cyrilzakka/clinical-trials huggingface dataset:
An Observational Study to Learn More About the Safety of Darolutamide in Men With Prostate Cancer in Korea

This is an observational study in which participants receive a treatment which is already available for doctors to prescribe for non-metastatic castration-resistant prostate cancer (nmCRPC) or metastatic hormone-sensitive prostate cancer (mHSPC). nmCRPC is a prostate cancer that has not yet spread to other parts of the body and does not respond to lowering testosterone in the body. mHSPC is a prostate cancer that has spread to other parts of the body and can be treated by lowering testosterone levels.

This study looks at the safety of the study drug, darolutamide, in Korean patients with nmCRPC or mHSPC. Darolutamide is currently available for doctors to prescribe to men with nmCRPC or mHSPC. It works by attaching to the special molecules called androgen receptors (AR) within prostate cells and blocks hormones called androgens from attaching to AR, which helps delay cancer growth.

To learn more about the safety of Darolutamide, the researchers will study whether the participants have adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. The researchers will also learn more about how well darolutamide is working in these participants.

During this study, the researchers will collect information from the medical records of patients who have been prescribed darolutamide by their doctors.

Each participant will be in this study for 1 year. The whole study will last about 6 years. During this time, the participants will visit their doctor every 2 to 4 months as part of their usual care. At these visits, the doctors will do scans to check the patients' cancer and take blood samples. The patients will answer questions about any medications they are taking and whether they have any adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Male aged ≥19 years
* Patients with high risk nmCPRC

  * Castrate level of serum testosterone (\< 1.7 nmol/l \[50 ng/dL\])
* Patients with mHSPC

  * histologically or cytologically confirmed prostate cancer, and metastases detected on bone scanning, contrast-enhanced computed tomography(CT), or magnetic resonance imaging (MRI).
  * be candidates for androgen-deprivation therapy and docetaxel
* Patients for whom the decision to initiate treatment with Darolutamide as a first time was made as per investigator's routine treatment practice
* Written informed consent from subject or legal representative; assent from subject when appropriate

Exclusion Criteria:

* Patients participating in an investigational program with interventions outside of routine clinical practice
* Participants with contraindication according to the locally approved prescribing information
Adaptive Planning in Bladder Cancer

To demonstrate that radiotherapy treatments for bladder cancer can be delivered with greater accuracy using a new planning method and that this method can be used simply and effectively by those delivering treatment.

This study integrates a novel adaptive planning methodology, Adaptive-Planning Organ LOcalisation (A-POLO), with optimised margins and cone beam CT technology for improving the accuracy of radiotherapy treatment delivery.

The previous study (CCR2873, REC 07/Q0801/13) evaluated the use of cone beam CT in radiotherapy for bladder cancer. A larger than expected number of bladder radiotherapy treatments were seen to have been delivered with some element of geographic miss. Using the novel adaptive planning method these fractions of radiotherapy could have been correctly treated. The feasibility of this method has been proven in the previous study, particularly it has been shown that this method is appropriate and provides a simple solution to the problem. It can be carried out by the radiographers at the treatment unit without adding extra time to the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* Histologically confirmed invasive carcinoma of the bladder
* Patient planned to receive hypofractionated radiotherapy to the bladder.
* No previous pelvic radiotherapy
* Written informed consent given according to ICH/GCP and national/local regulations.

Exclusion Criteria:

* Urinary catheter in situ: the presence of a urinary catheter degrades cone beam image quality and thus images would not be evaluable. Patients with a urinary catheter would not be expected to show variation in bladder filling.
A Randomized, Double-blind, Parallel-group Assessment of the Safety and Efficacy of Telmisartan 40mg Plus Hydrochlorothiazide 12.5mg (Micardis Plus) in Comparison With Losartan 50mg Plus Hydrochlorothiazide 12.5mg in Taiwanese Patients With Mild to Moderate Hypertension

The primary objective of this trial is to compare the efficacy and safety of telmisartan 40 mg/hydrochlorothiazide 12.5mg (Micardis Plus) with that of losartan 50 mg/hydrochlorothiazide 12.5 mg, a reference AIIA combined with diuretic, in Taiwanese patients with mild to moderate hypertension.


