cyrilzakka/clinical-trials huggingface dataset:
To Evaluate the Safety, Tolerability, PK, PK-PD Relation of KD101 in the Fed State in Obese or Overweight Subjects

To Evaluate the safety, tolerability and pharmacokinetic property after KD101 multiple oral dosing in the fed state in obese or overweight subjects.

dose block-randomized, double-blinded, placebo controlled, single or multiple ascending dose study. AEs, PE, Vital signs, ECGs and Clinical lab tests

* Part I : multiple dose study (KD101 or placebo) / male and female
* Part II : single dose study (KD101) / male only

Eligibility Criteria:
Inclusion Criteria:

* Male or Female adults aged 20 to 55 at screening (Part II : Male adults aged 20 to 55 at screening)
* Healthy volunteer whose BMI ≥ 27 (Part II : Healthy volunteer whose BMI ≥ 18)
* Female who are not pregnancy possibility or Male/Female who can abstinence or contraception during clinical trials

Exclusion Criteria:

* Subjects who had clinically significant disease history (liver,kidney,nervous,pulmonary,endocrinal,urinary,cardiovascular,musculoskeletal,mental system,blood,tumor) or diagnosed within 1 month from screening
* Subjects who had gastrointestinal disease(Crohn's disease, ulcer, acute/chronic pancreatitis) that affect the absorption of test drug or gastrointestinal operation (However, appendectomy, herniotomy induced by acute appendicitis are excluded)
* Subjects who had following history. \[myocardial infarction (diagnosed by cardiac enzyme and/or diagnostic ECG), cerebral infarction/stroke, arrhythmia needed to medical treatment, unstable angina, pulmonary hypertension\]
* Subjects who had positive result to Human Immunodeficiency Virus, Hepatitis B virus, Hepatitis C virus during screening
* Subjects who had allergy history (ex. allergy for aspirin, antibiotics, etc) or had clinically-significant allergy
* Subjects whose systolic BP was \<85mmHg or \>145mmHg, or diastolic BP was \<50mmHg or \>95mmHg, or pulse was \>100/min after 3 minute-seating position. (BP can be re-measured twice at leat 5 minute-interval)
* Subjects who would take prescribed/oriental drug(within 2 weeks from the first dosing day) or OTC drug or vitamines (within 1 weeks from the first dosing day)
* Subjects who drink over than 21 unit (1 unit = 10g of pure alcohol) or cannot quit drinking alcohol during clinical trial period
* Subjects who ate following food within 2 days from the first dosing day or cannot quit following food \[grapefruit-contain food, caffein-contain food(coffee, green tea, black tea, soft drink, coffee milk, energy drink)\]
* Subjects who didn't agree contraception
* Subjects who didn't agree to quit smoke
* Subjects who donated his/her blood within 2 months (whole blood) / 1 month (apheresis) or who took transfusion within 1 month
* Subjects who participated another clinical trials within 3 months from first dosing day. (The clinical trial completion day is defined as the last dosing day of past clinical trial)
* Subjects who are not adequate to this trial by lab examination and another reasons
* Subjects who weighed loss more than 5kg in 3 months
Violence in ICU: Outcomes, Lessons, and Experiences of ICU Team (The VIOLENT-Study)

This study aims to investigate the perceptions, experiences, and responses of healthcare professionals working in intensive care units in Switzerland concerning patient violence.

Workplace violence, as defined by the International Labor Organization, includes any action, incident, or behavior that assaults, threatens, harms, or injures a person during their work. Healthcare workers face the highest risk of workplace violence among all professions. Violence can take many forms, including verbal abuse, physical offenses to sexual harassment. While most research focuses on psychiatric and emergency departments, workplace violence in intensive care units (ICUs) is understudied and often underreported. As a result, little is known about its prevalence and risk factors, leading to a lack of awareness and effective prevention strategies.

This study examines the perceptions, experiences, and responses of healthcare professionals in Swiss ICUs. A questionnaire-based survey will assess various aspects, including personal background (such as education and professional role), the frequency and nature of past incidents of workplace violence, responses and measures taken, psychological or professional consequences, current prevention strategies, and suggestions for improving workplace safety.

Since workplace violence is a common issue, the results of this study could help improve the work environment and safety in ICUs and other healthcare settings.

Eligibility Criteria:
Inclusion Criteria:

* Consenting nurses and physicians currently working in Swiss intensive care units
* Nurses and physicians consenting to participate will be included

Exclusion Criteria:

* Nurses and physicians who do not consent
Structural and Functional Left Ventricular Remodelling in Patients With Obstructive Sleep Apnea

The purpose of this study is to determine whether patients with obstructive sleep apnea have any changes in left ventricular function and structure after 06 months of continuous positive airway pressure treatment.

