cyrilzakka/clinical-trials huggingface dataset:
Compare Sequential and Quadruple Therapy for the Eradication of Helicobacter Pylori in Korea

1. To compare 10-day sequential therapy and 14-day modified bismuth quadruple therapy and to establish more effective first-line regimen for the eradication of Helicobacter pylori in Korea.
2. To evaluate the effect of H. pylori eradication therapy on the symptom improvement of functional dyspepsia

Emerging evidence shows that the eradication rate of proton pump inhibitor (PPI)-based triple therapy for the first-line treatment of Helicobacter pylori has decreased. The reason for the decrease in the efficacy of PPI-based triple therapy is mainly due to the increase in the resistance against clarithromycin. Sequential therapy seems to be more effective than the PPI-based triple therapy, however, the eradication rate of sequential therapy in Korea, which is mostly under 80%, is still not satisfactory. Modified bismuth quadruple therapy which replace metronidazole with amoxicillin (contained PPI, bismuth, tetracycline and amoxicillin) can be a promising regimen because the antibiotic resistance rate of tetracycline and amoxicillin are relatively low in Korea and amoxicillin is more easy to take in comparing with metronidazole. Therefore, the aim of this study is to compare 10-day sequential therapy and 14-day modified bismuth quadruple therapy and to establish more effective first-line regimen for the eradication of Helicobacter pylori in Korea.

In addition, previous studies reported that H. pylori infection also associated with functional dyspepsia (FD) and recommended H. pylori eradication in patients with FD. However, until now, there was no randomized prospective study in Korea, therefore the another aim of this study is to evaluate the effect of H. pylori eradication therapy on the symptom improvement of FD.

Eligibility Criteria:
Inclusion Criteria:

* Male and female Korean Adult (Aged ≥ 18 years)
* Patients who diagnosis of H. pylori infection by any of following three methods

  * positive rapid urease test (CLOtest)
  * histologic evidence of H. pylori by modified Giemsa staining
  * positive 13C-urea breath test

Exclusion Criteria:

* Age under 18 years
* Previous eradication treatment for H. pylori
* Patients who took any drug which could influence the study results such as proton pump inhibitor, H2 blocker, mucosal protective agent and antibiotics
* History of gastrectomy
* Advanced gastric cancer or other malignancy
* Abnormal liver function or liver cirrhosis
* Abnormal renal function or chronic kidney disease
* Other severe concurrent diseases
* Previous allergic reactions to the study drugs
* Pregnant or lactating women
Safety, Tolerability, and Pharmacokinetic Study of EVP-6124 in Patients With Alzheimer's Disease

This study is being conducted to determine the safety, tolerability, and pharmacokinetics (PK) of three different doses of an investigational medication, EVP-6124, in individuals with mild to moderate Alzheimer's disease who are also taking an Alzheimer's medication (AChEI \[acetylcholinesterase inhibitor\]: either donepezil or rivastigmine). In addition, PK of AChEI medications will be assessed. Cognitive function will be evaluated on an exploratory basis.

This is a randomized, double-blind, placebo-controlled, Phase 1b safety study of three dose levels of EVP-6124 in subjects with mild or moderate Alzheimer's disease and who are taking an AChEI medication (donepezil or rivastigmine).

Study drug will be supplied as capsules and will be orally administered once daily for a total of 28 days. Eligible subjects will be admitted to an inpatient study unit on Day -2 (two days before the first dose of study drug is administered) and will remain confined to the inpatient study unit for a total of five days. Starting on Day 4, subjects will continue the study in the outpatient setting, with study visits on Days 7, 14, 21, and 28. Safety assessments, PK sampling, and cognitive testing will be performed inpatient and at each study visit.

Eligibility Criteria:
Inclusion Criteria:

* male and post-menopausal or surgically sterile female pts
* 50-90 yrs old, who meet clinical criteria for probable Alzheimer's disease (Mini-Mental State Examination of 18-26; Hachinski Ischemic Score ≤4)
* must be taking donepezil or rivastigmine for at least 3 mos.

