cyrilzakka/clinical-trials huggingface dataset:
Bismuth-Metronidazole Triple Therapy for H. Pylori First-line Treatment

This randomized controlled clinical trial will compare the eradication efficacy of bismuth-metronidazole triple therapy (PPI+bismuth+ metronidazole) with that of bismuth-metronidazole quadruple therapy (PPI+bismuth+ metronidazole+ amoxicillin) for Helicobacter pylori first-line treatment. The completion of this trial will expand new therapy for the treatment of Helicobacter pylori, which can not only ensure clinical efficacy, but also reduce the use of antibiotics.


Eligibility Criteria:
Inclusion Criteria:

* Participate in the trial voluntarily, fully understand the trial, and sign the informed consent form (ICF).
* 18-75 years old on the day of signing the ICF.
* Helicobacter pylori infection confirmed by 13C-urea breath test or rapid urease test.
* Have not received Helicobacter pylori eradication treatment before.

Exclusion Criteria:

* Have received Hp eradication treatment.
* Patients with severe heart, lung, kidney, liver, blood, nerve, endocrine, and psychiatric diseases.
* Subjects or guardians refused to participate in the trial.
* Alcohol and/or drugs Abuse (addiction or dependence) or poor compliance with doctor's judgment.
* Have taken antibiotics, bismuth, PPI or Chinese traditional medicine 4 weeks before treatment.
* Pregnant or lactating women.
* Active peptic ulcer.
* allergic to drugs used in the trial.
* any other circumstances that are not suitable for recruitment.
Effects of a Smoking Cessation Program for Prison Inmates

According to WHO database, an average of 540 million people worldwide dies from smoking related diseases every year. The use of tobacco products may reduce the average life expectancy of about 15 years. The data of 2009 from Department of Health Bureau of Health showed 38.57% male adults and 4.75% female adults smoked in Taiwan. Studies about smoking rate within prison inmates were between 64-91.8%, which was over 3 times than the general population. Smoking cessation can lower the risks of smoking related health problems. Two thirds of smokers in Taiwan once tried smoking cessation but the success rate was about 5% every year.

In view of high smoking rate within prison inmates in Taiwan, Agency of Correction, Ministry of Justice announced a smoking cessation program for inmates in April 2010. The purpose of this study was to investigate the effects of this program and the difference of cessation success rate between various interventional methods, using questionnaires for smokers and smoking cessation clinics database.


Eligibility Criteria:
Inclusion Criteria:

* Prison inmates with age equal or more than 20 years old and have smoked for equal or more than one year
Molecular Breast Imaging in Screening Breast Cancer

The molecular breast imaging (MBI) is a potential modality to screen breast cancer. In this study, we compare and evaluate the recall rate/diagnostic efficiency of MBI, mammography and breast sonography, and aim to determine best ways of breast cancer screening.

Keywords: molecular breast imaging, MBI, breast cancer, mammography, sonography

1. Background: In breast cancer screening, the sensitivity of mammography is about 71-96 %, but the sensitivity decreases in the three following groups: (1) under 50 years old; (2) dense breast parenchyma; (3) higher risk of breast cancer. The Health and Welfare Ministry data in recent 2 years showed Taiwanese women accepted mammography for screening in the ratio of only about 36%, representing many missed opportunities for early detection. One reason to reject mammography may be the discomfort caused by compression. To solve the above mammography possible weakness, other screening methods came into being, such as molecular breast imaging (MBI) of nuclear medicine. Radiotracer of Tc-99m sestamibi was found for targeting breast tumor 20 years ago, and approved by the FDA in 1997. However, the application is limited due to the suboptimal scanning camera design. Ten years later, the Mayo Clinics developed MBI technology, using small-sized semiconductor detectors. Then it become possible that the nuclear technologist have patient's breast tissue fit the detector in almost the same fashion of mammography without heavy compression.
2. Objective: The aim of this study is to evaluate the recall rate and diagnostic accuracy of MBI, mammography and breast echo, for female population.
3. Study design: Female patients referred to Nuclear Medicine Department for myocardial perfusion scan will be recruited in this study. It is because that MBI and myocardial perfusion scan share the same radiotracer. Then MBI will become additional scanning only. About 1800 female subjects will involve, and further mammography and/or breast sonography will be arranged within 6 months after MBI. Participants will be encouraged to receive mammography every 2 years and telephone survey. We hope that this study will help us to compare and evaluate the recall rate/diagnostic efficiency of MBI, mammography and breast sonography, and to determine best ways of breast cancer screening.