Several studies have been suggesting that Obstructive Sleep Apnea contributes to deterioration of left ventricular diastolic function. It may be associated to increased risk of cardiovascular events. We hypothesized that morphological and functional left ventricular changes might be reverted after treatment with Continuous positive airway pressure.

Eligibility Criteria:
Inclusion Criteria:

* Apnea-hypopnea index higher than 5 events per hour

Exclusion Criteria:

* Body mass index higher than 40 kg/m2
A Comparative Study of KHK6188

This is a placebo-controlled, double blind, crossover study to evaluate the efficacy and safety of KHK6188 in postherpetic neuralgia when administered orally for 2 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Patients with pain for ≥ 3 months and ≤ 1 year following onset of a herpes zoster rash
* Patients with a mean pain intensity score (11-point numerical rating scale) of ≥ 4
* Patients whose rash has been healed
* Patients who are able to fill their patient diary
* Patients who provided written voluntary informed consent to participate in the study

Exclusion Criteria:

* Patients who have other pain or disease which may impair the self assessment of pain
* Patients who have dementia, depression or schizophrenia which may affect the self assessment of pain
* History or presence of severe cardiovascular disease, hepatic dysfunction, renal failure, respiratory disease, blood disease or CNS disorder
* History or presence of a drug allergy
* Patients who have a history of a diagnosis of cancer or a treatment of cancer within 5 years prior to the study entry
* Patients received an investigational medication within 4 months (6 months for biologic medication such as antibody) prior to the informed consent
* Women of child bearing potential who do not agree to avoid pregnancy from the time of providing the consent until 3 months after the end of dosing, or men of reproductive potential who do not agree to avoid pregnancy from the time of the first dose until 3 months after the end of dosing
* Patients who are pregnant, lactating, or possibly pregnant
* Patients judged to be inappropriate to enter the study by a investigator or a subinvestigator
A Multi-Site RCT of a Stepped-Care Intervention for Emergency Department Patients With Panic Attacks and Panic Disorder

Using a randomized controlled trial (RCT) design, the main objective of this study is to evaluate the clinical, patient-centered, and economic effectiveness of a stepped-care intervention for patients with panic attacks and panic disorder presenting to the busiest Accident and Emergency (A\&E) departments of the largest public healthcare group in Singapore.

The RCT will have two arms: 1) treatment via an enhanced care pathway consisting of a stepped-care intervention for panic attacks and panic disorder; and 2) a control arm consisting of screening for panic attacks and panic disorder in the A\&E and discharge (routine care). In addition to the baseline assessment, the study follow-up visits will occur at 1, 3, 6, and 12 months.

Specific Aims and Hypotheses

Aim 1 (Primary): To evaluate the clinical effectiveness of a stepped-care intervention for A\&E patients with panic attacks and panic disorder as compared to screening alone.

Aim 2: To evaluate the patient-centered effectiveness of a stepped-care intervention for A\&E patients with panic attacks and panic disorder as compared to screening alone.

Aim 3: To evaluate the incremental cost-effectiveness of a stepped-care intervention for A\&E patients with panic attacks and panic disorder compared to screening alone from the health system perspective.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female
2. 21+ years of age
3. Triage level 2 or 3
4. English or Mandarin speaking
5. Able to provide informed consent and read study materials
6. Presenting complaint of chest pain, palpitations, dizziness, or difficulty breathing
7. Score ≥ 3 on CDR screener
8. Diagnosis of panic attack or panic disorder confirmed on SCID interview
9. Willing to enter randomized trial

Exclusion Criteria:

1. Altered mental status (dementia, psychosis, substance intoxication/withdrawal)
2. Triage level 1
3. Non-English or Mandarin speaking
4. Unwilling or unable to complete study procedures
5. Symptoms of clear cardiac origin as determined by A\&E physician
6. Deemed unfit due to possible adverse respiratory or cardiac outcomes by A\&E physician
7. Clear organic cause for panic symptoms as evidenced by laboratory tests (FBC, UE, ECG, TROPONIN T, CXR)
8. Does not meet criteria for panic attack or panic disorder on SCID interview
9. Received CBT for panic symptoms in previous 12 months
Outcome of Coronary High Angulated Bifurcation Lesions Treated With Kissing Ballooning or Sequential Ballooning Techniques

Coronary artery bifurcation lesions prone to occur with the worsening of atherosclerosis. Their structural properties make angioplasty technique to increase the difficulty of implementation, but also increased the risks of the in-stent thrombosis and restenosis. Standard treatment of coronary bifurcation lesions remains controversial manner, especially when the side branch (SB) was large combined with high angulated bifurcation lesions. Complex procedures and certain types of lesions are associated with poor prognosis. There is no standard treatment for such lesions even with the development of drug-eluting stents solve partial problems. The investigators reviewed patients who received coronary intervention between 2009-2012 years and met the inclusion criteria, and then analyzed the prognostic relevance of these cases the use of different treatment modalities.