Exclusion Criteria:

* Unstable medical condition that is clinically significant in the judgment of the investigator; major organ system dysfunction
* Untreated hypothyroidism
* Insufficiently controlled diabetes mellitus
* Diagnosis of major depression requiring antidepressant medications within the last 5 years
* Stroke within 6 months before screening, or concomitant with onset of dementia
* Certain concomitant medications
Review on Minimally Invasive Skin Incision in Vanguard PS Artificial Knee Joint System

This study will show whether Tri-Vector method can ensure more extensive visual field and conduct the precise surgery when compared with Mini Mid-Vastus method by conducting 2 types of skin incision approach, Tri-Vector for 36 patients or Mini-Mid Vastus for 36 patients in Vanguard PS artificial knee joint total replacement observational period before and during surgery.


Eligibility Criteria:
Inclusion Criteria:

* The patients who need artificial knee joint replacement in ordinary medical consultation are selected as the subjects.

Exclusion Criteria:

* Patients with infections such as osteomyelitis, or sepsis (Because the affected part is lesioned, excellent surgical results cannot be obtained.)
Transcutaneous Auricular Neurostimulation (tAN) for Symptoms of Opioid Withdrawal

Clinical performance data for transcutaneous auricular neurostimulation (tAN) as a method to aid in the reduction of symptoms associated with opioid withdrawal in order to support clinical substantial equivalence to a predicate device.

Prior evidence has demonstrated that non-invasive neurostimulation can modulate specific brains regions associated with opioid use disorder and reduce opioid withdrawal symptoms. This is a double blind, randomized, controlled, multi-center study in which subjects will be randomized in a 1:1 ratio to one of two groups: 1) active transcutaneous auricular neurostimulation (tAN) or 2) delayed-active tAN to determine reduction of symptoms related to opioid withdrawal. Subjects in the active tAN group will receive tAN immediately whereas those in the delayed-active tAN will have their therapy turned on after a 30 minute delay (inactive period). All subjects will be informed of their group assignment at the conclusion of the randomized, double blind period (following initial 30 minutes of active or inactive therapy) and all will continue to receive active tAN throughout the five-day study. Each clinical site will have pre-determined and qualified clinical opiate withdrawal scale (COWS) accessor(s) that will be blind to the subjects group designation during the randomized, double blind period and will not be informed that all subjects receive active therapy throughout the remainder of the study. This will ensure a non-biased assessment of the COWS score and maintain single blinding throughout the duration of the study.

Eligibility Criteria:
Inclusion Criteria:

1. Current opioid dependence; prescriptive or non-prescriptive
2. COWS score is ≥ 13 or in the opinion of the investigator the subject is in moderate to severe withdrawal
3. 18-65 years of age
4. English Proficiency
5. Participants must be able to provide informed con-sent and function at an intellectual level sufficient for study requirements

Exclusion Criteria:

1. Current evidence of an uncontrolled and/or clinically significant medical condition
2. History of seizures or epilepsy
3. History of neurological diseases or traumatic brain injury
4. Participants using long-acting opioids such as methadone or buprenorphine for a period of five or more consecutive days prior to enrollment
5. Recent suicide attempt leading to current hospital admission or continued expressed suicidal ideation
6. Presence of devices, e.g. pace-makers, cochlear prosthesis, neuro-stimulators
7. Abnormal ear anatomy or ear infection present
8. Women of childbearing potential, not using adequate contraception as per investigator judgment or not willing to comply with contraception for the duration of the study
9. Females who are pregnant or lactating
10. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
Hepatitis B Vaccine in Patients With Inflammatory Bowel Disease

The objective is to assess the efficacy of Hepatitis B Virus vaccination in a population of IBD patients treated with immunosuppressive medications.


Eligibility Criteria:
Inclusion Criteria:

* Male/female ≥ 18 years of age
* Evidence of IBD as diagnosed by clinical, laboratory imaging and endoscopic criteria.
* Treated with at least one immunosuppressive medication at the time of study initiation
* Provided written informed consent.

Exclusion Criteria:

* Pregnant women
* Diagnosis of chronic viral hepatitis B
* Any major acute medical event in the 30 days prior to recruitment that necessitated hospitalization ( acute myocardial infarction, CVA, pulmonary emboli, sepsis, major trauma)
* Any other chronic inflammatory condition not related to IBD ( connective tissue disease, Chronic liver disease, COPD, poorly controlled diabetes mellitus)
* Active hematologic or oncologic diseases
The Effect of Walking and Grounding in Women With Breast Cancer

This randomized controlled trial was conducted to examine the effect of walking and grounding on pain intensity, fatigue level and sleep quality in women diagnosed with breast cancer.