Eligibility Criteria:
Inclusion Criteria:

* Female patients undergoing myocardial perfusion imaging will be eligible if they sign the informed consent.

Exclusion Criteria:

* They are unable to understand and sign the consent form
* They are physically unable to sit upright and still for 20 minutes.
* They have undergone breast surgery or breast biopsy within the last 12 months.
* They have had trauma to the breast tissue or undergone radiation treatment to the breast within the last 12 months.
Evaluating Short-term Effects of Computerized Brain Fitness Exercises in Adult Cochlear Implant and/or Hearing Aid Users

In this study we are testing computer-based brain fitness exercises. The games are designed to improve people's cognitive abilities brain functions, like memory, concentration, and ability to do two things at once. We are testing whether this cognitive training brain exercises will improve understanding of spoken sentences speech comprehension in people who use cochlear implant and/or hearing aids. We predict that cognitive training will improve speech comprehension in cochlear implant and/or hearing aid users.

Aural rehabilitation is a life long process in spite of advanced innovative implant technology. Existing standard therapy is inadequate for some people, because even after years of surgery many implant users does not obtain significant benefits, like improved understanding of spoken sentences. In many cases it seems that the speech comprehension deficits are linked to particular cognitive functions in cochlear implant users, including memory and attention. In this study we will test whether a computer-based set of "cognitive fitness" or "brain training" games designed to improve memory and attention will help cochlear implant and hearing aid users to understand speech better.

Cochlear implant and hearing aid users will complete 10 weeks of computer-based cognitive training on their home computers. Half of participants will do this training immediately after being enrolled in the study; the other half will receive the training beginning 10 weeks after they are enrolled. Speech comprehension and cognitive abilities will be assessed at baseline, 10, 20 and 30 weeks in all participants.

Eligibility Criteria:
Inclusion Criteria:

* Adult cochlear implant users, and/or people with moderate/severe hearing loss using bilateral hearing aids, aged 19 or above
* Access to an internet-connect device that supports flash, and basic computer skills
* Medically stable patients

Exclusion Criteria:

* Patients with epilepsy, severe visual and cognitive difficulties, chronic fatigue syndrome, and serious co-morbid conditions which could be exacerbated by the computer training games will be excluded for safety reasons.
* Patients who are unlikely to adhere to the intervention due to dementia, Parkinson's disease, Parkinson-plus syndrome, movement disorders or disability that would impair the person's ability to perform the training (e.g., problems with attention, alertness, or learning disorders)
* Participants who cannot speak English (since study materials are only in English), or unable to give consent.
Study of CB-839 in Combination w/ Paclitaxel in Participants of African Ancestry and Non-African Ancestry With Advanced Triple Negative Breast Cancer (TNBC)

CX-839-007 is an open-label Phase 2 study of the combination of CB-839 with paclitaxel in participants of African ancestry and non-African ancestry with advanced triple negative breast cancer. Multiple single-arm cohorts will be enrolled in which 800 mg twice daily (BID) CB-839 will be administered in combination with the full approved dose of paclitaxel.

Participants will be enrolled into 4 cohorts, as follows:

* Cohort 1: patients of African ancestry with 2 or more lines of prior therapy for metastatic disease
* Cohort 2: patients of African ancestry with no prior lines of therapy for metastatic disease
* Cohort 3: same as cohort 1 but in patients of non-African ancestry
* Cohort 4: same as cohort 2 but in patients of non-African ancestry

Eligibility Criteria:
Key Inclusion Criteria:

* Meets criteria for 1 of the 4 defined study cohorts
* TNBC, defined as estrogen receptor (ER) and progesterone receptor (PR) negative (\< 1% by immunohistochemistry) and human epidermal growth factor receptor 2 (HER2)-negative (immunohistochemistry 0 to 1+ or fluorescence in situ hybridization \[FISH\] negative)
* Metastatic disease or locally-advanced disease not amenable to curative intent treatment
* Adequate hepatic, renal, cardiac, and hematologic function
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Recovery to baseline or ≤ Grade 1 Common Terminology Criteria for Adverse Events (CTCAE) version.4.0

Key Exclusion Criteria:

* Known brain metastases or central nervous system (CNS) cancer unless adequately treated with radiotherapy and/or surgery and stable for ≥ 2 mo
* Unable to receive oral medications
* Known hypersensitivity to Cremophor®-based agents
* Major surgery within 28 days of Cycle 1 Day 1
Safety and Immunogenicity of V540B in Healthy Adults (V540B-002).