We introduced a retrospective analysis for high angulated bifurcation lesions treated with either DES or BMS.

Primary endpoint: cardiovascular mortality, TLR, MACE. secondary endpoint: procedure time, fluoroscopy time, procedure success, angiographic success.


Eligibility Criteria:
Inclusion Criteria:

* Angulated bifurcation:MV(main branch) and SB(side branch) angle\>70 degree. MV diameter≥2.5mm and eligible for stenting. lesion stenotic severity\>70% by QCA(Quantitative coronary analysis). 1 stent strategy. SYNTAX\>22 Procedure success. de novo lesion

Exclusion Criteria:

* Bifurcation lesions intervention without side br. ballooning after stents deployment or procedure incomplete. Left main coronary artery bifurcational lesions. Elective,provisional or bail-out stenting for side br.
Exercise for Brain Health in the Fight Against Alzheimer's Disease

The investigators aim to compare the effects of a 6-month moderate intensity exercise training (ET) intervention to a low intensity flexibility exercise control condition (FC) on brain function, cognition, and physical function in cognitively healthy and physically inactive older adults (ages 60-80). Apolipoprotein E epsilon4 (APOE-ε4) allele carriers are known to be at substantially greater risk for cognitive decline and Alzheimer's disease (AD). Cognitively intact APOE-ε4 allele carriers, and non-carriers, will be randomly assigned to 6-months of either supervised moderate intensity aerobic exercise training (ET) or supervised flexibility exercise control (FC). The ET and FC each contain a group based exercise component and are run in local retirement communities near College Park, MD, or on the University of Maryland College Park campus. The primary aims of the study are to compare pre-intervention to post-intervention changes in episodic memory performance and MRI biomarkers.


Eligibility Criteria:
Inclusion Criteria:

* 60 to 80 years old
* Fluent in English
* Willingness to make the time commitment to participate in the project, including randomization to treatments
* Physically inactive (physical activity not more than 2 days per week for the past 6 months)
* Physician consent to undergo an exercise stress test and engage in moderate intensity exercise
* Determined to be safe for MRI

Exclusion Criteria:

* Neurological illnesses/conditions such as cerebral palsy, epi¬lepsy, brain tumor, chronic meningitis, multiple scle¬rosis, pernicious anemia, normal-pressure hydrocephalus, HIV infection, Parkinson's disease, and Huntington's disease
* Untreated hypertension, glaucoma, and chronic obstructive pul¬monary disease
* Untreated severe major depression
* Substance abuse or dependence
* Current use of psychoactive medications, except selective serotonin/norepinephrine reuptake inhibitor antidepressants
* Use of acetylcholinesterase inhibitors (e.g., Aricept)
* Unstable or severe cardiovascular disease or asthmatic condition
* History of transient ischemic attack, cerebral ischemia, or clinically diagnosed stroke
* Diagnosis of mild cognitive impairment or dementia, or objective evidence of cognitive impairment
Programming Strategy of VFS for Gait Impairments in PD

Variable Frequency Stimulation(VFS) is a stimulation pattern applied in Deep Brain Stimulation(DBS) therapy for Parkinson's disease(PD). Peking Union Medical College Hospital was the first centre conducting research on VFS. The studies in the past have resembled conclusion that VFS provides improvement not only in the major symptoms such as tremor and rigidity, but also in gait and balance disorder. However, the best programming strategy of VFS has not met agreement. The random-controlled double blinded crossover study is designed for participants who underwent DBS surgery in bilateral subthalamic nucleus for parkinson's disease. The investigators study several strategies on programming and observe the improvement of symptom to look for the best one. A 4-month follow-up is designed to observe a relatively long-term effectiveness of VFS. The study intends to gather more clinical evidence to guide further studies on VFS application.


Eligibility Criteria:
Inclusion Criteria:

* Idiopathic Parkinson's disease (according to the Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's Disease);
* 18-75 years of age;
* Hoehn \& Yahr ≤ 3 (in best OFF-medication condition)；
* Implanted bilateral subthalamic nucleus DBS for over 1 year；
* gait Impairments in OFF-medication condition；
* High Frequency Stimulation provides significant improvement；
* in OFF-medication On-stimulation condition, capable of walking ≥ 10m.