Grounding is the flow of electrons by direct contact of the body's natural electric charge with the earth. There are many methods of grounding. Earthing systems can be used while sitting or sleeping, or the cheapest and easiest way is to walk barefoot in a grassy park, garden or beach. Earthing improves circulation by increasing blood flow and oxygenation of each organ system, positively affecting cardiovascular function. Hormones normalize, cortisol drops, blood sugar stabilizes, sleep improves, energy increases and inflammation decreases. When electrical contact between the body and the earth is re-established through grounding, organ system function begins to optimize again. When people are grounded, they feel more alive, healthy and energized than when they are ungrounded. The literature reports that human grounding has many positive effects on pain, sleep and fatigue. Grounding can be an effective method in managing pain, fatigue and sleep problems, which are among the most common problems in patients with breast cancer. Earthing is one of the biggest challenges of the modern world. City life, contact with the land The decline of the earth's energy supply, living and working indoors, and wearing plastic shoes disrupt our natural energy circuit. Although barefoot walking is the cheapest and easiest way to become grounded, dirty soil, foot This method may be a disadvantage for women with breast cancer due to conditions such as wounding of the base. In this study, a conductive device is used for grounding cancer patients by providing indirect contact with the soil.

grounding will be ensured while walking with the stick. While grounding has many positive effects on health, no grounding study was found in the literature review in the field of nursing. This study is a part of both the It is thought to positively affect the pain, fatigue and sleep problems of women with breast cancer by walking with shoes and providing grounding in order to use the positive effects of grounding.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older,
* Can read and write and speak Turkish,
* Diagnosed with primary breast cancer and know the diagnosis,
* Volunteered to participate in the research,
* Living in Ankara province,
* Paclitaxel or Paclitaxel-Transtuzumab based chemotherapy treatment initiated,
* Eastern Cooperative Oncology Group (ECOG) Scale 0 or 1,
* NCI-CTCAE v5.0 Pain, fatigue and sleep toxicity grade 1 or 2,
* You have a phone with an iOS or Android processor,

Exclusion Criteria:

* Open wounds or edema of the hands and feet,
* NCI-CTCAE v5.0 motor and sensory peripheral neuropathy with toxicity grade 3,4 or 5,
* People with a disability that would prevent them from walking,
* Diagnosed cardiovascular and pulmonary disorders,
* Diagnosed psychiatric illness,
* Communication problems,
* Bone metastases,
* Bilateral mastectomies,
Spinal Anesthesia for Cesarean Delivery is Associated With Decreases in Regional Cerebral Oxygen Saturation as Assessed by Near- Infrared Spectroscopy

The cerebral oxygen saturation is assessed by means of near-infrared spectometry in parturients undergoing cesarean delivery under spinal anesthesia. The investigators hypothesis was that spinal anesthesia does not influence cerebral oxygen saturation.


Eligibility Criteria:
Inclusion Criteria:

* Term healthy parturients

Exclusion Criteria:

* Body Mass Index \> 35
* preeclampsia
* neurological,cardiovascular, respiratory disease
Circulating MrgD in Pulmonary Hypertension

The aim of the study is to observe the change of the circulating MrgD level in patients with pulmonary hypertension compared with subjects without pulmonary hypertension.


Eligibility Criteria:
Inclusion criteria for patients with pulmonary hypertension：

1. Male or female aged ≥18 years
2. Right heart catheterisation to check the mean pulmonary artery pressure (mPAP) ≥25mmHg
3. The patient is willing and able to provide written informed consent.

