associated with highly related to inflammatory molecules. Prebiotics and probiotics have shown to improve inflammatory cascade in animal model; In this study, the investigators propose the use of probiotics to improve the clinical evolution of septic acute kidney injury patients.

Acute kidney injury is most commonly caused by sepsis, where endotoxemia and an expanding inflammatory reaction play a key role in its pathogenesis, when this condition is present it is highly related to poor clinical outcomes and higher mortality rates. There is no current specific treatment, and the therapeutic approach is more orientated to complication management. In this study, the investigators propose the use of probiotics to improve the clinical evolution of septic acute kidney injury patients.

Eligibility Criteria:
Inclusion Criteria:

* Sepsis by SOFA
* Acute kidney injury by KDIGO

Exclusion Criteria:

* No presence of sepsis
* No presence of AKI
* Age below 18 years
* Inability or contraindication for oral capsules or probiotics by nasogastric tube
Effect of Monitoring of Step Number on Diabetes

In this study, investigators measured the number of steps, blood pressure, blood glucose, and weight in daily life through the smartphone personal health record application for patients with type 2 diabetes. The efficacy of text message intervention, which encourages an increase in the number of steps per week for 12 weeks, on an increase in the number of daily steps and changes in glucose levels, weight, and blood pressure will be investigated. Also, the durability of intervention will be checked after 12 weeks of intervention ending.

This clinical study is a single institution, randomized, prospective study and monitors the average daily number of steps per week using a smartphone personal health record application developed by Samsung Medical Center for patients with type 2 diabetes. The study subjects were divided into five groups such as 1) basal activity (\<2500 steps/day), 2) limited activity (2500-4999 steps/day), 3) low activity (5000-7499 steps/day), 4) somewhat active (7500-9999 steps/day), 5) active (10000-12499 steps/day), 6) highly active (≥12500 steps/day)according to the average number of steps per day. During the 12-week period, the intervention group receives the text messages that encourage step-by-step increments every week, and the control group does not receive text messages. The effect of 12-week step monitoring and education on the change in daily step count will be analyzed. Also, the effect of change in daily step count on glucose level, body weight, and blood pressure will be studied.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Type 2 diabetes aged 20-69 years
* Patients with a HbA1c of less than 8.5% measured during screening (may be replaced by a test value within 3 months of screening visit )
* Patients who have not been prescribed diabetic medication for the past 4 weeks or who have taken more than one oral hypoglycemic agent for more than 12 weeks at a certain dose
* BMI ≥ 23 kg/m2
* Available for use Samsung Galaxy S4 or later Android smartphone and wireless internet
* Patients who voluntarily agreed to participate in this clinical study

Exclusion Criteria:

* Diabetes other than type 2 diabetes, including type 1 diabetes, gestational diabetes
* Patients who are taking insulin or GLP-1 agonist other than oral hypoglycemic agent
* Patients with uncontrolled chronic liver disease
* Patients with acute kidney injury
* Patients with psychological disorder
* Patients who are taking weight lowering agent
* Patients with alcohol or drug addiction within the last 3
* Patients who are taking systemic steroid
* Patients who are breastfeeding or pregnant
* Patients who did not voluntarily agree to the study
* Patients who are unsuitable for participation in clinical research
Environmental and Sensory Intervention for Nursing Home Residents With Dementia Who Exhibit Persistent Vocalizations

The purpose of this study is to test a person-centered, nature-based non-pharmacological intervention for nursing home residents living with dementia who exhibit persistent vocalizations. The Environmental And Sensory Experience (EASE) involves the projection of a still nature image and the playing of nature sounds. Family members of the person living with dementia provide consent for the resident to participate in the study and complete a brief survey on nature preferences on the resident's behalf. The survey informs the research team on what nature scene to show. Participants will wear a watch that measures stress levels and research staff will monitor vocalization patterns. We will also recruit persons living with dementia from other settings such as assisted living, personal care units, and adult day care settings.

After enrolling in the study, participants will participate in three study visits. During the first two visits, study personnel will observe the nursing home resident to collect data on the resident's vocalizing behaviors (persistent vocalizations, PVs). These visits will last for roughly six hours, one during the day shift and one during the evening shift. The third visit will last approximately 90 minutes. During this visit, study personnel will observe vocalizing behaviors before, during, and after the EASE intervention is in use. Residents will also wear a watch for all three visits that records information about their heart rate and stress levels. All visits will occur in the resident's natural environment- either their room or common space and will be scheduled at the convenience of the resident and NH staff.