Exclusion Criteria:

* mental disorder or dementia;
* Pregnant women, lactating mothers or women who are unable to take effective measures to prevent pregnancy;
* With other diseases that can affect walking distance, such as joint diseases of the lower body, spinal diseases, neuropathy, or serious heart or lung diseases;
* In severe health condition, such as diseases associated with heart or liver;
* Epilepsy;
* Lead off target;
* Unable to willingly sign Written informed Consent;
* Disagree or unable to cooperate with follow-up sessions.
Renal Involvement in Adult Patients with Inflammatory Bowel Disease and Its Relation to Duration and Disease Activity

To Assess the pattern of renal injury in patients with inflammatory bowel disease and its relation to the duration and disease activity by Identification and characterization of early renal manifestations (e.g., proteinuria, hematuria, electrolyte imbalances) in IBD patients. and know Correlation between kidney involvement and IBD severity, including flare-ups and complications.

and know Impact of early renal manifestations on long-term renal outcomes, such as progression to CKD or development of AKI.

Inflammatory bowel disease (IBD), comprising ulcerative colitis (UC) and Crohn's disease (CD), is a chronic immunemediated disorder of the gastro-intestinal tract characterized by recurrent inflammation and epithelial injury of the intestine. Extraintestinal manifestations are seen in 6% to 47% of patients diagnosed with IBD. Renal and urinary tract involvement occurs in 4% to 23% of patients with IBD, with renal calculi being the most common form of renal involvement. IBD is associated with a range of renal manifestations, including nephrolithiasis, glomerulonephritis, tubulointerstitial nephritis, and secondary amyloidosis, which can lead to acute or chronic renal insufficiency. Several potential mechanisms might contribute to the higher risk of incident CKD and AKI in patients with IBD. First, in the context of IBD, acute or chronic loss of circulating volume (salt and water depletion) due to persistent inflammation of the intestine and repeated intestinal resection could lead to electrolyte abnormalities followed by acute and chronic loss of kidney function, which may not be always reversible. Second, dysbiosis in patients with IBD is associated with increased production of microbiota-derived uremic toxins and microinflammation, both of which promote the progression of renal diseases. Third, IBD-related alterations in the innate and adaptive immune systems may lead to elevated proinflammatory cytokines, which are particularly implicated in the progression of renal disease. Understanding these associations is crucial for management and monitoring of IBD patients, particularly for those who may develop renal complications, so mitigating impact on kidney function and overall health.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years or older
* Confirmed diagnosis of IBD either crohns disease or ulcerative colities based on clinical ,endoscopic ,histological and radiological findings . - Patients in any stage of IBD, including remission, active disease, and flare-ups. - Willingness to participate and provide informed consent. - Renal Assessment for participants.

Exclusion Criteria:

- Pre-existing chronic kidney disease (CKD) at any stage. - Known primary kidney diseases unrelated to IBD. - Current use of nephrotoxic medications not related to IBD treatment. - Pregnancy or breastfeeding. - Patients who are unable to comply with study protocols or follow-up assessment - Presence of other significant comorbidities that impact renal function or overall health
Bronchial Thermoplasty Global Registry

The primary objective of this Registry is to collect real-world data on patients undergoing bronchial thermoplasty (BT) treatment.

This Registry is a prospective, open-label, single arm, observational registry to collect outcome data as well as clinical and demographic characteristics of patients undergoing BT treatment in the "real world" setting. Patients will be recruited at participating study centers that offer BT as a treatment option to patients with asthma who remain symptomatic despite taking standard of care maintenance medications.

The Registry will be conducted at up to 80 sites globally and will enroll up to 500 patients. The treatment period is from the date of the first BT procedure until 6 weeks after the third (last) procedure (approximately 12 weeks). The post-treatment period starts at the date of the 6-week follow up visit after completion of the third (last) BT procedure for 2-years of follow-up.

The primary endpoint will be the proportion of patients who experience severe asthma exacerbations at 1 and 2 years following BT treatment with the Alair System.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is an adult aged 18 years or older and is scheduled to undergo BT treatment according to the Alair System DFU.
2. Patient is able to read, understand, and sign a written Informed Consent to participate in the Registry and able to comply with the registry requirements.

Exclusion Criteria:

1. Patient has any medical condition that would make them inappropriate for BT treatment, in the Investigator's opinion.
Drug-induced Repolarization ECG Changes

Studies have shown that the risk of developing heart arrhythmias, is increased in patients receiving medication for Attention-deficit hyperactivity disorder (ADHD) and depression. The QT-interval on a electrocardiogram (ECG) is often used to assess the patients risk of developing heart arrhythmias. The QT-interval defines the hearts electrical resting period and a long interval is linked to an increased risk of developing heart arrhythmias. In this project the investigators wish to examine possible side-effects in patients receiving medication for ADHD and depression and their dynamic QT-interval changes, by analysing the ECG changes that occur during "Brisk Standing".


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* Patients treated with Methylphenidate
* Patients treated with Methylphenidate and QT-prolonging SSRI
* Patients treated with Methylphenidate and a non QT-prolonging SSRI

Exclusion Criteria:

* Patients considered in an unstable phase in their psychiatric condition
* Patients that are not able to understand the information regarding the trial, or who are unable to cooperate.