Exclusion criteria for patients with pulmonary hypertension：

1. Age less than 18 years old
2. Mean pulmonary artery pressure (mPAP) \<25mmHg
3. Unable to provide informed written consent for participation in the study
4. Renal insufficiency
5. Liver insufficiency
6. Malignant tumor
7. Active infection
8. Pregnancy

Inclusion criteria for control subjects：

1. Male or female aged ≥18 years
2. No evidence of pulmonary hypertension on echocardiography or mean pulmonary artery pressure (mPAP) \< 25 mmHg on right heart catheterization, and no evidence of clinically relevant heart disease
3. No evidence of clinically relevant pulmonary disease

Exclusion criteria for control subjects：

1. Age less than 18 years old
2. Mean pulmonary artery pressure (mPAP) ≥25mmHg
3. Unable to provide informed written consent for participation in the study
4. Symptoms of heart failure or clinically relevant lung disease
5. Renal insufficiency
6. Liver insufficiency
7. Malignant tumor
8. Active infection
9. Pregnancy
IIIb 6 Week Open Label Multicentre Rosuvastatin & Simvastatin

The purpose of this study is to assess the effects on the kidney of rosuvastatin and simvastatin in subjects with Fredrickson Type IIa \& Type IIb Dyslipidaemia


Eligibility Criteria:
Inclusion Criteria:

* Fasting low density lipoprotein level as defined by the protocol.
* Fasting triglyceride level as defined by the protocol.

Exclusion Criteria:

* The use of lipid lowering drugs or dietary supplements after Visit 1.
* Active arterial disease eg Unstable angina, or recent arterial surgery
* Blood creatine levels above the limits defined in the protocol or +4 proteinuria during dietary lead in period.
* Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse.
Efficacy of Standardized-propolis Extract (EPP-AF®) Gel Formulation as Buccal Antiseptic

The purpose of this study is to evaluate the efficacy and safety of propolis on the treatment of oral candidiasis, more specifically denture stomatitis. Half of participants will receive a standardized-propolis (EPP-AF®) gel formulation while the other half will receive miconazole gel, both for oral use.


Eligibility Criteria:
Inclusion Criteria:

* Elderly patients with denture stomatitis

Exclusion Criteria:

* Recent use of anti fungals or antibiotics(2 months or less), dementia
Corneal Collagen Cross-linking With Hypotonic Riboflavin in Corneas Thinner Than 400 Microns

Corneal ectasia is a relative weakness in the structure of the cornea, which produces a progressive change in its shape which results in visual distortion. It is known that collagen cross-linking in the cornea occurs naturally with age, and in diabetes, both of which seem to prevent progressive ectasia. Corneal collagen cross-linking with riboflavin on corneas thicker than 400 microns has been shown to stabilize the cornea in keratoconus, and prevent progression of the disease.

The purpose of this study is to determine whether corneal collagen cross-linking with riboflavin in a hypotonic solution, with UV light, on corneas less than 400 microns thick, leads to stabilisation of corneal ectasia.

When cross-linking corneas of \> 400 microns, riboflavin in a solution with high molecular weight dextran T500 is used to prevent corneal swelling during the administration of the drops and the UV treatment. However if riboflavin is applied to a cornea in a hypotonic solution (saline), then transient corneal oedema is created with thickening of the corneal stroma. In this way it is thought that the temporarily thickened cornea can be treated with UV whilst still providing a sufficient thickness to absorb the UV to an extent that endothelial cell damage is avoided.

Eligibility Criteria:
Inclusion Criteria:

* Keratoconus
* Corneas thinner than 400 microns, but thicker than 250 microns

Exclusion Criteria:

* Evidence of other corneal disease in the eye to be treated (e.g., Herpes simplex keratitis)
* Women who are pregnant or nursing at the time of the initial treatment
A Double Blind Randomized Controlled Evaluation of the HBLPADD-coil Transcranial Magnetic Stimulation (TMS) Device - Efficacy and Safety In Subjects With ADHD.

Objectives:The purpose of the study is to explore the efficacy and safety of HBLPADD Coil deep brain TMS in subjects with ADHD.

Patient Population: The intention is to treat 40 patients diagnosed with ADHD. The patients will be of all racial, ethnic and gender categories, ranging from 18 to 65 years of age.

Structure: The study is a randomized, prospective, 5 weeks, double blind study. Blinding: The treatment administrator and the study personnel and patients will be masked to the treatment being administrated.

The study group will receive active dTMS treatment and the control group will receive an inactive, sham treatment


Eligibility Criteria:
Inclusion Criteria:

1. Patients between the ages of 18-65(male and female).
2. Diagnosed as suffering from Attention-Deficit Hyperactivity Disorder according to the DSM IV.
3. Patients taking medication for ADHD will give their consent to stop those medication 48 before entering the study and throughout the daily treatments.
4. Gave informed consent for participation in the study.
5. If referred by the treating psychiatrist, he or she approves of the subjects participation in the study.