The aims of the study are:

Aim 1: Examine the feasibility and preliminary efficacy of the EASE to reduce PVs among NH residents.

Aim 2: Evaluate the NH staff perception of the acceptability of the EASE within 48 hours post-intervention.

Aim 3: Examine the mechanism of action of the EASE.

Eligibility Criteria:
Inclusion Criteria:

* The participants must: 1) have a medical diagnosis of dementia; 2) have severe dementia as determined by a MMSE score of ≤9 (or another cognitive test indicating severe dementia); 3) have a history of PVs per staff report; 4) be 50 years older or greater; 5) require extensive assistance by staff to ambulate or is non-ambulatory (to allow for consistent video recording). In addition, consent will be obtained from the resident's Legally Authorized Representative (LAR) and assent from the participant.

Exclusion Criteria:

* Persons living with dementia will be excluded if they: 1) are blind; 2) are deaf; 3) give indications of dissent. Variations will be sought for gender, race and ethnicity.
Neurophysiological Effects of Mind-body Exercise in Healthy Adults

There is some clinical evidence showing that Baduanjin (BDJ) practice, a type of mind-body based physical exercise, can improve executive function (EF). However, the neurophysiological changes associated with improved cognitive function remain elusive. Therefore, this study aims to carry out randomised controlled trial to explore how the single-session BDJ practice affect the function of prefrontal cortex(PFC) and also the EF of healthy adults, measure by fNIRS and verbal fluency test accordingly. A total of 60 healthy adults (based on power analysis 80% (β= 0.20) chance (α = 0.05, two-tailed)), aged 18 to 40 year old, without any physical, neurological, and neuropsychiatric disorder, classified as right-handed by Edinburgh Handedness Inventory, also with normal intelligence as verified by the Test of Nonverbal Intelligence will be recruited and randomly assigned to treatment(i.e. BDJ), active control(i.e, exercise), and passive control(i.e. video viewing) group. The investigator anticipate that this single-session BDJ practice will result in - (1) enhancing executive functioning , and (2) changes in functional brain activation pattern in PFC in adults. The result will give a spotlight to neurophysiological treatment effect of single-session Baduanjin on healthy adults, in developing intervention for improving executive functioning of adults.


Eligibility Criteria:
Inclusion Criteria:

* Right-handed adults with normal intelligence (i.e. intelligence quotient ≥ 80), and without any physical, neuropsychiatric, and neurological disorders

Exclusion Criteria:

* Current positive history of head injury, seizure, stroke, other central nervous system diseases, other comorbid psychiatric illness, or reports of strong suicidal ideation.
Kuopio Lutetium-177 Study in Patients with PSMA-Positive Metastatic Prostate Cancer

KuPSMALu-trial is an observational study for patients treated with 177LuPSMA-I\&T in Kuopio University Hospital, Finland. Study focuses on efficacy, safety and biomarker research.


Eligibility Criteria:
Inclusion Criteria:

1. The patient must sign informed consent to participate in the study.
2. Patients must be over 18 years of age.
3. Patients must have histologically confirmed metastatic prostate adenocarcinoma. Histological samples may show neuroendocrine features, but the primary component must be adenocarcinoma.
4. Patients must have metastatic castration-resistant prostate cancer (mCRPC) that has been treated with at least docetaxel and abiraterone or enzalutamide, or the patients must have declined chemotherapy or be ineligible for docetaxel-based chemotherapy due to contraindications.
5. Patients must have an adequate performance status: WHO 0-2.
6. Castration must have been achieved either chemically (LHRH analog or antagonist) or surgically (orchiectomy). Castration is defined as a low testosterone level (S-testosterone ≤ 1.7 mmol/l).
7. Patients must have PSMA-positive tumor burden detected by 18F-PSMA-PET-CT imaging.
8. Patients must have adequate renal and liver function (Creatinine \< 2x upper limit of normal (ULN), ALT and ALP \< 5x ULN).
9. Patients' blood counts must be within acceptable levels (Hb ≥ 100 g/l, Platelets ≥ 100 x 10⁹/L, Leukocytes ≥ 3.0 x 10⁹/L, or Neutrophils ≥ 1.0 x 10⁹/L).
10. The expected survival must be more than 6 months.
11. Patients with ejaculatory capacity must commit to not donating sperm during the treatments and for 6 months after treatment completion.