Researchers are looking for new ways to prevent cancers related to human papillomavirus (HPV). HPV is a common virus that can cause an infection. There are many different types of HPV. Most people's immune system can fight HPV infection and it goes away without treatment. For some people, HPV infections can last longer and may cause cancer years later.

A standard vaccine to prevent HPV-related cancers is GARDASIL®9 (G9). G9 protects against 9 types of HPV but it does not protect against other types of HPV. The study vaccine (called V540B) is designed to protect against the same HPV types that G9 protects against plus other HPV types. The main goal of this study is to learn about the safety of V540B in healthy adults and if people tolerate it.


Eligibility Criteria:
Inclusion Criteria:

The key inclusion criteria include but are not limited to the following:

* Is in good health based on medical history, physical examination, vital sign (VS) measurements and electrocardiograms (ECGs) performed before randomization.

Exclusion Criteria:

The key exclusion criteria include but are not limited to the following:

* Has a history of abnormal Pap smears, HPV- related external genital lesions (eg,condyloma acuminate, vulval intraepithelial neoplasia (VIN), or prostatic intraepithelial neoplasia (PIN)) or external genital cancer (eg, penile cancer), HPV-related vaginal or anal lesions (eg, condyloma acuminata or vaginal intraepithelial neoplasia (VaIN)) or vaginal or anal cancer.
* Has a history of cancer (malignancy).
* Has received any HPV vaccine or is expected to receive any HPV vaccine during the study, outside the protocol.
Dynamic Contrast Enhanced Ultrasound for Predict and Assess Rectal Cancer Response After Neo-adjuvant Chemoradiation - RECT

In recent years the concept of organ sparing treatment in rectal cancer was introduced for selected good responders after neo-adjuvant treatment. In these patients replacement of the standard of care total mesorectal excision (TME) by transanal endoscopic microsurgery (TEM) or omission of surgery after chemoradiation (CRT) was proposed. Before organ sparing treatments could be applied in clinical practice a reliable patient selection procedure has to be available as only good treatment responders after neo-adjuvant therapy are candidates for such adapted therapy. Different imaging modalities have been studied for their ability to distinguish good treatment responders from others. Examples of such imaging modalities with some promising results regarding response assessment are fludeoxyglucosepositron emission tomography (FDG-PET), T2-weighted magnetic resonance imaging (T2w-MRI), dynamic contrast enhanced magnetic resonance imaging and diffusion weighted MR imaging (DW-MRI). Besides these modalities dynamic contrast enhanced ultrasound (D-CEUS) is a new modality used for tissue characterization and therapy response assessment in several tumor locations, like liver tumors and breast cancer. D-CEUS reflect tissue vascular perfusion. For rectal cancer, the value of D-CEUS for pathological response prediction and assessment has never been assessed. Therefore, in this study we assessed D-CEUS to predict and assess pathological response in rectal cancer after neo-adjuvant CRT.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed rectal carcinoma
* Stade ≥T2 and tumor size ≥3cm
* No detectable metastases
* Patient ≥ 18 years
* Patient information and written informed consent form signed
* Patient who can receive radiotherapy and chemotherapy
* Negative pregnancy test in women of childbearing potential
* Patient covered by a Social Security system

Exclusion Criteria:

* Indication for immediate surgery
* Primary tumor not measured at the MRI before inclusion
* Previous pelvic radiotherapy
* Contraindication to SONOVUE or MRI
Fluoroscopy Versus Ultrasound Guidance for Sacral Lateral Branch Radiofrequency Ablation

Sacroiliac joint is a diarthroidal and synovial joint that receives sensory innervatin by the sacral lateral branches ( commonly S1-3, with variable contributions from L5 dorsal ramus and S4 lateral branch). Sacral lateral branch radiofrequency ablation and block techniques are widely used for the management of sacroiliac joint pain. With the increasing use of ultrasound technology in pain medicine, the ultrasound guided approaches gained popularity. To our knowledge, there are no randomized controlled trials comparing the ultrasound and fluoroscopy approaches for sacral lateral branch radiofrequency ablation. This study aims to compare the ultrasound and fluoroscopy guidance techniques for sacral lateral branch radiofrequency ablation.