Exclusion Criteria:

1. Suffering from other diagnosis on axis 1.
2. antipsychotic treatment with stabilizers; medications from the Benzodiazepines group are allowed, if need be,to a maximum dosage of 2 mg lorazepam.
3. History of lack of tolerance to TMS.
4. Axis 2 diagnosis according to the DSM IV.
5. Substantial suicidal risk as judged by the treating psychiatrist or by an independent psychiatrist.
6. Attempted suicide in the past year.
7. High and not controlled blood pressure.
8. History of epilepsy, seizure, or hot spasm.
9. History of epilepsy or seizure in first degree relatives.
10. History of a significant head injury
11. History of metal in the head (outside the mouth space).
12. Known history of any metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, surgical clips or any medical pumps.
13. Use of hearing aids for hearing loss.
14. History of frequent or severe headaches.
15. History of drug or alcohol abuse during the last year.
16. Inability to achieve satisfying level of communication with the subject.
17. Participation in current clinical study or clinical study within 30 days prior to this study
18. Patients declared as legally incompetent, with an appointed physical guardian and/or cannot sign informed consent due to cognitive incompetence.
19. Women - Pregnancy or not using a reliable method of birth control.
Effect of PCSK9 Inhibitors on Coronary Atherosclerotic Plaques Derived From Optical Coherence Tomography

The presence of coronary atherosclerotic vulnerable plaque significantly impacts the clinical outcomes of patients diagnosed with coronary artery disease (CAD). However, the influence of PCSK9 inhibitors on stabilizing coronary atherosclerotic plaques in individuals with early-onset CAD, evaluated through optical coherence tomography (OCT), remains inadequately understood. Moreover, there is a notable absence of relevant randomized controlled trials investigating this phenomenon. This current study represents a single-center, randomized, controlled, open-label trial conducted among Asian patients with early-onset CAD. Its principal objective was to explore the effects of PCSK9 inhibitors on coronary atherosclerotic plaque morphology as assessed by OCT.

Following initial percutaneous coronary intervention (PCI) for culprit lesions in patients with early-onset coronary artery disease (CAD) and ≥2 additional lesions meeting baseline lipid criteria, optical coherence tomography (OCT) was employed to evaluate non-culprit lesion sites for detailed characterization of plaque features including calcification, fibrosis, fibrolipid deposition, necrosis, minimum fibrous cap thickness (mFCT), and maximum lipid arc (MLA). Subsequently, patients were randomized in a 1:1 ratio to receive either intensive statin therapy alone or a combination of PCSK9 inhibitor with moderate-intensity statin therapy, using a random number allocation method. After 1 year of treatment and follow-up, OCT reassessment of non-culprit vessel critical lesions was conducted, documenting plaque characteristics such as calcification, fibrosis, fibrolipid content, necrosis, as well as stability parameters like mFCT and MLA at lesion sites. OCT findings were compared longitudinally within each treatment group and between groups receiving PCSK9 inhibitor combined with statin therapy versus intensive statin therapy alone. Baseline clinical profiles, biochemical markers, imaging findings, and incidence of adverse cardiovascular events during the follow-up period were also meticulously recorded for all enrolled early-onset CAD patients.

Eligibility Criteria:
Inclusion Criteria:

* Men aged 18-55 years and women aged 18-65 years;
* CAD patients with coronary angiographically confirmed lesions in ≥2 vessels; at least one vessel was critically diseased (50-70% stenosis level);
* LDL-C \>3.4 mmol/L without regular statin therapy or LDL-C \>1.8 mmol/L after 4 weeks of statin lipid-lowering therapy.

Exclusion Criteria:

* Known allergies or contraindications to PCSK9 inhibitors and/or statin therapy;
* Prior use of PCSK9 inhibitors;
* Prior history of hemorrhagic stroke;
* Prior coronary artery bypass grafting or coronary intervention;
* Inability to perform OCT imaging or unclear imaging;
* Severe renal insufficiency (creatinine clearance \< 30 mL/min);
* Severe hepatic dysfunction;
* Baseline triglycerides \> 5.6 mmol/L;
* Pregnant or lactating women;
* Life expectancy not exceeding 1 year;
* In the judgment of the investigator, unsuitable for this study for any reason.