Eligibility Criteria:
Inclusion Criteria:

1. Mild to moderate hypertension as defined by a morning mean(\>95 and \<115mmHg) of two diastolic blood pressure measurements (DBP) after 5 min in the sitting position following a minimum 2-week placebo run in phase.Mean sitting systolic blood pressure (SBP) must be \>140 and \<200mmHg. The mean DBP and SBP values are calculated as the mean of the two sitting measurements taken 2 min apart just before the drug intake.
2. Male or female between 20 to 80 years old
3. Ability to provide written informed consent.

Exclusion Criteria:

1. Patients are still taking more than three anti-hypertensives at the screening visit
2. Pre-menopausal women
3. Known or suspected secondary hypertension
4. Mean sitting DBP\<95mmHg and/or mean sitting SBP \> 200mmHg at the end of placebo run-in phase
5. Hepatic and/or renal dysfunction
6. Known bilateral renal artery stenosis, patient with a solitary kidney, post renal transplant
7. Known NYHA functional class Chronic Heart Failure (CHF) III, IV
8. Unstable angina, myocardial infarction, cardiac surgery or stroke within the preceding six months
9. Post-Transluminal Coronary Angioplasty(PTCA) within the preceding three months
10. Sustained ventricular tachycardia, atria fibrillation, second or third degree AV block, VPC or APC (\>10% of heart rate) or other clinically relevant cardiac arrhythmia as determined by the clinical investigator
11. Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of aortic or mitral valve.
12. Once documented evidence by ophthalmological examination of significant retinal haemorrhages/ exudates
13. Clinically significant sodium depletion as defined by serum sodium level less than 130 mmol/L
14. Clinically significant hyperkalemia as defined by serum potassium level \>5.5 mmol/L
15. Non-insulin dependent DM poorly controlled whicih is defined as HbA1c\>8% twice consecutively within 6 months and/or AC blood sugar\>180 mg/dl.
16. Insulin Dependent Diabetes Mellitus
17. Chronic administration of oral anticoagulants and/or digoxin within the past 6 months.
18. Known drug or alcohol dependency
19. Administration of medication known to affect blood pressure, except medication allowed by the protocol
20. Angioedema with ACE inhibitors
21. Use of nitrates
Topical Clobetasol for the Treatment of Toxic Epidermal Necrolysis

The primary objectives of this study are to investigate the efficacy and safety of topical steroid ointment (clobetasol 0.05%) for the treatment of the cutaneous manifestations of toxic epidermal necrolysis (TEN).

The experimental focus of this trial is thus to evaluate the safety and clinical outcomes of topical steroid (clobetasol 0.05% ointment) for treatment of the cutaneous manifestations of toxic epidermal necrolysis (TEN).

The design of the study is a randomized, placebo-controlled, double-blind split-body Phase II clinical trial in which clobetasol 0.05% or placebo ointment will be topically applied to opposite arms for a period of fourteen days. The primary endpoints of the study are to determine the time to cessation of skin detachment in both groups as well as the safety of topical clobetasol to treat the cutaneous manifestations of TEN. Secondary outcome measures will evaluate efficacy by comparing the time to re-epithelialization and the percentage of affected skin between the clobetasol and placebo arms at various time points.

An additional aim of the study is to characterize the genes expressed during the TEN disease state and any changes in gene expression following treatment with topical steroids, particularly those genes involved in the regulation of programmed cell death (apoptosis). This will be accomplished though molecular analysis of skin biopsy specimens obtained after treatment with clobetasol and placebo ointments. The specific hypothesis being tested is that two weeks of topical clobetasol will promote epidermal keratinocyte survival through suppression of TNF signaling, decreased granulysin expression and inhibition of other pro-apoptotic pathways resulting in shorter disease duration and decreased time to re-epithelialization.