Exclusion Criteria:

1. Patients whose physical condition and cooperation are insufficient to follow the given instructions.
2. Patients who do not meet the criteria mentioned in the inclusion criteria.
3. Patients must not have PSMA-negative tumor burden in the liver. The amount of PSMA-negative tumor burden must not exceed the amount of PSMA-positive tumor burden.
4. Patients with symptomatic untreated spinal cord compression.
5. Patients must not have acute hydronephrosis or urinary tract obstruction.
6. Patients must not have a recurrent infection that impairs functional capacity.
Graded Repetitive Arm Supplementary Program Versus Task Based Training on Upper Limb Function in Stroke Patients

To determine effects of graded repetitive arm supplementary program versus Task based training on Upper limb function in stroke patients.

This study will be Randomized Clinical Trial. A total of 38 stroke patients will be recruited by using non-probability convenience sampling Technique. Patients will be Randomized and allocated into two interventional groups based on the inclusion and exclusion criteria. Patients in Group A will receive Graded repetitive arm supplementary program and Patients in Group B will receive Task based training. All participants will receive the treatment for 40 minutes per session, 5 days per week for 5 weeks. For the evaluation of all participant scales like be Chedoke Arm and Hand Activity Inventory for clinical relevance, Fugl Mayer assessment scale for performance assessment, Action Reach Arm Test for coordination and dexterity and Motor Activity Log for functional assessment of Upper limb in stroke patients. D

Eligibility Criteria:
Inclusion Criteria:

* Patients with Sub acute stage of stroke.
* Patients with Ischemic and Haemorrhagic stroke.
* Patients with Cognition level on Mini Mental State Examination must be \> 24
* Patients with mild pain in upper extremity according to Numeric Pain Rating Scale
* Patients with Grade 2 active movements in affected extremity Tone of upper limb at Modified Ashworth Scale Grade 1+.

Exclusion Criteria:

* Other neurological disorders e.g. brain tumor, encephalitis, meningitis, brain abscess.
* Use of antipsychotics
* Use of drugs for spasticity.
* Patients with vestibular impairment.
An Effectiveness and Safety Study of CONCERTA® (Methylphenidate Hydrochloride) in the Treatment of Adolescents With Attention Deficit Hyperactivity Disorder

The purpose of this study is to evaluate the safety and effectiveness of CONCERTA® (methylphenidate hydrochloride, a central nervous system (CNS) stimulant) versus placebo for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adolescents..

The objective of this study is to evaluate the safety and effectiveness of CONCERTA® (methylphenidate hydrochloride) in the treatment of adolescents with Attention Deficit Hyperactivity Disorder (ADHD). This is a multicenter, randomized, double-blind, placebo-controlled study with adolescents ages 13-18 diagnosed with ADHD. The study consists of four phases. The Screening Phase establishes the diagnosis of ADHD and provides a one-week washout period without any ADHD medication. The Open-Label Titration Phase initiates the treatment of patients with one CONCERTA® 18 mg daily. Thereafter, the dose is increased approximately every 7 days in 18 mg increments (to a maximum of 72 mg daily), until an individualized dose is identified, based on the clinical judgment of the investigator. During the Double-Blind Phase, subjects are randomized to receive either their individualized CONCERTA® dose or a placebo, for a period of 2 weeks. Subjects who successfully complete the Double-Blind Phase are eligible to receive CONCERTA® for an 8-week, Open-Label, Follow-up Phase. The primary efficacy measurement is the total score of the ADHD Rating Scale, evaluated by the investigator at the end of the Double-Blind Phase. Safety assessments include monitoring adverse events, electrocardiograms (ECG), blood pressure, pulse, height and weight throughout the course of the study. The study hypothesis is that CONCERTA® is more effective than placebo in the treatment of Attention Deficit Hyperactivity Disorder in adolescents, and is well tolerated.

Titration Phase: CONCERTA® 18 mg taken orally, once daily, and increased approximately every 7 days in 18 mg increments up to a maximum daily dose of 72 mg. Double-Blind Phase: Individualized dose of CONCERTA® or placebo for 2 weeks. Open-Label Phase: Individualized dose of CONCERTA® for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
* Children's Global Assessment Scale rating of 41-70 at baseline (Screening Phase)

Exclusion Criteria:

* Subjects who are known to not respond to methylphenidate
* Have had adverse experiences from methylphenidate or hypersensitivity to CONCERTA or its components
* Have marked anxiety, tension or agitation
* Have glaucoma, ongoing seizure disorder, psychotic disorder, Tourette's disorder or family history of Tourette's disorder