Eligibility Criteria:
Inclusion Criteria:

* Low back pain due to sacroiliac joint dysfunction \>6 months with a score ≥ 4 on a numeric rating scale.

  * 50% pain relief after prognostic sacral lateral branch block
* At least 3 positive physical examination maneuvers \[ Faber ( flexioni abduction and external rotation), POSH (posteripr shear), REAB ( resisted abduction), Gaenslen's test, Distraction test\]
* Refractory to conservative therapy

Exclusion Criteria: The exclusion criteria were;

* Uncontrolled psychiatric or neurological illness
* Sacroiliac joint pain due to other disorders,
* Lumbar radiculopathy
* Rheumatological diseases
* Systemic active infections
* Malignancies, previous surgery on the affected sacroiliac joint,
* History of traumatic hip injury,
* History of bleeding disorders,
* Platelet values \< 150.000 / µl,
* Sacroiliac joint injection within the preceding 3 months,
* Allergy to local anesthetics and steroids,
* Pregnancy, inability to concent, Implanted pacemaker or defibrilator.
Instructed Home-based Physical Exercise for Patients With Liver Cirrhosis

The study will compare two forms of advice regarding physical activity for patients hospitalized with cirrhosis that are preparing for leaving the hospital. One arm consists of current standard of care: simple oral advice on exercise. One arm instead gives patients a structured but simple paper template on physical activity.


Eligibility Criteria:
Inclusion Criteria:

* Liver cirrhosis diagnosed with previous clinical assessment and radiology (de-formed liver, noduli, varices, collaterals, splenomegaly \>12 cm) or with biopsy (fibrosis grade 4). ICD-code K70.3, K74.6.
* MELD \< 25
* Understanding the Swedish language.
* Signed informed consent.

Exclusion Criteria:

* Performance status ≥3.
* Severe pain which prevents the patient to perform the physical activities, as judged by the attending physician at time of discharge.
* Previously liver transplanted
* Unlikely to be compliant to follow-up (living in other parts of Sweden), as judged by the attending physician at time of discharge.
Effects of Percutaneous Coronary Intervention in Patients With Cardiac Arrest After Acute Myocardial Infarction: a 2-Year Study

The purpose of this study is To assess percutaneous coronary intervention 's effect on short- and long- term outcomes, and complication incidence in resuscitated victims of cardiac arrest after acute myocardial infarction


Eligibility Criteria:
Inclusion Criteria:

* underwent successful cardiopulmonary resuscitation from CA after AMI

Exclusion Criteria:

* late tumor;
* underwent Coronary Artery Bypass Grafting after CAG;
* with no attempted resuscitation.
Tin Filter Calcium Scoring

The aim of this study is to prospectively investigate the diagnostic performance and potential radiation dose reduction in coronary artery calcium scoring using the new tin filter system of the 3rd generation DSCT scanner.


Eligibility Criteria:
Inclusion Criteria:

* Subject must be between 19-90 years of age.
* Subject must have been referred for a clinically indicated coronary artery calcium scan and/or coronary CT angiography or TRO scan with coronary artery calcium scoring.
* Subject must provide written informed consent prior to any study-related procedures being performed.
* Subject must be willing to comply with all clinical study procedures.

Exclusion Criteria:

* Subject is a pregnant or nursing female. Exclude the possibility of pregnancy:
* By testing (urine BHCG) within 24 hours before scan, or
* By surgical sterilization, or
* Post menopausal, with minimum one (1) year history without menses.
* Subject has an acute psychiatric disorder or is cognitively impaired.
* Subject is using or is dependent on substances of abuse.
* Subject is unwilling to comply with the requirements of the protocol.
* Subject is in acute unstable condition.
Chronic Pain Master Protocol (CPMP): A Study of LY3526318 in Participants With Diabetic Peripheral Neuropathic Pain

The purpose of this study is to test the safety and efficacy of study drug LY3526318 for the treatment of diabetic peripheral neuropathic pain (DPNP). This trial is part of the chronic pain master protocol H0P-MC-CPMP (NCT05986292) which is a protocol to accelerate the development of new treatments for chronic pain.