IRB number: 642415-5

Eligibility Criteria:
Inclusion Criteria:

* Characteristic histological findings on diagnostic biopsy
* Clinical diagnosis verified by two independent physicians
* Greater than 10% affected body surface area (BSA)
* Ability to start treatment within seven days or less from the onset of erosions
* Actively worsening disease (enlarging area of involvement or new erosions occurring over the last 24 hours)
* Patient Body Surface Area (BSA) \> 1.0 m2
* Reproductive age female patients must have a negative pregnancy test prior to enrollment

Exclusion Criteria:

* Patients will be excluded if they are \< 7 or \> 85 years of age.
* Patients who have documented:

  * Uncontrolled infection (e.g. documented bacteremia)
  * Malignancy
  * Known prior immunodeficiency
  * Pregnancy
  * Concurrent use of systemic corticosteroids in the burn center greater than or equal to 0.5 mg/kg/day of prednisone or equivalent dose of similar medication.
  * Greater than 70% eroded skin
  * SCORETEN score \>3 on hospital admission
* Patients will also be excluded if they have: active hepatitis and/or an ALT or AST greater than four times the normal limits, or renal insufficiency with an estimated GFR\<50 mL/min/1.73m2.
Sleep Disordered Breathing in Children: Inflammation and Oxidative Stress

The purpose of the study is to measure markers of inflammatory and oxidative stress known to be associated with cardiovascular morbidity in snoring children.

In addition, to measure markers of local inflammation and to evaluate the response to treatment.


Eligibility Criteria:
Inclusion Criteria:

* children ages 6 months-18 years
* suspected sleep-disordered breathing or will attend the pre-operative ENT clinic for adenoidectomy or adenotonsillectomy

Exclusion Criteria:

* craniofacial abnormalities
* neurological disorders
* genetic disorders
* infectious disease
* chronic inflammatory disease
* any underlying chronic medical condition
Effect of Digitally Produced Custom Mouthguards on the Awareness and Sports Performance of Child and Adolescent Basketball Players

The aim of the study is to investigate the effects of custom mouthguards, prepared using digital workflow, on the sports performance of children and adolescents who play basketball, and to evaluate their views on the use of mouthguards.

Do digitally produced custom mouthguards have an effect on the sports performance of child and adolescent basketball players?

Will the awareness and opinions of child and adolescent basketball players regarding mouthguards be affected?

Participants will:

Undergo the Yo-Yo performance test both while using and not using mouthguards prepared with a digital workflow.


Eligibility Criteria:
Inclusion Criteria:

* Involved in basketball for at least one year,
* Amateur or semi-professional athletes,
* Possession of a health report confirming eligibility for high-activity sports,
* No severe skeletal or dental anomalies,
* Class I occlusion relationship,
* No or mild dental crowding issues,
* No severe nasal deviation that would interfere with sports,
* No prior use of any type of mouthguard,
* Training 4-5 days a week and actively competing in a basketball league.

Exclusion Criteria:

* Individuals with mouth breathing,
* Individuals with a history of adenoid vegetation or enlarged adenoids.
Nitazoxanide and Lansoprazole Based Regimens for H. Pylori Management

The study will evaluate the eradication rate and tolerability of modified LOAD regimens (three antibiotics and a proton pump inhibitor (lansoprazole)) for management of HP infection in treatment-naive patients as well as patients who failed previous therapies.

This will be randomized, parallel group, comparative open-label study that will be conducted to evaluate the efficacy and tolerability of a four-drug regimen (modified LOAD regimen) in eradicating HP. The study will evaluate the efficacy of modified LOAD regimens(levofloxacin/moxifloxacin, nitazoxanide, doxycycline and lansoprazole) inpatients who failed previous therapies and compare these regimens with the classic triple therapy (amoxicillin, clarithromycin and lansoprazole) in treatment naïve patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients presented with dyspepsia for more than one month with positive H. pylori antigen test in stool

Exclusion Criteria:

* Treatment with proton pump inhibitors, bismuth, H2 receptor antagonist, or sucralfate within the two weeks before study entry, recent use of antibiotics (within one month), allergy to any of the study drugs, active bleeding, gastric surgery, pregnancy, any current malignancy.
A Study of Tirzepatide (LY3298176) Once Weekly in Adolescent Participants Who Have Obesity or Overweight With Weight-Related Comorbidities

The main purpose of this study is to evaluate the safety and efficacy of tirzepatide in adolescents that have obesity or overweight with at least one weight-related comorbidity. The study will last approximately 90 weeks and may include up to 25 visits.