Eligibility Criteria:
Inclusion Criteria:

* Have a visual analog scale (VAS) pain value ≥40 and \<95 during screening.
* Have a history of daily pain for at least 12 weeks based on participant report or medical history.
* Have a body mass index \<40 kilograms per meter squared (kg/m²) (inclusive).
* Are willing to maintain a consistent regimen of any ongoing nonpharmacologic pain-relieving therapies (for example, physical therapy) and will not start any new nonpharmacologic pain-relieving therapies during study participation.
* Are willing to discontinue all pain medications taken for chronic pain conditions for the duration of the study.
* Have daily symmetrical foot pain secondary to peripheral neuropathy present for at least 6 months and as diagnosed through use of the Michigan Neuropathy Screening Instrument Part B ≥3 (©University of Michigan).
* Have a history and current diagnosis of type 1 or type 2 diabetes mellitus.
* Have stable glycemic control as indicated by a glycated hemoglobin ≤11 at time of screening.
* Are men, or women able to abide by reproductive and contraceptive requirements.

Exclusion Criteria:

* Have had a procedure within the past 6 months intended to product permanent sensory loss in the target area of interest (for example, ablation techniques).
* Have surgery planned during the study for any reason, related or not the disease state under evaluation.
* Have, in the judgment of the investigator, an acute, serious, or unstable medical condition or a history or presence of any other medical illness that would preclude study participation.
* Have a substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (5th edition; DSM-5; American Psychiatric Association).
* Have had cancer within 2 years of baseline, except for cutaneous basal cell or squamous cell carcinoma resolved by excision.
* Have fibromyalgia
* Are, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide.
* Have a positive human immunodeficiency virus (HIV) test result at screening.
* Have an intolerance to acetaminophen or paracetamol or any of its excipients.
* Have a history of alcohol, illicit drug, analgesic or narcotic use disorder within 2 years prior to screening.
* Have a current drug-induced neuropathy, for example, due to some types of chemotherapy, or other types of peripheral neuropathy.
* Have known hereditary motor, sensory or autonomic neuropathies.
* Are pregnant or breastfeeding.
Furosemide Stress Test to Predict Successful Liberation From RRT

The proposed study will evaluate if a standardised dose of furosemide administered in the 12 hours after RRT liberation can predict successful liberation in critically ill patients. The dose that will be administered is in accordance with the prescribing information.

Response to furosemide administration is commonly used in clinical practice to assess a patient's potential for RRT liberation. However, this administration is not standardized and practices varies greatly. Rapid recognition of unsuccessful RRT liberation is crucial to avoid further complications such as fluid overload or acid-base and electrolyte disorders. The FST corresponds to the intravenous administration of 1 mg/kg (1.5 mg/kg in previously exposed patients) of furosemide and the assessment of resulting diuresis in the following two hours. FST is able to predict progression from AKI stage I and II to stage III with a high sensitivity (87.1%) and specificity (84.1%), area under the ROC curve 0.87. However, the ability of FST to predict RRT liberation has never been formally assessed.

Eligibility Criteria:
Inclusion Criteria:

* Receiving continuous or intermittent RRT for AKI
* Having an indwelling urinary catheter
* Clinical decision by physician in charge to attempt RRT liberation
* lnformed consent signed by the patient himself / legal representative or authorization received from independent physician

Exclusion Criteria:

* Electrolyte disturbances or hemodynamic instability precluding the use of furosemide (sodium \> 155 mmol/L and/or potassium \< 3.0 mmol/L and/or metabolic alkalosis \> 7.50 and/or mean arterial pressure \< 60 mmHg)
* Known furosemide allergy
* Urine output ≥ 100 mL/h for at least two hours
* Recent (\< 24 hours) FST
* Known end-stage chronic renal disease at ICU admission
* Withdrawal of life support decision taken before inclusion
* Patient already participating in conflicting research study
* Patient having already participated in this current study
* Any other contraindication of furosemide