Eligibility Criteria:
Inclusion Criteria:

* Have obesity, as defined by BMI equal to or above the 95th percentile for age and sex, on age- and sex-specific growth chart, OR
* Have overweight, as defined by BMI equal to or above the 85th percentile but less than the 95th percentile for age and sex, on age- and sex-specific growth chart, with at least 1 weight-related comorbidity.

  * dyslipidemia
  * pre-hypertension
  * hypertension
  * nonalcoholic fatty liver disease
  * obstructive sleep apnea
  * prediabetes
  * documented preexisting condition of Type 2 Diabetes

Participants with Type 2 Diabetes Mellitus (T2DM)

* Have been treated with either diet and exercise alone or stable treatment with metformin for at least 90 days prior to screening and have a HbA1c\<9.0%

Exclusion Criteria:

* Have a self-reported, or by parent or legal guardian where applicable, decrease in body weight more than 5 kilogram (kg) (11 lbs.) within 90 days before screening irrespective of medical records.
* Have Type 1 Diabetes
* Have taken within 90 days before screening or intend to start prescribed or over-the-counter medications, or alternative remedies including herbal or nutritional supplements, intended to promote body weight reduction.
* Are prepubertal (Tanner stage 1).
* Have a family or personal history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia (MEN) Syndrome Type 2
* Have a history of chronic or acute pancreatitis.
* Have undergone or plan to undergo weight reduction procedure during the study, such as, but not limited to

  * gastric bypass
  * sleeve gastrectomy
  * restrictive bariatric surgery, such as Lap-Band gastric banding, or
  * any other procedure intended to result in weight reduction.
Cardiac Operation Under Totally Endoscope and Cardiopulmonary Bypass (CPB)

Conventional cardiac operations are performed with median sternotomy, which is related to great wound, morbidities, longer duration in hospital and most significantly, cosmetic problems. The investigators invested a new minimally invasive cardiac operation method totally under video-endoscope and peripheral cardiopulmonary bypass. The investigators' hypothesis is that this new minimally method could provide better cosmetic effects to the patients, and also relate to shorter postoperative hospital stay and better recovery.


Eligibility Criteria:
Inclusion Criteria:

* congenital heart defects or heart valve diseases require surgical correction

Exclusion Criteria:

* Body weight \< 10kg
* committed with complex congenital heart defect
* anticipated to perform aortic valve repair or replacement
* anticipated to perform aorta repair or replacement
* committed with Femoral vessel diseases unable to perform femoral cannulation
* refuse to perform totally thoracoscope minimally invasive surgery
Efficacy of Radiotherapy in Combination With Zoledronic Acid in Bone Metastasis Patients With Gastrointestinal Tumors

Bone metastasis causes bone destruction and skeletal related events (SRE) including compression fracture, hypercalcemia, and spinal cord compression. Therefore, palliative treatments for pain control and local control have become important and multidisciplinary multimodality approach is needed for treatment of bone metastasis.

The efficacy of radiotherapy (RT) for bone metastasis is well known. And the results that bisphosphonate decreases SRE in patients with solid tumor and multiple myeloma reported. In previous retrospective reports, the combination of local RT and systemic bisphosphonate was more effective than RT alone.

Therefore, Investigators designed a phase II study to evaluate the efficacy of RT in combination with zoledronic acid on pain relief and the safety of RT in bone metastasis patients with gastrointestinal tumors.


Eligibility Criteria:
Inclusion Criteria:

* Patients with radiologic detectable bone metastasis (spine or non-spine)
* Patients with clinical diagnosis of gastrointestinal cancer: esophagus, stomach, colorectum, anus, liver, pancreas, gallbladder, biliary tract, etc.
* Patients over 20 years of age of both genders
* ECOG: 0 \~ 2
* Pain: worst pain score on BPI ≥3

Exclusion Criteria:

* Undetectable bone metastasis on radiologic study
* Patients who have previous surgery history at same site
* Patients who are considered surgery first: pathologic fracture, neurological or radiological evidence of spinal cord compression, impending pathologic fracture
* Patients who have hypersensitivity for zoledronic acid or other bisphosphonate
* Patients who have treatment history with zoledronic acid or other bisphosphonate
* Abnormal renal function or history of kidney transplantation
* Patients with metabolic bone disease
* Synchronous symptomatic brain metastasis
* Women who are pregnant, breast-feeding, or possible pregnancy
Study to Evaluate Methods That Assess the Effect of AZD4017 in Adipose Tissue

The primary purpose of this study is to investigate different methods to evaluate the effect of AZD4017 in adipose tissue after single and multiple doses of AZD4017 in abdominally obese but otherwise healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed written and dated informed consent
* Have a body mass index (BMI) between 27 and 35 kg/m2
* Waist circumference of \>102 cm

Exclusion Criteria:

* History of any clinical significant disease
* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product
* Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator
Changes in Fitness and Strength in Postoperative Cardiac Patients Undergoing Exercise Therapy: Biological and Functional Mechanisms of Recovery

This study seeks to determine the biological, physiological and psychological effects of supervised exercise programs in patients surviving open heart surgery.

Patients who have survived open heart surgery and cleared for exercise by their clinical team will be approached to enter a 12-week exercise program. Patient will consent to train with a personalized program either in strength, functional or aerobic exercise in a supervised setting for 3 sessions per week for a minimum of 12-week period. The aim is to enroll males and females in this arm in 1:1 ratio if possible. A separate cohort of patients entering cardiac rehabilitation (CR) will also be included for comparison. The CR program includes three sessions per week for a maximum of 36 sessions. The enrollment and retention rates in CR will be monitored. In this study, five patients who have undergone cardiac surgery and chosen not to participate in organized exercise program will be included. Participants cardiorespiratory fitness will be measured either using a questionnaire or in person. Through each phase of the study, the change in fitness, strength, biomarkers, body composition, cognition and psychosocial recovery will be monitored. All subjects will undergo detailed assessments in the research lab 2 weeks before and after finishing or exiting exercise program. A short (3-month) and long term (12-month) outcomes including rates of survival, major adverse cardiac events, cognition and cardiac-related hospitalizations will be collected as well during the study.

Eligibility Criteria:
Inclusion Criteria:

- Patients at least 18 years of age or older who undergo open heart surgery and who intend to enroll in a cardiac rehabilitation program.

Exclusion Criteria:

* Patients may be excluded for inability to read or understand English
* suffering from a condition that precludes informed consent (for example, cardiogenic shock)
* hemodynamic instability
* ongoing trauma or substance overdoses
* known intellectual or developmental delay
* communication impairment
* active users of illicit substances
* active psychiatric illness
* inability to attend cardiac rehabilitation (homeless, in police custody, or living out of state)
* inability to exercise (lower limb amputation, bedridden, decompensated heart failure, ongoing cancer treatment)
Characteristics and Outcomes of Odontoid Fragility Fractures in Elderly

Usually, cervical spine fractures are not considered as osteoporotic fractures. However, recent studies show that odontoid fractures are the most common fractures of the cervical spine in elderly and may occur in a context of low trauma energy. Thus, the goal of this observationnal study is :

* to describe the different type of odontoid fracture and to characterize bone status in elderly patient (\>65 y) who underwent odontoid fracture in a context of low trauma energy.
* To describe short and long term outcomes

All patients over 65 y admitted for low trauma odontoid fracture will be consecutively included in the study after informed consent. The investigators will record:

* clinical risk factor of osteoporosis and health habits including accomodation
* type of fracture and characterization of the odontoid fracture on imaging (standard X ray / MRI / QCT)
* Bone status : bone mineral density on DXA, lab tests for secondary osteoporosis check-up, previous vertebral fracture on VFA or X ray
* osteoporosis managment : nutrition, vitamin D, anti-osteoporotic drugs
* treatment of the fracture : surgical / non surgical
* adverse event during hospitalization
* lenght of hospital stay
* type of discharge

Follow-up à 3 and 12 months : dead vs alive ; accomodation ; autonomy ; new fracture

Eligibility Criteria:
Inclusion Criteria:

* all patients over 65 y admitted for low traumat odontoid fracture

Exclusion Criteria:

* patient \< 65 y
* traumatic odontoid fracture